New EU rules on drug development will see Europe lose out on the research and development of new medicines, a report compiled for the industry says.
A report commissioned by the European Federation of Pharmaceutical Industries and Associations (Efpia) notes that while the European Commission has committed to carrying out a European competitiveness check on future legislation, it has not done so for pharmaceutical legislation being worked through the system.
It takes particular exception to proposed new rules to cut regulatory data protection, part of the intellectual property around new medicines.
Regulatory data protection protects the safety and efficacy of data produced by a pharma company in the development of a new product. It stops rivals, especially generic pharma companies, from using that data during the period of protection.
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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.
The issue is particularly sensitive for drug companies because they say regulatory data protection is often the final line of intellectual property protection for the exclusivity of its medicines.
While drug patents cover longer periods — 20 years — the clock on that cover starts ticking when the patent is filed, which a recent report from Novartis says is usually 10 to 15 years before any medicine is marketed.
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 Dolon report says Europe’s share of global research and development investment will fall by a third — from 32 per cent of pharma companies’ global R&D expenditure to 21 per cent — by 2040, amounting to a €2 billion cut each year across the bloc.
It says that over one in five medicines relying of regulatory data protection would no longer be economically viable in Europe. This, it says, could see the research and development “of around 50 out of 225 expected new treatments forgone over the next 15 years” leading to “increased mortality and premature death across the EU”.
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The report also criticises changes to the orphan drug regime governing the development of medicines for rare diseases, which it says will “disproportionately hit research for the 1.5 million patients with a rare disease”, as well as proposed new environmental controls.
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.
Pharma companies consistently point to the high cost of developing any new medicines and note that profits on a successful product cover not only its development costs but also the money spent on many other promising therapies that ultimately fail to deliver.
The EU also says shortages of certain medicines are becoming a growing problem for many member states.
“Consequences of such shortages include decreased quality of treatment received by patients and increased burden on health systems and on healthcare professionals, who need to identify and provide alternative treatments,” it says.
