On May 3rd of this year, Anvisa approved Resolution No. 786/2023 ("RDC 786/2023"), which addresses the technical and health requirements for the operation of clinical laboratories, pathology laboratories, and other services that perform activities related to clinical laboratory tests in Brazil. These activities encompass, but are not limited to, biological, microbiological, immunological, chemical, biochemical, immuno-hematological, hematological, cytological, anatomopathological, genetic, molecular biology, cell biology, mycology, parasitology, toxicology, urinalysis, or other tests on biological materials of human origin.

The approved regulation, which will come into effect on the first day of August, will replace Anvisa’s Resolution No. 302/2005, which has been considered outdated and ineffective for meeting the current advancements in the diagnostics sector, particularly regarding the modernization of instruments, equipment, technologies, and methodologies in the industry that have facilitated more efficient clinical laboratory testing and result acquisition, improved patient safety, and increased accessibility to clinical diagnoses for the population.

New issues currently intrinsic to the subject will finally be addressed, such as technological advancements in the sector, expanding access through screening tests beyond laboratory structures, mobile services, technical requirements for in-house methodologies, rapid tests, collection centers, monitoring the quality of screening and diagnostic tests, among other aspects.

According to Anvisa, the changes can be divided into two main groups: the modernization of the regulatory framework governing the operation of clinical laboratories and collection centers, and all the technical and health-related aspects related to the execution of clinical laboratory tests; and the expansion of activities related to clinical laboratory tests, allowing them to be performed in previously unauthorized establishments – such as the long-awaited possibility of conducting clinical laboratory tests in pharmacies, as a screening measure, and in isolated clinics. However, the results of these tests should not be used independently for clinical decision-making, as they are not intended to replace conventional laboratory diagnostics.

Therefore, a new categorization has been created for healthcare services that perform activities related to clinical laboratory tests, based on their complexity and infrastructure: (i) Type I Service, corresponding to pharmacies and isolated clinics[1]; (ii) Type II Service, corresponding to collection centers, and (iii) Type III Service, corresponding to clinical laboratories, support laboratories, and pathology laboratories.

It is important to emphasize that pharmacies and isolated clinics (i.e., Type I Service) will carry out their activities in accordance with the requirements and prohibitions stipulated in the regulation (i.e., Articles 8 to 13 of the new resolution). These include conducting all stages of the tests on the premises (in loco); prohibiting the use of in-house methodologies[2] for conducting the tests; the possibility of establishing a supervisory contract with a Type III Service for the use of reading or visualization instruments to perform some clinical laboratory test; and the execution of said tests by legally qualified professionals.

For the definition of the types of clinical laboratory tests that could be performed in pharmacies and isolated clinics (i.e., Type I Services) without the supervision of a Clinical Laboratory, Anvisa sought to identify the aspects that would characterize the so-called "rapid tests" (such definition or terminology does not exist in Anvisa regulations), similar to the "rapid tests" for COVID-19 permitted on a temporary and exceptional basis in the fight against the pandemic. In other words, those simple tests conducted at the point of care (POC) using devices exempt from most federal supervision requirements (and therefore designated as waived tests in the United States).

It is worth emphasizing that Anvisa’s Resolution No. 44/2009, which establishes Good Pharmacy Practices for the sanitary control of the operation, dispensing, and commercialization of products, as well as the provision of pharmaceutical services in pharmacies and drugstores, has undergone numerous changes that reflect the new understandings adopted by the new resolution. From now on, pharmaceutical care services also encompass the execution of Clinical Laboratory Tests (in accordance with current legislation), allowing for a wide range of tests to be conducted in pharmacies (i.e., Type I Service).

According to the Brazilian Association of Pharmacy and Drugstore Chains (i.e., in Portuguese, “Abrafarma”), at least 47 clinical laboratory tests, such as asthma, allergy, dengue, cholesterol, HIV, and others, can now be performed in pharmacy establishments, finally and definitively positioning them as an entry point to the healthcare system in the country. Until now, these units were only able to perform Covid-19 and blood glucose (i.e., glucose concentration in the blood) tests.

In the vote that supported the deliberation on the subject at Anvisa, the director assertively stated: "I highlight an article published in the journal Expert Review of Molecular Diagnostics, titled 'Current status and future prospects of point-of-care testing around the globe’, which emphasizes that in developing countries, on-site point-of-care testing can provide large-scale and cost-effective screening programs for HIV, tuberculosis, sexually transmitted diseases, and emerging infections such as Ebola, SARS, and other respiratory infections that can result in major epidemics. In countries like Brazil, Russia, India, China, and South Africa, point-of-care testing offers an opportunity to expand critical laboratory testing in rural areas and other locations with limited resources”.

