The IBA’s response to the war in Ukraine
Regulatory responses to health emergencies and product shortages during the Covid-19 pandemic in Brazil
Carolina de Souza Tuon
Machado Meyer Advogados, São Paulo
The pandemic generated by Covid-19 has instigated a chain of governmental responses on a worldwide scale, even before its official declaration by the World Health Organization on 11 March 2020.
In Brazil, Federal Law No. 13,979/2020 of 6 February 2020 provides measures to deal with the public health emergency scenario, such as:
- social isolation measures,
- determination to carry out mandatory medical examinations and laboratory tests;
- conducting an epidemiological study or investigation;
- exceptional and temporary restrictions on entering and leaving the country, according to the technical and reasonable recommendation of the National Health Surveillance Agency (ANVISA); and
- other measures provided for in Article 3 of Federal Law No. 13.979/2020.
Article 3 of the Federal Law, along with Provisional Measure (MP) No. 926/2020, gave way to a significant debate regarding the concurrence of ANVISA’s abilities with those of states and municipalities.
ANVISA is a regulatory agency created by Law No. 9,782 of 26 January 1999. It benefits from a special regime that guarantees more autonomy compared to other governmental institutions. Therefore, ANVISA is administrative and financially independent, although it is still subject to public policies dictated by the Ministry of Health.
While enumerating measures that may be taken in the Covid-19 pandemic, Article 3 of Law No. 13.979/2020 failed to specify which authorities should adopt these measures. Given that the Constitution safeguards concurrent competence among the federal government, the states, the federal district and the municipalities to legislate on public health (Article 23, item II), the lack of specifications in the aforementioned article left a legal gap that needed to be clarified.
As a result, on 15 May 2020, the Supreme Court decided unanimously that the measures adopted by the federal government in MP No. 926/2020 to confront the new coronavirus do not exclude concurring competence of the states and municipalities. The Supreme Court also clarified that Article 3 of Law No. 13.979/2020 should be interpreted as meaning that, although the federal government legislates on such matters, the other authorities must have their autonomy guaranteed.
On 20 March 2020, the Brazilian Ministry of Health issued Ordinance No. 454/2020, recognising the state of community transmission of Covid-19 and recommending the adoption of social isolation measures, shortly after which Legislative Decree No. 06/2020 recognised the occurrence of a state of public calamity as a result of Covid-19, with effects until 31 December 2020.
The Ministry of Health is the authority of the Federal Executive Branch responsible for organisation and elaboration of plans and public policies aimed at the promotion, prevention and care of Brazilian health. It is the Ministry of Health’s job to provide conditions for the protection and recovery of the population's health by reducing illnesses, controlling endemic and parasitic diseases and improving health surveillance, thus giving Brazilians a better quality of life.
Given that it is linked to the Ministry of Health, ANVISA has a federal regime, exercising its competence in concurrence with the states and municipalities of Brazil. Thus, ANVISA acts within the national territory, including ports, airports, borders and customs. Its institutional purpose lies in promoting the protection of the population's health by means of controlling the production and consumption of products and services subject to sanitary surveillance. The scope of sanitary surveillance ranges from the environment of production or consumption to the technology in manufacturing.
ANVISAis responsible for regulating health products and services, pesticides, food, medicine, sanitising products and cosmetics. In doing so, it must set forth rights and obligations of those who provide and consume the products and services of the referred scope, as well as implement health surveillance policies and define rules on food additives and others.
Specifically, with respect to medical drugs, according to Law No. 5,991/1973, any product claiming therapeutic effects, regardless of its nature (vegetable, animal, mineral or synthetic), shall be considered medication and must be registered before ANVISA in order to be manufactured and sold.
Ordinarily, for a drug to be registered, a duly authorised company must request the granting of registration pursuant to Law No. 6,360/1976, after which ANVISA evaluates the medication’s quality, effectiveness and safety. The entire process consists of the following phases:
- a non-clinical phase, in which tests are performed in order to verify the acting mechanism of a molecule;
- a development phase, in which the quality of the product is investigated to define quality criteria;
- a clinical phase, in which clinical trials are carried out to investigate the functioning and safety of the medication in humans, provided the trials have been approved by ethical and technical bodies;
- a registration phase, where the applicant shall, generally, present administrative documentation, evidence of standard quality assurance and evidence of safety and effectiveness of the medication subject to registration. The applicant must also present certifications of compliance with principles of good manufacturing practices and control of the place where the medication will be manufactured, as well as the respective sanitary authorisations for operation of the company; and
- the market phase, in which the approved medication is made available in the market, under surveillance so as to ensure its benefits surpass the risks it may pose.
