Imminent green light: the Medicines law and the Anti-Tobacco reform, ready for the Council of Ministers

Both draft bills have gone through the CGEYS and their approval is expected for this Tuesday, as confirmed by DEMÓCRATA.

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As DEMÓCRATA anticipated, the Ministry of Health was accelerating to approve in Council of Ministers before the summer break two important draft laws, the Medicines and the Anti-Tobacco. And indeed, those of Mónica García expect to comply. According to sources consulted by this newspaper, both have recently passed through the General Commission of Secretaries of State and Undersecretaries (CGSEYS) and would be ready to receive the green light, which is expected for this Tuesday.

The Draft Law on Medicines and Health Products, whose draft was exclusively revealed by DEMÓCRATA, introduces a new scheme of dynamic prices, leaving behind the “selected prices” that appeared in previous versions. This mechanism will be particularly aimed at medicines that no longer have commercial protection, such as generics, biosimilars or drugs with years of presence in the market, and seeks to stimulate competition without losing sight of the guarantee of supply.

The regulation also reinforces the concept of rational use of medicines and health products through a much broader approach than the one in force until now. The new wording incorporates a specific chapter within the National Health System and assigns this responsibility not only to health professionals but also to public administrations, patients, and the citizens themselves. In addition, it expressly recognizes the role of existing support structures both in the General Administration of the State and in the autonomous communities to promote a more efficient and safe use of these products.

The reform also introduces a greater flexibility in the groupings of equivalent medicines. Unlike what happened until now, it opens the door for different products of the same category to coexist with different prices. The supply capacity of companies and the prevention of possible supply problems become part of the criteria that will influence the configuration of prices, thus incorporating a strategic variable that until now had much less weight.

In parallel, the text separates more clearly the regulation of medicines and that of sanitary products. Although both continue to be linked to pharmaceutical provision when appropriate, each area will have its own regulatory development. This differentiation seeks to recognize the particularities of sanitary products in issues such as public funding, price review, the organization of groups, or the remuneration of distribution and dispensing channels.

Anti-Tobacco Law

Mónica García's team expects to approve in a second round the Draft Law for the reform of the Law on health measures against tobacco and regulating the sale, supply, consumption, and advertising of tobacco products, which received the first approval last September.

Its 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 to ensure they must comply with the requirements related to marketing and advertising.

From the Anti-Tobacco Law, the expansion of smoke-free spaces and the equalization of electronic cigarettes to conventional tobacco stand out

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 elimination of commercial communications or promotions in equipment, facilities, and furniture located in public or collective use spaces, which encompasses elements present in bars, nightclubs, terraces, or other leisure establishments. Thus, signs, posters, urban or hospitality furniture that incorporate logos, images, or references to tobacco product brands or related products cannot be used.

Real Possibilities?

The Ministry of Health is one of the departments with the most open initiatives, a overflowing will of optimism that, however, does not translate into news in the BOE. One thing is the governmental processing, where PSOE and Sumar have to come to an agreement (and not always), and another, the parliamentary processing, a path riddled with obstacles due to the lack of stable majority and a legislature that is reaching its final stages.

The Health Commission of Congress has important bills blocked, such as the Cohesion bill, the Universality bill, the Antiprivatization Law, or the Patient Organizations Law. A list that is expected to soon include both the anti-tobacco reform and the Medicines reform.

The problem for the department led by Mónica García is that none of these initiatives have a favorable horizon. The usual partners of the Government are especially wary on health issues due to a matter of competencies, but even counting on them, since the breakup of Junts with PSOE the numbers do not add up. The sum of PSOE (121), Sumar (26), ERC (7), EH Bildu (6), PNV (5) and the members of the Mixed group, Águeda Micó (Compromís), BNG, Coalición Canaria and the four from Podemos, results in a total of 172.

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What is the current parliamentary status of the draft bills on Medicines and the Anti-Tobacco reform after their passage through the Council of Ministers?

Available data indicates that the future Medicines Law has not yet entered the parliamentary phase: it remains in the draft bill phase within the Government, after passing through the Council of Ministers and the public consultation process. In contrast, for the announced anti-tobacco regulatory reform, there is no record yet of any bill or proposal registered in the Congress or Senate, so its parliamentary processing has not yet begun. Below I detail the status of each and clarify some initiatives that appeared in searches but do not correspond to these reforms.

