E-drug: Medicines in Europe Forum
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JOIN MEDICINES IN EUROPE FORUM
The Medicines in Europe Forum will hold a Press Conference on:
Medicines policy projects: A threat to consumers and patients
Monday 29 April 2002, at 11 a.m.
Mutualit� Fran�aise
255, rue de Vaugirard, Paris XV (France)
In an unprecedented move, the main French and European
consumers organisations, many national patient groups, French
organisations paying for medicines, together with a network of
independent medical journals for health professionals world wide,
take a stand on the proposed amendments to the European
Directive and Regulation on medicines. Medicines in Europe Forum
is alerting policy makers and the public to projects that threaten
consumers' and patients' interests. Medicines in Europe Forum will
present its assessment and make counter-proposals. The Press
conference will be initiated by Jean-Pierre Davant (President of
Mutualit� Fran�aise, AIM), with communications by Jacques Mopin
(UFC Que Choisir, BEUC), Emmanuel Trenado (Aides-TRT-5),
Claude B�raud (Mutualit� Fran�aise), and Bruno Toussaint (La revue
Prescrire).
Press contacts:
o Samia Nabi - Tel. : 33 1 49 23 72 96
o B�atrice Degrugillers - Tel. : 33 1 40 43 63 26
o Antoine Vial - Tel. : 06 73 00 15 40
o V�ronique Collard - Tel. : 33 1 41 83 46 11
As of April 26th, 2002 the following organisations have signed up
to our platform (see below).
To join Medicines in Europe Forum and add your signature, please
contact Christophe Kopp (ISDB): christophe.kopp@wanadoo.fr
Family and consumer organisations:
- Conf�d�ration Syndicale des Familles (CSF)
- Familles Rurales
- UNAF (Union Nationale des Associations Familiales),
- Union F�d�ration des Consommateurs (UFC) -Que Choisir
Patient groups:
- Act Up Paris
- Actions Traitements
- Association Fran�aise des Polyarthritiques (AFP),
- AIDES
- Association pour la Recherche, la Communication et les Actions
pour l'acc�s aux Traitements (ARCAT)
- F�d�ration nationale des accident�s du travail et des handicap�s
(FNATH)
- Ligue Nationale Contre le Cancer (LNCC)
- R�seau Hospitalier des Usagers (RESHUS)
- Sida info Service
- TRT-5 (groupe inter-associatif de 8 associations de lutte contre le
sida Nova dona, Sol en Si, Act Up Paris, AIDES, Actions
Traitements, Sida info Service, ARCAT, Dessine moi un mouton)
Organisations paying for medicines:
- Association Internationale de la Mutualit� (AIM) Bruxelles
- La Mutualit� Fran�aise
Professional health care organizations:
- Association Mieux Prescrire (AMP) et la revue Prescrire
- International Society of Drug Bulletins (ISDB)
- R�forme & Sant�
MEDICINES IN EUROPE FORUM
For a responsible, public-health-oriented policy
The proposed revision of medicines policy (regulation #2309/93 and
directive 2001/83/EC of European Parliament and Council) will be
discussed by Members of Parliament in May 2002, with a view to
first consultation by the Parliament by the end of 2002.
In response to this initiative, an action group called MEDICINES IN
EUROPE FORUM has been formed, with the aim of ensuring that
the overriding goals of European medicines policy are to serve
public health and to protect consumers. It includes national
consumer organisations, patient groups, independent national
organisations, French and international organisations paying for
medicines, and independent sources of drug information, all with
substantial experience in the field of health and medicines.
MEDICINES IN EUROPE FORUM is currently preparing amendments
to the draft directive and regulation, for the following reasons.
Medicines are not mere consumer goods.
Medicines are used by people who are either sick or have risk
factors for a particular disease. All medicines, whether used
therapeutically or preventively, have potential side effects. In
addition, the medicines market is captive: patients take drugs when
required, not by choice; they are not mere consumers. For these
reasons, approvals of new medicines must be thoroughly assessed;
known and potential side effects must be actively monitored; and
health professionals and citizens must have access to thorough and
reliable information on the medicines they may be called on to
prescribe, dispense or use.
The proposed directive and regulation consider medicines as normal
industrial products.
The current draft aims to simply reinforce competitiveness of
European pharmaceutical companies in the short term. It prolongs
protection of some clinical data; allows more flexible and faster
marketing approvals. It provides for marketing approvals to be
granted on a permanent basis (removing the current 5-yearly
renewal obligation), but fails to ensure adequate strengthening of
pharmacovigilance. It also provides for drug companies to
disseminate information (for information, read promotional material)
to the public on medicines used in asthma, diabetes and AIDS,
including prescription-only products. In short, the patients, and
public health in general, are not adequately taken into account.
Reducing the time for assessing a marketing application from 210
to 150 days (see article 17 of the proposed directive) means the
quality of assessment cannot be guaranteed.
It takes time to evaluate pharmaceutical, toxicological and clinical
data on new drugs, and the process cannot be accelerated without
compromising on quality. The experience of experts working with
the European Medicines Evaluation Agency shows that it is already
difficult to comply with the current period of 210 days. Relevant
data are often missing for rapid and quality assessment. Note that
the regulation does not demand that new drugs must be compared
with standard treatments.
In our opinion the current period of 210 days must be maintained.
The accelerated procedure should be reserved for exceptional
circumstances, such as medicines likely to offer a significant benefit
for patients who have no alternative treatment.
- Conditional marketing authorisation (article 13.4 of the proposed
regulation) In a narrow set of strictly defined health emergencies (to
be defined), where a drug is shown to be a real therapeutic
advance, conditional approval can be granted for one year, on
condition that the company subsequently completes the marketing
application file, and that the public is informed of whether or not
the company meets its commitments. This latter point is not dealt
with in the proposed article 13.4.
