The initiative by the Dutch Presidency of the European Union is welcomed by the Medicines in Europe Forum, given the enormous gap between the drug market and public health requirements in Europe and the rest of the world, especially poor countries.

The Medicines in Europe Forum points out, however, that development of new drugs is not the chief priority among possible measures designed to tangibly improve the health of European citizens. The leading priorities are the following:
• large-scale primary prevention, notably based on nutritional and environmental measures, as recommended by the World Health Organization at the 57th World Health Assembly in 2004;
• better prevention of errors linked to the use of existing drugs, notably through better packaging;
• better prevention of adverse effects of existing drugs, through more effective and transparent pharmacovigilance.

Regarding new drug development, the Medicines in Europe Forum identifies the following priorities:
• relevant comparative pre-marketing evaluation, in order to avoid the release of drugs with unknown added therapeutic value, which may prove to be more harmful than existing products;
• research aimed at palliating for current inadequacies in the following areas: useful older drugs that are considered no longer profitable by drug companies; drug utilization by patients; comparisons with non drug treatments; drugs for health disorders whose severity sometimes serves as a pretext for inadequate pre-marketing assessment (cancer, multiple sclerosis, Alzheimer's disease, viral infections, some rheumatic diseases and related pain); drugs for groups of patients at special risk, particularly the elderly ;
• decisions on research priorities and funding must be made transparently vis-à-vis European citizens.

Increasingly numerous pharmacovigilance scandals are shaking the foundations of the drug market and revealing the failings of drug companies and medicines agencies; decisive action by Member States and national health authorities is urgently needed.
The Medicines in Europe Forum would particularly welcome an initiative by the EU Presidency aimed at tightening rules on drug evaluation, focusing research on the most needy patients (including patients outside the EU), and making primary prevention a leading priority.

©Medicines in Europe Forum 18 November 2004