Biotechnology, AI and tobacco: the health agenda that Ireland will take to Brussels

Democrat agrees to the plans with which the new presidency of the Council of the EU wants to position health as a strategic economic asset, accelerate pharmaceutical and digital files, while being forced to resume entrenched debates such as that of tobacco taxation.

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Every semester, two diplomatic teams hand over the baton at the helm of the Council of the European Union. This is not a mere institutional formality. The rotating presidency plays a decisive role in the political and legislative orientation of the Twenty-Seven, setting the pace of negotiations, prioritizing certain files and relegating others to the background depending on the real possibilities of reaching consensus. This is precisely what will happen next July, when Cyprus hands over the baton to Ireland, a country that arrives in Brussels with a health agenda marked by a cross-cutting objective: to make health a key factor in economic competitiveness for the European Union.

The new presidency considers that health policy can no longer be analyzed exclusively from the perspective of citizen well-being. On the contrary, Dublin intends to integrate public health into the core of the community's economic and security strategy. Under the leadership of the Irish Minister of Health, Jennifer Carroll MacNeill, Jennifer Carroll MacNeill the Irish government will argue that resilient health systems are an indispensable condition for guaranteeing European productivity, innovation, and strategic autonomy.

According to drafts of the documents detailing Ireland's priorities for the next Council presidency, to which DEMÓCRATA has had access, the Irish Executive will promote the idea that a healthy population constitutes a first-class economic asset. The thesis it intends to convey to its European partners is that investments in prevention, diagnosis, and treatment should not be seen solely as public spending, but as tools capable of reducing future costs, strengthening the labor market, and stimulating technological innovation.

Women's health, at the center

One of the main novelties of the Irish health agenda will be the prominence given to certain pathologies that specifically affect women. In this area, the presidency intends to place endometriosis at the center of the European debate, a chronic disease that affects millions of women across the continent and which, according to various studies, continues to be underdiagnosed.

European Council
European Council -

Endometriosis occurs when tissue similar to the lining of the uterus begins to grow outside of it, affecting organs such as the ovaries, fallopian tubes, bladder, or even the intestines. Beyond its medical consequences, Ireland wants to focus on the significant economic and labor impact of this disease, especially in terms of absenteeism, productivity, and quality of life. The objective is to promote broader political recognition of these pathologies within European public health strategies, linking them directly to debates on competitiveness, the labor market, and demographic sustainability.

The Irish presidency also aims to accelerate several legislative files considered strategic for European industrial competitiveness. Among these are the negotiations on the Biotechnology Regulation I and the Directive on the placing on the market of genetically modified micro-organisms, two initiatives aimed at facilitating scientific innovation and strengthening the European biomedical research ecosystem.

Work will also focus on the practical application of the so-called Pharmaceutical Package, one of the most ambitious regulatory reforms promoted by Brussels in recent decades. This set of regulations seeks to modernize European pharmaceutical legislation, expedite patient access to innovative treatments, and strengthen the industry's competitiveness against the United States and China.

In parallel, Ireland wants to advance the update of the regulatory framework applicable to human organs and tissues intended for transplants and medical treatments, an area that is particularly sensitive from a health and ethical perspective. In the regulatory field, Dublin will also advocate for the simplification of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). The objective is to reduce administrative burdens, streamline certification procedures, and facilitate the arrival of new technologies in the European market without compromising safety standards.

Regarding the pharmaceutical package, the priority will be to accelerate its implementation and ensure that future EU rules translate into tangible benefits for both patients and the European industrial fabric.

The Critical Medicines Act gains weight

Another of the files that will receive a relevant political boost will be the future Law on Critical Medicines, conceived as a response to the vulnerabilities detected in pharmaceutical supply chains in recent years.

The regulation, which already has preliminary political backing among European co-legislators, aims to establish a legal framework capable of guaranteeing the continued supply of essential medicines within the Union. To this end, it contemplates joint purchasing mechanisms, solidarity tools among Member States, incentives for European industrial production, and new public procurement criteria aimed at strengthening the resilience of supply chains.

The initiative fully aligns with the open strategic autonomy strategy promoted by Brussels, especially in a context marked by geopolitical tensions and Europe's growing dependence on third countries for the manufacture of active pharmaceutical ingredients.

AI in pharmacies? 

