aesgp october conference report.pdf

8/10/2019 AESGP October Conference report.pdf

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Conference

report

Finding the right balance for herbal (medicinal) products,

food supplements and self-care medical devices

Introduction

On 7-8 October 2014, the Association of the European Self-

Medication Industry (AESGP) organised a conference in

Brussels on herbal (medicinal) products, food supplements

and substance-based medical devices: Paving the way

towards a coherent system.

The conference was opened by Roger SCARLETTSMITH,

AESGP President, and Markus FERBER, Member of the

European Parliament, who highlighted that the AESGP

event takes place just after the hearings of the designated

new European Commissioners by the newly composed

European Parliament.

The AESGP conference looked at the developments

achieved over the last years in the European legislative

framework for herbal medicinal products and foodsupplements but also discussed a number of key issues

which still remain non-harmonised - such as categorisation

of herbal products and health claims on botanicals in food.

The conference also gave an update on the proposed

changes for the legislation on medical devices that are

likely to be finally agreed upon in 2015. Markus Ferber, Member of the European Parliament

Roger Scarlett-Smith, AESGP President

Herbal (medicinal) products, food supplements, self-care medical devices

Paving the way towards a coherent system

Brussels, 7-8 October 2014

Conference

From left to right: Andreas HENSEL, Harald KANDOLF, Hubertus CRANZ, Ilaria PASSARANI, Joris GEELEN


2/15

Harald KANDOLF (Deputy Head of Cabinet, Commis-

sioner Tonio Borg) presented an overall view of the

current situation and the European Commission posi-

tion on three legal categories of consumer-care prod-

ucts: medicines, food supplements and self-care medi-cal devices.

Mr KANDOLF said that while in the field of herbal me-

dicinal products a framework for traditional herbal

medicinal products has been set up by the Traditional

Herbal Medicines Directive 2004/24/EC since 2004,

there will be changes in the field of medical deviceslegislation, which is currently being revised by the EU

Institutions. The Commission proposal for a new legal

measure on medical devices was voted by the European

Parliament in the first reading in April 2014 and it is now

being discussed with the Council of the EU. A possible

second reading agreement is foreseen in the first half of

2015.

Harald KANDOLF

Referring to food and food supplements, Mr KANDOLF

noted that this is a very complex legal category as there

are at least three major pieces of legislation in place: the

Claims Regulation (EC) No 1924/2006 adopted in 2006,

the food supplements Directive 2002/46/EC from 2002

and the newest Food Information to Consumers Regula-

tion (EU) No 1169/2011. He admitted that some legal

issues remain open as they have not been tackled by

the European Commission until now, including: mini-

mum and maximum levels for vitamins and minerals,

nutrient profiles for foods bearing health claims and the

evaluation of botanical health claims on foods and food

supplements.

Mr KANDOLF explained that the evaluation process of

health claims has started in 2008 - initially with a list of

40 000 claims, which was then consolidated by the

European Commission to 4 000 claims. The consolidatedlist was submitted in several batches to EFSA for a sci-

entific evaluation. As a result of this process, a l ist of 222

authorised health claims was published in 2012. Mean-

while, the evaluation of more than 2 000 health claims

on botanicals was put on hold in 2010 and the Europe-

an Commission has - in spite of the clear legal obliga-

tions - considered several options on how to proceed.

The first option was to continue with the scientific as-

sessment by EFSA as it is required by the Claims legisla-

tion. The second was to change the mandate given toEFSA on the evaluation however it was admitted that

this would need to be legally sound and also any

change of a mandate would need to be accepted by

EFSA. The third possibility was to prepare a new legisla-

tion which would take up to 3-5 years. A consultation of

Member States took place in August 2012, however

given a variety of the opinions expressed by Member

States and the stakeholders, the European Commission

is still reflecting on how to proceed on botanical claims.

