Agreement reached on EU's new pharma legislation

 Today, the EU Council and Parliament reached an agreement in principle on the long-awaited pharma reform package, but Europe's drug industry has already said it will not be enough to keep the sector competitive.

The wide-ranging package aims to introduce a simpler regulatory environment for medicines in the EU, provide more support for innovative new therapies, reduce the risk of medicines shortages, boost environmental protection standards, and tackle antimicrobial resistance. It is the first major update to regulations in 20 years.

Among the measures is a freeze on the current regulatory data protection (RDP) mechanism for new medicines, during which other companies cannot access product data, which will remain eight years for trial results, plus one year of market protection after approval.

According to EU pharma organisation EFPIA, that is an improvement on earlier drafts, which sought to reduce RDP to six years, but "is not enough to attract and retain global investment into European R&D."

The length of protection can be increased in some circumstances - for example, if a medicine addresses an unmet need or a significant clinical benefit over current therapies - but is capped at 11 years.

Earlier this year, a group of pharma leaders warned the EU that, without major reforms, including stronger IP protections, the bloc could see an exodus to the US of capital investments and R&D spending.

In a statement, EFPIA said: "If Europe truly wants to be competitive, it needs to increase investment in innovative medicines, strengthen rather than weaken IP, and make the process of getting new medicines to patients faster and more connected."

It also criticised a decision to extend the Bolar clause – which allows manufacturers of generic medicines to benefit from patent law exemption in certain circumstances – as "an unnecessary move that will frustrate IP enforcement and create legal uncertainty, further eroding competitiveness within the innovative sector."

The EMA had a different perspective, calling the agreement a "historic milestone" for European medicines regulation and EU patients.

A streamlined regulatory framework will see the number of the EMA's scientific committees for human medicines reduce from five to two, a reduced review time for marketing applications from 210 to 180 days, do away with the need for marketing authorisation renewals, and require applications to be done in digital formats.

The package also introduces additional features, such as regulatory sandboxes as a secure testing environment for truly novel medicines and adapted frameworks for certain non-standard treatments, like personalised therapies, as well as a transferable exclusivity voucher (TEV) with a complementary voluntary subscription model designed to stimulate R&D into new antibiotics and antimicrobials.

The political agreement is now subject to formal approval by the European Parliament and the Council.

"The EU pharmaceutical reform will redefine this sector for decades to come," said Olivér Várhelyi, EU Commissioner for Health and Animal Welfare. "It will boost our competitiveness, fast-track innovation, and increase the resilience of our health systems."

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