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04 December 2023
CARE, - Medicines

EFA participates in two European Commission consultations on the upcoming EU HTA Regulation implementation

Since its set up in June 2023, the European Commission Health Technology Assessment (HTA) Stakeholder network has been called to inform and support the European Commission on some of its preparatory work to start implementing the new 2021 EU HTA regulation from January 2025. EFA is member of the HTA Network represented by Isabel Proaño, Director of Policy and Communications, who brings the allergy and airways disease patients’ perspective to the discussions.

Both meetings were organised by the European Commission Directorate General for Health and Food Safety (DG SANTE).

Consultation on Joint Clinical Assessments (JCA) for Medicinal Products

In October, EFA participated in an online consultation on the main concepts for the upcoming Commission Implementing Act on Joint Clinical Assessments (JCA) for Medicinal Products. The consultation was structured around three main topics:

  • The interaction with health technology developers during JCAs
  • The interaction with patients, clinical experts and other relevant experts during JCAs
  • The templates to be provided by health technology developers for JCAs

EFA, and many other patient groups and medical societies, convened clearly that while having interaction with individual patients and clinicals is important for JCA for medicinal products, the HTA Coordination Group should also request input from patient organisations and medical societies.

Together with the other represented organisations, EFA insisted that for EU wide HTA procedures it is important to get the European perspective, and not to rely only on the individuals’ perspective that brings  national and biased point of view.

EFA also highlighted that future Commission legal information on who should be the patient interacting in the process should allow “carers” to represent patients, especially when the medicinal product is intended for  paedriatic patients, elderly or people with disabilities.

Finally EFA requested decision and clarity on important requirements such as a nationality (EU/non-EU), presumed expertise (diagnosed patient/patient representative) and the conflict of interest declaration (DOI).

The European Commission will draft an Implementing Act taking all this feedback into account. The proposal will be open for broad consultation and feeback in 2024 before adoption.

Workshop for guidance on HTA for oncology products and advanced therapy medicinal products (ATMPs)

In October, many members of the HTA network included EFA participated in an online workshop on HTA for oncology products and advanced therapy medicinal products (ATMPs). The focus on oncology is due to how the legislation will be implemented in practice. The EU has prioritised that joint HTA will be first and only implemented from 2025 to oncology medicines and ATMPs; orphan products will follow from 2028; while other products would only go through EU HTA from 2030 onwards. Therefore, all the legislative framework that will be put forward to serve first oncology products, will then be applicable for allergy and airways diseases medicinal products and technologies. See the roll out infographic on the EU HTA that has been produced by the European Commission.

The workshop was structured in three discussion groups:

  • How to approach best available evidence in oncology and ATMPs?
  • How to handle the wide range of treatment standards in cancer in Europe?
  • What kind of contextual information should be included in JCAs for oncology and ATMPs?

EFA participated in the third discussion group which serve to find priorities onwhat should be the contextual information given to the assessors of a technology to evaluate the product (apart from the legal requirements that include documentation such as the data summaries from the clinical trials and comparator technologies).

From EFA’s perspective, European or national level disease specific patients organisations should be asked to contextualise the unmet medical needs and expectations patients and carers have for a certain technology. This is something that is already being asked by the European Medicines Agency right at the beginning the Committee for Human medicinal Products (EMA CHMP) is starting an application review. EFA also highlighted that it would be relevant to contextualise the product according to the patients’ usability (including digital technologies) as well as its environmental assessment and footprint of the technology.

Next steps

Both consultation and workshop will serve to inform the Commission draft for implemented and delegated acts that will define how the EU HTA process is made in practice. EFA will continue actively participated in the HTA Stakeholder Network to bridge allergy and airways disease patients issues to the legislators.

The HTA Stakeholder network is composed of representatives from patients, healthcare professionals, public health organisations, academia and industry.

To know more about the EU HTA Regulation please visit the European Commission website.