Health opens the door to unify international vaccination services in Spain

A royal decree is a regulatory norm issued by the Government that develops laws or regulates administrative organization. It does not go through the Cortes, but it does follow a fairly structured internal procedure. After the public consultation (or the hearing and public information process), several technical and political phases still remain: final drafting of the text and reports, reports from other departments and advisory bodies, passage through the Government's collegiate bodies, approval by the Council of Ministers, and finally, publication in the BOE and entry into force.

1. Preliminary phases in the promoting ministry

Everything begins in the ministry competent by reason of the subject matter, which detects the need for regulation (for example, to develop a recently approved law, adapt European regulations, or reorganize administrative structures). Simplified, the initial phases are:

• Definition of the objective: the promoting management center (general directorate, state secretariat, etc.) identifies the problem to be solved and the objectives of the norm.
• Initial draft: the technical and legal services of the ministry prepare a first draft of the royal decree.
• Regulatory impact analysis report: a report is prepared analyzing the opportunity, economic and budgetary impact, social, gender, environmental, on SMEs, administrative burdens, etc.
• Consultation with internal units: the draft is contrasted with other internal units of the ministry itself (legal services, cabinet, technical general secretariat).

2. Prior public consultation and hearing / public information

Before approving a royal decree, the Government Law and good regulation rules generally require two types of participation:

• Prior public consultation: an announcement is published on the corresponding portal explaining the problem to be solved, the objectives, and possible regulatory alternatives. At this stage, there may not yet be an articulated text, only general lines. Opinions from citizens, companies, and organizations are gathered.
• Hearing and public information: at a later stage, already on a specific draft royal decree, the text is submitted to hearing of affected sectors and public information to receive specific allegations on the articles.

In some very justified cases (urgency, internal organizational norms, etc.) these procedures may be shortened or exceptionally omitted, but the general rule is to carry them out.

3. What steps remain after the public consultation?

If the prior public consultation has already been carried out, the typical procedure remaining until the approval of the royal decree includes, schematically, the following steps:

• a) Drafting the complete draft: based on the contributions from the consultation, the ministry prepares the articulated text of the royal decree and completes the regulatory impact report.
• b) Hearing and public information process (if not yet done): the text is published so that interested parties and the public can submit formal allegations. The ministry must analyze them and, if applicable, incorporate changes or justify why it does not.
• c) Reports from other ministries: reports are requested from ministries affected by subject matter (Finance if there is budgetary or fiscal impact, Labor if it affects labor relations, Economy, Ecological Transition, Equality, etc.). Often, these reports are processed coordinately through the technical general secretariat.
• d) Report from the Legal Advisory and regulatory quality: the ministry's legal services review the legality and regulatory technique of the text. Additionally, the coordination and regulatory quality unit of the General State Administration intervenes to verify that the royal decree respects the principles of good regulation (necessity, proportionality, legal certainty, etc.).
• e) Reports and opinions from advisory bodies: in certain cases, the project must be sent to the Council of State or other advisory bodies (for example, regulatory bodies or sectoral councils). Their opinions are usually not binding but carry great legal and political weight.
• f) Final version and integration of observations: with the reports and opinions received, the ministry adjusts the text and the report, justifying the decisions made (which allegations are accepted or rejected and why).
• g) General Commission of Secretaries of State and Undersecretaries: before going to the Council of Ministers, the royal decree usually passes through this preparatory body, where it is reviewed from an interministerial perspective.
• h) Approval by the Council of Ministers: the project is submitted to the Council of Ministers accompanied by the report and the mandatory reports. After deliberation, the Council approves it as a royal decree.
• i) Signature and publication in the BOE: the text, already as a royal decree, is signed by the King and the competent minister or ministers, and published in the Official State Gazette. From that moment it is a valid and enforceable norm.
• j) Entry into force: unless the royal decree itself provides otherwise (for example, a vacatio legis of several months), it enters into force twenty days after its publication.

4. Key ideas

In summary, after the prior public consultation, the most intense phase of legal and political drafting remains: hearing and public information on the articulated text, internal and external reports, advisory opinions, collegiate approval in the Council of Ministers, and publication in the BOE. Although the procedure is more agile than that of a law, the requirement of reports, opinions, and regulatory quality control makes the processing of a royal decree also complex and it can last several months.

