Last year the European Commission (EC) came out with a proposal to reform the EU’s core pharmaceutical legislation, aiming to address affordability, accessibility, and availability, among other objectives. One of the key changes proposed was reducing the EU’s baseline regulatory data protection (RDP) timeline, a plan that pleased the generics industry but got innovators up in arms. How has the reform advanced so far, what are its implications, and what are the next steps?
Sweeping Reform
The reform proposal, published on April 26, 2023, is the most significant revision of the EU’s pharmaceutical legislation in two decades. It set out to ensure medicines’ accessibility, availability, and affordability across the European bloc’s member states while supporting innovation and addressing issues such as antimicrobial resistance and the environmental impact of medicines.
Among other amendments, the plan aimed to reduce drugs’ baseline regulatory protection, or RDP, by two-years. Despite potential extensions, for pharma innovators, the proposed reduction favoured the generics and biosimilars industry. “The net impact of the proposals will undermine Europe’s competitiveness and slow the research, development and delivery of new treatments and vaccines in Europe,” said the European Federation of Pharmaceutical Industries and Associations (EFPIA) in a statement.
The generics and biosimilars industry group, Medicines for Europe, on the other hand, championed the proposed changes. “The central role of the off-patent medicines industry for the patient is clearly reflected in the intentions of the draft legislation, mirroring our commitment to make medicines available when and where they are needed evergreening and the adaptation of incentives to necessary equity of access across the EU,” said then president Elisabeth Stampa.
Compromises
What was the next step to making the new EU pharma legislation a reality? In March, the European Parliament’s Public Health Committee (ENVI) voted in favour of a few common positions, namely to slightly lower intellectual property protection periods with respect to the original proposal. In addition, they agreed to a minimum regulatory data protection period of 7.5 years, and a maximum of 8.5 years. This compromise has failed to please both innovators and consumer groups.
“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,” said EFPIA director general Nathalie Moll. “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,” lamented Ancel la Santos Quintano, senior health policy officer at the European Consumer Organisation (BEUC).
Rare disease advocates, however, were pleased with the agreement, with medicines addressing high unmet needs set to get up to 11 years of market exclusivity, compared to the 9 years suggested in the original proposal, and the introduction of a new European framework for rare diseases.
Regulators at the DIA Europe EU Regulatory Townhall seemed to have mixed feelings. While European Medicines Agency’s (EMA) chief executive Emer Cooke was enthusiastic, claiming that the overall desire for reform was “exciting and inspiring,” a poll of attendees at the townhall showed that 41 percent were “not confident” of the reform’s ability to improve access, availability and affordability.
An Accepted Position
On 10 April 2024, the European Parliament finally adopted its position on the reform, ahead of the parliamentary elections in June, a step, which according to experts marks significant progress in the overall process.
What exactly did they agree on? Most importantly for some, the position adopts a reduction in RDP with respect to the original proposal, lowering the baseline to 7.5 years, which still represents less default protection than the current eight years. Innovators will be able to potentially increase RDP, as Parliament has maintained the proposed RDP adjustment system with certain amendments. Companies can gain an additional 12 months for products that address unmet medical needs; 6 months if they conduct comparative clinical trials, as well as an added 6 months if they conduct “a significant share” of research and development in the EU in collaboration with public entities.
RDP is followed by 2 years of marketing protection instead of the additional 12 months of RDP originally proposed, but the position agreement has set a cap on the overall RDP of 8.5 years. This means that innovators can potentially get 6 more months of RDP than now, but with no certainty as to whether any additional time will be granted. In addition, the transferable exclusivity vouchers (TEVs) to incentivize the development of antimicrobials have been retained yet are subject to stricter conditions and orphan market exclusivity has been reduced.
“Through certain amendments that have enhanced the European Commission’s original proposals to develop a future-proof regulatory framework, the EFPIA’s Nathalie Moll said the vote was a “move welcomed by industry.” Patient groups also appear to be satisfied. “This landmark agreement brings us closer to achieving a more patient-centred EU pharmaceutical regulatory framework,” said the European Patients Forum (EPF) in a statement.
What’s Next?
Establishing the parliament’s position has moved the reform one step further, but it is still only a preliminary step. The final legislation will involve many more lengthy discussions and after meetings between parliament, the council, and the commission, a final voting process, which is expected between 2026 and 2028, will take place. Once the new legislation is adopted, there will be an 18-month transition period, meaning that the reforms will probably not come into effect before 2028.
