The proposed system of drug price regulation off-patent puts the supply of medicines and the pharmaceutical industrial fabric in Spain.

Madrid,8 of April of 2025.- The Council of Ministers' approval of the Pharmaceutical Industry Strategy 2024-28 last December was a major milestone in our country, recognizing the strategic nature of our sector and establishing a shared governance system through the Joint Strategy Committee. This Committee allows us to maintain an open dialogue for its implementation, especially regarding regulatory developments, such as the new Draft Law on Medicines and Medical Devices, which should be instrumental in strengthening the Spanish industrial fabric and, consequently, our strategic autonomy.

Regarding the aforementioned draft, we have maintained ongoing dialogue with the ministries involved and have transparently and constructively conveyed our observations on the issues we consider most concerning, such as the selected pricing system.

However, the government press release published this morning regarding the approval of the draft bill by the Council of Ministers maintains a proposal to create a system of selected prices that, by design, will automatically generate a tendency to minimize the prices of off-patent medicines, making the continuation of many drug production lines in Spain unviable and intensifying the current drug supply problems in an already highly tense market in Spain and Europe.

This measure is inconsistent with the Strategy, yet it is crucial for the Spanish pharmaceutical industry. We truly need an alternative model to replace the selected pricing system regulated in the Draft Law.

We find ourselves in a critical moment of enormous geopolitical instability, which, in our sector, follows a long, unfavorable period. We have had to absorb the inflationary impact of the post-pandemic years, the instability resulting from the draft European pharmaceutical legislation, the impact of multiple environmental regulations, and, finally, the new tariffs imposed by the American government. While keeping medicines outside the scope of these measures for the time being, they will impact global supply chains and the production of inputs for their manufacture in Spain, resulting in increased manufacturing costs in our country.

We know that we are all aligned, in Spain and in Europe, regarding the strategic value of the pharmaceutical sector, due to its ability to generate added economic, industrial, social, and well-being value. It is now a matter of making clear decisions that support the sector, and ensuring that regulatory reforms, whether laws or regulations, reflect this strategic nature of the sector, whose competitiveness and ability to attract investment have weakened in recent years. At a time when the country's strategic autonomy is especially relevant, we must strengthen the competitiveness of the large and small companies that make up our biomedical and pharmaceutical ecosystem and are a fundamental pillar for the health and future of all.

The Drug Law is the backbone of our sector. Some of its measures, such as the one outlined above, could affect the structure of our industrial and supply network, and it comes to light at a time of rapid and unstable geopolitical change. As the preliminary draft bill begins its hearing process, we request that its development return to the path outlined in the Strategy.

Signatory entities:

• AELMHU - Spanish Association of Orphan and Ultra-Orphan Drug Laboratories
• AESEG - Spanish Association of Generic Medicines
• AFAQUIM - Spanish Association of Fine Chemical Manufacturers
• ANEFP - Association for Self-Care of Health
• BIOSIM - Spanish Association of Biosimilar Medicines
• FARMAINDUSTRY - National Business Association of the Pharmaceutical Industry established in Spain.