Life Sciences & Healthcare - January 2021
Welcome to the Life Sciences & Healthcare Newsletter, a publication prepared by our multidisciplinary team dedicated to the Healthcare industry, under the coordination of partners Lior Pinsky and Renata Fialho de Oliveira.
ANS establishes operating rules for electronic administrative proceedings, effective as of end of March 2021
Andrea Piccolo Brandão
In accordance with Decree No. 8,539, of Oct. 08, 2015 ("Dec. 8,539/2015"), which provides for the use of electronic administrative proceedings within the scope of the Federal Public Administration, ANS issued Normative Resolution no. 464, of Dec. 29, 2020 ("RN ANS 464"), through which it regulates the functioning of electronic administrative proceedings within the scope of ANS.
Electronic proceedings are intended to ensure efficiency and effectiveness to government actions. It also aims to promote security, transparency, economy and facilitate citizen's access to administrative bodies.
With some similarities to Dec. 8,539/2015, RN ANS 464 brings some interesting topics, as follows:
- Mandatory Registration as an External User within 90 days of the date of issuance of RN ANS 464. The registration process is mandatory for (a) the legal representative of legal entities regulated by ANS; (b) technical directors, tax officers and extrajudicial trustees (liquidantes extrajudiciais) appointed by ANS; and (c) suppliers that have or intend to have with ANS a contract for the supply of goods or services, except in cases where ANS appears as a public service user. The registration is optional for other people not listed above, but that want to access the electronic administrative proceeding system;
- Registration Process. It must be requested through the system made available by ANS on its website and it is a personal and non-transferable act. After the registration, all communications with ANS will be carried out electronically;
- Access Powers conferred by the Registration. The External Users' registration allows the External Users to (a) file documents electronically (it is possible to register the document as confidential, even if the proceeding is public); (b) monitor the status of proceedings in which (s)he has petitioned or to which access has been granted; (c) receive electronic communication regarding procedural acts or for the presentation of information and/or documents; (d) signing agreements, covenants, terms, settlement agreements or other similar instruments entered into with ANS;
- External User's Exclusive Responsibilities. The following responsibilities stand out: (a) keep password secrecy; (b) veracity of information sent; (c) filing motion and legible documents in an appropriate format (eg. size limit of 5MB); and (d) periodic consultation to verify the receipt of recent communications;
- Electronic receipt of documents and tacit subpoenas. From the registration, all procedural acts and communications between ANS and external users or legal entities represented by it will take place electronically. If they do not access the subpoenas available within 5 days, they will be considered tacitly subpoenaed thereafter;
- Meetings with ANS. By filling out a form, the External User will be allowed to indicate whether he prefers to meet in person or by videoconference.
- Effectiveness. RN 464 will become effective 90 days after its issuance
Andre Augusto Mendes Machado, Mariana Murad Leiva
Counterfeiting vaccines may lead to criminal liability, usually for the crime foreseen in article 273 of the Brazilian Penal Code, that punishes with imprisonment from 10 to 15 years in addition to the payment of a fine the acts of "falsifying, corrupting, adulterating or modifying products intended for therapeutic or medicinal purposes". According to the first paragraph of this article, all those who contribute in any way to the sale of fake vaccines can be penalized: "the same penalties apply to those who import, sell, expose for sale, have in deposit to sell or, in any way, distribute or deliver for consumption the counterfeit, corrupted, adulterated or modified product."
The crime is punishable not only when committed by a willful misconduct - when there are awareness and willingness to practice the crime –, but also when an action or omission committed unintentionally, by fault or negligence, is identified.
It is worth mentioning that this crime is considered heinous when committed willfully, and therefore severe legal consequences stem therefrom, such as being non-bailable and having stricter rules to transfer the offender to a different prison regime.
Besides the crime against public health abovementioned, the sale of falsified vaccines, by leading third parties to error, may lead to liability for the crime of fraud, pursuant to article 171 of the Brazilian Criminal Code which punishes with imprisonment from 1 to 5 years in addition to a fine the act of "obtaining, for oneself or others, unlawful advantage, to the detriment of others, by inducing or keeping someone in error, using artifice, ruse, or any other fraudulent means". Alternatively, the conduct may be interpreted by the Authorities as a crime against consumer relations, pursuant to article 7, VII, of Law no. 8,137/1990, punishable by imprisonment from 2 to 5 years, or a fine. According to the referred article: "It is a crime against consumer relations: (...) VII - to mislead a consumer or user with a false or misleading information about the nature or quality of a good or service, using any means, including advertisement".
Given the number of cases involving the sale of fake vaccines in Brazil, both in street commerce or other types of commercial establishments and through advertisements in websites and social networks, police investigations related to the matter have been initiated in different states of the country, conducted by the Civil Police and by the Federal Police. The aim of the investigations is to stop the crimes due to the risk for the public health, as well as identify the offenders, so that the prosecution is able to press charges against those involved to determine criminal liability.
