This comprehensive strategy is designed to create a resilient, future-proof regulatory framework that aligns with the evolving needs of health systems, focusing on promoting research and technologies to meet patients’ therapeutic requirements and addressing market failures and sustainability.
Key Measures
So, what are the most significant measures coming out of the new proposals?
Perhaps the most significant changes are those aimed at streamlining the EU regulatory procedures in order to promote innovation and increase access to medicines. The potential regulatory protections for an innovative product granted a marketing authorisation will be shortened, with a reduction in the standard period of data protection from eight years to six years. This reduction is mitigated by proposals to grant additional periods of data protection when certain conditions are met, for example an additional 6 months of data protection if the medicine addresses an unmet medical need or an additional one year of data protection for a new therapeutic indication approved during the period of data protection.
For orphan medicines, the standard period of exclusivity is reduced from ten to nine years. Additional periods of market exclusivity may be available under specific circumstances. Whilst this could potentially extend the period of exclusivity up to thirteen years, concerns have already been expressed as the proposed conditions which have to be fulfilled in order to obtain an extension are strict and currently lack clarity.
The proposals also focus on availability of medicines with proposed changes to address shortages of medicinal products and ensure the security and robustness of pharmaceutical supply chains across Europe. These proposals include comprehensive reporting and monitoring obligations and obligations on marketing authorisation holders to prevent shortages.
Some of the other significant changes being proposed include proposals to simplify EMA’s Scientific Committee as well as introduce changes to streamline regulatory procedures in order reduce administrative burdens.
There are also a number of provisions aimed at encouraging prudent use of antimicrobials as well as a large range of new measures to address environmental risks.
Proposals to introduce temporary emergency marketing authorisations for use when there is a public health emergency following COVID -19 have also been included and there is a proposed new classification mechanism for borderline cases as well as new measures to regulate decentralised manufacturing.
It is worth noting that there are only limited changes proposed to the existing EU pharmacovigilance regime and the proposed changes to the framework governing advertising are also largely uncontroversial (with the exception perhaps of indirect forms of promotion and comparative advertising).
Impact on Pharmaceutical Companies
It may take years before the full package of proposals are adopted but pharmaceutical companies, need to understand and start re-evaluating their longer term strategy in light of these potentially far reaching new measures particularly for instance if they wish to achieve the same levels of data exclusivity as provided under the current framework.
The European Commission’s new pharmaceutical strategy and legislative proposals represent a watershed moment in the healthcare sector. By forging a resilient and adaptive regulatory framework, the EU’s strategy underscores a commitment to public health, and innovation, whilst seeking to address unmet medical needs. The balance between promoting affordability and rewarding innovation presents both challenges and opportunities for pharmaceutical companies, requiring a strategic revaluation to navigate the potentially far-reaching effect of the proposed legislative measures.
Timing and Next Steps
The Commission’s Proposal initiates the legislative process and whilst it is not possible to predict the timing of adoption of the proposed measures, it is fair to say that given the breadth of scope of these proposals and opposing views already expressed by a number of Member States, the legislative process could take many years to finalise.
For further information on these developments, and how it could affect business, we are always happy to provide our insights. You can also stay informed and ahead of the curve as we delve deeper into the implications and developments in future editions of our newsletter.
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