Healthy Skepticism Library item: 1765
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Medicines in Europe Forum, Medicines policy projects: A threat to consumers and patients
e-drug 2002 Apr 26
http://www.essentialdrugs.org/edrug/archive/200204/msg00108.php
Full text:
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‚ Française, AIM), with communications by Jacques Mopin (UFC Que Choisir, BEUC), Emmanuel Trenado (Aides-TRT-5), Claude Beraud (Mutualit‚ Française), and Bruno Toussaint (La revue Prescrire).
Press contacts:
o Samia Nabi – Tel. : 33 1 49 23 72 96
o Beatrice Degrugillers – Tel. : 33 1 40 43 63 26
o Antoine Vial – Tel. : 06 73 00 15 40
o Veronique 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 Française des Polyarthritiques (AFP), – AIDES – Association pour la Recherche, la Communication et les Actions pour l’accŠs 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‚ Française
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.
