The Government has presented this week its Annual Regulatory Plan for 2026 and, in the health sector, the outlook holds few surprises. The Ministry of Health, led by Mónica García, plans to bring five laws to the Council of Ministers throughout the year, all of them already known: the reform of medicines, the Framework Statute, the regulation on smoking, the anti-privatization law, and the law on patient organizations. However, beyond the calendar, the main question is their viability: none has an especially favorable horizon. In Demócrata we analyze each of these initiatives, their critical points, and their real chances of landing in the BOE.
Drug Reform
The Draft Law on Medicines and Health Products is pending a second reading by the Council of Ministers. The draft, exclusively revealed by Demócrata, received initial approval in April 2025. The Ministry is evaluating the allegations received from the sector and, although there is no tentative schedule, no progress is expected until after the summer.
With this law, the Ministry of Health intends to update the regulations to address disruptive scientific advances, deepen measures for rationalizing pharmaceutical spending, encourage the rational use of medicines, and introduce changes based on experience during the pandemic. Likewise, it aims to encourage generic and biosimilar medicines and lay the groundwork for strategic medicines.
The Medicines Law aims to regulate everything related to human and veterinary medicines, and health products, including in vitro ones; from research to marketing, as well as inclusion in pharmaceutical provision and their financing with public funds. One of its hot topics was the new reference pricing system, and it continues to be.
For the regulation of prices, clinical benefit, prices and other economic conditions of existing alternative treatments will be taken into account. Public funding of medicines will be subject to a reference pricing system, although there will be exceptions, in line with what the sector demanded. The reference price will be the maximum amount of the price range with which the presentations of medicines included in each of the determined sets will be financed, provided that they are prescribed and dispensed at the expense of public funds.
At the expense of the definitive proposal that Moncloa sends to Congress, another of the points to be resolved and which generates friction between the partners of the coalition Executive is the pharmaceutical co-payment. The draft revealed exclusively by Demócrata contemplated its reform, however, the preliminary draft did not.
Sanidad aspired to design a more progressive system incorporating more tiers. The current one, designed in 2012, establishes three tiers: incomes below 18,000 euros, who pay 40% of their medication; those that range between 18,000 and 100,000, who pay 50%; and those who exceed that figure, who disburse 60%. Pensioners adhere to the same tiers, but with a monthly cap in each.
Sanidad's initial proposal (the one that appeared in the draft) proposed three new brackets and raising the contribution of incomes over 100,000 euros to 65%. The new brackets ranged from 18,000 to 35,000 (50%), from 35,000 to 60,000 (55%), and from 60,000 to 100,000 (60%).
However, Mónica García does not give up on undertaking a similar reform and hopes to be able to promote it during the parliamentary process via amendment.
Framework Statute
The 2026 Annual Regulatory Plan includes the Law of the Framework Statute for Health Professionals, whose purpose is to update the legal regime of statutory health personnel, adapting it to the organizational, care, and professional changes of the National Health System, with the purpose of improving the organization of the public health function, working conditions, mobility, professional development, and the remuneration model.
Currently, it is deeply entrenched due to successive doctors' strikes, who demand a specific statute for the group, separate from the general regime of other health professionals. Among their main demands are the regulation of working hours, conditions for on-call duties, and improvements in retirement. For their part, the Negotiation Area unions are pressing and nursing technicians urge that the reform not be delayed any further.
Anti-smoking law
Health expects to approve the Draft Anti-Tobacco Law in a second reading, which received the first go-ahead last September. García's purpose is to strengthen the fight against smoking to improve public health, expanding protection in spaces and updating the regulation of tobacco and related products.
Among the most controversial measures, the expansion of smoke-free spaces and the equalization of electronic cigarettes to conventional tobacco stand out, not only to prohibit their consumption in the same places, but also so that they must comply with the requirements relating to marketing and advertising.
