EFPIA statement in response to the Council compromise agreement on the Commission Proposal for a Regulation on Health Technology Assessment

Today, more than 3 years after the European Council began debating the European Commission proposal for EU level collaboration on joint clinical assessments, COREPER I has mandated a start of negotiations with the European Parliament implying a common position of the Member States on the file and the willingness to start trilogue negotiations.
The length of the negotiations within the European Council indicates that, in spite of the willingness to support more collaboration at EU level on Health Technology Assessment, the Commission proposal has been received with an abundance of caution by Member States. EFPIA has supported the vision of the original Commission proposal of an efficient process for joint clinical assessments anchored in the principles of non-duplication of the assessment and the reliable commitment of Member States to actually use the assessments that were jointly established at EU-level as the basis of national decisions.
Unfortunately, we regret that the Member States’ compromise risks creating a more inefficient system. The compromise text now going into trilogues provides a maximum of flexibility for Member States in how they intend to use the joint assessment. EFPIA sees this as a lack of trust of Member States in each other’s ability to establish a functioning EU-level HTA framework and to jointly produce high quality clinical assessments. The resulting lack of predictability for all parties may not only lead to suboptimal and inefficient use of limited HTA capacity of Member States but also risks to further delay patient access. Now, more than ever, Europe needs to speak with one voice on clinical evidence in the best interests of patients and our healthcare systems. EFPIA hopes that this can still be achieved and looks to the European Parliament and European Commission to build a real European capacity.
A strong and predictable European system, built collaboratively by Member States, takes time to be established and to deliver against its objectives. The successful establishment of a consistent European regulatory system during the past 20 years may serve as a relevant example in this respect. The required level of trust was only established over time by means of progressive introduction combined with an ability to evaluate, adapt and adjust over time which has led to the EMA becoming a world leading agency.
Going into the trilogue negotiations, EFPIA considers that a similar approach is necessary with respect to the current discussions especially towards increasing predictability for health technology developers and other stakeholders. A number of evaluation steps of the system could be considered: for example, a first evaluation could take place once the rules and methodologies of the system are adopted and before the first oncology products are assessed by the system, or a formal evaluation could also occur before the extension of scope is made to cover orphan medicinal products. Moreover, the rules, timelines, methodologies etc. of the system need to be able to adapt and evolve, and take into account the perspectives of impacted stakeholders. Assessments are also set up for less optimal outcomes if there are no explicit opportunities for the health technology developers, as well as patients and clinicians, to be consulted during the assessment process.
While these steps are essential towards building the needed trust in the capacity and the quality of the future system, Member States should also commit themselves to using the jointly conducted clinical assessments. Without such a commitment, the system will not enable faster patient access but rather  create unnecessary administrative and regulatory barriers that will further delay patient access. At a time when science is radically changing treatment paradigms, a well-functioning European capacity for joint assessments is essential. Furthermore, strengthening the capacity of the future system to provide early scientific advice for all health technology developers is also an essential step enabling better predictability for all parties, including Member States, and significantly reducing the risk for misalignment or uncertainty during the joint clinical assessment phase.
EFPIA’s Director General, Nathalie Moll, said “We are at an important point in the legislative negotiations of the European HTA Regulation and we find ourselves still coming up short on one of the most important ingredients for a well-functioning system of joint clinical assessments: trust. As such, it is important to give ourselves the tools and time to achieve that trust. One tested method is to foresee enough opportunities to evaluate and adjust the work being carried out and learn together. It is also important to make sure that all stakeholders, including health technology developers are involved in the process. EFPIA continues to believe in the vision of EU level joint clinical assessments put forward by the European Commission in 2018. Ultimately, what we all want is a system that improves the availability of innovative technologies for patients.”