Anvisa updates clinical laboratory rules and expands the list of exams that drugstores can carry out

On May 10, 2023, Collegiate Board Resolution – “RDC” No. 786, of May 05, 2023, was published, which updates technical and sanitary requirements to the operation of clinical laboratories, anatomical pathology laboratories, and other Providers that carry out Clinical Analyses (“EAC”) .

In addition to replacing RDC No. 302, of October 13, 2005, RDC 786/2023 extends the list of exams that can be carried out by drugstores, which are provided for in RDC No. 44/2009.According to the new rule, drugstores and isolated practices¹ are classified as “Type 1 Providers”. Consequently, such establishments are allowed to collect and carry out the clinical analysis of human biological samples, provided that: (a) such analysis is entirely carried out after the collection of the sample inside the respective establishment; and (b) that there is no requirement of equipment to read, interpret or visualize the results of the analysis.

Also, art. 10 of RDC No. 786/2023 PROHIBITS drugstores from carrying out the EACs below:

Anvisa highlights that EACs carried out by drugstores will be used as methods of medical triage and supporting diagnosis, rather than main diagnosis resources. However, if the results point to the diagnosis of a notifiable disease, such as Covid-19, influenza, dengue, and others, the drugstore must notify the Ministry of Health, as provided for in Brazilian legislation.

Our Life Sciences team recommends and highlights the following aspects of RDC No. 786/2023:

• New services and business: despite expanding the list of clinical analysis procedures that can be carried out in drugstores, the new rule is expected to stimulate new partnerships between drugstores and laboratories. This is because the RDC introduces the permission to use reading or visualization equipment to carry out the EAC as an exception that is subject to a supervision agreement with a clinical laboratory (Type 3 Provider – clinical laboratories, supporting laboratories, and anatomical pathology laboratories), in compliance with the due legal requirements.
• Regulation of “collection centers”: sample collection centers were established as a service that is linked, corporate or contractually, to a single clinical laboratory. Such laboratory will collect and keep biological samples and has permission to carry out the same exams as Type 1 Providers, as well as in-person exams, carried out at the moment of the collection. This is one of the main innovations introduced by the RDC, given that it regulates the link between collection centers (Type 2 Providers) and clinical laboratories (Type 3 Providers). 
• Detailed impact assessment of the new rule: it is highly recommended that laboratories and drugstores cautiously evaluate the new rule regarding its potential impacts, costs, and risks, as well as the need to adjust and update procedures and the scope of operation.
• Adjustment period: companies that provide the services addressed in the new rule will have 180 days to adjust to its provisions, calculated from the entry into force of the RDC. Also, companies must adjust to provisions regarding physical infrastructure in the case of renovation and enlargement of facilities or new constructions aimed at adapting facilities that were not previously used in health care or whose spaces underwent changes.
• Evaluation of applicable licenses and inclusion of authorized activity: Type I Providers must have an operating license or equivalent certificate issued by the competent health authority. This license must include activities relating to EAC, in addition to the activities of the drugstore or isolated practice. Moreover, the companies that carry out the EAC must be registered with the Brazilian Registry of Healthcare Providers (“CNES”). As such, before offering the new services provided by the new RDC, drugstores are recommended to assess the status of the necessary permits.

The new RDC will enter into force on August 01, 2023.

Demarest’s Life Sciences team is monitoring the updates of the industry and is available to provide any further clarifications that may be necessary.

[1] Isolated health clinic: Health Care Facility (EAS) that carries out specialized health care under technical supervision of a certified health professional.