Revue Prescrire, article en une, Medicines in Europe: Appeal to EU Ministers March 2003 (12)
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Medicines in Europe:
Appeal to EU Ministers: don't forget the fundamentals!
 
The working party preparing the decisive meeting of the Council of Ministers on 2-3 June 2003 is meeting regularly and productively, but several key matters concerning public health have not yet been taken into account.
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Areas in which the draft Regulation remains to be improved, as of 4 February 2003
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Medicines in Europe: campaigning goes on!
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The notion of "added therapeutic value": a key element of transparency

The notion of added therapeutic value is quite simple. It has been precisely defined by many sources, including the Declaration on Therapeutic Advance of the International Society of Drugs Bulletins in November 2001 (1). Basically, a new medicinal product can be said to have added therapeutic value if sound clinical data show that it offers patients better efficacy, and/or better safety, and/or simpler administration, than existing alternatives.

Citing the free trade principle, the Regulation does not require medicinal products to offer added therapeutic value in order to be authorised for sale on the European market. All that is requested is a satisfactory balance between efficacy and safety. As a result, many new drugs are simply more or less equivalent to their predecessors.

Yet it is essential for patients, health care professionals and health economists to know whether or not a new drug offers added therapeutic value, so that they can make rational choices among the available treatments.

The Medicines in Europe Forum does not seek to make added therapeutic value a criterion for granting marketing authorisation, but simply requests that assessment reports on new medicinal products provide an analysis of added therapeutic value based on available data. Failure to do so is to deprive the public of useful information.

After the first sentence of article 12-3, another sentence should be added to the effect: " European Public Assessment Report (EPAR) conclusions will mention available data comparing the new medicinal product with existing treatments. It will provide a judgement on the degree of added therapeutic value offered by the new medicinal product, or state that comparative data are insufficient or lacking to determine the degree of added therapeutic value."

A sentence should also be added before the last sentence of recital 28a specifying that: "The EPAR must nevertheless mention available comparative data determining the place of the new medicinal product relative to existing treatments, or, if need be, the lack of comparative data."

©La revue Prescrire for the Medicines in Europe Forum 1 March 2003
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1- International Society of Drug Bulletins "ISDB Declaration on therapeutic advance in the use of medicines" Paris 15-16 November 2001.