The countdown to the entry into force of the Health Technology Assessment (HTA) Regulation in Europe comes to an end. The long-awaited rule will begin to be applied next Sunday, January 12, and will provide a significant improvement in access to pharmacological innovation, which will now be faster and broader. For its part, Spain is also finalizing its Royal Decree on Health Technology Assessment (ETS), which is included in the Pharmaceutical Industry Strategy for the next four years.
The new rules create an EU framework that encourages collaboration and ccoordination between EU Member States to evaluate these new medications. “This will help national authorities make more timely and informed decisions about the pricing and reimbursement of health technologies and to rationalize the procedure for health technology developers,” the European Commission points out.
The laws will apply to companies seeking marketing authorization for their products by introducing a new permanent EU framework for the study of these new medicines. One of the most important measures is the strengthening of the scientific quality of health technology assessment throughout the EU, while avoiding duplication of evaluations at national level.
will also be established faster procedures requiring joint clinical evaluations to be completed within 30 days from the authorization of the medicine; as well as the systematic consultation of patients and doctors during the preparation of the evaluations, and the participation and consultation of interested parties in the evaluation of these innovative drugs.
Calendar: cancer and advanced therapies first
As a first step, starting January 12, these new rules will apply to applications for marketing authorization of a new anticancer drug or an advanced therapy drug. The rules will be extended to orphan medicines in January 2028 and, from 2030, will cover all new medicines. Starting in 2026, certain high-risk medical devices will also be evaluated.
The new EU framework replaces the long-standing EU-funded project-based cooperation between Member States on health technology assessment. The EC clarifies that the text “fully respects the responsibility of Member States in the management of their health services as required by their national context.”
So things are, The European Medicines Agency (EMA) has shown its agreement with the legislation. “Although our role is supportive, the new regulation will allow our collaboration between decision-makers, reinforcing efforts to improve access to medicines for all EU patients,” said the agency’s executive director. European regulator, Emer Cooke.
The EMA will support the implementation of the new legislation in three areas. For example, it will support the timely conduct of joint clinical evaluations (CCTs) by the Coordination Group of these medicines that establish the relative clinical efficacy and relative clinical safety of a new health technology compared to new or existing technologies.
In this context, the EMA will provide relevant information from its own regulatory assessments; collaborate with the ETS Coordination Group in parallel joint scientific consultations to provide scientific advice to technology developers and facilitate the generation of evidence that meets the needs of both regulatory and ETS bodies; exchange information on upcoming applications and future health technologies, both for planning and foresight purposes.
Furthermore, the Regulation recognizes the value of cooperation between decision-makers, i.e. regulators, who assess the benefits and risks of medicines, and HTA bodies, who assess their effectiveness compared to the existing products. It is based on the long-standing cooperation between the EMA and drug evaluation bodies, developed with the European Network for Health Technology Assessment (EUnetHTA) until September 2023.
The EMA also has a legal obligation to provide information from ongoing regulatory assessments. The details to be exchanged will be developed together with the EMA committee for medicinal products for human use and the JCA subgroup. The ETS evaluation and the benefit-risk evaluation of a specific medicine continue to be carried out independently within their respective competences and following their respective legal frameworks.
“In our network strategy until 2028, paving the way for accessibility of new medicines for patients is a priority, and the framework for cooperation and information exchange between regulators and agencies provided by the new rules will help boost our efforts,” Cooke concluded.
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