The Medicines in Europe Forum, which was created in March 2002 in Paris, aims to ensure that European pharmaceutical policy serves the public interest. Christophe Kopp of International Society of Drug Bulletins describes why the Forum was created and introduces three principles that need to be reinforced in the proposed Pharmaceutical Directive and Regulation of the European Commission
In an unprecedented move, French and Belgium mutual insurance systems (1), consumer organisations, patient groups, Association Mieux Prescrire (2), and the International Society of Drug Bulletins (3) have launched an initiative to increase awareness among the public and policy makers of developments in pharmaceutical policy from a patient perspective. (For full details of the European organisations involved see list below - some are EPHA members).
The following statements provide not only the broad outline of the Forum’s programme but also point to the underlying reasons why Medicines in Europe Forum was created.
Medicines are not merely 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 preventatively, have potential adverse events. 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; side effects, both known and potential, 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.
Reducing the time for assessing a marketing application means the quality of assessment cannot be guaranteed. The accelerated procedure should be reserved for exceptional circumstances, such as medicines likely to offer a significant benefit for patients who otherwise have no alternative treatment.
Drug safety cannot be ensured if pharmacovigilance is passive and secretive (see articles 101-107 of the proposed Directive). The European Medicines Evaluation Agency (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.
Above all the EMEA must create an independent and proactive pharmacovigilance system. It must be given the means to conduct prospective surveys, in collaboration with the agencies of EU Member States and those of other countries.
Patients need information about medicines and illnesses, not promotional materials from those aiming to increase sales (see Article 88 of the proposed Directive).
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 of such information is welcome.
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 Pharmaceutical Directive
a. The principle of transparency
Secrecy now prevailing at the EMEA and in most national agencies. It presents an obstacle to rational drug use. Transparency must be improved if patients and health professionals are to regain confidence in these key organisations, and if these interested parties are to join forces for improving rational use.
b. The principle of independence
The proposed Directive and Regulation must restore key guarantees of independence. Community funding of the EMEA must be increased substantially to reinforce its independence vis à vis the industry and to provide it with the means required for its role and responsibilities to be fulfilled.
c. 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 remains non transparent, chaotic and highly variable in quality.
Family and consumer organisations:
Confédération Syndicale des Familles (CSF)
Familles Rurales - UNAF (Union Nationale des Associations Familiales)
Union Fédérale des Consommateurs (UFC) - Que Choisir, France
KILEN Consumer Institute for Medicines and Health, Sweden
Social Audit, UK
Act Up Paris
Association Française des Polyarthritiques (AFP)
Association pour la Recherche, la Communication et les Actions pour l’accès aux Traitements (ARCAT)
Fédération nationale des accidentés du travail et des handicapés (FNATH)
Ligue Nationale Contre le Cancer (LNCC)
Réseau 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)
European Federation of Asthma and Allergy Associations (EFA)
Organisations paying for medicines:
Association Internationale de la Mutualité (AIM) Bruxelles
La Mutualité Française
Agencia de Cooperación Internacional farmacéutica, Spain
Health-care professional bodies:
Association Mieux Prescrire (AMP) and la revue Prescrire
International Society of Drug Bulletins (ISDB)
Réforme & Santé
Mario Negri Sud, Italy
Ricerca & Pratica, Italy
BUKO Pharma-Kampagne, Germany
To join Medicines in Europe Forum, contact Christophe Kopp, Association Mieux Prescrire. E mail: email@example.com
1. AIM: Association Internationale de la Mutualité; FNMF: Fédération Nationale de la Mutualité Française
2. Association Mieux Prescrire is a non for profit organisation of health professionals providing comparative information on diagnostic tools, drugs and therapeutics. It publishes la Revue Prescrire and the English edition Prescrire International. Web address: www.prescrire.org
3. Created in 1986, the International Society of Drug Bulletins (ISDB) is an international network of drug bulletins that are independent from the pharmaceutical industry. Web address is www.isdbweb.org