He also revealed that the European Commission faces

now three types of court cases on the implementation

of the health claims legislation. Two cases argue that

fundamentally the Commission applied the Claims

Regulation too strictly. The third accused the Commis-

sion of not implementing the Claims Regulation in light

of its decision on putting the botanical claims on hold in

2010. Mr KANDOLF concluded by saying that the new

Commissioner will need to look into the pending issues

and eventually, a decision will need to be taken. He also

reminded that a correct implementation of the legisla-tion is one of the key obligations of the European Com-

mission.

European Commission position on consumer healthcare products


3/15

Andreas HENSEL(Professor, Institute for Pharmaceuti-

cal Biology and Phytochemistry, University of Mnster,

Germany) presented the state of play in the scientific

research on herbal substances and medicinal products.

He highlighted the need for intensified research anddevelopment and increased funding in the field of herb-

al medicinal products in order to help developing new

innovative products.

Professor HENSEL highlighted the differences between

registered medicinal products and food supplements

both with regard to the target populations (patients vs

healthy consumers) as well as with regard to the inno-

vation cost, quality and safety requirements, which are

different for medicines and food. He pointed out that

from a scientific point of view a simple extrapolation of

health claims from the medicinal products to food sup-

plements is not correct.

Andreas HENSEL

Research and innovation in the field of herbal medicinal products

Consumers perspective on health products

Ilaria PASSARANI (Head of the

Food and Health Department,

European Consumer Organisation

(BEUC)) said that finding a right

balance for all three products cate-

gories - herbal medicinal products,

food supplements and self-care

medical devices - is challenging forthe European decision makers. She

noted that while waiting for the

decision on the assessment of

health claims on botanicals, as well

as for finalisation of the new regu-

lation of medical devices, the Euro-

pean consumers are currently ex-

posed to a confusing situation in

the marketplace.

She said that the consumers wish is

to have three principles taken into

account in the policy decisions:

safety, effectiveness and legal clari-

ty. In relation to botanical claims,

she said that consumers organisa-

tions want all claims to be justified

by solid scientific evidence which

needs to be evaluated by EFSA.

Ilaria PASSARANI called for a har-

monised, coherent approach with

regard to product classification and

she said that the current rules al-

lowing Member States to classify a

product as a medicine, food sup-

plement or medical device can lead

to a situation where consumers in

different countries may receive

different information with regard to

the same product.

Meeting report


4/15

Belgian perspective on the evaluation of botanicals in food

A Belgian perspective on the evaluation of botanicals in

food was presented by Joris GEELEN (Federal Public

Service, Health, Food Chain Safety and Environment,

Belgium). GEELEN said that the Belgian Royal Decree on

Botanicals of 1997 regulates list of authorised and for-bidden plants, mandatory warnings and maximum

levels of these substances in food supplements. In

addition, Belgium together with France and Italy has

created a joint Belfrit list of 1000 plants. The joint list

was aimed to accelerate mutual recognition of plant-

based food supplements.

It remains to be seen whether there are any chances for

the Belfrit list to be expanded to other EU Member

States as different approaches to plants categorisation

are still very visible.

Joris GEELEN

Categorisation of herbal products

From left to right: Marisa DELB, Robert ANTON, Vittorio SILANO, Pilar AYUSO,Werner KNSS, Ioanna CHINOU

Chair: Pilar AYUSO


5/15

Robert ANTON (Professor Emeri-

tus, Faculty of Pharmacy, University

of Strasbourg, France) explained

the historical background of the

Traditional Herbal Medicines Di-rective 2004/24/EC and the estab-

lishment of the Committee on

Herbal Medicinal Products (HMPC)

at the EMA.

Professor ANTON said that while he

would support assessment of bo-

tanical claims on foods based on

the tradition of use of plants, he

would still have concerns withregard to herbals with well-known

pharmacological proprieties, for

example those containing anthra-

quinone derivatives or Hypericum/

St. John's wort, which can be used

in traditional herbal medicines but

also in food supplements, depend-

ing on the national classification.

Professor ANTON has also ex-

pressed his wish to have a clear

division of herbals traditionally

used as foods (e.g. aromatic plants

such as rosemary or cammomile)and plants with well-established

use as herbal medicines (e.g. Hy-

pericum/St. John's wort or Ginkgo).

