EFPIA position on proposal for a Regulation of the European Parliament and the Council on HTA and amending Directive 2011/24/EU

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the Commission proposal for a Regulation on health technology assessment (HTA). The proposal builds on many years of voluntary cooperation in HTA between Member States at EU level. It presents a unique opportunity for greater alignment in Europe on clinical evidence generation requirements, ensuring consistency, transparency and synergies in clinical assessments by Member States and evidence that is relevant for Europe. For patients, the availability of one common joint clinical assessment at the time of marketing authorization will expedite patient access to new medicines. For national healthcare systems, it would mean avoiding duplicative efforts on clinical assessments, leading to a better use of human and financial resources, while also helping Member States benefit from each other’s expertise. For companies, the proposal would move towards more predictable evidence generation requirements at the development stage. This paper outlines EFPIA’s views on the four pillars of EU HTA cooperation included in the Commission proposal. EFPIA, its national associations and member companies look forward to continuing the dialogue with all stakeholders including patients, healthcare professionals and policy-makers to ensure that a final text facilitates our common objective to improve the availability of innovative health solutions to patients across Europe.