Revue Prescrire, article en une, Medicines in Europe October 2003
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Medicines in Europe:
"Data protection" = protection of clinical trial results
 
Data protection is going to be significantly extended in the European Union, even though it is already among the longest in the world. The consequences would be delayed generic development and added financial constraints for national welfare systems (especially problematic for the poorer member states and acceding countries).
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Pharmaceuticals are not only protected by various types of patents. In Europe, the results of clinical trials sponsored by marketing authorisation holders are protected from exploitation by competitors. This places added constraints on generics manufacturers.

Generics are currently approved through a "light" (abridged) marketing authorisation procedure. The clinical evaluation dossier is not required to contain results from clinical trials conducted with the generic product: the data obtained with the originator product are considered sufficient, and can be included in the marketing application for the generic.

"Data protection" consists of forbidding competitors from using data on the originator substance for a fixed number of years. This period is currently six years in about half the European Union member states, and 10 years in the remainder. It is 10 years for all "biotech" drugs, which must be approved through the centralised procedure.

In 2001 the draft Directive and Regulation drawn up by the European Commission advocated that data protection be extended to 10 years for all drugs, and that an extra year be added for a new therapeutic indication.

In 2003, after amendment by the European Parliament and Council of Ministers, the draft Directive has been modified to permit "light" marketing applications to be made 8 years after initial authorisation of the originator drug, with market release two years later. In other words, data protection (and therefore marketing exclusivity) would amount to 10 years (8+2) for all drugs authorised by individual member states or through the mutual recognition procedure. The draft Regulation also recommended 10 years of data protection for drugs authorised through the centralised procedure, plus an extra year (once only) when one or several new therapeutic indications are granted.

As things stand, data protection is going to be significantly extended in the European Union, even though it is already among the longest in the world. The consequences would be delayed generic development and added financial constraints for national welfare systems (especially problematic for the poorer member states and acceding countries).

We found no historical reasons and no rational for extending the monopoly position of originator drugs, and the European Commission offers no figure to support their current position.

The proposed extension is clearly not intended to compensate manufacturers for time lost in administrative procedures (marketing application, health economic assessment, refunding negotiations, etc.): under pressure from the pharmaceutical industry, the time available for medicines agencies to evaluate new applications is already shrinking to dangerous levels.

In addition, the industry has obtained granting of "supplementary protection certificates" that prolong patent protection up to five years.

This is quite enough: no further lengthening of the data protection period is justified.

©Medicines in Europe Forum 15 October 2003