Publication of European Parliament’s Committee on Industry, Research and Energy’s draft opinion on HTA

The European Commission published a proposal for a Regulation on Health Technology Assessment (HTA) on 31 January. Since then, the European Parliament’s Committees, which are going to be involved in the legislative process, have been appointing their rapporteurs and shadow rapporteurs.

The Committee on Industry, Research and Energy (ITRE) has appointed Lieve Wierinck (ALDE, Belgium) as rapporteur for the opinion. She is in charge of preparing the Committee’s opinion on the Commission proposal, and has recently published a draft opinion. This opinion consists of amendments to the proposal accompanied by short justifications, and will be taken into account when drafting the Parliament’s position on the proposal.

Although she acknowledges the benefits of a reinforced cooperation on HTA in terms of market access and efficiency gains, Ms. Wierinck’s draft opinion includes a few amendments, the most significant one being to exclude medical devices from the scope of the joint collaboration on HTA on EU level:

  • Scope – The Rapporteur recommends excluding medical devices from the scope of a mandatory Joint HTA. Considering that the Medical Device Regulation (MDR) will not enter into force until 26 May 2020, she believes that it would be premature to refer to those medical devices subject to the scrutiny procedure when it is still unclear which devices would eventually be CE-marked under the scrutiny procedure. She further argued that the MDR and the IVDR reflects a decentralised approach and already provides for some efficacy assessment. The need for an HTA on Medical Devices needs to originate from the Member State’s authorities.
  • Methodology – Methodologies within this legislative proposal are not clearly defined and should be further developed in the future. The Rapporteur stresses that the European Commission should act in a supportive capacity in the execution and choice of methodologies.
  • Data – The Rapporteur emphasises the importance of confidential handling of data and supports the development of an IT platform. In this regard, her amendments focus on:
    • the sensitive nature of health information and the confidential handling of data;
    • the need for common rules on data;
    • the use of data from relevant sources, such as patient registries, databases or European Reference Networks.
  • Stakeholder involvement – The Rapporteur stresses the need for a structured involvement of patient organisations, industry and other stakeholders. She proposes to involve healthcare professionals in addition to patients, clinical experts and other relevant stakeholders who were already mentioned in the Commission proposal.
  • Joint Clinical Assessment Reports -  The opinion includes an amendment providing that “the assessor shall consult the developer on the [joint clinical assessment] report before its publication”.

The draft opinion will be discussed in ITRE Committee in the coming weeks. The deadline for tabling amendments has been set for 23 May. 

For more information, please find the draft opinion here.


Date: 03/05/2018 | Tag: | News: 780 of 886
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