AESGP Euro OTC News

Issue 292 | May—June 2017

Medicines

Regulatory News

▪ SMEs 3

▪ BREXIT 5

▪ Notes of CMDh-IP meeting on 16 May 6

▪ CMDh February 2017 Minutes 7

▪ CMDh March 2017 Minutes 7

▪ CMDh April 2017 Report 8

▪ HMA-EMA Big Data Workshop

– 27 June 2017 10

▪ EMA Management Board – Minutes

from March 2017 meeting 11

▪ EMA 2016 Annual Report 12

▪ EMA CHMP - Work Plan 2017 12

▪ EMA Report on CHMP Pilot Project on

the involvement of patients in discussions

on benefits & risks of medicines 13

▪ Environment 14

▪ Documents for comments 14

Pharmacovigilance

▪ Official launch of the enhanced EudraVigilance

system 15

▪ PRAC meetings 16

Herbal News

▪ Final Public Statements on Paeoniae radix

alba & Paeoniae radix rubra 16

▪ Documents for comments 17

Homeopathic News

▪ Regulation (EU) 2017/852 of the European

Parliament and of the Council of 17 May 2017

on mercury, and repealing Regulation (EC)

No 1102/2008 17

AESGP 53rd Annual Meeting

Conference Report included

Self-Care in a Changing World

30 May—1 June 2017, Vienna

EFSA

▪ EFSA Summary of the 2016 Data Collection

on Contaminant Occurrence Data 18

▪ EFSA Guidance on the risk assessment of

substances present in food intended for

infants below 16 weeks of age 18

DRV’s

▪ Public consultation on EFSA Scientific

Opinion on DRVs for riboflavin 19

Food Additives

▪ EFSA Re-evaluation of fatty acids (E 570)

as a food additive 20

▪ EFSA Re-evaluation of sorbitan monostearate

(E 491), sorbitan tristearate (E 492), sorbitan

monolaurate (E 493), sorbitan monooleate

(E 494) and sorbitan monopalmitate (E 495) 21

▪ EFSA statement on validity of conclusions

of mouse carcinogenicity study on

sucralose (E 955) 22

▪ Update on food supplements for infants

and young children 22

▪ Update on the reevaluation of iron

oxides (E 172) 23

▪ Reevaluation of Propyl gallate (E 310), Octyl

gallate (E 311) and Dodecyl gallate (E 312)

– Call for data 24

Food Supplements

▪ Maximum amounts for vitamins and minerals -

EU Court Judgment clarifying conditions under

which EU Member States are entitled to set

their own limits 24

▪ Belgium notifies amendment regarding

substances other than nutrients and

plants or plant 25

▪ Italy - Updated guidelines on nutrients and

other substances 26

Novel Food

▪ EFSA updated opinion on safety of

EstroG-100™ (extract of a mixture of three

herbal roots) 26

▪ EFSA opinion on alginate-konjac-xanthan

polysaccharide complex (PGX) 26

▪ EFSA opinion on cranberry extract powder 27

Health Claims

▪ EFSA opinion on Condensyl® and decreases

sperm DNA damage which is a risk factor for

male infertility 27

▪ EFSA Opinion on Curcumin and the normal

functioning of joints 28

Food

2 AESGP Euro OTC News | Issue 292

Medical Devices Regulation

▪ Regulation (EU) 2017/745 published on

5 May 2017 29

Cranberry Products

▪ Committee on Medical Devices voted on

draft decision on 19 May 2017 29

▪ AESGP comments on the JRC process for

developing device-specific guidance

documents (DSG) 30

▪ AESGP Medical Devices Committee

meeting on 2 June 2017 in Vienna 30

Medical Devices

3 AESGP Euro OTC News | Issue 292

Medicines

Regulatory News

■ SMEs

The Directorate-Generate (DG) for Internal Market, In-

dustry, Entrepreneurship and SMEs from the European

Commission has published an inception impact assess-

ment concerning the revision of the EU SME definition

for a 4-week consultation i.e. until 6 July 2017.

Inception Impact Assessments aim to inform stakehold-

ers about the Commission's work in order to allow them

to provide feedback on the intended initiative and to

participate effectively in future consultation activities.

Stakeholders are in particular invited to provide views

on the Commission's understanding of the problem and

possible solutions and to make available any relevant

information that they may have, including on the possi-

ble impacts of the different options.

The SME definition, as provided in Recommendation

2003/3618/EC is the structural tool to identify those

enterprises which are confronted with market failures

and particular challenges (e.g. access to finance) due to

their size, and therefore are allowed to receive preferen-

tial treatment in public support. It is a widely used tool

in EU policies and is relevant in the context of some Eu-

ropean administrative exemptions and reduced fees,

such as for the REACH regulation of chemicals. Current-

ly, around 100 EU legal acts contain a reference to the

SME definition.

The Commission works to create favourable framework

conditions for SMEs through their consideration across

all relevant policy fields and through its support pro-

grammes considering the importance of those compa-

nies for the economy and their specific, size-related dif-

ficulties.

The Recommendation in its general structure and scope

has been confirmed at several instances. However, over

time, some specific issues have been identified. They will

be assessed against the current business and financing

environment in the context of the evaluation of the per-

formance of the Recommendation.

Such concerns mainly relate to:

Financial thresholds: The current financial thresholds

(annual turnover and balance sheet total) were set in

2003 when the Recommendation was adopted. The

above-mentioned reports considered an update of

these thresholds not yet warranted. The thresholds set

by the Recommendation could lead to certain lock-in

effects that would discourage SMEs to scale-up by

fear of losing the support that the SME status pro-

vides. European SME associations claim that approxi-

mately 70% of SMEs prefer to maintain the SME status

rather than growing fast and thus creating growth and

jobs.

Legal certainty: On 15 September 2016, the Court of

Justice ruled on 2 cases against administrative deci-

sions of ECHA (European Chemicals Agency) involving

the SME definition and, more precisely, the independ-

ence of enterprises (Art. 6). The Rulings brought to the

Commission's attention that the said article is not for-

mulated in a clear way and can, in practice, lead to

granting the status of SMEs to groups of enterprises

whose real economic power exceeds that of genuine

SMEs. In addition, twelve years of implementing this

Recommendation has shown that a number of con-

4 AESGP Euro OTC News | Issue 292

cepts used in the text could be better described or

clarified in order to leave less room for interpretation

and thus simplify the practical application of the defi-

nition.

The overall objectives of the inception impact assess-

ment are to:

Ensure that available support and special measures to

reduce administrative burden are focusing on those

enterprises that are most in need of it.

Increase business predictability and legal certainty for

enterprises by making the SME definition clearer and

leave less room for interpretation.

Create a level playing field for EU-based SMEs within

the Internal Market by fostering equal treatment for

SMEs throughout the EU with regard to their access to

public support and finance.

The specific objectives are to:

ensure that the SME definition is fit for purpose and is

updated to the current economic conditions.

provide clear legal certainty and avoid companies

that in practice do not face the difficulties of typical

SMES to use loopholes in the definition to benefit

from SME status.

ensure that sector-specific particularities are suffi-

ciently considered when identifying SMEs.

The retrospective evaluation will assess to what extent

the Recommendation is fit for purpose and, on the basis

of the results, the Commission might decide to adapt

the legal text to take into account the current economic

and legal situation as well as solve the issues the evalu-

ation will have detected, if appropriate.

The following options could be considered:

Option 1: Baseline scenario: no change to the Recom-

mendation (i.e. the Court Judgement applies).

Option 2: A targeted intervention to keep the SME

definition up-to-date with economic developments,

enhance its user-friendliness and the legal certainty it

provides to enterprises.

Without prejudging the results of the retrospective

evaluation, possible sub-options are:

Adapt the financial thresholds included in the defini-

tion: turnover, balance sheet total, participation of

business angels, and budget of local public entities;

Clarify the wording and concepts, particularly in art. 6

to better reflect its original purpose to identify enter-

prises that are part of a larger group;

Introduce additional considerations to the benefit of

start-ups and scale-ups could also be envisaged.

These could, inter alia, concern enhanced participation

of venture capital or extension of the 2-year period

during which scale-ups would still maintain the SME

status.

Other options could be considered, based on the out-

come of the evaluation and/or public consultation.

Under option 2, in addition to revising the SME defini-

tion, Omnibus Act(s) would be prepared to amend the

legal acts that refer to the Recommendation.

The online tools that are currently available for enter-

prises to do a self-assessment or apply for funds or

grants, will be updated according to the chosen option.

An evaluation and an impact assessment will be pre-

pared "back-to-back" to support this initiative and to

inform the Commission's decision on the options. The

results of an external study will feed into both exercises.

The formal open online public consultation of 12 weeks

on the issues, objectives and policy options set out

above will be launched early 2018.

Additional input will be gathered through surveys and

interviews, and bilateral ad hoc contacts with key stake-

holders, representative business associations and Mem-

ber States' competent administrations

Stakeholders' input will be used both in the evaluation

and in the impact assessment of the policy options that

will be carried out back-to-back. The Commission will

report on the feedback received through the various

consultation activities.

Position papers of business associations and other

stakeholders will be taken into account.

5 AESGP Euro OTC News | Issue 292

On its side, the EMA published an Action plan for small

and medium-sized enterprises (SMEs) aiming to foster

innovation and support SMEs in the development of

novel human and veterinary medicines.

The action plan, which builds on the experience gained

and addresses the challenges identified by SMEs in a

report published by EMA on the 10th Anniversary of the

SME initiative, also takes into account EMA’s

new framework for collaboration with academia and the

new EU Innovation Network.

The plan covers four key areas and lists a series of new

and enhanced actions:

Awareness of EMA’s SME initiative: actions include

stepped-up engagement with actors in the pharma-

ceutical innovation environment such as incubators,

universities and investors.

Training and education: actions include training for

SMEs and academia, and expanding the EU Network

Training Centre.

Support the development of innovative medi-

cines: actions include maximising the use by SMEs of

regulatory tools to support the development of and

access to medicines for unmet medical needs; provid-

ing assistance to academia; and enhancing coopera-

tion with EU partners on projects subject to EU fund-

ing.

Engagement with SMEs, EU partners and stakehold-

ers: actions include contributing to the development

of the EU Innovation Network, EU initiatives support-

ing SMEs and start-ups in relation to funding and ad-

ministrative burden (Europe's next leaders: the Start-

up and Scale-up Initiative), and interacting with inter-

national regulatory authorities.

The EMA has also published its SME office 2016 annual

report which provides an overview of SME-related activ-

ities in 2016 and highlights incentives and platforms

that SMEs can leverage to advance innovative develop-

ments and regulatory strategies.

■ BREXIT

The EMA organised an information meeting with mem-

bers of its Management Board and heads of the Nation-

al Competent Authorities (NCAs) of the EU/EEA Member

States. The goal was to start discussing how the work

related to the evaluation and monitoring of medicines

will be shared between the Member States in view of

the United Kingdom’s (UK) withdrawal from the Europe-

an Union.

Although negotiations on the terms of the UK's depar-

ture have not yet officially commenced and one cannot

prejudge their outcome, work will now start on the basis

of the scenario that foresees that the UK will no longer

participate in the work of EMA and the European medi-

cines regulatory system as of 30 March 2019.

General principles for workload distribution will include:

ensuring business continuity;

maintaining the quality and robustness of the scien-

tific assessment;

continuing to comply with legal timelines;

ensuring knowledge retention, either by building on

existing knowledge or through knowledge transfer;

assuring an easy implementation and medium- and

long-term sustainability.

It is expected that all National Competent Authorities

(NCAs) will contribute to EMA activities as per the ca-

pacity and capability of each authority, to ensure an

optimised and robust allocation of the workload across

the network.

The envisaged working methodology will include a

mapping of current and future capacity and expertise in

the network and the identification of potential gaps.

This could help the network to increase its capacity in

selected areas and would be supported with enhanced

training opportunities.

Based on the general principles, EMA, its scientific com-

mittees and working parties, together with the NCAs,

will now assess the different options for workload distri-

bution. A follow-up meeting will take place on 5 July

2017.

The press release is available here.

6 AESGP Euro OTC News | Issue 292

The European Commission and EMA have published a

Notice to marketing authorisation holders of centrally

authorised medicinal products for human and veterinary

use, to remind them of their legal obligations in prepa-

ration for Brexit.

The United Kingdom submitted on 29 March 2017 the

notification of its intention to withdraw from the Union

pursuant to Article 50 of the Treaty on European Union.

This means that unless the withdrawal agreement estab-

lishes another date or the period is extended by the Eu-

ropean Council in accordance with Article 50(3) of the

Treaty on European Union, all Union primary and sec-

ondary law ceases to apply to the United Kingdom from

30 March 2019, 00:00h (CET). The United Kingdom will

then become a 'third country'.

In this regard, marketing authorisation holders of cen-

trally authorised medicinal products for human and vet-

erinary use are reminded of certain legal repercussions,

which need to be considered:

EU law requires that marketing authorisation holders

are established in the EU (or EEA);

Some activities must be performed in the EU (or EEA),

related for example to pharmacovigilance, batch re-

lease etc.

Preparing for the withdrawal is therefore not just a mat-

ter for European and national administrations, but also

for private parties. Marketing authorisation holders may

be required to adapt processes and to consider changes

to the terms of the marketing authorisation in order to

ensure its continuous validity and exploitation, once the

United Kingdom has left the Union. Marketing authori-

sation holders will need to act sufficiently in advance to

avoid any impact on the continuous supply of medicines

for human and veterinary use within the European Un-

ion.

In particular, the Commission and the European Medi-

cines Agency expect marketing authorisation holders to

prepare and proactively screen authorisations they hold

for the need for any changes. The necessary transfer or

variation requests will need to be submitted in due time

considering the procedural timelines foreseen in the

regulatory framework.

The EMA and the European Commission have published

guidance – in the form of a questions-and–answers doc-

ument – to help pharmaceutical companies prepare for

the United Kingdom's withdrawal from the European

Union.

The guidance relates to both human and veterinary

medicines and concerns information related to the loca-

tion of establishment of a company in the context

of centralised procedures and certain activities, includ-

ing the location of orphan designation holders, qualified

persons for pharmacovigilance (QPPVs) and companies’

manufacturing and batch release sites.

The EMA is preparing a series of further guidance docu-

ments which will be published on EMA’s dedicated

webpage on the consequences of Brexit.

■ Notes of CMDh-IP meeting on 16 May

Five AESGP delegates participated in the joint CMDh-

Industry meeting at the EMA premises in London on 16

May 2017.

On the topic of ‘agreeing the name of the products dur-

ing the procedure’, the CMDh stated that the CMDv

approach could not be taken up and that it was up to

the applicant to try and find an agreement on the name

with the competent authority during the European

phase of the MRP-DCP also taking advantage of the

clock-stop.

On the pilot on merger and splitting, the CMDh ex-

pressed its disappointment concerning the lack of pre-

paredness from the industry (the cases were not good

candidates for the pilot). The CMDh door is not closed

but their expectations were clearly not met.

There was a very long discussion concerning Brexit and

how to best prepare for the unknown. The UK is not

giving signs to endorse any of the existing scenari and

therefore a hard Brexit is likely. Marketing Authorisation

Holders (MAHs) have to get ready and prepare their

contingency plans. If the UK is the RMS, then the RMS

has to be transferred to one of the CMSs of the proce-

dure; if no CMSs agree to become the RMS, the CMDh

can be contacted. The guidance on the change of RMS

has been updated for this purpose as will be the case

7 AESGP Euro OTC News | Issue 292

for the variation grouping guideline. The transition peri-

od is the negotiation time; no other transition period is

foreseen.

The other topics for discussion included the availability

issue of paediatric medicines, the implementation of the

falsified medicines directive and e-submissions.

■ CMDh February 2017 Minutes

Brexit

The Chair presented a draft CMDh Brexit White paper.

The discussion aimed to collect a list of tasks to be ad-

dressed and to assess the impact on the workload with-

in the network to ease resource planning. Member

states were invited to comment on the document. The

CMDh agreed to have a monthly updated list with on-

going procedures in the Communication Tracking Sys-

tem (CTS). The UK stated that it will complete the as-

sessment of all applications for which it is acting as RMS

and which have not been finalised when the Article 50

procedure concludes.

OTC miconazole oral gel – contraindication with

Warfarin

UK informed the CMDh of their intention to contraindi-

cate OTC miconazole oral gel containing products in

patients taking warfarin, in view of reports of serious

bleeding events in patients taking OTC miconazole oral

gel and warfarin concomitantly. The CMDh agreed that

the introduction of the contraindication is only relevant

to the OTC supply of miconazole oral gel in the UK, as

the interaction is well known and it is already included

in warfarin-containing products.

■ CMDh March 2017 Minutes

The outcome of the meeting discussions was highly

relevant for the self-care sector.

First the report of the Maltese delegates of the HMA/

AESGP meeting held in Malta on 20-21 February 2017

was noted. The CMDh members were informed about

the discussed topics on the HMA agenda and the rele-

vant updates from the meeting discussions.

The EMA then relayed the information given at the

AESGP/HMA February meeting in Malta on the Joint

EMA/CMDh Multi-stakeholder Scientific Advice proce-

dure for OTC switches. The HMA had already en-

dorsed the initiative as a principle with details to be

further discussed with Member States.

The proposal aims to use the current existing Scientific

Advice procedure. This initiative falls under the HMA/

EMA Network Strategy to 2020 objective ‘Ensure time-

ly access to new beneficial and safe medicines for pa-

tients’, to apply the most appropriate legal classifica-

tion to products, to ensure that the mechanisms for

allowing those that can be safely reclassified as non-

prescription medicines are in place, effective and be-

ing used, thereby improving patient access.

A Workshop with stakeholders is intended to be or-

ganised in the second half of 2017 to discuss the ex-

pectations from regulators and industry, the composi-

tion and functioning of the OTC expert forum and

how to effectively run a joint EMA/CMDh multi-

stakeholder Scientific Advice Procedure.

The CMDh will further explore these concepts in the

Non-Prescription Medicinal Products Task Force.

The Chair of the Non-Prescription Medicinal Products

Task Force reported that two case studies where the

Brass model was used were discussed. The TF noted

that the model may be useful for companies in the

selection of products that may be suitable for non-

prescription supply. However, the TF also noted that

applications (marketing authorisations or variations)

proposing non-prescription supply also need to take

into account the existing Commission guidance for

changing supply classification.

Dr Martin Huber (BfArM/Germany) was elected at the CMDh

May 2017 meeting as Chair of the Non-Prescription Medicinal

Products Task Force in replacement of Virginie Bacquet (ANSM/

France). Dr Huber also represents BfArM in the EMA Pharma-

covigilance Risk Assessment Committee (PRAC) and is the head of

unit ‘PRAC and other committees’ at BfArM. He previously was a

pharmacovigilance assessor.

!

8 AESGP Euro OTC News | Issue 292

The TF received a presentation on the task performed

by the EDQM Committee of Experts on the classification

of medicines as regards their supply.

The CMDh nominated Peter Bachmann and Sophie

Colyn as CMDh representatives in Regulatory Optimisa-

tion Group (ROG). The CMDh discussed the need for

back-ups of the CMDh representatives and nominated

four CMDh members as back-ups in case the above rep-

resentatives should not be available to participate in a

ROG meeting. The AESGP representative in the group is

Andrew Thornley, who is now part of the AESGP team.

In addition, Brexit was also a topic on the agenda. The

CMDh discussed the comments received on the CMDh

Brexit White paper and appointed rapporteurs for some

of the tasks to be addressed. Germany, UK and Sweden

will work on simplifying the renewal procedure and

have a complete overview of the pending procedures.

MSs were requested to identify submitted renewal pro-

cedures not entered in CTS and send them to Denmark

for compilation. The CMDh agreed that the Variation

Working Party could explore the options on how to cov-

er Brexit related changes in the dossier, and if there is a

possibility to group variations. The CMDh proposed that

the October 2018 CMDh meeting would be the deadline

to stop appointing UK as Lead Member State (LMS) for

pharmacovigilance activities, subject to the outcome of

the negotiation and assuming a 24-month negotiation

time after Article 50 is triggered. At that point in time a

decision would need to be taken to appoint MSs for

new procedures and reallocate procedures where UK

has been appointed as LMS.

■ CMDh April 2017 Report

The CMDh has published the report from its meeting

held on 18-19 April 2017.

Among the items reported, the following may be not-

ed:

Revision of CMDh Standard Operating Procedure

(SOP) on decision-making process for new active

substance status or extension of marketing protec-

tion or data exclusivity

The CMDh agreed on a revision of the CMDh SOP on

the decision-making process for new active substance

status or extension of marketing protection or data

exclusivity. The SOP has been updated to also apply for

decisions on one year of data protection according to

Art. 74a of Dir. 2001/83/EC (change of classification of

a medicinal product).

Updated CMDh SOP on decision-making process for

new active substance status or extension of market-

ing protection or data exclusivity (clean / track

changes)

Follow-up of CMDh position on PSUSA procedure

for budesonide

In the January 2017 CMDh press release, following the

adoption of the CMDh position for the PSUSA(*) on

budesonide, the CMDh requested marketing authori-

sation holders (MAHs) of corticosteroid-containing

medicinal products to implement the outcome of the

PSUSA assessment with regard to “Blurred Vision” and

“Central Serous Chorioretinopathy”, which has been

identified as class risk effect of corticosteroids. MAHs

are reminded that the same wording as agreed in the

PSUSA should be implemented for all pharmaceutical

formulations. However, the frequency of the adverse

reactions mentioned in the PSUSA outcome is only

applicable to budesonide. For other corticosteroids

and/or formulations not covered by the PSUSA, the

frequency “not known” should be mentioned. The

MAHs should adapt the frequency for their products in

the future. For the implementation, the same timelines

as for the PSUSA apply.