Traditional Chinese Medicine
Traditional Chinese Medicine ("TCM") aims disease prevention. It focuses on the well-being of the patient and integrates psychosomatic, emotional, and physical matters for the patient's treatment. According to Marcelo Saad, TCM involves the use of phytotherapy (magisterial formulas containing herbs), physical means (such as heat and massage), corporal techniques (such as diet and exercises), breathing and meditation practices, among others.
The TCM is regulated by the National Health Surveillance Agency ("ANVISA") by means of the Collegiate Board Resolution - RDC No. 21, of April 25, 2014 ("RDC 21/2014").
According to Article 2º of RDC 21/2014, the products of TCM are: the formulations obtained from raw materials of vegetable origin, mineral and mushrooms (macroscopic fungi) according to the techniques of TCM and members of the Chinese Pharmacopoeia.
The products of TCM do not require registration with ANVISA, however, the manufacture, import and commercialization of products sold in irregular forms, with a composition that differs from those described in Article 2º of the RDC 21/2014 and said to pertain to TCM, results in a sanitary infraction and non-categorization of the product as a TCM product - notwithstanding other infractions that may be associated with such irregularity.
The RDC 21/2014, in its articles 6º and 7º sets forth the professionals who are qualified for the prescription and dispensing of TCM products. Such products are subject to commerce and can be prescribed and dispensed only by qualified professionals, that is, by health professionals authorized by their respective Professional Councils.
RDC 21/2014 further provides that qualified professionals may dispense TCM products solely towards companies and establishments duly licensed by the health authorities.
 Saad, Marcelo. A Medicina tradicional chinesa tem base científica? Available at: http://apps.einstein.br/revista/arquivos/PDF/665-EC%20v6n3%20p124-5.pdf. Access on January 8th, 2021.
Anvisa Technical Note Guidance for pharmacies during the COVID-19 pandemic period
Susan Uquillas Mosquera
On January 8, 2021, the National Health Surveillance Agency ("Anvisa") issued Technical Note No. 6/2021/SEI/GRECS/GGTES/DIRE1/ANVISA ("Technical Note 6/2021"), with guidelines applicable during the pandemic to minimize the risk of exposure to the virus and Covid-19. The guidelines are applicable to private pharmacies and, where appropriate, to public pharmacies, and are complementary to the guidelines determined by Resolution-RDC No. 44, of August 17, 2009, which provides for Good Pharmaceutical Practices.
Technical Note 6/2021 establishes that pharmacies shall use strategies to avoid agglomerations and foster social distancing, listing a series of suggestions on measures to be taken in the operation of pharmacies, in the dispensing of medicines and provision of pharmaceutical assistance, and in any occasional vaccination service.
Regarding vaccination, Technical Note 6/2021 further clarifies that the marketing and application of vaccines shall be carried out in pharmacies with specific licensing for such activity, under the terms of Resolution RDC n. 197, of December 26, 2017, which establishes the minimum requirements for vaccination services.
According to Technical Note 6/2021, private pharmacies will be able to provide vaccination services in the context of the government campaign if so determined by the local health authorities, as long as safety and quality in the activity are guaranteed. Furthermore, it is anticipated that, temporarily and exceptionally, infrastructure requirements may be more flexible for private pharmacies during the pandemic.
Regarding the administration of rapid tests, which must comply with RDC Resolutions no. 44/2009 and RDC n. 377/2020 and Technical Note nº 07/2021/SEI/GRECS/GGTES/DIRE1/ANVISA, the provision of the service outside the pharmaceutical establishment environment is not in accordance with the rules of Resolution-RDC nº 377/ 2020. Any administration of rapid tests, to be carried out outside the establishment's facilities, must meet the requirements for the execution of Remote Laboratory Tests/Rapid Tests determined by Resolution-RDC No. 302, 2005, which requires there to be a relation with a clinical laboratory, laboratory collection point or outpatient or hospital public health service.
Take-back system of drugs
Daniela Simões Diniz
The deadlines for implementing the take-back system of drugs for human use at home that are expired or in disuse, as well as their packaging, are already in progress.
For 2021, it is planned to carry out (i) the implementation of Phase 1 of the system, which encompasses the installment of a performance monitoring group and the structuring of the mechanism for providing information about the system and its results, and (ii) the beginning of the Phase 2, which encompasses the qualification of service providers, the draft of a communication plan, and the installation of drug collection points in drugstores, pharmacies and in potential other places defined by suppliers.
The schedule for installing collection points is 5 years from the beginning of phase 2. In the first 2 years, the installation must take place in the state capitals and in the municipalities with a population greater than 500 thousand inhabitants; in the last 3 years, in municipalities with a population over 100 thousand inhabitants.
Consumers should dispose of expired or out-of-use drugs, including their packaging, at such collection points. Manufacturers and importers of drugs for human use at home shall bear the costs to provide their environmentally appropriate destination.