The criteria for granting and renewing the registration of medications are described in specific regulation enacted under specific categories, such as synthetic and semi-synthetic, biological, phytotherapeutic and specific medicines, amongst others.
Not unlike other Brazilian authorities, ANVISAhas put in significant effort to address and reduce the risks of the Covid-19 crisis in Brazil. These regulations are likely to significantly influence law practice on a national level, especially given the international scope of the crisis. The remainder of this article will hence focus on the regulations enacted by ANVISAin the context of the Covid-19 pandemic in Brazil, specifically regarding product shortages and health emergencies.
Remedies for health emergencies at national level
Part of ANVISA’s authority within Brazilian jurisdiction lies in its ability to establish binding resolutions conceived by a collegiate board (RDCs). The following resolutions have been recently enacted to remedy health emergencies resulting from the Covid-19 crisis.
ANVISA’s Resolution RDC No. 348/2020 of 17 March 2020 provides for extraordinary and temporary measures for registration of both medical and biological products, including products for in vitro diagnosis. Its main focus is to accelerate registration requests of medical, diagnosing and biological products that may be used to treat or prevent the SARS-CoV-2 virus.
In order to benefit from faster registration procedures medications must
- be considered essential for the maintenance of life or used in the event of serious health risk; and
- be under threat of shortage, either imminent or current, within the national market, for reasons related with the Covid-19 crisis.
Furthermore, companies filing for fast-track registration requests are required to present field data that evidences the risk of shortage where imminent or current shortages in the national drug market must be certified by the company requesting the registration. The applicant is also required to provide information regarding possible substitutes for drugs already registered that are highly likely to attain the same effects. All documentation is subject to a strict analysis under ANVISA.
Should the applicant not have available all the documentation required, requests may be temporarily and conditionally approved by means of a term of commitment (TC), which shall satisfy the requirements of Resolution RDC No. 317/2019.
The TC, which may be signed at ANVISA's discretion, shall provide a detailed schedule for presentation of data and additional evidence supporting the risk of shortage and a benefit-risk assessment. The latter is to be carried out by the applicant in order to demonstrate a favourable benefit-risk ratio of the requested approval.
ANVISA's Resolution RDC No. 349/2020 of 19 March 2020 extraordinarily allows the registration requests of equipment for personal protection, mechanical ventilators and other medical devices identified as strategic in the fight against Covid-19. Eligible devices must be indicated either for the prevention or the treatment of the SARS-CoV-2 virus.
Regularisation requests must comply with the requirements set forth in Resolutions RDC No. 185/2001 and 40/2015, which specify procedures for registering and notifying medical devices before ANVISA. The absence of any stipulated requirement must be justified with technical indications that allow the evaluation of the product's safety and effectiveness.
Resolution RDC No. 349/2020 also stipulates that, given the crisis and in an attempt to remedy product shortages, devices subject to this resolution may also be exempt from being certified under the Brazilian Conformity Assessment System, which would be compulsory were it not for the Covid-19 crisis.
Requests granted in accordance with Resolution RDC No. 349/2020 will be valid for one year, at which point companies will be given the opportunity to provide certificates and documentation to formally standardise the devices under regular conditions unrelated to Covid-19.
The requests for registration of medical devices referred to in Resolution No. 349/2020 will be arranged to be analysed with priority, overriding the chronological criterion, by signaling the submission of the processes to the Management of Technology of Materials for Use in Health or to the Management of Technology in Equipment.
ANVISA’s Resolution RDC No. 377/2020 of 28 April 2020, authorises the use of ‘quick tests’ (immunochromatographic tests) for Covid-19 in pharmacies. One must note, however, that this measure is intended to support the investigation of antibodies or antigens of the virus, not aiming to necessarily widespread confirmatory diagnoses of Covid-19.
Pharmacies shall have the required health licence and operating authorisation in order to administer the immunochromatographic tests, which must be registered at ANVISA. Pharmacies shall also meet technical safety requirements for tests contained in RDC No. 302, of 13 October 2005, as applicable.
Procedures for the quick test will entail a pharmacist to be held responsible for its technicalities, who shall interview the applicant for the test in accordance with the instruction for using the test and its respective immunological window to demonstrate the feasibility of applying the specific test available at the establishment to the patient.
