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.