Brazil stands in favor of maintaining patents for Covid-19 at the WTO
In October, India and South Africa submitted a proposal to the WTO to allow countries to suspend patents and other intellectual property instruments related to combating the Covid-19 pandemic. The idea was to increase the world's productive capacity, allowing biotechnology laboratories and institutes around the world to gain some scale and help immunize the global population.
In closed WTO meetings, Brazil has repeatedly opposed the suspension of patents for the vaccines. Despite historically positioning itself in favor of the suspension of pharmaceutical patents, Brazil sided with the USA, European Union, Japan, Switzerland and others developed nations against the proposal, being the only one among the main emerging countries to oppose patent suspension.
In the last week, suffering political pressure in the race for the necessary doses of Covid-19 vaccines and the urgency to improve diplomatic relations with countries of the BRICS, like India, Brazil abstained and did not vote with the developed countries.
The patent is perhaps the type of intellectual property that most easily highlights its social function. In the face of a pandemic, and the vast economic and social repercussions it highlights, many inventions will emerge as efforts to contain, treat or cure the disease and, with them, the race for patents to protect such inventions and give their inventors a temporary monopoly over them. However, since it is a public health emergency, it is necessary to consider ways of guaranteeing access to these inventions to the population, and in the Brazilian context, the granting of compulsory licenses is applicable.
The legal basis for mitigating the right holder's power to prevent third parties from exploiting his patent is found in Law No. 9,279/96 (LPI). For a compulsory license to be granted, however, a few requirements set out in the law must be met.
The granting of a compulsory license occurs because the patent holders do not fulfill their social function of keeping the market supplied and with competitive prices and, thus, as a consequence, in the form of a punishment, their monopoly is suspended. The granting of compulsory licenses has already been used by Brazil, however, it creates political and diplomatic friction for the country.
On a compulsory license, the right holder does not lose his patent, he only has his monopoly suspended for the term of a compulsory license that must also be paid for.
An alternative to compulsory licenses is a negotiated avenue on a technology transfer agreements. Brazil has guaranteed the right to manufacture AstraZeneca/Oxford vaccines nationally - which will be produced at the Oswaldo Cruz Foundation - and Coronavac, developed by Chinese company Sinovac - produced at the Butantan Institute. In both cases, in a commendable initiative, Brazil paid to have the right to produce vaccines internally, fostering manufacturing and scientific research initiatives, without the need to grant a compulsory license.
Provisional Measure creates additional tools against the pandemic
Mauro Hiane de Moura
On January 6, 2021, Provisional Measure No. 1,026 was published - allowing the Administration to resort to new measures related to the acquisition of vaccines, services and supplies related to vaccination against covid-19.
Special procurement regime
The Provisional Measure authorizes the Public Administration to execute contracts for the purchase of such vaccines and supplies regardless of a previous public tender process — and before the Federal Health Surveillance Agency issues the appropriate "sanitary registration" or a "sanitary authorization for emergency use".
The "special procurement regime" created by the Provisional Measure has, among others,the following features:
- Purchases may be made from suppliers currently prevented from executing contracts with the Administration - the acquisition of assets or services may be made from suppliers currently subject to administrative penalties that would prevent them to execute contracts with the Administration - when such companies are the only suppliers able to deliver the assets and services deemed necessary by the Administration;
- Enhanced powers to unilaterally modify contracts - as a rule, the Administration may unilaterally increase or reduce a contract up to twenty-five percent of its adjusted initial value. For contracts subject to the new Provisional Measure, however, the Government is allowed to make increases or reductions of up to fifty percent of such value;
- Advance payments and absence of penalties - contracts signed by the Administration may contain clauses that are deemed "indispensable to obtain the asset or guarantee the provision of the service", such as the making of advance payments by the Administration and the definition of hypotheses in which the supplier will not be subject to administrative penalties;
- Priority status by control bodies – as a counterweight to the particularly flexible regime it created, the Provisional Measure determines that internal and external control bodies should grant priority status to the analysis of the contracts and expenses made in pursuance thereof.
Emergency and exceptional approvals
The Provisional Measure authorizes the Federal Health Surveillance Agency to "grant exceptional and temporary authorizations" for the import and distribution of any vaccines against covid-19, materials, medicines and health products, even if not yet registered before the Agency, provided that:
- They are considered essential to assist in combating covid-19; and
- They are registered at least before one of the following foreign authorities - and authorized for distribution in their respective countries:
- Food and Drug Administration (FDA – United States of America);
- European Medicines Agency (EMA – European Union)
- Pharmaceuticals and Medical Devices Agency (PMDA – Japan);
- National Medical Products Administration (NMPA – People's Republic of China);
- Medicines and Healthcare Products Regulatory Agency (MHRA – United Kingdom of Great Britain and Northern Ireland).
While examining such requests, as well as applications for the emergency and temporary use of vaccines against covid-19, the Federal Health Surveillance Agency has the prerogative of requesting - upon proper justification - the execution of further investigative measures and the subsequent presentation of additional data on a vaccine's quality, efficacy and safety.
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