2009-2010 - AESGP

ANNUAL Report
2009-2010
Highlights of the Year
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• Association of the European Self-Medication Industry
• Association Européenne des Spécialités
Pharmaceutiques Grand Public
• Europäischer Verband der Arzneimittel-Hersteller
Gaining
wide support for
Smart Regulation 2015
Following a review of its vision and mission in 2007 and the launch of
its manifesto ‘Smart Regulation 2015’, AESGP focused in 2009-2010 on
the communication of its proposals for the future regulation of self-care
to a wide range of stakeholders.
Particular attention was paid to wellfunctioning
national and European
marketing authorisation and variation
systems and to the need for adequate
communication rules. These efforts
dovetailed with the intensive debates on
the so-called ‘pharma package’, where
AESGP closely followed the ensuing
discussions on the planned legislation
concerning falsified medicines and
pharmacovigilance.
Interaction with the newly elected and
reappointed Members of the European
Parliament and with representatives of other
European institutions was facilitated by the
well-attended AESGP Annual Reception in the
premises of the European Parliament in Brussels
on 6 October 2009.
Welcoming the guests at the AESGP Annual
Reception: AESGP President Hans REGENAUER
and Dagmar ROTH-BEHRENDT,
Vice-President of the European Parliament
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“... non-prescription medicines ... play an important role since they offer economic as well
as social benefits. Self-medication empowers patients to treat or prevent short term or chronic
illnesses which they consider not requiring the consultation of a physician or which may be
treated by the people after an initial medical diagnosis. Consequently, access and availability
of these medical products require particular attention.”
CHAllEnGES rESulTInG
froM THE ‘PHArMA PACkAGE’
While the reduction of unjustified
administrative burdens remains
a key objective for AESGP,
particular focus had to be put
on the reaction of the Council
(EU Ministers) and the European
Parliament to the Commission’s
proposals.
AESGP welcomed the pragma-
tism shown in the proposal on
falsified medicines but discovered
with concern that this was
challenged by a considerable
number of Member States and
some Members of the European
Parliament, who would like to see
the obligation to impose Europewide
harmonised safety features
extended to at least some
non-prescription medicines. This
would include the obligation for
product mass-serialisation, which
is simply not proportionate in the
case of non-prescription medicines.
During the debate additional
problematic suggestions
for the self-medication industry
were brought up. These included
a systematic inspection of all
manufacturing of active pharma-
ceutical ingredients and excipients outside
the European Union to verify GMP
(Good Manufacturing Practice) conformity.
On a more positive note, there was
a strong desire to better cover the risks
related to Internet sales and to reinforce
the penalties/sanctions for counterfeiters
while at the same time clearly differentiating
between medicine falsifications and
production errors.
The proposed new rules concerning
pharmacovigilance were overall supported
as they are aimed at overcom-
ing unnecessary regulatory requirements
without negatively impacting on public
health. AESGP was pleased to see that
some of its proposals concerning the
submission of Periodic Safety Update
Reports and the monitoring of literature
had been taken into account in the Commission’s
proposal, although the wording
would need improvement. On the other
hand AESGP also had several concerns
with the proposal, for instance about the
extended reporting requirements for nonserious
suspected adverse reactions and
the way public hearings were going to
be organised. The association therefore
continues to contribute comprehensively
to the ongoing political debate.
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Member of the European Parliament
Françoise GROSSETÊTE at the AESGP Reception

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Source: Communication of the European
Commission on “Safe, Innovative and
Accessible Medicines: a Renewed Vision
for the Pharmaceutical Sector” of 10
December 2008
CuTTInG rEd TAPE
Some concrete progress towards ‘better regulation’ was made
with the new European variations system.
Regulation 1234/2008 on variations
was adopted in November 2008 and
came into force on 1 January 2010. It set
up a new variations system for centrally
authorised medicines as well as for medicines
authorised through the mutual recognition
and decentralised procedures.
It introduced new concepts such as the
‘do and tell’ notification, the possibility to
group variations in one submission, and
the work-sharing procedure which aims
at simplifying the whole system. Although
this is a notable improvement compared
with the previous framework, AESGP
regretted that the changes did not capitalise
more on the existing German or
Austrian systems for variations.
In another legislative step, the Commission
was empowered to extend the new
variations system to all marketing authorisations.
Although the last concrete phase
of the Regulation’s modification to include
nationally authorised medicines is not yet
completed, a majority of Member States
already apply the new rules to all medicines
in their territory.
