EFPIA statement on European Parliament Plenary on HTA regulation

At today’s Plenary session, the European Parliament adopted the Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA). 

Speaking about today’s vote, EFPIA Director General, Nathalie Moll said “All Member States conduct clinical assessments as part of national HTA processes. It makes sense to join forces to provide one, high quality clinical assessment for use across Europe. This will support better decision-making and ultimately benefit all patients across the EU.”

Today’s report included welcome refinements ensuring quality in process and methodology of joint clinical assessments. EFPIA appreciates the clear references to the tried and tested methodological framework of the EUnetHTA Joint Actions, which all Member States’ HTA agencies have contributed to develop. As they do today, EFPIA member companies stand ready to provide the right evidence for HTA, generated through cutting edge clinical research. “Feasibility is key”, underlined Nathalie Moll. “It is not about providing every single data point on a particular product, it is about the right evidence to answer the research question at hand”. Joint scientific consultations remain a key element in the framework. They will help ensure that companies meet assessors’ expectations regarding study designs, in light of specific product and disease situations. However, failure to adopt the proposal for scoping meetings as part of Article 6 represents a lost opportunity for the health technology developer to meet with assessors to jointly define the scope of the assessment and the evidence to be submitted.

Like many partners in healthcare, not least the patient community, EFPIA strongly supports the original Commission requirement for Member States to use joint clinical assessments and not duplicate them in their national HTA processes. As Nathalie Moll underlined “Member States represented in the Coordination Group will be responsible for conducting joint clinical assessments as well as ensuring reports are of high quality and fit for national use. It should follow that they have confidence in their own work and that of their peers.” As clarified by the European Parliament, joint clinical assessments remain distinct from national appraisals and pricing and reimbursement decisions, so that Member States should have no subsidiarity concerns moving forward.

Nathalie Moll underlines that “It is only by guaranteeing the use of joint clinical assessments and avoiding unnecessary duplication that patients can really benefit from the increased consistency, speed, transparency and quality of clinical assessments.” We note that MEPs have opened the door for Member States to conduct their own “complementary assessment”. We believe that this introduces uncertainty, complexity and an unnecessary additional barrier to patients getting access to new treatments. The introduction of a potential additional hurdle will inevitably lead to delays and is a waste of resources. We urge policy-makers to ensure that there will be no duplication between joint clinical assessments and national assessments in the future. A duplicative system would mean the introduction of a fourth layer to patient access, which would be of great concern to EFPIA member companies.

Nathalie Moll went on to say. “We acknowledge the challenging timelines that the European Institutions are working against in order to find an agreement on this Proposed Regulation, however, patients are the ultimate beneficiaries of the increased consistency, transparency, speed and quality afforded by joint clinical assessments. Our hope is that the Council will zero-in on the patient benefit of greater co-operation in joint clinical assessment and scientific consultations, we hope they will be ambitious in the time-frames for adoption of the regulation”.