Europe is losing its competitiveness and attractiveness for pharmaceutical R&D because it does not reward innovation sufficiently, its research base has been weakening substantially, the market is not functioning well and is highly fragmented and the region is lacking an industrial strategy, according to the European Federation of Pharmaceutical Industries and Associations.

However, Europe has a great deal to gain in health and economic terms from having a strong and competitive research-based pharmaceutical sector, says the group, in its response to the European Commission’s public consultation on the future of the European Union (EU) single market in pharmaceuticals. To achieve this, EFPIA believes that a number of measures are essential, especially: limiting the scope of EU member states’ price controls to the territory of the country concerned; clarification of the Transparency Directive, in light of judgements by the European Court of Justice; maintenance of high standards of intellectual property protection, both within the EU and worldwide; and reforms to provide the industry with “legal certainty” on provision of information on its medicines.

A submission from the Pharmaceutical Research and Manufacturers of America (PhRMA) strongly supports EFPIA’s response, and also provides the Commission with the US industry’s “top four” recommendations for improving the future of innovative medicines in Europe. These call for: amending EU Directive 2001/83 so that drugmakers may provide non-promotional information about their products to patients; greater regulatory cooperation and enforcement of existing regulations, in order to support advances in innovative medicines, create more efficient means to ensure drug safety and efficacy and help deliver medicines more rapidly to the market; in the areas of parallel trade and counterfeit medicines, full implementation of Recommendation 6 of May 2002’s G 10 report (which states that a member state’s authority to regulate prices should extend only to medicines reimbursed by the state), plus a ban on re-packaging; and strong global intellectual property rights.

Other views
In all, the Commission’s DG Enterprise and Industry has received 104 contributions to its consultation. In its response, the UK government calls on the Commission to “set out a clear direction on where we want the European environment for pharmaceuticals, both medicines and vaccines, to be heading in future years, and a clear plan of action for achieving this.”

However, the responses from a number of consumer and patient groups are critical of what they see as the consultation paper’s emphasis on industrial competitiveness rather than public health and safety. The European Consumers’ Organisation (BEUC) claims that the document “clearly supports the idea that the point of departure for community policy on medicines is rooted in the industrial policy perspective and is not viewed as a health policy issue,” and adds: “we urge the European Commission to change the perspective and to address medicines as integral part of health policy for a more coherent policymaking. The prime objective of any pharmaceutical policies, both at national and EU level, should be meeting patient needs. “

Patient advocacy group Picker Institute Europe welcomes the consultation document’s recognition of patients’ proactive role in seeking information about their health and of their requirement for access to quality information, but it questions the document’s “implied position that the answer to patients’ information needs lies with industry.”

And, in a joint statement, the Medicines in Europe Forum (MiEF), Health Action International Europe (HAI), and the International Society of Drug Bulletins (ISDB) wonder about “the real reasons” for this “consultation.” The solutions being proposed by the Commission fail to take patients interests into account and, instead, “pander to the pharmaceutical industry’s wish list of legislative changes,” they say, adding: “patients and healthcare professionals, and European citizens in general, cannot fail to see that this ‘consultation’ ignores their uppermost concerns.”