Regulation on Health Technology Assessment (HTAR) 

HTAR was proposed by the European Commission in 2018, formally adopted in December 2021, and will apply from January 2025.

Scope of the HTAR

The legislation covers the clinical aspects of Health Technology Assessment (HTA). This means the relative clinical effectiveness of a new health technology, when compared with medicines or therapies already approved for the European market.

Under the HTAR, safety and effectiveness will be assessed via Joint Clinical Assessments (JCAs), conducted by the Member States’ HTA bodies.

In addition, the HTAR also provides for:

  • Joint Scientific Consultations, to advise technology developers on clinical study designs that generate appropriate evidence
  • Horizon-scanning exercises, to identify promising health technologies at an early stage and help health systems prepare for them

Out of scope of the HTAR

The following responsibilities remain the exclusive domain of the individual Member States:

  • Economic evaluation, i.e. cost-benefit assessment
  • Pricing and reimbursement decisions
  • Ethical and legal considerations

HTAR benefits

  • Pooling member state expertise and HTA resources.
  • Joint Clinical Assessment reports that are of high scientific quality, transparent and accessible.
  • Clarity and predictability for developers concerning clinical evidence requirements.
  • Efficiency, as there will be a single EU-level submission for JCAs.

As a result, the HTAR will be crucial for improving timely and equitable access to innovative therapies across the EU.

Stepwise application

  • January 12, 2025: new oncology medicines and advanced therapy medicinal products.
  • January 13, 2028: orphan medicinal products.
  • January 13, 2030: all new medicines will come under the scope of the Regulation.

EHA involvement

From the initial legislative process, to being selected as a member of the formal HTA Stakeholder Network, EHA has been instrumental in shaping implementation of the HTAR.

In 2025, we were selected for the HTA SN Working Group on identification of patients and clinical experts.

Our advocacy

Involvement of clinical experts

We’ve emphasized that the involvement of clinical experts should be:

  • Timely
  • Structural
  • Meaningful

Structural and effective involvement of medical societies

We’ve highlighted the importance of the structural and effective involvement of medical societies, especially on the following issues:

  • Expert identification and selection
  • The educating and training of clinicians on HTA
  • Advice on methodologies and guidance documents
  • Establishing standards of care (clinical practice guidelines)
  • Aligning with patient representatives and supporting their involvement

Overcoming practical challenges

We’ve signaled challenges that may affect the involvement of clinical experts and medical societies. By extension, these issues could affect the quality and impact of EU HTA. Examples of these challenges include:

  • Timelines
  • Conflict of Interest policies
  • The facilitation and recognition of the value of clinicians’ contribution to HTA by employers (such as hospitals or universities)

Harmonization

We’ve emphasized that a successful HTAR requires real harmonization in terms of:

  • The formulation of PICO criteria (by national HTA bodies)
  • The alignment of evidence generation (EMA-HTA-payers)
  • Expert selection (not only at the national but at the European level)
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