Publications

Category: Life sciences and healthcare

The Collegiate Board of the National Health Surveillance Agency (Anvisa) decided, on August 30, to maintain, on a definitive basis, the permission for remote delivery of drugs subject to special control, including within the public health programs scope.

The new rule approved by Anvisa permanently modifies Ordinance SVS 344/98, which approves the technical regulation on substances and drugs subject to special control, and Anvisa RDC 4/2009, which establishes good practices for dispensing and marketing products in pharmacies and drugstores.

For context, it should be remember that due to the quarantine and social distancing measures adopted during the covid-19 pandemic, Anvisa published in March 2020 the Anvisa RDC 357/20. The goal was to temporarily increase the maximum quantities of drugs subject to special control and allow remote delivery during the Public Health Emergency of International Importance (PHEIC) period.

The pandemic period has brought significant changes in the behavior and the way products are consumed in the digital environment (via e-commerce platforms or marketplaces), including an increase in transactions involving drugs, medical devices, supplements and food.

The same happened with assistance services, which led to the approval of Law 14,510/22. This standard establishes guidelines for the practice of remote services by health professionals (so-called telehealth), including physicians, nurses, psychologists, physiotherapists, occupational therapists and speech therapists.

Definitive changes in the controlled medicinal products rules

The standard approved by Anvisa permanently modifies Ordinance SVS 344/98, which approves the technical regulation on substances and drugs subject to special control and Anvisa RDC 44/09, which establishes good practices for dispensing and marketing products in pharmacies and drugstores.

From now on, in order for pharmacies or drugstores to deliver drugs subject to special control remotely, including via government programs, the original copy of the corresponding prescription notification or special control prescription must be retained.

In addition, the dispensing establishment must provide pharmaceutical care to the patient and monitor the drugs remote dispensing.

Regarding the procedures that must be adopted, the regulation establishes that the prescription notification or special control prescription must be withdrawn at the address informed by the patient or received via electronic prescription – that is, a prescription that necessarily has a digital signature certified by the Brazilian Public Key Infrastructure system (ICP-Brasil) and can be forwarded to the patient or his legal representative via SMS, email or QR Code.

Online dispensing remains prohibited

Drugs subject to special control purchase and sale over the internet remains expressly prohibited, but is expected to be relaxed soon.

In 2021, Anvisa held an event to discuss the issue, recognizing the need to update the existing rules due to the evolution of consumer behavior and the adoption of technologies in recent years.

In the first half of 2022, the agency also created a working group, through Anvisa Ordinance 76/22, to review the technical requirements for remote request for drug dispensing, under the coordination of the Inspection and Supervision of Drugs and Pharmaceutical Supplies Management (Gimed).

The agency is currently preparing a Regulatory Impact Analysis, to be completed by the end of the current regulatory agenda. it is expected that a draft modernizing the current sanitary rule will be put out for public consultation in the coming months.

Category: Life sciences and healthcare

On August 18, the National Health Surveillance Agency (Anvisa) published Anvisa RDC 811/23, which establishes a new deadline for the technical analysis of priority requests involving drugs.

The new regulation – already in force – amends the Anvisa RDC 204/17, which addresses the rules for classifying petitions for registration, post-registration and prior approval in clinical drug research.

Another amended resolution was Anvisa RDC 205/17, which establishes a special procedure for approving/ clinical trials, certification of good manufacturing practices and registration of new drugs for the treatment, diagnosis or prevention of rare diseases.

Rare diseases are those that affect up to 65 people in every 100,000 individuals, as defined by the National Policy for Comprehensive Care for People with Rare Diseases. This definition is based on official national data or, in the absence thereof, on data published in technical-scientific documentation.

Dismissal of petitions

Anvisa RDC 204/17 stated that the petition would be rejected if the request for inclusion in the priority category was denied during the technical analysis.

The regulated sector, however, pointed out that the reasons for the rejection were not disclosed, as well as there was no forecast on how long it would take to analyze requests for prioritization.

Anvisa’s technical area, in turn, concluded that the possibility of rejection led to a decrease in applications that did not meet the prioritization criteria. The agency also found that the number of rejections recorded in the period from 2017 to 2023 – after the enactment of Anvisa RDC 204/17 and Anvisa RDC 205/17 – is less than 20%.

To avoid an excessive number of requests for prioritization, which would affect productivity and analysis time, Anvisa maintained, in the new resolution, the rejection of petitions that do not meet the criteria for inclusion in the priority category.

