EU HTA – Health Technology Assessment across Europe

How to bridge the gap between EUnetHTA's cessation and an EU Regulation's application?

Considering the fact that EUnetHTA Joint Actions (JAs) cease definitely in May 2021, stakeholders and people interested in creating a sustainable system for a European cooperation on health technology assessment (HTA) wonder what might happen beyond.

The envisaged EU Regulation on HTA is still in the stage of first reading during the ordinary legislative procedure of the European Union (EU).
In January 2018 the European Commission published its proposal for an EU Regulation, and the European Parliament decided on its first reading position in the resolution of February 2019. After seven Presidencies of the Council of the EU (Bulgaria 2018 through Portugal 2021) and intensive discussions within its preparatory bodies (in particular the Working Group on Pharmaceuticals and Medical Devices) Member States could agree on a so‑called draft text for an EU Regulation on HTA that constitutes the Council's mandate to start negotiations with the European Parliament (at the level of the Permanent Representatives Committee of the Member States, Coreper I). In trilogues the Parliament, the Council and the Commission will try to achieve an agreement. Three trilogues are currently planned until June 2021 (Portuguese Presidency). As hopefully expected by interested parties, the Regulation might come into force during 2022. In this case, its application could be scheduled for 2025.

However, there are serious concerns that the encouraging results and outputs of the joint work undertaken in the EUnetHTA activities through one and a half decade (2006‑2021) might get lost, and the high level that Member States' cooperation on HTA has reached will be in vain.

Therefore, AMS and other interested parties are recently looking forward to a call for tenders that has been offered in the framework of the EU's Health Programme. The European Health and Digital Executive Agency (HaDEA)* takes over coordination and administration for this call for tenders as follows:

 

 Third EU Health Programme: Tender ‘EU cooperation on HTA’

“Service Contract for the Provision of Joint Health Technology Assessment (HTA) Work Supporting the Continuation of EU Cooperation on HTA” 

(CHAFEA/LUX/2020/OP/0013) – Further information on the EU Health Programme open call for tenders on HTA | News article 14 April 2021

 

*    As from 1 April 2021 mandate and activities of the Consumers, Health, Agriculture and Food Executive Agency (Chafea) are reassigned and thus,

the EU Health Programme is delegated to the newly created European Health and Digital Executive Agency ‘HaDEA’.

The subject of this call for tenders is

• to address key methodological issues which have been identified as instrumental to foster the value of EU cooperation on HTA and
• to support joint HTA work beyond May 2021 – when the EU co‑funded EUnetHTA JA3 ends –, thus providing relevant input to a potential new legal framework on HTA.

The service is expected to cover the following key areas:

1. Further development of HTA methodology to be applied when carrying out joint work – i.e.
   Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC) – in particular in areas where divergent opinions still persist in order to advance methodology for joint work and facilitate reaching consensus when carrying out JCA and JSC.
2. Support joint HTA work – in regard to medicinal products: 1–2 JCA and 6–8 JSC
   – the latter is to be carried out in parallel with the scientific advice provided by the European Medicines Agency (EMA).

The project will presumably start in mid‑June/early July 2021 (as soon as all parties have signed the contract) and shall be carried out in no more than 24 months.

During the recent years AMS has gained experience by supporting pharmaceutical companies in performing
Early Dialogues and rapid Relative Effectiveness Assessments (rapid REAs) within the EUnetHTA Jas (more information about our services).

AMS will observe the advancement of this call for tenders that offers the chance to further participate in shaping European joint work on HTA.
Based on its insightful experience AMS wants to continue cooperation with partners from the pharmaceutical industry – companies as well as their associations – along the European way to create and establish an EU HTA system. Having a common perspective to further develop HTA work at EU level we will be able to successfully bridge the gap between EUnetHTA JAs and the upcoming EU Regulation on HTA.

Status: May 2021