The categorisation of variations, which
brings more flexibility to the system, was
laid out in a new guideline. Another guideline
clarified the details around the practical
application of the new procedure.
AESGP wishes to have the ad hoc group
that developed the new variation rules
monitor the early implementation stages
to ensure a fully harmonised – and hence
successful – variation system.
The reform of the variations regime was
part of a list of 10 fast-track actions to
reduce administrative burdens presented
by the European Commission in March
2008 to stimulate economic growth, and
fits into the Community’s framework programme
to reduce administrative burdens
for business by 25 percent by the year
2012.
BOOSTING INNOVATION
Reducing red tape is critical, but creating
incentives and the right environment to
support innovation is equally important.
In this context, AESGP participated in the
UK Ministerial Industry Strategy Group
(MISG) on widening access to medicines
in London on 3 December 2009. The
aim of this high-level strategic meeting
was to consider the development of a
streamlined reclassification model to deliver
wider access to medicines in the UK
and ultimately across Europe.
Through its interaction with EU or national
competent authorities, AESGP continues
to call attention to and educate about the
various benefits of self-care, but also to
emphasise the need to take account of
the sector’s specificities. At the European
Medicines Agency’s workshop on transparency
in October AESGP highlighted
the particularly competitive environment
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“... Promotion of effective self-care is important not only to reduce health-care costs,
but it can also lead to improvement of equity in health.”
in which the self-care sector finds itself,
and recommended careful consideration
of the data that should,
or should not, be released to the
public….including competitors.
In a note to the Heads of Medicines
Agencies dated March 2009, the
European Commission made it clear
that centrally authorised medicines
would have to be switched using
the central route, and the first central
switches of orlistat and pantoprazole
in January and June 2009, respectively,
marked a major milestone in
the history of the self-care sector.
It may be expected that several innovative
switch applications will
be reviewed by the Committee for
Medicinal Products for Human Use
(CHMP) in the near future, allowing
the products concerned to become
pan-European. The constructive discussions
between the Agency and
AESGP during the regular platform
meetings are therefore fundamental
to creating mutual understanding
and to ensuring a constructive way
forward. Through direct interaction
with a CHMP sub-group at the next
platform meeting, the Committee is
expected to share the lessons learnt
from the first two central switches.
AESGP is eagerly looking forward
to the CHMP’s vision for the future.
Turning towards the decentralised
and mutual recognition procedures,
AESGP is equally keen to ensure
that these procedures work well. A
performance tracking survey carried
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out through the AESGP membership in
the second half of 2009 provided an
objective picture of the situation. Although
a number of improvements and
efforts could be noted, some delays and
backlogs still needed to be resolved.
The results were presented to a panel of
CMD(h) members at the AESGP conference
in January and led to an enriching
and open debate which, at the request of
some authorities, may be followed up by
meetings at the national level to discuss
the country-specific findings.
ICH
AESGP continued to coordinate the International
Conference on Harmonisation
(ICH) activities on behalf of the World
Self-Medication Industry (WSMI) of
which it is a founding member. Experts
participated in the June ICH meetings in
Yokohama, Japan and in St Louis, USA,
in October.
Source: WHO Report of the Regional Consultation: Self-care
in the Context of Primary Health Care, January 2009.
DAILY REGULATORY AND
SCIENTIFIC WORK
On top of its political activities, AESGP
continued to provide its membership with
a continuous flow of information and opportunities
to take part in consultations
and meetings. On the issue of quality/
GMP, AESGP participated in the yearly
joint EMA Quality Working Party/Interested
Parties meeting and in a workshop
on variations sponsored by both the
Agency and the Co-ordination Group
for the Mutual Recognition and Decentralised
Procedures – Human (CMD(h)).
The association presented the results of its
membership survey on the issue of atypical
actives to the Good Manufacturing
Practices/Good Distribution Practices Inspectors
Working Group, and pledged
it would continue to monitor the issue.
AESGP also discussed early experience
with the PSUR work-sharing group at its
meeting in September and participated
in the CMD(h) paediatric subgroup in the
same month. AESGP also played an active
role in the Commission’s workshop
to prepare a written consultation on the
Clinical Trials Directive and attended
an Agency meeting on Good Clinical
Practices. Over the past 12 months the
association contributed to consultations
on a wide variety of topics with over
30 position papers and response documents
and responded in a timely manner
to the many scientific and/or regulatory
requests from its members.

NEW AESGP
PUBLICATIONS ON
NON-PRESCRIPTION
MEDICINES...
