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Conference report

51st AESGP Annual Meeting

Barcelona, Spain | 26-28 May 2015

Citizen empowerment: A megatrend of the 21st century

Citizen empowerment:

A megatrend of the 21st century

was the central theme of the 51st

AESGP Annual Meeting which

took place in Barcelona from 26

to 28 May 2015. The meeting

gathered nearly 500 participants

from 42 countries, including

representatives of the European

and national governments and

regulatory authorities, media, the

umbrella organisations of health

professionals, consumers/patients,

as well as the consumer health

industry.

The event in Casa Llotja de Mar

was opened by Boi Ruiz, Minister

of Health of Catalonia, who wel-

comed the participants in the

capital of his region and empha-

sised the importance of self-care

for the health care systems and

citizen empowerment. This was

echoed by Agustin Rivero, Direc-

tor General of the Spanish Ministry

of Health, who highlighted the

efforts of the Spanish government

to promote self-care and make it

more available to the consumers.

"We need to empower citizens in

health care through new technolo-

gies, said Jordi Ramentol, Presi-

dent of the Spanish Association of

the Self-Medication Industry anefp

and CEO of Ferrer. He expressed

appreciation of the progress made

in Spain on the promotion of self-

care and stressed a need for conti-

nuous cooperation between the

authorities and the industry.

Opening remarks of Boi Ruiz, Agustin Rivero and Jordi Ramentol

The opening event at Casa Llotja de Mar

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Consumer Health Industry: how to provide the best service?

The messages of the opening evening were fol-

lowed up by Pedro Nueno, Professor in the De-

partment of Entrepreneurship at IESE Business

School and Professor and President at CEIBS

(Shanghai, Beijing). The increase in the life expec-

tancy of modern society is causing major and unaf-

fordable health costs, said Nueno. By that the im-

portance of the self-care sector is getting more and

more recognised and the cost savings are well do-

cumented.

Global perspectives on Citizen Empowerment

Roger Scarlett-Smith, AESGP President and Head of Global Categories at

GSK Consumer Healthcare, shared his enthusiasm about the direction that

self-care is taking and expressed hopes that a more positive business cli-

mate can be created which will lead the long-term improvements of consu-

mer empowerment. To make real progress for self-care and consumer em-

powerment, trust and collaboration between industry and policy makers are

needed, said Scarlett-Smith. The self-care sector needs a balanced policy

framework which would combine mandatory and voluntary measures that

expand consumer access, preserve information to consumers, protect priva-

cy and maintain consumer safety, at the same time allowing room for inno-

vation.

An overview of the OTC market trends, also in the context of consumer em-

powerment was presented by Andy Tisman, Senior Principal Consumer

Health at IMS Health. The global OTC market increased by 4,8% in 2014.

Particularly impressive was the increase in Latin America, but also South

Asia and the Middle East benefitted from the positive economic climate.

Less positive was the development in North America and Japan. Central and

Eastern Europe did again better than Western Europe.

Tisman noted that different industry sectors not only

pharma but also fast-moving consumer goods (FMCG)

companies are moving into consumer health and

wellness products. This shift of focus has led to new

transversal market segments of cosmeceuticals, nutra-

ceuticals and nutricosmetics, attracting new competi-

tors. The consumer empowerment is a major trend

and will be a key driver for growth in the future, con-

cluded Tisman.

Pedro Nueno

Roger Scarlett-Smith

Andy Tisman

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Meeting report

We have a highly regulated European framework

which protects us and it will not be appropriate to

leave it away, urged Dagmar Roth-Behrendt, a

former Member of the European Parliament, com-

menting on the new Better Regulation initiative of the

new European Commission. Roth-Behrendt said that

better regulation efforts are supported if they aim for

a good overall balance. Not every lifting of rules is

leading to better regulation. She called for a cautious

approach when it comes to ideas to change of legisla-

tion as the outcome in the current political constella-

tion is very uncertain. In addition, the legislation in

place is often not so bad but the problem is with its

implementation.

Marketing authorisation and variation procedure for

medicines with well-established substances are cer-

tainly too complex. Communication rules are often no

longer in line with information society and the intel-

lectual property rights are insufficient for the work

done in the area of innovation with well-known subs-

tances. Innovation needs to be made easier through

well-functioning centralised and national procedures,

including the move of medicines from prescription to

non-prescription status.

