Spain's Council of Ministers approves draft legislation on patient organisations

The Council of Ministers of Spain has approved the Draft Bill on Patient Organisations, a piece of legislation aimed at establishing a dedicated legal framework for these entities and recognising them as legitimate stakeholders within the National Health System.

With the dual objective of filling the gap left by the absence of a specific legal framework and aligning with European models, the Council of Ministers approved the draft bill on 10 February at the proposal of the Ministry of Health. The legislative initiative seeks to consolidate these organisations as recognised stakeholders within Spanish National Health System, thereby reinforcing their institutional role, guaranteeing their participation in the development of health policies, and setting out the full range of rights and obligations that correspond to them in the exercise of their activities.

Until now, patient organisations were treated legally as non-profit associations and were governed by Organic Law 1/2002, of 22 March, regulating the right of association, and Law 14/1986, the General Health Act. The draft bill goes a step further by establishing a specific framework that recognises their unique character as organisations composed of patients, family members or carers and contributes to consolidating a more participatory healthcare model.

Scope of application

The scope of the draft bill is limited to patient organisations operating at national level that are registered in the National Register of Associations. These are defined as non-profit associative entities that defend the rights of persons requiring healthcare, as well as their families and non-professional carers. The draft bill also includes within this category organisations that address common needs arising from various health conditions and those that promote the training and participation of patients, family members and non-professional carers in relevant health policies.

Right of access

The right of access to information is expressly recognised. Patient organisations will have the right to access relevant public information on health matters, to receive assistance in searching for such information, and to obtain the information requested within the legally established timeframes.

Right to public participation

The right to public participation and involvement in governance bodies is reinforced. The draft bill guarantees the active participation of these organisations in the drafting, amendment and review of strategies, plans and provisions affecting their interests, including the right to submit representations and observations.

It also provides for their right to participate, amongst others, in the Advisory Committee of the National Health System, the Open Health Forum, and the Governance Council of the system for the assessment of the effectiveness of health technologies.

Census of patient organisations

The creation of a census of patient organisations is envisaged with the aim of facilitating dialogue between patient organisations and the Central State Administration.

Right to public funding

In the economic sphere, the right to public funding is recognised. Patient organisations will be able to access public funding through calls for grants, subsidies, or other equivalent instruments, in accordance with objective and transparent criteria.

Right to continuing training

The draft bill also promotes the right to continuing training, through training programmes aimed at the institutional strengthening of patient organisations.

These programmes will cover, amongst other areas, legal, administrative, health, scientific-technical and equality-related matters.

Patient participation body

With a view to institutionalising collaboration and reinforcing dialogue, the creation of a patient participation body is envisaged, conceived as a permanent forum for dialogue between the ministry and patient organisations.

This body will address issues relating to health policies and will be composed of representatives from the competent Ministry and from the relevant organisations.

Low-prevalence diseases regime

Finally, the draft bill introduces a specific regime applicable to patient organisations dealing with low-prevalence diseases, set out in its first additional provision.

This specific regime is to be developed by means of a ministerial order within a period of three months from the entry into force of the law.

While the main patient platforms have welcomed the progress represented by the draft bill, the Platform of Patient Organisations has expressed its disagreement with the definition of patient organisations as set out in the text.

It has argued that the definition is excessively broad, as it would permit the inclusion of entities not effectively governed by patients, family members, or carers. Accordingly, it is urging that the definition be amended in order to restrict its scope and ensure genuine and effective patient representation.

Osborne Clarke comment

The reactions from the sector highlight the need to review certain key aspects of the draft bill, in particular the very definition of "patient organisations", in order to ensure that the future law genuinely and effectively regulates the participation of patient organisations in the healthcare system.

The public consultation period, which remains open until 4 March, provides an opportunity to put forward proposals for improvements to the text.

In any event, the draft bill represents a significant step forward in establishing a specific legal framework for the participation of these organisations in the National Health System.