The Spanish Council of Ministers Approves the Draft Bill on Pharmaceuticals and Medical Devices
The Spanish Council of Ministers has approved a landmark reform of pharmaceutical legislation aimed at adapting the healthcare system to 21st-century challenges. This initiative seeks to accelerate access to innovative treatments, enhance system sustainability, and strengthen strategic autonomy following the lessons learned during the pandemic.
Key highlights of the draft bill:
Prescription by active ingredient: Introduced as a rule to promote the rational use of medicines and ensure the sustainability of the healthcare system.
Homogeneous groups of equivalent medicines: The Spanish Agency of Medicines and Medical Devices (AEMPS) will define these groups, comprising all therapeutically equivalent prescription medicines, including both branded and generic products. Patients will be able to choose among these options in the pharmacy or, if no preference is stated, receive the most cost-effective alternative.
First-prescription medicines: A new category enabling pharmacies to dispense recurring treatments without requiring a new prescription, provided professional supervision is ensured.
Nurse prescribing: Within a year of the law’s entry into force, the framework enabling nurses — and subsequently physiotherapists — to prescribe and dispense certain medications and medical devices will be updated. In Spain, pharmacists do not currently have prescribing authority, and their role remains focused on dispensing and advising within the boundaries of medical prescriptions.
Updated reference pricing: A dynamic new model introduces a “selected price range” to foster competition among manufacturers. Companies may submit price offers every six months, and the Ministry will select those that combine a competitive price with guaranteed supply. This marks a shift from the current system, which applies a single reimbursement price to all equivalent medicines.
Strategic medicines: Special measures will maintain market availability and enable rapid AEMPS response to any supply issues. These are typically medicines with no available therapeutic alternatives on the market and/or those at risk of supply shortages, making their continued availability critical for public health.
Faster access to innovation: Provisional financing pathways for high-value medications will speed up patient access while final reimbursement decisions are still under review. These high-value medicines are defined as those with special added value for specific patient groups, addressing unmet needs or offering significant clinical benefits over existing alternatives.
In parallel, the Council of Ministers has also approved the Bill to establish the State Public Health Agency (AESAP). This new body will bolster preventive measures and rapid, coordinated responses to future public health risks, reinforcing Spain’s capacity to protect the health and well-being of its citizens.
The new draft law presents significant opportunities for the pharmaceutical industry, including faster market access for high-value medicines, a more flexible and competitive pricing system, special protections for strategic drugs, and clearer evaluation pathways. It also opens the door for innovative reimbursement models and reinforces Spain’s commitment to healthcare innovation and supply resilience. However, the reform also brings challenges, such as increased pricing pressure, stricter supply obligations, and the need for rapid adaptation to new evaluation and reimbursement frameworks.
For any enquiries or deeper insights on these developments, or to learn how we can support your product launches in Spain, feel free to reach out to our team at: enquiries@decisiveconsulting.co.uk
Source: https://www.sanidad.gob.es/gabinete/notasPrensa.do?id=6651
Written by Jorge Ferrer
Decisive Dialogue 11th April 2025