Brussels, 10 January 2025
On Sunday, 12 January, the Regulation on Health Technology Assessment (HTA) will become applicable, bringing a significant improvement in ensuring that innovative and effective health technologies are available to patients across the EU.
The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU Member States. This will help national authorities to make more timely and informed decisions on the pricing and reimbursement of health technologies and streamline the procedure for health technology developers. This will contribute to faster and wider access to new and more effective innovative products for patients.
The rules will apply to companies seeking marketing authorisation for their products by introducing a new and permanent EU framework for Health Technology Assessment, including through:
- introducing a single EU-level submission file for joint clinical assessments in order to ensure pooling of resources at the EU level and strengthening the scientific quality of HTA across the EU whileavoiding duplication of assessments at national level.
- establishing faster procedures requiring Joint Clinical Assessments to be completed within 30 days after the authorisation of the medicine;
- the systematic consultation of patients and clinicians during the preparation of the assessments as well as the involvement and consultation of the HTA stakeholders.
As a first step, starting on 12 January, these new rules will apply to marketing authorisation applications for a new cancer medicine or an advanced therapy medicinal product (ATMP). The rules will be extended to orphan medicines in January 2028 and will as of 2030 cover all new medicinal products. Selected high-risk medical devices will also be assessed as of 2026.
The new EU framework replaces the long standing EU-funded project-based cooperation between Member States on health technology assessment, while fully respecting Member States’ responsibility for the management of their health services as their national context requires.
Background
Health technology assessment is a scientific, evidence-based process that aims to inform the creation of safe and effective health policies by summarising information about the medical, social, economic and ethical issues related to the use of a health technology.
The European Commission adopted its proposal for a Regulation on Health Technology Assessment on 31 January 2018. Adopted in December 2021, the Regulation, a key deliverable of the EU Pharmaceutical Strategy, entered into force in January 2022. It applies from 12 January 2025. During this three-year transitional period, the Commission and the Member States prepared by seting up the necessary governance structure and drafted preparatory documents to support an effective application.
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Quote(s)
Supporting Member States and providing better access to evidence-based healthcare and innovative technologies is key for patients. With these new rules, we are strengthening EU-wide cooperation in health and reinforce the competitiveness of the EU’s health ecosystem. This will save Member States and health technology developers precious time, effort and resources and will help patients across the EU to have timely access to the most effective and efficient therapies and medicines.
I welcome the start of application of the new EU rules on Health Technology Assessment. European patients need quicker access to innovative and lifesaving medicines and medical devices and we are one step closer to making this a reality. We must now ensure that these rules are fully put into practice across the EU – to make better use of available resources, to ensure faster entry into the market for pharmaceuticals with lower costs, less red tape and faster administrative procedures to get them included into the reimbursement schemes. This is central for a strong European Health Union that delivers for citizens and strengthens the EU’s competitiveness.
Source – EU Commission
Questions and Answers on the new Health Technology Assessment
What is Health Technology Assessment (HTA)?
Health Technology Assessment (HTA) is a scientific evidence-based process that summarises information about medical, economic, social, and ethical issues related to the use of a health technology. Examples of health technologies include medicines and medical devices.
HTA evaluates the added value of new health technologies to assess whether it works better, equally well, or worse than existing alternatives and answers clinical questions like: “How well does the new technology work compared with existing alternatives”? It can also answer economic questions like: “What costs are entailed for the health system”? HTA is therefore a key tool for Member States when deciding on the use, price, and reimbursement of a new health technology, supporting them in ensuring quality, accessibility and sustainability of healthcare.
The development of health technologies is a key driver of economic growth and innovation in the EU. It is an innovative sector of the economy that forms part of an overall market for healthcare expenditure accounting for 10% of EU gross domestic product.
Who will benefit from the new Regulation?
Patients and clinicians will benefit from Joint Clinical Assessment reports that are of high scientific quality, transparent and accessible to the public. Health experts and most importantly of 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, whilst improving the competitiveness of the EU’s medical industry. Patients and clinicians will also be directly involved in the joint work.
Member States will be able to pool their HTA resources and expertise. Joint Clinical Assessments will be high quality, timely scientific reports that Member States will give due consideration to in their national HTA processes. The HTA Regulation will therefore support Member States in taking more evidence-based and timely decisions on patient access to new medicines and medical devices.
