Ferrer and Vinces present the program of their conference on public procurement of medicines: speakers and discussion panels

Modifying public healthcare procurement does not always require approving a new law. The procedures depend on whether one wants to take advantage of existing possibilities, develop its regulation, or change the legal rules. The main reference is Law 9/2017 on Public Sector Contracts (LCSP), along with regional competencies and European requirements.

1. Changes through specifications and administrative decisions

If the goal is to incorporate quality, innovation, or environmental aspects related to the contract's object, it is not necessarily required to reform the LCSP: it already pursues the best quality-price ratio. There are also instruments for aggregated and innovative purchases.

The healthcare administration would have to justify the need, choose the permitted procedure, approve the file, the expenditure, and the specifications, and process the tender. Internal instructions can standardize practices, but they cannot modify the law nor create exceptions to publicity or competition. Health explains the possibilities of public procurement of innovation.

2. Regulatory development and centralization

When the change fits within the law, it may require a royal decree, a ministerial order, or a regional regulation. The file must include justification and impact assessment, mandatory reports, and the corresponding consultation, hearing, and public information procedures. Royal decrees are approved by the Council of Ministers; orders by the competent ministry. Afterwards, they are officially published.

There is a specific authorization to centralize healthcare purchases. The twenty-seventh additional provision of the LCSP allows declaring supplies and services for centralized acquisition by order of the Ministry of Health, following a favorable report from the competent Treasury body. The Order SND/682/2021 applies this mechanism through framework agreements: it sets conditions to award subsequent contracts. Autonomous communities can join through the corresponding agreement; they are not automatically incorporated.

3. Legal reform: when and how

To create exceptions or alter legally established requirements, a norm with the rank of law would be necessary: modifying the LCSP or approving a healthcare law that expressly introduces those changes. The ordinary route would be an ordinary law, not an organic law since it concerns healthcare.

• Government preparation: draft bill, impact assessment, public participation, and required reports; subsequently, approval of the project by the Council of Ministers and submission to the Congress.
• Congress: publication and initial period of fifteen working days for amendments, extendable; debate on the entirety if such amendments are presented; committee report and opinion. Final approval may occur in a committee with full legislative competence, without a final plenary vote.
• Senate: may approve, amend, or veto. The Congress decides on amendments and can override the veto by absolute majority or, after two months, by simple majority.
• Closure: sanction, promulgation, publication in the BOE, and entry into force on the scheduled date.

A parliamentary bill follows a similar path but usually requires consideration: voting on whether to start its processing. Government projects do not require this procedure, according to the Congress Regulations.

4. Autonomous communities and urgent procedure

The autonomous communities can approve laws, decrees, and organizational decisions for their health services, respecting the state bases, as recalled by STC 68/2021. A territorial coordination agreement does not replace the necessary norms.

Exceptionally, the Government could resort to a decree-law for extraordinary and urgent necessity, subject to constitutional limits and parliamentary validation within thirty days. In any route, European rules must be respected and it must be specified how the change will apply to existing contracts and future tenders.

The Director General of the Common Portfolio of Services of the National Health System and Pharmacy leads the body responsible for the common portfolio of benefits, pharmaceutical policy, and certain financing and healthcare cohesion functions. Their competencies are mainly set out in Article 5 of Royal Decree 718/2024, of July 23, which develops the basic organic structure of the Ministry of Health, modified by Royal Decree 1137/2025, of December 10.

The regulation assigns the functions to the Directorate General, dependent on the State Secretariat for Health, and distributes their exercise among its subdivisions. Therefore, not all should be interpreted as personal and exclusive decisions of its holder.

1. Pharmaceutical policy, financing, and pricing

Article 5.1 entrusts them with "the direction, development, and execution of the Department's pharmaceutical policy." Section 2 specifies these responsibilities:

• Public financing: deciding on the financing of each medicine and its indications, and of medical devices dispensed via official prescription; determining prescription and dispensing conditions, including prior authorizations, and assigning national codes to financed medical devices.
• Prices: providing technical and administrative support to the Interministerial Commission on Medicine Prices; preparing and applying general price revisions; proposing maximum prices for medical devices and issuing reports on distribution and dispensing margins.
• Economic conditions: proposing financing conditions, patient contributions, and exclusions of medicines; processing offers to the public system, managing contributions based on sales volume, and reporting on pharmaceutical expenditure.
• Coordination and rational use: coordinating with autonomous communities on pharmaceutical provision and regulation; proposing prescription and hospital order requirements and common collaboration criteria with pharmacies.
• Information and evaluation: managing information on financing, prices, prescriptions, and hospital purchases; coordinating pharmacological protocols, technology evaluation, and health outcomes monitoring.
• Advertising, training, and control: controlling advertising and the quality of professional information; promoting health education, pharmaceutical care, training, and scientific collaboration; participating in regulation, instructing and resolving sanctioning procedures within its competence, promoting precautionary measures, and reporting on appeals.