The quick test will be registered in the Pharmaceutical Service Declaration, which is to be filed by the pharmacy as proof that the application of the test occurred accordingly to its instructions for use and respecting the immunological window. The results of the tests, whether positive or negative, shall be reported to the competent health authorities, through established official channels.
Failure to comply with the Resolution’s provisions constitutes a health violation, under the terms of Law No. 6,437 of 20 August 1977, in addition to the applicable civil, administrative and criminal responsibilities.
The Resolution will be in force until the Ministry of Health declares the end of the public health emergency situation of national importance, recognised by Ordinance No.188/GM/MS of 3 February 2020.
Remedies for product shortages in Brazil
Much like health emergencies are part of ANVISA’s agenda in is the Covid-19 crisis, providing mechanisms of resilience regarding product shortages has also been a focal point for the health authorities. The following resolutions are a few of the most significant measures that have been recently enacted in this respect.
ANVISA’s Resolution RDC No.350/2020 of 19 March 2020 regulates exceptional and temporary standards for production of antiseptic and sanitising cleansers, which shall apply to companies that manufacture medicine, sanitisers and regulated cosmetics, and that possess an operating licence.
The following substances hence do not require ANVISA’s authorisation to be produced in the abovementioned conditions: 70 per cent ethanol, 80 per cent glycerin ethanol, alcohol gel, 75 per cent glycerin isopropyl alcohol and 0.5 per cent chlorhexidine digluconate. Cosmetic and sanitising companies, however, have the permission to manufacture and sell the abovementioned products exclusively for 70 per cent alcohol in its various forms.
ANVISA’s Resolution RDC No.356/2020 of 23 March 2020 temporarily exempts otherwise mandatory requirements for manufacturing, importing and acquiring critical medical devices to treat the SARS-CoV-2, such as surgical masks, N95 respirators, face shields, disposable hospital garments, circuits and respiratory connections used in healthcare. The exceptional and temporary exemptions comprise company operating authorisations, notifications to ANVISA and other sanitary authorisations.
Individual protection equipment, pulmonary ventilators, circuits, connections and respiratory valves, parametric monitors and other medical devices essential for combating Covid-19 may be purchased or received as a donation even if not yet regulated by ANVISA, provided they are regulated and commercialised within the jurisdiction of an International Medical Device Regulators Forum (IMDRF) member, by public or private agencies or entities, or by healthcare, when similar devices regulated by ANVISA are not available for trade.
ANVISA’s Resolution RDC No. 395/2020 of 9 June 2020 modifies Resolution RDC No. 352/2020, of 20 March 2020, which establishes compulsory prior authorisation for the exportation of raw material, semi-elaborated products, bulk products or finished pharmaceutical products intended to combat Covid-19. The resolution’s main objective is to maintain control of exports to avoid shortages of these inputs and medicines in Brazil during the current pandemic.
The enlisted substances added to Resolution RDC No. 352/2020 are:
- swine sodium heparin;
- bovine sodium heparin;
- enoxaparin sodium;
- warfarin; and
In a very similar manner, and with the same objective, Resolution RDC No. 351/2020 of 20 March 2020, included chloroquine and hydroxychloroquine in the list of substances under special control of Ordinance SVS/MS No. 344 of 12 May 1998.
Due to the Covid-19 pandemic, the Brazilian legal framework has adapted to provide responses to the resulting crisis to mitigate risks in diverse fields that are bound to be widely affected.
As discussed in this article, through the joint efforts of the Ministry of Health and ANVISA, various resolutions were conceived on facilitating registration of medication, regulation of medical equipment, medical prescription and distribution, implementation of quick diagnostic tests, manufacture of sanitising and antiseptic cleansers, and manufacture and acquisition of medical devices, amongst others.
Without prejudice to the actions of ANVISA and the Ministry of Health at the federal level in combating the pandemic of Covid-19, Brazilian states and municipalities have also adopted measures complementary to those determined by ANVISA and the Ministry of Health, to mitigate the effects of the pandemic. It is true that the actions of the states and municipalities are complementary to the guidelines established by ANVISA and the Ministry of Health, but these actions are extremely relevant.
In view of the above, in the field of health surveillance, it is not possible to know whether other measures will be enacted in order to mitigate the effects of the global crisis resulting from the Covid-19 pandemic. However, the strong role and efforts of ANVISA and the Ministry of Health in mitigating these effects have been noted.