Since 1995, AESGP has annually issued
a comprehensive study on the
Economic and Legal Framework for
Non-Prescription Medicines with information
on practically all important
elements playing a role in the
market place for non-prescription
medicines.
Every country section covers the
following areas:
1. Classification
2. Marketing authorisation
3. Patient information
4. Advertising to the general public
5. Trade names
6. Waste
7. Distribution
8. Distance selling
9. Pricing
10. Price build-up
11. Market data
12. Restrictions concerning imports
13. Switch climate
14. Pharmacy training and attitudes
15. Doctors’ training and attitudes
16. Relations with consumer associations/patient
groups
17. Consumer attitudes/research
18. Other national developments
19. Electronic information
20. AESGP or WSMI member association
The study covers most markets inside Europe
as well as the following non-European
countries: Argentina, Australia, Brazil,
Canada, China, India, Indonesia, Israel,
Japan, Mexico, the Philippines, Thailand
and the United States. The homogeneous
structure of the country chapters allows
an in-depth comparison of 40 important
markets around the globe and provides
an insight into the most relevant horizontal
and vertical pieces of EU legislation
and guidance for manufacturers of selfcare
products.
The 16 th edition is in preparation and will
be published in June 2010.
2 nd
edition
...AND HERBAL MEDICINES
Phytotherapy is one of the most
ancient forms of medicine. It is still
very much used today as shown
by the World Health Organization’s
estimate that 80% of people
worldwide rely on herbal medicines
for some aspects of their primary
healthcare.
Based on this, AESGP will expand the
geographic coverage of the 2009 edition
of its Legal and Regulatory Framework
for Herbal Medicines. The new
edition will still cover most EU countries
and Switzerland but also some EU candidate
countries as well as some of the
largest worldwide (Australia, Canada,
India, China…).
For each country, a specific chapter will
address the legal framework for herbal
medicines, dossier requirements, evaluation
process, product information, trade
name, advertising and distribution as
well as other useful information.
AESGP trusts that the expanded study
will prove useful for industry, regulators
and, in general, for anyone having an
interest in learning more about the regulatory
framework for herbals.
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iNcReAsiNg Access
to HeRBAL MeDiciNes
AESGP is intent on ensuring the proper functioning of the registration procedure
for traditional herbal medicines laid down in Directive 2004/24/
EC in the spirit designed by the legislator. So far, the uptake is still quite
limited with 134 registrations being granted in Europe at the end of
February 2010. AESGP is preparing a comprehensive priority document
to highlight the importance of a faithful implementation of the Directive.
Moreover, the association recommends inserting incentives in the legislation
to stimulate the growth of the sector and to promote research into
herbals. Such a paper will be presented at the next hearing with the
HMPC Working Party on Community Monographs and Community List
(MLWP) in May 2010.
AESGP contributed to the Committee on Herbal Medicinal Products’ (HMPC) calls
for data by sending literature references. The association moreover provided the
HMPC with elaborate comments on nearly all draft Community monographs, list
entries and public statements. It welcomed the improved quality of Community
monographs and the HMPC’s pragmatic approach in its guidance on genotoxicity.
AESGP was equally pleased with the European Commission’s confirmation that Community
monographs should be followed by the Member States without deviations,
and that detailed justification should be provided in case of a deviation. AESGP is
continuing to work for a successful system and the cost-effective use of resources. For
this to become a reality, systems should be in place at the national level to evaluate
registration applications for traditional herbal medicines with commensurate fees
and reasonable timelines.
EUROPEAN PHARMACOPOEIA – INTERACTION
AESGP keeps its members informed of the work programme of the European Directorate
for the Quality of Medicines (EDQM) and relays to the EDQM any expression
of interest from its members to participate in the revision or drafting of monographs/
general chapters.
Building on the constructive exchange a year earlier, an AESGP delegation met with
the EDQM in November at the European Pharmacopoeia premises in Strasbourg.
The discussions focused on topics related to herbals and homeopathics, including
new analytical methods for herbal substances in pharmacopoeial monographs,
reference materials and safety assessment.
COOPERATION WITH WHO AND WIPO
AESGP continued to take part in consultations and to follow activities led by the
World Health Organization (WHO) and the World Intellectual Property Organization
(WIPO). AESGP participated on behalf of WSMI in the discussion on the revised
WHO Good Distribution Guideline during the October WHO expert committee
meeting week in Geneva.
AesgP
conference
london
19-20 January 2010
Following the first two successful
applications to switch a medicine
to non-prescription status through
the centralised procedure, the
conference provided an excellent
platform to look at future opportunities
for the self-care industry
and at how to make the various
authorisation/registration systems
work effectively.

