Draft Law on patient organisations

On February 10, 2026, the Council of Ministers approved the Draft Law on Patient Organisations ("Draft Law"), a regulatory initiative that aims to provide these entities with a differentiated legal regime, recognizing their uniqueness and strengthening their institutional role within the National Health System. To date, patient organizations carried out their activity under the Organic Law 1/2002, of 22 March, regulating the Right of Association, lacking a specific framework that recognized their position as agents in the design of public health policies.

The regulation thus responds to a historical demand of the sector and is inspired by consolidated models at the European level, such as the concept of "health democracy" developed in France, the integration of patient participation groups in the National Health Service of the United Kingdom, or the German experience of participation without vote in the Federal Joint Committee.

Main new features of the Draft Law

Some of the most relevant elements of the regulatory proposal are set out below:

• Right of access to public information. Patient organizations will have the right to access relevant public information on health matters, to be assisted in their search for information and to receive a response within the legally established deadlines. 
• Participation in the development of health policies. The right to participate effectively in the preparation, modification and review of strategies, plans and provisions of a general nature related to the defence of their interests is guaranteed.
• Access to public funding. Access to financing is contemplated through grants, subsidies or agreements, designed with objective and transparent criteria.
• Continuous training programmes. The Administration will promote training programmes for the institutional strengthening of organizations, covering legal, administrative, health, scientific-technical and equality aspects.
• Duties. Duties are set for patient organizations related to transparency, prevention of conflicts of interest and accountability.
• Creation of the Patient Participation Board. It is established as a stable space for institutional dialogue between patient organizations and the Ministry of Health to address issues related to health policies.
• State Census of Patient Organizations. A census is instituted whose purpose is to guarantee publicity, facilitate institutional dialogue and order the representation of the sector. 
• Participation in governance bodies. Organizations may participate in the Advisory Committee of the National Health System, the Open Health Forum, the Governance Council of the health technology assessment system and other bodies that are determined by regulation.
• Specific regime for diseases of low prevalence. A proportional regulation for patient organizations of rare diseases will be developed by ministerial order within three months of the entry into force of the law. 

Sector’s response

Despite the fact that the sector has been calling for years for a specific regulation that recognizes the role of patient organizations, the approval of the Draft Law has received criticism among some actors in the sector.

In particular, the Platform of Patient Organizations ("POP"), has publicly expressed its position under the slogan "Yes to the Law of Patient Organizations, but not like this". The main objection focuses on the overly broad definition of the concept of "patient organization". The POP warns that this provision expands the concept in an excessive and undefined way, incorporating entities that can work "in health" without necessarily being governed by patients, relatives or caregivers.

On the contrary, the Spanish Patients’ Forum has positively valued the Draft Law considering that it is "a necessary advance, but one that requires ambition and commitment".

Timeline for the hearing and public information procedure

To participate in the hearing process, the following deadlines must be taken into account:

• Start date for submission of contributions: February 11, 2026;
• Deadline for submission of contributions: March 4, 2026.
  

Conclusion

The Draft Law on patient organizations represents a significant advance in the institutional recognition of these entities and in the configuration of structured participation mechanisms within the National Health System. However, as evidenced by the reactions of the sector, its parliamentary processing will require a constructive dialogue to reach consensus on key aspects such as the delimitation of the concept of "patient organization". The public hearing period, open until March 4, 2026, is an opportunity for the different actors to formulate contributions that contribute to improving the regulatory text.

For more information, please contact our specialists through the Knowledge and Innovation Area.