1. Draft Bill on Medicines and Medical Devices

1.1. Current phase

The Ministry of Health processed the Draft Bill on Medicines and Medical Devices as urgent. According to the Council of Ministers reference, on April 8, 2025, the Council of Ministers adopted an agreement authorizing the urgent administrative processing of the draft bill and linking it to the commitments of the Recovery, Transformation and Resilience Plan (component C18, reform R5).

Subsequently, the text was subjected to public consultation and information between April 9 and 30, 2025, according to the official Ministry of Health record and the draft bill text available in PDF (public consultation text). There is no trace that the Council of Ministers has yet approved the final text as a bill nor that it has been sent to the General Courts.

With the available information, the current situation is:

  • Phase: pre-legislative within the Government (draft bill).
  • Milestones achieved: Council of Ministers agreements of 4/8/2025 and public consultation 4/9–4/30/2025.
  • Pending milestones: closure and analysis of allegations, mandatory reports, if applicable, opinion of the Council of State and, finally, approval as a bill and submission to the Congress.

Therefore, as of today there is no file in the Congress or Senate corresponding to this draft bill, and it cannot yet be strictly called a “parliamentary status.”

1.2. Related but distinct initiatives

Other initiatives on medicines appear in searches that may cause confusion but are not the future Spanish Medicines Law:

  • In the Senate, there is the Proposal for a Regulation of the European Parliament and the Council on the availability and safety of the supply of essential medicines, with identifier (15)574/000050, whose record is on the Senate website (initiative 574/000050). This is an EU regulatory proposal, not the national medicines law.
  • Also in the Senate, there is a communication from the Diputación of Huelva (15)812/000087, related to Law 7/2023 on animal welfare and Royal Decree 666/2023 on veterinary medicines; its record is found in this initiative 812/000087. It is a concluded initiative unrelated to the new general medicines law.

2. Anti-tobacco regulatory reform

2.1. Absence of bill or proposal in the General Courts

For the announced anti-tobacco regulatory reform, specific searches in the Congress (such as “anti-tobacco regulatory reform”) have not returned any bill or law proposal in the XV Legislature with that purpose. Consequently, it can be stated that, with the available information, the anti-tobacco reform has not yet been registered in the General Courts as a legislative initiative.

This implies that, strictly speaking, it has no parliamentary status: there is no publication of the text as a bill or proposal, no opening of amendment periods, nor identifiable committee, plenary, or working group phases. If the Government is working internally on a draft bill or modifying regulations via royal decree, those works have not yet materialized into a recognizable parliamentary file in the consulted databases. No further information is available in the consulted sources about the details of its internal processing.

2.2. Other reforms that are not anti-tobacco

In the same searches, several reforms unrelated to anti-tobacco policy appear, but whose files are advanced and may have been confused due to similar terms. Notably, the Proposal to reform the Statute of Autonomy for Castilla-La Mancha (file 127/000002), in full processing in the Congress, with multiple publications and amendments. Its texts can be consulted in various official bulletins of the Congress: initial publication of the initiative (BOCG-15-B-242-1), intermediate publications (BOCG-15-B-242-2), total amendments (BOCG-15-B-242-3) and article amendments (BOCG-15-B-242-4). The tracking record is available on the Congress website at [link], but it is a statutory reform, not tobacco regulation.

In summary: the anti-tobacco reform you mention, despite being politically announced, is not yet recorded as a bill or proposal in the Congress or Senate, so it remains, at best, in the Government's internal phase.

What timelines could the Government follow to transform the draft Medicines Law into a bill and submit it to Congress? What substantive changes does the draft of the new Medicines Law introduce compared to the current Law 29/2006? What specific measures have been publicly advanced regarding the future anti-tobacco reform (smoke-free spaces, vapes, taxation, etc.)?

What are the competencies attributed to the Ministry of Health according to Spanish legislation?

The competencies of the Ministry of Health are generally defined in the royal decrees of basic organic structure and in state health legislation. According to this regulation, the Ministry assumes the proposal and execution of the Government's policy in health and public health matters, as well as the general coordination of the National Health System (SNS) and certain pharmaceutical policies. Additionally, it performs functions in health surveillance, sanitary border control, pharmaceutical and medical products, digital health, and international relations in the health field. Below is a summary of these competencies by major blocks, taking as reference, among others, the Royal Decree 1047/2018 and the mention of Royal Decree 718/2024 included in its erratum.

