Pharmacovigilance

We applaud:
•the Commission rejected the amendment obliging drug companies to contribute to the funding of the Agency's pharmacovigilance activities (amendment 67, new article 25ter), which will bolster the Agency's independence in this very sensitive area;

• the Commission accepted the principle of market withdrawal as soon as a drug presents "a negative risk-benefit balance under normal conditions of use", rather than an "unacceptable level of risk" as initially proposed (amendment 14, recital 24);

• the Commission accepted that the Agency's missions be explicitly extended to cover the verification of pharmacovigilance obligations (amendment 90, article 51-1-g);

• the Commission accepted the principle of adverse drug reaction notification by patients, but only to health professionals and health authorities, and not to drug companies (amendment 54, article 20-3).

Cause for concern
• the Commission accepted the principle that companies must not communicate information on pharmacovigilance matters to the public without the European Agency's consent (amendment 61, article 22-3bis). This amendment is aimed at ensuring consistency between the information offered by drug companies and national medicines agencies, but could further delay access to crucial information when the agencies concerned are secretive (as is usually the case). It can only be accepted if transparency is guaranteed, and with a reasonable time limit for making such information available.

We regret:
• the Commission refused that patient information leaflets should bear words to the effect "newly authorised drug; please report side effects" for the first five years on the market (amendment 42, article 13-3bis), under the pretext that patients cannot notify side effects directly to companies, but only to health professionals and authorities (see above);

• the Commission refused that the medicinal products database should contain pharmacovigilance information (amendment 157, article 51-2), under the pretext that a specific pharmacovigilance database is planned. This would explain why pharmacovigilance is "forgotten" in amendment 95 (allegedly accepted by the Commission, see below). Once again we see that the Commission sticks to a complicated system that is difficult for the public to access and understand;

• the European Parliament recommended the Agency set up a system dedicated to active pharmacovigilance data collection during the first two years that new drugs are on the market, but the Commission transformed this obligation into a simple "possibility" (amendment 64, article 24-3bis);

• the Commission has written that it accepts amendment 95 (on the European medicinal products database), but forgot to mention "pharmacovigilance data" in the list of what this database will contain, even though this is mentioned by the amendment adopted by Parliament.

©La revue Prescrire 15 January 2003