New technologynew guidancebetter self-care

Today, new technology is key to drive the consumer empowerment, pointed out Brian McNamara, Region

Head Europe and Americas at GSK Consumer Healthcare. This creates unprecedented opportunities for the

consumer health care industry. The companies with innovation potential will have the most to gain.

We therefore need to continue investing in innovation, called McNamara on the conference delegates.

Current trends in digital health were presented by Ryan

Olohan, Industry Director Healthcare at Google. He gave

numerous examples of self-care electronic devices and

smartphone applications used for monitoring and sup-

port for diagnosis as well as online networks, social chan-

nels and health related videos for consumers and pa-

tients. Olohan also revealed that 1 in 20 Google queries -

equivalent to 3.5 billion searches everyday - is health care

related which indicates a growing patient and consumer

empowerment.

Dagmar Roth-Behrendt

Brian McNamara

Ryan Olohan

Among the top search categories are headache,

indigestion, skincare and allergies. Google also

recognises that a major global trend is internet

access from mobile devices, including new inter-

net users.

A large number of digital health startups are emerging into the healthcare sector while classic pharma and

med tech players respond slowly to this trend, said Ashley van Heteren, Associate Partner at McKin-

sey&Company. Companies must address many questions related to digital healthcare in order to really benefit

from technological innovations and to make them useful for consumer empowerment.

By 2020, 75% of all deaths and healthcare costs will result from chronic

diseases estimated Didier Deltort, Global Monitoring Solutions Gene-

ral Manager at General Electrics Healthcare Finland, who looked at glo-

bal trends in health. An increased number of chronic diseases will in-

fluence the future of industry and is expected to drive structural

changes of healthcare, said Deltort. General Electrics Healthcare pre-

dicts that a shift from todays healthcare delivered in analog/paper way

to tomorrows digital/networked tools will enable real-time, continuous

information flow and comprehensive view of health and chronic disease

management, wellness and prevention.

Carlos Lens of the Ministry of Health in Spain,

highlighted recent measures of the Spanish go-

vernment, taken in collaboration with the Spa-

nish Association of the Self-Medication Industry

(anefp), to promote the self-care sector to en-

sure that citizens can practise self-care more res-

ponsibly. This included enhancement of prescrip-

tion of non-reimbursed medicines by medical

professionals.

Ashley van Heteren

Didier Deltort

Carlos Lens

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How to make health care affordable?

With the ageing populations, increasing disease

burden, and new treatment options, the global

healthcare costs become unaffordable. The role of

self-care in the sustainability of the healthcare sys-

tems becomes increasingly recognised by the natio-

nal authorities, highlighted Jaume Pey, Director

General of the Spanish Association of Self-

Medication Industry (anefp). He emphasised that

investing in self-care provides significant savings for

the national healthcare systems.

The economic impact of a hypothetical switch of a

medicine from prescription (Rx) to non-prescription

status (OTC) in Spain was analysed by Laura Pellis,

Senior Researcher Center for Research in Health and

Economics (CRES) at the University Pompeu Fabra

(UPF) in Barcelona. According to the CRES study, a

switch of 5% of prescription medicines used to treat

minor ailments to non-prescription status would ge-

nerate total savings of over 3 million EUR for Spain

over 5 years.

These results show the positive impact of

self-care for the entire health care system

thanks to its contribution to increased

patients empowerment noted Pellis.

She concluded that the positive impact of

Rx-to-OTC switch from a societal point of

view should be combined with in-

vestments in educational programmes on

patients self-care.

Health care professionals, including medical

doctors, play an important role in supporting

and promoting self-care. Integration of self-care

medicinal products in the Electronic Prescription

System REC@T in Catalonia was explained by

Toni Gilabert, Director of Pharmacy and Medi-

cines at Catalonia Health Department.

Jaume Pey

Laura Pellis

Toni Gilabert

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Meeting report

The advantages of the system are improved patients

safety in the context of avoiding medicines interac-

tions, increased patients empowerment, promotion of

sustainability and rational use of medicines and facili-

tation of coordination and communication among the

health care professionals.