(*) A PSUR is a pharmacovigilance report submitted

regularly by a marketing-authorisation holder at de-

fined time points following a medicine's authorisation.

A single assessment of related PSURs (PSUSA) is car-

ried out for medicines that contain the same active

substance or combination of active substances, as in-

cluded in the list of EU reference dates (EURD list).

! Budesonide (nasal) has non-prescription legal status in the UK,

Sweden and Denmark]

It was explained at the CMDh meeting with Interested Parties

on 16 May 2017 that this was a very specific case, not illustra-

tive of the normal process.

9 AESGP Euro OTC News | Issue 292

Working Party on Harmonisation of SmPCs

The CMDh agreed to disband the Working Party on

Harmonisation of SmPCs. The Working Party was al-

ready temporarily suspended since 2015. Since then,

discussions related to the harmonisation of SmPCs

have taken place in the CMDh plenary. This practice

will continue. The subpage of the working party on the

CMDh website will be deleted. Relevant documents will

be moved to “Product information, Harmonisation of

SmPCs – Article 30 referrals”.

Update of Question & Answer documents

A new Q&A on the use of the European reference me-

dicinal product has been added to the Q&A on gener-

ics (clean / track changes) to recommend the use of

the ERP in the RMS. In the case of a Reference Medici-

nal Product (RMP) (or originator product) never author-

ised in the chosen Reference Member State (RMS) or

the chosen Concerned Member State(s) (CMS), an RMP

authorised by another national competent authority or

by the European Commission can be chosen. This RMP

is the so-called European Reference Product (ERP).

A new Q&A has also been added to the Q&A docu-

ment on applications for marketing authorisation

(clean / track changes). The new Q&A outlines the pre-

requisites for extension applications when these

should be included in an existing marketing authorisa-

tion.

The Working Group on Active Substance Master File

(ASMF) procedures has prepared an update of Q&As

on ASMF (clean / track changes). Several questions

have been updated to clarify the guidance given. The

revised document was adopted by the CMDh via writ-

ten procedure.

MRP

10 AESGP Euro OTC News | Issue 292

DCP

■ HMA-EMA Big Data Workshop – 27 June 2017

A workshop, the purpose of which is to enrich the work

of the HMA/EMA Joint Task Force on Big Data with con-

tributions from relevant stakeholders, is planned for 27

June 2017. The EMA has invited maximum 3 representa-

tives per industry association to this meeting to inform

the work of the taskforce. Participants with expertise in

data sources, bioinformatics or experience in the inte-

gration of heterogeneous and disparate data sources

are particularly welcome in addition to those with a vi-

sion as to how Big data may be applied meaningfully

across the product life cycle from drug development

through to post authorisation. AESGP has nominated

three lead experts in their respective field for this work-

shop.

The draft agenda includes an update on international

developments on Big Data with participation of Health

Canada and the US FDA, round table discussion on

mapping of relevant data sources and format and round

tables discussion on usability and application of data.

An HMA/EMA Joint Task Force on Big Data was established earlier

this year as the joint response from HMA and EMA to the chal-

lenges presented by Big Data. Indeed, data provenance and quality and

the methodologies to integrate disparate datasources is less assured

and the “signal to noise” ratio is likely to be much larger and uncertain

than currently. In addition, the explosion in use of so-called

“wearables” capturing various health data has created an entirely new

setting in which enormous real-time data sets emerge on large popula-

tions.

The task force has as its mandate not only to explore the emerging

challenges presented by big data but also to identify the likely uses and

applicability across the product life cycle. As such the deliverable of this

task force will be a set of recommendations regarding e.g. legislation,

regulatory guidelines, ethical considerations and competencies as well

as an evaluation of the usefulness of big data in the regulatory setting.

In the process of developing a set of recommendations, the task force

will:

Map relevant sources of big data and define the main formats in

which they are expected to exist;

Identify the usability of big data;

Describe the current state, future state and challenges with regard to

e.g. regulatory expertise and competences, need for legislation and

guidelines, and responsibility for raw data analysis;

Design a big data roadmap.

Further information on the task force can be found on the HMA web-

site and on the EMA website.

i

11 AESGP Euro OTC News | Issue 292

■ EMA Management Board – Minutes from March 2017 meeting

The EMA has released the Minutes from the March

2017 Management Board meeting.

Brexit

The EMA Executive Director stated that the implemen-

tation of the 2017 Work Programme is progressing

broadly in line with expectations for 2017, however the

Agency is ready to reallocate or reprioritise resources

should the need arise as a consequence of an im-

portant staff loss and will inform the board according-

ly.

The European Commission representative insisted on

the fact that the relocation of the European Medicines

Agency should be carried out without any business

disruption.

The representative of the UK offered full cooperation

until arrangements for leaving the EU are put in place,

referring also to the expression of interest by the Sec-

retary of State on future close cooperation with EMA.

The representative of the European Commission invit-

ed all to focus on the preparation that is needed in

order to ensure continuity and effectiveness of EMA

operations. In particular, Member States will need to

build up their capacity to compensate for the contribu-

tion by the UK once it is no longer part of the EU. The

EMA confirmed that the list of EMA criteria for the re-

location will be shared with the board once they have

been transmitted to the European Commission.

The EMA Management Board was updated on the

work done by the Operations and Relocation Prepar-

edness Task Force (ORP) which, amongst others, un-

dertook activities including identifications for remedial

solutions also in collaboration with the European Insti-

tutions and the Scientific Committees of the Agency,

development of a dedicated Brexit BCP (Business Con-

tinuity Plan) in case of staff loss and of a physical relo-

cation BCP, development of a dedicated recruitment

and selection strategy and of a ‘Relocation transition’

package for staff, conduct of two staff surveys and

continuous provision of up- to-date information to

staff, development of arrangements for requests for

information and for visits to EMA to increase under-

standing of the operations and functioning of the

Agency.

The board expressed its wish for an early decision on

the relocation of the Agency and welcomed the oppor-

tunity that will be provided to discuss more in depth

also matters concerning workload and resources. A

reprioritisation impacting on Work Plan deliverables

will be discussed and agreed by the board. Members

expressed their commitment to increase their contri-

bution to scientific work and called for an orchestrated

approach, that will allow single NCAs to invest in areas

where resources need to be usefully allocated.

EU/US Mutual Recognition Agreement (MRA) on

pharmaceutical Good Manufacturing Practices

(GMPs)

The Agreement, which was concluded on 1 March, is to

be considered a real accomplishment by all parties

involved. Now the focus should be on the implementa-

tion of the Confidentiality commitment to be signed

by EC/EMA and the FDA, and on the completion of the

assessments of the Member States in order to meet

the deadline for recognition of inspections from 1 No-

vember 2017 onwards. It is therefore important that

Member States ensure sufficient resources for the sub-

mission of the necessary information to the US and

meet key dates in the agreement.

Update on PSUR Repository

The board heard an oral update on the PSUR Reposi-

tory maintenance phase. Introduced by the EU phar-

macovigilance legislation, the PSUR repository is a sin-

gle, central platform for periodic safety update reports

(PSURs) and related documents to be used by all regu-

latory authorities and pharmaceutical companies in the

EU. The PSUR Repository provides an important simpli-

fication for marketing authorisation holders allowing

them to send all PSURs and related submissions to a

single recipient. After beginning of its mandatory use

in June 2016 it is now in the maintenance phase where

usability releases ca. every 2 months ensure that con-

tinuous development takes place. The system is con-

sidered to be intuitive and fit for purpose, as shown by

a steep decrease in technical queries by NCAs and In-

dustry since its mandatory use, and by the high vol-

ume of use since its go-live. All in all the system has

delivered all benefits that were envisaged, and its user

friendly interface is appreciated.

12 AESGP Euro OTC News | Issue 292

■ EMA 2016 Annual Report

The EMA has published its 2016 Annual Report (+ An-

nexes) which was adopted by the EMA Management

Board at its March 2017 meeting.

The following points from the report may be worth not-

ing:

The EMA recommended 81 medicines for human use

for marketing authorisation (compared to 93 in 2015).

A total of 32 referral procedures started in 2016 (there

were 21 in 2015), among which 6 were pharmacovigi-

lance-related (under Articles 31, 20 or 107i), and 19

were finalised.

The report also highlights some of the main projects,

initiatives and achievements in 2016, among which:

▪ Evaluation and monitoring of medicines

▪ Advancing human health, with amongst others

the PRIME scheme, the continuation of the

adaptive pathways pilot project, smart regula-

tion for safer medicines and the publication of

clinical reports

▪ Communication, including a strengthened en-

gagement with stakeholders

▪ International collaboration through bilateral and

multilateral interactions

As for herbal medicines, it is stated that in 2016, the

assessment of 10 new herbal substances was com-

pleted – leading to the publication of 8 final European

Union monographs and 2 final public statement. In

addition, 9 monographs were updated and revised in

the frame of the systematic review of monographs.

A related press release has also been published.

A referral is a procedure used to resolve issues such as concerns

over the safety or the benefit-risk balance of a medicine or a

class of medicines. The matter is ‘referred’ to the European Med-

icines Agency so that it can make a recommendation for a har-

monised position across the European Union. Article 107i proce-

dures are triggered because of safety issues, Article 20 proce-

dures are triggered when there are quality, safety or efficacy

issues with centrally authorised products, and Article 31 proce-

dures are triggered when the interest of the Union is involved,

following concerns relating to the quality, safety or efficacy.

i

■ EMA CHMP - Work Plan 2017

The EMA published the 2017 Work Plan of the Commit-

tee for Medicinal Products for Human Use (CHMP).

Among the envisaged CHMP activities for 2017, the fol-

lowing may be noted:

Multi-stakeholder consultation to facilitate optimi-

sation of clinical evidence generation in drug devel-

opment programme

Establishing the modalities to provide multi-

stakeholder consultation on OTC switch applications

involving “switch bodies”. This will be done through

the Scientific Advice Working Party (SAWP) and refers

to the proposal for a joint EMA-CMDh multi-

stakeholder scientific advice for OTC switches, which

was briefly presented at our bilateral meeting with the

EMA on 11 January 2017. This was also the subject of

the presentation given by Zaide Frias/EMA at the

AESGP Conference in Malta in February 2017.

Benefit/Risk methodology

Monitoring the implementation of benefit-risk tem-

plate structure and guidance.

Further exploring the application of benefit-risk meth-

odologies for decision making and communication

(e.g. output of IMI-PROTECT), including visual displays

and value elicitation, in co-ordination with relevant

EMA scientific committees (linked to Patients involve-

ment in assessment work topic).

Quality assurance of SmPCs

Maintaining and developing guidance and other tools

(training material, checklist, metrics or labelling review

guide) supporting SmPC review such as those pub-

lished on the EudraSmPC webpage (which aims to

facilitate a harmonised review of SmPC within the reg-

ulatory network and its public interface).

13 AESGP Euro OTC News | Issue 292

Generating the reports of revised processes to ensure

scientific committees' labelling review based on the

scientific assessment and to the development of met-

rics.

Providing support and training on any matters related

to SmPC.

Preparing an annual report on the related activities.

Considering the recommendations of the Commission

report on "Shortcomings in the SmPCs and the pack-

age leaflet".

Monitoring the need for stakeholder involvement with

regard to the product information.

Supporting a consistent approach in the process of

defining therapeutic indications to ensure their clarity

for stakeholders.

To continue and monitor the pilot on the wording of

the therapeutic indication.

Interface of precision medicines and diagnostics

Defining the scope of diagnostics or diagnostic meth-

ods to be included.

Exploring how characteristics/features of diagnostics

used in pivotal trials can be made transparent.

Exploring how the dependence of a medicine’s benefit

-risk balance from the accuracy of the crucial diagno-

sis can be described.

The EMA Pharmacovigilance Risk Assessment Committee

(PRAC) will liaise with the CHMP on the following:

Pharmacovigilance activities

Engaging with the Scientific Advice Working Party

(SAWP) on the need for specific registries at the prod-

uct level.

Identifying or further developing a guideline/guidance

on the best use of registries (taking into account exist-

ing guidance, engagement with patient registries).

Ongoing work with the Pilot phase, (4 candidates se-

lected, 17 pending consideration), evaluation of rele-

vant registries and desired characteristics of a modi-

fied/new registry as applicable.

Geriatric medicines strategy

Developing a geriatric Good Pharmacovigilance prac-

tise (GVP) module (PRAC involvement).

Continuing the pilot on 10 products with revised geri-

atric Assessment report (5 products have been final-

ised).

Adopting the final points to consider on frailty (public

consultation ended).

Completing the Quality Working Party (QWP) geriatric

packaging and formulation guideline.

Monitoring the geriatric medicines strategy.

■ EMA Report on CHMP Pilot Project on the involvement of patients in discussions on benefits & risks

of medicines

The EMA has informed on the publication of a final re-

port on the experience gained during its pilot project to

involve patients directly in the assessment of the bene-

fits and risks of medicines in its Committee for Medici-

nal Products for Human Use (CHMP).

The report concludes that the overall feedback received

from both the CHMP/EMA members and the patients

involved during the pilot is very positive and reflects the

usefulness and benefit of including patients within

CHMP discussions when there is an opportunity to en-

rich the benefit/risk (B/R) discussions with a patient per-

spective. Patients report a very positive experience; they

felt listened to and included and this increases transpar-

ency and trust in the work of the Agency. The CHMP

members felt that it was ‘important’ and ‘very helpful’ to

have the patient input during the oral explanation and

subsequent discussions.

At the end of the pilot phase and the analysis of the

feedback received, it was proposed to continue to invite

patients to oral explanations on a case-by-case basis

(when input could be valuable to the assessment), but

also to use additional methods and consult patients on

a more regular basis. This could include participating in

CHMP discussions by teleconference or through written

consultations at any time during an evaluation (respond

to specific pre-defined questions). These options allow

for consultations to be conducted outside of plenary

meetings and not limited to oral explanations, they also

give the opportunity to gather feedback from a larger

number of patients, when required. Elicitation of patient

preferences is also another patient engagement meth-

odology which the committee and the EMA is currently

investigating.

The CHMP members agreed unanimously on the pro-

posed way forward as it is clear that the inclusion of a

AESGP Euro OTC News | Issue 292 14

patient viewpoint enriches the overall evaluation of the

benefit and risk of the medicine.

It was also felt that the learnings from this pilot could

be shared with other committees, for example the Phar-

macovigilance Risk Assessment Committee (PRAC)

which also evaluates B/R, with a view to making more

use of this mechanism during such assessments.

■ Environment

A Roadmap for the Commission's

initiative on a strategic approach to

pharmaceuticals in the environment

has been published for a 4-week

consultation period.

The main objectives of the initiative

will be to:

identify remaining knowledge

gaps and uncertainties, and pre-

sent possible solutions for filling

them;

explore how to address the chal-

lenge to protect the environment

(and human health via the envi-

ronment) and at the same time

safeguard access to effective and

appropriate pharmaceutical treat-

ments for human patients and

animals, considering inter alia the

opportunities for innovation.

The strategic approach will aim to

address pharmaceuticals in the en-

vironment generally, meaning

largely but not only the water envi-

ronment, in order to cover the re-

quirements in the water and phar-

macovigilance legislation, noting

that the latter refers also to soils. It

could include policy options relat-

ing to a number of different areas,

given that emissions of pharmaceu-

tical substances to the environment

occur during their whole lifecycle,

i.e. from production through con-

sumption to disposal.

The Commission will reflect on poli-

cy options already identified in a

report and on outputs from a Com-

mission workshop held in Septem-

ber 2014 at which participants dis-

cussed a range of options from that

report. It will also consider possible

additional options identified during

the course of a supplementary

study to support the development

of the strategic approach. Finally, it

will include feedback from a Com-

mission public consultation.

Possible options include the stimu-

lation of voluntary initiatives at EU

or national level, as well as manda-

tory measures. In view of the need

to take into account the outputs of

the supplementary study, it is

premature to identify the options

that might be included in the stra-

tegic approach.

This document was circulated to

the AESGP pool of experts Environ-

ment for feedback until 19 May

2017. AESGP is participating in the

regular joint Inter Association Phar-

maceuticals in the Environment

(PiE) task force teleconferences

aiming at putting together the in-

dustry response. Most of the estab-

lished Ecopharmacostewardship

(EPS) documents will form the basis

of the industry response.

Further details on the initiative, in-

cluding comments already sent to

the Commission, are available here.

■ Documents for comments

DOCUMENT AESGP DEADLINE FOR

COMMENTS

EMA Guideline on Good Clinical Practice compliance in relation to trial master file (paper and/or elec-

tronic) for content, management, archiving, audit and inspection of clinical trials 21 June 2017

Inter-association TF on pharmaceutical in the environment (PIE) on extended Environmental Risk As-

sessment (eERA) review groups SWOT analysis and essential attributes 26 June 2017

WHO draft monograph on Capillary Electrophoresis 3 July 2017

EMA Concept Paper on the revision of the guideline on the role of pharmacokinetics in the develop-

ment of medicinal products in the paediatric population 5 July 2017

AESGP Euro OTC News | Issue 292 15

DOCUMENT AESGP DEADLINE FOR

COMMENTS

EMA Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical

trial protocol 14 July 2017

EMA Draft guideline on multiplicity issues in clinical trials 8 September 2017

EMA Guideline on equivalence studies for the demonstration of therapeutic evidence for products that

are locally applied, locally acting in the gastrointestinal tract as an addendum to the guideline on the

clinical requirements for locally applied, locally acting products containing known constituents

8 September 2017

Pharmacovigilance

■ Official launch of the enhanced EudraVigilance system

Further to the conclusions of an independent audit and

a subsequent favourable recommendation from the

EMA Pharmacovigilance Risk Assessment Commit-

tee (PRAC), the EMA Management Board has confirmed

that the updated EudraVigilance system has achieved

full functionality.

The EudraVigilance system, i.e. national competent au-

thorities, marketing authorisation holders and sponsors

of clinical trials, have to make final preparations to en-

sure that their processes and local IT infrastructure are

compatible with the new system and the internationally

agreed format.

The enhancements for reporting and analysing suspect-

ed adverse reactions of the new EudraVigilance system

will support better safety monitoring of medicines and a

more efficient reporting process for stakeholders. Ex-

pected benefits include:

Simplified reporting of individual case safety re-

ports (ICSRs) and the re-routing of ICSRs to Member

States as marketing authorisation holders will no

longer have to provide these reports to national

competent authorities, but directly to EudraVigilance,

which will ultimately reduce duplication of efforts. An

ICSR provides information on an individual case of a

suspected adverse reaction to a medicine;

Better detection of new or changing safety issues,

enabling rapid action to protect public health;

Increased transparency based on broader access to

reports of suspected adverse reactions by healthcare

professionals and general public via

the adrreports.eu portal, the public interface of

the EudraVigilance database;

Enhanced search and more efficient data analysis ca-

pabilities;

Increased system capacity and performance to sup-

port large volumes of users and reports (including

non-serious adverse reactions originating from the

EEA);

More efficient collaboration with the World Health

Organization (WHO) as EMA will make the reports of

individual cases of suspected adverse reactions within

the EEA available to the WHO Uppsala Monitoring

Centre (UMC) directly from EudraVigilance; Member

States will no longer need to carry out this task.

The enhanced EudraVigilance system will be launched

on 22 November 2017, i.e. six months after the func-

tionalities of the EudraVigilance database have been

established and have been announced by the Agency.

Together with the launch, the obligations set forth in

the following legal provisions will become applicable to

the mandatory electronic reporting through EudraVigi-

lance:

Section 1 “Recording and reporting of suspected ad-

verse reactions” of Chapter 3 “Recording, reporting

16 AESGP Euro OTC News | Issue 292

and assessment of pharmacovigilance data” under

Title IX “Pharmacovigilance” of Directive 2001/83/EC3,

and

Articles 24(4), 28(1), 28a(1)(c) and 28c(1) of Chapter 3

“Pharmacovigilance” under Title II “Authorisation and

supervision of medicinal products for human use” of

Regulation (EC) No 726/2004

The reporting of adverse reactions by patients and

healthcare professionals to national competent authori-

ties based on local spontaneous reporting systems will

remain unchanged. There will also be no changes to the

reporting of suspected unexpected serious adverse re-

actions during clinical trials until the application of the

new Clinical Trial Regulation.

Training & Support

The Agency will support national competent authori-

ties, marketing authorisation holders and sponsors

of clinical trials in the EEA through targeted e-learning

and face-to-face trainings, webinars and information

days. Users can trial the new functions of

the EudraVigilance system and the internationally

agreed format for ICSRs in a test environment as of 26

June 2017. Further information is available on

the EudraVigilance training and support webpage.

Signal management process associated with the new

Eudravigilance system was the main focus of the 11th

Pharmacovigilance industry stakeholder platform held

on 2 June 2017. AESGP was represented by 7 delegates.

■ PRAC meetings

At the PRAC meeting of 6-9 June, levonorgestrel (signal

follow-up), orlistat (follow up to PSIR/PSUSA procedure)

and ulipristal (interim results of PASS) were discussed.

In addition the PRAC continued its review of the parace-

tamol-modified release under the article 31 referral.

The PRAC also decided it will hold its very first public

hearing on 26 September 2017 at the Agency’s premises

in London, in the context of the safety review of the use

of valproate-containing medicines in the treatment of

women and girls who are pregnant or of childbearing

age. EU citizens will be invited to share their experiences

with these medicines so that this can be taken into ac-

count in the Committee’s recommendation. Valproate-

containing medicines are approved nationally in the EU

to treat epilepsy, bipolar disorder and in some countries,

migraine.

