EU regulators and industry clash on pharmaceutical reform package

BRUSSELS – European Union officials said a proposal to reform the EU pharmaceutical legislation will go a long way towards providing equal access to new medicines, yet the proposal faced pushback from representatives of pharmaceutical companies who argued that shortening the marketing exclusivity periods for new drugs will hurt innovation and stymie clinical research in the region.

Both regulators and industry weighed in on the pharmaceutical reform proposal during a session at DIA Europe on 12 March.

In April 2023, the European Commission published its proposals to reform the EU’s medicines regulations; the first such reform in 20 years. (RELATED: EU releases draft legislation that will reshape pharma regulation, Regulatory Focus 25 August 2023)

The legislation would reduce of the minimum period of regulatory protection for innovative medicines to eight years, down from 10 years under the existing legislation. This exclusivity will be extended to a maximum of 12 years if drugs are launched in all member states and address unmet medical needs to incentivize companies to reach more patients.

The proposal has been sent to the European Parliament and European Council for their approval. The European Parliament’s Environment, Public Health, and Food Safety (ENVI) committee is set to vote on the proposal at its upcoming meeting on 19 March 2024.

Not starting from scratch

Emer Cooke, executive director of the European Medicines Agency (EMA), stressed that access to medicines is a key element of the proposal. She said that “I have really learned the hard way that regulatory frameworks are not enough. You can have a wonderful marketing authorization but there is absolutely no value to the patient unless it gets to the patient. We have to think about how we engage with different stakeholders and work collectively to facilitate access.”

Cooke further noted that the proposed pharmaceutical legislation builds on the foundations of existing regulatory initiatives, and that the joint clinical assessment and the joint scientific consultations in the proposal “is not new.”

She said that “I think what is important here is that we are not starting from scratch. We are starting form a very solid foundation.”

Industry concerned with impact of proposal on R&D

Yet Sabine Atzor, head of EU regulatory policies for F. Hoffmann-La Roche, said that industry is concerned about the plan to shorten marketing exclusivity by two years and the impact on innovation.

“As you can imagine from an industry perspective, we are extremely concerned about the decline in R&D,” said Atzor, noting that the proposal “also has repercussions on a number of clinical trials performed in Europe. This is really on top of our minds, and we see this as having repercussions on the daily business decisions” of companies.

Christine Kampf of Marinus Pharmaceuticals concurred, asserting that “I think the reduction in exclusivity is especially problematic.”

A poll conducted at the meeting found that 41% of the 229 respondents were “not confident” that the reforms in the proposals will address one of the main objectives of the proposal, to make medicines more available, accessible, and affordable. Twenty four percent were not strongly confident, 21% were neutral, 13% were confident, and only 1% were strongly confident that the pharmaceutical legislation would improve the measure.

DIA Europe

EU regulators and industry clash on pharmaceutical reform package

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