On November 29, the Brazilian House of Representatives approved the proposed text of Bill of Law No. 7,082/17 (PL 7,082/17), which aims to create a legal framework for clinical research with human beings in Brazil, in addition to establishing ethical guidelines and control of good practices through research ethics committees (CEPs).

The Bill of Law will now be analyzed by the Federal Senate's Committee on the Constitution and Justice and Citizenship (CCJC) and then go to the plenary.

As a general rule, clinical research is a study that aims to discover or confirm disease risk factors, new therapeutic indications, adverse reactions, and/or effects on a particular therapy (including gene or cellular), technique, drug, and/or medical device.

The purpose of this type of research is to evaluate aspects involving quality, efficacy and safety of the product in human volunteers. The main steps involve:

  • Preclinical stage: manipulation of cells and/or animals to verify the feasibility of a substance or product becoming a new therapy, to know the mechanisms of action and to evaluate the potential for toxicity.
  • Clinical stage: carried out in human beings with the aim of progressively testing the safety and efficacy of the new therapy, divided into:
  • Phase 1 (group of 20 to 100 participants) – evaluate the safety of therapy on a preliminary basis.
  • Phase 2 (group of 100 to 300 participants with a certain disease and/or condition) – Analyzes the efficacy and possible adverse effects of the molecule, substance, or product.
  • Phase 3 (group of 800 or more patients with a certain disease and/or condition) – Evaluates the therapeutic advantage, establishes indications, contraindications, dosages and routes of administration, among others.

In practice, the results of these surveys must be submitted to the health agencies of each country (in the case of Brazil, the National Health Surveillance Agency – Anvisa), for regularization and commercialization of the product, as applicable.

In addition, this evidence can also be analyzed in the context of health technology assessment (HTA) for incorporation into the Unified Health System (SUS) or in the list of procedures for mandatory coverage by health plans established by the Brazilian National Supplementary Health Agency (ANS). This analysis considers aspects of cost-effectiveness, necessity, and financial/budgetary impact.

There is also the possibility of a phase 4 research, after commercialization, when the therapy is already used by hundreds or thousands of patients. The purpose is to collect and process real-world data (RWD), develop real-world evidence (RWE), monitor pharmacovigilance actions, and search for new indications.

In practical terms, Brazil already has a structured clinical research system that includes the Brazilian Health Council (CNS), the Brazilian Research Ethics Commission (CONEP), and research ethics committees (CEPs) established in hospitals, research centers, and academic institutions.

Bill of Law No. 7.082/17, however, intends to bring legal certainty, in addition to legal ballast, to the regulation and inspection of public and private institutions that carry out research with human beings in Brazil.

It is also expected that this new legal framework will bring predictability and more attractiveness to the performance of international studies, boosting technical and scientific development.

Check out the main points of the Bill of Law below.

Definitions and operational aspects

According to the text approved by the Brazilian House of Representatives, research with human beings includes the management of their data, information, or biological material, directly or indirectly, and can be divided into three categories:

  • Scientific, technological or innovation research – Study that interacts with human beings (individually or collectively), directly, without the objective of registering the product under research.
  • Clinical research – A set of scientific procedures developed  systematically with the aim of:
    • evaluate the action, safety and efficacy of medicines, products, techniques, procedures, medical devices or health care for preventive, diagnostic, or therapeutic purposes;
    • to verify the distribution of risk factors, diseases, or conditions in the population;
    • assess the effects of health factors or states.
  • Clinical Trial – Its purpose is to discover or confirm the clinical, pharmacological, or any other pharmacodynamic effects of the investigational drug, to identify any reaction to the drug or to study its absorption, distribution, metabolism, and excretion, to analyze and verify the action, safety and efficacy of the investigational drug.

In these cases, it will be necessary to submit a research protocol to a prior ethical analysis, to be carried out in a single instance by the Research Ethics Committee (CEP), putting an end to the double review carried out by CONEP, which today still occurs in specific cases.

As in other countries, the study will continue to be previously evaluated by the IRBs, considering ethical principles, such as protection of dignity; based on a risk-benefit relationship (individual and/or collective) favorable to the research subject; voluntary participation; preventing foreseeable damage; and respect for dignity, safety, and well-being.

Bill of Law No. 7,082/17 also provides that a body for the registration, inspection, and training of CEPs will be created by the Executive Branch within a period of up to two years.

Another regulatory gap that will be filled concerns the establishment of a maximum period of 30 days for deliberation by the CEPs, except when it comes to research of strategic interest to the SUS, which will have priority and will have special evaluation procedures. For sanitary analyses by Anvisa for sanitary registration of the product  under investigation, the maximum period may vary between 90 and 120 days.

Post-study supply

According to the proposed text approved by the Brazilian House of Representatives, before the start of the clinical trial, the research sponsor and respective researcher must submit a post-study access plan to the CEP.

This plan should contain details on whether it is necessary to provide the investigated product free of charge at the end of the clinical trial. The obligation will be incumbent on the sponsor as long as it is considered the best therapy or treatment for the research participant's clinical condition.

Contrary to what is currently provided for in the CNS regulation, this supply may be interrupted in the following situations:

  • the research participant's own decision;
  • cure of the disease or health problem that is the subject of the clinical trial;
  • introduction of a satisfactory therapeutic alternative;
  • when the continued use of the investigational drug does not bring benefit to the research participant;
  • when there is an adverse reaction that makes it impossible to continue the investigational drug, even in the face of possible benefits;
  • impossibility of obtaining or manufacturing the investigational drug for technical or safety reasons, provided that the sponsor provides an equivalent or superior therapeutic alternative existing on the market;
  • after five years of the commercial availability of the experimental drug in Brazil; or
  • when the experimental drug is available in the SUS.


Bill of Law No. 7,082/17 innovates by establishing that, in the case of research sponsored by governments, national or international government agencies, or non-profit institutions, the collaborating Brazilian institution may assume and exempt the responsibilities of one or more sponsors who participate in the research from the obligation to indemnify and provide health care for any damages caused.

Open points

Other operational points that should be contemplated in a regulation to be issued by the regulatory body include:

  • availability of information about the research on a publicly accessible website;
  • definition of standard operating procedures and best practices;
  • rules for biobanks and biorepositories;
  • mandatory clauses for clinical research contracts;
  • definition of special groups;
  • procedures for suspension or termination of zip codes;
  • monitoring rules for research;
  • definition of information and procedures for ethical analysis by the IRBs;
  • creation of a national registry of volunteers in bioequivalence studies;
  • requirements for the design and implementation of a post-study supply program or continuation of the experimental treatment;
  • specificities of research in the humanities and social sciences;
  • functioning of independent ethics committees (IECs).