However, from now on Anvisa has established a maximum period of 45 days for such rejection, after which it will be sent to the ordinary analysis queue, in the position corresponding to the date on which the request was filed. This deadline change was extended to Anvisa RDC 205/17.

The rule will apply to petitions made after the new resolution comes into force, as well as to requests that had already been made and were still awaiting technical analysis.

Future changes

Anvisa recognized the need for future changes in order to address other issues, including:

• the possibility of submitting a Term of Commitment for other priority drugs, in addition to rare diseases; and
• expanding the possibility of submitting long-term stability studies for other priority biological drugs, in addition to rare diseases.

These issues, however, will be addressed in a specific regulatory process.

To learn more, check out our Life Sciences & Healthcare team.

Category: Life sciences and healthcare

On September 26, 2023, the Ministry of Health (“MoH”) announced the new strategy for strengthening the health economic industrial complex, applicable to medicines, APIs, vaccines, diagnostic reagents, treatments and health services (“New CEIS Policy”). The Brazilian government estimates R$42.1 billion in investments (new Growth Acceleration Program - “PAC” for the CEIS, via public and private funding).

Check out our special publication on the subject to see what will change for companies in the sector.

Category: White-Collar Crime

The Provisional Measure 1.182/23, published on 25 July, amends significant points of Law 13.756/18, which regulates the operation of the lottery of fixed-quota bets by the Union, such as sports betting. The aim is to create clearer rules for the functioning of the betting market in the country.

Although it modifies several provisions of Law 13,756/18, MP 1,182/23 does not yet regulate the betting market, which remains pending. For example, there is no express rule on how the Ministry of Finance will grant the authorization to operate companies in the sector in the country.

As a possible response to the criminal investigations initiated at the beginning of the year to investigate the practice of sports corruption in football matches (which constitutes a crime, in the form of Articles 41-C, 41-D, and 41-E of the Law 12.299/10), MP 1.182/23 also brings new devices to prevent practices of manipulation of sporting events by the betting market.

The provisional measure on sports betting prohibits the partner or controlling shareholder of a fixed-quota lottery operating company - individual or part of a control agreement - from holding a direct or indirect stake in a football corporation or in a professional sports organization, as well as prohibiting the person in these conditions from acting as a leader of a Brazilian sports team (art. 33-C).

The measure also requires the betting operator to adopt security and integrity mechanisms in performing lottery of fixed quota bets (art. 33-D), establishing the following measures:

• The sporting events linked to bets will have actions to mitigate the manipulation of results and corruption by the operating agent in the real sports event (art. 33-D, §1º);
• The operating agent shall be part of a national or international sports integrity monitoring body (article 33-D, paragraph 2);
• The Ministry of Finance may determine the suspension or prohibition, to all operating agents, of bets on intercurrent or specific events, occurring during the race or the match, other than the specific prognosis of the final result (article 33-D, paragraph 3); and
• The operating agent shall report suspected manipulation events to the Ministry of Finance within five working days, counted from the moment the operating agent became aware of the suspicious event (article 33-D, paragraph 4).

These measures are relevant to repress sports manipulation beyond the criminal sphere, as they create civil/administrative obligations to prevent these crimes in the betting market. The application of these measures is conditioned, however, to a pending regulation from the Ministry of Finance.

MP 1.182/23 reinforces that, although pending specific regulation, the practice of sports betting is no longer a criminal offense in the country, to the extent that there is a permissive norm of conduct. Thus, Article 50 of the Decree-Law 3.688/41 it may no longer be applied to punish such conduct.

However, this interpretation does not extend to other bets – such as casinos and other gambling – which remain formally classified as a criminal offense by Article 50 of Decree-Law 3,688/41. In any case, the typicality of the conduct of establishing and exploiting gambling may have its unconstitutionality recognized by the Federal Supreme Court in the context of the judgment of Extraordinary Appeal 966.177/RS, whose extraordinary repercussion has already been recognized (Theme 924 – reception of article 50 of Decree-Law 3.688/41 in view of the Constitution of the Republic of 1988).

Also pending approval is the bill that provides for the legalization of gambling and the reopening of casinos in the country (PL 186/14). The project contemplates the game of the animal; video bingo and video games; Bingos; casinos in integrated leisure complexes; sports and non-sports betting; and online casinos. In addition, there is a provision for accreditation for the exploitation of the game of bingo and video bingo for 20 years and casinos for 30 years, both of which can be renewed for the same period.

