Key data
| Regulation | Resolution of September 15, 2026, from the Carlos III Health Institute, O.A., M.P., publishing the Agreement for the creation of the State Consortium in Network for the Development of Advanced Therapy Medicinal Products (CERTERA) |
|---|---|
| BOE Publication | October 3, 2026 |
| Entry into force | September 11, 2026 (date of agreement signature) |
| Affected parties | Biomedical research centers, hospitals, universities, pharmaceutical and biotechnology industry |
| Category | Regulatory Changes |
| Year | 2026 |
| Number of founding entities | Over 40 institutions (hospitals, research foundations and universities) |
| Promoting bodies | Carlos III Health Institute (ISCIII) and CIEMAT |
| Legal framework | Law 40/2015 on Legal Regime of the Public Sector and Law 14/2011 on Science |
| Public policy framework | PERTE for Advanced Health (approved 2021) and Post-COVID Recovery Plan |
The Spanish pharmaceutical and biotechnology industry has a new heavyweight interlocutor: CERTERA, the State Consortium in Network for the Development of Advanced Therapy Medicinal Products, whose founding agreement was signed on September 11, 2026 and published in the BOE on October 3, 2026 through a Resolution from the Carlos III Health Institute.
This is not a statement of intent: the consortium is born with solid legal foundation (Law 40/2015 and Law 14/2011 on Science), over 40 statutorily committed entities and financial backing from the PERTE for Advanced Health and the Post-COVID Recovery Plan. For any company in the sector, ignoring it would be a strategic error.
What does this regulation establish?
The ISCIII Resolution publishes the agreement that gives legal life to CERTERA. The consortium's mission is to coordinate national capabilities in advanced therapies, with focus on two specific technological areas:
- Gene therapy: modification or correction of genetic material to treat diseases.
- Cell therapy: use of living cells (autologous or from donor) as a therapeutic agent, including CAR-T and similar.
The stated objective is to promote precision medicine at national scale, avoiding the fragmentation of capabilities that has existed until now among hospital centers, universities and research laboratories.
Participating entities are not mere signatories: they assume statutory commitments for governance and joint financing. This implies that the consortium will have its own decision-making structure, shared budget and defined participation rules in its bylaws.
| Element | Detail |
|---|---|
| Official name | State Consortium in Network for the Development of Advanced Therapy Medicinal Products (CERTERA) |
| Promoting bodies | Carlos III Health Institute (ISCIII) and CIEMAT |
| Type of participating entities | Hospitals, research foundations and universities |
| Number of entities | Over 40 |
| Therapeutic areas | Gene therapy, cell therapy, precision medicine |
| Financing framework | PERTE for Advanced Health (2021) and Post-COVID Recovery Plan |
| Entity commitments | Statutory governance and joint financing |
Economic and operational impact
For the private industry, the creation of CERTERA has implications in two opposite directions that must be analyzed carefully:
Opportunities: The consortium brings together in a single structure over 40 institutions with clinical and translational research capabilities. For a pharmaceutical or biotechnology company wanting to develop or validate advanced therapies in Spain, CERTERA can become the single interlocutor for collaboration agreements, access to infrastructure and participation in nationally coordinated clinical trials.
Competitive risks: The public sector consolidates its own muscle in an area of high strategic value. Companies competing in the development of gene or cell therapies will face an actor with public financing (PERTE + recovery funds), a network of over 40 centers and institutional backing from ISCIII and CIEMAT.
Operational impact for private clinical research centers: Centers currently collaborating bilaterally with hospitals or universities must assess whether their existing agreements are affected by the adhesion of those institutions to CERTERA and its new statutory commitments.
Who does it affect?
- Pharmaceutical industry: Companies that develop or commercialize advanced therapy medicinal products (ATMPs) in Spain. CERTERA can be ally or competitor depending on the business model.
- Biotechnology companies: Especially those specialized in gene therapy, cell therapy and precision medicine. They must position themselves before the new public ecosystem.
