AEMPS extends agreement with patients: what changes for the healthcare sector in 2026

Key data

Patient organizations and the healthcare sector in Spain maintain their institutional collaboration framework with the Spanish Agency for Medicines and Health Products (AEMPS). The resolution published on April 13, 2026 formalizes the amendment extending the agreement with the Platform of Patient Organizations (POP), effective from March 30, 2026.

This agreement does not introduce new regulatory burdens for private sector companies, but it does have direct implications for patient organizations and for any healthcare entity working on rational medicine use programs or collaborating with the POP.

What does this regulation establish?

The resolution publishes the amendment extending the existing agreement between the AEMPS and the Platform of Patient Organizations. The purpose of the agreement remains unchanged from the original agreement and covers two main areas:

• Promotion of safe and rational use of medicines among the public, through information, training and awareness activities aimed at patients and their representatives.
• Strengthening confidence in the European Union Medicines Regulatory Network, aligning institutional communication with European pharmaceutical regulation standards.

The extension guarantees that all joint programs and projects already underway between the AEMPS and the POP continue without interruption, avoiding gaps in the institutional cooperation framework.

This is not a new regulation that modifies existing obligations, but rather the temporal extension of a collaboration agreement already operational between the national pharmaceutical regulator and the main representative platform of patients in Spain.

Economic and operational impact

This resolution does not generate direct costs for private companies in the pharmaceutical sector or for other market operators. Its impact is fundamentally institutional and operational for the parties signing the agreement.

For patient organizations integrated into the POP, the extension means:

• Continuity in access to resources, tools and communication channels provided by the AEMPS under the agreement framework.
• Maintenance of training and awareness projects already initiated, without the need to renegotiate conditions or initiate new membership procedures.
• Preservation of the institutional framework for direct dialogue with the national pharmaceutical regulator.

For the healthcare sector in general, the extension strengthens the communication ecosystem on rational medicine use, which may have an indirect impact on therapeutic adherence and public perception of European pharmaceutical regulation.

Who does it affect?

• Platform of Patient Organizations (POP) and all organizations integrated into it: they are the direct beneficiaries of the extended agreement.
• Patient organizations that develop information or training activities on medicines in collaboration with the AEMPS.
• Citizens who use medicines: final recipients of the awareness and training activities contemplated in the agreement.
• Healthcare sector: professionals and entities working on rational medicine use programs or collaborating with the POP or AEMPS in this area.
• Pharmaceutical laboratories and market operators that closely follow the AEMPS regulatory policy and its relationship with patient representatives.

Practical example

A patient organization with chronic disease, integrated into the Platform of Patient Organizations (POP), had a therapeutic adherence training program underway at the beginning of 2026, co-financed and institutionally supported by the AEMPS under the agreement framework.

Thanks to the amendment extending the agreement signed on March 30, 2026, that program is not suspended nor does it require new negotiation with the AEMPS. The organization can continue executing the planned activities, using the agreed materials and channels, and maintaining its direct dialogue with the regulator, without administrative interruptions.

Without the extension, the organization would have needed to initiate a new agreement process, with the timelines and procedures involved, risking the continuity of its ongoing programs.

What should organizations do now?

1. Verify if your organization is integrated into the POP: Only member organizations of the Platform of Patient Organizations are covered by this agreement. If you are not, assess the channels for membership.
2. Review projects underway with the AEMPS: Confirm that the training, information or awareness programs you were executing under the agreement can continue without modifications under the extension.
3. Update your internal documentation: Record the amendment extending the agreement (Resolution of March 30, 2026) as a current document in the files related to the AEMPS-POP agreement.
4. Maintain dialogue with the AEMPS: Take advantage of the continuity of the institutional framework to strengthen collaboration in the areas of safe medicine use and communication on European pharmaceutical regulation.
5. Follow regulatory developments: The extension is temporary. Anticipate possible renewal or modification of the agreement to avoid future interruptions in joint programs.

Official source