EU-level collaboration on joint clinical assessment of medicines in a post-COVID-19 world
COVID-19 has had a significant impact on the functioning of the regular EU institutional decision-making process. In March, the EU institutions moved to an ‘all hands-on deck’ approach to try to mitigate the impact of COVID-19 on healthcare systems across EU member states. There have been some notable successes, especially when it comes to measures to ensure the continuous supply of medicines, across borders, to patients when and where they need them, or continuation of clinical trials or cross-sector collaboration in research for treatments or vaccines, under IMI.
However, understandably, a number of other files on the EU health agenda have been deprioritized in the short-term, like, for example the Council level discussions on the proposal for an EU Regulation on HTA.
As we get to grips with what the ‘new normal’ looks like, we are also trying to identify the lessons learned from the COVID-19 pandemic. At EFPIA, one of the key insights from the crisis has been the value of collaboration. No single stakeholder in the healthcare system has the capacity to deal with the new demands and implications for our healthcare systems. Collaborating and pooling resources together will become all the more important as we expect the next months (and maybe years) to be difficult to navigate, with expected lower economic activity and increased budgetary pressure on healthcare systems across the EU.
In this context, there are numerous benefits to be derived from EU level collaboration on joint clinical assessments between Member States, as such collaboration can improve patient access to innovative medicine, through harmonization of clinical data requirements and removal of duplicative assessments at country level. Moreover, such collaboration would also improve efficiencies and reduce pressure on national HTA agencies to carry out the same clinical assessment on increasing number of health technologies and interventions.
Over the last 18 months, the EFPIA Health Technology Assessment Working Group (HTA WG) has worked on a number of key themes issues to support the development of an EU level system of joint clinical assessment that is fit for purpose and will achieve the objectives set out in the European Commission proposal. We have recently published a full article summarising the experience of EFPIA members with EUnetHTA assessments (link). One critical recommendation for the future system relates to the need for a discussion to take place between companies and HTA agencies on the data needs for assessments. This has to start as early as possible during the development phase through joint scientific consultations. Currently, such consultations are too few and far between and only a sustainable legal framework can establish suffient capacity for them (without proper capacity for joint scientific advice future joint assessments are at risk). The discussion needs to continue in the critical scoping phase, which allows prospective MAH and assessment authors to discuss the research questions that need to be answered, and how to best do so given the data at hand. The right legal framework also needs to be in place to ensure legal certainty, including the right to appeal to the relevant entity in case of disagreement. This is one of the fundamental principles of any legal system complying with the rule of law, and should not be any different in a context of joint clinical assessments. The European Commission plays here a critical in this respect.
In addition to having the right process and checks and balance in place, EU joint clinical assessments should adopt the methodological standards that are demanded from increasingly complex technologies and disease pathways as well new innovation in areas of high unmet need. Research involving HTA methods experts, which we intend to disseminate later this year, highlights the methodological challenges that warrant resolution for a future HTA system to work. The need to align on comparators, agree on appropriate analytical techniques for indirect treatment comparison, establish consensus on the suitability and rationale for the use of various clinical endpoints are just some of the topics that need to be at the heart of discussions of any new system.
The European Commission has recently published its Roadmap to the EU Pharmaceutical Strategy – ‘Timely patient access to affordable medicines’. Strengthening EU cooperation on health technology assessment (HTA) as envisaged in the Commission proposal is one of the instruments foreseen in the Strategy. EFPIA looks forward to engage in this important debate to ensure that the EU puts in place a state-of-the-art system for joint clinical assessment.
 EUnetHTA Joint Action 3 aims to define and implement a sustainable model for the scientific and technical cooperation on Health Technology Assessment (HTA) in Europe and provides the opportunity for stakeholders to gather relevant experience.