Herbal News

■ Final Public Statements on Paeoniae radix alba & Paeoniae radix rubra

The EMA HMPC has published the final Public State-

ments on Paeonia lactiflora Pallas, radix (Paeoniae

radix alba) and Paeonia lactiflora Pall. and/or Paeonia

veitchii Lynch, radix (Paeoniae radix rubra) respective-

ly which were adopted by the HMPC at their meeting

on 31 January 2017.

No changes were made compared to the draft ver-

sions circulated for comments on 17 February 2016

(AESGP did not send any comments as no input was

received). The conclusion for both Public Statements

remains that a European Union herbal monograph

cannot be established at present.

The final Public Statements, together with their final

Assessment Report and List of references, are availa-

ble respectively on the ‘Paeoniae radix alba’ page and

the ‘Paeoniae radix rubra’ page, under the ‘All Docu-

ments’ tab.

Paeonia lactiflora

17 AESGP Euro OTC News | Issue 292

■ Documents for comments

DOCUMENT AESGP DEADLINE FOR

COMMENTS

EMA HMPC draft European Union herbal monograph on Melilotus officinalis (L.) Lam., herba

(Rev.1) 23 June 2017

EMA HMPC draft European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng.,

folium (Rev.2) 23 June 2017

Homeopathic News

■ Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercu-

ry, and repealing Regulation (EC) No 1102/2008

Regulation (EU) 2017/852 of the Eu-

ropean Parliament and of the Council

of 17 May 2017 on mercury, and re-

pealing Regulation (EC) No

1102/2008 has been published on 24

May 2017 in the Official Journal of

the European Union (L 137/1).

Article 3 (export restrictions) and

article 4 (import) are the most im-

portant one for the homeopathic

industry:

Article 3

The export of mercury shall be

prohibited.

The export of the mercury com-

pounds and of the mixtures of

mercury listed in Annex I shall be

prohibited as from the dates set

out therein.

By way of derogation from para-

graph 2, the export of the mercury

compounds listed in Annex I for

the purposes of laboratory-scale

research or laboratory analysis

shall be allowed.

The export, for the purpose of

reclaiming mercury, of mercury

compounds and of mixtures of

mercury that are not subject to

the prohibition laid down in para-

graph 2 shall be prohibited.

Article 4

The import of mercury and the

import of the mixtures of mercury

listed in Annex I, including mercury

waste from any of the large sources

referred to in points (a) to (d) of

Article 11, for purposes other than

disposal as waste shall be prohibit-

ed. Such import for disposal as

waste shall only be allowed where

the exporting country has no access

to available conversion capacity

within its own territory.

Without prejudice to Article 11 and

by way of derogation from the first

subparagraph of this paragraph, the

import of mercury and the import

of the mixtures of mercury listed in

Annex I for a use allowed in a Mem-

ber State shall be allowed where

the importing Member State has

granted written consent to such

import in either of the following

circumstances:

a) the exporting country is a Par-

ty to the Convention and the

exported mercury is not from

primary mercury mining that is

prohibited under Article 3(3) and

(4) of the Convention; or

(b) the exporting country not

being a Party to the Convention

has provided certification that

the mercury is not from primary

mercury mining.

Without prejudice to any national

measures adopted in accordance

with the TFEU, a use allowed pur-

suant to Union legislation shall be

deemed to be a use allowed in a

Member State for the purposes of

this paragraph.

The import of mixtures of mercury

that do not fall under paragraph 1

and of mercury compounds, for

the purpose of reclaiming mercu-

ry, shall be prohibited.

The import of mercury for use in

artisanal and small-scale gold min-

ing and processing shall be prohib-

ited. 4.Where the import of mercu-

ry waste is allowed in accordance

with this Article, Regulation (EC)

No 1013/2006 shall continue to

apply in addition to the require-

ments of this Regulation.

It should be noted that mixtures are

defined as “mixtures of mercury with

other substances, including alloys of

mercury, with a mercury concentra-

tion of at least 95% weight by

weight”.

18 AESGP Euro OTC News | Issue 292

Food

EFSA

■ EFSA Summary of the 2016 Data Collection on Contaminant Occurrence Data

EFSA has published its analysis of the 2016 annual col-

lection of analytical results on chemical contaminants in

food and feed covering the sampling year 2015.

Data are submitted annually to EFSA by European data

providers to support EFSA’s work programme in the

area of contaminants. Overall, 837 154 analytical results

were submitted. The analyses were performed on 124

987 samples collected by different European organisa-

tions. The data providers were governmental and com-

mercial organisations; more than 93% of the data were

analytical results submitted by governmental organisa-

tions. The report provides an overview of the number of

results reported by substance, country of the data pro-

vider and FoodEx1 food or feed group; the distribution

of results by country of the data provider is also pre-

sented.

■ EFSA Guidance on the risk assessment of substances present in food intended for infants below 16

weeks of age

The EFSA Scientific Committee (SC) published its Guid-

ance on the risk assessment of substances present in

food intended for infants below 16 weeks of age

For the purpose of this guidance, the term 'infants be-

low the age of 16 weeks' was used to describe the par-

ticular infant subpopulations where health-based guid-

ance values (HBGV) had traditionally not been consid-

ered applicable. This population includes preterm neo-

nates receiving enteral feeding.

In preparing this guidance, EFSA’s SC considered the

physiological, developmental and nutritional aspects

that are specific for infants below 16 weeks of age, with

particular attention to the latest scientific develop-

ments in the field. The EFSA SC notes that during the

period from birth up to 16 weeks, infants are expected

to be exclusively fed on breast milk and/or infant for-

mula. The EFSA SC views this period as the time where

HBGVs for the general population do not apply with-

out further considerations.

In its approach to develop this guidance, the EFSA SC

has taken into account the following:

for the exposure assessment it is taken that in non-

breastfed infants, formula is expected to be the only

source of nutrition for the first 16 weeks of life;

the overall toxicological profile of the substance

identified through the standard toxicological tests,

including critical effects;

toxicokinetic data, especially:

the absorption of the substance from the GI

tract

impaired renal excretion

The composition of foods intended for infants and young

children is regulated at EU level and such rules include re-

quirements concerning the use and/or presence of substances

such as food additives, pesticide residues, contaminants and

substances migrating from food contact materials in those

foods. Adopting legal provisions on those matters that are in

line with the current scientific knowledge requires a compre-

hensive evaluation to be carried out by EFSA on a number of

aspects, including the appropriateness of health-based guid-

ance values for infants below 16 weeks of age. Of particular

relevance for the food supplements sector, the safety of food

additives necessary for the formulation of food supplements for

infants will be assessed under this guidance.

i

19 AESGP Euro OTC News | Issue 292

metabolism in the neonatal organism com-

pared with the adult;

knowledge of organ development (critical windows)

in human infants;

the effects of exposure of neonatal animals at equiv-

alent life stages of human infants;

the relevance for the human infant of the neonatal

animal models used and of the reported effects in

toxicological testing;

whether additional relevant effects are revealed or

whether the effects occurred at lower doses in the

neonatal animals, by comparison with standard toxi-

cological studies.

The EFSA SC concludes that:

High infant formula consumption per body weight is

derived from 95th percentile consumption and the

first weeks of life is the time of the highest relative

consumption on a body weight basis. Therefore, when

performing an exposure assessment, EFSA SC propos-

es to use the highest consumption figures reported

for the period of 14 to 27 days of life, i.e. 260 mL/kg

bw per day. This approach would cover acute toxicity

and consider potential periods of high sensitivity for

other toxicity endpoints.

A decision tree approach is proposed that enables a

case-by-case risk assessment of substances present in

food intended for infants below 16 weeks of age.

(Figure 7 on page 39)

DRV’s

■ Public consultation on EFSA Scientific Opinion on DRVs for riboflavin

EFSA Panel on Dietetic Products, Nutrition and Allergies

(NDA) launched a Public consultation on the draft scien-

tific opinion on dietary reference values for riboflavin.

Following a request from the European Commission, the

NDA Panel proposes Dietary Reference Values (DRVs)

(*) for riboflavin. The Panel considers in this Scientific

Opinion that vitamin B2 is riboflavin.

The Panel concluded that:

Average Requirement (ARs) and Population Reference

Intakes (PRIs) for riboflavin can be derived for adults,

pregnant women, lactating women and children over

1 year of age.

For infants aged 7–11 months, no sufficient data are

available to set an AR, thus the Panel sets an Ade-

quate Intake (AI), based on upward extrapolation by

allometric scaling from the estimated intake of ribofla-

vin of exclusively breastfed infants from birth to six

months.

Summary of DRVs for riboflavin

Riboflavin or 7,8-dimethyl-10-ribityl-isoalloxazine, is a water-

soluble compound naturally present in food of plant and animal

origin as free riboflavin and, mainly, as the biologically active deriv-

atives flavin mononucleotide (FMN) and flavin adenine dinucleotide

(FAD).

Riboflavin is an integral part of the coenzymes FAD and FMN that

act as the cofactors of a variety of flavoprotein enzymes such as

glutathione reductase or pyridoxamine phosphate oxidase (PPO).

FAD and FMN act as proton carriers in redox reactions involved in

energy metabolism, metabolic pathways and formation of some

vitamins and coenzymes. In particular, riboflavin is involved in the

metabolism of niacin and vitamin B6 and FAD is also required by

the methylenetetrahydrofolate reductase (MTHFR) in the folate cycle

and thereby is involved in homocysteine metabolism. Signs of ribo-

flavin deficiency are unspecific and include a sore throat, hyperae-

mia and oedema of the pharyngeal and oral mucous membranes,

cheilosis, glossitis (magenta tongue), and normochromic normocytic

anaemia characterised by erythroid hypoplasia and reticulocytope-

nia. No Tolerable Upper Intake Level has been set for riboflavin.

i

Age AR (mg/day) PRI (mg/day)

7–11 months - 0.4 (Adequate Intake)

1–3 years 0.5 0.6

4–6 years 0.6 0.7

7–10 years 0.8 1.0

11–14 years 1.1 1.4

15–17 years 1.4 1.6

≥ 18 years 1.3 1.6

Pregnancy 1.5 1.9

Lactation 1.7 2.0

20 AESGP Euro OTC News | Issue 292

(*) For ease of reference please see below the following

definitions:

Dietary Reference Values (DRVs) - quantitative refer-

ence values for nutrient intakes for healthy individuals

and populations which may be used for assessment and

planning of diets.

Population Reference Intakes (PRI) - the level of

(nutrient) intake that is adequate for virtually all people

in a population group.

Average Requirement (AR) - the level of (nutrient)

intake that is adequate for half of the people in a popu-

lation group, given a normal distribution of require-

ment.

Adequate Intake (AI) - the value estimated when a

Population Reference Intake cannot be established be-

cause an average requirement cannot be determined.

An Adequate Intake is the average observed daily level

of intake by a population group (or groups) of appar-

ently healthy people that is assumed to be adequate.

More information can be found in the EFSA Scientific

Opinion on principles for deriving and applying Dietary

Reference Values (2010).

Food Additives

■ EFSA Re-evaluation of fatty acids (E 570) as a food additive

EFSA has published its Opinion re-evaluating the safety

of fatty acids (E 570) as a food additive.

The Panel concluded that the food additive fatty acids (E

570) was of no safety concern at the reported uses and

use levels.

According to the conceptual framework for the risk as-

sessment of certain food additives re-evaluated under

Commission Regulation (EU) No 257 /2010 (EFSA ANS

Panel, 2014) and given that:

the safety assessment carried out by the Panel was

limited to the use and use level s received from indus-

try in eight food categories out of 67 food categories

in which fatty acids (E 570) is authorised;

fatty acids used as a food additive (E 570) were ab-

sorbed in the same way as the free fatty acids from

the regular diet;

fatty acids used as a food additive (E 570) were me-

tabolised in the same way as fatty acids when derived

from lipid molecules present in the regular diet;

the toxicity database was limited, however, no adverse

effects were observed in subchronic toxicity studies up

to 10% in the diet (equivalent to 9,000 mg lauric acid/

kg bw per day);

there was no genotoxicity concern for these fatty ac-

ids;

the contribution of fatty acids (E 570) represented on

average only 1% of the overall exposure to saturated

fatty acids from all dietary sources (food additive and

regular diet);

Recommendations

The Panel recommended that:

the European Commission considers lowering the cur-

rent limits for toxic elements (arsenic, lead and mercu-

ry) in the EU specifications for fatty acids (E 570) in

order to ensure that fatty acids (E 570) as a food addi-

tive will not be a significant source of exposure to

those toxic elements in food;

i

Fatty acids (E 570) is authorised as a food additive in the European

Union (EU) in accordance with Annex II and Annex III to Regulation

(EC) No 1333/2008 on food additives and specific purity criteria

have been defined in the Commission Regulation (EU) No

231/2012. Currently, fatty acids (E 570) is included in the Group I of

food additives authorised atquantum satis (QS). The EU Scientific

Committee on Food in 1991 established a group acceptable daily

intake (ADI) ‘not specified’ for four fatty acids(myristic-, stearic-,

palmitic- and oleic acid). The Panel noted that that caprylic acid,

capric acid and lauric acid, which can also be present in the food

additive E 570, were not included within the fatty acids considered

in the Scientific Committee on Food (SCF ) evaluation in 1991.

21 AESGP Euro OTC News | Issue 292

since only data for eight out of the 67 food catego-

ries in which fatty acids (E 570) is authorised were

available, more information on uses and use levels

should be made available to the Panel in order to

perform a more accurate exposure assessment.

The data AESGP submitted in response to the call for

data (Batch 4) have been taken into account by EFSA

in its exposure assessment.

■ EFSA Re-evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan

monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495)

EFSA has published its Opinion re-evaluating the

safety of sorbitan monostearate (E 491), sorbitan tri-

stearate (E 492), sorbitan monolaurate (E 493), sorbi-

tan monooleate (E 494) and sorbitan monopalmitate

(E 495) when used as food additives.

The Panel concluded that:

the exposure at the mean and the 95th percentile

level, using non-brand-loyal scenario, did not ex-

ceed the ADI in any of the population groups.

on the request for an amendment of specifications

regarding the removal of ‘congealing range’, this

removal would result in less characterisation of the

various sorbitan esters of saturated fatty acids, but

this identification parameter could be replaced by

another one such as melting point.

The Panel noted that after oral administration sorbi-

tan monostearate can be either hydrolysed to its fatty

acid moiety and the corresponding anhydrides of

sorbitol and excreted via urine or exhaled as CO2 or

excreted intact in the faeces.

The Panel considered that sorbitan esters did not

raise concern for genotoxicity.

The Panel concluded that:

there is no need for a separate ADI (E 493 and E

494) and established a group ADI of 10 mg/kg bw

per day, expressed as sorbitan, for sorbitan esters

(E 491, E 492, E 493,E 494 and E 495) singly or in

combination based on the NOAEL of 2,600 mg sor-

bitan monostearate/kg bw per day identified in a

long-term toxicity study in mice , taking into ac-

count the ratio between the molecular weight of

sorbitan monostearate (430.62 g/mol) and sorbitan

(164.16 g/mol ) and applying an uncertainty factor

of 100.

considering the non-brand-loyal scenario, the

mean and the 95th percentile level did not exceed

the ADI in any of the population groups and that

there is no safety concern for the use of sorbitan

esters (E 491, E 492, E 493, E 494 and E 495) as

food additives at the reported uses and use levels.

on the request for an amendment of specifications

regarding the removal of ‘congealing range’, this

removal would result in less characterisation of the

various sorbitan esters of saturated fatty acids, but

this identification parameter could be replaced by

another one such as melting point.

Sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbi-

tan monolaurate (E 493), sorbitan monooleate (E 494) and sorbi-

tan monopalmitate (E 495) are authorised as food additives in

food supplements in accordance with Annex II to Regulation (EC)

No 1333/2008 on food additives and specific purity criteria have

been defined in the Commission Regulation (EU)No 231/2012.

Toxicological data for sorbitan monostearate (E 491), sorbitan

tristearate (E 492), sorbitan monolaurate (E 493), sorbitan

monooleate (E 494) and sorbitan monopalmitate (E 495) were

evaluated by the Scientific Committee on Food (SCF) in 1978. The

Committee established an acceptable daily intake (ADI) of 25 mg/

kg body weight (bw) per day for sorbitan monostearate(E 491),

sorbitan tristearate (E 492) and sorbitan monopalmitate (E 495)

singly or in combination. The SCF also established a separate

group ADI for sorbitan monolaurate (E 493) and sorbitan

monooleate(E 494) singly or in combination of 5 mg/kg bw per

day calculated as sorbitan monolaurate. The latest evaluation of

sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbi-

tan monolaurate(E 493), sorbitan monooleate (E 494) and sorbitan

monopalmitate (E 495) by Joint FAO/WHO Expert Committee on

Food Additives (JECFA) was done in 1982 where an ADI of 0–25

mg/kg bw per day were confirmed.

i

22 AESGP Euro OTC News | Issue 292

■ EFSA statement on validity of conclusions of mouse carcinogenicity study on sucralose (E 955)

EFSA Panel on Food Additives and Nutrient Sources

added to Food (ANS) has published its Statement on

the validity of the conclusions of a mouse carcinogenici-

ty study on sucralose (E 955).

The Panel concluded that the available data did not

support the conclusions of the authors (Soffritti

et al., 2016) that sucralose induced haematopoietic neo-

plasias in male Swiss mice.

Taking into consideration the publication from Soffritti

et al. (2016), the technical report and additional infor-

mation provided by the Ramazzini Institute and other

information available for sucralose (E 955), the Pan-

el noted:

the design of the bioassay that considers exposure

from gestation up to natural death of animals implies

an increase in background pathology that results in

the possibility of misclassifications and a difficult in-

terpretation of data, especially in the absence of both

an appropriate concurrent control group and a recent

historical database;

the lack of a dose–response relationship between the

exposure to sucralose and incidence of lymphomas

and leukaemias (combined);

the lack of a mode of action and failure to meet all

the Bradford-Hill considerations for a cause–effect

relationship between intake of sucralose and the de-

velopment of tumours in male mice only;

a comprehensive database was available for sucralose

and no carcinogenic effect was reported in adequate

studies in rats and mice. Moreover, there was no reli-

able evidence of in vivo genotoxicity.

Sucralose (E 955) is currently authorised in all forms of food sup-

plements at various maximum levels under the Food Additives

Regulation 1333/2008. According to Commission Regulation (EU)

No 257/2010, the full re-evaluation of sucralose shall be com-

pleted by December 2020.

i

■ Update on food supplements for infants and young children

Further discussion took place on the use of additives

in food supplements destined at Infants and Young

Children at the food additives Working Group meet-

ing on 4 May.

Although no draft proposal from the Commission has

been presented to the Working Group, the Commis-

sion has explained its approach and listed the addi-

tives that it is intending to permit or not permit in

supplements containing nutrients that have been rec-

ommended by Member States’ health authorities.

The Commission has divided the additives into 3

groups – green – acceptable use, orange – case by

case assessment and red – unacceptable use.

Please note that this classification takes into account

if an additive 1) is a group I food additive or not, 2) is

currently authorised in food category 13.1 of Annex II

of Regulation 1333/2008/there is an evaluation for its

use in food for the age group of infants and young

children, 3) the latest scientific opinions of EFSA re-

garding the re-evaluation of some of the food addi-

tives included in this list and 4) the targeted age

group (e.g. from birth onwards, for young children

only, etc.).

AESGP has collected and submitted to the Commission such justi-

fication in May 2016 in response to the Commission’s call for data.

In response to this call, we understand that the Commission has

received information about more than 100 formulated products

containing a very high number of additives. The Commission has

been filtering the list by double checking the national supplementa-

tion policies in place and that the list of additives requested in the

corresponding food supplements is justified and can be supported by

existing safety assessment for this age group (taking notably into

the outcome of the EFSA reevaluation opinion). Since the Member

States without supplementation policies in place are really reluctant

to authorise food additives in food supplements for infants and

young children, the list to be approved by the majority of the Mem-

ber States has to be restricted to the minimum number of additives

required to formulate the food supplements necessary to meet the

national supplementation policies and for which no further safety

assessment by EFSA is required. The other additives not included in

that list will be required to go through an individual authorisation

procedure.

i

23 AESGP Euro OTC News | Issue 292

There is a total of 21 food additives distributed as

follows:

green (4) - E306 Tocopherol-rich extract, E307 Al-

pha-tocopherol, E330 citric acid, E 570 Fatty acids

orange (11) – E310 propyl gallate, E339ii disodium

phosphate, E392 Extracts of rosemary, E413 Traga-

canth gum, E415 Xanthan gum, E421 Mannitol,

E422 Glycerol, E433 polysorbate 80, E463 hydroxy-

propylcellulose, E470b magnesium salts of fatty

acids, and E551 Silicon dioxide, and

red (6) – E 160a(I) Beta-carotene, E172 Iron oxides,

E202 Potassium sorbate, E211 Sodium benzoate,

E950 Acesulfame potassium, E955 Sucralose.

As indicated above, the “orange” additives are to be

permitted on a case by case basis. Regarding poly-

sorbate 80, the EFSA opinion on its reevaluation has

shown an exposure issue. Regarding silicon dioxide, it

is included in category 0 of Annex II meaning that it

is authorised in ‘All categories of foods excluding foods

for infants and young children, except where specifi-

cally provided for’. Regarding the gums, due to the

risk of choking hazards, their use in dehydrated foods

for kids is very carefully considered.

As regards the “red” additives, the recent EFSA re-

evaluation reduced the ADI for sorbic acid to a tem-

porary one of 3 mg/kg bw/day rather than the previ-

ous ADI of 25.

In light of the classification criteria listed above, the

Commission has asked the Member States to provide

by the beginning of June a sound justification

(supporting data on e.g. case of need, exposure data)

for the use of the additives in the food supplements

containing nutrients that have been recommended

by their national health authorities.

