BioWorld International Correspondent
BRUSSELS, Belgium - By this evening, Europe's biotechnology companies should be operating in a more competitive environment - and the climate should go on improving until it becomes perfect in 2010.
That, at least, was the reasoning behind the get-together of the leaders of the European Union's 25 member states in Brussels Tuesday and today. This is the meeting scheduled to re-launch Europe's struggle to turn itself into a world-beating, high-technology economy - in line with the EU's so-called "Lisbon strategy." After five years of frankly acknowledged failure, the UK's Tony Blair, France's Jacques Chirac, Germany's Gerhard Schroeder and their colleagues say they are determined to turn the Lisbon strategy into a success in the next five years.
At the heart of the strategy is a series of commitments to boost state spending on research, cutting the red tape that stifles innovation, and promoting an economy based on high technology - with biotechnology among the most frequently cited examples of what EU leaders believe the EU should be focusing on. And at the heart of the March summit is how far the individual member states are ready to live up to those commitments.
Senior European biotechnology industry executives, inured to disappointment, told BioWorld International on the eve of the summit that they were cautiously optimistic that this time around, EU politicians might be ready to move from fine words to concrete action. And they pointed out, with all the diplomatic restraint they could muster, that the member states are still the biggest obstacle to the development of an EU market receptive to innovation: Most evident, the five-year de facto moratorium that most member states have imposed on the launch of new biotech-derived products shows how wide the gap is between rhetoric and reality, they said.
Parliament Shows Support For Biotech Firms
Meanwhile, Europe's smaller biopharmaceutical companies have won some friends among members of the European Parliament - and gained some support for their arguments.
UK MP Robert Sturdy said last week, "The level of technology and the potential benefits that these companies are going to bring to Europe's patients is unbelievable." And he went on to urge his colleagues in Parliament to help create a conducive environment. Smaller firms "cannot do this without our help," he said.
EU legislation with crucial significance for European biotech firms is shortly to be discussed in the Parliament, including new proposals on support measures for smaller pharmaceutical firms, and a new EU research program that could put billions of dollars directly into biotechnology research over the next seven years.
"We need to show with actions, not just words, that we are behind smaller European biotech firms," Sturdy said. "It's a risky business that they're in, but we need them and they need us."
Another Price Hike For Biotech Product Approvals
It is going to cost €232,000 (about US$440,000) to get the simplest form of marketing authorization from the European Union's medicines agency in London in 2005. The agency just issued its new price list, and that is the tag the agency put on assessing a single strength associated with one pharmaceutical form.
There will be an additional fee of €23,200 for each additional strength or form, providing it is submitted at the same time. Even a variation to an existing authorization will cost as much as €69,000. For companies aiming to launch biotechnology-derived products in Europe - those that are obliged to use the agency to seek authorization - the prices are starting to add up. They have been rising steadily in the 10 years the agency has been in business.