Verbatim report of proceedings

Monday, 1 October 2018 - Strasbourg

Health technology assessment (debate)

  Christos Stylianides, Member of the Commission. – Madam President, I am very pleased to have the opportunity to discuss with you the Commission proposal for a regulation on health technology assessment (HTA), which we adopted last January. The European Parliament has shown very active and constructive engagement on this issue, leading to the adoption of the report by the Committee on the Environment, Public Health and Food Safety (ENVI) on 13 September by an overwhelming majority.

First of all, I would like to congratulate Ms Cabezón Ruiz on her timely work as rapporteur, as well as the shadow rapporteurs in the ENVI Committee, and the Members of the Committee on Industry, Research and Energy (ITRE) and the Committee on the Internal Market and Consumer Protection (IMCO).

The Commission appreciates Parliament’s overall support for its proposal, including a clear and ambitious product scope on medicinal products and medical devices. While time does not allow me to comment in detail on all the various amendments, I would at least like to mention briefly a few areas of modification.

First, on the issue of the national use of European joint clinical assessments, the Commission welcomes Parliament’s strong support in ensuring that joint clinical assessments will be used by Member States – and will not be repeated. The approach suggested by Parliament, of adding some clarification as to the meaning of non-duplication, should address the concerns expressed by some Member States in the Council. This specifies that the legislation should not prevent Member States from conducting complementary clinical assessments outside the scope of the joint clinical assessments.

Other amendments were aimed at further clarifying the proposal, as they stress that Member States continue to be responsible for drawing their own conclusions on the added therapeutic value of health technologies in the context of their health system.

The second general area I would like to comment on concerns the respective roles of the Commission and the Member States in the cooperation process. In this area, the amendments follow the spirit of the text as they aim to clarify the Member States’ responsibility for conducting the joint work, and the supporting role of the Commission.

The third important area relates to the quality and transparency of joint work produced through EU cooperation. The proposed amendment should ensure the submission of appropriate evidence by technology developers as well as providing for high scientific quality, independence and transparency in the joint work. These were important objectives of the Commission proposal.

Lastly, let me stress that the Commission has serious concerns when it comes to the removal of harmonisation of national rules related to clinical assessments. This was one of the essential elements of our proposal, notably to ensure a high level of human health protection. In proposing such a harmonisation of national HTA methodologies, we had actually responded to previous calls for action from the European Parliament, including to your resolution on access to medicines, which called for the harmonising of HTA tools and methodologies.

I would like to conclude by stressing that the Commission welcomes Parliament’s constructive proposals and stands ready to continue to discuss and explore solutions to outstanding issues with the co—legislators. Patients are at the heart of this proposal, which aims to deliver more efficient, transparent and effective EU HTA, and this new model of EU cooperation has clear potential to facilitate better access to innovative health technologies. I therefore call on you to help make this initiative a success for the benefit of patients across Europe.

I now look forward to hearing your views.