EFPIA/Vaccines Europe statement on Building a European Health Union: preparedness and resilience

Vaccines Europe, as part of EFPIA, welcomes the proposals from the Commission to strengthen the resilience and preparedness of Europe against serious cross-border health threats, including through reinforcing the capacities of the EMA and ECDC.

The first wave of the COVID-19 pandemic revealed several weaknesses in Europe’s capacity to respond to a public health crisis of this magnitude and to ensure sufficient coordination and evidence-based decision-making at all levels to effectively combat the pandemic and its consequences. Issues raised by EFPIA to the Commission and other actors and stakeholders included:

  • The importance to keep borders between Member States open and avoid unilateral export restrictions and stockpiling measures in order to ensure the continued supply of critical medicines to the patients most in need;
  • The need to get reliable data on actual demand for medicines in Member States and robust forecasts on future demand to enable manufacturing and supply chain planning and management;
  • The need for a direct channel between the European Medicines Agency and manufacturers to monitor stock levels and potential shortages of critical medicines;
  • The need for common guidelines on how to ensure continuity of clinical trials during the pandemic;
  • The need to set up fit for purpose and effective preparedness mechanisms that accelerate research, development, evaluation and deployment of diagnostic, therapeutic and preventive products and their combinations to address emerging infectious diseases.

Commenting on the proposals, Nathalie Moll said. “For many of these issues, ad hoc solutions were eventually found that mitigated some of the disruptions that were evident during the first phase of the pandemic, but it is essential to build on these learnings and permanently strengthen the capacity and tools of the EU and its agencies in order to ensure a more agile and robust response for future public health crises.”

EFPIA therefore welcomes the proposals from the Commission to strengthen Europe’s capacity to prepare and respond to public health threats, including through strengthening the capacity of the EMA and the ECDC as well as the proposal to set up an EU Health Emergency Response Authority (HERA), which should aim to address these and other identified weaknesses.

For the ECDC, it is critically important that the agency can get full and immediate access to all relevant data from Member States, and also has the internal capacity to provide robust monitoring, surveillance, risk assessment and forecasting on epidemiological trends, health system capacities and demand for treatment in relation to serious cross-border health threats. Furthermore, and going beyond pandemic preparedness, surveillance networks and capabilities need to be strengthened to better assess (1) the burden of infectious disease (2) evolving and changing infectious disease epidemiology (3) vaccine safety (4) vaccine effectiveness and (5) vaccination coverage rates.

For the European Medicines Agency, to ensure the optimal functioning of the executive steering group on shortages, tight collaboration between the EMA, the European Commission and stakeholders established during the current crisis needs to be prioritised. Inclusion of marketing authorization holders and other relevant interest groups should not only be considered on an ad hoc basis but as a permanent element. The EU should ensure a consistent and workable definition of shortages (covering both the supply and demand sides) and agree on standardised reporting requirements on clearly defined shortages based on actual patient needs rather than national demand from operators. The information contained in the national data repositories set up in the context of the Falsified Medicines Directive could be used to monitor net stocks levels at aggregate level. EFPIA stands ready to contribute to this work.

Accelerated and free of charge scientific advice, through establishment of the Emergency Task Force, on questions related to the development of treatments and vaccines and advice on clinical trial protocols for public health emergency will facilitate the development and the faster regulatory assessment of these critical products. Providing an option for joint opinions on emergency use of products, i.e. conducting the Article 5.2 assessment centrally similar to the US emergency approval, is a welcomed improvement to the EU regulatory framework. EFPIA is willing to work with the EMA and Member States to ensure the Agency’s expanded mandate in emergency situations adds value over and above the current nationally-led approach for the management, oversight and reporting of clinical trials.

Integrating EMA into the future European Health Data Space, enabling the Agency to

access or query real world data (RWD) for evidence to better support decision-making throughout the product lifecycle, will address some of the longer-term aspirations to improve the better use of RWD. Advancing acceptance of new sources of data for high-quality evidence generation that

supports regulatory and HTA review, and holistic review of value of medicines has been a standing priority for EFPIA. Moreover, after the authorisation of vaccines, it is necessary to have safety and effectiveness data to complement the set of data generated by industry in support of the authorisation. The proposals provide for an IT platform to allow EMA and ECDC to coordinate vaccines safety and effectiveness studies. EFPIA is looking forward to a dialogue with the agencies on practical aspects of how the successful running of such studies could be achieved.

Regarding the overall coordination of Union and Member State response to serious cross-border threats to health, it would be important to ensure a system where the free movement of medicinal products and essential workers is protected, and where unilateral decisions by Member States do not threaten the supply of essential medicinal products to the patients that need them most.

Furthermore, EFPIA would like to point out that when it comes to the European Medicines Agency, the current strengthening of its mandate should only be a first step in future-proofing the capacity and mandate of the agency. Going beyond the specific issues of pandemic preparedness and the challenges revealed by the COVID-19 pandemic, and to deliver on the objectives in the coming EU pharmaceutical strategy, the EMA needs further strengthening to ensure that Europe has a regulatory framework that is stable but adaptable, fast, effective and globally competitive. EFPIA supports an agile governance of EMA and the EU Medicines Regulatory network pooling best experts independent from their country of origin and streamlining delaying interfaces with other stakeholders. This principle should also be applied for a strengthened and expanded role of EMA, through an establishment of an executive steering group, in scientific dialogue, coordination and assessment of drug-delivery devices, companion diagnostics and digital tools used in combination. This will be key for adopting an integrated EU pathway for the assessment of these products and delivering the innovative technologies to the patients. New EMA Expert Panels on high risk medical devices should support this objective. EFPIA is ready to work with the Commission, the legislators and all stakeholders to ensure that the proposals published today will be taken forward in a successful manner, and also to actively contribute to the important discussions leading up to the proposal for an EU Health Emergency Response Authority later in 2021. EFPIA is also looking forward to taking part in broader discussion on the role of the ECDC and EMA in the context of the EU pharmaceutical strategy as well as the overall EU mandate in the area of health in the context of the coming Conference on the Future of Europe.