The digital transformation of the healthcare sector will also occupy a prominent place on the Irish agenda. Sources consulted indicate that the presidency will prioritize the implementation of the European Health Data Space Regulation, one of the central pieces of the community digital strategy. The objective is to guarantee the secure exchange of health data, strengthen interoperability between national systems, and create a framework of trust that facilitates both research and the provision of cross-border medical services.

The presidency considers that the correct exploitation of clinical data can become an engine of innovation for the entire European economy. Therefore, Ireland also wants to promote regulatory frameworks that facilitate the development of solutions based on artificial intelligence applied to healthcare, always maintaining high standards of safety, traceability, and human supervision.

The challenge will be to find a balance between innovation and patient protection, an issue that will continue to gain weight in the coming years as the use of algorithmic tools in the diagnosis and treatment of diseases increases.

The experience accumulated after the COVID-19 pandemic continues to condition a large part of European health priorities. In this context, Ireland will seek to accelerate negotiations on the future Regulation on Preparedness and Response to Health Emergencies, promoted by the European Commission with the aim of improving community coordination in the face of future cross-border threats.

The intention is to strengthen the joint response capacity of the Member States through more agile procedures, more robust coordination mechanisms, and better strategic planning of critical resources.

This philosophy will also be transferred to the debates on the European Civil Protection Mechanism, where Dublin intends to deepen the integration of European health capabilities to deal with crises, natural disasters, or large-scale emergencies.

The main stumbling block: tobacco taxation

However, one of the most complex health files will continue to be the reform of the Directive on Tobacco Taxation.

The lack of consensus among Member States recently forced the Cypriot presidency to withdraw this matter from the agenda of the next Ecofin Council. For months, negotiating teams held intense technical and diplomatic discussions to try to bring positions closer. Nevertheless, divergences persist and several governments continue to maintain red lines that are difficult to overcome.

Diplomatic sources acknowledge that, despite some specific progress made in the latest negotiation rounds, the unanimity required to approve the reform remains out of reach.

From the Cypriot presidency, they maintain that all possible alternatives were explored to save the text, including compromise proposals aimed at balancing the opposing interests of the different community partners. However, the deadlock ended up prevailing just before the institutional handover to Ireland.

The currently frozen proposal is part of the European strategy to fight cancer and proposes a profound transformation of the tobacco market over the next decade. The approach rests on three fundamental pillars: regulatory harmonization, increase in minimum taxes, and automatic indexing of levies to inflation.

The President of the European Commission, Ursula von der Leyen and the President of Cyprus, Nikos Christodoulides at the informal European Council summit in Nicosia. ALEX MITA
The President of the European Commission, Ursula von der Leyen and the President of Cyprus, Nikos Christodoulides at the informal European Council summit in Nicosia. ALEX MITA -

The stated objective is to reduce consumption, combat smuggling, and minimize existing distortions between national markets. The latest drafts prepared by the Cypriot presidency contemplated a gradual tightening of fiscal pressure. For conventional cigarettes, the current mixed system—composed of a specific per-unit component, an ad valorem component linked to the sales price, and the corresponding VAT—was maintained, although significantly raising the minimum thresholds required.

The proposal stipulated that the total tax burden should represent at least 60% of the weighted average retail price, also setting an absolute minimum threshold of 200 euros per 1,000 cigarettes.

With this, Brussels aims to reduce the enormous price differences that currently exist between Member States, a circumstance that the Commission considers one of the main incentives for smuggling and cross-border purchases within the single market.

The Social Agenda

From a broader public health perspective, Ireland also aims to boost discussions related to substance use and harm reduction policies. The presidency will promote exchanges of good practices within the framework of the future European Union Drugs Strategy 2026-2030, addressing both prevention and risk reduction mechanisms associated with consumption.

Among the planned initiatives is the organization of a specific "mutual learning" meeting for national coordinators, focused on the relationship between problematic drug use and homelessness. The issue is gaining increasing relevance in numerous European capitals, where local authorities observe greater interaction between social exclusion, mental health problems, and addiction. Ireland believes that an effective response requires closer coordination between health, social, and housing policies, an approach that is likely to gain prominence during the next six months at the helm of the Council of the European Union.

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AI-GENERATED CONTENT

At what stage of the parliamentary process is the future Critical Medicines Act in the European Union?

