The reform’s numerous objectives include:
Nevertheless, the goal of this reform remains to improve the health outcomes of European citizens. The Commission believes that all individuals should have the opportunity to access a wide range of available medicinal products at reasonable prices across all 27 EU member states.
This vision is encapsulated by the ‘3A’ formula: accessibility, availability, and affordability.
Fulfilling these conditions would render pharmaceutical companies eligible for regulatory incentives, which include marketing the authorised medicinal product in all EU member states, developing medicines that address unmet medical needs, conducting comparative clinical trials, and creating medicinal products with additional therapeutic indications (repurposed medicines).
On the other hand, the Commission recommends reducing the regulatory protection granted to ‘ordinary’ medicinal products from eight to six years, aiming to expedite the availability of generic and biosimilar medicinal products in the market. This approach signifies a shift away from a ‘one-rule-fits-all’ strategy towards a more flexible framework that rewards companies dedicated to achieving the EU’s priority objectives of safeguarding public health.
Presently, manufacturers introducing innovative drugs to the market enjoy eight years of regulatory data protection and market exclusivity, with an additional two years of market exclusivity (resulting in a total of 10 years). If a new therapeutic indication is developed, an extra year of protection is granted. This system is commonly known as the ‘8 + 2 + 1’ formula.
The proposed provisions envision a general reduction in the period of regulatory data protection and market exclusivity from eight to six years (although the proposed text is likely to undergo amendments during the ordinary legislative procedure involving the Council and the European Parliament). An extra two years would be added if the concerned medicinal product is marketed in all EU member states – unless specific member states declare their lack of interest in marketing the medicine within their territories, thereby opposing an extension.
Furthermore, an additional six months would be granted if the clinical trials supporting the initial application for marketing authorisation use a relevant and evidence-based comparator, as advised by the European Medicines Agency (controlled clinical trials). Lastly, an extra six months would be provided if the medicinal product is indicated for a serious or life-threatening disease without any available therapeutic solutions (unmet medical needs).
Under the new framework, the maximum regulatory protection (including up to nine years of data protection and the existing two years of market exclusivity, with an additional year for new therapeutic indications) could extend to 12 years for companies demonstrating exceptional adherence to these regulations, while less compliant companies would have a limit of eight years.
It is important to note that the proposed reform does not impact patent protection, which remains unaffected. However, the possibility of extending regulatory protection, even for significant durations, is considered part of this reform. Consequently, access to the generics and biosimilars market could be delayed if innovative companies are granted one or more of the regulatory incentives proposed.
The regulatory incentives approach described above aligns with the objectives of improving accessibility (by promoting the marketing of medicinal products across the EU), availability (by reducing regulatory data protection periods), and affordability (by facilitating quicker access to more affordable generic and biosimilar medicinal products). According to the Commission, the additional two years of regulatory protection for companies launching medicines in all member states is expected to enhance access by 15% throughout the EU.
Considering that we are only at the initial stages of the ordinary legislative procedure and that the final text will likely undergo substantial amendments during parliamentary discussions, significant opposition is to be expected. However, while the Commission may display flexibility in reconsidering the time periods associated with the proposed incentives, reducing the two-year regulatory protection period for those who market the product in all member states to 18 months or one year could potentially avoid intense opposition. Yet, it is unlikely that the Commission will abandon the reward mechanism and agree to maintain the current ‘one-rule-fits-all’ approach.
Additionally, the Commission is unlikely to compromise on the proposed restructuring of the European Medicines Agency’s organisation, which involves reducing the number of scientific committees, including the Committee on Advanced Therapies (CAT) and the Paediatric Committee (PDCO). The introduction of Temporary Emergency Marketing Authorisation (TEMA), allowing for faster authorisation of essential medicines during public health emergencies, is also unlikely to be compromised.
Can the Commission strike the delicate balance between promoting and protecting innovation, supporting the competitiveness and sustainability of the pharmaceutical industry, ensuring access to affordable medicines for patients, and addressing unmet medical needs? Undoubtedly, it will be a significant challenge. However, what is certain is that negotiations on the reform must – and will likely – forge ahead.
Of Counsel, Vincenzo Salvatore is leader of the Healthcare & Life Sciences Focus Team at BonelliErede. A professor of European Union law, he joined BonelliErede in 2015, bringing his specific regulatory and compliance skills in terms of clinical trials, marketing authorisation procedures, pharmacovigilance, personal data protection, promotion and marketing of medical devices, inspections, and enforcement. He has gained significant experience in complex litigation representing public and private entities before the European Court of Justice based in Luxembourg in EU law disputes.
In addition, he was head of the Legal Service at the European Medicines Agency from 2004 to 2012. Salvatore is a member of the editorial board of The European Pharmaceutical Law Review (EPLR), one of the most authoritative journals that tracks the latest legal and regulatory developments in the pharmaceutical sector.