Belgian MEP Frederique Ries has proposed tailoring market exclusivity periods for orphan drugs to foster innovation, advocating a 12-year exclusivity period for orphan drug indications lacking authorised medicinal products in the EU.
In a race to set the stage for a more robust European innovation agenda, the Belgian Presidency is trying to navigate looming contentious issues, mainly the regulatory data protection periods and the orphan market exclusivity.
Emmanuel Chantelot, VP of International Policy and Government Affairs at Bristol Myers Squib, underscored the profound significance of the revisions.
He told Euractiv: “We live in an era of unprecedented scientific and medical invention. The proposal to revise the pharmaceutical legislation is a once-in-a-generation opportunity to reinvent the regulatory framework so that the EU has a modern approach matching an ambition to be a hub for scientific innovation.”
Divided opinions on RDP
One problematic issue is the European Commission’s proposal to reduce the baseline regulatory data protection (RDP) period.
The proposed reduction of regulatory data protection from eight years to six is of particular concern to the industry. While adjustments seek to balance protection with accessibility, industry leaders including Chantelot advocate for maintaining the RDP period at eight years.
Unlike the United States, where generics can be launched despite ongoing patent protection, Europe’s ‘launch at risk’ practice underscores the vital role of RDP in providing an iron-clad period of protection for preclinical and clinical trial data of reference medicinal products.
“As the European Parliament and the Council of the EU debate the legislative proposals, BMS believes that two pieces of it are especially important to get right: maintaining the RDP period at eight years and modernising the regulatory framework,” said Chantelot.
The industry is delivering new classes of medicines. But, as a region, the EU has been falling behind other parts of the world, with fewer clinical trials and approval times for new medicines that are much too long.
Maintaining the current RDP is seen as vital to nurturing innovation and competitiveness, ensuring a robust ecosystem for pharmaceutical development and safeguarding Europe’s position as a global hub for scientific advancement.
“The revision is a chance to make the EU more globally competitive for healthcare technologies and for attracting industry investments in research, development and manufacturing,” said Chantelot.
EP’s orphan market amendments
Amidst the debates, attention turns to orphan market exclusivity amendments. MEP Frederique Ries, a Belgian liberal and member of the European Parliament’s ENVI Committee, advocates for a nuanced approach to market exclusivity periods, particularly concerning orphan drugs.
While Ries supports the 8-year baseline for general RDP, her proposal for the orphan market focuses on tailoring market exclusivity periods to foster innovation in areas with limited treatment options.
She suggests extending market exclusivity to twelve years for indications lacking authorised medicinal products in the EU, promoting advancements in orphan drug development.
Furthermore, her amendments advocate for extensions for indications with limited approved products or for introducing novel mechanisms or technologies promising significant patient benefits.
However, products failing to meet these criteria would adhere to an 8-year exclusivity period, maintaining a regulatory focus on impactful innovation and predictability.
Additionally, her provisions refine the framework by proposing a 12-month extension for each new therapeutic indication, capped at two indications, and a dedicated 3-year period for subsequent indications.
Notably, her proposal includes a provision for a 12-month extension for products debuting in the European market first, aimed at bringing the latest and most innovative treatments to European patients.
“These amendments aim to strike a delicate balance between incentivising innovation and safeguarding public health, laying the foundation for a dynamic and responsive pharmaceutical industry capable of meeting the evolving needs of European patients,” said MEP Ries.
High stakes innovation
As the debate unfolds, it has become clear that the revision is not merely about regulation but about securing Europe’s position as a global leader in healthcare innovation.
The recent “Global Trends in R&D 2024” report by the IQVIA Institute for Human Data Science underscores this imperative, highlighting a growing gap in R&D activity between regions.
Despite rebounding R&D funding levels in 2023, the EU4+UK lags behind the US in launching novel active substances, risking its competitiveness.
MEP Nicolás González Casares raises concerns about pharmaceutical innovation outside Europe, questioning if current incentives can reverse this trend. He advocates halting public investment in innovation outside the EU to prevent external companies from profiting without contributing to EU innovation or production.
Additionally, stakeholders like AIM, the International Association of Mutual Benefit Societies, caution against prolonged incentives, citing adverse effects on public health and access to generic alternatives, especially in lower-income countries.
[By Nicole Verbeeck, Edited by Vasiliki Angouridi, Brian Maguire, Euractiv’s Advocacy Lab]
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