The Ministry of Health has, at the state and exclusive level, the organization of international traveler vaccination services, integrated into external health. The key legislation is Law 33/2011, General Public Health Law, complemented by the historic Royal Decree 1418/1986 on external health, regulations on border control, and the application of the International Health Regulations (IHR-2005). From this legislation derive powers of planning, service provision, coordination with autonomous communities and international organizations, as well as epidemiological surveillance and emergency response. Below is a systematic summary of the main current functions.

General framework of external health and international health

Law 33/2011 dedicates a specific chapter to external health and international health, which it declares an exclusive competence of the State. Within this framework:

• The Ministry of Health is responsible for "organizing and guaranteeing" the provision of services linked to the international transit of people and goods, explicitly including international traveler vaccination.
• The idea of "border health" is surpassed and integrated into a policy of international health, linked to cooperation and Spain's participation in global alert and response systems.

Specific functions in international traveler vaccination

Expressly, Law 33/2011 establishes that, in exercising the competence of external health, the Ministry of Health must:

• Organize and guarantee healthcare for the international transit of travelers, including prevention of traveler diseases and injuries and, separately, international vaccination services.
• Articulate these services so that vaccination "is more accessible to citizens who must comply with this requirement," allowing collaboration with autonomous communities through management assignments or other legal formulas.
• Require and verify the necessary health authorizations and certifications in the international traffic of people, goods, and means of transport, including checking international vaccination or prophylaxis certificates required by the IHR or destination countries.
• In case of non-compliance with hygienic-sanitary norms, adopt proportional measures, reaching, if the risk requires, the suspension of activities of facilities or means of transport.

Application of the International Health Regulations and points of entry

The same Law 33/2011 designates the Ministry of Health as the National Focal Point with the World Health Organization (WHO) and makes it responsible for the application of the International Health Regulations (IHR-2005), in coordination with other departments. This implies:

• Managing international alerts that enter through the IHR, including those related to vaccine-preventable diseases.
• Maintaining the necessary national capacities to fulfill notification and response obligations.

Resolution of March 25, 2014 publishes the Council of Ministers Agreement that designates Spanish ports and airports as "points of entry with capacity to attend public health emergencies of international concern," according to the IHR-2005. It is also supported by Royal Decree 1418/1986, which attributes to the Ministry of Health a regime of coordinated and immediate action in the face of health emergencies in international traffic.

Health control at borders and interministerial coordination

International vaccination is part of a broader health control device at borders:

• Order PJC/756/2024 updates the delimitation of actions of official border control services functionally dependent on Health and Agriculture. It refers to articles 36 and 37 of Law 33/2011, which obligate the Ministry of Health to guarantee health controls of goods and international traffic of people, corpses, animals, and products.
• Order SPI/2136/2011, modified by Order SSI/2375/2014 and Order SCB/278/2019, regulates health control at borders of medicines, health products, and other products and the external health IT system. Although it focuses on goods, it is part of the external health framework in which vaccination obligations for travelers are inserted.

Economic and management aspects

The fee for international traveler vaccination, provided in article 29 of Law 13/1996, is articulated through fee code 058. The Resolution of December 23, 2009 and the Resolution of December 23, 2009 regulate the self-assessment and electronic payment of this fee, directly linked to vaccinations performed in authorized international vaccination centers.

Overall, the current legislation configures a system in which the Ministry of Health plans and guarantees international vaccination services, coordinates the network of centers and the relationship with autonomous communities, integrates vaccination into international surveillance (IHR-2005), and has economic and organizational instruments for its effective provision.

Other related regulations

Within the broader framework of external health, surveillance, and health structure, other provisions are inserted that, although they do not directly regulate international vaccination, contextualize the functions of the Ministry of Health: [link], [link], [link], [link], [link], [link], [link], [link], [link], [link], [link], [link], [link], [link], [link], [link].

In the consulted state regulations, there is no specific and detailed regulation of “international vaccination centers” as a differentiated category; rather, these are framed within the general regime of vaccination centers and units and within the competencies of external health. The key piece is Royal Decree 1277/2003, which sets the general bases for the authorization of health centers and defines the vaccination care unit, and Royal Decree 1418/1986, which attributes to the Ministry of Health the functions of external health, including traveler vaccinations. Based on this framework, the specific requirements (including many operational aspects) are completed through regional regulations and external health protocols, which are not detailed in the analyzed sources. No further information is available in the consulted sources about additional specific state requirements for international vaccination centers.

