The European Federation of Pharmaceutical Industries and Associations (EFPIA) is today publishing its official response to the draft Pharmaceutical Legislation [published 26 April].

It reiterates Industry’s view that the proposals, in their current form, would harm patient access to medicines and innovation in the EU. 

Members of the European Parliament should now take the opportunity to amend the legislation so that it can foster the development of new treatments in Europe and support faster, more equitable access to medicines for European citizens.

The sweeping consensus from innovators and investors - those who develop new medicines and vaccines in Europe - is that the cumulative impact of the proposals would lead to companies, both large and small, carrying out research and development outside of Europe.

The reduction - by a quarter - of Europe’s regulatory data protection (RDP) for innovations, and the addition of complex and unattainable targets for companies to recover that – will undermine competitiveness. It will accelerate a trend in the region - which has already lost a quarter of its R&D investment to countries like the USA and China over the past two decades. The industry, which in 2022 spent a total of €44.5bn on European R&D now sees R&D spending growth four times lower than China between 2018 and 2022.

The assertion that the proposals will enhance the accessibility of medicines and vaccines is misleading. Research shows that around 75% of the delays that patients face come after a company has filed for pricing and reimbursement in a Member State. Mandating companies to launch a new medicine in all 27 EU Member States within 2 years of EU approval or lose 2 years of their protection, penalises the innovator for decisions that lie outside of their control.

EFPIA shares the ambition to level-up European medicines availability and is again asking partners – Member States, patient organisation and policy makers – to get round the table and fix the issues. The real causes of delays in Member States cannot be solved by EU legislation and requires urgent coordinated actions and new ways of working together to find pragmatic solutions like fair pricing schemes based on a country’s ability to pay. The Industry European Access Hurdles Portal is one example of how joint working can help address the barriers and delays outside of the legislation and based on a shared understanding of the evidence available.

As the Members of the European Parliament debate the legislation, Industry believes that the following amendments would help the legislation achieve its dual objectives of improving access and regaining Europe’s place as a leader in the discovery and development of new treatments:

• In line with the European Council Conclusions (March 2023), Europe needs to strengthen, rather than cut, the region’s Regulatory Data Protection baseline and Orphan Market Exclusivity.
• Provide meaningful and predictable incentives, attainable fairly, that would encourage additional R&D investment compared to today.
• Jointly addressing barriers and delays to access based on a shared understanding of the evidence generated by the European Access Hurdles Portal
• Limit Bolar exemption for activities related to seeking regulatory approval.
• Develop a patient-centred, more inclusive definition of unmet medical need. By acknowledging the value of innovation and encouraging advancements in prevention, treatments and care, Europe can ensure that no patient is left behind.
• A robust framework for mechanism of action paediatric Investigation Plans (PIPs) is essential to ensure that this new obligation is effective to achieve its purpose and is manageable for developers.
• Further optimise the regulatory framework and ensuring maximum use of expedited pathways in support of patient needs.
• Ensure that supply chain and environmental requirements are proportionate and fit-for-purpose while not prohibiting or delaying patient access to medicinal products.

The pharmaceutical industry currently contributes more to the EU trade balance than any other sector, and employs 865,000 across the region, it is therefore inconceivable that the legislative process should move forward without a comprehensive competitiveness check. 

Until such a time that the Commission decides to carry this out, EFPIA has commissioned this vital, missing piece of research, which will help inform the debate later this year.

Nathalie Moll, Director General, EFPIA, said:

“The proposals in their current form are harmful no matter how much they are being presented as positive to Europe’s patients and the research-based industry. These companies are telling us the opposite is true – we should listen.”

We have to make sure that the legislation works for patients and healthcare systems, and we must also stop and reverse the downward trends in Europe’s research and development investment, numbers of clinical trials and medicines manufacturing. By working together, I believe we can achieve both.”

Full consultation response available here and here