1. General functions of the department

The royal decrees of basic organic structure assign to the Ministry of Health, transversally, the function of developing and proposing to the Government the health and public health policy, and ensuring its execution within the scope of the General State Administration. This includes normative initiative in state health matters (laws, royal decrees, ministerial orders) and strategic planning of health policy.

Likewise, the Ministry exercises the superior management of its directorates and attached public bodies (for example, the Spanish Agency for Food Safety and Nutrition, which creates its electronic headquarters through the resolution published in the BOE according to this AESAN resolution). It also assumes budgetary functions (setting spending limits and subsidies, as reflected in Order SND/147/2025) and management of its own personnel and material resources.

2. Health, public health, and coordination with Autonomous Communities

In a decentralized system, the Ministry of Health acts as the general coordinating body of the SNS and public health policies. In light of recent regulations, it is assigned functions such as:

  • Defining the common service portfolio of the SNS and its periodic updating, through royal decrees and orders, as illustrated by the portfolio modification by Order SND/454/2025 or the creation of the Advisory Committee for the genetics portfolio and portfolio changes by Order SND/606/2024.
  • Management of cohesion and compensation instruments between territories, such as the Health Cohesion Fund, whose regulation is updated, for example, in Order SND/976/2024.
  • Regulation of human and care resources at the state level, reflected in norms such as Order SND/496/2024, which creates statutory personnel categories in the National Institute of Health Management.

Additionally, the Ministry coordinates actions against public health risks, including sanitary border control and certain competencies in food safety and external health. An example is Order PJC/756/2024, which defines the actions of official border control services functionally dependent, among others, on the Ministry of Health.

3. Pharmacy, medical devices, and pharmaceutical provision

Competencies in medicines and medical devices are one of the department's core areas. From the regulations published in the BOE, it can be identified that the Ministry:

  • Updates the reference pricing system for medicines financed by the SNS, as done by Order SND/1074/2024 and its subsequent annual update by Order SND/1118/2025.
  • Regulates aspects of pharmaceutical provision and medical devices, including granting subsidies in this area, as covered by Royal Decree 666/2025.
  • Intervenes in the authorization of health centers and services by modifying annexes of Royal Decree 1277/2003, according to Order SND/1002/2024.

4. Digital health, health information, and international coordination

The Ministry has strengthened in recent years its competencies in digital transformation and health information management. Order SND/76/2025 creates and regulates the Ministerial Commission for Digital Administration of the Ministry of Health, which channels the functions of planning, coordination, and monitoring of internal digitalization and electronic services linked to health.

In parallel, the department promotes SNS information systems and participates in the international coordination of health policies (for example, in the European Union and international organizations), although available sources are limited to occasional references and do not allow detailing these functions article by article. No further information is available in the consulted sources about the specific content of Royal Decree 718/2024, beyond its erratum, which alludes to coordination aspects with European agencies in drug matters.

5. Other relevant competencies

Recent ministerial orders also show transversal competencies such as:

  • The regulation and management of the Ministry's archival system and its bodies, according to Order SND/671/2025.
  • Participation in the Pharmaceutical Industry Strategy through presence in interministerial bodies such as the Committee created by Royal Decree 664/2025.

Overall, these regulations allow concluding that the Ministry of Health concentrates the state health policy, coordinates the SNS and basic pharmaceutical policies, exercises external health and sanitary product control, and leads digitalization and standardization of health information within the General State Administration.

Could you detail how the Ministry of Health is internally organized after Royal Decree 718/2024, for example in secretariats of state and general directorates? What exact role does the Ministry of Health have in the Interterritorial Council of the National Health System and how are decisions made there? What regulations specifically govern the pharmaceutical policy and medicine pricing managed by the Ministry of Health?

What were the results of the last general elections for PSOE, Sumar, ERC, EH Bildu, PNV, and the Mixed Group deputies?

In the last general elections on July 23, 2023, PSOE obtained 121 seats and around 31.7–31.68% of the national vote; Sumar achieved 31 seats and 12.33%; ERC secured 7 deputies with 1.89%; EH Bildu got 6 deputies and 1.36%; PNV obtained 5 deputies and 1.12%. The Mixed Group was initially composed of 8 deputies from various small parties, but as a parliamentary group and not an electoral list, it does not have its own vote percentage. These figures come from the official count of 23-J, collected in RTVE's 2023 Congress results special and press summaries.