Developers in the pharmaceutical and medical device sectors will have more clarity and predictability concerning the clinical evidence requirements for HTA. Developers will also benefit from efficiency gains when submitting clinical evidence for HTA, as there will be only a single EU-level submission file for Joint Clinical Assessments (rather than, as in the past, multiple parallel submissions to the different national HTA systems).
Which parts of HTA will the new Regulation cover?
The Regulation focuses on the clinical aspects of HTA, i.e. the relative clinical effectiveness and relative clinical safety of a new health technology as compared with existing technologies. Under the regulation, the HTA coordination group and its sub-groups, composed of national HTA bodies jointly conduct Joint Clinical Assessments of new medicines and certain high-risk medical devices, starting with new cancer medicine and advanced therapy medicinal product (ATMP). These assessments are to be completed within 30 days after the medicine is authorised, saving time for patients, health systems and developers. Currently, due to different approaches to HTA in different EU countries, health technology assessment may happen years after a medicine is authorised.
As set out in the HTA Regulation, these HTA bodies may also engage in Joint Scientific Consultations to advise technology developers on clinical study designs that generate appropriate evidence. Moreover, the Member States will work together on “horizon scanning” exercises to identify, at an early stage, promising health technologies, to help health systems prepare for them. In addition to this mandatory scope of the HTA Regulation, Member States may also engage in further voluntary cooperation, e.g. on health technologies other than medicines and medical devices, or on economic aspects of HTA.
What products are covered by the Joint Clinical Assessments?
The new rules are introducing a staged approach towards all medicinal products seeking centralised marketing authorisations.
As a first step, starting on 12 January, a marketing authorisation application for a new cancer medicine or an advanced therapy medicinal product, which is validated by the European Medicines Agency, will trigger a joint clinical assessment under the authority of the Member State Coordination Group on Health Technology Assessment. Selected high-risk medical devices will also be assessed as of 2026. The rules will be extended to orphan medicinal products in January 2028 and will as of 2030 cover all new medicinal products.
How will Member States use Joint Clinical Assessment reports?
Member States must give due consideration to the Joint Clinical Assessment report when carrying out a national HTA. They will also annex the published Joint Clinical Assessment report to the HTA report at Member State level. In addition, for each national HTA on a technology which has been subject to Joint Clinical Assessment, Member States will provide information on how the Joint Clinical Assessment has been considered in the national process.
Member States may complement the Joint Clinical Assessment with additional clinical analyses that may be needed in their national HTA process (e.g. analyses related to national disease epidemiology or the specific national healthcare context). Member States may also complement the Joint Clinical Assessment with non-clinical analyses (e.g. on budget impact or cost-effectiveness). Member States remain responsible for drawing conclusions on the overall value of a new health technology for their healthcare system, and pricing and reimbursement decisions.
Finally, Member States will report to the Commission, no later than two years after the date of application of the new HTA Regulation, on the consideration of joint work in their national HTA processes, including the way joint clinical assessment reports have been considered when carrying out national HTAs. Member States will also report on the workload of the Coordination Group and on whether they have considered the developed methodological guidance.
How does the new framework of EU HTA cooperation work in practice?
The Regulation established a Member State Coordination Group of members designated by each country. The Coordination Group oversees the joint technical work carried out by subgroups of national representatives for specific types of work (e.g. Joint Clinical Assessments, Joint Scientific Consultations, or methodological guidance documents).
A Stakeholder Network was set up in 2023 to facilitate a regular dialogue between European umbrella stakeholder organisations and the Coordination Group.
The Commission serves as secretariat to the cooperation, ensuring that procedures are followed, and joint work is produced in a timely and transparent manner. The Commission has put in place a secure IT platform which will be used for submission of information by health technology developers and for Member States’ assessors to draft the joint clinical assessment reports and joint scientific consultation documents. The Commission facilitates exchange of information with other relevant EU agencies and bodies (e.g. the European Medicines Agency).
The HTA Regulation entered into force in January 2022. Why is it being applied only from 12 January 2025?
The three-year period between the entry into force and start of application ensured that there was enough time to set up the organisational framework of the HTA Regulation (e.g. the Coordination Group and its subgroups, the Stakeholder Network) and to adopt the implementing and delegated acts and methodological guidance documents provided for by the Regulation. It also gave Member States time to adjust their national HTA legislation and processes to the new HTA Regulation as needed, and stakeholder organisations, in particular health technology developers, had the time to familiarise and comply with the requirements of the new framework.
Source – EU Commission