- Better coordination at EU level and continuous dialogue with stakeholders
- More transparency and public awareness
- Supporting innovation and quality of clinical evidence
Early Tuesday morning, Parliament and Council negotiators reached a provisional agreement on the increased cooperation of member states on health technology assessment (HTA) at EU level.
Enhanced coordination, transparency and impartiality
The regulation establishes a new “Member State Coordination Group” - each EU country will designate its representatives in the Coordination Group as well as in various subgroups. The agreed text underlines that all representatives and experts must not have any interests in the health technology developers’ industry which could affect their independence or impartiality. Parliament negotiators ensured that a clear voting mechanism for the Coordination Group is in place regarding political strategic issues and scientific technical issues.
Wider stakeholder dialogue
In order to ensure the inclusiveness and transparency, the Coordination Group is expected to engage and consult widely with relevant stakeholders, including organisations representing patients, healthcare professionals, clinical experts, HTA developers, consumers. Negotiators agreed that a stakeholder network should be set up in order to facilitate this dialogue.
Greater transparency in joint work
Parliament successfully secured greater transparency of reports and work in relation to joint clinical assessments, joint scientific consultations and other joint work, as well as clear criteria on diverging scientific opinions to ensure that the legitimacy of reports is not questioned. Several other key aspects include the introduction of clear safeguards on the uptake of joint clinical assessments to ensure that they are annexed to national assessments and that member states must report on their use in national HTAs; setting clear criteria on the selection of joint scientific consultation to ensure a level playing field for all relevant actors; as well as a shorter timeline for the full implementation of the scope of health technologies.
Rapporteur Tiemo Wölken (S&D, DE) said: “We have today come to an informal agreement on a legislative proposal, which will strengthen EU cooperation on health technology assessment. Especially now, faced with a health crisis, it is increasingly important that we, as a Union, pool our expertise and resources to ensure good quality joint assessments whilst contributing to timely access of innovative health technologies. The regulation will dramatically reduce duplications of clinical assessments, ensure sustainable cooperation on HTA and provide us with a framework to better face health issues, such as rare diseases, personal medicine and orphan medicines. Parliament fought for stronger provisions with regards to the uptake of joint clinical assessments. We secured safeguards to ensure that joint assessments cannot be ignored.”
Parliament and Council are now expected to endorse the content of the agreement.
Health technology assessment (HTA) is a research-based tool to support decision-making in healthcare. HTA assesses the added value of new or existing health technologies – medicines, medical devices and diagnostic tools, surgical procedures, as well as measures for disease prevention, diagnosis or treatment – compared with other health technologies. The HTA process is performed by currently about 50 European HTA agencies. The regulation proposed by the Commission in January 2018 aims to strengthen EU-level cooperation among Member States for assessing health technologies. In March 2021, the Council agreed, after three years of discussions, on a mandate for negotiations with Parliament.