It is a complex reform, as is everything related to medicines and health products, due to its enormous economic implications for the system (more than 32,000 million euros per year), for the industry, innovation, and especially for what it means for the health of citizens.
Read more Julio Martínez is positioned as the ‘go-between’ for Zapatero’s businesses
The Council of Ministers has approved the Draft Law on Medicines and Health Products, a comprehensive reform that replaces the 2015 regulatory framework and seeks to guarantee equitable access to innovation, ensure the supply of critical drugs, and strengthen the sustainability of the National Health System (SNS), according to sources from the department headed by Mónica García. It is estimated that this reform would mean an annual reduction of 2,100 million euros.
There are many new features for the industry, but also for citizens. For now, they will be able to acquire a medicine of a specific brand, even if it is not financed, by paying the difference.
The legal reform introduces the possibility that, within the same active ingredient, dose, and pharmaceutical form, financed and non-financed medicines can coexist for selection and substitution purposes. Until now, homogeneous groupings only included financed medicines with those that are financed and form part of a homogeneous group.
If the patient wants a specific brand that is outside the financed range, they can obtain it by paying the difference
That is, the Ministry sets a maximum financing price. All medicines below that cap are financed. If the patient chooses the cheapest option or any other within the financed range, they only pay their usual co-payment. But if the patient wants a specific brand that is more expensive and outside the financed range, they can obtain it by paying the price difference, in addition to their co-payment.
Among the main changes, the draft law incorporates new instruments to prevent shortages. To do this, it introduces the concept of “strategic medicine,” defined as one indispensable for the health system whose supply chain is vulnerable.
To ensure its permanence in the market, the Spanish Agency of Medicines and Health Products (AEMPS) may adopt special economic and regulatory measures to prevent shortages. And in the face of public health emergencies, reporting obligations for stocks by laboratories, distributors, and pharmacies are strengthened.
Read more Woman found dead with signs of violence in Benahavís
The rule allows innovative medicines to be incorporated early into public provision
Another novelty refers to conditional financing for innovation. The rule allows certain innovative medicines to be incorporated early (before 180 days) into public provision when they cover an unmet medical need or when treatment cannot be delayed, even if there is still uncertainty about their effectiveness in real clinical practice or their definitive economic impact. That is, while the company and the Ministry of Health negotiate.
During this provisional period of 180 days, the medicine may be used in National Health System patients, and its results will be monitored. If it confirms the expected benefit, financing may be consolidated under the agreed conditions. If the results are not satisfactory, or if the definitive price is lower than the provisional one, the laboratory must compensate or return the corresponding amounts.
The legal reform establishes a new financing and pricing model. The rule redefines the pricing model to foster competition and savings, establishing reference prices and dynamic prices. The new rule articulates a coexistence model between two systems under the strict rule that the same medicine cannot be subject to both at the same time.
Prescription by nurses and physiotherapists
And new prescribing competencies are included. The prescribing capacity of nursing and physiotherapy professionals is formally recognized, integrating them into the prescribing team alongside doctors, dentists, and podiatrists within their scope of competence.
To guarantee the effectiveness of this measure, the regulatory framework will be updated within one year to harmonize the exercise of prescription by all these authorized professionals.