Results by party (seats and vote)

According to the final count of the general elections, compiled in the Ministry of the Interior special and disseminated by media such as RTVE's results special, the graphics of El País and data analysis from EPData, the distribution for the forces you ask about was as follows:

  • PSOE
    • Seats: 121 deputies.
    • National vote percentage: 31.68% (7,821,718 votes).
    • These data are confirmed in multiple subsequent analyses referencing 23-J (for example, survey comparisons collected by Demócrata in Target Point, GESOP, Sigma Dos or InvyMark).
  • Sumar
    • Seats: 31 deputies.
    • National vote percentage: 12.33% (3,044,996 votes).
    • Included Podemos and other forces to the left of PSOE, as various survey aggregators analyzed by Demócrata recall in this aggregator.
  • ERC (Esquerra Republicana de Catalunya)
    • Seats: 7 deputies.
    • National vote percentage: 1.89% (466,020 votes).
    • Lost 6 seats compared to the 2019 general elections, a fact cited in several post-election analyses such as those from El País by communities and press summaries like Infobae or CNN en español.
  • EH Bildu
    • Seats: 6 deputies.
    • National vote percentage: 1.36% (335,129 votes).
    • Gained one seat compared to 2019; its weight in Congress and in the investiture negotiation is extensively analyzed in Demócrata's report “Partners who pressure but do not strangle”.
  • PNV (Basque Nationalist Party)
    • Seats: 5 deputies.
    • National vote percentage: 1.12% (275,782 votes).
    • Maintained its representation compared to the previous legislature; its role as a key partner is also described in the cited Demócrata article and in later analyses about Euskadi such as this Basque sociometer or this territorial balance.

The percentages indicated for ERC, EH Bildu, and PNV are always over the total valid national vote. In their main constituencies (Catalonia for ERC; Basque Country and Navarra for EH Bildu and PNV) their percentages are much higher, but the standard data published by the Electoral Board and the Ministry of the Interior are offered at the national scale, as can be seen in comparative tables used by media such as ABC, La Razón or historical series analyses from Electoral History.

Mixed Group: 8 deputies after 23-J

The Mixed Group of the Congress does not run as its own electoral list but groups deputies from parties that do not meet the requirements to form a parliamentary group. After 23-J it was initially formed with 8 deputies, coming from several territorial scope formations (including BNG, Canary Coalition, UPN, PRC, Teruel Existe, or CUP, according to count summaries offered by El Mundo and the interactive map of RTVE).

For that reason, there is no unified vote percentage for the Mixed Group: each of those parties has its own percentage (usually very low at the national scale) and their implantation is limited to one or a few provinces. The press and analysts usually refer to this group more by its composition and its role in parliamentary arithmetic than by an aggregated vote figure, something seen in pieces like the analysis on groups and seat transfers in the Congress and Senate by Demócrata ([link]).

Context and additional references

The 23-J data are used today as a reference for surveys and projections published by Demócrata and other media (for example, GESOP, Hamalgama, Sociométrica, CIS November, CIS February, survey average, Sociométrica 2025, La Sexta Barometer, Ipsos, [link], etc.). These works coincide in taking as a starting point the figures I have summarized: 121 seats for PSOE, 31 for Sumar, 7 for ERC, 6 for EH Bildu, 5 for PNV, and 8 deputies in the Mixed Group.

Other electoral and legislative context documents, although they do not provide more detail on the 23-J results, help understand the subsequent political environment: Demócrata's analyses of commissions and spokespersons (Hacienda spokespersons, commission constitution), as well as results of other electoral processes (European in the BOE: JEC Agreement; Basque and Catalan regional elections collected by INE in EPV 2024 and EPC 2024 or by the Basque Government in this vote forecast study), which serve to compare the relative strength of these parties at different institutional levels.

Can you break down how those seats are distributed by provinces for PSOE, Sumar, ERC, EH Bildu, and PNV? Which specific parties currently form the Mixed Group and how many deputies does each contribute? How did these 23-J results translate into Pedro Sánchez's investiture and the agreements with ERC, EH Bildu, and PNV?

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