European Medicines Evaluation Agency is ahead of national licensing authorities

Editor—The European Medicines Evaluation Agency was set up in 1995, and, as the constantly updated status reports on our internet website (http://www.eudra.org/emea.html) show, it has now carried out evaluations of 100 medicinal products for human and veterinary use. As Abbasi and Herxheimer pointed out in their editorial, the creation of the agency reformed the way in which health professionals and patients can obtain information about the medicines they prescribe and use.¹

The key reform introduced with the creation of the agency is the European public assessment report. This is made available for each medicinal product as soon as it is authorised. The report sets out the scientific assessment carried out by the agency, together with the summary of product characteristics and the patient leaflet.

The agency’s commitment to transparency means that all European public assessment reports, as well as much other information, are systematically made available on the agency’s website. As the editorial points out, most national competent authorities do not currently publish assessment reports, though they are now starting to follow our lead.

Such a radical concept as the European public assessment report was bound to be difficult to implement. A consultation exercise led to a workshop in October 1997 attended by all interested parties, representing patients, consumers, health professionals, and industry, and the European Union institutions. Details are available on our website. The European Medicines Evaluation Agency is currently examining an analysis by the International Society of Drug Bulletins of nine early European public assessment reports. We intend to make our response public before the end of the year, once we have consulted the scientific committee for human medicines.

After the transparency workshop I formulated rules on access to documents of the European Medicines Evaluation Agency; these rules are available on the agency’s website. In line with the recommendation of the international transparency and accountability working group cited in the editorial, the rules provide that refusals to disclose documents are subject to appeal to the agency’s management board, made up of representatives of the European parliament, European Commission, and 15 member states.

The agency’s efforts towards transparency and openness continue. At a meeting on 30 September the management board endorsed my proposals to improve the transparency of opinions adopted by the agency’s scientific committees before the granting of marketing authorisations, to be introduced next January. Statistics will also be made available on the number and grounds for withdrawal of applications.

The provision of quality information to healthcare professionals and patients is important to the agency. Improving what we provide, and how, remains one of our priorities.