Status of the future Critical Medicines Act in the EU (June 2026)

Brief answer: final phase, after the Parliament-Council political agreement

As of June 2026, the future Critical Medicines Act is in the final phase of the ordinary legislative procedure of the European Union. The European Parliament and the Council have already reached a provisional political agreement in the trilogues (closed on May 12, 2026), so the content negotiation is practically concluded. The file is now pending legal-linguistic revision and formal approvals by the Parliament (plenary vote) and the Council. Only after these steps will the signing, publication in the Official Journal of the EU, and subsequent entry into force of the regulation proceed.

1. Type of act and relation to pharmaceutical reform

Although it is usually presented as part of the reform of EU pharmaceutical legislation, the Critical Medicines Act is a separate legislative file: an autonomous Regulation (the Critical Medicines Act) complementary to the new general pharmaceutical Regulation and Directive. This regulation specifically focuses on:

– The identification of critical and essential medicines.
– The resilience and diversification of the supply chain.
– Measures on stockpiles, procurement, coordination, and response to shortages.

The proposal was presented by the European Commission on March 11, 2025, as part of a broader package aimed at strengthening the availability and supply of medicines in the EU, as reflected in analyses such as those from Gaceta Médica and technical summaries like that of Nitid.

2. Status in the European Parliament

According to summaries from the Parliament's “legislative train” and specialized press, the essential itinerary has been as follows:

January 20, 2026: the European Parliament adopts its first reading position on the proposed Critical Medicines Regulation, based on the report from the competent committee (ENVI).
Trilogues: at least three rounds of interinstitutional negotiation were held: February 2, March 16, and May 11, 2026.
May 12, 2026: a political agreement with the Council on a compromise text is announced.

In parallel, information gathered by media such as El Global indicates that, in the competent parliamentary committee, the normative pieces related to the supply of essential medicines were approved by large majorities (for example, 29 votes in favor, 3 against, and 6 abstentions for the regulation, and 30-2-6 for the related directive). This confirms that politically, the Parliament has already closed its position.

The next pending step in the Parliament is the plenary vote on the text agreed in trilogue, which various analyses place at the latest by October 2, 2026, according to information cited by the European Movement in this note on legislative priorities.

3. Status in the Council of the EU

On the Member States' side, the key milestones have been:

December 2, 2025: the EPSCO Council adopts its “general approach” on the Critical Medicines Act, defining its negotiating position. This phase is reflected in notes published by European information platforms such as InfoEuropa UV.
– Winter-spring 2026: development of trilogues with the Parliament.
May 12, 2026: Council and Parliament announce a provisional political agreement on the Regulation text, reported by sector media like Diariofarma and professional organizations such as the General Council of Medical Colleges in Médicos y Pacientes.

After that agreement, the Council is now in a mainly technical phase: validating the text resulting from the legal-linguistic revision and preparing the formal adoption as a regulation, likely by qualified majority.

4. Current phase and remaining steps

With the available information, the file is in the “formal adoption” phase of the ordinary legislative procedure:

Political negotiation closed: substantive content was agreed in trilogues; no major substantive changes are expected.
Legal-linguistic revision of the agreed text.
Formal approval in Parliament: plenary vote on the compromise text.
Formal approval in the Council: adoption of the regulation as an agenda item or in a forthcoming EPSCO Council.
Signing and publication in the OJEU: once signed by the Presidents of Parliament and Council, the regulation will be published and normally enter into force after 20 days (unless the text provides otherwise).

Several analyses suggest that the effective implementation of some obligations (e.g., preparation of critical medicines lists, resilience plans, or notification duties) could be phased throughout 2027, consistent with summaries in articles like those from Diariofarma and the context note from Salud y Fármacos.

5. Overall status within the “pharmaceutical package”

Within the set of EU pharmaceutical reforms, the Critical Medicines Act is one of the most advanced files. While the general pharmaceutical Regulation and Directive are still in broader negotiation phases, the Critical Medicines Act has already passed the substantive phase and is only pending the final formal steps before its definitive adoption.

What are the competencies and political background of Jennifer Carroll MacNeill, Ireland's Minister for Health?

