The COVID-19 pandemic posed a very worrying question: what happens when you are totally reliant on other countries for access to life-saving medicines?
The EU was fortunate during the COVID-19 pandemic that several experienced and early-stage vaccine developers exist in Europe, but the bloc got a taste of the challenge of competing with other regions for the finished product when it struggled to procure quantities of the very vaccine its scientists and companies had created.
The soul-searching these events triggered revived a phrase first coined by discerning French officials well before the pandemic: ‘strategic autonomy’. Commissioner for Trade, Executive Vice President Valdis Dombrovskis, recently described this as “acting multilaterally wherever and whenever we can but being able to act autonomously if we must”.
The need for Europe to develop strategic autonomy in health goes beyond crisis response and manufacturing supply chains. With an ageing population, increasingly burdened public health systems, and a rise in chronic diseases, the conversation around strategic autonomy should start with ensuring a thriving research and development ecosystem. A robust life sciences community of early-stage, mid-stage and mature companies can provide the continuous stream of homegrown research and development that corresponds to European needs.
Right now, Europe’s life-sciences sector is struggling in comparison to the U.S. and the rest of the world. But the revision of the EU’s pharmaceutical legislation is a once-in-a-generation opportunity to help, not hinder, progress towards a strong innovative health care sector that will be an economic driver in the 21st century.
Innovate to elevate
The development of new medical technologies is the building block of an autonomous health care ecosystem. However, figures show that 47 percent of new treatments come out of the U.S., compared to just 25 percent from Europe. A complete reversal of the situation 25 years ago.
Fewer drugs are also being submitted for approval in Europe. Given that EU and U.S. approval agencies come to similar decisions in over 90 percent of cases when a medicine is filed for approval with both, the lower number of approvals sought in the EU should cause alarm in Brussels and member country capitals. EU decision-makers must seek to elevate Europe’s status as a place where medicines can be developed and launched to ensure Europeans receive the health and economic benefits of new medical discoveries.
Turning ideas into reality: the European research ecosystem
Europe is no stranger to life science and biotech research — we produce twice the publication output of the U.S. and apply for a similar number of patents. Yet Europe accounts for just a quarter of global biotech company creations. In other words, we lead the world in ideas but fall behind when the time comes to make those ideas a reality.
One answer as to why these figures are so bleak may lie in the number of partnerships being struck in Europe. In health care, public- and private-sector collaboration isn’t a nice-to-have, it’s a proven necessity. But data shows that European pharmaceutical companies actually pay more in terms of upfront payments for partnerships with U.S. biotechs than they do with European ones. In fact, European biotech companies secure far fewer partnership deals with pharmaceutical companies in general than their U.S. counterparts, with a smaller share of deals commanding large upfront payments.
Data shows that collaboration between academic institutions and the pharmaceutical industry results in significantly higher success rates at each phase of clinical development. The success rate after phase three, the final phase, is 63 percent under a collaboration, versus 0 percent when under no collaboration. A separate analysis showed the remarkable impact that the involvement of large biopharma companies has on value creation and success of biotech start-ups. Investment by larger companies does not just mean much-needed financing, but also knowledge transfer and the involvement of experienced experts.
To serve the needs of EU patients, we must create a framework that allows for private investment to build on top of a strong foundation of public science, helping European innovators to successfully translate innovation and academic output into company creation, and avoid the so-called ‘valley of death’ that so commonly exists between early research and practical application.
A framework to cultivate autonomy
The data is clear; the EU is launching fewer new medicines, EU patients are waiting longer for those medicines, and European pharmaceutical companies collaborate more with American biotechs than European ones. Therefore, we simply cannot afford to let more potentially life-changing ideas fall down the ‘valley of death’ only to materialize in other parts of the world.
The fragility of the biotech ecosystem in Europe speaks to a need for stability and predictability in the European life sciences environment — a necessary, yet not a sufficient condition. This has traditionally been done through world-leading intellectual property (IP) policies that allow innovative companies to realize a return on their risky investments. We know IP incentives work because treatments in the field of rare diseases barely existed before their introduction. There are now over 200.
Existing EU Commission plans to reduce exclusivities run the risk of providing those protections with too many strings attached. One such example is the potential loss of exclusivity protection of a medicine if it is not launched simultaneously in all EU countries; this requirement is virtually impossible to predict given the EU member countries’ patchwork of market access and pricing approval policies. Exclusivity periods are critical to ensure a return on the significant at-risk investment that is necessary to explore and establish the safety and efficacy of new medicines. Shortening exclusivity periods would reduce the opportunity to achieve a positive return on investment, and thus further compressing exclusivity periods would logically lead to more tempered and selective investments, resulting in less translation of science and innovation into potential new medicines.
The Commission’s Pharmaceutical Strategy and New European Innovation Agenda float some good and important proposals for supporting the life sciences industry, such as improving access to finance for European start-ups, futureproofing the European Medicine Agency’s market authorization system and supporting regional innovation valleys. Yet, all these efforts risk being in vain if they are undermined by creating uncertainty in the incentives system.
EU pharmaceutical legislation is a chance to ensure that Europe steers companies’ investment decisions in a positive manner, so that our scientists and entrepreneurs can succeed in bringing next-generation treatments to Europe’s most vulnerable patients. But it is impossible to achieve strategic autonomy in health care without considering the health of the whole life sciences ecosystem.