Biopharmaceutical CEO Brussel meeting with EU leaders focuses on equitable access to tackle COVID-19, fostering innovation and unmet needs

The Biopharmaceutical CEO Roundtable (BCR), which represents the world's leading biopharmaceutical companies, held their first face-to-face meeting since December 2019 in Brussels on Monday 21 and Tuesday 22 June, to discuss global health challenges and public health policies impacting biomedical innovation.

The fourteen biopharmaceutical industry CEOs who attended in person represent a global industry which is heavily invested in Europe, as key players in the research and development ecosystem, local economies and with health care systems. Their programme included meetings with European Commission Vice-President Schinas, Commissioner Kyriakides and Commissioner Breton, as well as Belgian Prime Minister Alexander De Croo, and covered a range of topics, including the development and scaling up of COVID-19 vaccines and how to foster an environment that invests in innovation. The CEOs explained the incredible innovations coming down the pipeline for patients, such as combination therapies, advanced therapies and Artificial Intelligence guided therapy.

The multifaceted root cause of unavailability and delay to innovative medicines were discussed, and the need to find solutions to reduce the time before patients have access to innovative medicines. The group tabled a number of proposals including the establishment of an industry portal targeting European access hurdles reflecting the shared aspiration of companies to file pricing and reimbursement applications within 2 years from the granting of the marketing authorization. The CEO delegation made concrete proposals to ensure equity of access and solidarity across EU member states, by means of equity-based tiered pricing, which would require an intergovernmental framework for it to be implementable and effective. There was clearly a shared commitment to ensure safe and efficacious innovative products reach the market and patients, enabled by a first-class regulatory system. The EU's regulatory system, which stood up well to the pandemic challenges, could remove the bottlenecks and catch up with regulatory systems in other parts of the world in terms of speed and flexibility of assessment by rationalising the decision making (expertise based) and reducing interfaces.

The innovation eco-system involving academia, biotech SMEs, bigger pharma companies or public-private partnerships such as the IMI and the future Innovative Health Initiative (IHI) is key to future innovation and Europe's competitiveness. While many aspects of the system work well, more could be done to create a better environment for European biopharmaceutical SMEs. Encouraging a culture shift in academia to increase its focus on translational research is one key element, as is looking at how to keep entrepreneurs of biotech start-ups in Europe, who often leave for countries which have more favourable innovation and tax incentives. The fact that there are fewer large venture capital funds or similar options in Europe willing to take on the level of risk biotech SMEs face also plays a role in innovators leaving Europe.

The BCR delegation shared its views on the COVID-19 crisis and how to ensure treatments and vaccines reach all who need them. The CEOs explained how they share the ambition of ensuring global access to all therapies and vaccines especially in response to global pandemics. While considerable progress has been made to develop vaccines in record time and deliver them globally, the delegation was concerned that this aspiration had not be met yet, by any means. The delegation shared with Vice-President Schinas, Commissioner Kyriakides and Commissioner Breton their short term five step plan to urgently support stepping up dose sharing and continue efforts to optimize production of COVID-19 vaccines, so that the goal of equitable access of COVID-19 vaccines around the world is met.

The CEOs discussed plans to make inroads on tackling the silent pandemic of antimicrobial resistance.The delegation gave an update on the progress of the AMR Action Fund which biopharmaceutical companies launched by raising close to US 1 billion (over EUR 825 million) to help bring to market two to four new antibiotics by 2030. The CEOs welcomed the recent G7 statements on AMR and confirmed their commitment to work with governments to pilot new incentives that could resolve the lack of a sustainable pipeline for new antibiotics. Transferable exclusivity vouchers or subscription fee could be explored in the European context, as both encourage innovation and ensure the health care system is prepared to treat antibiotic-resistant infections.

IFPMA and EFPIA invited Hans Kluge, the World Health Organization's Regional Director for Europe to a separate meeting with the members of the BCR. They discussed the Oslo Medicines Initiative and how industry could contribute to the initiative's vision for collaboration between public and private sectors to improve sustainable access to innovative medicines across the WHO Europe region.

BCR Chairman, Jean-Christophe Tellier and IFPMA President & Chief Executive Officer & Chairman of the Executive Committee, UCB in his concluding remarks said:

"The BCR meeting in Brussels has provided a very important opportunity to interact with European leaders; as well as important exchanges with Belgian Prime Minister De Croo. While delayed, the timing of our meeting has been fortuitous. The unprecedented shock caused by the COVID-19 pandemic has highlighted the value of effective collaboration between the EU institutions, Member States and private stakeholders. It also highlighted the considerable vaccine manufacturing capacity in Belgium. The BCR delegation brought the message that industry is committed to work with the European institutions and Member States to ensure that patients across Europe get the medicines they need during COVID-19 and beyond, while building Europe's resilience and pandemic preparedness.  

As industry, we hit the ground running when the pandemic was declared. Werepurposed treatments, checked compound libraries, entered into an unprecedented number of partnerships for development and scaling up of tests, treatments, and vaccines. Thankfully some of our efforts, in particular four safe and highly effective vaccines are coming through for world.  What's more,pharmaceutical supply chainshave proved to be pretty resilient.

This year, there should be enough vaccines to make considerable inroads to vaccinating large swaths of the world population, but this will only be achieved if there is greater solidarity and leadership from those governments that have secured larger numbers of doses than they will ever need. Manufacturers, governments, and non-governmental organizations must work together to take urgent steps to further address this inequity. 

Immediate action must focus on stepping up responsible dose sharing and maximizing production without compromising quality or safety. We are committed to support stepping up dose sharing, continue efforts to optimize production, call out trade barriers to be eliminated, support country readiness, and continue driving innovation.

COVID-19 cannot and has not be our sole focus during the past two days. We were encouraged by the shared focus on looking ahead: to be better prepared for future pandemics, to bring the best practices from the last 18 months into business as usual and to be ready for the exciting new technologies and products that industry will deliver - from a pipeline that has never been more innovative.

Challenges remain both in terms of tackling COVID-19, but also in making sure that Europeans get fast access to all our innovation, many of which we hope can be "home-grown" and thereby strengthening Europe's global competitive position in this sector. We thank all those who received us, and we look forwards to continuing our discussions to explore the various proposals we tabled, which we believe could set us on a new and exciting path that ensures Europeans and citizens around the world have access to innovative medicines."