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New Framework Enhances Health Technology Innovation Transparency in Austria

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The European Commission has introduced new rules for health technology assessments (HTA) across the European Union. These regulations, outlined in the Implementing Regulation (EU) 2024/1381, aim to establish a uniform procedure for the preparation and update of joint clinical assessments of medicinal products for human use. Effective from January 12, 2025, this regulation will enhance cooperation between member states, improve transparency, and ensure timely access to innovative health technologies.

Health Technology Innovation: New EU Rules on Public Funding Disclosure

Article 57 of the new EU pharmaceutical legislation proposal mandates detailed disclosure of public funding for the development of medical innovations. However, it has limitations: it does not require disclosure of the funding period or indirect financing (e.g., tax breaks). To address this, the Austrian Institute for Health Technology Assessment (AIHTA) is developing a framework to capture and categorize public contributions to research and development (R&D). This framework aims to assist policymakers in price negotiations. Initial results indicate that public and philanthropic contributions to medical product development (drugs and devices) can be clearly identified, with indirect contributions playing a significant role.

Article 57 requires applicants and holders of marketing authorizations to disclose all direct financial support for R&D from public funds. This obligation extends beyond EU countries, covering any direct financing for R&D activities related to drug development. However, it does not include indirect financial flows such as regulatory or tax incentives. The AIHTA framework, developed under the EU project HI PRIX (Health Innovation Next Generation Payment and Pricing Models, Grant Agreement No. 101095593), aims to standardize reporting, clarify distinctions between direct and indirect contributions, and establish necessary categories. This initiative involved a literature review and interviews with stakeholders. The review of 26 publications revealed that more than half of all approved drugs and over 90% of target molecules are associated with public sector institutions or their spin-offs.

Health Technology

The AIHTA identified eight categories of public contributions to medical innovations along the value chain, from basic research to post-market monitoring. These categories highlight continuous public involvement in various stages of medical R&D, including technology transfer, support for university spin-outs and startups, regulatory assistance, clinical trials (even in later stages), and evidence generation post-market approval. For example, 18 advanced therapy medicinal products (ATMPs) were approved in Europe and the US by September 2023, mostly originating from publicly funded research institutions or philanthropic organizations. Ownership of these products typically transfers after early development phases, when the risk of failure decreases, increasing the company’s value with each ownership change based on the product portfolio’s assessment.

Enhancing Health Technology Assessment Through Transparent Public Contributions

Addressing how direct and indirect public contributions can be identified and differentiated is crucial for leveraging these insights in pricing strategies. This requires political willingness to establish regulatory guidelines and use all transparent information on public contributions. To initiate a paradigm shift, AIHTA proposes several design options, including standardized reporting of public and philanthropic R&D expenditures at the EU and national levels. This should be mandatory for the industry, including results like spin-outs and patents, and be available to the public and researchers. Furthermore, clear contractual agreements on conditions and requirements, such as clauses on fair prices, free access to intellectual property rights, profit-sharing, and repayment of initial investments or license fees to the public, must be established.

Overall, the Implementing Regulation (EU) 2024/1381 represents a comprehensive and forward-looking approach to health technology assessment in the EU. By establishing a uniform procedure, enhancing cooperation and transparency, and incorporating the perspectives of patients and clinical experts, the regulation aims to ensure that new health technologies are assessed in a timely, efficient, and patient-centered manner. This will ultimately support the goal of providing high-quality, innovative health technologies to patients across the European Union, improving health outcomes and contributing to the sustainability of healthcare systems.

 

 

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Resource: Astrian Institute for Health Technology Assesment, May , 2024

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