Strengthening Europe's Competitiveness in Healthcare Innovation: The Need for a Strong Pharmaceutical Framework

Introduction

In a recent European Council meeting on March 23, the Heads of the EU27 Member States highlighted some critical issues related to "Access to healthcare innovation” and the "Competitiveness of Europe.[i]" Their conclusions underlined the urgent need to address these topics and get Europe back to the forefront of global healthcare innovation. In this light, the revision of pharmaceutical legislation[ii] presents a once-in-a-generation opportunity to refine and evolve Europe's regulatory framework[iii]. In this article, I would like to explore the importance of enhancing EU competitiveness through an innovation-focused pharmaceutical legislation and the potential consequences of failing to seize this opportunity.?

Reclaiming Europe's Leadership in Healthcare Innovation and consequences of inaction

Europe has witnessed a gradual decline in R&D investments, manufacturing capabilities, and overall competitiveness in the healthcare sector over the past 25 years[iv]. To regain its leadership position in the global competition for healthcare innovation, Europe must prioritize attracting R&D investments, fostering innovation, and ensuring swift access to innovative treatments for patients. The revision of the pharmaceutical legislation offers a strategic path to revitalize Europe's position in this field[v].

If Europe does not take this opportunity, it may become a mere consumer of others' innovations. This scenario would lead to a loss of high-value jobs, diminished investment in European research and manufacturing infrastructure, and delayed access to life-saving treatments for patients across the continent. The consequences of inaction are far-reaching and could hamper Europe's economic growth and global competitiveness in the long run.

Balancing Protection, Access and Innovation

While the revision of the pharmaceutical legislation aims to address barriers to access and incentivize innovation, it is crucial to utilize fit-for-purpose policy interventions to achieve this ambitious goal. Reducing the protection period of new medicines (Regulatory Data Protection) and conditioning recovery of lost protection on factors beyond the control of medicine producers can create a complicated and globally uncompetitive system.

Linking access to Regulatory Data Protection as a means to enforce faster and continuous access to medicines may not effectively address the access inequalities across EU Member States. Factors such as health budgets, market readiness, and administrative capacities play significant roles in determining access to medicines. Rather than relying solely on Regulatory Data Protection, a comprehensive approach is needed to streamline pricing and reimbursement processes, ensuring timely access for patients while considering the challenges faced by each Member State.

Recognizing the urgency of the situation, the European pharmaceutical industry has taken steps to advance pricing and reimbursement filings across all EU27 markets within two years of EU marketing authorization[vi]. This commitment, coupled with the establishment of an access portal to monitor access hurdles and delays, emphasizes the industry's dedication to transparency and collaboration. Such initiatives are crucial in bridging the gap between innovation and patient access.

Preserving Europe's Attractiveness for R&D and Manufacturing Investments

Any legislative changes must carefully consider the impact on R&D investments and the predictability of the intellectual property framework. It is essential to ensure that Europe remains an attractive and competitive destination for innovation and investment. Failing to do so may further erode Europe's attractiveness as a location for R&D and manufacturing, discouraging small and medium-sized enterprises (SMEs) and boost the declining trend witnessed over the past two decades.

Conclusion

In conclusion, the revision of pharmaceutical legislation presents a crucial opportunity for Europe to enhance its competitiveness in healthcare innovation, attract investments, and ensure swift access to treatments. Failing to seize this opportunity risks Europe becoming a consumer of others' innovation, resulting in job losses, diminished investment, and delayed access for patients. It is imperative that legislative changes preserve Europe's competitiveness, support innovation, while allowing the efficient and timely access for all patients. Fostering meaningful dialogue among all stakeholders is crucial in our quest to achieve shared objectives effectively and sustainably. By giving due consideration to industry’s proposals[vii], we can pave the way for collaboration and progress. By embracing these proposals and engaging in constructive discussions, we can forge a brighter future where access to innovative and life-saving treatments becomes a reality for all.

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[i] https://www.consilium.europa.eu/media/63269/st00004-en23.pdf

[ii] https://health.ec.europa.eu/publications/proposal-regulation-laying-down-union-procedures-authorisation-and-supervision-medicinal-products_en

[iii] https://www.efpia.eu/news-events/the-efpia-view/blog-articles/why-europe-must-future-proof-its-pharma-regulation/

[iv] https://www.efpia.eu/media/676753/cra-efpia-investment-location-final-report.pdf

[v] https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_1844

[vi] https://www.efpia.eu/news-events/the-efpia-view/efpia-news/new-proposals-from-the-research-based-industry-can-reduce-inequalities-in-patient-access-to-medicines/

[vii] https://www.efpia.eu/news-events/the-efpia-view/efpia-news/new-proposals-from-the-research-based-industry-can-reduce-inequalities-in-patient-access-to-medicines/