Pharmaceutical companies say new EU rules on drug development will mean Europe loses out on the research and development of new medicines. Photograph: iStockrules on drug development will see Europe lose out on the research and development of new medicines, a report compiled for the industry says.
The Efpia report, compiled by the Dolon consultancy, says the proposed changes would reduce the incentive for companies to invest in new medicines in Europe by 55 per cent over the next 15 years. Regulatory data protection kicks in only from the moment a medicine is actually approved for marketing. In the EU currently, it lasts for eight years from that point: the proposed legislation reduces this to six, although the term can be extended under certain circumstances.
The EU says it needs to act as patient access to medicinal products across the EU and security of supply are growing concerns. Restricted budgets and the high price of new medicines — especially more modern high-tech drugs and those targeting small patient populations – have become a headline issue in Europe with high-profile campaigning against profit margins charged by drug companies.
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