Debate: Health technology assessment
Date: MONDAY, 13 DECEMBER 2021
Speaker: Stella Kyriakides
Language: EN

I would also like to thank once again the rapporteur, Tiemo Wölken, and the European Parliament for their very constructive approach and commitment to this file throughout the negotiations for the benefit of EU patients. This regulation represents the very first output of the pharmaceutical strategy for Europe and is integral in ensuring a stronger European health union. It builds on many years of hard work by experts across the EU and the experience gathered during the three EU net HTA joint actions, facilitating cooperation between Member States. It provides a comprehensive and sustainable legal framework to make a much—needed step forward and it will deliver concrete benefits to our citizens, our Member States and our healthcare systems.  The HTA Regulation will enable high—quality joint clinical assessments of innovative medicines and some medical devices at EU level. It will secure inclusiveness and transparency in the health technology assessment process, and it will increase predictability for Member States’ authorities and for industry. It will help Member States to take more timely and evidence-based decisions on patient access to innovative technologies within healthcare systems. Let me give you an example. The joint work will start by assessing cancer medicines and advanced therapies like gene therapies. These are the type of products which are scientifically complex to assess and, at the same time, so very challenging to ensure access to across the EU. Pooling resources and expertise will be key to support all Member States in their national decisions and negotiations. While the text of the regulation changed throughout the negotiations, the final compromise maintains the key elements of the Commission proposal, which the European Parliament shared and supported. The joint work will target the scientific clinical aspects of health technology assessment. The national health technology assessment bodies will drive the joint work, and the joint work will be of the highest quality, provided in a timely manner and produced following inclusive and transparent procedures.  I want to stress the point on inclusiveness and transparency, which I know was especially important to this Parliament. You were determined to ensure that the involvement of external experts and stakeholder organisations was well reflected in the final compromise. So I am truly very pleased with the outcome, as the general involvement of stakeholders in the HTA process is essential to ensure the quality of work. I want to close by highlighting two important points. First, this is about patients and improving access to innovative technology. And second, with this regulation we’re building a new type of cooperation in health among Member States. More than ever, the current pandemic has underlined the need for enhanced cooperation between Member States, and this regulation reflects and responds to that need. It is another important step towards a stronger European health union. With this regulation, we are giving health experts, producers, and most importantly of all, patients, a new framework that will help us to address unmet medical needs and facilitate access to innovative medicines and medical devices.  I want once again to thank the rapporteur, the shadow rapporteurs and every Member of the Parliament for supporting this, and I look forward to continuing working together to ensure the new rules are successfully implemented in a timely manner.