Greece has one of the lowest percentage of pharmaceutical ingredients classified as OTC in the EU, said

Harris Mylonas of the National School of Public Health in Greece. He presented results of a case study on

the economic value of switching medicines from prescription to non-prescription status in Greece, which

showed significant benefits from a possible OTC list expansion, with overall savings for the national economy

summing up to 160 million EUR.

The new EU Platform for the

promotion of self-care

systems

PiSCE - the EU-funded pilot project on the promo-

tion of self-care systems in the EU - was presented

by Rosa Suol, Director General in Avedis Dona-

bedian Institute in Barcelona. The Avedis Institute

is one of the international organisations involved

in the PiSCE Consortium, along with the Dutch

Institute for Healthcare Improvement, the Danish

Committee for Health Education and the Standing

Committee of European Doctors (CPME). Suol

explained that the PiSCE project work on guide-

lines on the promotion of self-care and on actions

fostering collaboration on self-care at the EU level.

This included the creation of the PiSCE Platform of

25 European experts in different areas, including

policy makers, consumers and patients, healthcare

professionals, educators and researchers.

Harris Mylonas

Rosa Suol

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The doctors perspective on the promotion of self-care in the EU was given by Birgit Beger, Secretary Ge-

neral of the Standing Committee of European Doctors (CPME). Beger highlighted that in order to identify

the areas where self-care can and should be promoted, necessary evidence needs to be collected, to pro-

vide a common understanding of which minor or acute ailments or long-term conditions are manageable

through self-care.

Low health literacy is a barrier to self-care, highlighted Cristina Cabrita, Senior Project Officer at the Portu-

guese Consumer Organisation (DECO) speaking on behalf of the European Consumer Organisation (BEUC).

The results of the consumer organisations survey on self-management of chronic diseases carried out in

Belgium, Italy, Spain and Portugal show that around half of the consumers surveyed in these countries are

lacking skills when trying to find health-related information on the internet. One third expressed difficulties in

using simple information on drug administration and 40% of the consumers surveyed in Spain to nearly 70%

in Portugal do not feel at ease to ask health professionals to explain unclear issues about their health pro-

blems. Cabrita noted that these are the barriers to effective self-care which should be addressed by the PiSCE

project in order to create a more self-care friendly environment.

The new communication technologies have poten-

tial to provide citizens with truthful, relevant and

high quality information to enhance their self-care,

recognised Carmen Pea, President of the Interna-

tional Pharmacists Federation (FIP). Pea called on

doctors, pharmacists, patients and industry to

further cooperate and agree on how to enable the

European citizens access to responsible self-care.

Birgit Beger

Cristina Cabrita

Carmen Pea

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Meeting report

The pharmaceutical industry works intensively to

provide relevant and accurate information to the citi-

zens, summarised Jaume Pey, Director General of

the Spanish Association of the Self-Medication In-

dustry (anefp). Pey illustrated this with the Spanish

self-regulatory assessment for advertising of non-

prescription medicines which was developed by

anefp. Pey also said he was supportive of training

programmes for the pharmacists.

Jaume Pey, Rosa Suol, Birgit Beger, Cristina Cabrita and Carmen Pea

Self-care medical devices and food supplements:

New drivers for the self-care market?

The new comprehensive AESGP Databanks

system on regulatory, legislative and market

provisions on self-care products was official-

ly launched at the conference by Hubertus

Cranz, AESGP Director General. The new

Databanks system includes the on-line

AESGP Med Databank on medicines with a

new dedicated section on medical devices

and the new on-line AESGP Databank on

food supplements.

The comprehensive AESGP Databanks system should be a

most useful tool for companies to set market transparency

and is in line with the AESGP commitment to provide evi-

dence as part of its political activities. Evolution of diffe-

rent regulatory environments of product categories in-

fluence and drive the self-care market, the conference

delegates heard. Medical devices and food supplements

are gaining an increasing role in self-care and by that they

are getting a lot of attention both from the business as

well as from the regulatory communities.

The role of the European Food Safety Authority (EFSA)

for the food supplements industry was explained by

Valeriu Curtui, Head of the Nutrition Unit at EFSA, who

focused on the scientific evaluation process for health

claims and stressed that EFSA applies the highest stan-

dard of scientific evidence for all claims.