2. Service portfolio and health evaluation

In this area, they are responsible for unifying and guaranteeing health insurance, preparing and updating the common portfolio, ordering benefits, and defining their guarantees. They must also monitor compliance with autonomous communities.

Additionally, they coordinate the Spanish Network of Health Technology Assessment Agencies and Benefits; identify emerging technologies and organize evaluations, monitoring studies, and supervised uses. They prepare studies on health needs and resources, analyze system financing and economic needs, evaluate the economic impact of benefits, and prepare health expenditure statistics.

3. Cohesion, specific benefits, and European cooperation

• Promote efficiency and develop and manage the Health Cohesion Fund and the Assistance Guarantee Fund.
• Establish criteria and procedures to designate centers, services, and reference units and coordinate their integration into European networks.
• Manage the fundable supply of dietary and orthopedic products and review their maximum financing amounts.
• Coordinate cross-border healthcare procedures and support European Reference Networks.

4. Reform and organization

The December 2025 reform transferred coordination and regulatory management on assisted human reproduction and reproductive cells to the Directorate General of Public Health and Health Equity, previously attributed to this Directorate General.

Pharmaceutical functions are articulated through the Subdirectorate General of Pharmacy; benefits and compensation functions through the Subdirectorate General of SNS Service Portfolio and Compensation Funds. Pharmaceutical information management is carried out in collaboration with the Spanish Agency of Medicines and Medical Devices.

References: BOE of 07/24/2024 and 2025 reform.

Public administrations must incorporate social and environmental criteria in the procurement of medicines when they are related to the object of the contract. It is not enough to reward a laboratory for its sustainable reputation: the requirements must be objective, proportionate, transparent, and verifiable, respect competition, and maintain healthcare guarantees.

1. Legal basis and connection with supply

Article 1.3 of Law 9/2017 on Public Sector Contracts (LCSP) establishes the transversal and mandatory incorporation of these criteria, provided they relate to the contractual object. The law incorporates European public procurement directives into Spanish law.

The connection may refer to the medicine or processes in its life cycle: manufacturing, packaging, transport, storage, or waste management. For example, improvements in logistical packaging or working conditions of those executing the supply may be considered. In contrast, a general social responsibility policy, without demonstrable connection to the contracted service, does not justify an advantage by itself.

2. Choosing the appropriate instrument

The administration must distinguish between functions that are not interchangeable:

• Technical specifications: set the minimum characteristics required of the supply.
• Award criteria: allow comparing offers and valuing social or environmental improvements to obtain the best quality-price ratio.
• Special execution conditions: bind the awardee during contract fulfillment. Article 202 requires including at least one condition of social, environmental, or employment-related nature.
• Solvency: certifies the supplier's capacity. Environmental requirements used for this purpose must be necessary and proportionate to the contract.

Including a scoreable environmental improvement does not replace the obligation to establish the corresponding special execution condition.

3. Defining and accrediting criteria beforehand

The specifications must specify what is required or valued, its weighting, the evaluation method, and supporting documents. Open expressions like “sustainable supplier” without indicators allowing offer comparison and commitment verification should be avoided.

For example, if the environmental footprint of the supply is valued, the scope of the calculation and admissible evidence must be defined so that all companies compete on comparable bases. Labels and certifications can serve as proof but legally valid equivalences must be accepted; they cannot become an unjustified barrier.

4. Respect equality and competition

Requirements cannot unduly favor a company, technology, or geographic origin. Their intensity must be proportionate to the service and not unnecessarily restrict participation. Preliminary market consultations can help understand which improvements are feasible but do not replace the legal justification of the specifications.

5. Maintain pharmaceutical guarantees and control compliance

Sustainability does not allow lowering the quality, safety, or efficacy of the medicine nor altering its authorized storage and distribution conditions. Procurement must also respect the applicable financing and pricing regime. The consolidated text on medicines requires preserving quality during transport: a less polluting logistical solution cannot compromise conservation.

Finally, the specifications must foresee evidence, monitoring, and consequences for non-compliance, including penalties or termination when appropriate. The legal key is to contract concrete and verifiable commitments, not general declarations from the supplier, maintaining patient safety and supply continuity.