EU publishes proposed drug laws overhaul, setting up tussle with industry

[April 26, 2023]  By Maggie Fick

LONDON (Reuters) - Brussels on Wednesday published a long-awaited draft of its proposed overhaul of laws governing the European Union's pharmaceuticals industry, setting up a tussle with drugmakers which warn they will invest and innovate elsewhere.

The biggest overhaul of existing medical laws in two decades is aimed at ensuring all Europeans have access to both innovative new treatments and generic drugs, and ending huge divergences in access and price between countries, EU Health Commissioner Stella Kyriakides told reporters after publication.

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 get before generics can enter the market from 10 to eight years.

But it also offers a sweetener for companies: they get 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 provide access to new medicines to around 70 million more citizens compared to today".

Following publication, the European Parliament, Commission and member states will now thrash out final details of the law, which could take years.

Pharmaceutical tablets and capsules are arranged in the shape of a Euro currency sign on a table in this picture illustration, August 20, 2014. REUTERS/Srdjan Zivulovic/Illustration

The Commission hopes the reforms will create a "single European market for medicines", while preserving Europe's attractiveness for pharmaceutical investment, Kyriakides added.

But industry, from big pharma companies including Bayer and Novo Nordisk to small biotech firms, has said for months that reforms will have the opposite effect and result in Europe missing out on the newest treatments.

GSK said on Wednesday the EU must "regulate for growth and competitiveness" because companies "have choices on where our capital and resources are focused".

The reforms also aim to prevent drug shortages like those seen this winter with critical antibiotics by requiring companies to notify the EU of possible supply issues earlier. And they aim to streamline the EU's drug regulator to speed up the time it takes for new treatments to be approved.

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(Reporting by Maggie Fick; Editing by Josephine Mason and Mark Potter)

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