On the basis of the information received, the Com-

mission will further work on a refined draft list for

discussion at the following Working Group meeting

at the end of June.

■ Update on the reevaluation of iron oxides (E 172)

Business operators are invited to submit the scientific

and technical data needed to address issues identi-

fied by EFSA in the re-evaluation of the safety of iron

following the call for data published by the Commis-

sion in December 2016. AESGP will submit data on

actual use levels of yellow iron oxide, red iron oxide

and black iron oxide in food supplements.

Iron oxides producers interested to submit the tech-

nical and scientific data are now to confirm the sub-

mission of the required data and to determine dead-

lines and milestones for such submission by 19 June

2017. In that regard, AESGP participated in a meeting

with suppliers to discuss the call for data on 11 May

2017. The main objective of the meeting was for the

major producer for food applications to present to

the participants its approach of the call for data and

the results of the time and cost evaluation it has

commissioned as well as to share some thoughts on

the size and purity determination. On 22 May, an offi-

cial request from the iron oxides producers was sent

to all downstream users (DU) including AESGP to col-

laborate to collect and/or generate the data required

by EFSA or to participate in the sharing of cost to

generate the EFSA required data. AESGP members

interested in this initiative were kindly requested to

express their feedback by June 8, 2017 sending back

the dedicated template to the producers’s designat-

ed contact person.

While AESGP agreed position in response to the offi-

cial request from the iron oxides producers is not – as

an association – to take part in the collaboration initi-

ative, AESGP will participate in the meeting organized

on June 15, 2017 by the iron oxides producers in

Brussels keeps its members informed of the status of

the initiative.

24 AESGP Euro OTC News | Issue 292

■ Reevaluation of Propyl gallate (E 310), Octyl gallate (E 311) and Dodecyl gallate (E 312) – Call for data

The European Commission has published a Call for

scientific and technical data on the permitted food

additives Propyl gallate (E 310), Octyl gallate (E 311)

and Dodecyl gallate (E 312).

The first two steps of the process are as follows:

Step 1: Registration of the contact details of business

operators interested in submitting data must be

completed by 7 July 2017. The list of interested busi-

ness operators will be available after completion of

step 1.

Step 2: Confirmation of data submission, deadlines

and milestones will then be required by 30 Novem-

ber 2017. The list of data that will be submitted,

deadlines and milestones will be available after com-

pletion of step 2

NB: Unlike for iron oxides and hydroxides (E 172),

there is no request for data on actual use levels of gal-

lates in food therefore AESGP does not intend to ex-

press interest under Step 1 to submit data.

Food Supplements

■ Maximum amounts for vitamins and minerals - EU Court Judgment clarifying conditions under which

EU Member States are entitled to set their own limits

The European Court of Justice has issued its Judgment

in Case-672/15 opposing the French Public Prosecutor

to the food supplement distributor Noria Distribution

SARL.

No EU maximum levels have yet been set under the

provisions of the EU Food Supplements Directive

2002/46, meaning EU Member States are entitled, in

principle, to set their own limits under certain condi-

tions to comply with EU law.

By this judgment, the Court of Justice generally con-

firms the opinion of the Advocate General and clarifies

these conditions.

The Court makes clear that national rules setting

maximum levels must comply with EU law (in partic-

ular the treaties and the Food Supplements Di-

rective) as well as with EU settled case law on the

free movement of goods and principle of mutual

recognition. Accordingly, national legislation (like

the French Order at issue) which does not provide

for a procedure for the placing on the market (…) of

food supplements whose content in nutrients exceeds

the maximum daily doses set by that legislation and

which are lawfully manufactured or marketed in an-

other Member state is precluded. Such a procedure

must be one which is readily accessible and can be

completed within a reasonable time, and, if it leads

to a refusal, the decision of refusal must be open to

challenge before the courts. Further, an application

to obtain the authorisation to market those supple-

This case follows Case C-446/08 opposing Solgar Vitamin’s

France and other seven food supplements manufacturers to the

French Ministry of Economy on related questions concerning

the compatibility of French Order of 9 May 2006 with EU law.

The Judgment of the Court of 29 April 2010, in this case, is

available here.

Following that 2010 CJEU judgment, the French referring court

(Conseil d’Etat) had to assess on a case-by-case basis if the

setting of the maximum amounts of concern in the French

Order could be justified by taking into account the criteria in

Article 5(1) and (2) of Directive 2002/46 and if such setting

complied with the principle of proportionality.

By a judgment of 27 April 2011, the French court - taking into

account the servings recommended by the manufacturer -

annulled the Order of 9 May 2006 in so far as it determines, in

its Annex III, the maximum daily dose that can be used in food

supplements, for vitamins K, B1, B2, B5, B8 and B12. However,

the French court did not annul the Order as regards the maxi-

mum daily dose for phosphorus, copper, manganese, selenium,

molybdenum, vitamins B3, C, E and B6.

On the basis of the 2011 judgment of the French court, the

referring court in this new case C-672/15 considers that ques-

tions remain concerning the compatibility of the French Order

of 9 May 2006 with EU law, and, by a judgment of 3 March

2015, referred its questions to the CJEU.

i

25 AESGP Euro OTC News | Issue 292

ments may be refused by the competent national

authorities only if those supplements pose a gen-

uine risk to public health. (The Court refers to

previous cases where French legislation was chal-

lenged for similar reasons such as the one on pro-

cessing aids). (Emphasis added)

The Court also gave directions as to how maximum

levels of minerals and vitamins should be set: on a

case-by-case basis and taking into account all of

the elements in Article 5(1) and (2) of that directive,

in particular of the upper safe levels established, with

respect to the nutrients at issue, after a comprehen-

sive scientific assessment of the risks for public

health, based not on general or hypothetical consid-

erations, but on relevant scientific data. (Emphasis

added)

Finally the Court ruled that the scientific assessment

of the risks (…) prior to the establishment of upper

safe limits which must in particular be taken into ac-

count in order to set the maximum amounts (…), be

carried out solely on the basis of national scien-

tific opinions, even though recent international sci-

entific opinions concluding in favour of the possibility

of setting higher limits are also available on the date

of the adoption of the measure at issue. (Emphasis

added)

It is now for the French referring court to apply the

answer given by the Court in its final judgment and to

decide whether it further annuls the French Order of 9

May 2006 still in force for the remaining maximum dai-

ly doses set.

■ Belgium notifies amendment regarding substances other than nutrients and plants or plant

Belgium has notified its draft Ministerial decree amend-

ing the Ministerial Decree of 19 February 2009 regard-

ing the manufacture and marketing of food supple-

ments that contain substances other than nutrients and

plants or plant preparations to the European Commis-

sion through the TRIS procedure (*).

The standstill period (**) will end on 11 August 2017.

Further information on this notification is available here.

The draft defines the minimum and/or maximum values

of four substances to be consumed per day in food

supplements, namely:

caffeine: maximum 80 mg/day

lutein: between 2 and 10 mg/day

lycopene: between 2.5 and 15 mg/day

red yeast rice or any other source of monacolin K:

maximum 10 mg/day of monacolin K

In order to ensure safety, a compulsory warning shall be

introduced for caffeine and red yeast rice, which must

appear on the product labelling:

caffeine: ‘Unsuitable for children or pregnant or lac-

tating women.’

red yeast rice: ‘This product is unsuitable for preg-

nant or lactating women, children and adolescents,

those over 70 years of age, those with liver, kidney or

muscular problems, those taking medicinal products

liable to interact (e.g.: cholesterol-lowering drugs) or

those intolerant to statins. If in doubt, please seek

advice from your doctor or pharmacist.’

As a transitional measure, food supplements that do

not meet the provisions of the draft decree but do meet

the provisions of the existing decree may continue to

be traded or labelled until [publication date + 10 days];

those which do not meet the provisions of the latter

may continue to be marketed until stocks have been

exhausted or until [signature date + 1 year], with the

exception of products based on red yeast rice for which

the decree shall be effective immediately, due to the

increasing evidence of adverse effects.

Background on the 2015/1535 procedure (formerly known as

98/34 procedure):

(*) It allows the Commission and the Member States of the EU to

examine the technical regulations the Member States intend to

introduce for products (industrial, agricultural and fishery) and for

Information Society services before their adoption. The aim is to

ensure that these texts are compatible with EU law and the Internal

Market principles. It applies in a simplified manner to the European

Free Trade Association (EFTA) Member States which are signatories

to the Agreement on the European Economic Area (EEA) and to

Switzerland and Turkey.

(**) Starting from the date of notification of the draft, a 3-month

standstill period – during which the notifying Member State cannot

adopt the technical regulation in question – enables the Commis-

sion and the other Member States to examine the notified text and

to respond appropriately. More information on this procedure and

what happen next can be found here

i

26 AESGP Euro OTC News | Issue 292

■ Italy - Updated guidelines on nutrients and other substances

The Italian Ministry of Health has

recently revised the following

guidelines (only available in Italian):

Guideline on permitted daily lev-

els of vitamins and minerals

The revision concerns the increase

of the maximum levels for the fol-

lowing vitamins to:

vitamin D: 50 µg per day

vitamin K: 180 µg per day

vitamin B12: 1000 µg per day

The levels are regularly changing to

reflect the most recent scientific data

on safety.

Guideline on nutrients and other

substances with a nutritional or

physiological effect

The following modifications have

been brought to the guideline:

the warning statement for food

supplements containing creatine

has been reworded; the maxi-

mum level of 3 g, however, re-

mains unchanged

the newly listed substance Pal-

mitoylethanolamide (PEA) has

been added to list 3 of permitted

substances for use in food sup-

plements without a defined max-

imum limit

Novel Food

■ EFSA updated opinion on safety of EstroG-100™ (extract of a mixture of three herbal roots)

EFSA Panel on Dietetic Products,

Nutrition and Allergies (NDA) just

published a statement on the safety

of EstroG-100™ as a novel food pur-

suant to Regulation (EC) No 258/97.

Following a request from the Euro-

pean Commission, the NDA panel

was asked to update its scientific

opinion on the safety of EstroG-

100™ as a novel food (NF) in the

light of additional information sub-

mitted by the applicant.

In its previous scientific opinion of

2016, the Panel concluded that Es-

troG-100™, which is a hot-water

extract of a mixture of three herbal

roots, is safe for the use in food

supplements at the maximum intake

level of 175 mg/day in post-

menopausal women, which is lower

than the maximum intake level pro-

posed by the applicant (514 mg/

day). The Panel reached its conclu-

sions based on the effects of EstroG

-100™ on liver and haematology as

observed in several oral toxicity

studies, the lack of information on

liver and haematological parameters

in human studies and the absence

of chronic toxicity data. In view of

the Panel's conclusion on the safety

of EstroG-100™, the applicant has

now provided additional infor-

mation on haematological and liver

parameters for the human interven-

tion study with EstroG-100™ and

historical control data related to the

subchronic 90-day oral toxicity

study with EstroG-100™.

After assessing the additional infor-

mation provided by the applicant,

the Panel considers that the conclu-

sion of the scientific opinion on the

safety of EstroG-100™ does not

need to be revised, and thus, the

Panel reconfirms that the NF is safe

for the use in food supplements at

the maximum intake level of

175 mg/day in post-menopausal

women.

■ EFSA opinion on alginate-konjac-xanthan polysaccharide complex (PGX)

EFSA Panel on Dietetic Products,

Nutrition and Allergies (NDA) has

published its opinion on the safety

of alginate-konjac-xanthan polysac-

charide complex (PGX) as a novel

food pursuant to Regulation (EC)

No 258/97.

The panel concluded that the safety

of the novel food, PGX, for the in-

tended uses and use levels as pro-

posed by the applicant, has not

been established.

The NF is an off-white granular

powder composed of three non-

starch polysaccharides (NSP): konjac

glucomannan, xanthan gum and

sodium alginate. These NSP are

mixed in a specific ratio, which has

been claimed proprietary and

confidential by the applicant and

processed by a proprietary process.

The information provided on the

composition, the specifications, the

batch-to-batch variability and the

stability of the NF is sufficient and

does not raise safety concerns. The

production process is sufficiently

27 AESGP Euro OTC News | Issue 292

described and does not raise con-

cerns about the safety of the NF.

The applicant intends to add the NF

to a variety of foods such as yo-

ghurt, bread, biscuits, cereals, pasta

and juices. The applicant also in-

tends to market the NF in capsules

(750 mg NF per capsule). The rec-

ommended maximum daily intake

of the NF from fortified foods and

food supplements is 15 g.

The target population proposed by

the applicant is adults from 18 to 64

years of age.

Considering the NOAEL of 1.8 g/kg

bw per day and the highest mean

and 95th percentile anticipated dai-

ly intake of NF from fortified foods

the margin of exposure (MoE) is 12

and 6, respectively, whereas the

MoE for the NF from food supple-

ments is 9. The Panel considers that

the MoE for the NF at intended uses

and use levels is not sufficient for

the target population.

■ EFSA opinion on cranberry extract powder

EFSA published its Scientific Opin-

ion on the safety of cranberry ex-

tract powder as a novel food ingre-

dient pursuant to Regulation (EC)

No 258/97.

The EFSA Panel on Dietetic Prod-

ucts, Nutrition and Allergies (NDA)

concludes that the cranberry extract

powder is safe as a food ingredient

at the proposed uses and use levels.

The novel food (NF) contains about

55–60% proanthocyanidins (PACs).

The Panel considers that the infor-

mation provided on the composi-

tion, the specifications, batch-to-

batch variability and stability of the

NF is sufficient and does not raise

safety concerns.

Cranberry extract powder is pro-

duced from cranberry juice concen-

trate through an ethanolic extrac-

tion using an adsorptive resin col-

umn to retain the phenolic compo-

nents. The Panel considers that the

production process is sufficiently

described and does not raise con-

cerns about the safety of the novel

food.

The NF is intended to be added to

beverages and yoghurts to provide

80 mg PACs per serving. The target

population is the adult general pop-

ulation. The mean and 95th percen-

tile estimates for the all-user intakes

from all proposed food-uses are 68

and 192 mg/day, respectively, for

female adults, and 74 mg/day and

219 mg/day, respectively, for male

adults.

Taking into account the composi-

tion of the novel food and the in-

tended use levels, the Pan-

el considers that the consumption

of the NF is not nutritionally disad-

vantageous. While no animal toxico-

logical studies have been conducted

on the NF, a number of human clini-

cal studies have been conducted

with cranberry products. Consider-

ing the composition, manufacturing

process, intake, history of consump-

tion of the source and human data,

the Panel considers that the data

provided do not give reasons for

safety concerns.

Health Claims

■ EFSA opinion on Condensyl® and decreases sperm DNA damage which is a risk factor for male in-

fertility

EFSA Panel on Dietetic Products, Nutrition and Allergies

(NDA) has published its opinion on the scientific sub-

stantiation of a health claim related to ‘Condensyl® and

decreases sperm DNA damage. The scope of the appli-

cation was proposed to fall under a health claim refer-

ring to disease risk reduction (Article 14 of the NHCR).

The Panel concludes that a cause and effect relationship

has not been established between the consumption of

Condensyl® and reduction of sperm DNA damage in

the context of reducing the risk of male infertility.

The food which is proposed by the applicant to be

the subject of the health claim is Condensyl®, a tab-

let containing a fixed combination of opuntia fruit

dry extract (Nopal pulpe violin powder) (100 mg) ,N-

acetyl cysteine (250 mg), zinc (15 mg), nicotinamide

(16 mg), vitamin E (succinate) (12 mg), vitamin B6

(pyridoxine) (1.4 mg), vitamin B2 (riboflavin) (1.4 mg),

folic acid (0.40 mg) and vitamin B12

(cyanocobalamin) (2.5 mg). Nopal (Opuntia ficus indi-

ca (L.) Mill.) powder is standardised for the content of

quercetin (5 mg/100 g), indicaxanthin (13.2 mg/100

28 AESGP Euro OTC News | Issue 292

g) and betanin (28.8 mg/100 g). The Panel considers

that the food/constituent Condensyl®, which is the

subject of the health claim, is sufficiently character-

ised.

The claimed effect proposed by the applicant is

‘reduction of sperm DNA damage (sperm nuclear

decondensation index and DNA fragmentation in-

dex), high sperm DNA damage being a risk factor for

male subfertility/infertility’.

The proposed target population is ‘males in repro-

ductive age with unknown reason leading to subfer-

tility’. The Panel notes that the term ‘ subfertility’ has

not been defined by the applicant. The Panel also

notes that infertility is clinically defined by the failure

to achieve a clinical pregnancy after 12 months or

more of regular unprotected sexual intercourse. In

this context, the Panel assumes that the disease that

is the subject of the application is male infertility and

that the target population for the claim includes

males wishing to increase their fertility but excludes

males with clinical infertility.

The Panel notes that the applicant did not provide

evidence to establish that a reduction of sperm DNA

damage decreases the risk of male infertility. There-

fore, the Panel considers that the reduction of DNA

sperm damage is a beneficial physiological effect in

the context of reducing the risk of male infertility, as

long as evidence is provided that Condensyl® induc-

es a reduction in both DNA sperm damage and male

infertility.

The applicant provided four human intervention

studies as being pertinent to the claim. The Panel

notes that all these studies were conducted in males

with established clinical infertility and that they relate

to the treatment of the disease, and therefore, the

effect of the intervention on the incidence of male

infertility cannot be assessed. In addition, the Panel

notes that two of these studies had no control group

and that a third study was conducted with a product

not complying with the specifications of the food for

which the claim is proposed. The Panel considers that

no conclusions can be drawn from these studies for

the scientific substantiation of the claim. In the ab-

sence of evidence for an effect of Condensyl® in re-

ducing sperm DNA damage and the risk of male in-

fertility in vivo in humans, the studies provided by the

applicant on the proposed mechanisms by which

Condensyl® could exert the claimed effect were not

considered by the Panel for the scientific substantia-

tion of the claim.

■ EFSA Opinion on Curcumin and the normal functioning of joints

EFSA Panel on Dietetic Products, Nutrition and Allergies

(NDA) has issued its Opinion on the scientific substanti-

ation of a health claim related to the claimed effect

‘Curcumin contributes to the normal functioning of

joints’.

The Panel concludes that a cause and effect relationship

has not been established between the consumption of

curcumin and maintenance of joint function.

The Panel considers that curcumin is sufficiently char-

acterised.

The claimed effect proposed by the applicant is

‘normal functioning of joints by reducing the bi-

omarkers of inflammation’. The target population

proposed by the applicant is the general population.

Upon a request from EFSA to clarify whether the

claimed effect is related to the normal function of

joints or rather to the reduction of inflammation, the

applicant did not address this issue in the reply.

The Panel assumes that the claimed effect refers to

the maintenance of joint function.

The Panel considers that maintenance of joint func-

tion is a beneficial physiological effect.

The Panel considers that no conclusions can be

drawn from 15 human intervention studies conduct-

ed in patients with osteoarthritis or rheumatoid ar-

thritis and from one study in obese subjects on se-

rum cytokines for the scientific substantiation of the

claim.

In the absence of evidence for an effect of curcumin

on the normal function of joints in humans, the re-

sults of the human studies on curcumin pharmacoki-

netics, safety and mechanistic studies, the animal

studies and the in vitro studies submitted by the ap-

plicant cannot be used as a source of data for the

scientific substantiation of the claim.

29 AESGP Euro OTC News | Issue 292

i

Medical Devices

Medical Devices Regulation

■ Regulation (EU) 2017/745 published on 5 May 2017

The MDR has been published in the

EU Official Journal on 5 May 2017

Regulation (EU) 2017/745 of the

European Parliament and of the

Council of 5 April 2017 on medical

devices, amending Directive

2001/83/EC, Regulation (EC) No

178/2002 and Regulation (EC) No

1223/2009 and repealing Council

Directives 90/385/EEC and 93/42/

EEC.

The MDR will:

enter into force on 25 May 2017

be applicable (= actually put the

requirements into daily practice)

from 26 May 2020 (subject to the

derogations listed in Article 123).

The IVDR has also been published:

Regulation (EU) 2017/746 of the

European Parliament and of the

Council of 5 April 2017 on in vitro

diagnostic medical devices and re-

pealing Directive 98/79/EC and

Commission Decision 2010/227/EU.

Cranberry Products

■ Committee on Medical Devices voted on draft decision on 19 May 2017

The Committee dealing with the Draft Commission Imple-

menting Decision on the group of products whose princi-

pal intended action, depending on proanthocyanidins

(PAC) present in cranberry (Vaccinium Macrocarpon), is to

prevent or treat cystitis met in the format of the Regulato-

ry Committee on Medical Devices (foreseen under the

Medical Devices Directive) on 19 May 2017. This meeting

took place on the same day as the (first) meeting on

‘MDR Future Implementing Acts’ that seems to be the

first meeting of the ‘Committee on Medical Devices’ set

up by the MDR.

AESGP submitted detailed comments in March on this

draft decision under the 4-week ‘feedback procedure’*

and urged the Commission together with the Member

States not to proceed with its adoption.

Although an overview of the feedback received by the

Commission (22 feedbacks in total) was expected to be

presented to the Committee dealing with this decision,

the Commission dedicated webpage only confirms that

the Regulatory Committee on Medical Devices voted on

19 May in favour of the Commission decision on the qual-

ification of cranberry products.

Regarding the timing for the formal adoption and publi-

cation of the decision, we understand that they are ex-

pected in the coming weeks.

