Transparency of the European Medicines Evaluation Agency (EMEA)

We applaud:
The Commission accepted the following points:
• information on refusals to grant marketing authorisation, and on negative opinions issued by the licensing committee, should be made public (amendments 36 and 75, articles 11-2bis and 33-2bis);

• documents describing scientific conflicts between the European Medicines Evaluation Agency (EMEA) and other EU or national scientific committees should be made public (amendments 98 and 99, articles 53-3 and 4);

• the medicinal products database, which is open to the public and for which EMEA will be responsible, should be extended to cover all drugs marketed in the EU, whatever the licensing procedure (amendment 95, article 51-2);

• each year, all members of EMEA committees and advisory boards should list their conflicts of interest, and this list should be made public (amendment 110, articles 56-2-1, 1bis and 2);

• the European Court of Auditors should prepare a yearly report on EMEA activities (amendment 125, article 60-9);

• companies should be required to inform EMEA, at least two months in advance, of their intention to withdraw a product from the EU market, either temporarily or permanently (amendment 141, article 21bis);

• EMEA should inform national medicines agencies whenever a marketing application is withdrawn by a drug company, and give the reasons for this withdrawal (the company is required to inform EMEA of its reasons) (amendment 153, article 10b);

• national agencies have a duty to keep health professionals informed, notably through their professional organisations (amendment 50, article 18-4bis);

• financial penalties imposed on drug companies for failure to respect certain legal obligations should be made public, along with the name of the company concerned (amendment 135, article 74-3).

We regret:
• the Commission does not accept the principle that the medicinal products database should permit comparisons to be made among drugs of the same therapeutic category (amendment 91, article 51-1-2-j);

• most of the amendments concerning EMEA transparency referred to European Regulation 1049/2001 on access to documents and specially created public registers (mainly amendments 38, 43, 51, 53, 79, 81, 87, 109 and 131). The Commission accepted the principle of public access, but considered that:
- some documents were already accessible (e.g. licensing committee assessment reports) and that new legal obligations were unnecessary;
- that access to other documents will be provided for in a separate proposal;
- that it is unnecessary to group together other documents (e.g. clinical trial reports) in registers, as these documents will already be accessible through a separate database (this would mean that clinical trial data would be separated from marketing approval data);
- that different levels of access are required, depending on the origin of requests: drug companies, health professionals, or members of the public (the case of adverse effects).

©La revue Prescrire 15 January 2003