General framework of external health

Royal Decree 1418/1986, on the functions of the Ministry of Health and Consumption in external health matters, establishes that external health activities include “all those carried out in the surveillance and control of possible health risks derived from the import, export, or transit of goods and international traveler traffic.” Among the functions is expressly included the carrying out of “vaccinations and other preventive or prophylactic measures for public health reasons in the international traffic of people” and the issuance of medical certificates and personal international health documents, according to the International Health Regulations, as per Royal Decree 1418/1986 itself.

On this basis, the State designates ports and airports as points of entry with capacity to respond to public health emergencies (Council of Ministers Agreement published by the Resolution of March 25, 2014) and approves models of external health medical documents through Order SSI/200/2013. The Law 33/2011, General Public Health Law completes this framework, reinforcing state competencies in public health and external health, without entering into micro requirements for specific centers.

Authorization of health centers and vaccination unit

Vaccination centers, including those providing services to international travelers, are governed by the general authorization bases established in Royal Decree 1277/2003, of October 10, on the authorization of health centers, services, and establishments, its correction of errors ([link]) and its partial modification by Order SCO/1741/2006. This norm defines the catalog of centers and care units and sets the bases on classification, registration, and general requirements for administrative authorization.

In that catalog, Royal Decree 1277/2003 includes the care unit U.5 “Vaccination”, defined as “a care unit where health personnel store and administer vaccines. The custody and conservation functions of these will be under the responsibility of a pharmacist,” according to Royal Decree 1277/2003 itself. From this provision, at the state level, at least two basic requirements arise for any authorized center offering vaccination (including international):

• Health personnel qualified to administer vaccines.
• Responsibility for custody and conservation of vaccines assigned to a pharmacist.

The general system of authorization of health centers also implies compliance with structural and operational requirements set by the autonomous communities in development of Royal Decree 1277/2003 (infrastructure, equipment, quality system, etc.), but those detailed requirements are not included in the examined state norms.

Other related state elements

At the economic-administrative level, international traveler vaccination is subject to a specific state fee (code 058 “Fee for international traveler vaccination”), whose liquidation and electronic payment procedure is regulated in the Resolution of December 23, 2009 and whose inclusion in the electronic registry is recorded in another Resolution of the same date. The authorization of this fee is linked to fiscal measures laws such as Law 4/2004 and its interaction with previous norms like Law 14/2000, Law 24/2001, or Law 66/1997.

Regarding user and consumer rights, Royal Legislative Decree 1/2007, which approves the consolidated text of the General Law for the Defense of Consumers and Users, applies, complementing the provisions of Law 7/1996 and others. However, none of these norms detail conditions of cold chain, registration systems, or specific civil liability coverage for international vaccination centers; such aspects remain, according to available information, to regional development and external health practice.

Absence of specific state regulation and regional role

No state norm has been located in the BOE that, with the rank of law or ministerial order, establishes a closed set of particular requirements for “international vaccination centers” differentiating, for example, between public and private centers or setting concrete standards of training in travel medicine, registration systems, or civil liability policies. The available information suggests that, based on the general framework of external health (Royal Decree 1418/1986), public health (Law 33/2011), and authorization of health centers (Royal Decree 1277/2003 and its development), it is the autonomous communities and the external health services themselves who specify these requirements in their regulations and internal protocols. No further information is available in the consulted sources about those regional regulations or internal instructions.

Other cited normative links

The research also shows, due to their relation to health, data files, or state activities, the following references, which do not directly regulate international vaccination centers but are part of the general normative context: Order SND/1205/2020, Regulation (EC) 1760/2000, University of the Basque Country Resolution, Resolution on international treaties, correction of errors, Order of February 4, 2000, Regulation (EC) 1907/1999, University of Valencia Resolution, Regulation (EC) 3243/94, Regulation (EC) 212/94, CSIC Resolution, Spain–Morocco Transport Agreement, Order SAS/2738/2009, Order SCO/3597/2008, External Health Services Improvement Plan, Agreement with Algeria, Interbus Decision, Agreement with Slovakia, Scientific cooperation Decision, Avian vaccination Decision, Order HAP/2478/2013, Order APU/2074/2004, Order APU/325/2003, Foot-and-mouth disease vaccine Decision, correction of errors, Regulation (EC) 1825/2000, rectification of Regulation 1254/1999, Order December 27, 2001, Order SCO/3158/2003, Royal Decree 590/2005, Order PRE/407/2006, Royal Decree 1616/2005 and Instrument of adhesion to the MARPOL Protocol, as well as the creation of a National Reference Center in sports innovation, which is unrelated to the health field but appears among the results.