European Commission launches consultation on future of medicines in Europe

The European Commission has launched a consultation on the future of medicines in Europe that it intends to use to define its pharmaceuticals strategy.

The initiative covers a broad range of subjects but could have only a limited impact, as the Commission may not use it to produce legislative proposals.

The consultation is for all stakeholders, including the pharmaceutical industry (federations and individual companies), member states' public authorities, patient associations and healthcare professionals. It covers subjects such as clinical trials, prices and reimbursement, patient information and pharmacovigilance.

"It is a very broad-ranging document that goes beyond what is already in circulation in the Commission," Nicolas Rossignol, one of the managers of this initiative set up by the enterprise and industry directorate-general. "The idea is to get stakeholders' viewpoints and see if and how these differ from the Commission's own internal analysis."

On the basis of this consultation - which concerns only medicines for human use and lasts up to and including 11 October 2007 - the Commission will send a communication to the Council (representing member states) and to the European Parliament. For the moment no timetable has been fixed for this communication.

"Concrete actions" may be proposed, but these will not necessarily be legislative proposals, warned Rossignol, citing the possibility of setting up working groups, such as those in the Pharmaceutical Forum, launched by the Commission in 2005.

EU pharmaceutical legislation was already reformed in 2004. "This reform constitutes the base from which we look to the future," he explained, citing the example of variations to marketing authorisations, an area in which he is currently working. Both brand-name manufacturers and the generics industry consider the current system to be extremely cumbersome and expensive.

Clinical trials are another area in which "there is scope for better regulation," the Commission says.

Clinical trials were the subject of a European directive adopted in 2001. This directive is constantly criticised by trial organisers, who complain about cost increases and delays in carrying out trial programmes since it was implemented - and transposed in various different ways by different member states.

The consultation also covers pharmacovigilance - which was already subject to public consultation last year - as well as counterfeits and parallel trade.

Two of the themes discussed in the Pharmaceutical Forum are raised again in the consultation: prices/reimbursement and information for patients. On the question of prices and reimbursement, which are the exclusive domains of member states, the document launching the consultation notes that "different national pricing and reimbursement schemes still coexist, leading to market fragmentation, parallel trade, disparities in prices and time-to-market delays".

Regarding the inclusion of parallel trade on this list, Rossignol said that the document lists the consequences of disparities in price and reimbursement, but that these consequences are not necessarily negative.