MEP involved in the file confirms pharma reforms will be delayed until after next year’s EU elections

The reform of the EU’s pharmaceutical legislation will not be adopted ahead of June’s European elections, an MEP involved in the negotiations in parliament has acknowledged.

As things stand, the two proposed revisions of the text are diametrically opposed, meaning there are awkward negotiations ahead. With the clock running down, parliament’s objective now is to reach agreement and vote on the text in the final plenary of this term in April.

That will put in place the mandate for subsequent negotiations, but with the elections intervening these are unlikely to begin until October 2024 at the earliest, said MEP Tomislav Sokol, EPP’s shadow rapporteur for the file.

“There are big differences between the main groups, EPP and S&D, so I would expect these to be pretty complicated negotiations,” Sokol said. With the revisions proposed by the two rapporteurs, EPP’s Pernille Weiss and S&D’s Tiemo Wölken, so at odds with each other, agreeing the final text “won’t be easy to achieve”, he told the Science|Business ‘Health innovation and the future of medicines development’ conference yesterday (15 November).

“It is possible to make it, but a lot will depend on the two rapporteurs,” said Sokol.

A key issue is the protection of clinical trial data. The Commission wants to reduce the length of this protection unless treatments are launched in all member states within two years of approval. S&D supports this as a way to improve access to medicines, while EPP and the pharmaceutical industry want to see this protection extended.

Another key area of disagreement is the Commission’s proposal for regulatory sandboxes, to allow for the testing of new approaches to regulating novel therapies. While the EPP believes this will stimulate innovation, Wölken deleted all mention of sandboxes in his draft report, warning the proposal was vague and would create a parallel regulatory framework.

Objectives not challenged

A compromise will need to be reached - which may be close to the Commission’s proposal in certain areas, said Lilia Luchianov, policy officer at the directorate general for health.

“I was happy to see that the parliament agrees with the principles. The objectives of the reform have not been challenged,” she said.

This is the first major reform to the pharmaceutical legislation in two decades, and whatever is decided is expected to shape the industry for the next 20 years.

While the proposed reductions to regulatory data protection and market exclusivity have attracted much of the attention, it is not the only element the industry is worried about.

For example, Wölken’s report includes an amendment to set uniform standards for the design of scientific studies, which is “completely unworkable” and would stifle innovation, said Janina Dzambazoska, head of regulatory affairs for Europe at Novartis.

“We need to ground ourselves in the truth of how the drug development and the research works, which is sometimes accidental, sometimes deliberate, and sometimes it’s a byproduct of something else we found,” she said.

Dzambazoska also believes removing the potential for sandboxes would be a “missed opportunity” when it comes to ensuring the legislation has the flexibility to adapt to groundbreaking innovation.

Growing gap

The reform aims to ensure the drugs of the future are not only developed in Europe but that they can be accessed by patients across the EU. The pharma industry is the biggest private investor in R&D in Europe and one of the EU’s major exporters. But it has been clear for some time that the sector is losing ground to the US and Asia.

In 2002, pharmaceutical companies spent €2 billion more on R&D in the US than in Europe. That gap has since grown to almost €25 billion, according to a report from Charles River Associates consultancy, commissioned by the trade association the European Federation of Pharmaceutical Companies and Associations.

“We as a global healthcare company made the strategic decision to put our next research site in Boston,” Robin Evers, senior vice president of Denmark’s largest company, Novo Nordisk, told the conference.

“There needs to be an ecosystem that allows larger pharmaceutical companies to collaborate with smaller and medium sized companies,” he said. This applies both to drug development partnerships and the acquisition of products and companies.

“We've seen over the last several years there have been more opportunities for that growth out of centres of excellence in east coast or even west coast US,” Evers said.

For Paul Csiszar, a director at the Commission’s competition directorate general, this is indicative of a more general gap in R&D spending between the EU and competitors such as the US and Japan. This is partly down to “the scale of the venture capital sector” he said.

That scale and the more open approach to risk means the “velocity of learning” is different on the other side of the Atlantic, said Hugues Bultot, CEO of Belgian life sciences company Univercells. “In every aspect, entrepreneurship, science, technology, you are allowed to make far more errors and to learn from them.”