Joshua Parfitt
Spain’s largest pharmaceutical association has slammed the upcoming 2025 Medicamentos law, warning it could disrupt access to prescription medicines.
Farmindustria claims the new law – approved in principle by Spain’s Council of Ministers on April 8 – could mean patients could see a price hike due to their use of a particular brand.
The body also criticised the impact the law may have on supply issues.
In a statement, the group said the proposed law: “proposes a selected pricing system that will automatically push down prices on off-patent medicines — making it impossible to maintain many production lines and intensifying current supply issues in Spain and Europe.”
What is the Medicamentos law?
The Ley de los Medicamentos y Productos Sanitarios (Law of Medicines and Health Products) aims to modernize Spain’s pharmaceutical system, improve access to innovative drugs, and cut costs.
According to the Ministry of Health, the goal is to save €1.3 billion annually. Spain currently spends €27.7 billion each year on pharmaceuticals.
The law also seeks to prevent future supply disruptions like those seen during the COVID-19 pandemic.
Here’s a summary of the key reforms, based on details from Spain’s Ministry of Health:
- Generic prescriptions. Doctors will prescribe based on the active ingredient, not the brand—unless the medicine is for a chronic illness, the patient is vulnerable, or the drug can’t be substituted.
- Pharmacy-level decisions. If a medication isn’t available, pharmacists can offer a substitute without needing a new prescription.
- Recurring prescriptions. Some drugs (e.g. migraine treatments) will only need to be prescribed once, and can be collected later as needed.
- Nurse prescribing. Nurses (and soon, physiotherapists) will be allowed to prescribe certain treatments—a “historic demand” according to Spain’s General Nursing Council.
- New pricing system. Instead of one fixed price, off-patent medicines will fall into a price band. Only the cheapest options will be fully covered by the public system. Consumers buying a brand which is more expensive, they will pay the difference.
- Strategic medicine stock. New rules will ensure access to essential drugs during emergencies.
- Faster access to innovations. Some breakthrough medicines will receive early, conditional approval and funding.
- Health technology review. A new agency will evaluate the effectiveness and cost of new medical technologies and treatments.
While the reforms have been discussed for years, Spain’s pharmaceutical industry fears the new pricing model will cause long-term damage.
They argue it could discourage companies from producing or stocking low-margin drugs, hurting investment, employment, and patient care. It could also complicate how prescriptions are managed in pharmacies and clinics.
The industry also criticizes the reform as being “against the concept of open strategic autonomy” – a key principle in the government’s own pharmaceutical strategy passed last December.
What the Medicamentos law means for prescription medicines
Let’s say you have been prescribed Gelocatil, a branded paracetamol.
Under the new law, if it’s more expensive than the cheapest generic version available (which could be fully subsidised) you’ll have to pay the difference out of pocket.
The same could happen with, say, allergy medications.
If you prefer a branded version and there’s a cheaper, equally effective option, the public system will only cover the cheapest.
That said, if you have a chronic condition, are a vulnerable patient, or have a known issue with a certain drug, you’ll still be able to access specific treatments under the current terms.
Not all industry bodies are opposed to the reforms.
Spain’s General Nursing Council welcomed the move to allow nurse prescribing, calling it a “historic demand” that acknowledges their qualifications.
Spain’s Medicines and Health Products Agency added that recurring prescriptions – such as those for triptans (migraine medication) – not needing constant renewal is helpful for patients who have periodic health concerns.
The law now begins the legislative process in parliament. If passed as expected, the government aims to implement it in stages over the next year.
To find out how it affects your prescriptions, you can speak to your local pharmacist or check with your centro de salud (local health center).
It’s a good time to review any regular prescriptions and ask how these changes could affect you.
