Transparency of the activities of medicines agency, and access to documents: secrecy is no longer acceptable

As in its draft Regulation, the Commission opposes all harmonisation of public access to official documents, under a variety of pretexts.

For example, it rejects three amendments that call for information to be provided on medicines agency websites, considering that nothing obliges agencies to use this medium. Yet all national agencies, and those of candidate member states too, already have operational websites that would simply require more input.
Amendments 75, 76 and 103, article 1 points 37 and 54, must be upheld.

The Commission considers that the protocols of clinical trials on which marketing authorisation is based do not need to be reproduced in the summary of product characteristics (SPC). This is nevertheless the case in the United States and elsewhere.
Amendment 189-article 1 point 9 would allow health professionals to have a better idea of what they can expect from a given drug and how best to use it. This amendment must be upheld.

The Commission systematically rejects all amendments requiring that all documents relating to a given drug be available from a single readily accessible registry, under the pretext that the information already exists elsewhere, or that the legislation of some member states does not refer to this type of registry.

The use of registries, which is already obligatory by virtue of regulations on European documents (which apply to all European decisions taken through centralised procedures; see the Forum's appeal to health ministers on the Regulation), would nevertheless provide the public with comprehensive information. Such registries should be rationally organised and contain all available information on a given drug, including clinical trials, pharmacovigilance data, and marketing authorisation documents. A Directive underlining the value of registries would contribute to inducing positive changes in national legislation and national administrative practices.
Rejection of amendments 51 and 52, article 1 point 18, and amendments 116, 123 and 124 article 1 points 62 and 64 would perpetuate administrative secrecy. European citizens would find it hard to understand if these amendments were not upheld.

©La revue Prescrire, for the Medicines in Europe Forum 7 April 2003