Competencies and political background of Jennifer Carroll MacNeill

Jennifer Carroll MacNeill is the current Minister for Health of Ireland, appointed on January 23, 2025, and one of the emerging figures of Fine Gael, Ireland's main center-right party. She has been a Teachta Dála (TD) for the Dún Laoghaire constituency since 2020, a seat she renewed in 2024. Her profile combines political experience, advanced academic training in public policy, and a professional legal career as a solicitor and barrister. In health, her declared priorities revolve around improving access to medicines, ensuring supply, and strengthening the financial sustainability of the system.

Competencies as Minister for Health

According to the official biography from the Irish Department of Health, Carroll MacNeill is the head of the Department of Health and therefore the main political responsible for the State's health policy (gov.ie). This involves directing the strategic orientations of Irish public health, overseeing system performance (including the HSE, hospital network, primary care, and public health), and representing the Government on all health matters at both domestic and European levels.

The consulted sources do not provide an exhaustive list, article by article, of her legal competencies, but they confirm that her portfolio includes:

• The political direction of health and coordination of the cabinet's health priorities.
• Responsibility for planning and financing health services, including pharmaceutical policy.
• Representation of Ireland in European and international forums related to health and biotechnology.

Priorities and initiatives in health matters

During her tenure as Minister for Health, Carroll MacNeill has placed the issue of access to medicines and supply stability at the forefront. According to sector information, one of her goals is to accelerate public funding of innovative drugs to approach the legal deadline of 180 days to decide on their reimbursement, thus reducing delays for patients (farmaceuticos.com).

Another central line is to strengthen supply security against shortages. To this end, the minister promotes framework agreements with the pharmaceutical industry, while betting on the entry of generics and biosimilars and greater regulatory predictability, aiming to contain expenditure and ensure the financial sustainability of the health system (farmaceuticos.com).

On the European level, various reports note that Ireland, under her impetus, has placed biotechnology, medicines, and data as axes of its agenda for the EU presidency, highlighting the future Biotechnology Act as a “strategic priority” for European competitiveness (diariofarma.com). This connects her Health portfolio with industrial and innovation policy at the community level.

Previous political career

Carroll MacNeill joined and developed her career in Fine Gael, a pro-European and liberal-conservative party. She was elected TD for Dún Laoghaire in 2020 and re-elected in 2024 (Wikipedia, jennifercarrollmacneill.ie, finegael.ie).

Before becoming Minister for Health, she held various executive positions:

Minister of State for European Affairs and Defence between 2024 and 2025, with a prominent role in the European and security agenda (gov.ie).
Minister of State at the Department of Finance (2022-2024), responsible for financial services, credit unions, and insurance, an area in which she worked on regulatory and sector stability issues (jennifercarrollmacneill.ie, gov.ie).

In the parliamentary sphere, she was vice president of the Fine Gael parliamentary group and spokesperson on Equality, and was part of key committees such as Public Accounts, Justice, and the committee on the implementation of the Good Friday Agreement; she also joined the British-Irish Parliamentary Assembly (jennifercarrollmacneill.ie, finegael.ie). This path has given her experience in expenditure control, justice, constitutional issues, and British-Irish relations.

Education, ideological profile, and positions

Her biography highlights her training as a solicitor and barrister and, especially, her PhD in public policy, with research on political institutions and the judiciary (jennifercarrollmacneill.ie, gov.ie). Before being elected, she worked as a legal advisor and special advisor in various government areas and within Fine Gael's structure.

Regarding her ideological line, journalistic profiles cited by Wikipedia describe her as a supporter of a conservative fiscal approach, favoring low taxes and social benefits conditioned on resources. She has shown strong involvement in combating domestic violence and coercive control, and advocates for a stance of secularism in education. In foreign policy, she supports a two-state solution for the Israeli-Palestinian conflict and has spoken in favor of Ireland recognizing the State of Palestine.

In public policy and health, recent interventions emphasize her focus on using evidence and research for decision-making (YouTube) and her defense of balancing freedom of protest with the protection of essential health services and critical medical deliveries (YouTube). With this, she consolidates a profile mixing technocracy, emphasis on the rule of law, and an active social agenda on equality and rights.

What requirements and procedures must be fulfilled for the approval of new regulations on medical devices and in vitro diagnostics in the EU?

