Healthcare, the EU marks a new era for access to innovation

3 years after its entry into force, the health technology assessment is finally applied from 12 January 2025 (Health Technology Assessment, HTA)an evidence-based process that synthesizes information on medical, economic, social and ethical issues related to the use of a health technology.
The development of health technologies is a key driver of economic growth and innovation in the EU.
This sector is part of a global market for healthcare spending that represents 10% of Europe’s gross domestic product.

HTA, a fundamental tool

There health technology assessment (Health Technology Assessment, HTA) evaluates the added value of new health technologies to see if they work better, as well or worse than existing alternatives.
Answers clinical questions such as: “How well does the new technology work compared to existing alternatives?“, but also to economic questions such as: “What are the costs for the healthcare system”?
The new rules create a framework for the assessment of health technologies, such as medicines and medical devices, promoting collaboration and coordination between EU Member States.
National authorities will be supported in make more timely and informed decisionsi on pricing and reimbursement of health technologies and the process for developers of such technologies will be streamlined, helping to make patients’ access to new and more effective innovative products faster and broader.
The rules will apply to companies wishing to obtain a marketing authorization for their products, introducing a new and permanent EU framework for health technology assessment, including through:

  • the introduction of a single presentation dossier at EU level for joint clinical assessments to ensure pooling of resources at EU level and increased scientific quality of HTA across the Union, avoiding duplication of assessments at national level
  • the establishment of faster procedures which require the completion of joint clinical assessments within 30 days of authorization of the medicinal product
  • there systematic consultation of patients and doctors during the preparation of assessments and the involvement and consultation of stakeholders in the health technology assessment sector.

The evaluation of health technologies governed by the new regulation

The regulation focuses on clinical aspects of the evaluation of health technologies, i.e. on the effectiveness and clinical safety of a new health technology compared to existing technologies.
Under the Regulation, the HTA Coordination Group and its subgroups, composed of national HTA bodies, jointly conduct clinical assessments both new medicines and certain high-risk medical devicesstarting with new anticancer medicines and advanced therapy medicines (ATMPs). Assessments must be completed within 30 days from drug authorization, saving time for patients, healthcare systems and developers.
HTA bodies can also proceed with joint scientific consultations to advise technology developers on clinical trial designs that generate adequate evidence.
Member States will work together on horizon scanning exercises to identify promising health technologies at an early stage, with a view to help health systems to prepare.

The beneficiaries of the new Regulation

The subjects who will benefit from the provisions of the Regulation are:

  • Patients and doctors. Health experts and, above all, patients will have a new framework that will help address unmet medical needs, facilitate access to innovative medicines and some high-risk medical devices, improving the competitiveness of the EU medical industry . Patients and doctors will also be directly involved in joint work.
  • The member states. Joint clinical assessments will be timely and high-quality scientific reports that Member States will take into account in their national health technology assessment processes. The HTA Regulation will support Member States in taking more timely, evidence-based decisions on patient access to new medicines and medical devices.
  • The developers in the pharmaceutical and medical device sectors. They will have greater clarity and predictability regarding the clinical evidence requirements for HTA and will benefit from efficiency gains in the submission of clinical evidence for HTA, as there will be a single submission dossier at EU level for joint clinical assessments.

The products covered by the joint clinical assessments

The new rules introduce a phased approach to all medicines requiring centralized marketing authorisations.
The application for authorization toplacing a new medicine on the market anticancer or advanced therapy medicinal product, validated by the European Medicines Agency, will trigger a joint clinical assessment under the authority of the Member State Coordination Group for Health Technology Assessment.
From 2026, selected high-risk medical devices will also be evaluated.
The rules will be extended to orphan medicines in January 2028 and will cover all new medicines from 2030.

How the new EU cooperation framework on health technology assessment works

The regulation established a Member State Coordination Group composed of members designated by each country. The coordination group oversees joint technical work carried out by subgroups of national representatives for specific types of work. A stakeholder network was established in 2023 to facilitate a regular dialogue between the European Coordination Organizations and the Coordination Group.
The Commission serves as secretariat for cooperationensuring that procedures are followed and that joint work is carried out in a timely and transparent manner, and facilitates the exchange of information with other relevant EU agencies and bodies, such as the European Medicines Agency.
Furthermore, one was created IT platform which will be used for the submission of information by health technology developers and to enable Member State evaluators to prepare joint clinical assessment reports and joint scientific consultation documents.

How Member States will use joint clinical assessment reports

Member States must take due account of the joint clinical assessment report when carrying out a national health technology assessment. It is possible to integrate the joint clinical assessment with further clinical analyzes that may be necessary in their national health technology assessment process, just as it is possible to integrate the joint clinical evaluation with non-clinical analyses.
The Member States remain responsible for drawing conclusions on the overall value of a new health technology to their health system and on pricing and reimbursement decisions.

The application of the HTA regulation

The three-year period between entry into force and the start of application, on 12 January 2025, ensured that the organizational framework of the HTA Regulation was established and the delegated and implementing acts and documents were adopted. of methodological guidance provided for by the regulation.
It also gave member states time to adapt national legislation and processes on health technology assessment to the new HTA Regulation, if necessary, and stakeholder organisations, in particular health technology developers, have been able to familiarize themselves with and comply with the requirements of the new framework.