Category: White-Collar Crime

The plenary of the Federal Supreme Court (STF) dismissed the Direct Action of Unconstitutionality 4,273 (ADI 4,273). The ADI was presented by the Attorney General's Office (PGR) and challenged the constitutionality of articles 67, 68

These articles limit the power of the State to punish in case of payment of the tax debt. Thus, when the debt is paid in full, criminal liability is extinguished.

In the case of entering a tax debt installment program, the punitive claim of the State on tax crimes will be suspended during the payment of the installments. When all installments are paid, the criminal liability will be extinguished due to the full payment of the tax debt.

The Supreme Court sustained the decriminalizing measures on the grounds that the criminal sanction is the last resort to be used by the State. With the collection of due taxes, either by payment at once or in installments, the tax objective is achieved. Thus, it makes no sense to maintain such a severe measure as the imposition of a criminal penalty.

ADI 4,273 was presented in 2009 by the PGR, which claimed that these articles would be contrary to the State's duty to promote a fair society because they would impair the ability of the tax authorities to collect taxes.

The main argument the PGR makes is that the criminal protection given to the tax order and the threat of punishment are the main means of incentive for the payment of taxes. From this reasoning, it is inferred that the limitation of the threat of penalty, guaranteed by the challenged articles, would violate the fundamental rights to a fair, egalitarian, and free society provided for in articles 3 and 5 caput of the Federal Constitution.

According to the vote of the reporting justice, Kassio Nunes Marques, who was accompanied by all the other ministers, the challenged articles are not incompatible with the constitutional text.

The main points of his vote were:

• the tradition of the Brazilian criminal legislature of prioritizing the payment of the due tax and the reparation of the damage caused to the detriment of the criminal punishment of the taxpayer;
• the suspension of the punitive claim during the installment payment of the tax debt be recognized in other legal texts;
• the existence of several laws in Brazilian law that provide for the extinction of criminal the liability after the payment of the due taxes;
• the fact that tax crimes are not sufficiently offensive for the privileged application of the criminal law and, therefore, to require punishment even after reparation for the damage caused;
• Criminal law is the last resort (ultima ratio) as a means of protecting any legal asset, in this case the protection of the treasury. That is, criminal law is only necessary when the other norms do not achieve the objective sought by the law;
• the suspension of the punitive claim of the State and the extinction of the liability due to the payment of the tax debt fulfill the function of guaranteeing the collection, making unnecessary application of the criminal law. As such that, if the installment payment is not complied with, the punitive claim will be resumed; and
• The suspension of criminal punishment during installments, in addition to promoting tax collection, contributes to the promotion of economic activity and, consequently, the generation of jobs. Thus, contrary to what the PGR defends, the suspension and extinction of liability and the emphasis of the legislator on the reparation of damage to public property contribute to the fulfillment of the fundamental objectives expressed in Article 3 of the Federal Constitution.

This decision is extremely relevant for taxpayers, especially for business leaders who face an uphill battle with the tax authorities to comply with all the rules of collection in a complex tax system in which the courts themselves present divergent interpretations.

This is because, as legal entities cannot be held criminally responsible for tax crimes, the criminal exposure falls on their representatives and/or executives.

The confirmation of the constitutionality of the two decriminalizing measures – payment and installment of the due tax – makes it possible to close criminal proceedings initiated against individuals due to the alleged tax default of the legal entity.

^[1] Art. 67.  In the event of installment of the tax credit before the offer of the complaint, this can only be accepted in the event of default of the obligation object of the complaint.

Art. 68.  The punitive claim of the State, referring to the crimes provided for in the articles, is suspended. 1st and 2nd of Law No. 8,137, of December 27, 1990, and in the arts. 168-A and 337-A of Decree-Law No. 2,848, of December 7, 1940 – Penal Code, limited to suspension to debts that have been the subject of installment concession, until the installments referred to in the articles are rescinded. 1st to 3rd of this Law, subject to the provisions of Article 69 of this Law.

Single paragraph. The criminal statute of limitations does not run during the period of suspension of the punitive claim.

Art. 69. The punishability of the crimes referred to in article 68 is extinguished when the legal entity related to the agent makes full payment of debts arising from taxes and social contributions, including accessories, which have been the subject of installment payments.

Single paragraph. In the event of payment made by the natural person provided for in § 15 of article 1 of this Law, the extinction of punishability will occur with the full payment of the amounts corresponding to the criminal action.