Robert ANTON

Vittorio SILANO (Medical School, II University of Rome, Italy) out-

lined the current complex situation of the herbal products in the EU,

where herbal substances are used both in food supplements and in

medicinal products.

Professor SILANO also explained different legal requirements apply-

ing to herbal medicinal products and food supplements and funda-

mental differences between the two categories. Professor SILANO

noted that while food supplements are intended to complement the

normal diet, medicinal products are intended to treat or prevent

disease therefore indications for these two categories should be

visibly different. He called on the European Commission, Member

States, EFSA and EMA to work on a coherent approach to identify

and characterise botanical species according to their use as food or

as a medicine as well as to develop harmonised criteria for safetyand efficacy assessment of plant substances.

Meeting report

Vittorio SILANO


6/15

Werner KNSS (Chair of the Committee on HerbalMedicinal Products, HMPC, EMA) presented the work ofthe Committee on Herbal Medicinal Products (HMPC),which was established at the EMA in September 2004.

The HMPCs main task is to develop Community herbal

monographs and list entries of herbal substances, prep-arations and combinations thereof. It also providesscientific advice on question related to herbal medicinalproducts.

Professor KNSS also presented a comparison of the

quality, safety, efficacy, pharmacovigilance requirements

for well-established and traditional herbal medicinal

products.

He also expressed his

wish to have clear defi-

nitions of different legal

categories of products

which would allow

better categorisation/distinction of medicinal

products, food supple-

ments, medical devices

and cosmetics.

Werner KNSS

Ioanna CHINOU (Chair of the Working Party on

Community Monographs and Community List, MLWP,

EMA) gave an insight into the work of HMPC on

drafting the Community herbal monographs for well-

established use and traditional use of medicines.

She agreed against the concept of traditional use of

herbals in food supplements since the harmonised EU

definition of a food supplement only exist since 2002.

On the contrary, plants have a long tradition of

medicinal use, sometimes even dating from ancient

times. She also reminded that food supplements, by

definition, have different properties than medicines and

she challenged the use of some plants in food.


7/15


8/15

Dr LIESE also shared his views on the pending issues

related to the Claims legislation, including nutrient

profiles and botanical claims. Although he expressed his

reservations to the concept of nutrient profiles on foods

(which in his opinion was undermining the importance

of a personalised diet fitting individual dietary needs for

particular nutrients), he supports a full implementationof the Claims Regulation on the botanical claims. He

reminded that the Claims Regulation was adopted by all

three EU Institutions, i.e. the European Commission, the

Council and the European Parliament, and that the

Regulation should have been fully implemented by now.

Dr LIESE, who is a medical doctor by profession, high-

lighted the therapeutic importance of herbal medicinal

products and the role of the industry to provide the

highest quality products to the European patients and

consumers. In this context, he was also concerned about

the safety aspects of some botanical food supplements

and he asked the European Commission not to acceptdouble standards and to acknowledge years of re-

search and investment done by the European compa-

nies to develop high quality herbal medicinal products.

From left to right: Vittorio SILANO, Werner KNSS, Ioanna CHINOU, Peter LIESE, Marisa DELB, Robert ANTON, Hubertus CRANZ

Ensuring the right assessment of food supplements and health claims

Chair: Michle RIVASI From left to right: Evelyn BREITWEG-LEHMANN, Basil MATHIOUDAKIS, Michle RIVASI,Valeriu CURTUI, Amire MAHMOOD, Hubertus CRANZ


9/15

Evelyn BREITWEGLEHMANN (Federal Office of Con-

sumer Protection and Food Safety, Germany) presented

the recent German, List of Substances of Plant and Plant

Parts which is aimed to help the competent authorities

in Germany to categorise plants ingredients, especially

in case of borderline products.

She also presented a decision tree composed of several

questions used to assess a potential use of a plant as a

food, novel food or a medicinal product. It was noted

that the list is not legally binding and can be updated in

the future.

Evelyn BREITWEGLEHMANN

Valeriu CURTUI (Head of the Nutrition Unit, EFSA)

gave an insight into the scientific assessment of

health claims done by the EFSA Panel on Dietetic

Products, Nutrition and Allergies, NDA.