*Background on the feedback procedure:

As part of its better regulation agenda, the Commission wants to

listen more closely to the views of citizens and stakeholders. To do

so, the Commission created a space where they can share their

views on:

roadmaps and inception impact assessments, which set out

ideas for new laws and policies, or for evaluations of existing ones

legislative proposals and accompanying impact assess-

ments, once they have been agreed on by the Commission and

put forward to the EU Parliament and Council

draft delegated and implementing acts, which either amend

or supplement existing laws or, set the conditions for existing laws

to be implemented in the same way across the EU

While the Commission will not provide an individual response, the

feedback is expected to be taken into account by the Commission

when further developing the act. An overview of the feedback

gathered will be presented to the committee dealing with this act.

A summary of the discussion will be included in the summary

record, which is published in the comitology register.

30 AESGP Euro OTC News | Issue 292

■ AESGP comments on the JRC process for developing device-specific guidance documents (DSG)

In its comments, AESGP appreciates the emphasis the

document places on giving a prominent role to stake-

holders in the process and highlights that full transpar-

ency from regulators is a crucial element when adopting

Device Specific Guidances (DSG): this concept should be

related not only to clinical evaluation and investigation,

but to all the guidance documents issued by the Com-

mission and relating to technical aspects on medical

devices. While AESGP fully supports the principle of ob-

jectivity, it believes that the overall process should in-

clude targeted mechanisms for stakeholder engage-

ment, while preserving the independence and transpar-

ency of the process. Like EU agencies such as European

Food Safety Authority (EFSA) and European Medicines

Agency (EMA), AESGP would like to encourage the JRC

to broaden the range of sources of scientific input it

relies on as well as to engage more widely with stake-

holders who can bring experience from the field.

DSG documents are primarily aimed at manufacturers (MFs) and

notified bodies (NBs) and concern the evaluation of clinical data on

medical devices (typically of high risk). DSG documents are intend-

ed to provide guidance for MFs and NBs with regard to clinical

investigations and the subsequent evaluation of all clinical data as

legally required. DSGs should further be used by NBs as part of

their Design Dossier review or Type Test certification and any sub-

sequent significant change notifications. Finally, DSGs are also

intended to support Member States Competent Authorities when

verifying that the device meets the essential requirements relating

to post market surveillance.

i

■ AESGP Medical Devices Committee meeting on 2 June 2017 in Vienna

Following the publication of the Medical Devices Regu-

lation, the Committee met on 2 June in Vienna in con-

junction with the 53rd

AESGP Annual Meeting taking

place from 30 May to 1st June 2017. The Committee no-

tably discussed:

Burning interpretation issues under the MDR;

AESGP priorities regarding the implementation of the

Regulation in light of the Commission work program;

AESGP positioning at the upcoming meetings of the

working groups and taskforces planned for the sec-

ond semester of 2017;

the latest developments regarding MDR EUDAMED

and the ongoing work of the EUDAMED steering

Committee and ad-hoc working groups.

1

Conference report

The 53rd AESGP Annual Meeting - the annual gathering of the self-care sector in Europe – was held in Vien-

na, Austria from 30 May – 1 June 2017. Entitled “Self-Care in a Changing World”, the conference looked at

this overarching theme from three angles: marketplace, regulation and policy covering non-prescription

medicines – including herbal medicinal products – food supplements and self-care medical devices.

Around 350 representatives from the industry and many stakeholder organisations attended the meeting.

The first day of the conference heard success stories, delved into how the industry is doing with the recent

unprecedented level of consolidation in the pharmaceutical sector including the consumer health industry

and gave an overview of the changing environment for health care professionals.

Opening Evening

Birgit Schuhbauer, President of the Association of the

European Self-Medication Industry (AESGP), and Global

Vice President of Johnson & Johnson’s OTC Franchise,

welcomed delegates to the 53rd AESGP Annual Meeting

in Vienna, Austria, in a speech at the opening evening in

the Vienna City Hall.

She applauded the progress made in self-care in Europe

from “both on the regulatory side and political side”

since the launch of the association’s Agenda 2020 last

year.

“I feel particularly encouraged by the recommendations

on the future of self-care submitted to a European Un-

ion (EU) project by the European Umbrella Organisation

of Medical Doctors, the CPME,” she stated.

Details of the CPME’s recommendations on the future of

self-care would be presented during the conference, she

explained, by the organisation’s President Jacques de

Haller.

Globalisation, mergers and acquisitions, the role of

health professionals, social media and big data, would

also be high on the conference agenda, she pointed

out, along with new legal and regulatory developments

for non-prescription medicines, food supplements and

self-care medical devices.

Birgit Schuhbauer

2

It was important to keep in mind, she said, that the

meeting was “taking place against a background of un-

precedented debates on the future of Europe – with

new hopes after the elections of this year but also dis-

appointing votes in 2016”.

“Let me clearly say that we would like to see a strong

Europe,” she insisted. “‘Single Market’ is not a very pop-

ular phrase these days, but is still high on our agenda.”

Pointing out that it was only eight years since the

AESGP had held its Annual Meeting in Vienna,

Schuhbauer said that the choice recognised the 50th

birthday of the country’s local association IGEPHA, and

the organisation’s efforts to improve self-care in the

country.

Also speaking at the Vienna City Hall opening evening,

Dr Gerhard Lötsch, President of IGEPHA, the Austrian

Self-Care Association, said the Austrian healthcare sys-

tem was a good one, but healthcare systems cost mon-

ey. IGEPHA could offer viable solutions, he maintained,

by providing methods to help improve health literacy as

well as inexpensive but effective ways to treat oneself.

IGEPHA is also keen to work with regulators, he added,

to widen access to medicines.

Former President of the Austrian Self-Care Association,

Alfred Grün, was thanked for his 25 years of service

within the AESGP Economic Affairs and Public Relations

Committee (ECOCOM). Schuhbauer remarked that “for

most us, you were always there”, noting the “significant

impact” of Grün’s work for “a quarter of a century”.

Taking over in 2010 as Chair of the ECOCOM from Brian

McNamara – now Chief Executive Officer at GSK Con-

sumer Healthcare and Chair of the World Self-

Medication Industry (WSMI), Grün’s contribution

“became even more evident.” Alfred Grün’s role was

however not limited to the AESGP as he also served as

President of the Austrian Self-Care Association (IGEPHA)

from 2007 to 2014. In this function, he also represented

IGEPHA on the AESGP Board, a function which he had

kept until now.

“Thank you on behalf of all of us for your outstanding

work, the great achievements, but above all your excel-

lent leadership and personal friendship,” Schuhbauer

said, joined by the applause of the 300 guests attending

this evening at the Vienna City Hall.

Gerhard Lötsch Alfred Grün

3

Global Changes and their Implications on Consumer Healthcare

In her opening remarks, the session moderator Cathy

Smith introduced the theme of the conference. Self-

care and the self-care industry are changing massively,

and over the coming days, speakers will provide an

overview of general trends, changes in the digital space,

where the scope is for innovation, and update on new

regulatory developments. The focus of the first session

was global developments and its implications for Eu-

rope as a whole and the provision of healthcare.

Global economy and the impact on con-

sumer spending

Nenad Pacek, President of Global Success Advisors,

began by acknowledging the difficulties with budgeting

and predicting where markets are going. He explained

how declines in sales growth, for example, in Saudi Ara-

bia, are often difficult to predict. The reason, he ex-

plained, resides in the fact that the financial industry has

“hijacked” deregulation; there is massive speculation in

commodity and currency markets but also in buying

government bonds of Ghana/ Brazil or treasury bills of

Indonesia. “No one is attempting to regulate those ac-

tivities whatsoever,” he went on to explain. “Less than

3% of all oil trading in the world is done by countries

and people who need oil. This raises budgeting con-

cerns for markets and territories and often the changing

external environment is to blame.

He recognised that this has gotten worse over the last

ten years, as we are living in the aftermath of the 2009

financial crisis. The year 2009 saw the biggest global

crisis in 80 years, and its consequences can still be felt

today.

In the US, half of the money from quantitative easing

programs ended up in financial institutions, and some

were used to buy government bonds in South Africa.

Emerging markets were doing well thanks to cash from

the US leading to inflation of assets. When there was an

outflow of capital in 2015 and 2016, all commodity mar-

kets went down – Latin America, the Middle East, Aus-

tralia, Indonesia and Russia. The quantitative easing pro-

grammes created a large amount of volatility in the US

since 2010.

“We are now recovering from this,” Nenad explained.

“The US economy following this huge money printing

will continue to grow, consumer spending is recovering,

unemployment rates are low, and the federal reserve

will have increase interest rates (which he noted, are

signs of a recovering economy).

“The Eurozone is having its best year since 2007 and

2008,” he commented. The EU has its own quantitative

easing program since 2015, which made the euro

cheaper, making European exports more competitive.

“Exports are doing well,” he remarked, and this is lead-

Cathy Smith

Nenad Pacek

Conference report

4

ing to improved consumer spending.” Lending is also

improving banks now have freshly printed cash.” He

explained that most countries except Greece have easy

access to finance, so governments can spend more

freely instead of having austerity programmes in place.

“This strong performance in the Eurozone is helped by

the weak global commodity prices, which means that

there is no inflation and interest rates will remain low.”

“When the quantitative easing programme ends in

2017, we will start to see the first increase in interest

rates in 2018,” he warned, which may affect the con-

sumer. “For the next 12 months, however, consumer

spending should remain robust,” he reassured.

Labour shortages in central Europe are driving wages

up, and driving retail sales. In the East, Russia is barely

growing, but volume growth is coming back in local

currency. In Russia, 2/3 of its exports are hydrocarbon

related, and the country relies a lot on commodities.

A growth of 6% is the forecast for emerging countries in

Asia. In China, “local players are gaining an upper hand

over multinationals.” Japan is trying to escape deflation

with falling prices. The Middle-East is struggling as oil

prices are low, even in markets not driven by oil such as

Egypt. Pakistan is doing well, with a double-digit market

growth. Brazil is experiencing the worst recession in 80

years.

“Competition will get worse as well.” From a competi-

tion standpoint, he described four threats: large multi-

nationals which are better and better organised around

the world, the threat from emerging markets, the threat

from small, medium-sized companies and the rise of

family business. “The external environment will be vola-

tile from a macroeconomic side,” he added.

“Innovate more,” he urged, “but make these innovations

deeply relevant to the local market. Ensure your product

and marketing mix is right, do frequent consumer re-

search as the consumer is changing in this volatile world

and don’t get lazy with your marketing messages.”

“The traditional distributor model is dying,” he said.

“You must be present in the market. Look at your oper-

ations and ask if you have enough local people in place

to get the insights into the market you need,” he ad-

vised. “The quicker you localise the better.” He ex-

plained that centralising operations and leaving prod-

ucts in the hands of local distributors was a model that

would no longer work, especially in volatile emerging

markets.

Simplify to improve switch

Karl Broich, Director General, Federal Institute for

Drugs and Medical Devices (BfArM), Germany gave an

overview of global developments from a European and

German authority perspective. He explained that in Eu-

rope there is a centralised marketing authorisation

route for non-prescription medicines leading to a har-

monised marketing authorisation and the decentralised

procedure. However, there are different approaches

used across Europe. Therefore, the Co-ordination Group

for the Mutual Recognition and Decentralised Proce-

dures-Human (CMDh) established a European platform

for non-prescription medicines to get more harmonisa-

tion around non-prescription status.

The Non-Prescription Medicinal Products Task Force, he

explained, aims to explore new ways to improve conver-

gence on evaluation and facilitate access to safe and

effective OTC products for EU citizens. Efforts to im-

prove the functioning of the marketing authorisation

system for non-prescription medicines along the lines of

the AESGP Self-Care Agenda 2020 will be a further key

element. The Task Force will provide recommendations

to the CMDh and the Heads of Medicines Agencies

(HMA) on matters relating to OTC products, explore

best practices both at the level of national competent

authorities (NCAs) and industry, revise the Best Practice

Karl Broich

Conference report

5

Guide on the Decentralised Procedure (DCP) for non-

prescription medicines and engage with relevant trade

associations to discuss OTC status at European level.

The Task Force is constituted for the period of time

needed to complete tasks committed by the CMDh. It is

composed of members of the CMDh or experts from

NCAs and BfArM is actively involved with German

CMDh member participated from the beginning and

Martin Huber as the recently elected chair of the Task

Force. Non-European Union countries may also partici-

pate if they are prepared to sign confidentiality agree-

ments.

Another committee at European level is the Committee

of Experts on the Classification of Medicines as regards

their supply set up by the Committee of Ministers under

Article 17 of the Statute of the Council of Europe. Its

tasks include reviews on classification practices, underly-

ing rationale, develop and promote good classification

practices, monitor trends and the impact of the classifi-

cation of medicines on medicines’ safety and accessibil-

ity to the patient and develop further and coordinate

the updates of a web published database presenting

the classification status of medicines in the Member

States (MELCLASS database).

In Germany, he explained, a substance-based classifica-

tion system is laid out in the German Medicines Act

(‘Arzneimittelgesetz’), and decisions are taken by the

Ministry of Health in a legal act. Except in cases where a

substance is not generally known – where it is automati-

cally subject to medical prescription – prior consultation

of an Expert Advisory Committee is warranted. The

committee is composed of stakeholders and experts in

the field (academia, clinical practice etc.) BfArM acts as

the secretary/contact point for this committee and hosts

the meeting.

The National Switch Committee meets twice a year. A

company or any other party can submit an application

for a change of the legal classification, and the applica-

tion is then sent to BfArM for validation and scientific

assessment, which will then go to the Expert Advisory

Committee.

He explained that more and more, BfArM are consider-

ing the international experience with the usage of a

medicine in an OTC setting outside Germany and out-

side the European Union. The application together with

the BfArM assessment is then being considered by the

Expert Advisory Committee. The committee can consult

further external experts on a case-by-case basis for spe-

cific topics. The committee then issues a recommenda-

tion as to whether the legal status should be changed.

The recommendation is addressed to the Ministry of

Health which takes the final decision.

He stressed that a standardised approach to future sub-

missions to change legal status should be put in place.

Although it is always a case-by-case assessment, the

“Brass et al. benefit-risk model and methodology pro-

vides an established standard for evaluating and decid-

ing on switch applications in Europe.”

He also urged industry to make use of the improved

level of OTC expertise at national agencies and engage

with these agencies prior to filing, noting that in line

with the AESGP 2020 agenda, BfArM had the ability to

offer scientific advice and preparatory meetings on

switch proposals before an application was made.

“We should be more visible as regulators,” he remarked.

On the issue of transparency regarding the criterion

used to evaluate products and changes in classification

status as described in the AESGP 2020 agenda, he ex-

plained that detailed guidance on switches is available

on the BfArM website. Procedural clarification meetings

are also provided. He believes that the same standards

for safety should apply regardless of prescription status,

“without being too risk-focused”.

He concluded with BfArM’s future priorities, which in-

clude further interaction and exchange of views with

stakeholders within Europe and outside Europe,

strengthening expertise in the field of OTC medicines,

optimising Scientific Advice regarding OTC switches

(both at EU and national level) and the use of other data

sources (e.g. digital media) in the decision-making pro-

cess.

Trust driving the Self-Care Agenda forward

Brian McNamara, Chief Executive Officer, GSK Consum-

er Healthcare and Chair, World Self-Medication Industry

(WSMI), gave his perspective on how both GSK and the

industry are serving consumers and driving the self-care

agenda forward.

OTC contributes over 100 billion dollars per year in the

US - $7 is saved for every $1 of OTC sales. In Spain,

€835 million euros could be saved each year by switch-

ing 5% of prescription medicines to OTCs and in the UK,

£2 billion could be saved each year in reduced doctors’

6

visits for minor ailments were self-treated with OTCs,”

he quoted. “Reacting to the changing environment,

there is a huge opportunity to increase access and drive

the safe use of consumer healthcare products,” he ex-

plained.

Against a backdrop of Brexit and uncertain elections

across the continent - France, Netherlands, Germany,

Austria, the US/Trump administration and drama in

North Korea businesses need to navigate through the

challenges of emerging markets slowdown and high

volatile, tightening government and household budgets,

drug pricing focus, demanding capital markets and a

trust deficit.

At the same time, there is clear interest and opportunity

in self-care. Google searches for ‘self-care’ have reached

a five-year high immediately after US election last No-

vember. “As we deal with the challenging environment,

it’s important to put consumers at centre of all we do,”

he explained. “By placing the consumer at the centre of

what we do,” he insisted, “we can further build trust in

products and brands and drive forward the self-care

agenda.”

“GSK has three priorities: innovation, performance and

trust.” Performance, he explained, is about consistently

delivering on consumer needs, which allows GSK to con-

tinue to invest in their brands and people. Innovation is

the “life-blood of our industry - and goes beyond prod-

uct innovation to packaging, claims and experience.”

He also believes that the interaction between the con-

sumer and pharmacists is critical, and will become more

important with enhancements from digital and data.

“Earning and retaining the trust of consumers will be the

key to expanding the consumer healthcare market,” ac-

cording to Brian McNamara.

Public trust in systems of government and in business

was at an all-time low, but in the portfolios of consumer

healthcare companies around the world, there were

brands with a great deal of loyalty and trust. To grow

the industry, he added, this asset needs to be leveraged.

“Industry, by doing business the right way - ensuring

quality, efficacy and safety – can leverage the trust in

the brands that have been in people's lives for many

years,” he said.

He concluded by stating his belief that “the success of

self-care is founded on three fundamental pillars: one,

putting consumers at the centre; two, enabling self-care

to improve health and healthcare systems; and the final

pillar, building trust in our products and brands. These

are the building blocks of serving consumers and mov-

ing the self-care agenda forward.”

Brian McNamara

7

Performance of the Self-Care Industry

Merger and Acquisition trends and “The

Year of the Deal”

Fuad Sawaya, Co-founder and Managing Director,

Sawaya Segalas, a New York-based global boutique in-

vestment bank which exclusively serves clients in the

consumer industry, began his presentation by providing

his perspective on Merger and Acquisition (M&A)

trends. The year 2014 saw deal values greater than the

last seven years combined. This was followed by a di-

gestion year in 2015, and increase in M&A activities in

2016/2017. There has been a record number of scale

transactions and transaction multiples have peaked and

then stabilised somewhat. The entrance of generic com-

panies into the OTC industry have been met with mixed

successes, private equity has become active again and

under the radar, an aggressive consolidator (Prestige

Brands) is on the move that has emerged as a global

top ten, sourcing from private equity, large pharmaceu-

tical companies and from family businesses. He explains

that until this year, the two largest deals involved the

$16.6 billion Pfizer deal back in 2006 and the more re-

cent Bausch & Lomb sale to Valeant. Since then, 5 of

the top 7 deals in size were done in the last 3 years and

it is not just the big pharma companies that are in-

volved in these transactions. There have been asset

swaps, strategic collaborations, private equity involve-

ment and the generic entry with the Omega Pharma

deal. “In the last three years, 13 transactions were in

excess of 500 billion Dollars”.

He notes that in 2017, M&A activity has not been ag-

gressive/active like it was in 2014 which was driven by

higher stock prices. He asks what will come next since

most of the chess moves were already played in 2014

and 2016. He adds that “focus and prioritisation is the

way forward for the big players. Focusing on the big

ideas, leveraging R&D, putting resources behind them

and making them happen.”

“We are at an inflexion point. We have not seen an ac-

celerated pace for traditional OTC portfolio optimization

-its very ad hoc”. He explains the percolating im-

portance of “following the consumer” in the industry

and as a result, there is an evolving definition from OTC

to consumer healthcare. As a result of the expanded

definition, there are new competitors and new entrants

looking at the industry from a different perspective.

“From a divestment standpoint, we have had three large

deals and very little come out of it” However, according

to Mr Sawaya, this may change.

Looking at the industry construct there are 10,000

brands with 50 million Euro or less out there which will

be a source of an extensive trail that will be available for

M&A going forward. In his view, Europe is most likely to

see the most action in the future in terms of those di-

vestitures.

There are increased blurred lines between OTC and con-

sumer health (including functional foods, devices, infant

nutrition, light therapy). FMCG (fast moving consumer

goods) leadership is coming into pharma companies,

and pharma leadership is coming into FMCG compa-

nies, which brings new thinking. For example, in GSK the

combined OTC and FMCG market has been dubbed

FMCH (fast moving consumer healthcare). M&A is now

following those expanded category definitions. For

Reckitt Benckiser, 7 out of their top 10 power brands

focus on healthier lives and more and more companies

are converging towards this messaging.

He concludes by stating that consolidation trend is like-

ly to continue, but will also evolve. He does not antici-

pate more mega deals. However, he believes that as the

financial characteristics of the industry are quite unique,

the industry offers tremendous opportunity.

Fuad Sawaya

Conference report

8

Developing regions drive growth

Andy Tisman, Global Senior Principal, Consumer

Health, QuintilesIMS gave his insights on the consumer

market. The global OTC market continues to grow at

solid mid-single-digit rates. Pharma growth has

dropped, and it is expected that the OTC market may

overtake pharma again in the next year or so. The

strong start to cough/cold in 2016/17 winter season (10

-15% growth), has not been maintained through Q1

dropping to less than 5%. He explains that growth is still

driven by emerging markets and developing economies.

Developing regions contributed 82% of the growth of

the global OTC market that exceeded €100 billion for

the first time in 2016. This was despite them only having

a 50% share of the market that grew by 4.6% to 101

billion Euro at manufacturers’ selling prices. Two re-

gions, in particular, are growing very strongly – CEEMEA

(Central and Eastern Europe, Middle East and Africa)

and APAC (Asia-Pacific). In contrast, sales growth has

dropped closer to share growth in Latin America and

China. This has had a knock-on effect on other countries

dependent on China for their growth such as Australia

(which had a buoyant market in the last few years due

to its exports to China).

