Revue Prescrire, article en une, Medicines in Europe January 2004
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EU medicines policy:
Influence of bigpharma lobbies
and emergence of civil society
The legislative framework that will apply to medicines in the enlarged Europe has been adopted following two years of a democratic process, then by force of influence of the Commission and the Council.
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The Medicines in Europe Forum thanks all Euro-MPs who showed consideration for patients' interest and public health and, despite pressure, forced the adoption of welcome provisions, particularly those in favor of greater visibility by citizens of medicines agencies' decisions and workings. Unfortunately bigpharma lobbies and health ministers defending national interests joined force to impose decisions that will endanger health care and welfare systems of all member states.

The four key players of the Forum (patients groups, family and consumer bodies, mutual insurance systems, and health professional organizations) come back on the positive and negative decisions in the adopted texts:

Patients groups
Patients groups welcome the formal possibility for patients desperately lacking treatments to use not-yet-authorized drugs in compassionate use programs but deplore the rejection of all provisions that would have enforce application of these programs. Indeed the adopted texts fail to compel member states and companies to help patients. Rejection of patient direct reporting of side effects to authorities is also a negative outcome: patients are not yet recognized as legitimate partners in pharmacovigilance.

Family and consumer bodies
Family and consumer bodies are delighted at the massive rejection of an initial proposal by the Commission, i.e. de facto allowing of direct-to-consumer advertising for prescription-only medicines. Although it is to be feared that some proposals of the Commission about public oriented information might go in the wrong way, the European situation is currently not as bad as in the USA or New Zealand. Consumers welcome the measures (vainly opposed by the Commission) favoring informative labeling such as the International Nonproprietary Name (INN) or use of Braille on drug packaging.

Health professionals
Health professionals are happy with the obligation to re-evaluate drugs after 5 years on the market (10 years if safety problems occur) while bigpharma pushed for unlimited marketing authorization. They also welcome the continuation of the time frame for examining marketing applications, against shortening proposals by companies. They welcome the steps towards greater transparency of decisions and documents of regulatory agencies (centralized or national) but highly regret that nearly total secrecy will still prevail in pharmacovigilance matters. They condemn the stubborn refusal by the Commission to allow comparison of new drugs with older ones, therefore encouraging unbridled marketing of medicines with unknown therapeutic merits.

Mutual insurance organizations

Mutual insurance organizations and those in charge of welfare systems faced a powerful pharmaceutical lobby pushing for a prolongation of commercial exclusivity for originator drugs. To good purpose the bigpharma lobby used clever gimmicks: modification of generic definition, introduction of a fake definition of 'biogeneric' in order to prevent generic development, and outrageous prolongation of clinical data protection. Appeal to common sense by new Member States was of no avail: the adopted measures will result in huge financial problems. The consequence will be even more dramatic if the principle of a 'single EU drug price' is adopted. Vigilance is therefore needed.

The Medicines in Europe Forum, who was created at the start to this legislative review, has learned a great deal about EU institutions. It regrets that the Parliament has so little weight as compared to the Commission and the Council of ministers. The Forum is determined to influence the coming debates on medicines, particularly on the single drug price and disguised advertising to the general public.

©Medicines in Europe Forum 1 January 2004