Fraunhofer-Gesellschaft
Reforming pharmaceutical legislation could make the supply of medicines more secure and strengthen Europe’s competitiveness.
When I began my career, thirty years ago, one in every two new medicines originated in Europe. Now it’s just one in five. Over the last two decades, Europe has lost a quarter of its share of global pharmaceutical R&D investment, most notably to the U.S. and China. In today’s era of breakthrough innovation and intense global competition for cutting-edge science, the question is not if medical progress will happen, but rather where it will happen. Do we want the European Union to be dependent on innovations from other regions around the world? Or do we want it to recognize the importance of innovation and reward it accordingly? If we take the latter path, it would benefit patients, drive investment, create jobs and spur economic growth. Europe needs to address its competitiveness crisis and healthcare challenges. There are real concerns about sovereignty, national security and supply chain resilience. Trade tensions are creating uncertainty, inciting European pharmaceutical companies to announce massive investments in the U.S. But “sweet are the uses of adversity”. Today the pharmaceutical industry — the largest contributor to the EU trade surplus and a provider of 900,000 jobs in the region — is finally being recognised as a key strategic sector in significant statements of intent and by decision makers at the highest level. We need now to rapidly turn this intent into policy change if we are to build a healthier and more competitive Europe. The most imminent opportunity to do so is through the General Pharmaceutical Legislation (GPL).
We need a Europe that attracts innovators and investment.
Europe is entering the final stages of the legislative process for the GPL, which will define how medicines are developed, authorized and made available across Europe for decades to come. Despite the need for predictable, world-class Intellectual Property (IP) protection to offset the high-risk nature of medical R&D, proposals include a reduction of current regulatory data protection. Bayer’s decisions on research, development and production locations are based on a range of factors that, in combination, afford us the best chance of successfully bringing novel medicines to patients. It is imperative that Europe use this legislation to strengthen its IP in order to be competitive.
We need a Europe that accelerates the translation of ideas into applications.
Europe has world-renowned academic institutions and a highly skilled workforce. Yet it struggles to turn breakthrough science and research into commercially viable products. One way to improve this is to foster life science hubs, as in San Francisco or Boston, where all stakeholders across the public and private sector can flourish. We need to nurture our start-ups so that they do not need to look abroad for financing or fail before they have the chance to deliver for patients. Indeed, if Europe is to remain an engine room of innovative medicine, we need to reinvigorate financing at all stages of development.
We need a Europe where Europeans get fast and equitable access to medicines.
It is unacceptable that patients in the EU have access to less than half of all approved innovative medicines. Nor that the average time from approval to patient access now amounts to 578 days. These delays and disparities arise from a combination of factors largely tied to Member States’ medicine access and reimbursement processes. Urgent and real dialogue among industry, European institutions, and national policymakers will be essential to create harmonized EU mechanisms and national access strategies that value and reward innovation and ensure medicines are accessible to everyone in Europe.
We need a Europe that acknowledges health expenditure for what it is: an investment in our collective future.
The healthcare industry helps people live longer and feel better, while driving prosperity, resilience and security. Yet, in Europe, policymakers and society at large often view innovative medicines solely as a cost rather than an investment in health and the economy. This perception needs to change. Only by doing so will Europe remain at the forefront of medical research, development and manufacturing. I am confident that it will.