Health organisations remain concerned about issues such as regulatory data protection and innovation incentives, following the European Parliament’s Public Health Committee’s (ENVI) compromise on the revision of the EU pharmaceutical legislation.

ENVI members voted on Tuesday (19 March) in favour of common positions on the directive and regulation comprising the revision of the EU’s pharmaceutical legislation. Health organisations reacted to the compromises with mixed reactions.

Despite heated debates and wildly different approaches to key parts of the revision proposed by the Commission in April 2023, lawmakers finally agreed on their opinion.

The directive gathered 66 committee votes in favour, two against and nine abstentions, while the regulation passed with 67 votes in favour, six against and seven abstentions.

The rapporteur for the directive, Danish EPP Member of the European Parliament (MEP) Pernille Weiss, admitted negotiations were tough but called the final text a “pragmatic and stable compromise.”

Tiemo Wölken, German S&D MEP and rapporteur for the regulation, was likewise pleased with the results, saying the legislation could “improve the lives of many patients in Europe.”

The final texts include suggestions to lower only slightly intellectual property protection periods compared to the Commission’s proposal, while keeping the controversial transferable data exclusivity voucher as a method for incentivising the production of urgently needed new antimicrobials.

The latter works by granting an additional year of regulatory data protection to developers of new antibiotics to be used for another approved product.

The suggestions also include increasing requirements for environmental risk assessments and moving the EU’s health emergency body, HERA, from the Commission to the European Centre for Disease Prevention and Control (ECDC).

The Green group in the Parliament called it a “clear step forward”, although both of their shadow rapporteurs said the negotiations had been difficult due to the strong pharmaceutical lobby.

“We would of course have loved to improve the pharmaceutical system even more, but what we managed to reach is an agreement that is an acceptable compromise,” said Luxembourg Green shadow rapporteur on the regulation, Tilly Metz.

Health organisations want more

Reacting to the votes in committee, Ancel.la Santos Quintano, senior health policy officer at the European Consumer Organisation (BEUC) said in a press statement, “Consumers need urgent action to tackle the high prices of medicines which, if they continue to rise, will endanger healthcare systems. There must also be a coordinated effort, to prevent ever more frequent medicine shortages.

“The position adopted by Parliament’s lead committee to deal with these twin issues is a mixed bag,” continued Quintano.

From the perspective of the European Federation of Pharmaceutical Industries and Associations (EFPIA), the MEPs’ agreed text was not enough to eliminate the industry’s concerns about undermining Europe’s competitiveness.

“Despite pragmatic improvements to the initial text, the industry remains concerned that the net impact of the proposals will make Europe less competitive and less attractive as a region for researching and developing medicines and vaccines,” said EFPIA director general Nathalie Moll, in a statement.

“It is hard to comprehend how reducing incentives for companies to discover, develop and deliver new treatments in Europe is in the best interests of patients in the region,” said Moll.

Longer protection periods

A key element of the pharmaceutical law revision is to incentivise research and innovation inside the EU and ensure competitiveness and independence from third countries.

While the Commission suggested regulatory protection for innovative medicines for up to 12 years, MEPs only slightly lowered the suggestion to 11.5 years.

They agreed to a minimum regulatory data protection period of 7.5 years, and a maximum of 8.5 years.

Extension opportunities will include; if the product meets unmet medical needs, comparative clinical trials are conducted, and significant parts of the development of the product are taking place in the EU.

MEPs kept the Commission’s suggestion of two years of market protection, the time generic medicines must stay off the market despite having received marketing authorisation, with the option for extending by 12 months.

“The Parliament has disappointingly failed to shorten the period during which a new medicine is protected from competition. Shortening this period would help make medicine prices more affordable,” said Quintano.

Medicines for Europe, an organisation representing Europe’s generic, biosimilar and value-added medicines industries, was also not satisfied with the length of the regulatory protection periods.

“Regulatory data protection will be extended but will remain closer to the current level of protection. It continues to provide by far the longest protection period in the world,” they wrote in a statement.

“In exchange for this extension, we would like to see more effort to ensure equitable access across the Union.”

A win for orphan drug development

The specific rules applying to medicines for rare diseases, which address high unmet medical needs, should, according to MEPs, enjoy up to 11 years of market exclusivity. This is a change compared to the 9 years suggested in the Commission’s proposal.

For EURORDIS, an alliance of rare disease patient organisations this was a good step forward. “We believe that the proposals passed today mark an important moment in European policymaking on rare diseases, with a meaningful step taken toward bridging the gap between rapid scientific progress and the slower advancement in patient care,” said Simone Boselli, public affairs director at EURORDIS, in a statement.

They were also pleased about an amendment to the regulation’s article 73b, which would require the Commission to introduce a European framework for rare diseases.

Boselli noted the repeated calls for a European Action Plan for Rare Diseases, highlighting previous comments from EU health commissioner Stella Kyriakides, suggesting a strategy for rare diseases similar to the approach in Europe’s Beating Cancer Plan from 2021.

The texts are scheduled for votes in the Strasbourg plenary on 11 April. After the Council has adopted its position, trilogues will begin. These will take place in the next political mandate, after the European elections.

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