On the other hand, collection centers (i.e., Type II Services) will be able to perform all clinical laboratory tests permitted for Type I Services, provided they comply with the same conditions established for this type of service, in addition to other activities, such as: receiving, storing, handling, processing, and transporting biological samples; conducting face-to-face clinical analysis at the time of collection; offering itinerant, home-based, and workplace collection services and clinical analysis; and transcribing reports (issued by Type III Services), ensuring the accuracy of the data and traceability of the service responsible for the analytical stage.

Thus, the approved regulation allows for screening tests to be performed in Type I and Type II Services, which do not exceed conventional laboratory diagnosis or replace it, as their role is complementary. For example, the result of a rapid test requires interpretation by healthcare professionals who must associate it with the individual's clinical data and perform additional confirmatory laboratory tests.

Regarding Type III Services, Clinical Laboratories and Pathological Anatomy Laboratories are authorized to perform all Clinical Laboratory Tests, as well as collect, receive, store, handle, and transport biological samples. They are also allowed to send biological material for analysis to Support Laboratories and provide collection and execution of clinical analysis in itinerant units, at home, in companies, and in Healthcare Assistance Establishments. Only Type III Services are permitted to develop and use their own methodology (in-house), with the sale, transfer, donation, or delivery of reagents or any products derived from this operation being prohibited. It is mandatory to ensure traceability of all inputs, reagents, and other components used in the analysis.

The recently approved resolution also introduces other important aspects related to:

(i) Implementation of technical and sanitary requirements for quality management of the services provided. All services performing clinical laboratory tests, including the distribution center, must establish a Quality Assurance Program (QAP) and ensure the reliability of the tests through Quality Control Management (QCM).

(ii) Update of criteria concerning physical infrastructure, material resources, and organization of the clinical laboratory test executing service (including itinerant units).

(iii) Contractualization of activities provided by Type I, II, and III Services, with minimum requirements for provisions such as the responsibilities of the parties, criteria for control and qualification of the stages of the clinical laboratory testing process, flow of records for traceability control, obligation for the parties to comply with requirements to ensure the safety, quality, and reliability of the test results, etc.

(iv) Possibility of defining other environments for clinical laboratory testing execution within public health promotion and protection policies by the Ministry of Health and state, municipal, or federal district Health Departments.

(v) Policies and responsibilities regarding the information system, to be defined by the clinical laboratory test executing services, to establish: (v.i) a systematic approach for accessing patient and service professionals' data and information, including protection against unauthorized access; (v.ii) access control for data entry and result changes, containing historical records with dates, times, user, and location of data entry or information changes; (v.iii) a systematic process for releasing patient test results and reports, whether automated or manual; and (v.iv) a privacy and confidentiality policy for information.

The establishments categorized as Services Type I, II, and III, as addressed in the new regulation, will have a 180-day period (until November 10, 2023) to adapt to the new scenario of conducting clinical laboratory tests. By doing so, they will be able to legitimately and safely expand the range of services offered to the Brazilian population.

"This essentially indicates that companies operating in this sector can continue (or maximize) capitalizing on this trend by expanding their solution offerings, developing user-friendly platforms, and integrating remote monitoring devices to manage patients' conditions", Victoria said.

"Nevertheless, it is evident that while these opportunities exist, entering these markets requires careful planning, understanding of regulatory frameworks, and a focus on addressing patient privacy and security issues", Juliana added.

CMA info

This article describes the current thinking at Campos Mello Advogados on these topics and should not be viewed as a legal opinion. 

Campos Mello Advogados is a Brazilian law firm which has worked in cooperation with DLA Piper LLP across the globe since 2010.

[1] According to Anvisa Resolution No. 786/2023, "isolated clinic" refers to a Healthcare Assistance Establishment that performs specialized healthcare activities under the technical responsibility of a legally qualified healthcare professional at the higher education level.

[2] According to Anvisa Resolution No. 786/2023, "in-house methodology" corresponds to an analytical methodology, reagents, or analytical systems developed, produced, and validated by a Type III Service for use within their own environment. This methodology can be applied in research or in support of diagnosis and therapy.