- Compassionate use (article 73 of the proposed regulation) Article
73 provides for early access to a medicine within the framework of
a compassionate use programme. Any medicines that may provide
substantial benefits to patients with life-threatening illnesses and no
adequate treatment must be made accessible before conditional or
full approval is granted. This compassionate use programme must
benefit all patients waiting for a treatment and not participating in
clinical trials (planned for marketing approvals).
Within this framework, marketing approval must be conditional on a
programme of compassionate use of adequate scope. The
programme should have, two aims:
- to evaluate the safety of the new medicine in a patient population
that cannot participate in normal pre-marketing trials;
- to provide the new medicine to people in therapeutic emergencies
on a not-for-profit basis, following agreement between the company
and the relevant health authorities.
- Protection of clinical and preclinical data (article 10 of the
proposed directive) Prolonging the protection of evaluation data will
hinder the development of generic drugs. The possibility of using
evaluation data of an initially marketed drug can avoid the need for
repeated evaluation.
Given the rate at which new scientific knowledge now
accumulates, medicines must be re-assessed regularly (contrary to
article 24 of the proposed directive)
Re-assessment of adverse drug reactions in the light of new
pharmacovigilance data is essential to guarantee patient safety and
rational use.
It's also important to e-assess the comparative benefits of different
drugs in the light of new international data so that patients can
always be prescribed the most effective treatment.
The five-yearly renewal of marketing approval demanded in the first
European directive was not intended to increase red tape, but to
protect public health. In our opinion it must be maintained, actively
applied (which is not the case), and broadened to cover all available
clinical data, so that benefits and risks of medicines are
re-assessed.
Drug safety cannot be ensured if pharmacovigilance is passive and
secretive (see articles 101-107 of the proposed directive)
EMEA already collates spontaneous notifications of adverse drug
reactions, but what purpose do the data serve if those most directly
concerned -- health professionals and patients don't have access to
them? The database of adverse drug reactions must be accessible
on request, and so must pharmacovigilance reports.
Likewise, what is the use of manufacturers conducting regular
pharmacovigilance updates on their drugs if the end-user remains in
the dark? Once again, these reports must be accessible on request.
Above all the European Medicines Evaluation Agency must create
an independent and proactive pharmacovigilance system. It must be
given the means to conduct prospective surveys, in collaboration
with the agencies of EC member states and those of other
countries. Proactive pharmacovigilance is a major tool in public
health, as it helps avoid safety crises and hasty drug withdrawals.
Unfortunately, proactive pharmacovigilance is not provided for in
the draft directive.
Do patients need information about medicines and illnesses (see
article 88 of the proposed directive)? Certainly.
Article 88 of the proposed directive has become increasingly vague
and ambiguous with successive drafts. The question of patient
information is dealt with in a section on advertising, implying that it
refers to information provided by drug companies. This is confirmed
unambiguously in the memorandum relating to the directive by the
wording 'promotional information' (i.e. advertising).
What consumers and patients actually need is reliable, comparative
and legible information on medicines, alternative therapies, and
health in general. Patient groups, public-health bodies and
independent therapeutics journals, already distribute such quality
information. Further development and improvement of such
information is welcome.
Yet patients and consumers believe that drug advertising, which, by
definition, is designed to increase consumption, does not give them
the reliable information they need.
If directive 2001/83/EC is to be amended, current advertising
controls should be strengthened and actively enforced. So far, few
companies have been punished for flouting existing regulations.
Three principles must be reinforced in the directive.
The founding directives regulating medicines in Europe (#65/65,
75/318 and 75/319) placed public health and patient safety
uppermost. As it stands, the proposed directive serves only the
interests of drug companies.
Three principles need to be reinforced in all sections of the
proposed directive if European citizens are to be given every public
health guarantee:
The principle of transparency.
The Charter of Fundamental Rights of the European Union and
Regulation (EC) No 1049/2001 of the European Parliament and of
the Council regarding public access to documents from the
European Parliament, Council and Commission (including agencies),
imply that citizens must have free access to information and to the
reasons underlying administrative decisions, including those
concerning medicines.
Secrecy now prevailing at the European Medicines Evaluation
Agency is an obstacle to rational drug use. Transparency must be
improved if patients and health professionals are to regain
confidence in this key organisation, and if these interested parties
are to join force for improving rational drug use.
- Real patient representation in the EMEA (articles 58, 50.3 and
51.1 of the proposed regulation) Representatives of patients must
be allowed to participate actively in all EMEA consultative bodies.
Article 58 must provide for balanced representation of patients and
drugs companies on the EMEA Management board, as well as
transparent procedures for selecting these representatives.
The principle of independence.
The fact that the organisations dealing with drug-related matters are
currently part of the Enterprises Directorate of the European
Commission rather than the Health and Consumer Protection
Directorate means that public health priorities are overlooked.
Likewise, the fact that the EMEA is funded mainly by drug
companies (through fees for approval procedures) compromises the
true role of the agency that of a public health safeguard, and not
only a mere service provider for industry.
The proposed directive and regulation must restore key guarantees
of independence. Community funding of the EMEA must be
increased substantially to reinforce its independence and to provide
it with the means required to fulfil its role and responsibilities.
The principle of harmonisation.
A considerable effort has already been made to harmonise the
regulation of medicines in Europe. But much remains to be done in
the field of pharmacovigilance at the European and international
levels, and also to improve marketing authorisation procedures.
While the centralised procedure has a good performance in terms of
harmonisation, the mutual recognition procedure is still chaotic, and
its quality is highly variable. In addition the mutual recognition
procedure is not trustworthy because it is totally opaque
The proposed directive does not provide for improvements in this
respect, and it should be amended further.
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