The proposed price regulation system for off-patent medicines puts the drug supply and the pharmaceutical industry in Spain at risk.

Madrid,10 of April of 2025.- The Draft Law on Medicines and Health Products recently approved in the first round by the Council of Ministers includes a new regulation of the prices of off-patent medicines in Spain, the so-called 'selected pricing system'. If implemented, this system would lead to a serious deterioration in the prices of supply problems, would have a very negative impact on the structure of the pharmaceutical industrial fabric of our country and would mean a reduction of pharmacies with the consequent impact on patients.

All of this would be contrary to the concept of open strategic autonomy, a fundamental objective of the Government and the Pharmaceutical Industry Strategy which was approved last December, and would have a negative impact on investment decisions and economic growth and employment in Spain, in addition to deteriorating the maintenance of quality healthcare services for citizens.

The system, regulated in article 116 of the Draft Law on Medicines and Health Products, consists of establishing every six months prices for each homogeneous group of substitutable medicines based on the 'blind' offers from companies. This way there will be a lowest-priced drug, a grouping of drugs with selected prices within a price range, and a grouping of unselected drugs that would change every six months. The system aims to achieve a continuous and sharp drop in prices, precisely in the market with the lowest profit margins, such as off-patent medicines. Furthermore, the system It does not include specific rules to ensure the permanence of medicines off-patent within full funding.

This system would be a radical change of model, with very negative consequences that have not been sufficiently assessed when drafting the Preliminary Draft and which are set out below:

About the drug manufacturing industry:

• An unpredictable and volatile model like the one proposed in the APL would generate un new scenario of instability and economic uncertainty for companies, with the consequent negative impact on investment and growth decisions in Spain.
• La primacy of price over any other consideration would give advantage to opportunity operators that have neither the capacity nor the will to supply the market in a stable manner over the long term. Therefore, the proposed model would jeopardize the productive fabric in Spain, which has 106 production plants for human medicines, many of them SMEs.
• This regulation would be a significant obstacle to the resilience of the supply chain and the country's strategic autonomy. Opting for cheaper products would generate short-term public savings, but the destruction of the productive fabric would undermine the capacity for economic growth in the form of productive activity and skilled employment.
• With this new system, which unpredictably places products in three different groups every six months, it would be impossible to plan production and diversify suppliers to improve resilience of the supply chain, which would prevent it from operating at full capacity, with the consequent loss of jobs.
• Without plants or with plants reduced in their capacity would sink the Spanish exports of medicines, which exceeded 21.000 billion euros in 2023 (the fifth most exported national product), and extra-EU imports would increase, with the consequent deterioration of the trade balance.
• And all of this impacts on a very tense international context for the pharmaceutical industry: the inflation derived from the war in Ukraine, which resulted in more than 1.500 billion euros in additional costs in just two years; the uncertainty created by the revision of the legEuropean pharmaceutical industry and new environmental regulations; the instability derived from the imposition of tariffs by the US, which, although it currently excludes medicines, will have an impact on global production chains.

Sin the drug supply chain:

• The model awould tax los Problemas de current shortages in an already very tense market in Spain and Europe, by reducing the number of offering laboratories, impacting the entire drug chain.
• The management of selected prices would have a very negative impact on wholesalers. The uncertainty resulting from constant price revisions would make it difficult to forecast demand and estimate adequate drug stock levels, creating disruptions in the supply chain and jeopardizing drug availability.
• It would discourage the marketing of medicines with limited supply in Spain. in favor of EU countries with higher prices, while encouraging las exportnes parallel, circumstances that would cause additional supply problems.
• This would favor manufacturers that offer lower prices, possibly to the detriment of other aspects of supply. This situation could lead to a greater dependence on external suppliers (outside the EU), compromising national strategic autonomy in the pharmaceutical field.
• It would discourage development and subsequent launch of new generic and biosimilar medicines, Spain would become an opportunistic country with high uncertainty in marketing volumes at very low prices.

About pharmacies:

• Pharmacists in pharmacies would be subjected to the same uncertainty as the rest of the agents in the chain due to the lack of clear information and significant price fluctuations.
• The implementation of selected prices would reduce adherence to treatments and would increase the risk of patient errors and problems associated with medication use, as the dispensed drug is frequently changed.
• By limiting the drugs selected, the choice and availability of medications in the pharmacy would be drastically reduced, and would generate supply problems that would make it difficult to continue the treatments. They would also have a significant impact on the pharmacy network and employment associated with them, especially in the most vulnerable environments, leaving numerous towns and neighborhoods without a pharmacy, without its professionals and without access to medication.

For all these reasons, the signatory entities request that the regulation of the selected pricing system be eliminated from the Draft Law and that the reforms be debated and agreed upon with the sector and other stakeholders in the chain within the Joint Committee created for this purpose within the framework of the Pharmaceutical Industry Strategy approved by the Government.

PRESS CONTACTS

• Spanish Association of Generic Medicines (AESEG)
  Marisol Atencio / matencio@aeseg.es – Tel.: 608 74 72 02
• Spanish Association of Biosimilar Medicines (BIOSIM)
  Ana Alcón / anaalcon@biosim.es – Tel.: 682 71 66 09
• General Council of Official Colleges of Pharmacists (CGCOF)
  Laura Gutiérrez Ibañes / lauragutierrez@redfarma.org – Tel.: 607 11 09 40
• National Association of the Pharmaceutical Industry (Farmaindustria)

Rosario García del Río / rgarciadelrio@farmindustria.es – Tel.: 616 83 43 23

• Federation of Pharmaceutical Distributors (FEDIFAR)
  Juan Nieto / jnieto@fedifar.net – Tel.: 606 57 84 46