Manfred SCHESKE, Vice-President, AESGP,
President, Consumer Healthcare Europe,
GlaxoSmithKline and Patrick LE COURTOIS,
Head of Human Medicines Development
and Evaluation Unit, s
EMA
s
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Celebrating the 15th anniversary of the European Medicines Agency (EMA): Hubertus
CRANZ, AESGP Director General, Giuseppe NISTICO, Member of the CHMP and of the
EMA Management Board, Eric ABADIE, CHMP Chairman, Thomas LÖNNGREN, EMA
Executive Director and Hans REGENAUER, AESGP President
Panel with CMD(h) participants Christer BACKMAN – Sweden, Katalin VARSANYI –
Hungary, Shirley NORTON –United Kingdom, Vanessa BINAMÉ – Belgium, Sandra
PETRAGLIA – Italy and Peter BACHMANN – Germany; Glenn CARPENTER, Senior
Director Regulatory Affairs, Johnson & Johnson is third from the left
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Martina CVELBAR, Director, Agency for Medicinal
Products and Medical Devices, Slovenia, Truus
JANSE-DE HOOG, Chair of the Co-ordination Group
for Mutual Recognition and Decentralised Procedures
– Human (CMD(h)) and Graham PARR, Assistant Vice
President, Pfizer Consumer Healthcare
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HOMEOPATHIC MEDICINES
The work of the Homeopathic Medicinal Products Working Group (HMPWG) carried
out under the umbrella of the Heads of Medicines Agencies was also followed
closely. AESGP responded to the call for comments on the draft HMPWG “Points to
Consider on the Justification of Homeopathic Use” and on the three HMPWG Drafts:
“Structure of list of first safe dilutions”, “Introduction to list of first safe dilutions” and
“Assessment Report First Safe Dilutions”.
BALANceD APPRoAcH foR
fooD sUPPLeMeNts
Active involvement in all regulatory developments around food supplements
has long been a key part of AESGP’s activities.
IMPLEMENTATION OF THE NUTRITION AND HEALTH CLAIMS
REGULATION
AESGP closely followed the implementation process related to Regulation
1924/2006 on nutrition and health claims made on food. This included the adoption
of the Community-wide list of permitted Article 13 health claims, rules concerning
the use of disease-risk reduction claims and claims relating to children’s development
and health, as well as claims based on newly developed scientific evidence and/
or which included a request for the protection of proprietary data, amendments to
the list of permitted nutrition claims, the establishment of nutrient profiles, etc.
Article 13 health claims cover functional claims referring to the role of a nutrient or
other substance in growth, development and the functions of the body, or psychological
and behavioural functions. Work on the consolidation of the national lists
of Article 13 health claims resulted in a Community list being submitted to the European
Food Safety Authority (EFSA) for scientific evaluation. In this context, AESGP
supported an evidence-based approach in the scientific evaluation, in line with the
scientific criteria for the food sector.
From a procedural point of view, AESGP recommended the adoption of one single
legislative measure for Article 13 health claims, with a reasonable date of effect
allowing manufacturers to streamline the planning and implementation of the resulting
labelling and packaging modifications. Moreover, transitional measures for
rejected Article 13 health claims should take into account the particularities of food
supplements and their typically longer shelf-life than that of other food products.
They should be designed in a way to allow manufacturers to phase their products
out in a feasible way.
AesgP 45 th
Annual Meeting
Vienna
3-5 June 2009
How to adapt to the changing selfmedication
was the key theme of
the 2009 AESGP Annual Meeting,
which provided an excellent opportunity
to look into recent developments
with regard to a broad range
of issues including the distribution
of medicines, consumer behaviour
and attitudes, and the new role for
health professionals. This was combined
with updates on legislative
and regulatory developments in the
market place and AESGP’s role in
these. The Annual Meeting also provided
the opportunity to present an
update on the pharmacist/pharmacy
students training programme in relation
to non-prescription medicines,
which AESGP carried out together
with the European Pharmaceutical
Students’ Association (EPSA)
and the European Association of
Faculties of Pharmacy (EAFP)
and the London School of
Pharmacy.