- Private clinical research centers (CROs): Their agreements with hospitals and universities participating in CERTERA may be conditioned by the consortium's new statutory commitments.
- Hospitals and research foundations: The over 40 signatory entities assume governance and joint financing obligations from September 11, 2026.
- Universities with biomedical research groups: Must review their intellectual property and technology transfer commitments in light of CERTERA's bylaws.
- Investors and venture capital funds in biotech: The map of actors in advanced therapies in Spain is changing. Valuations of sector startups must incorporate CERTERA's presence as a variable.
Practical example
A Spanish biotechnology company is developing a CAR-T therapy for a type of lymphoma and has collaboration agreements with three university hospitals for its phase II clinical trials. Two of those hospitals are founding entities of CERTERA and have assumed statutory commitments for governance and joint financing with the consortium.
As of September 11, 2026, the company must verify:
- Whether the new statutory commitments of those hospitals with CERTERA affect the current collaboration agreements (intellectual property rights, exclusivity, use of infrastructure).
- Whether CERTERA offers formal public-private collaboration channels that allow the company to access the network of over 40 institutions under a unified framework, rather than negotiating bilaterally with each center.
- Whether the financing from the PERTE for Advanced Health channeled through CERTERA generates collaboration calls to which the company can apply.
What should companies do now?
- Identify whether any of your research partners is a founding entity of CERTERA. Review current collaboration agreements with hospitals, foundations and universities to detect possible conflicts with the consortium's new statutory commitments.
- Analyze CERTERA's bylaws. The governance and joint financing conditions assumed by participating entities may affect intellectual property generated in shared projects. Request a copy of the bylaws and review them with specialized legal advice.
- Evaluate strategic positioning before the consortium. Decide whether the company's strategy is to collaborate with CERTERA (as external partner or service provider), compete in the same space or ignore it. All three options have different consequences and require explicit decision.
- Monitor PERTE for Advanced Health calls. Public financing channeled through CERTERA may generate opportunities for access to funds for advanced therapy projects. Designate a person responsible for monitoring calls.
- Update the competitive map of the sector. CFOs and strategy executives must incorporate CERTERA as a relevant actor in their market analyses for advanced therapies in Spain from 2026 onwards.
Frequently asked questions
What is CERTERA and when does it start operating?
CERTERA is the State Consortium in Network for the Development of Advanced Therapy Medicinal Products, created through an agreement signed on September 11, 2026 by the Carlos III Health Institute, CIEMAT and over 40 institutions including hospitals, research foundations and universities. It operates from that same date, although the Resolution publishing the agreement was published in the BOE on October 3, 2026.
Can a private company collaborate with CERTERA?
The regulation does not close the door to public-private collaboration: the consortium is framed within the PERTE for Advanced Health, which contemplates industry participation. However, the specific conditions for collaboration with private entities will depend on the consortium's bylaws. Interested companies should review those bylaws and contact ISCIII or CIEMAT as promoting bodies.
What commitments do entities that have joined CERTERA assume?
The over 40 participating entities assume statutory commitments for governance and joint financing. This implies participating in the consortium's decision-making bodies and contributing economically to its operation as established in the bylaws. The specific details of each commitment are contained in the agreement published in the BOE (BOE-A-2026-20582).
What types of therapies does CERTERA focus on?
CERTERA focuses on advanced therapy medicinal products, with special focus on gene therapy (modification of genetic material to treat diseases) and cell therapy (use of living cells as a therapeutic agent, such as CAR-T therapies). The overall objective is to promote precision medicine at national scale by coordinating the capabilities of over 40 institutions.
What is CERTERA's relationship with European recovery funds?
CERTERA is framed within the PERTE for Advanced Health, approved in 2021, and the Post-COVID Recovery Plan financed with European Next Generation EU funds. This means that part of the consortium's financing comes from those funds, which strengthens its budget stability in the medium term and its capacity to launch collaboration calls with industry.
Official source
Consult complete regulation at official source
Notice: This article is purely informational in nature and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2026-20582