Hubertus Cranz

Valeriu Curtui

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Dr Curtui also explained that EFSA is in charge of the

safety evaluation of food supplements ingredients as

well as processing aids such as food additives. He also

revealed that the EFSA Compendium of botanicals of

concern when used in food or food supplements will be

updated by the end of 2016.

Insights on the current revision of the medi-

cal devices legislation were shared by Gwe-

nole Cozigou, Director of Internal Market,

Industry, Entrepreneurship and SMEs Direc-

torate GROWTH at the European Commis-

sion. Cozigou said that the Commission

proposal for a new regulation on which the

European Parliament expressed a first rea-

ding position in 2014 is now being intensi-

vely discussed among the Member States

experts in the Council. One of the key issues

is the Rule 21 for substance based medical

devices. The Latvian Presidency of the

Council is trying to enable agreement on a

compromise text by the end of its mandate in June 2015. The rapid adoption of the new regulations on me-

dical devices is important to restore confidence in the EU regulatory system and to ensure competitiveness in

this industry sector concluded Cozigou.

In the given context, the audience appreciated an up-

date on the European regulatory framework for herbal

medicinal products and the options for market access

were explained by Werner Knoess, Chair of the Com-

mittee on Herbal Medicinal Products (HMPC) at the Eu-

ropean Medicines Agency (EMA). Knoess presented the

set of requirements for herbal medicinal products inclu-

ding quality, safety, efficacy, labelling, advertising and

pharmacovigilance. He also expressed his wish to have

clear definitions of the different legal categories of pro-

ducts, which would allow better categorisation/

distinction of medicinal products, food supplements,

medical devices and cosmetics.

Werner Knoess

Gwenole Cozigou

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Meeting report

Switching: A mega trend?

Switching is not just a mega trend, it is a necessity for our industry, stated Suneet Varma, President of

Pfizer Consumer Healthcare. He addressed the benefits of a potential switch of statins in the U.S. in the

context of efficiencies, outcomes and savings.

Faster access in case of emergency, con-

venience for patients and savings of

healthcare resources were key reasons for

switching ellaOne to OTC, said Frd-

rique Welgryn of HRA Pharma who ana-

lysed the recent switch of an emergency

contraception pill ellaOne (ulipristal

acetate) through the EU wide centralised

procedure. HRA Pharma estimates that

thanks to switch of ellaOne from pres-

cription to non-prescription status over 48

million more European women will be able

to get the morning-after pill. Such a broad

impact was possible thanks to the suc-

cessful use of the EU centralised

procedure.

Legislators need to ensure that self-care is at the

heart of the healthcare system, said Darragh

OLoughlin, President of the Pharmaceutical Group of

the European Union (PGEU). The regulatory environ-

ment must be balanced, proportionate and focused

on meeting the needs and expectations of patients

and other stakeholders. According to the studies pre-

sented by PGEU, patients in many countries prefer to

access self-medication in pharmacies, even when avai-

lable from other sources. Switching naturally expands

the role of pharmacists said OLoughlin.

Suneet Varma

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We urge the national medicines agencies to be

sensitive to the changing society of increasingly

empowered citizens said Beln Escribano, on be-

half of the Spanish Agency for Medicinal Products

and Medical Devices (AEMPS). She explained the

way AEMPS enables access to information on me-

dicinal products including a dedicated mobile ap-

plication, a regional e-prescription system listing

both OTC and Rx medicines and guidance on um-

brella branding.

Frdrique Welgryn, Beln Escribano, Darragh OLoughlin, Suneet Varma and Hubertus Cranz

How to ensure availability of safe products?

Protection of human health and product safety

are number one priority for the industry stressed

Vincent Warnery, Senior Vice President of Sanofi

Consumer Healthcare Division. He noted that the

safety of medicinal products needs to be put in

the context of a benefit-risk balance. He

highlighted that this is a part of the responsible

approach of the consumer health industry and

needs to be addressed in the continuous dialogue

with the health authorities.

Natalie Gauld, Director at Pharmacy Projects in New Zealand, explained

the positive experience of her country with a number of switches of medi-

cines from prescription to non-prescription status. She explained that only

accredited pharmacists with a completed training can supply emergency

contraception and that the mandatory pharmacists training is also used

elsewhere, e.g. for vaccines in Australia, hormonal contraceptives in Cali-

fornia or for patient group directions, e.g. trimethoprim (cystitis), oselta-

mivir (influenza) and sildenafil (erectile dysfunction) in the UK.

