Following POLITICO Pro’s publication of the Commission’s Pharmaceutical Legislation Impact Assessment the future of Europe’s life sciences sector remains in sharp focus.
From the outset of this Commission, President von der Leyen’s aims — to ensure Europe has the supply of affordable medicines to meet its needs, and to support the European pharmaceutical industry to ensure that it remains an innovator and world leader — gave some hope to an industry in Europe that’s seeing investment leave its shores for Asia and the U.S.
The question now is do some, or even any, of the options laid out in the Pharmaceutical Legislation Impact Assessment support Europe to achieve those goals?
Back in 1994, the EU’s Communication on the “Outlines of an Industrial Policy for the Pharmaceutical Sector in the European Community”, said that the “pharmaceutical industry is a substantial asset for growth and employment in the European Union” and that“there are signs that the competitiveness of the Community industry is yielding in comparison with its main competitors”.Thirty years later, this prediction has become painfully true. Today, 47 percent of new treatments are of U.S. origin compared to just 25 percent emanating from Europe (2014-2018).
The question now is do some, or even any, of the options laid out in the Pharmaceutical Legislation Impact Assessment support Europe to achieve those goals?
We failed to act then but this Commission, through the revision of the legislation, has a unique and perhaps the last opportunity to retain a pharmaceutical research ecosystem in Europe. There remains a misnomer that the decision in front of the Commission is either to help member countries address the access, availability and affordability of medicines by facilitating the early entry of older generic medicines or to ensure that research, development and access to the latest advances in patient care happens in Europe. We believe this doesn’t need to be a choice. By using the right policy to address the right issue, we can drive innovation and improve access.
Coupled with the fact that despite the incredible advances in treatment over the past two decades the cost of medicines as a percentage of health care spend has remined flat at around 15 percent, should leave space for the Commission to create a new legislation that will retain a life-science ecosystem in Europe as well as help address access issues in partnership with industry and member countries.
Take the proposal in Option C of the Impact Assessment to link market launch in all 27 member countries to Regulatory Data Protection (RDP) and Market Exclusivity (ME) periods. We share the aim of faster, more equitable access to new medicines across Europe. It’s why we published our companies’ commitment to file for pricing and reimbursement in all EU countries within two years of receiving marketing authorization. But linking this commitment to intellectual property (IP) protections designed to support the research and development of new treatments and vaccines 15 years before they are launched will not facilitate faster access for patients, on the contrary. It will, however, further erode existing IP provisions protecting medical innovation across the region.
So how do you support Europe to be at the forefront of the next generation of treatments and vaccines while delivering faster, more equitable access to medicines across Europe?
It means developing a longer term (15-20 year) European strategy, creating stability and confidence to attract biopharmaceutical investment over the 10-15 years it takes to develop a medicine It means rethinking our approach to the research, development and manufacture of advanced therapies, realizing the potential of digitalization, fostering sustainable procurement and pricing policies as well as investing in truly world class hubs for medical innovation. It can only be built on a robust, world leading intellectual property framework and an ambitious evolution of the EU regulatory framework to ensure it is future-proofed against increasing demand on its resources and the rapidly advancing science.
Europe’s political reality is that most of the policy tools that impact on access, availability and affordability of medicines rest with member countries. To make real progress on access requires a shared, evidence-based understanding of root causes of barriers and delays to access and the right competencies around the table. And there are some changes that can be made at a European level. Modelling by IQVIA predicts that the industry’s commitment to file would increase the availability of medicines from 18 percent up to 64 percent in several countries and critically, reduce the time patients wait for new medicines by four to five months in countries such as Bulgaria (-179 days), Poland (-129 days) and Romania (-155 days). All without linking the commitment on access to IP tools such as regulatory data protection and market exclusivity that are fundamental to R&D investment in the next generation of treatments.
A fairer system to connect pricing of treatments to EU countries’ ability to pay and the use of new and flexible ways to spread costs overtime or link reimbursement to the results for patients can help both access to, and the sustainability of, health care more broadly.
The question for European policy makers is not if innovation will happen but where.
Why it matters
With over 8,000 new medicines in development the question for European policy makers is not if innovation will happen but where.And that matters.It matters for patients, for our health care systems and research ecosystem. It matters for our resilience, for jobs and growth.
We want to ensure that European patients are not at the back of the queue or relying on diagnostics, treatments and vaccines developed in other parts of the world. We want Europeans to be able to participate in clinical trials run in Europe.
We want to ensure that our academic, SME and research community continues to benefit from the €42 billion industry invests in R&D across the region. We want the 840,000 employees of the industry in Europe to continue to discover, develop and deliver new medicines right here in the EU, helping our industry to remain the biggest contributor to the EU trade balance of any sector. As a life-scientist and a passionate European but also as a mum and daughter, I am deeply concerned by the long-term trend of research and development activity moving to other regions and particularly, the impact that will have on European patients. I hope that the revision of the pharmaceutical legislation can be a catalyst for Europe to shake the access vs. innovation dogma and work together to achieve both.