Dr CURTUI explained that while EFSA NDA Panel is in

charge of evaluation of the scientific evidence sub-

mitted to substantiate a health claim, decisions on

authorisation of claims or classification of substances

are not up to EFSA, according to the EU law. He

explained that the Claims Regulation requires EFSA

NDA Panel to apply a single highest possible stand-ard of evidence for substantiation of all categories of

health claims and all foods, including food supple-

ments.

As an illustration of the EFSA evaluation process ofhealth claims, Dr CURTUI presented an example of a

recent NDA Panel positive opinion on a health claim

on hydroxyanthracene derivatives and improvement

of bowel function. He explained that NDA Panel

considered all available scientific information, includ-

ing EMA monographs, and concluded that a cause

and effect relationship between consumption of

hydroxyanthracene derivatives and improvement of

bowel function is well-established; however some

restrictions of use (based on possible side effects)

were also proposed.

Valeriu CURTUI

Meeting report


10/15

The NDA Panel could not provide any advice on the

safety of hydroxyanthracene derivatives as this would

be outside of its remit in the context of the Claims

Regulation but Dr CURTUI indicated that this could be

done in a separate EFSA opinion following a new

mandate given by the European Commission.

Dr CURTUI also gave an overview of the most com-

mon issues encountered by the applicants while

submitting a dossier to EFSA and he indicated that

EFSA may provide more supports to the applicants inthe future.

The important role of Member States in the risk

management process and in particular in the health

claims authorisation was presented by

Amire MAHMOOD (Federal Ministry of Health,

Austria). Dr MAHMOOD admitted that classification

of food supplements is a major challenge for Mem-

ber States. She said that although the Food Supple-

ments Directive 2002/46/EC was much welcomed by

Austria, a number of non-harmonised issues still

need to be addressed, for example minimum and

maximum levels of vitamins and minerals and cate-

gorisation of other substances such as botanicals.

Dr MAHMOOD also addressed challenges for Mem-

ber States related claims authorisation such as:

classification of claims as a health claim or medicinal

claims; beauty claims linked to skin, hair or nails;

pending issues of the assessment of botanical

health claims and establishment of nutrient profiles

for foods bearing a health claim.

Role of Member States

Amire MAHMOOD


11/15

An overview of the current state of implementation of

the Claims Regulation was given by Bas-

il MATHIOUDAKIS (Head of Unit Nutrition, food com-

position and information, European Commission).

Mr MATHIOUDAKIS said that currently 30 nutrition

claims and 254 health claims are authorised, while 1995

health claims are non-authorised and 2095 health

claims remain on hold, including 2078 claims on bo-

tanicals and few claims on caffeine. Caffeine claims

positively went through the EFSA evaluation but during

the authorisation process the European Commission

asked EFSA for an additional safety assessment of caf-

feine (which is expected in 2015).

Concerning botanical claims, Mr MATHIOUDAKIS ex-

plained that as similar plants are used as ingredients of

food supplements and herbal medicinal products the

European Commission decided - in spite of the clear

legal obligations - to stop the evaluation of botanical

health claims and has started a reflection process on

whether the tradition of use can be considered as

sufficient evidence in the assessment process of botani-

cal claims. He acknowledged that this position is now

challenged through new Court cases and that there are

evidently strong legal arguments in favour of continuing

the evaluation. However, MATHIOUDAKIS indicated that

from his perspectives the priorities of the new European

Commission including stimulation of jobs, investment

and economic growth and strengthening of the Europe-

an internal market need to be taken into account and

that this may speak in favour of stopping the process of

evaluating botanical claims. MATHIOUDAKIS was asked

in the discussion why companies should at all invest in

high quality herbal medicines but indicated that from

his perspective herbal medicine manufacturers wouldthen have to adjust. Many participants at the conference

did not agree with MATHIOUDAKIS and his approach,

and could not understand why the well functioning

system of herbal medicines should be abandoned.

