The EU Pharmaceutical Legislation will shape the future of research, development and manufacturing in Europe for decades to come. Unless changes are made, Europe will become reliant on other regions' medical innovation and our citizens will wait longer for the latest advances in care.
EFPIA and its member companies share the goals of the EU Pharmaceutical Strategy to increase patient access to medicines across Europe and strengthen the competitiveness of Europe’s pharmaceutical sector.
However, we believe that the proposed EU pharmaceutical legislation will have the opposite effect. 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.
The proposed legislation significantly reduces European intellectual property (IP) rights while adding complex, incompatible and unworkable criteria to recover the lost IP protection. Its impact will accelerate several negative trends:
The assertion that the proposals will enhance the accessibility of medicines and vaccines while boosting scientific research and innovation in Europe is misleading. The proposals jeopardize advances in care for all people, from those living with the most common chronic conditions to those with poorly understood, ultra-rare diseases. It will further accelerate the loss of Europe’s industrial base to the US and Asia, and Europeans will miss out on advances that will be available elsewhere instead.
To close the gap, EFPIA proposes to:
Deliver on the core purpose of Europe’s pharmaceutical legislation by further optimising the regulatory framework and ensuring maximum use of expedited pathways in support of patient needs.
In line with the European Council Conclusions (March 2023), strengthen, rather than cut, the region’s RDP baseline as well as creating separate incentives to drive innovation and meet health care challenges.
Jointly address barriers and delays to access to new treatments based on a shared understanding of the evidence generated by the recently published Industry European Access Hurdles Portal.
Unmet medical need
Include a patient-centred, broad definition of UMN that would incentivise avenues of research to meet the needs of people living with rare diseases and chronic conditions, and appropriately value incremental innovation.
Ensure that supply chain requirements are proportionate and fit for purpose, to best support our shared objective of increasing supply of medicines.
Ensure that environmental requirements are proportionate and fit for purpose, to best support our shared objective of reducing our sector’s environmental impact.
Design a meaningful incentive to encourage antimicrobial R&D and tackle AMR.
Deliver a simple and predictable system of orphan incentives with a strengthened orphan market exclusivity baseline to encourage more R&D in rare disease.
Deliver a robust framework for mechanism of action Paediatric Investigation Plans (PIPs) to ensure that it is effective and manageable for developers, including an additional reward for this increased obligation.
Over the coming months, EFPIA and its members remain committed to working with Members of the European Parliament (MEPs), Member States and other stakeholders to close, rather than widen, the gap between the EU and the US and Asia.
Download our assessment of main provisions and key EFPIA recommendations on the revision of the pharmaceutical package
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