Revise pharmaceutical legislation, or long-term access to medical breakthroughs for Europeans will be harmed
In June, the newly elected Presidency team of the European Federation of Pharmaceutical Industries and Associations convened in Brussels to express their concerns about the impact of the proposed Pharmaceutical Legislation - and their desire to collaborate on updating the legislation to improve the prospects of patients in Europe.
Lars Fruergaard Jørgensen, President and CEO Novo Nordisk has been elected as EFPIA President. Stefan Oelrich, Member of the Board of Management of Bayer AG and Head of its Pharmaceuticals Division, and David Loew, Chief Executive Officer of Ipsen have been elected first and second Vice Presidents.
EFPIA, its member companies and the European Commission share the goals of increasing patient access to medicines across Europe and strengthening the competitiveness of Europe’s pharmaceutical sector. However, the proposed legislation as currently set out will have the opposite effect. The net impact of the proposals will be to harm innovation and further undermine Europe’s competitiveness.
The proposed legislation does begin to evolve Europe’s regulatory system, which has not been extensively modernised in the last twenty years and is increasingly slower than the US and other leading regions. However, it significantly reduces European intellectual property (IP) rights while adding complex incentives for additional IP protection which in practice makes it impossible to achieve these incentives.
In reality, the proposals will accelerate several negative trends, including the 25% relative decline in European R&D and reduction in Europe’s global share of clinical trials from 25% to 19%. Annual figures released by EFPIA today show that R&D spending growth in China was more than three times higher than in Europe between 2018 and 2022.
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. The innovation community, from large, research-based pharmaceutical companies to biotechs, have given repeated warnings that the proposals 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.
Industry is therefore seeking the following amendments to the draft proposals:
- 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 and orphan drug market exclusivity 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 unmet medical need (UNM) 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 and environmental requirements are proportionate and fit for purpose, to best support our shared objectives of increasing supply of medicines and reducing our sector’s environmental impact.
Considering that the industry contributes more to the EU trade balance than any other sector, a comprehensive competitiveness check should also immediately be carried out on the Commission’s legislative proposals.
Lars Fruergaard Jørgensen, EFPIA President, and Chief Executive of Novo Nordisk, said:
“At a critical time for Europe, a resilient and globally competitive pharmaceutical sector is essential to ensure the long-term health of Europeans as well as strategic autonomy and a thriving economy. These objectives support each other and can help to secure a strong Europe in a changing world.
We need to work in partnership to innovate new medicines that change people’s lives, improve the effectiveness of health systems, and benefit society as a whole. This is what a competitive sector can deliver for Europe, but we face many challenges in achieving this today. We look forward to working with policymakers across Europe to reach a shared understanding of how we can best achieve our goals for competitiveness and health, together”
Stefan Oelrich, Member of the Board of Management of Bayer AG and Head of its Pharmaceuticals Division and EFPIA Vice President, said:
“Europe is a powerhouse of science and innovation, but unfortunately the innovation doesn’t get translated into patents and products as efficiently as it should. The challenge for the coming decades is not if medical innovation will happen but rather where it will happen and how patients in Europe can benefit from this huge potential.
As an industry, we are committed to doing our part to address this including the issue of timely access to new treatments. Europe cannot afford to miss out on key innovative drugs that hold the potential to transform patient health. I am committed to working with the EFPIA Board and all stakeholders involved towards our shared goal for a more competitive, healthier, and stronger Europe.”
David Loew, Chief Executive Officer Ipsen and second Vice President of EFPIA, said:
“We are all united in our vision of a strong and independent Europe with secure employment, where citizens have continuous access to the medicines and vaccines they rely on. Having a robust production and supply chain in Europe is essential to achieve these goals. Medicine shortages, resulting in part from a fragmented EU landscape, are putting people at risk.
I see an opportunity for all of us to work together to find ways to ensure a healthy and resilient supply chain by increasing production capabilities in the EU, prioritizing critical medicines, and removing barriers to ensure Europeans’ wellbeing, now and in the future.”
Nathalie Moll, Director General, EFPIA, said:
The data is showing us that we are losing ground to the US and Asia and companies have given numerous warnings that the proposals will exacerbate this trend. If we are to realise the ambition of the legislation – to boost research and innovation and to improve healthcare for patients across the EU – we must work together and agree on a vision that works for patients, health systems and the future of European science.”
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.
We must ensure that the revised pharmaceutical legislation meets the needs of people, healthcare systems, Member States and Europe’s life science sector, while minimising impact on the environment.