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Regulatory Focus™ > News Articles > European Commission Establishes Framework for EU-Wide HTA Network

European Commission Establishes Framework for EU-Wide HTA Network

Posted 27 June 2013 | By Alexander Gaffney, RAC

The European Commission (EC) has implemented a new set of rules for the establishment and management of an EU-wide health technology assessment (HTA) network meant to evaluate the cost-effectiveness of healthcare products.

The rules come out of Article 15 of Directive 2011/24/EU ("Directive on Patients' Rights in Cross Border Healthcare"), which directed the EU to "support and facilitate cooperation and the exchange of information among Member States working within a voluntary network connecting national authorities responsible for HTA" as designated by their respective Member States.

The network, known as the "HTA Network," is voluntary for Member States to either join or leave, but is intended to avoid the duplication of assessments and the resources it takes to generate them. The assessments themselves are meant to capture the total value of a product within the context of a patient and their place in society, and come up with a reimbursement value that would be reasonable for a government.

"The HTA Network of National authorities will help facilitate efficient use of HTA resources in Europe, create a sustainable system of HTA knowledge sharing, and will promote good practice in HTA methods and processes," EC explained in an accompanying statement posted on its website. "To date, the cooperation is conducted by the EUnetHTA consortium, reaching key success on methodological development and testing of pharmaceutical products and medical devices."

The EC's 26 June 2013 announcement on the HTA network includes criteria regarding membership in the network and how to join, procedural rules, rules of operation, meeting procedures and expense reimbursement.

EC - 2013/329/EU - Commission Implementing Decision

EC Statement

Tags: HTA, CER, EU

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