Albedo

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Brussels Report

While Europe's political leaders were paying lip-service to creating a more competitive Europe at their spring summit in Brussels, European pharmaceutical technologists were tackling the serious business of turning political rhetoric into practical reality.

The EU is trying to bring some clearer definition to the borders of its pharmaceutical legislation...

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Defenders of the research-based industry are hoping for an early Christmas present from the European Court of Justice (ECJ). All the signs are that a small but significant victory is on the way against parallel importing. Right at the end of October, a senior judge responsible for a leading case at the court made clear his view that international drug firms do not necessarily have to make life easy for parallel importers. The formal ruling on the case at issue is expected within weeks.

In Europe ... the onward rush of time has imposed no change at all during the last 25 years. Anyone could step back in at any point, at any moment, and find the same depressingly familiar debates, interminably failing to reach any real conclusions.

What Medawar is calling for is "an overhaul of the secretive and profoundly inadequate system of medicines control," and hopes the unfolding crisis of dependency on antidepressants will prove to be a watershed.

The parallel importing battle continues between wholesalers and manufacturers. The two sides are slugging it out across member states, the courts and even in the streets of Brussels. The EU, meanwhile, has done what it does best - bury its head in the sand and hope that the whole thing blows over.

New Hurdles Ahead?

Europe is debating the process by which drugs receive marketing authorization. As ever, the debating table features the EU, the pharmaceutical industry and the usual suspects among the European lobbies. The crux of the matter? Should comparative efficacy play a role in marketing authorizations?

Europe's pharmaceutical R&D has recently come under a barrage of criticism. Nobel laureate, Kary Mullis, highlighted the issue of over-legislating biotechnology and the business industry expressed its dismay concerning the EU's overly cautious approach to any kind of development. Action is needed before the sector's future resembles the plot of a Shakespearean tragedy.

By its own admission, as the European Union tries to keep pharmaceutical and biotechnology development moving in the right direction, things are not going exactly to plan. With companies cancelling research projects at an alarming rate, it is politics, yet again, that is clouding the main issues of research and financial resources. And increasing pressure from the US isn't making life easier.

Indecision and incoherence in Brussels is leading to major concerns regarding the development of medicines in the EU. Political conflicts and lack of co-ordination on topics such as cancer research, stem cells and genetically modified animals have added to the air of uncertainty concerning the future conditions for the European pharmaceutical industry. And while European politicians, officials and researchers continue to squabble, people in developing countries requiring urgent access to drugs continue to go without essential treatment.

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