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Political and technical tensions in the EU.
The year 2005 has seen the European pharmaceutical environment become an even more complex combination of political and technical tensions.
At the political level, the European Commission has been trying to stimulate innovation and to promote an enterprise culture, in the face of persistent major divergences among EU member states about the right way for Europe to respond to the new pressures of globalization. These discussions have repeatedly degenerated into polarized views about whether Europe should focus on protecting the jobs it has, or on creating new ones—and are still, towards the end of the year, totally unresolved.
Although pharmaceuticals is demonstrably one of the most successful of Europe's industrial sectors and continues to create high-quality jobs, it is a victim of this strategic confusion. Thus the commission's announcement of a new industrial strategy for Europe, angled towards innovation and enterprise, ran straight into heavy fire from French President Jacques Chirac, determined to demonstrate to his electorate that he was going to make no concessions to a policy that did not pay as much attention to job protection as job creation.
Similarly, the ambitious earlier drafts of new commission strategies specifically for pharmaceuticals and biotechnology had to be watered down to a shadow of their initial aims to avoid offending sensitivities in key member states. As a result, both of these supposedly major plans turned out to be very little more than repetitions of earlier formulae adorned with lavish expressions of pious hope and empty rhetoric.
At the technical level, 2005 has been a challenging year for the European Medicines Agency in London. Its main responsibility remains unchanged: the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The Agency continues to coordinate the evaluation and supervision of medicinal products throughout the EU, bringing together the scientific resources of the 25 EU member states in a network of 42 national competent authorities, and it has maintained its close cooperation with international partners.
The Agency marked its 10th anniversary in operation during the year, and saw the full entry into force of new legislation that is shaping its future development. At the same time it is having to cope with the emergence of new medical technologies and therapies; the increasing globalization of the pharmaceutical industry and its regulatory environment; the competitiveness of Europe's biotechnology, pharmaceutical, and health care industries; and the increased expectations of society on information access, communication, and transparency. At the last official count, it had about 360 staff members, and a network of some 3500 European experts underpins its scientific work and committees.
Particular attention has been given to reinforcing the safety of medicines, accelerating the availability of medicines to EU patients, and creating the right environment to stimulate research. These initiatives include implementation of the concept of risk management plans, expansion of the scope of medicines to be authorized through the EU's centralized procedure, and the establishment of accelerated assessment, conditional authorization, and compassionate use procedures, as well as procedures for authorization of biosimilar and generic products.
Similarly, and also at technical level, there is also continual expansion in the range of activities that the pharmaceutical unit in the commission covers. It continues to cover its classic areas of responsibility for health-related matters, such as marketing authorizations, clinical trials, blood- and plasma-derived medicines, vaccines, and good manufacturing practice. It retains a strong role in economic affairs too, overseeing competition policy, transparency of pricing and reimbursement, parallel imports, and penalties for noncompliance with EU rules. But it has had to take on additional or intensified tasks, ranging from orphan drugs and pediatric medicines to pharmacovigilance and international harmonization and cooperation, and from counterfeit medicines, pharmacogenetics, and human tissue engineering to making preparations for the accession of future member states to the EU.
At the same time, the staffing situation in the commission remains imperfect. There are only some 20 officials in the unit, and even a year after it lost its senior official (she was transferred to the private staff of European Commission President Jose Manuel Barroso), a permanent head of unit is still to be confirmed, and it remains under the leadership of only an acting head.
Peter O'Donnell, the View from Brussels columnist for Applied Clinical Trials, is a freelance journalist who specializes in European health affairs. He is based in Brussels, Belgium.
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