A battle may be looming between the EU and pharmaceutical companies after the release of proposed and updated laws for the industry, with drugmakers threatening to invest and innovate elsewhere.
While patient and consumer groups have applauded the proposals, with the European Public Health Alliance (EPHA) calling them “a win for people across the EU” because of the changes to what it sees as a too-generous incentives system for industry, big companies, like Bayer, say the reforms will have the opposite effect and result in Europe missing out on the newest treatments
The intention of the biggest overhaul in 20 years of existing medical laws is to ensure all Europeans have access to both innovative new treatments and generic drugs, and end the huge divergences in access and price between countries, said EU Health Commissioner Stella Kyriakides.
There were few major changes in the proposal from the draft reviewed by Reuters earlier this month, except for details of changes to protections before generic versions of drugs enter the market.
The commission proposes to cut the length of basic market exclusivity that drugmakers have before generics can enter the market – to eight, from 10 years.
But it also offers companies two more years of protection if they launch their new medicines in all 27 member states within two years.
Kyriakides said the new incentives system would give access to new medicines “to around 70m more citizens compared with today”, Reuters reports.
The commission hopes the reforms will create a “single European market for medicines”, while preserving Europe’s attractiveness for pharmaceutical investment.
However, Novo Nordisk CEO Lars Fruergaard Jørgensen labelled the proposals “poison for innovation and competitiveness in Europe”, and said the EU must “regulate for growth and competitiveness” because companies “have choices on where our capital and resources are focused”.
The reforms also want to prevent drug shortages – like those seen this winter with critical antibiotics – by requiring companies to give earlier notification to the EU of possible supply issues, and to speed up the approval for new treatments.
The European Parliament, Commission and member states will now thrash out final details of the law, which could take years.
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