Adjusting the medical device legislation to consumer needs

From left to right: George JESSEN, Judite NEVES, Gesine MEISSNER, Danielle VAN MULUKOM, Hubertus CRANZ

Meeting report

Basil MATHIOUDAKIS


12/15

In her introductory statement,

Gesine MEISSNER (Member of the

European Parliament) spoke on the

European Parliaments first-reading

report on medical devices adopted

in April 2014. While the report has

detailed the views of the European

Parliament on medical devices, thesession Adjusting the medical

device legislation to consumer

needs offered an opportunity for

stakeholders such as Industry,

Member States and Patients or-

ganisation to provide their perspec-

tives and exchange views on sub-

stance-based medical devices.

Substance-based

medical devices

As explained by George JESSEN

(Member of the AESGP Committee

on Medical Devices), substance-

based medical devices are devicescomposed of substances or combi-

nation of substances intended to

be used in a self-care context by a

lay person and which do not

achieve their principal intended

action by pharmacological, immu-

nological or metabolic means in or

on the human body but which may

be assisted in its function by such

means.

This emerging category includes

toothpastes, dental cleansers, den-

ture adhesives, throat lozenges and

irrigation solutions, which are cur-

rently placed on the market in

accordance with Rule 4, 5 or 17 of

the 93/42/EC Directive on medical

devices. Industry recognised that

the Medical Devices Directives havenot anticipated the emergence of

self-care medical devices and sub-

stance-based medical devices at

the time of the harmonisation of

the safety and performance of

medical devices in the nineties.

Proposal for a

regulation on MD

A proposal for a regulation on

medical devices adapted to todays

and tomorrows needs was thus

adopted by the European Commis-

sion in September 2012. It intro-

duced the following points:

Rule 21 proposing an up-classification of substance-based

medical devices intended to be

ingested, inhaled or adminis-

tered in the highest-risk class

(class III), and

Compliance of these devices

with the Annex I of the Medici-

nal Product Directive 2001/83/

EC.

The industry representative, George JESSEN, stressed

the need to differentiate a mode of action and a thera-

peutic effect, as a same therapeutic effect can be deliv-

ered via a pharmacological and a non-pharmacological

modes of action.

In November 2012, AESGP suggested a deletion of both

points, resulting in a case-by-case assessment of sub-

stance-based medical devices, based on the risk associ-

ated with the device. In addition, the safety of these

devices would continue to be assured by the application

of established risk management to medical devices such

as the EN ISO standard 14971:2012 on the application

of risk management to medical devices and the relevantstandards from the EN ISO 10993 family on the biologi-

cal evaluation and testing within a risk management.

Under the ordinary legislative procedure, the European

Parliament and the Council of the European Union

(Member States) examine and propose amendments to

the European Commissions proposals. While discus-

sions within the European Parliament are public, discus-

sions within the Councils working party on pharmaceu-

ticals and on medical devices are confidential.In that sense, the session was a real opportunity to hear

the views of two members of the Councils working

party on pharmaceuticals and medical devices.

Gesine MEISSNER


13/15

First to speak then, was the Director

of the Health Products Directorate at

the Portuguese Competent Authority

(Infarmed), Judite NEVES. She recog-

nised that substance-based medical

devices have being historically classi-fied as medicinal products, while they

do not primarily act by a pharmaco-

logical mode of action.

In line with the better law approach

which supports a proportionate and

risk-based approach, the Portuguese

Competent Authority has proposed

an alternative to Rule 21 on the basis

of the systemic absorption of ingested

medical devices.

This approach is different from the

AESGP one which proposed a stratifi-

cation of the risk on the basis of their

duration of use namely in class IIa if

the devices are intended to be used

for not more than 30 days and in class

IIb if these devices are used for more

than 30 days, as explained by the

industry representative, George

JESSEN.

