EU pharmaceutical deal gets mixed reception

The EU is set to introduce new incentives to stimulate pharmaceutical R&D, particularly for new antibiotics and treatments for rare diseases, after lawmakers reached a provisional agreement on December 11, but industry is warning the plans don’t go far enough to support innovation.

“If this is the legislative framework that is expected to attract the medicines innovation of the next 20 years to Europe, the outcome of the trialogues is underwhelming,” said Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations (Efpia).

Europe has historically benefited from a strong pharmaceutical industry, but it is increasingly facing competition from the US and China. Europe’s share of global clinical trials sponsored by a pharmaceutical company fell from 22% in 2013 to 12% in 2023, according to research commissioned by Efpia and Vaccines Europe.

The upcoming legislation, which is the first major revision of EU pharmaceutical laws since 2004, has the dual aims of boosting investment and innovation and ensuring the availability of safe and affordable medicines throughout Europe.

The initial proposal from the European Commission was controversial as it would have reduced the baseline regulatory data protection period during which other companies cannot access product data to get marketing approval for generic or biosimilar drugs. The industry warned this would push investments outside of Europe.

The agreement, which came after two and a half years of deliberations, will keep data protection at eight years, plus one year of market protection during which generic or biosimilar products cannot be sold, a reduction from the present two years, but with possible extensions for medicines meeting certain conditions.

“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,” Moll said, referring to intellectual property (IP) protections.

Industry is also unhappy with the extension of the Bolar exemption, which will allow manufacturers to undertake trials or other necessary steps to ensure that generic versions of a medicine can be made available on day one after the intellectual property rights have expired. This “will frustrate IP enforcement and create legal uncertainty,” according to Efpia.

Antibiotics and rare diseases

Patient groups, meanwhile, are largely positive about the agreement. Avril Daly, president of Eurordis, an alliance of rare disease patient organisations, called it “a momentous advance for people living with rare diseases.”

The text proposes creating a new category of “breakthrough orphan drugs,” which are drugs for rare diseases where there is no existing treatment. These will benefit from an extended period of data and market protection. Today, around 95% of rare diseases have no approved treatment.

With the new incentives for orphan drugs and other treatments, “Europe has created the conditions to stimulate innovation, including for the rarest and most complex conditions,” Daly said.

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Biotech industry group EuropaBio, however, argues IP protection for rare disease treatments should be even stronger.

“It’s clear that governments recognise the need for increased market attractiveness,” said EuropaBio’s director general Claire Skentelbery, “but concerns remain that the scale of ambition does not reflect seismic global changes that are shaping the future for innovation and patients.”

Approval times

Both Eurordis and Efpia welcomed steps to shorten the European Medicines Agency’s (EMA) approval process and to introduce regulatory sandboxes to test innovative treatments. The agreement would see the EMA’s assessment time reduced from 210 to 180 days, while simplifying its committee structure and requiring marketing authorisation applications to be submitted electronically.

“By simplifying procedures, embracing digitalisation and rationalising our use of scientific resources, we will be better positioned to support innovation and ensure that promising new treatments reach patients faster,” said Emer Cooke, EMA’s executive director.

Meanwhile, the introduction of transferable exclusivity vouchers and a voluntary subscription model, two tools that will support the development of new antibiotics by decoupling revenue from sales, is “an important step towards tackling a major health crisis,” says Efpia.

Hot on the heels of the provisional agreement on the pharmaceutical package, on December 16 the Commission presented its proposal for the first of its planned Biotech Acts, which aims to accelerate the development of innovative new treatments and medical devices.