Market leader Sanofi with a 5.1% share had outstripped

the others with a 3.6% growth in the OTC market (albeit

slightly under the market growth rate) due to recent

asset swap with Boehringer Ingelheim, propelling it

ahead of both Bayer and GlaxoSmithKline that had

grown by 1.0% and 2.3% respectively. Their 4.8% market

shares were larger than Johnson & Johnson’s 4.0% in

fourth place, despite a stronger 3.1% sales rise during

the year. However, he noted that only PGT (which in-

cludes P&G North America), Reckitt Benckiser and No-

vartis had grown ahead of the market growth rate. In

9

Europe, only Stada and PGT grew ahead of the OTC

market in Europe in the first quarter of 2017. Novartis,

Sanofi and Reckitt Benckiser approached market

growth. Noting that the extent and timing of the cough/

cold season remained a strong influence on the mar-

ket’s performance – the first quarter of 2017 had damp-

ened a buoyant fourth quarter of 2016 – and he points

out that none of the world’s top four OTC companies

had done better than the market as a whole.

Outside of top 10 Abbott, Stada and Menarini achieved

strong global growth. Abbott’s OTC sales had risen by

9.5%, Stada’s increased by 8.4%, while Menarini’s rose

by 7.9%, driven by the focus areas in their portfolio.

In Europe, France had performed better in 2016 than its

growth rate over the previous three years (due to a

buoyant analgesic market), but Germany, Italy, Spain

and the UK had not done so well. In Central and Eastern

Europe, there is a stronger growth picture driven by

Russia, Turkey and Kazakhstan (local currency growth),

except for Poland which lagged slightly behind.

From a category view, cough, cold, respiratory and vita-

mins and minerals grew ahead of the Europe’s OTC

growth, while pain and digestive products continue to

see strong growth.

On M&A, he reports that the Sanofi and Boehringer

Ingelheim deal created the No. 1 player in 4 regions and

gives Sanofi consumer health care a strong presence in

Japan. The deal was well matched in terms of comple-

mentary businesses. Within respiratory Sanofi’s strength

is in anti-allergy, while Boehringer Ingelheim’s is in ex-

pectorants. And in the gastrointestinal category, Sanofi

core brands in liver remedies, antidiarrhoeals and probi-

otics complement Boehringer Ingelheim’s core brands

in Laxatives and Inflammatory Bowel Disease (IBS). Their

businesses are also synergistic from a regional perspec-

tive.

He points out that the Reckitt Benckiser acquisition of

Mead Johnson Nutrition extended its focus on ‘mums’

to include babies, recalling the keynote address of CEO

of Reckitt Benckiser, Rakesh Kapoor, from the AESGP

Annual Meeting London 2014 that it’s all about “mums

not molecules.”

He observes that overall, there is fragmentation in the

market, and a polarised picture, with consolidation at

the top and fragmentation, lower down, as local and

regional player continue to grow strongly and take

shares from the mid-tier players. As a result, the gap

between the market leader and No.10 continues to

grow, illustrating the difference in scale, as the big play-

ers become enormous. There has also been a lot of pri-

vate equity interests, interested in the OTC space.

He notes that innovation remains the key growth driver,

particularly in developed countries (where there tends

to be base volume decline). New products, market ex-

tensions, and OTC switches remain the only way of driv-

ing value in the market. Globally OTC is 41% bigger than

it was 5 years ago in 2011, with 29% growth being

through new products/line extensions, 9% through price

increases of existing products and 3% through volume

increases of existing products.

Looking to the future, Tisman highlighted the

“increasing leverage” of combining research and devel-

opment and consumer insights to drive differentiation

and growth. “Switch is being leveraged as a growth driv-

er with successes and failures. “The market continues to

broaden from OTC to health and wellness,” he observed,

“with medical devices potentially offering a faster ‘go-to

-market’ innovation route.” Chanel mix and go-to-

market continue to be important and companies contin-

ue to face the challenge of resource splitting between

the direct-to-consumer, the healthcare professional and

the trade customer.

“Overlaying all of that”, he says is “the rise of digital

which is playing an ever more important role, both in

terms of promotion and a route of distribution for prod-

ucts”. He also notes that increasingly companies see the

value in open innovation.

Andy Tisman

Conference report

10

He concludes by stating that the OTC market continues

to show steady growth and attract new competitors.

Mega-deals have driven corporate growth. The question

is how can those in the “middle ground” avoid the

squeeze as the local and regional players continue to

grow strongly.

Market perspective

Chris Slager, Global President, Pfizer Consumer

Healthcare presented his perspective on the OTC busi-

ness coming from a food industry background. He be-

gins by comparing and contrasting the two industries

with some market fundamentals. Looking expansively,

he comments that both are very large. The food indus-

try is a $3 trillion market. OTC Health and Wellness is

about $2.5 trillion and incorporates functional nutrition,

personal care, hygiene, wellness services, consumer

health equipment and wearables.

Both have similar global compound annual growth rates

(CAGRs). There are mid-single digit CAGRs which con-

tinue to grow. Both industries have a diverse set of

competitors. Who really is the competitor is changing

everyday as the consumer’s perspective changes. He

also notes that regulation is another area where the

food and consumer healthcare businesses overlap.

Both businesses are characterised by significant pricing

and margin pressures given retail consolidation. He

points out that increasingly, we can see consolidation in

food and OTCs as a way to gain scale and manage

costs/profitability. One significant difference between

businesses is the prescription to OTC switch. “In the

food industry”, he concedes, “the ability to dramatically

increase revenue and income doesn’t exist”.

The biggest trend in both businesses is the growing

interest in wellness and the consumer’s focus on well-

ness is blurring the lines between OTCs and food as

consumers are seeking wellness solutions. Consumers

are looking for a quality experience which he describes

broadly with the terms “trust, ingredients, and conven-

ience.” He explains that consumers want brands they

can trust against the backdrop of a global decline in

institutional trust.

Trust is higher with small businesses than big ones and

the gap is widening. According to the Gallup poll, confi-

dence in small business has increased by 6 percentage

points between 2014 and 2016, while confidence in big

business has declined by 3 points. He explains that the

same trend is evident in the food industry. He explains

that Nielsen data show how these trends are impacting

Chris Slager

11

the processed food business. Small and medium brands

account for 35% of sales, but an overwhelming 75% of

growth. While the top 50 brands still account for the

majority of sales, it is smaller brands that account for

growth in the market of the top 50% of brands account-

ing for only 3% of growth.

When consumers trust a brand, they try more, buy more

and pay more, which leads to a greater market share for

smaller companies. He explains that this trust is chang-

ing the way “consumers vote with their dollars day in

and day out.”

From an ingredients standpoint, consumers are looking

for more accessible information. Consumers gravitate

towards buzz words like “organic” because of connota-

tions of trust and a quality experience. Consumers also

want convenience. E-commerce and the growth of mo-

bile shopping and options such as “click and collect”

indicate where investors see the future of retailing.

He remarks that the theme of the conference “Self-care

in a changing world” is very appropriate, given trends in

the market; focus on wellness; the blurring of lines be-

tween food and OTCs; and consumer’s desire for brands

they trust, leading to a demand for a quality experience.

“Our consumers are shaping this”, he says and “we need

to keep a focus on consumer’s needs.” “Thinking

through how to build trust, better ingredients and deliv-

er convenience”, he says “will help us to deliver self-care

in a changing world.”

How to Be Successful in Self-Care

Olaf Schwabe, Chief Executive Officer, Schwabe, de-

scribed the history of his company, Schwabe, which cel-

ebrated its 150th

anniversary in 2016. It was founded by

Dr Willmar Schwabe who was his great great grandfa-

ther in Leipzig. In 1878, the first phytopharmaceutical

product, Hametum, was developed. In 1946, the compa-

ny relocated to Karlsruhe and, in 1961 DHU, which is

specialised in homoeopathic products, was founded.

Schwabe has a presence in all five continents. Relevant

Research and Development (R&D) investment takes into

account the focus on self-care. Home market sales grew

by 11 % from 2013 to 2016 and international sales grew

in the same period by 42 % - now representing 3/4 of

Schwabe Group sales. It had seen major growth in

North America and China. Tebonin®

is their biggest

brand with approximately 30% of the total sales volume.

Launched in Germany in 1965, Tebonin®

– the first ever

Ginkgo medicine – gained the number one position in

the German pharma market in the 1980s and is the

number one Ginkgo brand worldwide. Ginkgo biloba

Special Extract EGb 761®

is approved for the treatment

of cognitive disorders, tinnitus and vertigo. “Analysis

over 10 years and almost 400 batches of EGb 761®

found that it has a unique, consistent composition,

while other ginkgo extracts differ significantly,” he said.

Schwabe has its own Ginkgo plants and decades of ex-

perience in creating batch to batch consistency for EGb

761®

with a patented 20+ step extraction process.

”More than 50 randomised controlled clinical trials with

more than 7.000 patients and several meta-analyses

confirm efficacy”. Tebonin®

is included in therapeutic

guidelines related to their indications in many countries

in Europe as well as outside Europe.

All non-prescription medicines in Germany were exclud-

ed from reimbursement by public health insurances in

2004 following a package of cost containment measures

which were a significant threat to Tebonin®

, as more

than 60 % of sales came from prescription. However,

Schwabe was able to even increase sales with a two-

Olaf Schwabe

Conference report

12

step strategy: Medical doctors were re-assured of the

therapeutic benefits of Tebonin®

and convinced to fur-

ther recommend Tebonin®

(without reimbursement or

only coverage by private insurance) and investments in

direct to consumer communication were increased (e.g.

TV promotion). Schwabe also extended its business in-

ternationally to become less dependent on the home

market.

Tebonin®

is now available in more than 50 countries.

The most recent countries include India and Israel. Inter-

national sales have almost doubled in 5 years. He ex-

plained that the success is based on the fact that it is of

high quality and clinically tested. Manufacturing takes

place in Germany and, by that, an excellent quality is

produced close to the customer.

“To further remain successful, it is important to identify

relevant consumer needs and trends and adapt accord-

ingly.” There is no doubt that health will remain a mega-

trend – especially as the global population gets older. In

less than 30 years more than 1 billion people will be

over the age of 65. Often the industry is asked to offer

convenient solutions for different health issues. But he

explained that the 65-year-olds of the year 2050 are

today in their early 30s and in many ways they will be-

have differently – not only in media usage but also in

expectations towards a more individualised medicine.

He explained that this is one of the reasons why we

need to transform, “from being a manufacturer and

marketer of medicines to a company that offers individ-

ual health solutions.”

“Digitalisation will be key” in this process,” he said. He

gave the example of a newly developed Tebonin App

with exercises for Vertigo sufferers. This innovative solu-

tion ensures an individualised exercise programme that

reflects the specific needs of the user. It was launched in

Germany at the beginning of this month and will be

rolled out in Europe soon.

The Schwabe business has significantly changed in the

past 150 years. He concluded by saying that, as a family

company, Schwabe will continue to strive for innovative,

efficient and safe solutions for various health issues with

products from nature according to their vision: From

nature. For health.

Succeeding in smoking cessation through

consumer insight and innovation

Catherine Devine, Global President, OTC Franchise,

Johnson & Johnson, gave an example of a success story

based on consumer insights and partnering with the

consumer. Rather than focusing on the functional char-

acteristics of its products, Nicorette’s mission is “to save

the lives of consumers by being the partner of choice to

help smokers take control of their quit journey and

break free from tobacco for good.”

“The smoking cessation category is important, as there

is still a significant number of smokers in the world – in

total 1.4 billion – which is the current population of Chi-

na.” Contrary to all political efforts, smoking is expected

to continue to rise in the next 20 years. Smoking has a

known and significant negative impact on health. The

World Health Organisation (WHO) cites six million

deaths from tobacco and causes hundreds of billions of

dollars of economic damage worldwide each year. “If

current trends continue, by 2030, tobacco will kill more

than 8 million people worldwide”, she quoted. “86% of

Catherine Devine

13

all lung cancer in the UK are linked to smoking”, she

added.

The dangers of tobacco are becoming more known;

hence consumers are trying to quit smoking. However,

many underestimate how difficult it is, with most people

in need of numerous attempts to successfully quit – and

many never managing to do it. Quitting is made diffi-

cult because of the physiological addiction from nico-

tine and the physical, emotional, situational and social

‘addictions’ that comes with giving up smoking. “As it is

most personal, it can feel that smokers are giving up

part of who they are – they are defined by their smok-

ing, and are fearful of what it means if they are not a

‘smoker’ any longer.”

In order to be able to help a quitter to give up smoking,

Nicorette®

built on these consumer insights of the quit-

ting journey and developed an innovative approach in

many senses in relation to communication. From this,

Nicorette®

came up with their slogan: “Do Something

Amazing.”

It speaks to the huge sense of achievement that comes

with finally beating smoking and the opportunities it

can open up. Mrs Devine explained that it is very moti-

vating to speak to smokers like people, not patients,

and applauded those who are brave enough to try and

quit and it focused on the positive end goal, not just

the struggle.

Their latest innovation QuickMist also leverages the key

consumer need around those tough ‘struggle’ mo-

ments. QuickMist provides the fastest craving relief in

the category and is supported by strong claims (150%

more likely to quit, relieves cravings in 60 seconds).

Nicorette’s approach to insight-led innovation has re-

ceived a number of recent recognitions and awards.

“Through insights, Nicorette®

was able to create truly

consumer-led innovation (communication, product, and

channel innovation) to ultimately help consumers break

free from cigarettes and live a longer, happier life,” she

summarised.

On digitalisation, she explained that to stay current in

what was a rapidly changing digital environment, com-

panies could afford to take a “leap into the dark” on

new digital services.” Generally, digital activities were

low cost and so companies could afford to “throw a lot

of things out there.” “If you are not having failures [in

digital], you are not moving fast enough,” she insisted.

She warned delegates of the conference that we need

to “get comfortable with having two-way conversations

with consumers in the digital space or become irrele-

vant.”

Consumer centricity, digital and partner-

ships

Dirk Ossenberg-Engels, AESGP Vice-President and

Head Region Europe South, Central Eastern Europe &

Middle East, Bayer Consumer Care, began by acknowl-

edging that we are in “an exciting and challenging mo-

ment for self-care.” He asked the audience what is the

reason they get up in the morning, “is it to sell boxes”

or to “make an impact on consumers and society”?

He went on to explain his perspectives on how to be

successful in self-care, which in reality features a combi-

nation of consumer centricity, digital and partnerships.

He explained that consumer behaviour is changing

more rapidly and is becoming more diversified. It is

therefore increasingly important to address consumer

needs, “and pick up on nuisances” to find targeted solu-

tions for consumers.

He then gave an example of turning a consumer insight,

driven by a medical need, into a clear tangible benefit

with a line extension. One of Bayer’s franchises, Copper-

tone®

, is based on a consumer insight that the single

biggest barrier to applying sun protection is how the

cream feels on the skin. It also addresses the need to

prevent skin cancer, which is the number one cancer in

the US and is growing. Coppertone®

whipped launched

into 2017 and has been the recipient of a number of

awards.

Conference report

14

“The future is not digital,” he said, keeping the audience

in suspense, “the future is now.” 60-80% of consumers

use smartphone today. It is a reality for our consumers.

$1.9 trillion was the turnover through e-commerce in

2016 and this is expected to increase. Digital can be

used as a platform to provide services, information and

engage with consumers.

Bepanthen®

, he explained, is based on a consumer in-

sight that after pregnancy, the attention shifts from the

mother to the baby. They then developed the 10th

-

month initiative. He then showed a video illustrating the

emotional bond they created with this initiative.

Launched in Turkey, in a few weeks it was seen by 2 mil-

lion people. The website is also now online in nine

countries, six in Europe.

Big data is expected to double every 24 months. He

gave an example of the product Aleve®

in the US which

made use of big data. The company received feedback

from consumers for a non-systemic alternative, and big

data, online threads were used to confirm this gap in

available treatment. They partnered with the TENS

(transcutaneous electrical nerve stimulation) technology

and launched Aleve®

direct therapy in 2015.

“We are getting in better on digital partnerships,” he

said. Ossenberg-Engels then described some non-

commercial partnerships, which he believes companies

should develop. Bayer has partnered with 18 stakehold-

ers – including the White Ribbon Alliance (which advo-

cates for mother and baby’s rights and health), the Unit-

ed Nations where Bayer participated in the ‘Every Wom-

an, Every Child’ Movement and WHO – to launch a poli-

cy position on the role of self-care in maternal, new-

born and child health.

“Success in self-care ultimately provides a unique bene-

fit to consumers, society and health care systems,” he

concluded.

Dirk Ossenberg-Engels

15

The Changing Environment for Health Professions

From left to right: Jacques de Haller, President, Standing Committee of European Doctors (CPME); Briain de Buitleir, CEO, PGT Healthcare; Cristina Cabrita, Senior Project Officer, Deco Proteste, representing the European Consumer Association BEUC; Jurate Svarcaite, Secretary General, Pharmaceutical Group of the European Union (PGEU); Lilian Azzopardi, Presi-dent, European Association of Faculties of Pharmacy (EAFP); Max Wellan, President, Austrian Chamber of Pharmacists

A key prerequisite for a positive development of self-

care remains the attitude and support provided by

health professionals including in particular medical doc-

tors and pharmacists. Leading representatives of the

professions discussed concrete ways forward in times of

growing consumer empowerment and an unprecedent-

ed variety of information. Briain de Buitleir, Chief Exec-

utive Officer, PGT Healthcare, introduced the session by

saying that we are all in the same business, healthcare

professionals, regulators, because “our business” is giv-

ing patients “longer, healthier lives” and in this business

the demand is insatiable. This is creating a crisis for the

pension industry as people live longer lives. He remarks

that we are at an inflexion point because there is the

question now of whether this rate can increase further.

Self-care has an important impact on this rate.

“Looking ahead,” he said, “self-care and the professions

have increasing opportunity to make a positive impact

and better tools and technologies to do it with.”

Of the money spent on helping people live longer, 80%

is spent on chronic disease. However, he believes that

money is better spent on prevention, diagnosis, and

pharmacogenomics. Prevention is accelerating at an

enormous rate, he said, and elaborated on this with an

example of capsules which can be “injected into a per-

son’s hand to read blood and act as a security mecha-

nism.”

CPME supports Self-Care

Jacques de Haller, President, Standing Committee of

European Doctors (CPME), first introduced CPME, which

is the umbrella association for the National Medical As-

sociations of 28 countries in Europe. It represents both

General Practitioners and specialists and, by that, more

than 1.5 million doctors. CPME articulates the medical

profession’s point of view to EU institutions and Europe-

an policy-making through pro-active cooperation on a

wide range of health and healthcare related issues.

The key point of Dr de Haller’s presentation was an ex-

planation of the outcome of the EU-funded pilot project

on the promotion of self-care systems in the European

Union (PiSCE), which has been developing and produc-

Conference report

16

ing communication tools and a series of proposals and

EU policy recommendations and actions on self-care. To

come up with the recommendations, three main meth-

ods were used: review of existing self-care related EU

policies; a survey on the needs of people/patients; and

input of the PiSCE Platform of Experts. This began with

a mapping of existing European self-care initiatives,

which found, for example, that patient safety is at a

more advanced stage of implementation compared to

health literacy.

The main findings of the survey on the self-care needs

of people/patients conducted by the European Con-

sumer Organisation (BEUC) and the European Patient’s

Forum (EPF), identified that the needs of persons ex-

posed to self-management interventions were health

information, access, support from healthcare profes-

sionals, patient groups and families. The main barriers

to self-care were low health literacy, costs of self-care,

difficulty to navigate the healthcare system and lack of

information. The survey also found that vulnerable

groups should be the main target when developing and

implementing self-care policies. 65% of respondents

indicated that they are ready and willing to bear neces-

sary costs of self-care (reflecting an understanding of

the importance of self-care).

Existing self-care related EU policies

Jacques de Haller

17

Themes brought up by the PiSCE Platform of Experts

include empowering patients to be more ‘internet-

savvy’ in terms of judging the quality of information,

empowerment through knowing when to seek profes-

sional advice, good inter-professional cooperation and

the need to educate pharmacists, doctors and patients

to change their behaviours.

The EU Policy Recommendations integrate new tech-

nologies to support people’s self-care (making health

information easily accessible for patients to make in-

formed decisions), embed self-care in health literacy

initiatives (which is still not usual practise), to establish

a framework that will encourage the exchange of best

practices on self-care, to secure an Engagement Plat-

form to support national or regional initiatives on self-

care, and to include self-care in school education and

life-long learning to teach young people how to man-

age their health (which, Dr de Haller remarked, was a

strong proposal of the PiSCE project). The inclusion of

skills to support self-care as part of the curriculum in

education and training of health professionals was also

part of PiSCE project.

He stated that “CPME supports self-care”, commenting

that the association has been fighting prejudice about

this for years. Self-care supports and enhances the dig-

nity of patients. However, he believes that self-care

must not lead to or permit missed or belated diagnosis,

lead to wrong or dangerous use, to the abuse of medi-

cations, or be used as a commercial lever (as patients

aren’t just consumers).

“Self-care will change lots of things over the next 20

years, including the professional identity of doctors,

pharmacists and other healthcare professionals”.

He concluded with the following remark that “self-care

belongs to society as it develops nowadays […] and it is

essential that health professionals be realistic members

of the society.” He also remarked that self- care should

play a greater part in our health systems.

PiSCE Recommendations

Cristina Cabrita, Senior Project Officer, DECO

(Portuguese Consumer Organisation), Proteste, Portu-

gal who works as an expert in the PiSCE project talked

more about the policy recommendations of the PiSCE

project, which covers five minor disease areas, namely

cough, cold, urinary tract infections, heartburn and ath-

lete’s foot. These were selected after a benefit-cost

analysis by the European Commission.

