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Why is it important to have access to documents of the European Medicines Evaluation Agency (EMEA)?
Leaflet N°10
09 September 2002

Medicines in Europe Forum believe transparency is a prerequisite for a responsible and ambitious European medicines policy. The EU regulation must stress the need for access to complete, clear and correct information, to study protocols and results, not only from the European medicines agency but also from pharmaceutical firms.


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A medicine is nothing without the minimum scientific and regulatory information allowing one to get to know the clinical usage and dosage, as well as contraindications. To obtain marketing authorisation for a medicine, pharmaceutical firms must provide data allowing for the benefits and limitations of the medicine to be defined. The medicines agencies therefore have at their disposal, lots of information, some of which is vital for health professionals and patients, to use the medicine to its best effect. A minimum of transparency of the functioning of agencies is also necessary so that the public and health professionals can understand and assess the rationale behind their decisions.

In practice, most of the medicines agencies in Europe, including the EMEA tend to be secretive rather than transparent.
Currently, only medicines authorised via the centralised procedure, a minority of medicines licensed in Europe, are described in evaluation reports that are made available to the public after being supervised and expurgated. Unfortunately, the quality of these reports is mediocre and varies widely, which means it is difficult to make good use of the information.
The EMEA gives hardly any access to data on the side effects that are reported to the agency. In addition, no (or very little) information is made available for medicines that are approved through the mutual recognition procedure, also called decentralised.

The information on medicines published in Europe is therefore the very small tip of the documentary iceberg. Without access to this "iceberg", health professionals and users lack crucial information on the benefits or disadvantages of the medicine compared to others. They are also deprived of a great deal of scientific work carried out by the experts.

In such a very sensitive domain, transparency in the working of institutions is the only way to gain the confidence of health professionals and patients with a view to involving them in the correct use of medicines. Secrecy brings with it suspicion and distrust. It hinders the participation to public health actions.
Now the Charter of Fundamental Rights of the EU citizen, together with Regulation 1049/2001 of December 2001 on public access to documents of the Commission and its agencies, provide for the setting up of registers of "public documents".