Policy Recommendations for PCP implementation
The 2CARE4EU Cluster is a joint endeavour of four Pre-Commercial Procurement (PCP) projects: INCAREHEART, CareMatrix, ROSIA, and eCare. These initiatives share a common goal of advancing innovative ICT-based solutions to address critical challenges in health and care, including improving chronic disease treatment, enabling rehabilitation in remote areas, enhancing predictive analysis for frailty prevention, and advancing integrated care. This collaborative endeavour, spanning from 2021 to 2025, showcases the commitment of diverse stakeholders to advancing healthcare innovation.
Partners from the four initiatives, including public procurers and knowledge organisations, have emphasised that the PCP framework demands a distinctive approach, with phases and objectives specifically tailored to co-creating and testing innovative solutions in real-world environments. This White Paper delves into the challenges encountered, ranging from legal and regulatory barriers to operational and technological constraints.
This document serves a dual purpose: first, to consolidate the key lessons learned from the 2CARE4EU Cluster’s implementation of PCPs, and second, to offer actionable recommendations for the European Commission and policymakers based on these insights. The goal is to inform and shape the next generation of PCP instruments, ensuring they are better equipped to drive innovation, address emerging healthcare needs, and promote sustainable collaboration both within and beyond the EU.
By sharing these experiences and proposing strategic improvements, the 2CARE4EU Cluster aims to contribute to a more effective and impactful future for PCPs, enabling transformative advancements in healthcare technology and delivery.
Key Recommendations
Policy and process improvements
▪ Establish a dedicated regulatory helpdesk to support PCP implementation. A centralised helpdesk could guide procurers and suppliers on legal, compliance, and procurement-related challenges, ensuring smoother PCP execution and reducing administrative burden.
▪ Encourage more flexible procurement models that allow for iterative development, phased funding mechanisms, and adaptability to emerging technologies while maintaining compliance with EU procurement rules.
▪ Simplify ethical and regulatory approvals: Streamlining ethical clearance and MDR compliance processes would prevent lengthy delays that currently hinder PCP implementation. Coordinating with national regulatory bodies to align approval processes would enhance efficiency.
Strategic vision for the future of PCPs
▪ Enhance monitoring and impact assessment of PCP-funded solutions. Implement systematic tracking of PCP-funded innovations to assess their long-term adoption, scalability, and economic impact. This would provide valuable data such as adoption rates and/or cost savings to improve future PCP funding and policy decisions.
▪ Align PCPs with broader EU Health and Data Strategies. Ensuring PCPs align with initiatives like the European Health Data Space (EHDS), AI Act, and Digital Health Strategy will improve integration and adoption.
Enhancing PCP impact
▪ Ensure timely allocation of funding for sustainability actions beyond project timelines. Many PCP innovations fail to transition to full-scale adoption due to a lack of financial support after project completion. Dedicated funding mechanisms should be available at the right time to bridge this gap, ensuring that promising solutions receive the necessary resources for commercialisation, deployment, and long-term impact.
▪ Expand support for clinical trials, MDR certification, and early-stage pilot design. Many PCP solutions face barriers in obtaining market approval, particularly in regulated sectors like healthcare. Additional funding and advisory support for clinical trials, CE/MDR certification, and regulatory navigation would improve the market readiness of innovative solutions.
▪ Encourage public-private partnerships (PPPs) for co-financing PCP innovations. Establish incentives and funding schemes to attract private-sector investment in PCP-developed solutions.
▪ Reduce the administrative burden on PCP participants. PCPs' administrative complexity can deter participation from small companies and startups. Streamlining application processes and compliance requirements would improve inclusivity and participation rates. Besides, more agile and flexible mechanisms may be better adapted to healthcare organizations' innovation needs and challenges.