^[2] Art. 9 The punitive claim of the State is suspended, referring to the crimes provided for in the articles. 1st and 2nd of Law No. 8,137, of December 27, 1990, and in the arts. 168A and 337A of Decree-Law No. 2,848, of December 7, 1940 – Penal Code, during the period in which the legal entity related to the agent of the aforementioned crimes is included in the installment payment regime.

• 1 the criminal prescription does not run during the period of suspension of the punitive claim.
• 2 Extinguishes the punishability of the crimes referred to in this article when the legal entity related to the agent make full payment of debts arising from taxes and social contributions, including accessories.

Category: Litigation

Among the various decisions that need to be taken in the corporate and business sphere, one of the most relevant is what should be done with the corporate participation of the individual partner or shareholder after his death. It is an issue that often goes unaddressed in companies' legal instruments and can give rise to huge disputes.

When a partner of a limited company dies, the general rule is, under Article 1.028, caput, of the Civil Code, to liquidate his share and partially dissolve the company. This involves calculating the value of his stake and paying the corresponding amount to the heirs.

However, as provided for in Article 1,028 of the Civil Code itself, the general rule of partial dissolution can be waived by:

• miscellaneous provision in the contract;
• option of the remaining partners to dissolve the partnership; and
• Agreement with the heirs, regulating the replacement of the deceased partner with the consequent entry of the heirs in the social framework.

On the other hand, in privately held corporations, the general rule is usually the transfer of shares to the heirs.

It is common (and recommended), however, for the parties to make a prior agreement on the subject to define specifically whether or not the heirs can remain in the partnership, how the value of his share will be calculated and what will happen to specific rights that the deceased had.

This type of arrangement, both in joint stock companies and in limited partnerships, usually occurs through a partners' agreement, but can be included directly in the contract or bylaws.

Under Article 118 of Law 6,404/76 (Lei das S.A.), shareholders' agreements must typically deal with purchase and sale, acquisition preference, voting rights and power of control. However, they may also deal with other related matters, such as non-compete clauses, rules for exercising the right to vote, and provisions on succession.

Given this, the question arises: with the death of the partner/shareholder, do the parasocial agreements signed by him bind his heirs? That is, is the heir contractually obliged to follow the provisions of the agreement signed by the deceased?

The basic principles of succession law indicate that it does. This happens because, with the opening of the succession upon the death, the inheritance is automatically transmitted to the heirs of the deceased (Article 1.784 of the Civil Code, known as the principle of saisine).

The heirs, however, have the prerogative to accept the inheritance or renounce it, provided that they do so completely. Legislation prohibits partial acceptance or waiver, under condition or term.

Inheritance is the set of assets, rights and obligations transmitted to heirs through succession. When the heirs accept the inheritance, they also assume all the obligations of the deceased, including those existing in the agreements entered into in relation to the companies in which he held a stake.

The heirs take the place of the deceased in the positions contractually assumed by him and are responsible for paying the debts left up to the limit of the value of the inheritance.

The share of each heir will only be delivered and the division materialized after the payment of the creditors and the extinction of the debts.

Thus, just as it is not possible to accept the inheritance "with conditions", it is not possible for the heir to assume the position of the deceased, receiving the shares/shares held by him, without agreeing and assuming parasocial agreements previously signed.

If there are very personal rights attributed to the deceased, it is necessary to make clear how they will be treated so that there is no doubt about what rights and duties will be transmitted to the successors.

Although there are legal provisions, the appropriate and specific treatment of the subject in the agreements of members and, when necessary, in the contracts or bylaws is relevant for all involved:

• for the company, it represents the regulation of the succession of its management, transition planning of decision-making and financial programming, considering that, depending on the treatment adopted, the death may represent the payment of assets to the heirs;
• for the heirs, it indicates clarity about the destination of the equity interests held by the deceased and guides the best way to conduct that business, either by sale or by joining the company; and
• For the remaining partners, it gives security to the fate of the company, especially with regard to the relevance of the personal participation of each partner for the conduct of activities.

The absence of adequate treatment opens the door to questions about the fate of the shareholdings, the value to be considered for their calculation and the exercise of rights.

Thus, it is essential to regulate the transfer of shares in the event of the death of the partners/shareholders for two reasons: in addition to helping plan the transition and the future of the company, the regulation binds any heirs who may become holders of the equity interest after the death of the owners.