AseBio values the call for grants aimed at the development of UiC positively but regrets that it does not incentivize collaboration with Spanish biotech SMEs

On July 1st, the Official Newsletter of the State published Order CNU/709/2024, of July 1st, which approves the regulatory bases for the granting of aid for the development of Clinical Research Units (UiC, by its initials in Spanish), under the PERTE for cutting-edge health, and within the framework of the Recovery, Transformation, and Resilience Plan, and issues the call for 2024.

The call, launched by the Ministry of Science, Innovation and Universities, is based on a series of grants aimed at promoting research and innovation in the healthcare sector. These grants are intended for public healthcare entities and institutions with clinical care activities (such as hospitals or primary care centers, among others), and aim to create or improve Clinical Research Units. The funding for these grants amounts to 45 million euros, and applications must be submitted electronically through the electronic headquarters of the Carlos III Health Institute (ISCIII).

In November 2023, AseBio was consulted for the development of these grants so that the call could take into account the reality of the Spanish biotechnology industry. This is a sector in which biotech companies dedicated to healthcare generate significant added value in the early stages of drug discovery and design but, unlike in other countries, lack the financial capacity to develop more advanced clinical stages of their drugs. This situation means that the R&D&I generated in our country cannot maximize its full potential, and the affected companies, including their entire value chain, cannot grow and establish themselves as leading national companies.

Given that 96% of biotech companies in Spain are SMEs or micro-SMEs, AseBio believes that the sector's growth must be accompanied by a financing program that suits the needs and impact of their innovations and adapts to each stage of the innovation cycle. In this line, in our contributions to the then-future call, we advocated for UiCs to have mechanisms that would facilitate collaboration with Spanish biotech companies that contribute decisively to the innovation capacity of the ecosystem.

What have we achieved at AseBio?

Based on our proposals and after analyzing the document, we positively value the inclusion of IVD and iMD in the scope of UiC's activities and celebrate their introduction into the 20% capacity reserve quota.

Regarding the deadlines for the implementation of the subsidized activities, the initial deadline of December 31, 2025, implied a too-limited timeframe, especially for those infrastructures that might require construction work. In line with AseBio's proposal, the deadline for the subsidized activities has been extended to December 31, 2026.

How can it be improved?

At AseBio, we positively value the inclusion of some of the proposals we made in the formulation of the final text, but we regret that the call does not sufficiently incentivize collaboration with the Spanish biotechnology business sector, particularly SMEs that are behind the most disruptive biomedical innovations.

At AseBio, we advocate for the inclusion of specific measures aimed at compensating for the lower financial attractiveness of small and medium-sized biotech companies, as their collaboration with UiC has the potential to contribute to the country's fabric and generate greater economic and industrial impact in the country. In this regard, AseBio proposes the establishment of a quota for clinical trials promoted by Spanish biotech SMEs. This way, UiCs would be incentivized to dedicate part of their capacity to these companies, compensating for their lower financial attractiveness as clients, and the added complexity that trials sponsored by them usually have.

Furthermore, AseBio proposed the creation of centralized multicenter UiCs in rare diseases, due to the extra difficulty they pose in patient recruitment and the high investment required for research in this area relative to the number of patients who will benefit from the treatment, thus hindering the return on investment.

If you are interested in the call, you can access all the information through this link.