BioWorld International Correspondent

BRUSSELS, Belgium - The London-based European Medicines Agency is expecting a high level of activity in 2007, and much of the work is likely to come from evaluation of new biotechnology medicine applications.

The 2007 work program and budget that the agency's management board adopted at the end of 2006 forecasts 65 initial marketing authorization applications for new human medicines, including orphan drugs. That figure is similar to 2006.

Increased work is expected in relation to post-authorization activities performed by the agency (notably in relation to pharmacovigilance), mainly due to the natural increase over time in the number of centrally authorized products on the market.

Requests for scientific advice on preparing marketing authorizations for human medicines also are expected to increase by 25 percent. This is due in part to the start of enforcement early this year of the EU's new pediatric legislation, which will give the agency a new role in stimulating the availability of safe and effective medicines for use in children. Companies will have to present plans for development of pediatric formulations of most new products, in return for obtaining enhanced intellectual property protection.

A further increase in workload will result from the accession to the European Union of Romania and Bulgaria, which took effect Jan. 1. That brings the number of countries participating in the work of the agency to 30 (27 EU member states, plus Iceland, Liechtenstein and Norway).

The management board accordingly adopted a 2007 budget totalling €155 million (US$190 million), above the 2006 figure of €139 million. Staff levels also will be raised from 424 to 441.

Meanwhile, the European biotech industry is looking forward to 2007 with a mixture of hope and trepidation. The key hopes relate to winning a more predictable and supportive political environment for the industry.

A European Parliament debate scheduled for late January offers the prospect of a strongly supportive resolution recognizing the merits of biotechnology as an innovative and valuable contribution to Europe's research base and its welfare - particularly its food production capacity. A review of the European Union's strategic policy on biotechnology, currently scheduled for the spring, also might deliver a strong affirmative message.

Much of the trepidation for the new year arises from concerns over the continuing discussions within the so-called European Pharmaceutical Forum, the high-level group of senior European Union politicians and officials set up in 2006. It is due to report in late 2007 on how to improve the balance between medicine innovation and access to medicine. Many industry executives are expressing quiet concern that the discussions currently are focussing far more on how to cut national drug spending rather than on facilitating research and innovation.

The worst-case scenario on the horizon could be new - and inconsistent - national assessments of comparative efficacy as preconditions to granting reimbursement status to new medicines, which industry executives fear would further discourage medicines innovation, particularly in the advanced therapies that biotechnology could help make available.