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EU unveils pharmaceutical industry overhaul amid pushback

Brussels published a long-awaited draft of its proposed overhaul of laws governing the European Union’s pharmaceuticals industry on Wednesday. The move is likely to set 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.

Today we present once in a generation proposals to ensure medicines are accessible, available and affordable at all times for 🇪🇺 citizens no matter where they live.

A Single Market for medicines delivering for citizens and keeps our industry as a 🌎 leader.#EUPharmaStrategy pic.twitter.com/u5l5xRTtmT

— Stella Kyriakides (@SKyriakidesEU) April 26, 2023

The Commission’s draft proposes to cut the length of basic market exclusivity that drugmakers get before generics can enter the market from 10 to 8 years.

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”.

Strengthening access to medicines is crucial for children and citizens living with rare diseases that have few or no treatment options.

This is why our proposals will encourage more innovation in new medicines ➡️ to leave no patient behind. #EUPharmaStrategy pic.twitter.com/X5OULeBwXp

— Stella Kyriakides (@SKyriakidesEU) April 26, 2023

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

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

Today we propose a major pharmaceuticals reform:

→ A single market for medicines: affordable, accessible, available for all, everywhere

→ A framework for easier, speedier innovation and a competitive industry

→ An initiative to tackle antimicrobial resistance… https://t.co/xawZPbfLd9

— Ursula von der Leyen (@vonderleyen) April 26, 2023

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.

Today’s proposals aim to do away with medicines shortages in our Health Union.

Shortages will have to be reported earlier and prevention plans need to be put in place to address them.

An EU list of critical medicines is in preparation.#EUPharmaStrategy pic.twitter.com/Lej4LiYCIR

— Stella Kyriakides (@SKyriakidesEU) April 26, 2023

Backlash

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

GSK (global biopharma company) said on Wednesday the EU must “regulate for growth and competitiveness” because companies “have choices on where our capital and resources are focused”.

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