The Ministry of Health has initiated the process of prior public consultation for the approval of the Draft Royal Decree on international vaccination, with which it aims to establish an updated and coherent regulatory framework throughout the country.
Thus, citizens, organizations, and associations that wish to do so may submit their contributions on the points included in the future regulation until September 7, via the email "saniext@sanidad.gob.es". The purpose is to respond to the lack of a comprehensive, systematic, and up-to-date regulation of international vaccination activities.
With this Royal Decree, it is also intended to correct the absence of common and well-defined criteria regarding the minimum requirements for authorization, organization, operation, and supervision of the centers that offer these services; as well as the lack of a homogeneous definition of the portfolio of international vaccination services, the interventions it encompasses, and the conditions for its provision.
The document disseminated by the Ministry of Health also includes the existing differences in certain organizational and procedural aspects, which make it necessary to reinforce the homogeneity in the provision of these services throughout the national territory. It also emphasizes the importance of improving the accessibility of the population to international vaccination services through new modalities of care, including telephone consultation when appropriate.
At the same time, it seeks to address the lack of a common framework for the management, documentation, registration, and monitoring of international vaccination and prophylaxis actions, which ensures the traceability, quality, and interoperability of the information. It also aims to overcome the absence of shared criteria that allow for proper organization and coordination of the network of International Vaccination Centers of External Health and the authorized centers to provide these services.
A dispersed and outdated regulation
The Draft Royal Decree aims, furthermore, to correct the lack of adaptation of the current regulatory framework to the present patterns of international mobility and to the evolution of health risks linked to travel abroad. As context, it is noted that the current regulation in this area is fragmented into various norms of different ranks and origins, among which are international provisions, state health regulations, and specific regulations on External Health.
In this sense, the regulatory proposal seeks an efficient provision of international vaccination services and to guarantee the quality and safety of the actions, providing legal certainty and ensuring equity in access to the service. Likewise, it will facilitate the integration of international vaccination into national strategies for epidemiological surveillance and preparedness against cross-border health risks, through uniform procedures for the registration of administered vaccines, the notification of incidents, and the management of alerts.
The document emphasizes that all of this will help to strengthen the capacity of the health system to prevent and control threats to public health, given that international vaccination is a key activity to protect the health of people traveling to geographical areas with specific risks.