- The Senate has hosted the conference “Regulatory Challenges of Healthcare Technology,” organized by the Federación Española de Empresas de Tecnología Sanitaria, Fenin. Senators, representatives from administrations and health services, and members of the industry reflected on how to ensure access to technological innovation through factors such as a solid regulatory framework and efficient public procurement.
- The PP spokesperson in the Senate Health Commission, Enrique Ruiz Escudero, indicated that “the speed of this sector usually stays ahead of the pace of administrations; legislative processing must never be an obstacle to the development of this industry.”
- César Hernández, Director of the Common Portfolio of NHS Services and Pharmacy of the Ministerio de Sanidad, confirms a “differentiated space” for medical devices in the future Law on Medicines and Medical Devices, and defends limiting the ‘weight’ of price in public tenders for healthcare technology.
The Healthcare Technology Sector needs its own stable and predictable regulatory framework that allows for the full potential of its innovations to be leveraged for the country’s progress and the improved health and quality of life of the population. A solid and differentiated regulatory framework is required to, in turn, guarantee the viability and competitiveness of this industry.
This was highlighted at the conference “Regulatory Challenges of Healthcare Technology,” held today at the Senate by the Federación Española de Empresas de Tecnología Sanitaria, Fenin. At this conference, senators, representatives from public administrations and health services, along with members of the industry, analyzed how to ensure access to technological innovation through, among other factors, a solid regulatory framework and efficient public procurement of healthcare technology.
The PP spokesperson in the Senate Health Commission, Enrique Ruiz Escudero, participated in this meeting. The popular senator highlighted that “the Healthcare Technology industry is not only a strategic and essential sector for the better health of the population, but also for the advancement and progress of the country. The speed at which this sector develops innovation and benefits for the healthcare system usually stays ahead of the pace of administrations. Legislative processing must never be an obstacle to the development of this sector. The Administration, just as it is a guarantor in legislative processes, can also accelerate these processes so they go hand in hand with the advancement and reality of the sector. For example, regarding the commitment to Open Strategic Autonomy, which must be a priority in this industry.”
For his part, Pablo Crespo, Secretary General of Fenin, highlighted that “our sector faces various challenges, of which the regulatory framework is one of the most relevant. We need our own regulatory framework that addresses the peculiarities of the sector, certainty, and institutional support to exploit its full potential. A support that translates into changes such as the indexing of public contracts and a commitment to public healthcare procurement based on value and quality.”
Analysis of the legislative framework under development
There are many regulations currently being processed or developed with implications for the technology and medical devices industry, both at the national and European levels: the Royal Decree on Health Technology Assessment, the transposition of the new European medical device regulations, the draft of the new Law on Medicines and Medical Devices (and the modification of the Law on Public Sector Contracts included in its text), etc. This first approach to the current and upcoming regulatory framework for medical devices was carried out at the meeting by Carmen Ruiz Villar, Head of the Medical Devices Department of the Agencia Española de Medicamentos y Productos Sanitarios (Aemps).
Due to its special importance as a core regulation for Healthcare, the analysis of the draft Law on Medicines and Medical Devices took center stage at this conference, through a presentation by César Hernández, Director General of the Common Portfolio of NHS Services and Pharmacy of the Ministerio de Sanidad. The ministerial representative defended the specific characteristics of medical devices compared to medicines and the Ministry’s interest in developing a “differentiated space” in this regulation for medical devices. “The time has come to grant them differentiated treatment and their own chapters within the law,” he detailed.
This draft also contemplates the implementation of a ‘Protech Plan’ for this industry which, among other questions, recognizes company investments and reduces the economic contributions made by companies for their sales charged to the SNS. Regarding this issue, César Hernández indicated that “it is an essential sector that, therefore, also deserves to have its own strategy, as the medicine industry already has with the Pharmaceutical Industry Strategy.” “The ‘Protech Plan’ would be an instrument within this broader strategy. The objective is not to collect revenue, but for those funds to generate a return of value for the system as a whole. For example, allocating them to compensation pools for early access to highly innovative but also high-uncertainty products, public-private R&D, or even in equipment renewal plans,” he specified.
Finally, the Director of the Common Portfolio of NHS Services and Pharmacy also valued the possible modification of the Law on Public Sector Contracts (through an additional provision in the draft) to limit the maximum weighting of price to 20% in the award criteria for public healthcare technology tenders, thus giving more ‘weight’ to criteria linked to the value, quality, and sustainability that innovation provides. “We believe it is better to put this cap on the prominence of price and require justification for anything that exceeds this percentage,” he explained.
Towards “efficient” public healthcare procurement
Related to the above, the conference also reflected on the challenges faced by procurement managers and contracting teams of health services when incorporating technological innovation into the system. In this regard, María Blanco, Procurement and Contracting Manager of the Instituto Catalán de la Salud, advocated for a change in the focus of current models to allow innovation to reach the patient through criteria of efficiency, sustainability, and value.
In this objective, Blanco valued the Guide for Efficient Public Procurement of Healthcare Technology, a consensus tool promoted by Fenin with leading experts in contracting from the autonomous communities, as a “necessary” initiative that facilitates that all CC. AA. “can share fundamental issues in these procedures.”