EU Pharmaceutical Legislation will shape the future of research, development and manufacturing in Europe for decades to come. If the necessary changes are not made, Europe will rely on the medical innovation of other regions and our citizens will have to wait longer for the latest in their treatment.
SFEE and our member companies support and share the goals of the EU Pharmaceutical Strategy to enhance patient access to medicines and strengthen the competitiveness of the pharmaceutical industry in Europe.
However, we believe that the proposed EU pharmaceutical legislation has the opposite effect. The net impact of the proposals has the effect of undermining Europe’s competitiveness and slowing research, development and the arrival of new treatments and vaccines in Europe and in Greece.
The proposed legislation significantly reduces European intellectual property rights while adding complex, inconsistent and unenforceable criteria for recovering lost protection. Whereas, Europe is already far behind other countries such as the USA and China.
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.
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.
Make Europe a frontrunner in modern, digital and green manufacturing.
SFEE will continue to work with all stakeholders in order to find solutions that will bridge rather than widen the gap between Europe, the USA and Asia, while formulating a sustainable European and National policy centered on the patient and public health.
For more information, please visit the EFPIA website: EFPIA website
