Declaration of conformity for public healthcare establishments

On October 2, Ordinance No. 237/2024/1 came into effect, establishing the requirements for the opening and operation of healthcare units owned by public legal entities, among others, and clarifying the procedure for obtaining the declaration of conformity for these units.

Indeed, the 1990 Framework Law on Health exempted healthcare establishments from the public sector the licensing regime, requiring only private healthcare units to obtain a license as a condition for their operation. Thus, there were no legal norms defining the rules for the opening and operation of public healthcare units, particularly regarding the quality and safety requirements in the provision of healthcare services (e.g., in terms of facilities, equipment, technical resources, and human resources).

With the reform of the licensing regime for private healthcare units, enacted through the entry into force of Decree-Law No. 127/2014, the aim was to extend the verification of minimum requirements for opening and operating healthcare establishments to all types of establishments, regardless of their legal nature or owning entity.

According to paragraph 2 of article 2 of the aforementioned Decree-Law, the verification of the technical requirements for the operation of private establishments continues to be carried out through a license. In turn, for establishments owned by public legal entities, this verification is done through a declaration of conformity.

Until now, the ordinance that was meant to define the “specific” procedure applicable to obtaining said declaration of conformity for public healthcare establishments had not been published. This ordinance was also supposed to determine the technical requirements applicable to the operation of the concerned establishments.

Thus, 10 years after the entry into force of Decree-Law No. 127/2014, Ordinance No. 237/2024/1 came to fill this regulatory gap, defining the legal regime applicable to the opening and operation of healthcare establishments owned by public legal entities.

However, upon closer examination of the Ordinance, it becomes apparent that the Ordinance does not bring any significant novelty or innovation, as it refers, in all these aspects, to the regime applicable to the licensing of private healthcare units.

On one hand, the legislator determined that the technical requirements applicable to establishments owned by public legal entities would be the same as those established in specific regulations, namely those established for private healthcare units.

On the other hand, regarding the “specific” procedure for obtaining the declaration of conformity, the legislator merely reiterated what was already established by Decree-Law No. 127/2014 for private healthcare establishments: either the simplified or the ordinary licensing procedure applies, depending on the type of healthcare services the establishment intends to provide.

How the transitional regime will function 

Finally, there is the question on how the transitional regime will function for public establishments to adapt to the technical requirements and the obtaining of the declaration of conformity.

Decree-Law No. 127/2014 stipulates that healthcare establishments that were in operation before its entry into force and that were not licensed would have to adapt to the new regime within the period established in the ordinances that define the technical requirements for each type of healthcare services.

In turn, the ordinances that approve the technical requirements for the different types of healthcare services, many of which were “renewed” in March of this year, either (i) do not provide any transitional period for adaptation to the technical requirements or (ii) provide that public healthcare establishments have a period of five years from the entry into force of the ordinances to adapt to the technical requirements.

In our view, the deadline imposed by the ordinances for public healthcare establishments to adapt to the technical requirements can only begin as of October 2, 2024, considering that only then did these ordinances become applicable to public healthcare establishments. Lastly, it remains to be seen what will happen to public establishments dedicated to types of healthcare services for which the respective ordinances do not provide for any transitional periods.