Faster entry of innovations into EU markets and greater transparency for both patients and manufacturers are the main objectives of 25 joint European clinical trials of medicines planned for this year. They are to cover 17 oncology medicines and eight advanced therapy medicinal products.
The European Health Technology Assessment (HTA) Regulation, in which the European Medicines Agency (EMA) will play an important role, came into force on Sunday 12 January. The aim of the new regulation is to improve health protection in the European Union, to speed up the entry of innovations into EU markets, to increase transparency for patients and manufacturers, and to avoid duplication of work. The first application period for joint clinical trials will start in February, according to the EMA.
This groundbreaking framework aims to enhance the availability of innovative and effective health technologies, ensuring patients across the EU benefit from timely access to life-changing treatments. Discussing the HTA, Olivér Várhelyi, Commissioner for Health and Animal Welfare, noted: “I welcome the start of application of the new EU rules on Health Technology Assessment.
Streamlining closer to reality
“European patients need quicker access to innovative and lifesaving medicines and medical devices, and we are one step closer to making this a reality,“ the Commissioner said.
„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.”
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The new rules will initially apply to new active substances for the treatment of cancer and to all advanced therapy medicines. They will be extended to orphan medicines in January 2028 and to all centrally authorised medicines from 2030. From 2026, selected medical devices falling into the high-risk class will also be evaluated.
HTAs explained
So how is the process for new technologies at European level supposed to work at the moment? A drug first passes regulatory evaluation by the EMA and is approved for use in patients. At the same time, it will be examined by health technology assessment bodies to help member states make decisions on use, price and reimbursement levels. The HTA Regulation established a Health Technology Assessment Coordination Group (HTACG) for this purpose, composed of representatives of member states, in particular HTA authorities and bodies.
Health Technology Assessment is an evidence-based, scientific process that evaluates the medical, social, economic, and ethical dimensions of health technologies. Its purpose is to guide policymakers in crafting informed and safe healthcare strategies. The new regulation builds on a vision proposed by the European Commission in January 2018 and represents a significant achievement of the EU Pharmaceutical Strategy.
Following its adoption in December 2021, the regulation entered into force in January 2022 but allowed for a three-year transitional period to establish the necessary governance structures and prepare for seamless implementation.
The HTA establishes a unified framework for assessing health technologies, including medicines and medical devices, by promoting collaboration among EU member states. This approach will streamline processes for developers, ensure higher scientific quality, and reduce redundancy in national assessments.
Key new elements
Developers will submit a single EU-level dossier called unified submission file for joint clinical assessments, minimising duplication and pooling resources for greater efficiency.
Joint Clinical Assessments will now be completed within 30 days of a product’s authorisation, speeding up market entry for critical treatments.
Systematic consultations with patients, clinicians, and other stakeholders will ensure assessments reflect diverse perspectives of the various stakeholders.
From 2026, high-risk medical devices will be incorporated into the framework. This phased approach reflects the EU’s commitment to ensuring a smooth transition while addressing the varying complexities of health technologies.
