ESIP position on Health Technology Assessment

ESIP publishes a position paper welcoming the European Commission proposal to provide for a sustainable framework for cooperation on HTA. Nevertheless, ESIP has identified a number of common concerns of the healthcare payers regarding the current draft in relation to the independence, quality and use of joint HTA reports. 

Governance of joint assessments and independence of the scientific process 

In order to guarantee the independence of the scientific process, ESIP believes that the Coordination Group should have the final say on the approval and publication of joint assessment reports and that stakeholder involvement should only be foreseen once a draft report has been completed.

Harmonising clinical assessments: quality and methodology

As currently there is no commonly agreed methodological framework for joint clinical assessments, the proposal creates a high level of uncertainty. In order to counter this uncertainty, ESIP proposes to limit harmonisation to joint assessments at EU level.

Applying joint assessments at national level – clarifications on the question of non-duplication and uptake

ESIP believes that more flexibility should be introduced to allow adaptation to national requirements. 

Implementing and delegated acts – giving national decision-makers a strong voice

National decision-makers need to be actively involved when elaborating the implementing and delegated acts that will define the methodology and procedural rules.

Ensuring cooperation of developers in the framework of joint assessments

ESIP considers that to guarantee the success and quality of the joint assessment, the proposal should go further to ensure the cooperation of health technology developers by including a legal and enforceable obligation to cooperate and deliver the required information. 

Find out more about our comments and proposed amendments in our position paper.