MedTech Europe recently wrote an open letter to EU Member States’ Representatives on EU Health Competitiveness. The letter discusses the strategic importance of medical technology, and it focuses on developing the EU’s healthcare sector and maintaining competitiveness. Here’s a detailed analysis of these points:
Strategic Investments in EU Healthcare Competitiveness
MedTech Europe calls for investment in efficient healthcare systems. They emphasize the role of digital health and medical technologies which matches the European Health Union’s goals. The EU aims to improve health systems across member states. The Commission highlighted that digital health as crucial and that these tools can help address challenges like cancer care and prevention.
Regulatory Framework Reform
The letter calls for a structural reform of the regulatory framework, specifically the implementation of Regulations (EU) 2017/745 and 2017/746, to foster timely and safe innovation launches. This is echoed in prior open letters by MedTech Europe that highlights the urgent need for action on medical technology regulations (IVDR and MDR) to ensure device availability and competitiveness. The industry proposes immediate ‘bridging measures’ to reduce certification times and costs and to improve the efficiency of assessing changes to medical technologies.
Policy Synchronisation
MedTech Europe advocates for policy synchronisation to align regulatory requirements across different policy domains, thereby reducing legal uncertainty and the regulatory burden. This approach supports the European Health Union’s goal of streamlining processes and improving coordination. For instance, the European Commission’s proposed reform of the pharmaceutical legislation aims to cut red tape and expedite drug evaluation procedures, which is part of a broader effort to synchronize and streamline regulatory processes.
Value-Based Procurement
The letter promotes procurement practices focused on value and complements a joint decarbonisation and competitiveness approach. This is consistent with investing in governance and public health infrastructure, as emphasized by the European Public Health Association (EUPHA) and the European Health Management Association (EHMA). They stress the importance of direct financial incentives to support actions that boost workability, emphasize prevention, and allow for additional capacity in health systems.
Innovation and Competitiveness
MedTech Europe stresses the need to strengthen Europe’s global leadership in healthcare innovation. This is a recurring theme across various sources discussing the medical technology sector’s role. The European Commission’s Pharmaceutical Strategy for Europe and the proposed reform of pharmaceutical rules aim to support health innovation. Nonetheless, there are concerns from stakeholders, such as the European Federation of Pharmaceutical Industries and Associations (EFPIA), that certain reforms could undermine the EU’s competitiveness in health innovation.
Patient Empowerment and Health Literacy
The MedTech Europe letter doesn’t directly discuss patient empowerment. However, this remains crucial for the European Health Union. EUPHA and EHMA stress two key points: health literacy and patient empowerment. They believe patients should be active partners in making decisions about their care.
Addressing Social Disparities
The European Health Union aims to address social disparities in healthcare. Building fairer health systems is a core goal. EUPHA and EHMA advocate for better health promotion. They focus on fixing disparities that grew worse during COVID-19.
In summary, MedTech Europe’s letter outlines vital areas for EU healthcare. It covers investments, reforms, and policy changes. The letter discusses value-based procurement and innovation support. It also addresses social gaps in healthcare. Multiple sources back these recommendations. These include European Commission reports and joint statements. EUPHA and EHMA also support this comprehensive approach. Together, they aim to strengthen EU medical technology.