The self-care platform, she explained, consisted of 23

experts on self-care from all over the EU with expertise

in self-care: self-management, patient empowerment,

health literacy, integrated care, health technologies, self

-medication, and expertise related to EU, national and

regional levels. Experts are individuals with affiliations

that represent central actors needed for EU, national,

regional and local levels on self-care: primary care phy-

sicians, pharmacists, nurses, patients, academia, com-

munication specialists, consumers, the self-medication

industry, etc.

Part of the project was the carrying out of a survey to

identify barriers for practising self-care.

Weak health literacy, she explained, leads to less

healthy choices, less therapeutic adherence/

compliance, riskier behaviour, poorer health, less self-

management and more hospitalisation.

“Around 50% of people have difficulties when trying to

use Internet to look for health-related information.”

This was related to not having the skills to evaluate the

health resources found on the Internet and difficulties

to find correct health-related information. Functional

literacy was also assessed and revealed difficulties

when asked to use simple information to manage the

administration of a drug.

Health literacy and self-care in early childhood are criti-

Cristina Cabrita

Conference report

18

cal, she explained, and interacting with parents and

family members through early childhood programs is

important, e.g. through child-to-child programmes.

Children can then teach parents about self-care. It is

therefore important to equip teachers to integrate self-

care in schools and in the curriculum. She then gave

examples of videos, play games which were developed

to test health knowledge, run by the Finnish Medicinal

Products Agency, targeted to each year school. It should

be lifelong learning and be either informal through daily

reading or formally structured.

To include self-care in health professional education,

this requires skills, knowledge and attitudes from

healthcare professionals, to treat the person as an indi-

vidual, to actively listen, communicate and set goals

together.

She concluded by stating that self-care needs to be evi-

dence based, with teachers and parents on board and a

political will behind it.

Community Pharmacists and Self-care

Jurate Svarcaite, Secretary General, Pharmaceutical

Group of the European Union (PGEU), began by noting

that surveys from the European Consumer Organisation

(BEUC) and the European Patient’s Forum (EPF) shows

that patients are more willing to make self-care deci-

sions. “Self-care is not just self-medication but includes

anything patients do to care for themselves.” She ex-

plained that increasingly patients are seeking holistic

care, not just seeking treatment as a condition, “as a

migraine” for example, but to be treated individually to

maintain their health and stay active members of socie-

ty. Healthcare is not just about treating diseases. It is

also good for the economy as people can continue to

live their usual lives. Pharmacists can act as gatekeepers,

to refer/signpost the patient as appropriate, highlight-

ing that inter-disciplinary collaboration is important.

However, she explains that self-medication is a tool to

provide immediate support.

On the PiSCE recommendations, she added that the

greatest strength of the project, for the pharmacists,

was sitting down and discussing the ideas together as a

healthcare team even though the recommendations

could have been a little more challenging.

Reflecting on earlier discussions on digitalisation, she

explained that “the world is changing and healthcare

professionals are also changing.” The pharmacy profes-

sion was one of the early adopters of technology, and

are increasingly writing blogs and interacting with pa-

tients through other channels, for example, pharmacy

Facebook pages.

Alluding again to changing patients, she explained that

“we [healthcare professionals] need to change with

them”.

Barriers to self-care according to PiSCE survey

19

“Access is not just about having a pharmacy around the

corner”, and her vision is for community pharmacy to

be “the smart care around the corner.”

Shifts in pharmacy education

Lilian Azzopardi, President, European Association of

Faculties of Pharmacy (EAFP), began by describing the

challenges for pharmacists in managing complex pa-

tients, handling big data, complex therapies and from

an industrial perspective, how production facilities are

affecting the environment. When EAFP was set up, it ran

a curriculum mapping exercise, which found that chem-

istry subjects dominated the curriculum. In 2006 anoth-

er curriculum exercise was run, which showed a shift in

focus to the medical sciences in pharmacy curricula.

Leufkens, with leaders in clinical pharmacy in the 1990s,

came up with a model that for pharmacists to maintain

their position as healthcare professionals, they need to

put the patient first, be proactive, and partner with the

patient and other healthcare professionals towards im-

proving self-care.

This shift in education was confirmed by a publication

in 2016. The curriculum with the highest mean percent-

age of clinical sciences was the United States at 16.7%

followed by Malta and the Netherlands at 12.3%.

This shift in education goes hand in hand with the need

to maintain knowledge and merge science. Realising

that practice is changing and that patients need to be

supported to navigate health information are important

prerequisites to make change happen.

The future vision is to include clinical pharmacy, and

pharmacy practice as subjects in the EU Directive on

Pharmacy Education, and to support the development

of faculty and opportunities for research in self-care.

At the University of Malta, there is a post-graduate pro-

fessional post doctorate in pharmacy (EU-USA collabo-

Jurate Svarcaite

Conference report

20

rative degree) which focuses on self-care and empower-

ing patients. A third-year student of this programme

completed a research project on Optimising Patient Self

-Medication through the Community Pharmacist which

identified that out of 203 patients reviewed in commu-

nity pharmacy, 38 (19%) had at least one drug-related

issue.

At their recent annual conference in Helsinki, EAFP re-

flected on the challenges and what needs to be done

from an academic perspective. The conclusion was that

there is a need to maintain the science-based aspects of

the curriculum, to have lifelong learners, individual pa-

tient inspiration, interdisciplinarity, and be able to deal

with new therapies, innovations, health systems, and

technology.

“Pharmacy education rather than looking at subjects

should look at the competencies graduates need to

contribute to self-care, to look at what is needed in

pharmacy education and how the future should be

shaped,” she concluded.

Pharmacogenetics and “ApoApp”

Max Wellan, President, Austrian Chamber of Pharma-

cists, began by explaining that patients and people are

mobile. Seven years ago, apps provided on medical/

pharmaceutical information but did not provide trustful

information. Now ApoApp, by the Austrian Chamber of

Pharmacists, is the number one app in healthcare in

Austria for six consecutive years. It provides information

on pharmacy opening hours, contact information and

information about medicines. They also invited the self-

care industry to provide additional tutorials about their

products, so that it can be accessible from the app. It

contributes to health literacy by having all the infor-

mation at hand and also signposts when to seek a phar-

macist’s advice.

“Apoatschool” is an app designed to equip pharmacists

to go into schools and signpost red flags to look out for

(which meets a PiSCE recommendation to include self-

care in school education). He remarks that “patients are

not consumers but are the co-producers of their health,

pharmacists are co-producers, and we are all co-

producers of health.”

The Austrian Chamber of Pharmacists also ran a phar-

macogenetic project in the form of a self-experiment

and invited pharmacists to make their own pharmaco-

genetic profiles. This project would enable pharmacists

to counsel patients on pharmacogenetics and to pro-

vide information to doctors. He remarks that a lot of self

-care products are also connected to pharmacogenetics,

highlighting the need for pharmacogenetic counselling,

as an additional safety step for self-care products.

Lilian Azzopardi Max Wellan

21

Digital Revolution – Self-Care Revolution

Conference report

One of the most exciting trends in healthcare is the

more and more visible impact of digitalisation. The ses-

sion, moderated by Alan Main, Executive Vice-President,

Sanofi Consumer Healthcare, provided an overview of

the challenges for the industry as a whole and the op-

portunities resulting from the developments in the digi-

tal space. An important part of the session was dedicat-

ed to the developments around the use of big data.

Alan Main introduced the session by describing the

positive implications of digitalisation for self-care, also

making reference to the recent ransomware attacks, and

the need for increased vigilance. He explained how digi-

talisation has had the biggest impact on the capability

of systems: Diagnosis (such as advanced MRI scans to

detect prostate cancer), treatment (using nanotechnolo-

gy), monitoring (remote monitoring cardiac devices)

and mobile health apps. “This digitalisation is empower-

ing patients, who now want to play a more active role in

their own health,” he said. He also remarked that digi-

talisation could be used as a mechanism to build trust

with patients.

“Data is often uncensored and unviewed.” Main quoted

that 85% of data was created in the last two years. Re-

ferring to a US survey, Main noted that 80% of people

are willing to share data if they believed it would im-

prove health outcomes for them individually. 60%

would share their data for health research, and 40%

would share information for money. He noted that 85%

of people would be willing to share information with

healthcare professionals, 40% of health insurance com-

panies (for discounts). Interestingly, 16% of people

would be ready to share healthcare information with

industry, 8% with Tech businesses and 8% would share

health information with the government.

He concluded by saying that the data is there, and peo-

ple are willing to share it. “The question is: how are we

going to capture that?”

What do big industry players think?

Brian Ager, Secretary General, European Round Table

of Industrialists (ERT), opened his presentation by ex-

plaining who and what the ERT are. “Members include

55 Chairmen and CEOs of major European multinational

global companies,” he told delegates of the AESGP con-

ference. “These multinationals are primarily cross-

sectorial and cross-country industrials,” he explained.

Since the 1980s, one of its early objectives was to stimu-

late and establish the European Single Market. ERT’s

vision is to “strive for a strong, open and competitive

Europe, with the EU as a driver for inclusive and sustain-

able growth.”

Its priority concerns at the moment are the stabilisation

and promotion of the European Union without the UK,

the impact of globalisation on citizens, and to maintain

and strengthen transatlantic relations and open trade.

Some of it workstreams, each led by a CEO, include en-

ergy and climate change, trade and market access, soci-

etal changes (arguing for the best prospects for youth

employment), gender diversity, encouraging entrepre-

neurship, and digital. Outputs then feed into its contact

programme with political leaders. ERT meets regularly

with political leaders such as Chancellor Merkel or the

European Commission President Juncker.

“Digitisation offers opportunities for all industrial sec-

tors,” he purported. “It is a driver of growth, competi-

tiveness and jobs (for the private, public, and govern-

ment sectors), and to regain its industrial strength, Eu-

rope needs to embrace the new digital society,” he ex-

plained. “It will also demonstrate that the EU can deliv-

er,” he added.

Alan Main

22

He explained that ERT policy priorities on digitalisation

are to deal with the high level of Cybersecurity required,

improving connectivity in Europe by investing in tele-

communications infrastructure to overcome barriers to

the single market fragmentation and harmonisation and

cross-border cooperation. He highlighted the need for

“a real European Digital Single Market” with “all mem-

ber states working together in the same structures.”

On digital data, “free flow of data is vital.” He comment-

ed that the General Data Protection Regulation (GDPR)

is not bad regarding setting out a level playing field for

Europe, but the e-Privacy Regulation “duplicates and

counteracts it.” We are moving fast, and Europe must

optimise its involvement if we are to succeed and move

forward in the coming years.

Customer experiences in the digital world

Max Orgeldinger, Senior Digital Strategist, at Torben,

Lucie und die gelbe Gefahr (TLGG), a digital agency, de-

scribed how digital experiences could affect patient be-

haviour with the example of a Taco Bell’s Snapchat ac-

count. “It is always interesting to see the peculiar expe-

riences that can arise when new technology arises,” he

remarked.

One of the most significant current trends is the dra-

matic increase of smartphone devices over the last few

years.

An example he gave of a company profiting from in-

creased mobile technology was Instagram. Founded in

2010, it was bought by Facebook and is now worth $55

Billion, far above the value it generates.

Smartphones are now surpassing desktop computers

and “the number of microprocessor transistors in a giv-

en space is doubling every 18 to 24 months.”. “This

means smaller, faster, cheaper technology that is ena-

bling all kinds of experiences.” Orgeldinger explained

that these tend to be simple experiences, in areas such

as information sharing, communication, entertainment,

and transactions. But more importantly, it will “reinvent

a given behaviour around the technology that has

emerged.”

Technological progress is creating new possibilities at

exponential growth rates, but not all companies are lev-

eraging this. “CEOs don’t all take these developments

seriously, such as how Netflix was perceived in the be-

ginning,” he noted.

“Technology takes the path of least resistance. It is diffi-

cult to force internet experience on users, and even if it

may currently control customer experience that doesn’t

mean they will continue to follow that experience”, he

explained. Successful companies have become a verb to

own that experience, for example, Twitter’s experience is

“to tweet.” They then get customers used to associate

that experience with their service.

Companies that reinvent experiences around techno-

logical changes often see robust growth, he remarked.

“Convincing customers to adapt new behaviours re-

quires extremely refined experiences and creating these

experiences requires companies to take digital serious-

ly,” he reminded delegates at the AESGP Annual Meet-

ing.

Brian Ager Max Orgeldinger

23

Conference report

Age of disruption and opportunity

John Walsh, Co-founder of Smart Insight Lab, referred

to the Fourth Industrial Revolution and remarked that

there “has never been a more interesting and challeng-

ing time to live in than today in terms of technology

and business.” He emphasised the importance of ethics

and “what do we want as a company/individual to go

forward.” Social Media will help us to move forward, he

explained, and empower people more to decide what

they want. “Digital is the driving force (“oxygen”), with

customers at the heart, and people as the soul in the

company/organisation.”

He reflected on the 2020 healthcare landscape where

informed and demanding patients are now partners in

their healthcare. In the era of digitised medicine – there

would be new business models to drive new ideas.

Wearables would be used to measuring the quality of

life rather than just being clinical indicators. Health data

and big data will be pervasive requiring new tools &

models.

“This business is lagging behind,” he said, as some com-

panies face problems from new competition, emerging

technologies, the explosion of new data and psycholog-

ical/behavioural economics. A Deloitte survey on where

healthcare is going found that “healthcare is a moving

environment which is lagging behind, and needs to be

moving faster and better.”

He remarked that there is minimal data out there on “a

girl’s headache” since there is little open data and

closed data is expensive to access. “More and more

people are going online/on Social Media/Google to see

if there is a knowledge base available to consult before

buying.” Massive time is spent on building a decent

knowledge base, he said.

He reflected on the importance of social engagement

and intimacy involved in selling information about a

product and giving customer “an experience”. We have

been “so focused with disruption we were not looking

at the bigger picture,” he said. In his view, a 2030 strate-

gy needs to be developed to incorporate the 4th indus-

trial revolution scope and digital and data strategies.

“There is a need to focus on corporate digital transfor-

mation programme, the full journey, and to refresh the

existing operational model(s),” he said. Customer and

business adaption to the new GDPR is required. Howev-

er, he warned that if business adaption to GDPR is too

slow, it will lag behind. He also recommended that

pharmacy sites become more integrated, open to en-

gaging the customer. “New business models to engage

customers are also required,” he explained.

As we move from “big data” to “smart data”, as he pre-

fers to call it, his advice to OTC companies was to take a

broader longer-term view. “We are currently focused on

disruption,” he said. “Now is the time to look at the big-

ger picture and develop a robust digital and data strate-

gy.”

24

Smart data helps build wise companies to think ahead.

He explained that machine learning would become big

in the next two to three years (and has already been

introduced with Microsoft Office 365). He also remarked

that at least one in ten big data projects fail to meet

their objectives.

He concluded with some key messages on data privacy

and the new General Data Protection Regulation which

guards private and personal data. “There is an oppor-

tunity to build trust with customers and value-driven

approach and in doing that we should see GDPR as a

value proposition,” he said.

Finally, he raised the question “how can we regain data”

and commented that popular search terms don’t in-

clude “Europe” and recommended a single platform for

online health information.

Thomas Senderovitz, Director General, Danish Medi-

cines Agency, Denmark, explained that nowadays tech-

nology development is exponential. “Patients are be-

coming consumers; the population is ageing and data is

big.”

“Every 24 months the volume of electronic healthcare

data doubles” he explained. There are more than 210

exabytes of available healthcare data today, he stated.

“90% of the world’s data has been created in past two

years.” However, 80% of data is unstructured, so the

challenge is how to make sense of this data.

Another problem is turning big data into knowledge

and knowledge into decisions, regulatory decisions,

pharma decisions, and medical/scientific decisions. He

explained that the work plan of the joint Heads of Med-

icines Agencies (HMA)/European Medicines Agency

(EMA) Task Force on Big Data, of which he is co-chair, is

to characterise relevant sources of big data and define

the format. Sources of big data include genomics and

other “omics”, observational data, clinical trial data, So-

cial Media health, IT/infrastructure and spontaneous

adverse drug reactions (ADRs). Other objectives in the

work plan are to identify areas of usability and applica-

tion of datasets, describe the current status, future

needs and challenges and generate a list of recommen-

dations and a Big Data Roadmap.

Recommendations for how European regulators should

deal with the exponential growth of big data will be

made in just 18 months’ time, he promised. “We cannot

spend the next five years working on a guideline – it

would simply take too long,” he said. “Regulators can-

not ignore the role of real-world data after drugs have

been approved,” he added.

He also highlighted the role of Social Media, wearables

and sensors in generating post-approval data. “We have

to look at data differently, and we have to devise differ-

ent ways of making decisions,” he explained. Drug de-

velopment and approval had been a linear process tra-

ditionally, but the timescales now were such that in fu-

ture some of the regulatory work would have to be car-

ried out in parallel, he believed.

Data quality was an issue for Senderovitz who was dubi-

ous that the algorithms that were being used in health

apps had been properly validated and were making the

right recommendations. “More and more, it’s a black

box,” he said.

He concluded by stating that big data is relevant for

regulators, sponsors, healthcare professionals and citi-

zens/patients and that the HMA/EMA has started to

address the challenges and opportunities that come

with big data.

John Walsh Thomas Senderovitz

25

The session, moderated by Laurent Faracci, Global Cat-

egory Officer and Head of RB’s Category Development

Organisation for infant and child nutrition, discussed

what digitalisation means in concrete terms, what the

role of companies like Google and Facebook could be

and how European consumers see these developments.

Acquiring Mead Johnson “created an inflexion point in

the growth of RB as a business and will have a signifi-

cant impact on RB’s consumer health portfolio,” accord-

ing to Faracci.

“It increases the firm’s consumer healthcare franchise by

90%,” he added. The deal – which is expected to close in

the third quarter of 2017 – would also considerably in-

crease its market presence in Asia.

Introducing the topic of the session, Faracci also made

reference to the increased use of mobile phones and

decrease in time spent watching TV. He also noted that

increasingly voice is beginning to replace typing in

online queries. “20% mobile queries were made via

voice in 2016, and the accuracy is now about 95%” he

explained.

Google’s potential in the healthcare space

Karl Pall, Director Brand Solutions, Google, started off

his presentation by giving background on where Google

sees itself sitting in the health area. “Google’s mission is

to organise the world’s information and make it univer-

sally accessible and useful. So, it should not be a sur-

prise that since the beginning we have always seen our-

selves as an outlet for information about healthcare,” he

said.

“Digitisation has rewritten the rules of the game in

healthcare information. The internet is now the number

one source for healthcare information. Information is

just a fingertip away.” Many people look at their phones

150 times a day.

“The result is that there are now billions of healthcare

queries every day. In Germany alone, there are more

than 6.2 billion per year,” he quoted. One in 20 searches

on Google is health-related. It is one of the most

searched topics on Google, and it is growing, with query

growth rates of around 10%, he explained.

Google is “the world’s largest database of intentions” –

people ask Google everything. Google can, therefore,

offer a broad array of publicly available tools by aggre-

gated search data, and thus can help provide valuable

consumer insights by understanding the patient/

customer journey better and help provide the right in-

formation to consumers/patients.

“Over 85% of people who use the Internet say that

when they have a health concern or question they begin

at a search engine like Google to find information”.

Ehealth Facilitating Self-Care

Conference report

Laurent Faracci Karl Pall

26

“Therefore, Google has taken the responsibility of bring-

ing health information to consumers/patients and have

enhanced their health search functionalities over the

years, most recently with things like the health

knowledge panel which shows up on the right side of

the screen on a desktop or the top of the screen on mo-

bile when a query around a condition is entered.” He

explained that data are vetted by 11 physicians and ap-

proved by Harvard Medical School and the Mayo Clinic.

“Google also sees some health trends.” He explained

that each time someone searches for a health-related

term, a drug name or condition; it provides an insight as

to how consumers are seeking to learn about their

health. “So understanding this data is something that is

very important to Google as we think about what our

next big bets are,” he explained.

Facebook keen to partner with Healthcare

industry

Leigh Thomas, Director of Global Client Partnership,

Facebook, said that Facebook was interested in partner

with consumer healthcare companies for the good of

both the healthcare industry and the over a billion peo-

ple that used the platform.

She began by explaining that healthcare was built on

trusted relationships, and people come to form their

relationships now not just on Facebook, but on mobiles.

She quoted that “1 in 5 hours of people's time on mo-

bile is spent on Facebook and Instagram”, which she

explained is a tremendous opportunity, and “can

change our behaviour.”

Facebook Healthcare groups are one of the fastest

growing. By joining a group, she explained, “you be-

come part of a valuable community, where members

support and encourage each other.” She gave an exam-

ple of at-risk men who joined an HIV prevention group

on Facebook that was eleven times more likely to re-

quest an HIV testing kit.

Doctors also use Facebook personally and professional-

ly, and she highlighted the research on this topic. For

example, when asked, 65% of physicians surveyed indi-

cated interest in engaging with clinical data via social.

“Healthcare is one of the fastest growing verticals in

Facebook at the moment, so the healthcare business is

finding oxygen on the Facebook platform,” she ex-

plained

The opportunity for people based marketing, at scale, is

enormous. Facebook is now home to over 1.95 billion

people. Messenger and WhatsApp now connect over

1.2 billion people around the world, and Instagram rev-

olutionises the way 700 million people capture and

share the world’s moments.

Facebook is also innovating against its mission and

wants to build technology that helps the blind commu-

nity experience Facebook the same way as others do.

Building a digital world consumers can

trust

Ilaria Passarani, Head of the Food and Health Depart-

ment, European Consumer Organisation (BEUC), which

promotes consumer interests, explained that more than

40% of consumers say that information found via Social

Media affects the way they deal with their health.

