In an era marked by rapid technological advancements and fierce global competition in health, the European Union’s position and attractiveness as a hub for pharmaceutical innovation and manufacturing has faced a steady decline. While the vaccines industry constitutes a relatively small segment within the broader pharmaceutical sphere, it holds paramount importance for the EU. Based on findings from a new report commissioned by Vaccines Europe and developed by Charles River Associates, the European Commission’s industry scorecard demonstrates that the health industry delivers the second highest level of investment value when compared to other innovative industries. It also significantly contributes to the EU economy, providing hundreds of thousands of jobs each year while also serving as an investment that delivers health and prosperity, protecting people against infectious diseases at all stages of life.
The COVID-19 pandemic further spotlighted the industry’s role and importance through the creation and delivery of effective COVID-19 vaccines that protected the public. Nearly half of patent applications for COVID-19 vaccines came from European companies and by January 2022, the EU had contributed to nearly 40 percent of the world’s COVID-19 vaccine exports. Despite this, policy discussions do not prioritize vaccines. To pave the way for future vaccine breakthroughs, we need a vibrant ecosystem that not only acknowledges the pivotal role of the vaccines industry but also entices substantial investments. To get there, all actors must acknowledge and partake in crucial discussions regarding vaccine research, development, manufacturing, regulatory, and access.
As we navigate these policy priorities, working to secure the EU’s global leadership in vaccine innovation, policymakers and industry alike have an opportunity to collaborate and ensure that the EU continues to play a pivotal role in safeguarding the health and well-being of populations worldwide.
Reinvigorating the EU vaccine ecosystem
The EU has been a hub for vaccine research, development and manufacturing, hosting approximately 22 percent of global clinical trials over the 2000-2009 period. The region is also home to research facilities of many of the world’s largest vaccine companies. However, the vaccines industry in the EU is grappling with some challenges.
While the EU has traditionally been an important region for vaccine development, limited funding, incentives, and support for diverse vaccine types and platforms have posed significant barriers. This has led companies to move elsewhere, resulting in 56 percent fewer biotechs involved in vaccine research in the EU compared to the United States. Additionally, current data shows a 35 percent decline in global vaccine clinical trials conducted in the EU since 2000. Major contributors to this include extensive and sometimes inconsistent clinical trial requirements and approval timelines among certain member states. While crucial for demonstrating vaccine quality, safety and efficacy, this can sometimes become unwieldy, delaying the development process.
This mirrors trends across the European pharmaceutical industry in general. Research by Charles River Associates last year showed that the EU has lost 25 percent of its global investment over the past two decades, as companies increasingly look to the more ambitious life-science sectors in the U.S. and China.
Another glaring issue is the lack of support toward vaccine manufacturing including inadequate financing, complex requirements and suboptimal manufacturing infrastructure present in the EU. Although home to many of the world’s leading vaccine manufacturers, several challenges continue to persist. There is room for improvement around financial incentives toward development and manufacturing infrastructure, as well as a vaccine life cycle management process.
These challenges call for change within the vaccine ecosystem to ensure the EU’s continued prominence in the global vaccines arena.
Tackling vaccine access and hesitancy
While the responsibility for access and distribution rests primarily with member countries, the EU is poised to play a crucial supporting role in ensuring equitable vaccine uptake. Inadequate budget allocation for vaccines and vaccination campaigns, coupled with occasionally rigid tendering practices and lengthy reimbursement times, present a formidable challenge. Currently, 77 percent of member countries allocate less than 0.5 percent of their health care budget to immunization. Even more concerning, data reveals that in a staggering 30 percent of member states, the reimbursement process for new vaccines frequently extends beyond a lengthy six-year horizon.
Adding to the complexity of these challenges is vaccine hesitancy, which lingers in the wake of the COVID-19 pandemic across the EU. A recent survey shows a troubling trend, revealing that some member states now grapple with hesitancy levels that surpass global averages. Further, the 2022 State of Vaccine Confidence in the EU report spotlights increasingly diverging perceptions toward vaccines between 18-34 year olds. This is a particular cause for concern as high vaccine confidence in this age cohort is critical to ensure the continued uptake of routine childhood immunization programs and embrace the new challenge of adult immunization. It is imperative to continue tracking these trends in vaccine confidence to inform the appropriate policy actions.
Charting the future
The EU vaccines industry is a ready and willing partner in innovation. With 100 vaccine candidates in the Vaccines Europe members’ pipeline, of which 46 percent aim to address disease areas for which no vaccine has yet been registered, we — both industry and the EU — have an opportunity to work together to resolve these issues and retain our position as a global leader within the vaccines ecosystem. For the EU, this means advocating for increased investment in vaccine research, development and manufacturing, community engagement, improved infrastructure, coordination, and regulatory flexibility as well as accountability and prioritization by EU member states.
This action has become even more urgent. The EU continues to face major challenges such as climate change, an aging population and the growing threat of AMR. These issues are directly related to the spread and rise of existing and new infectious diseases that threaten the health of our population. However, their impact can be reduced through resilient and sustainable health systems supported by strong immunization programs and vaccine innovation.
The EU now stands at a crossroads. It’s time to fan the flames of change, breathing new life into this vital industry. As we reflect on the EU’s impressive legacy and continued commitment to vaccine innovation and excellence, it’s clear that with strategic reforms, collaborative efforts, and a renewed focus on health for all Europeans, the EU can reclaim its attractiveness on the global stage.
Sibilia Quilici, executive director, Vaccines Europe at EFPIA – European Federation of Pharmaceutical Industries and Associations.