In addition, the Portuguese Compe-

tent Authority proposes to revise the

essential requirements by taking into

account the particular characteristics

of these products. Manufacturers

should also provide information such

as the general profile of interaction

and the overall qualitative composi-

tion and quantitative information on

the main constituent responsible for

achieving the principal intended ac-

tion. These proposals were in principle

in line with the views of the Dutch

Ministry of Health which were pre-

sented at the session by Danielle

VAN MULUKOM, from the Depart-

ment of Pharmaceuticals and Medical

Technology. However, as far as the

essential requirements are concerned,

the Dutch Authority would prefer

keeping the system flexible, and de-

tailing these in the harmonized stand-

ards instead of the body text of the

regulation.

Meeting report

Judite NEVES

Danielle VAN MULUKOM


14/15

The presentation of the European Patients Forum Secre-

tary General, Nicola BEDLINGTON focused on the pro-

posal for a regulation on medical devices and what it will

mean for the EU patients. She highlighted four key priori-

ties, including the need to emulate the model of patientinvolvement developed by the European Medicines

Agency to the medical devices sector. According to Nico-

la BEDLINGTON, substance-based medical devices com-

plement the self-management of adverse events that

patient encounter when living with long-lasting condi-

tions. She recognised that there should not be an up-

classification without a proper justification, although

these products may bear a risk due to their dispersion

and/or absorption in or on the human body.

Other issues of concern

George JESSENhighlighted the other AESGP issues of

concern related to self-care medical devices which are

the definitions of pharmacological, immunological and

metabolic means and the Helsinki Procedure. The Hel-

sinki Procedure was created in 2002 to allow exchange

of information and opinions between National Compe-

tent Authorities from the 28 EU Member States, EFTA

countries and Turkey over the classification of a productas a medical device or not. However, AESGP regrets the

lack of involvement of concerned manufacturers and

notified bodies in these discussions.

Both topics are currently being discussed within the

European Commissions expert group on borderline and

classification composed of representatives from Nation-

al Competent Authorities, Industry, Notified Bodies, and

the European Medicines Agency. On this subject, the

Secretary General of the European Patients Forum,

Nicola BEDLINGTON recognised that the European

Patients Forum may need to be sporadically involved inthese discussions.

The categorisation of medical devices and the border-

line issue with other categories, including medicinal

products were also highlighted by Judite NEVES. The

enclosed qualification process is helpful in determining

whether a product is a medicinal product or a medical

device.

Nicola BEDLINGTON

George JESSEN

Patients perspective on substance-based medical devices


15/15

The political action points resulting from the conference

were summarised by the AESGP Director General,

Dr Hubertus CRANZ.

Speaking on behalf of the European Self-MedicationIndustry active in all three categories medicines, food

supplements and medical devices Dr CRANZ said that

clear and stable legal frameworks are crucial for the

companies business planning and investment into the

innovative self-care products offered to the European

consumers.

Dr CRANZ noted that while the pharmaceutical industry

has positive experience with the interaction with the

European Medicines Agency, the area of food supple-ments seems to suffer from a lack of adequate interac-

tion between applicants and the European Food Safety

Authority (EFSA). While AESGP appreciates EFSA efforts

to improve dialogue with the applicants, a real progress

has not been made over the last years. Dr CRANZ high-

lighted that this should be tackled as an issue of urgen-

cy by the new European Commission and all other

parties involved.

Referring to the complex discussions on botanicals, DrCRANZ said that it the current situation with 28 EU

Member States of different approaches and views on

the categorisation and status of herbal products, a full

harmonisation at the EU level is very difficult to achieve,

if at all possible.

The Conference also showed that although the regula-

tory situation for herbal medicinal products is well-

established, it is important to ensure that the EMA work

is smoothly implemented by the Member States author-

ities at the national level, without unnecessary adminis-

trative burdens.

Concerning medical devices, Dr CRANZ said that AESGP

is curious to see the results of the negotiations within

the Council, and later on between the Council and the

Parliament.

The conference was concluded by an invitation to the

next AESGP Annual Meeting which will take place in

Barcelona on 26-28 May 2015.

Conclusion

Meeting report

From left to right: Hubertus CRANZ,, George JESSEN, Judite NEVES, Gesine MEISSNER, Danielle VAN MULUKOM

Hubertus CRANZ

aesgp october conference report.pdf

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