The European Commission has issued its long-awaited response to the G10 Medicines Report, intended as a blueprint for improving the European pharmaceutical industry's competitiveness while ensuring high levels of public health protection.
In the Commission's view, the burning issues raised by the G10 report centre around the individual member states' pricing and reimbursement systems, given that the Commission still wants an internal market for pharmaceuticals, and the need to complete the pharmaceutical legislative review before EU enlargement next year.
However, critics of the report are concerned that clauses relating to the provision of 'high-quality medical information' to patients may become a license to advertise drugs directly to consumers, something which is legal in the USA but not in Europe.
The G10 report, published by the European Union High-Level Group on Innovation and Provision of Medicines in May 2002, came as a direct response to the finding of an earlier study in 2000 that European pharmaceutical competitiveness was deteriorating relative to its rivals around the world.
The group, made up of industry representatives, consumer groups and legislators, put forward a series of measures intended to improve the European research-based pharmaceutical industry, including the setting up of centres of R&D along the lines of the US National Institutes of Health.
Other key issues identified in the report include improving regulation of medicines to hasten the approval of innovative new drugs, as well as a revamp of European intellectual property standards and a strengthening of data exclusivity provisions. In addition, another aim is to establish a genuine EU wide single market for non-reimbursed medicines.
"The Commission response is not an end in itself but a step of a process," said Brian Ager, director general of the European Federation of Pharmaceutical Industry Associations. "This is not a paper exercise. What must happen now is the implementation and monitoring of the recommendations. This will be particularly crucial in the enlarged Europe", he added.