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Biotech industry wants better implementation of EU regulations

Published 27 September 2005 - Updated 28 May 2012
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Healthcare biotech industry representatives say that the inadequate implementation of EU regulation on the biotech sector hinders innovation and blocks SMEs' access to the market.

Four and half years after the Stockholm summit, the biotech industry is calling on the Commission to keep its promise - as "we have kept ours by delivering on our promise to develop answers to all kinds of diseases," it said. Statistics show that biotech medicines account for 20% of all medicines on the market and 50% of all new drugs under development in clinical trials. 

With the launch of its 'Healthcare Manifesto' on 22 September 2005, the industry expressed its concerns about the slow implementation of the EU strategy on biotechnology. "Europe is the only region in the world to have a real strategy on biotechnology and that strategy is worth its weight in gold if, and when, implemented," said Patricia Pellier from Serono. Industry is therefore calling on the member states to implement the existing regulation to bring Europe's strategy forward.

In its latest progress report on the European lifesciences and biotechnology strategy and action plan, the Commission had already identified the weaknesses in the implementation of the strategy and stated that:

  • the lack of national implementation of internal market legislation (especially the directive on the legal protection of biotechnological inventions) is seriously hampering biotech industry's development;
  • slow progress on the Community Patent has prompted companies to turn to the US for protecting patents;
  • member states need to implement the new GMO legislation; 
  • access to finance for biotechnology companies must be improved as the market matures.

The 'Healthcare Manifesto' calls for EU policy support to ensure innovative healthcare (innovative medicines, orphan drugs such as those developed to treat rare diseases, advanced therapies), engagement with society and creation of wealth through a friendly environment for SMEs in the sector.

Positions: 

EuropaBio, the voice of the biotechnology industry in Europe: The aim of the Healthcare Manifesto is to "set out the policy agenda to deliver a more patient-oriented approach to human healthcare by delivering innovative and dynamic growth of products that can substantially improve the quality of life for patients and meet unmet medical needs," said the Chairman of EuropaBio’s Healthcare Council Dr Andrea Rappagliosi. 

TiGenix  a biotechnology SME: "Absence of regulation hinders innovation. We are, weirdly, asking for more regulation - harmonised reguation," said CEO of Tigenix, Gil Beyen.

Eurobarometer polling Europeans' general attitudes towards science and technology (June 2005): 65% of EU citizens believe that biotechnology and genetic engineering will have a positive effect on our way of life in the next 20 years, whereas 20% think it will have a negative effect. Austrians, Greeks and Latvians are the most sceptical about the benefits of biotechnology while Hungarians, Spanish and Danes together with Czechs, Estonians, Swedish and Italians are the most enthusiastic about this new technology. 

Next steps: 
  • The Commission will present its third progress report on the European strategy for life sciences and biotechnology to the Competitiveness Council on 11 October 2005. 
Background: 

The Stockholm European Council conclusions (March 2001) state Europe's desire to "utilise the full potential of biotechnology and strengthen the European biotechnology sector's competitiveness..." 

Following a stakeholder consultation, the Commission presented 'Life Sciences and Biotechnology - A Strategy for Europe' on 23 January 2002. The strategy consists of a policy paper and includes an action plan, which outlines specific measures on how to implement the strategy.

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