According to sources consulted by Demócrata, this proposal generates not only tensions with the usual partners of the investiture bloc, but also between PSOE and Sumar. Specifically, there are differences in the ambitious prohibition of advertising, which expressly includes the suppression of commercial communications or promotions in equipment, facilities, and furniture located in public or collective use spaces, which covers elements present in bars, nightclubs, terraces, or other leisure establishments. Thus, signs, posters, urban or hospitality furniture that incorporates logos, images, or references to brands of tobacco products or related products will not be able to be used.
Anti-privatization Law
The Ministry of Health not only expects to approve it throughout the year, but they intend to take it to the Council of Ministers this month.
If it prospers and reaches the BOE, the preliminary draft would repeal Law 15/1997, which allows public-private collaboration in Healthcare. The purpose is to limit privatizations to exceptional situations, and always with prior evaluation, thus prioritizing public management.
The text would only allow the hybrid model (indirect provision) in the event that direct management by public administrations or entities or through consortia formed between several public administrations or entities was not possible (article 5 of the text).
Furthermore, indirect management must always guarantee financial sustainability and efficiency; while complying with requirements for quality, continuity, accessibility, and affordability of the service.
While it is true that the main point of friction between the PSOE and Sumar has been smoothed over, which was the limitation of exceptions that would allow privatizations and the consequent repeal of Law 15/1997, its parliamentary processing seems more than complicated.
The Health Commission has become a sort of pit into which, law that arrives, law that runs aground. The only exception, the State Public Health Agency. Regarding the content as such of the preliminary draft on anti-privatizations, negotiations with ERC, Junts, and PNV are foreseen as insurmountable due to the impact of public-private collaboration in health matters in Catalonia and the Basque Country.
Patient organizations
The other law that the Government wants to take to the Council of Ministers in 2026 is that of patient organizations, which passed its first reading recently, in February. Its objective is to reinforce the role of patient organizations as interlocutors in the healthcare system, guaranteeing their participation in public policies and regulating their rights, obligations, and institutional support.
Uncertain future
The Ministry of Health is one of the departments with the most open initiatives, a will overflowing with optimism that, however, is not translated into news in the BOE. The parliamentary arithmetic of the current legislature makes the approval of laws in Congress enormously difficult, and the health sector is not only no exception, but is one of the most affected.
The Government's usual partners are especially wary on health matters due to a question of competencies, but even with them, since Junts' break with the PSOE, the numbers don't add up. The sum of PSOE (121), Sumar (26), ERC (7), EH Bildu (6), PNV (5) and those attached to the Mixed group, Águeda Micó (Compromís), BNG, Coalición Canaria and the four from Podemos, amounts to 172. The only glimmer of hope is that, at least, none of the aforementioned initiatives are organic and therefore do not require an absolute majority, an abstention would suffice.
It is for that reason that the royal decrees that the Government plans to approve this year are of special relevance, as they will be regulations without having to go through the Cortes Generales. These are the ones that Health commits to approving this year:
- Royal Decree regulating the registration and conditions for authorization, manufacture, marketing, and use of biocides.
- Royal Decree regulating the Evaluation of Health Technologies.
- Royal Decree on the manufacture, presentation, and marketing of tobacco and related products.
- Royal Decree on the State Plan for preparedness and response to serious health threats.
- Royal Decree on the return and destruction of narcotic and psychotropic substances and narcotic medicines by pharmacy offices and services.
- Royal Decree reforming the procedure for authorization, registration, and dispensing conditions of industrially manufactured human medicines.
- Royal Decree establishing quality and safety criteria in radiodiagnosis and quality and safety criteria for nuclear medicine care units.
- Royal Decree establishing measures for the homogeneous treatment of information on waiting lists in the National Health System.
- Royal Decree on the special employment relationship of residency for the training of health science specialists.
- Royal Decree on the functions of the Guardia Civil Health Service and the determination of the psychophysical fitness of its personnel.