The unique reclassifi-

cation of vaccines

from prescription to

non-prescription sta-

tus in New Zealand

was explained by Ali-

son van Wyk, Head

of Professional Ser-

vices at Green Cross

Health.

Vincent Warnery

Natalie Gauld

Alison van Wyk

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Meeting report

The UK government policy

is to widen access to medi-

cines which enables best

use of healthcare professio-

nal resources and supports

patient empowerment

through self-care, stated

Sarah Branch, Deputy Di-

rector at the Medicines and

Healthcare products Regula-

tory Agency (MHRA) in the

UK. Branch said that this leading role is reflected in the streamlined MHRA

classification guideline which focuses on benefit/risk analysis, early discus-

sion with the regulators and early engagement with stakeholders.

The session then moved to the topic of falsification of medicines and pro-

vided an update on the work in Spain and on the European level. The Spa-

nish perspective on the implementation of the EU Falsified Medicines Di-

rective was given by Beln Escribano, Head of the Pharmaceutical Inspec-

tion and Enforcement Department at the Spanish Agency for Medicinal

Products and Medical Devices (AEMPS). Escribano highlighted that the

new requirements should effectively decrease the risks of falsified medici-

nal products, increase the quality of medicinal products and reinforce the

supply chain against falsified medicinal products including on-line supply

channels.

The new EU rules on safety features were explained by Stefano Soro,

Head of Unit Medicinal products quality, safety and efficacy at the Eu-

ropean Commission. The EU Falsified Medicines Directive introduces obli-

gatory 'safety features' to allow verification of the authenticity of medici-

nal products for human use ('unique identifier'). The European Commis-

sion prepared a delegated act on safety features which has been extensi-

vely discussed with the EU Member States. While prescription medicines

will have an obligation for the safety features, the OTC medicines shall not

bear the safety features unless they are at a serious risk of falsification,

explained Soro. OTC medicines with safety features will be included on a

so-called black list of exceptions. The European Commission foresees

that the new delegated act will be published in the Official Journal of the

European Union by the end of 2015.

Sarah Branch

Beln Escribano

Stefano Soro

Vincent Warnery, Alison van Wyk, Natalie Gauld, Sarah Branch, Beln Escribano, Stefano Soro

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Dr Liese was also wondering if there is a need for more European coordina-

tion of Health Technology Assessment and the possible future role of the

EMA in this respect. Regarding the future of the food legislation, Liese re-

ferred to the ongoing discussions on the new Novel Food Regulation as well

as to the pending issues related to the Claims Regulation such as nutrient

profiles and the scientific assessment of botanical health claims. According to

Dr Liese all health claims, including botanicals, should be evaluated by EFSA.

Concerning medical devices, Dr Liese shared his wish that the ongoing revi-

sion of the medical devices legislation will progress quickly and that the three

EU Institutions (European Commission, Council of Ministers of EU Member

States and the European Parliament) will find a reasonable compromise.

Perspectives for the future

Peter Liese, Member of the European Parliament, reflected on the future of the health care sector. Dr Liese

highlighted that the year 2015 marks 50 years of pharmaceutical legislation as the first directive related to

medicinal products was adopted in 1965. He raised important questions on the future of financing the

healthcare system in the long run and how to best manage the impact of significant therapeutic innovation

on health care budgets. In this context, self-care and consumer empowerment will play a key role.

Noel Wathion, Chief Policy Adviser at the European Medicines Agency (EMA),

acknowledged that important changes in the regulatory environment require

both regulatory authorities and pharmaceutical industry to continuously re-

view the impact on their day-to-day operations. There is a need for conti-

nuing dialogue to better understand expectations and needs in order for the

most cost-efficient approach to be developed, said Wathion. Particularly

challenging in this context are the new pharmacovigilance requirements and

all the work around the new IT systems.

Invitation to the 52rd AESGP Annual Meeting in 2016

The Conference was concluded

by the invitation of George Do-

kios, Executive Director of the

Association of the Greek Self-

Care Industry EFEX, to the 52nd

AESGP Annual Meeting which will

be held in Athens from 31 May

to 2 June 2016 .

George Dokios

Noel Wathion

Pieter Liese

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Meeting report