BioWorld International Correspondent

BRUSSELS, Belgium - Improving Europe's exploitation of biotechnology is at the heart of a new €3 billion (US$3.6 billion) agenda for innovative medicines, released here on Sept. 18. The so-called Innovative Medicines Initiative aims at eliminating unnecessary delays in developing new medicines, particularly by better prediction of safety and efficacy, and by boosting training for researchers.

The European Union-sponsored plan has been drawn up by 350 senior figures from biopharmaceutical and health care companies, patient organizations, universities, hospitals and regulatory authorities. The next step is to create in 2007 a public-private partnership to coordinate patient-centered projects.

Full implementation of the plan is calculated to require €460 million per year for an initial seven-year period, starting in 2007, shared between the European Union and the European Federation of Pharmaceutical Industries and Associations. The EU contribution will fund academic research and small biomedical companies, while larger biopharmaceutical companies will entirely fund their own involvement.

The agenda is aimed at correcting the relative under-funding of biomedical R&D in Europe compared to other regions of the world. According to the initiative's mission statement, "Pan-European public and private sector collaboration and coordination is essential to ensure that patients benefit from advances in biotechnology, such as the decoding of the human genome." The plan claims it will help secure long-term prosperity for Europe through biotechnology and attract biomedical R&D investment in Europe.

Jonathan Knowles, head of global research at Roche, who has led the European pharmaceutical industry input into the agenda, said European research directors "are eager" to start implementing the research projects defined in the agenda. Speaking for patients, Mary Baker of the European Parkinson's Disease Association, welcomed the agreement.

The chances for the plan's success were boosted on Sept. 25, when EU ministers gave their agreement to a €50 billion framework program for research, which will fund the medicines initiative until 2013. However, the European Parliament still has to give its approval to the proposal.

Industry Wants Clearer Pharmacogenetics Perceptions

The European pharmaceutical industry is worried that misconceptions about pharmacogenetics could limit the scope for harnessing its potential. The European Federation of Pharmaceutical Industries and Associations published on Sept. 19 a lengthy manifesto defending the emerging discipline, and warning that there are risks in premature or ill-judged regulatory action.

"As with any evolving technology, the limited number of examples for the application of pharmacogenetic strategies to medical practice preclude currently a general evaluation of pharmacogenetics," said EFPIA. "Ongoing research initiatives are therefore vital to generate a broader evidence base upon which future decisions regarding pharmacogenetic applications can be made."

As the use of pharmacogenetics in regulatory decision making increases, an environment that is conducive to such research in the EU must be created, says EFPIA. It insists that policies and processes developed "must adequately protect research participants, without being overly restrictive, to allow optimal use of data and samples as new scientific knowledge and technology emerges."

The EFPIA paper also rejects as "simplistic" the increasingly discussed notion that pharmacogenetics will automatically decrease the commercial return on a particular medicine because the medicine will be more accurately targeted on only a subset of the population. "Pharmacogenetics does not alter the proportion of patients who would benefit from a particular therapy; rather it offers a better way of understanding variable patient response to pharmacological agents and of defining prospectively patient groups that will benefit from the medicine," said the industry association.

GM Rice Still Raising Protests

Doubts over the reliability of European control measures against unauthorized GM rice imports led on Sept. 21 to calls for suspension of all long grain rice imports from the U.S.

Twelve consignments of rice, imported from the U.S. through the Dutch port of Rotterdam, were released in early September into the UK, Belgium, France and Germany after they had been certified as free of contamination by the European Rice Millers Federation. But the European Union authorities admitted last week that retesting had revealed traces of the unauthorized GM rice LL601, and national authorities now have been asked to trace the contaminated shipments.

New Senior Official For EU Research

Daniel Jacob, a Belgian lawyer, has been appointed deputy director-general in charge of European Union research programs. He was head of staff for the previous European commissioner for research, Philippe Busquin, from 1999 to 2003.

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