Pharmaceutical Legislation: Two things that need to happen now
05.04.23
With further delays announced until the publication of the EU pharmaceutical package, for me, there are two things that need to happen now.
- We have to find routes outside of the legislation to urgently address access to, and availability of medicines
- For legislation which will have a long-term impact on a sector that contributes more to the EU trade balance than any other, it is inconceivable that this legislation is not subject to a comprehensive competitiveness check.
Addressing issues of access and availability
Citizens in some European countries are waiting more than 6x as long for some new medicines as people in neighbouring countries. European patients do not have the luxury of waiting years for the EU to develop and progress legislative proposals which at the end of a protracted process, are unlikely to have any impact on improving access since access decisions are made at a national level.
By getting round the table now, building a shared, evidence-based understanding of the reasons behind delays and barriers to access, I am convinced that we can develop pragmatic solutions that really work. And we can make that change now rather than waiting for another 3-5 years for legislation to take effect.
Actions like creating a framework to differentiate medicine’s prices between countries, filing for pricing and reimbursement within 2 years of marketing authorisation and introducing novel ways to price and finance new treatments are beginning to happen now and don’t need to wait for legislation. They just require some new ways of thinking and a collaborative approach.
Information emerging from the WAIT indicator, the CRA report on the root causes of access delays and the industry access portal clearly demonstrates that barriers and delays to access are multifactorial with many lying out with company control and EU competence. As a consequence, the proposal to link Regulatory Data Protection which supports innovation to launching in all markets will not address the majority of access problems but will create capacity issues for Member States and make Europe a less attractive location for research, investment and jobs. It is lose-lose for Europe and Member States when we could take a win-win action now instead.
Why no competitiveness check?
Both President von der Leyen’s public commitment to introduce a standard competitiveness check on all new legislation and the recent European Council conclusions to strengthen EU competitiveness and incentives for innovation have underlined the importance of EU policy making supporting rather than hindering the competitiveness of its key industries.
It seems inconceivable that legislation so integral to the healthy future of patients in Europe, our life-science ambitions and the future of a sector that contributes more to Europe’s trade balance than any other, has not been subject to a comprehensive competitiveness check. We, like many, want to avoid legislation designed to save millions, in practice costing the region billions in lost investment and growth. If the Commission is no longer able to deliver a competitiveness check on this critical legislation, we sincerely hope and trust that Members of the European Parliament and Council will.
The industry needs this revision of the legislation. Not least to bring our regulatory framework in Europe up-to-date with the rapidly advancing science and help make us be more competitive. However, to move forward with confidence requires a comprehensive competitiveness check along the lines of what the Commission has proposed for future legislation. And finally, while the EU legislative wheels turn, I strongly believe that it should not be a barrier to action on access and availability of medicines. Access and availability of medicines are our shared priority now. With the right people around the table, we can and must take action for patients immediately.