Approval procedure for new medical device and IVD regulations in the EU

Summary

In the European Union, new regulations on medical devices and in vitro diagnostics (IVD) must follow the ordinary legislative procedure: a proposal from the European Commission, joint negotiation and approval by the European Parliament and the Council, and subsequent publication and application in Member States. These rules set requirements for safety, clinical evaluation, post-market surveillance, and CE marking, which are then applied through national authorities and notified bodies. In Spain, their incorporation and application are articulated through royal decrees, orders, and the actions of the AEMPS, within the general framework decided in Brussels. I do not currently have detailed step-by-step information for each phase of each specific regulation, but I do have the general scheme governing this type of regulation in the EU and its impact in the Spanish context.

European regulatory framework: MDR and IVDR

European medical device policy is currently structured around two major regulations directly applicable in Member States:

1. Medical Devices Regulation (MDR)
Regulates “classic” medical devices (implants, instruments, medical software, etc.), replacing the old directives. It sets essential safety and performance requirements, a risk-based classification, conformity assessment rules, and obligations for manufacturers, importers, and distributors.

2. In Vitro Diagnostic Medical Devices Regulation (IVDR)
Applies to laboratory tests and IVDs (e.g., genetic tests or disease detection). It particularly strengthens clinical/diagnostic evaluation and control of so-called “in-house tests” by laboratories.

Both regulations were approved through the EU ordinary legislative procedure, but their deployment requires implementing legislation and administrative organization in each State, including Spain, which is channeled through national rules and coordination with the AEMPS and regional health authorities.

Legislative procedure for new regulations in the EU

Although I do not have an exhaustive breakdown regulation by regulation, the general scheme to approve new regulations or amend existing ones on medical devices and IVDs is usually as follows:

1. European Commission initiative
The Commission identifies the need to update the framework (e.g., to address new technologies, detected market surveillance deficiencies, or health crises). Before submitting a formal proposal, it usually launches public consultations and assesses economic, health, and social impact.

2. Proposal of regulation or directive
The Commission sends a draft text to the European Parliament and the Council. In the field of medical devices, regulations are normally preferred because they guarantee uniform application across all Member States without full transposition, although national adjustments are needed.

3. Debate and amendments in the European Parliament
The proposal is assigned to a competent parliamentary committee (typically environment and public health). MEPs debate the text, propose amendments, and vote on a report that will serve as the Parliament's position for negotiation with the Council.

4. Position of the Council of the EU
In parallel, Member States, gathered in the Council, discuss the proposal, incorporate changes, and set their own negotiating position. Health ministries and national agencies (in Spain, the AEMPS and Ministry of Health) participate in defining that stance.

5. Interinstitutional negotiation and adoption
Parliament and Council negotiate (trilogues) until they agree on a common text. When both institutions formally approve it, the regulation is adopted and published in the Official Journal of the EU with its entry into force and phased application deadlines.

Material requirements usually demanded

In the technical content of these regulations, the main requirements that sector agents (manufacturers, authorized representatives, distributors, importers, laboratories) must fulfill include:

Safety and performance: the product must meet essential requirements of safety, biocompatibility, risk management, and clinical/diagnostic performance, according to its risk class.
Conformity assessment: for most medium or high-risk products, the intervention of a notified body is necessary, which audits the manufacturer's quality system and technical documentation.
CE marking: once conformity is demonstrated, the product carries the CE mark, allowing its marketing throughout the EU internal market.
Post-market surveillance: manufacturers must monitor product behavior, report serious incidents, and apply corrective measures (including market recalls).
Transparency and traceability: unique device identification systems and registration in European databases are required, facilitating supervision and recalls.

Application in Spain and role of national authorities

Although the user asks about the European procedure, in Spain the practical application of these regulations involves:

1. Internal implementing legislation
Through royal decrees or other provisions, the Spanish Government adapts administrative organization and specifies aspects that the regulation leaves to the States (e.g., designation of competent authorities, sanctioning regime, or fees).

2. Competent authority and control
The Spanish Agency of Medicines and Medical Devices (AEMPS) acts as the competent authority for medical devices and IVDs, supervising the market, authorizing certain trials, cooperating with other States and the Commission, and managing incidents.

3. Territorial coordination
The autonomous communities, through their health inspection services, participate in control in hospitals, clinics, and laboratories, under the European and national regulatory umbrella.

I do not have more specific information on a particular regulation other than the general framework described. For more detailed analyses on a specific regulation (e.g., a punctual amendment of the MDR or IVDR), it would be necessary to consult the legal text and the corresponding Commission and Council documents.

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