Consumers continue to have concerns around the secu-

rity of online data, yet, more than ever they are trusting

health information shared on social networks, she ex-

plained. “18 to 24-year-olds are more than twice as like-

ly than 45 to 54-year-olds to use Social Media for health

-related discussions”.

“90% of respondents from 18 to 24 years of age said

they would trust medical information shared by others

on their Social Media networks” she went on to explain.

Leigh Thomas

27

Conference report

She cited some interesting statistics which found that

“19% of smartphone owners have at least one health

app on their phone,” with exercise, diet, and weight

apps being the most popular types. “28% of health-

related conversations on Facebook are supporting

health-related causes, followed by 27% of people com-

menting [on] health experiences or updates,” she ex-

plained.

However, she pointed out that 74% of people world-

wide are worried about how companies use their infor-

mation. Only a third of respondents usually read the

terms and conditions, and two-thirds of respondents are

concerned about not having complete control over the

information they provide online. Nearly two-thirds of

respondents say that they do not trust online businesses

to protect their personal information, with more than a

quarter saying that they do not trust them at all.

Privacy and data protection were the biggest concerns

when it came to using digital in the healthcare sector,

she said, but if these issues were solved, consumers

would benefit considerably.

“Increased access to information in many formats,” she

insisted, “must be exploited for the benefit of public

health.”

Ilaria Passarani

How Regulation Helps Self-Care to Develop

The development of self-care remains strongly influ-

enced by the legal and regulatory framework. An up-

date was provided on the most relevant changes in the

area of food and non-prescription medicines, referenc-

ing AESGP’s priorities.

Christa Wirthumer-Hoche, Chair of Management

Board of the European Medicines Agency (EMA), and

Head of the Austrian Medicines and Medical Devices

Agency (AGES MEA) opened the session by describing

an Austrian national provision which provided for a sim-

plified registration procedure for traditional herbal

medicines. With the European Union (EU) legislation on

traditional herbal medicinal products adopted in 2004,

out of around 300 herbals, only 10% submitted dossiers

according to the new legislation, 20% migrated to the

food sector and some to medical devices and cosmetics.

“The registration for traditional herbal is expensive,

analysis is expensive and there are demanding require-

ments for quality, which encourages a move into the

food supplements sector”, she said.

“Some discussion is ongoing as to whether the scope

for traditional herbal medicines will be enlarged to in-

clude vitamins and minerals”, she added.

Wirthumer-Hoche explained that the availability of non-

prescription medicines is high on the agenda of the EU

Medicines Agencies Network Strategy to 2020, and ap-

preciated that “AESGP stands for the adoption of a bal-Christa Wirthumer-Hoche

28

anced regulatory framework, and that the framework

has to facilitate innovation and rapid market access, in a

harmonised way across Europe.”

Developments in food safety and “REFIT”

Sabine Jülicher, Director of Food and Feed Innovation,

Directorate General Health and Food Safety, European

Commission, gave an outline of developments in the

food legislation, particularly relevant to consumer

healthcare industry.

She began by describing some developments in the

area of food safety and explained that with food crises

which have occurred related to BSE and Dioxin in the

late 1990s, it is very easy for consumers to lose trust.

“Today we have the most stringent system for the man-

agement of food risks in the world”. By that we are bet-

ter placed today to deal with food crisis, but it is still

important to remain alert. The European Commission is

currently conducting a so-called REFIT exercise on the

General Food law to see whether it is still fit for purpose,

and to find out whether there is anything that can and

should be improved. Instead of rushing to add on to the

regulatory framework without evaluating, it will first be

checked if it works and if there is an added value for the

EU.

“People’s expectations have changed. They expect their

food to be not just safe but nutritious and to be pro-

duced in a sustainable manner”. This has called for EU

nutrition polices. In December 2016, the introduction of

mandatory nutrition labelling was finalised. The regula-

tion on nutrition and health claims sets the legal frame-

work for food businesses wishing to highlight beneficial

properties of their products, and to enable customers to

make healthier choices. She explained that a REFIT eval-

uation is currently being undertaken on this regulation,

and is expected to be completed in 2018. The outcome

will help the Commission to take an informed decision

on health claims for botanicals and whether there is a

need to harmonise the use of botanicals in the EU. The

final report of an external study on this is expected end

of September 2017.

She then moved on to talk about reformulation of pro-

cessed foods – a voluntary initiative, to reduce levels of

saturated fat and sugars in the diet. It is an example of

where the European Commission is co-operating with

manufacturers and also member states’ authorities in

terms of monitoring systems. “In health and nutrition,

through voluntary initiatives a lot can be achieved, and

the Commission believes there is room for a dual ap-

proach (regulatory and voluntary)”.

In the current environment, the main challenge, she de-

scribed “is empowering consumers while leaving

enough flexibility to allow for innovation in the food

industry and safeguard the functioning of the internal

market.” The aspiration for a more expansive food poli-

cy is not matched by a public appetite for food related

innovation. “Risk aversion is prevalent in the food sec-

tor, e.g. in relation to Genetically Modified Organisms

(GMOs) and food additives which is getter bigger and

finding its way into public discussion. “There is a reluc-

tance to embrace new approaches which clashes with

the need for food systems to evolve.”

“We need to address the mistrust, hostility, science and

evidence-based decisions” she said which is becoming

increasingly difficult.

Jülicher concluded by saying that the European Com-

mission recognises that consumers increasingly take

responsibility for their own health, and will support con-

sumers in a transparent way, by ensuring that food is

safe and food information is not misleading. This frame-

work contributes to fair competition between food op-

erators, but also ensures that “the limited budget of

consumers goes toward products that work.” She also

added that the objective of the Commission is to take a

forward-looking approach to innovation in food pro-

duction. She reflected on earlier discussions and that

“the Commission must also address the erosion of trust

in a transparent manner.”

Sabine Jülicher

29

Conference report

Hubertus Cranz, Director General of AESGP, gave his

perspective on the discussions from an AESGP point of

view, by explaining that AESGP sees itself as an evidence

based industry. Reflecting on the discussions about

trust, it was pointed out that “the worst thing that can

happen to your business is losing trust. And evidence

base goes hand in hand with trust”. On the right imple-

mentation of rules, he also noted that “self-regulation

matters but needs to be based on a proper legal basis”.

In his view, overall the legal basis is adequate, but suffi-

cient resources are important for the implementation

and supervision process.

On botanical claims, he explained that the process has

been long. He remarked that although “non- action may

seem sometimes like the easiest political solution, it can

have important market implications.”

Challenges in EFSA

Bernhard Url, Executive Director, European Food Safety

Authority (EFSA), described the role of EFSA and chal-

lenges they meet. “Risk management and risk assess-

ment are separated in Europe stringently” he said. The

latter is outsourced to EFSA in Parma while the former is

the responsibility of the European Commission. EFSA is

a small organisation of 450 staff persons, which mobilis-

es 1000-2000 experts on a voluntary basis (but they are

not employed by EFSA) for a three-year mandate to

conduct risk assessments in the food and feed chain.

“There is still a long way to go to achieve globalised risk

assessments in the food and feed chain (although EFSA

is working on this)”, he informed.

On health claims, he acknowledged that the botanical

health claims are still on hold. He also noted that the

EFSA guidance document needs updating to develop

clear criteria on the substantiation of health claims. Two

guidance documents were updated in 2016, and in 2017

guidance on the preparation and presentation of health

claims was published. EFSA has also set up a catalogue

of services to applicants and has introduced an SME

office in a pilot phase to support industry when prepar-

ing and submitting health claims.

Scientific challenges that EFSA faces include endocrine

active substances, antimicrobial resistance and the sur-

vival of beehives. EFSA also faces challenges in sourcing

expertise on issues related to transparency and the in-

dependence of its experts (which he notes is made diffi-

cult as the European research policy, Horizon 2020, forc-

es universities to collaborate with industry).

EFSA has set up a complex system of managing expert

interests to assess conflicts of interest, which can be

burdensome. Finding independent experts, he said, may

be more challenging for EFSA than the EMA. He also

commented that in the food industry there is a high

benchmark for experts as there is a high expectation for

quality in the sector - and EFSA do not pay for experts.

“We need to find new models of reimbursing these ex-

perts/their organisations. EMA has double the staff and

four times the budget”, which EFSA looks on with envy

as it relies on volunteers.

The second challenge is transparency which goes back

to trust. Trust depends on competence (for EFSA scien-

tific competence and opening itself to scrutiny) and

character (being transparent so that its activities could

be replicated). However, industry data cannot be made

public as this would infringe on intellectual property

rights and trade secrets. There is no legal framework in

place to make raw data available to academia for scien-

tific scrutiny. However, he commented that if EFSA

could move in a regulated approach towards this, it

would help regain trust in the industry.

EFSA also faces specific challenges “when science meets

values/policy.” “If EFSA comes out with a scientific opin-

ion that supports the political agenda of a group, EFSA

is praised” he remarked. He gives the example of EF-

SA’s opinion which established the risk of nicotinates to

bees which the European Commission supported, and

was therefore well received.

Bernhard Url

30

He concluded by saying that it is no longer enough to

do good science. “You have to engage with the civil so-

ciety, (and build trust) to come up with a co-evolution of

science which is a challenge for EFSA in the years to

come”.

Hubertus Cranz, Director General of AESGP, gave his

perspective on the discussions from an AESGP point of

view. He expressed his appreciation of EFSA’s efforts in

the improvement of services, such as the help desk. He

also stated AESGP’s belief that a closer interaction be-

tween applicants and scientists (panelists in EFSA’s case)

can improve decision making, and the output of scien-

tific evaluations. “That the pharmacovigilance system is

covered by fees, while nothing is paid into EFSA, is a

discrepancy in the system which is not easy to explain”,

he stated. AESGP disagrees with fees as a pure financing

instrument. However, he acknowledged that fees may

be acceptable if services can be improved by a well-

organised and transparent interaction between appli-

cants and panel members.

Regulatory optimisation and “self-care in a

changing Europe”

Regulators are making efforts to optimise regulatory

operations and ensure greater access to non-

prescription medicines, according to Zaïde Frias, Head

of Human Medicines Evaluation Division, European

Medicines Agency (EMA).

She presented two initiatives, which she said addresses

half of AESGP’s 2020 goals. The first initiative is on the

Regulatory Optimisation Group (ROG), chaired by Stan

Van Belkum from the Dutch Medicines Evaluation Board

and co-chaired by herself, which will formally kick off on

14 June. For the first time, it brings regulators and in-

dustry together to review existing regulatory proce-

dures. The group also brings business and IT together to

leverage the advantage of technology and develop

common ICT platforms. The ultimate goal is to identify

value added data that could be captured in a structured

way to support product life cycle maintenance and deci-

sion making.

She explained that a challenge for the ROG is that it is

“quasi impossible to track the product history over its

entire lifecycle in the European environment”, referring

to pantoprazole, which was switched to non-

prescription status throughout the European Union by a

centralised procedure, but had originally undergone

decentralised authorisations. She also noted that sub-

mission formats have also changed from paper to elec-

tronic documents and will continue to evolve into more

structured data and emerging international regulations/

standards (ISO IDMP).

There is a significant cost linked to send/receive, vali-

date, maintain and distribute Marketing Authorisation

Application data. The idea is to reduce regulatory bur-

den for applicants and regulators, saving administrative

and scientific resources for the more valuable areas of

the regulatory work.

The first target of the ROG would be Type IA variations

and it would be presenting its first business case for

handling such variations to the Heads of Medicines

Agencies (HMA) in September.

She also reminded the audience about the joint multi-

stakeholder initiative of the EMA and the Co-ordination

committee for the Mutual-recognition and Decentral-

ised procedures - human (CMDh) in the area of scientific

advice procedures for OTC medicines – an initiative co-

sponsored by herself and Peter Bachmann as chair of

the CMDh. It targets timely access to non-prescription

medicines and reinforces the regulatory capacity and

capability of the network. Its first stakeholder workshop

would be held in the third quarter of 2017, she said, to

discuss the composition and function of the OTC Expert

Forum that would be led by the CMDh.

Zaïde Frias

31

Conference report

The aim is to build on an early interaction with Appli-

cants/Marketing Authorisation Holders (MAHs) and

stakeholders on relevant aspects of OTC switch for Na-

tional/Mutual Recognition Procedures/ Decentralised

Procedure and Centralised Procedure and create plat-

form for exchange on factors that influence decisions on

switching, beyond the scientific balance of benefits and

risks, and bring relevant stakeholders including experts

from national switching bodies, healthcare professionals

and patients around the table.

“This workshop would be organised, against a backdrop

of every second medicine in the European Union being

non-prescription, yet only four medicines had been

switched through the EU’s centralised procedure in 10

years, and only five medicines were available in every EU

member state.”

She explained that there are two parallel switching

worlds in Europe. At EMA there are first in class switches

of the centralised product or innovative (switch by de-

sign) switches with ultimately a harmonised legal status.

Switches at National/CMDh level which effectively drives

most switches at EU level but do not result in a harmo-

nised legal status in the end. The idea would then be to

bring the “best of both of these worlds” to debate the

full spectrum of switches. It would also provide a forum

to exchange real world experience and the perception

of risks. The aim is to use a well-established EMA scien-

tific advice procedure. A CMDh led expert group would

advise the scientific advice group on whether there is an

interest to invest in the switch. Such a group would also

be able to engage with further stakeholders. It remains

to be decided who these stakeholders might be.

Hubertus Cranz, AESGP Director General commended

on the initiatives from an AESGP perspective. He ex-

plained that it is “fully in line” with the association’s

Agenda 2020, launched at its 52nd Annual Meeting in

Athens a year ago. “We are ambitious but honestly we

didn’t expect such success within the first 12 months

after launch of the agenda”, he remarked.

Putting greater access to non-prescription medicines on

the regulatory agenda, reducing regulatory burden

through the ROG and involving multiple stakeholders in

a non-prescription scientific advice procedure are all top

issues for the self-care industry. AESGP will continue to

contribute to the discussions and looks forward to see-

ing the results.

Hubertus Cranz

32

Challenges Ahead

Medical Devices Regulation – Regulatory

framework and challenges ahead

Gesine Meissner, Member of the European Parliament

(MEP) and Shadow Rapporteur for the new Medical De-

vices Regulation (MDR) and In-Vitro Diagnostics Regu-

lation (IVDR) for her political group and, by that, closely

involved in the negotiation process, began her presen-

tation by giving an overview of the adoption process of

the new regulations. Agreement in the so-called Trilos

was reached on 25 May 2016. The formal adoption by

the European Parliament and Council took place on 5

April 2017. The MDR entered into force on 25 May 2017

and is applicable from 26 May 2020.

As a co-legislator, the European Parliament’s involve-

ment is limited from now on, but the work between the

Member States, the European Commission and the

stakeholders has just begun. In 2020 manufacturers and

notified bodies must be ready to apply the new rules

and the EUDAMED database must be functional. Politi-

cal core issues during the negotiations included the

reprocessing of single use devices, the “scrutiny proce-

dure”, “CMR’s”, Aesthetic Devices, liability, traceability,

the Implant Card, classification rules on nanomaterials

(Rule 19), and substance-based medical devices (Rule

21) and more recently unannounced audits. As a mem-

ber of the Liberal party (Group of the Alliance of Liber-

als and Democrats for Europe), Mrs Meissner was di-

rectly involved in the debate on Rule 21 which was not

previously the focus of discussions in the Parliament.

Gesine Meissner

Transitional provisions under Article 120.4 allowing the devices to stay on the market or under Article 120.3 to be placed on the market after the date of application under certain conditions

33

Conference report

Mrs Meissner updated on the outcome of the debate on

Rule 19 concerning nanomaterials. The Council position

was that the text should read “can be released” vs.

“intended to be released”, the latter being the European

Parliament position. It was finally agreed that for nano-

materials a classification according to the risk of expo-

sure would be defined in the implementing acts. The

European Commission, who is in charge of the imple-

menting acts, should now define based on scientific

knowledge and latest findings, what high, medium or

low risk means. On Rule 21 concerning substance-based

devices, the Parliament managed to move the position

from a complete ban/ complete up classification to all

Class III to an agreement on the classification according

to absorption level and intended purpose.

According to Mrs Meissner, for the implementation

phase of the MDR and, in particular, Rule 21, the con-

cept of a risk-based approach shall be maintained dur-

ing the implementation process. The classification must

always be justified by the intended purpose and the

inherent risk. This is key for a proportionate implemen-

tation approach. “We should define a broad under-

standing of low risk”. In her opinion, substances with a

long history of safe use (e.g. foodstuffs) should be con-

sidered as low risk. She also highlights the need for

clear guidance on what ‘systemic absorption’ is, which

she trusts the European Commission will implement in

consultation with stakeholders to achieve a common

understanding.

She explained that in general, experience from the Hel-

sinki Procedure, has shown that insufficient involvement

of manufacturers and notified bodies result in unsatis-

factory outcomes. It should, therefore, be ensured that

notified bodies and concerned manufacturers are

properly involved and systematically informed at an ear-

ly stage of the procedure.

Stressing the importance of scientific advice, she calls

for a clarification on the consultative role of EMA, EFSA

and ECHA. She also calls for data on a category of prod-

ucts published on the Commission website prior to the

launch of the examination procedure. This would not

only allow a fair and transparent start of the procedure

but also guarantee that the views of all concerned man-

ufacturers and notified bodies are fully taken into con-

sideration by the committee which delivers an opinion

when considering the classification of a specific product

or category of products.

In her view, the principal mode of action of the product

is a key determinant when it comes to differentiating a

medical device from a medicinal product. It is therefore

critical to have proper definitions of pharmacological,

immunological and metabolic means.

She also gave an overview of the transitional arrange-

ments in place. All devices placed on the market pursu-

ant to the Directives can continue to be made available

on the market or put into service until 27 May 2025 if

certain requirements are met. Certificates will become

void on 27 May 2024. However, there are many new

requirements related to an up-classification to Class III

(including new clinical investigations). Accordingly,

manufacturers of substance-based medical devices re-

classified in Class III will face potentially expensive new

requirements.

In light of this, the transitional period in Article 120

should be implemented adequately and uniformly to

provide sufficient time for industry and notified bodies

to ensure availability of substance-based medical devic-

es.

Challenges – the Notified Bodies

Roberta Marcoaldi, Director of Notified Bodies Istituto

Superiore di Sanità (ISS), Italy, gave her perspective on

the implications of the new MDR from a Notified Body

perspective. Since 1996, the Notified Body 0373 works

in the field of medical devices in according to European

Directive 93/42/EEC. The Notified Body 0373 has been

designated for CE Certification for Class III devices. Since

2009, Notified Body 0373 also works in the field of in

vitro diagnostic medical devices in according to Europe-

an Directive 98/79/EC.

Roberta Marcoaldi

34

In the last years, the Istituto Superiore di Sanità has de-

veloped a specific know-how on the evaluation of sub-

stance-based medical devices. In her view, substance-

based medical devices represent a great opportunity for

the healthcare sector.

In the case of substance-based medical devices, the

close correlation between medical devices and medici-

nal products also needs to be considered.

The definitions of medical device and medicinal prod-

ucts are, from her perspective, overlapping. Both can

have same intended use (treatment or prevention of

diseases) but do have different mechanism of action by

which they reach their effect. The terms ‘therapeutic

effect’ and ‘mechanism of action’ are not used consist-

ently, which complicates the situation. A definition of

different mechanisms of action is still lacking.

This is one of the reasons for the increasing number of

products that are on the borderline between medical

devices and medicinal products. However, at the end a

‘case by case’ approach and assessment are necessary.

MDR requirements define also a more stringent ap-

proach to assess such medical devices, which represent

a new challenge for manufacturers and Notified Bodies.

The MDR established the category of substance-based

products and defines a special classification rule: The

Rule 21. As a result, substance-based medical devices

will no longer be classified as Class I. This will mean an

increasing number of medical devices requiring the

evaluation of a Notified Body.

Rule 21 introduced the concept of substance absorp-

tion. It will, therefore, be necessary to define a correct

interpretation of Rule 21 and understand the term

‘absorption’ of substances. The absorption of substanc-

es can determine the different classification of medical

devices. This will determine the kind of documentary

evidence in the product technical dossier with Annex II,

which manufacturers have to provide.

Mrs Marcoaldi expressed the wish that a close collabo-

ration between Notified Bodies and manufacturers is

established during the implementation process of the

new regulation.

Engaging patients / consumers emotionally

to build powerful brand relationships

Ralph Ahrbeck, Founder and CEO, Arqus Advisory,

concluded the session with examples of some success-

ful companies that have leveraged an intimate under-

standing of their consumer to further develop self-care.

35

Conference report

“Understanding what consumers think, their attitudes

and values”, he says “is vitally important today”. “Trust in

brands is an intangible asset and is at all time low”.

Trust in a brand increases compliance/product use and

results in better patient outcomes. Trust in OTC brands

reduces visits of General Practitioners for minor ailments

and reduces the burden on the healthcare system. How-

ever, he points out that typically, advertising is all about

preaching product benefits to consumers; what the

problem is and what is the solution. He stresses that we

must speak differently to our consumers. “Today’s em-

powered consumers want us to engage them, under-

stand their needs/wants, go beyond functional and es-

tablish an emotional bond.” A brand is the combination

of tangibles and intangibles – a mix of product, service,

images, associations, people and visual statements that

create a certain perception.

Empowered consumers want companies to take a stand,

have a point-of-view, be modern and relevant.

Ralph Ahrbeck

Invitation to Amsterdam 2018

At the end of the conference, Bernard Mauritz, Executive Director, Neprofarm, invited all participants as well as all

those interested in the latest developments on self-care around the world to the 54th AESGP Annual Meeting, which

will take place in Amsterdam from 5-7 June 2018. The program will be available by the end of this year.

Bernard Mauritz