1 The medical doctors’ view:
Michael WILKS, President, CPME
2 The view of the host: Alfred GRÜN,
President of the Austrian Self-
Medication Industry IGEPHA
3 The regulators’ view: June RAINE,
Medicines & Healthcare products
Regulatory Agency, United Kingdom,
and Chair of the EMA Working Party
on pharmacovigilance
4 The View of the European
Commission: Philippe BRUNET,
Head of Cabinet of Androulla
VASSILIOU, European Commissioner
for Health
5 The pharmacists’ view: John CHAVE,
Secretary General, PGEU
6 The retailers’ view :
Ashley HICKS, Category
Director Healthcare, Tesco
The industry
leadership panel
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2 3
4 5 6
1
Closing event at the
Hofburg Imperial Palace
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Opening evening with a
performance by the Vienna
Boys Choir
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AESGP commented on the draft frequently asked questions (FAQ) document developed
by the European Food Safety Authority on the assessment of applications for
Article 13.5 and Article 14 health claims (i.e. claims based on newly developed
scientific evidence and/or which include a request for the protection of proprietary
data, disease risk reduction claims and claims relating to children’s development
and health). In this area, AESGP will continue to ask EFSA to allow pre-submission
meetings with companies considering the submission of individual applications for
these types of claims.
SETTING OF MAXIMUM AMOUNTS FOR VITAMINS AND
MINERALS IN FOOD SUPPLEMENTS / RULES ON “OTHER
SUBSTANCES”
The setting of harmonised maximum and minimum levels for vitamins and minerals
in food supplements in order to reduce both production costs and the bureaucratic
burden on industry remained one of AESGP’s priorities. AESGP also closely followed
the discussions on the establishment of specific rules for nutrients or substances with
a nutritional or physiological effect other than vitamins and minerals (so-called ‘other
substances’), such as herbals, fatty acids, amino acids, probiotics etc. In this context
AESGP attended an Athens workshop entitled “Safety Assessment of Botanicals
and Botanical Preparations Intended for Use as Ingredients in Food Supplements”
organised in November by the European Food Safety Authority (EFSA).
PARTICIPATION IN EFSA’S WORK
Besides participating in various technical meetings organised by EFSA and contributing
to a wide range of consultations, AESGP continues to be an associate member
of the EFSA Stakeholder Consultative Platform which meets regularly to assist the
Authority in the development of its overall relations and policy with stakeholder
organisations.
REVISION OF THE LEGISLATION ON LABELLING
The proposal to revise the EU’s food labelling legislation launched in early 2008 is
currently under discussion by the Council of the European Union and the European
Parliament. AESGP keeps its membership informed of the main developments with
regard to this proposal, which will consolidate the general food labelling requirements
applicable to food supplements.
AESGP maintained that all legislative changes in the food labelling should
take account of re-labelling costs and internal administrative burdens for
companies, and that all revisions should be carefully coordinated in order
to avoid multiple reformulations and re-labelling exercises.
AesgP conference
Brussels
7 october 2009
The participants’ desire to be updated
on the numerous changes in
the regulatory landscape for herbal
(medicinal) products and food supplements
resulted in a fully packed
conference room. This paved the
way for an intensive discussion with
key decision-makers from the European
Parliament, the European Commission
and the EU Member States
on how to establish a stable and
predictable environment that would
allow the best consumer protection
and choice through the provision of
high-quality products with a sound
scientific basis.

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Discussing the future of
herbal medicines ...
...and food supplements
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Listening carefully:
Ioanna CHINOU, Chair of the Working
Party on Monographs and Lists and
Vice-Chair of the EMA Committee for
Herbal Medicinal Products and Pilar
AYUSO, Member of the European
Parliament
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Explaining EFSA work on herbal
substances: Professor Vittorio
SILANO, Chair of EFSA’s
Scientific Committee
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AesgP
country
organisations:
• Association of the European
Self-Medication Industry
• Association Européenne
des Spécialités Pharmaceutiques
Grand Public
• Europäischer Verband der
Arzneimittel-Hersteller
ContaCt
dr Hubertus Cranz
director General
AESGP
7, Avenue de Tervuren
B-1040 Brussels • Belgium
Tel: +32 (2) 735 51 30
fax: +32 (2) 735 52 22
E-mail: info@aesgp.be
www.aesgp.be
iGepHA, Austria
BAcHi, Belgium
SopHArmA, Bulgaria
pif, finland
BAH, Germany
mAGYoSZ, Hungary
AnifA, italy
neprofArm, the netherlands
pASmi, poland
SpmA, Slovenia
Lif, Sweden
ieiS, turkey
pharma.be, Belgium
BeLupo, croatia
ferrosan, Denmark
AfipA, france
efeX, Greece
ipHA, ireland
Aconitum, Lithuania
Lmi, norway
ApifArmA, portugal
Arfp, russia
Anefp, Spain
ASSGp, Switzerland
pAGB, united Kingdom