Clinical laboratories demand urgent updating of agreed tables

The National Association of Clinical Laboratories (ANL) called on Wednesday for an urgent review of the new rules on the licensing and operation of public and private health units, claiming they are disproportionate and were determined without consulting the sector.

"These ordinances are not just legislative excess; they are a diagnostic error. Applying the same requirement model to a hospital and a small provider is disproportionate and could result in the silent closure of many of these facilities," warned ANL's general director, Nuno Castro Marques, in a statement.

At issue is a set of government decrees, published in the Official Gazette in April, which determine the minimum requirements for the licensing, installation, organization, operation and human resources of health units in various areas of activity owned by public and private entities and military and private social solidarity institutions.

These new ordinances amended others from 2024, which regulated the legal framework for the opening and operation of healthcare establishments, with the Government justifying the corrections with "some inaccuracies or inconsistencies" detected in the initial ordinances.

In light of the new legal requirements, the association, created in 2025, launched a "public appeal for an urgent review" of the decrees in question, taking into account the "harmful effects" that these changes could have on the continuity of agreed care throughout the country, particularly in areas where private laboratories are the main access point for tests subsidized by the National Health Service (SNS).

According to the ANL, the new ordinances were also published without “prior consultation with the entities representing the sector” and, under the justification of “alleged correction of errors” in previous ordinances, they “changed, in some cases radically, the technical and infrastructural requirements, which are now similar to those applicable to large hospital units”.

According to the association representing laboratories, the new measures did not take into account the specific needs of local and outpatient healthcare providers.

The ANL also highlighted that around 78% of the approved laboratories have fewer than 10 employees, but are responsible for more than 100 million laboratory procedures per year, of which more than 54 million are performed on NHS users.

“The legal framework for licensing is jeopardizing this installed capacity by constantly imposing disproportionate works, renovations, and technical requirements that are incompatible with the reality of these structures,” the association warned.