Radiological Protection

On December 29, 2023, Decree-Law no. 139-D/2023 was published, instituting substantial amendments to the legislative framework governing radiological protection (Decree-Law no. 108/2018, of December 3, which incorporates Directive 2013/59/Euratom into the Portuguese legal system).

Although Decree-Law no. 139-D/2023 entered into force on the January 1, 2024, the first set of main changes enacted by this legislation only became effective on the July 1, 2024.

Within the first set of main changes, the following key points are underscored:

•  Introduction of the Health Regulatory Entity (Entidade Reguladora da Saúde – ERS) as the competent authority within the scope of practices connected with medical exposures, and consequent modification of the responsibilities of the competent entities;
• Clarification of situations where registration, license and insurance are required;
• Changes to the recognition of professional qualifications in the area of radiological protection.

(i)           Introduction of ERS as a competent authority for practices involving medical exposure

Considering the regulatory and supervisory functions of the Health Regulatory Entity (Entidade Reguladora da Saúde – ERS) in the health sector, covering the public, social, and private sectors, Decree-Law no. 139-D/2023 introduced ERS as a competent authority within the scope of the radiological protection framework, for practices related with medical exposures, and consequently altered the distribution of functions previously allocated to APA in this context, with effects as of July 1, 2024.

ERS and the Portuguese Environment Agency (Agência Portuguesa do Ambiente – APA) jointly prepared an interpretative note (available here) to assist with the application of Decree-Law no. 108/2018. This note outlines the allocation of functions between the two entities, and it is clarified that APA is accountable for all situations related to radiological protection, excluding those involving practices with medical exposure, for which ERS holds responsibility. However, there are still certain functions/assignments related to practices involving medical exposure for which the responsible entity needs to be defined.

It is worth noting that as of the July 1, 2024, authorization applications to pursue practices involving medical exposures are to be submitted directly to ERS. Applications that were previously being processed by APA for this category have been transferred to ERS, which will oversee their further processing. ERS has also highlighted that the holders of medical exposure practices must be healthcare providers with facilities registered in the system operated by ERS, whereby the location of the equipment for which the practice authorization will be requested must match the location of the facilities.

Notwithstanding the above, the responsibilities of the General Inspection of Health Activities (Inspeção-Geral de Atividades de Saúde – IGAS) in terms of monitoring compliance with the obligations imposed by this legal framework in the area of healthcare, in both the public and private sectors, remain unchanged.

(ii)          Clarification of situations where registration, license and insurance are required

Experience in applying Decree-Law no. 108/2018 highlighted that there were uncertainties and ambiguities regarding the need to obtain registration versus licensing for certain practices related to radiological protection, as well as the situations where insurance is demanded. Consequently, it has become essential to provide clarification on these issues.

Accordingly, Decree-Law no. 139-D/2023 introduced alterations to Article 22 of Decree-Law no. 108/2018, which foresees which practices are subject to registration or licensing, and to Article 23, which foresees which practices are exempt from prior notification. As an example, after much discussion with the Professional Association of Veterinary Medics, it has been defined that the operation of radiation generators at a fixed location or not for veterinary purposes will only require registration, instead of a license.

As for insurance requirements, Decree-Law no. 108/2018 determines that all holders of practices subject to licensing/registration are obligated to compensate whenever there is harmful impact on the environment or individuals and their property as a result of an accident or any operational anomaly, regardless of fault. Accordingly, it was previously defined that said holders had to have civil liability insurance. In this context, Decree-Law no. 139-D/2023 clarified that it is the holders of practices involving sealed radioactive sources of high activity specifically that must have civil liability insurance, whereby the minimum capital to be covered and the conditions will still be defined by Ordinance.

It was also clarified that it is prohibited to exclude radiological risks in civil liability insurance contracts for activities covered by the legal framework on radiological protection.

(iii)         Changes to the recognition of professional qualifications

Under Decree-Law no. 108/2018, it was necessary for professionals performing functions in the context of radiological protection (i.e., radiological protection specialists, radiological protection delegates (formerly designated as “persons responsible for radiological protection”) and specialists in medical physics) to obtain a formal recognition of their competences prior to engaging in these functions.

The obtainment of the recognition of professional qualifications of radiological protection specialists and the former “persons responsible for radiological protection” was regulated by Decree-Law no. 227/2008. This regime has been revoked by Decree-Law no. 139-D/2023, with effects as of January 1, 2024. Notwithstanding, the recognitions issued under the previous regime remain valid under the transitory rules.

The new terms of recognition of professional qualifications of radiological protection specialists will take effect on January 1, 2025. As for radiological protection delegates, these professionals will no longer be subject to a recognition process of their professional qualifications but will have to meet certain requirements regarding their training. These changes will also be applicable as of on January 1, 2025. 

The intention was to consolidate the requirements for recognition of professional qualifications and training of radiological protection professionals under the same legislative framework (i.e., under Decree-Law no. 108/2018), without prejudice to the Ordinances still to be published on these matters.

As for the recognition process of specialists in medical physics, this process remains unaltered. However, Decree-Law no. 139-D/2023 has introduced a new requirement, with effects as of July 1, 2024: specialists in medical physics who, in the context of the recognition process of their professional qualifications, obtain training in public health units, must be admitted to training through tender procedures for the conclusion of an employment contract in public functions with the Executive Directorate of the National Health Service, for an uncertain fixed term (or on a service commission basis, if there is a previously established public employment relationship for an indefinite period).