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Results from the US Securities & Exchange Commission Inspection in 2023

April 1, 2024

Many people wonder why the US Securities & Exchange Commission (SEC) has been so successful, which has anequivalent agency in Brazil. The reason for its effectiveness is not hard to understand: the agency does not hesitate to investigate and impose penalties to curb irregularities that impact the day-to-day operations of the US stock market, including instances of corruption.

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When Supporting Gender Equality Conflicts with Privacy Rights

March 15, 2024

At a time in history when the topics of diversity and inclusion are more and more relevant, a federal law enacted in 2023 is causing great controversy, even forcing a rush to the courts to ensure its compliance.

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The Fight Against Corruption in Singapore

March 6, 2024

Corruption poses anever-present concern for democracies on every continent. It is no different inAsia, especially in Singapore, which alongside New Zealand and Scandinaviancountries stand out as examples of best practices in infrastructure and legal frameworkemployed to combat corruption.

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Medication Leaflets of Generic and Patented Medicines

February 29, 2024

The use of medication is undeniably crucial for extending our lives with the highest possible quality, aligning with advancements in science. As a result, medication leaflets are familiar to everyone, whether or not they are involved in the pharmaceutical sector. However, the same level of familiarity does not extend to the concepts of generic medicines and patented drugs.

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Petrobras at the Top of Brazilian Patent Applicants

February 19, 2024

According to a publication on the website of the newspaper A Gazeta, the Brazilian Patent and Trademark Office (BRPTO) has disclosed that, in 2023, 25,367 utility patents were filed in Brazil. This data was divided as follows:

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The Corruption Perceptions Index in 2023

February 6, 2024

Transparency International, headquartered in Berlin, it is a non-profit organization focused on anti-corruption operating internationally. Its purpose is to combat corruption and associated criminal activities.

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The Inheritance Loss due to Unworthiness

February 1, 2024

Dealing with death is never easy. Especially if it happens to someone close to us, such as a family member. Despite this, the mourning and pain for the loss of a loved one should not hinder the obligation imposed by law on executing the probate proceedings within 60 days, under penalty of a fine of 10% of the tax amount. If the delay exceeds 180 days, the fine is increased to 20%. Furthermore, the deceased taxpayer who paid taxes throughout their whole life must still witness, wherever they are, the unpleasantness of having part of their properties literally confiscated by the public authorities, under the title of cause mortis estate and gift tax (ITCMD).

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Electronic Drug Labels

January 22, 2024

The Brazilian Congress approved on May 11, 2022, Law #14,388/2022, also known as the Electronic Drug Labels Act. Its aim was to shift from paper package inserts to digital labels, resulting in amendments to Law #11,903/2009, which regulated the tracking of drug production and consumption through electronic data capture, storage, and transmission technology. In turn, this law had already been partially changed by Law #13,410/2016, which addressed the National Medicines Control System.

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The Definitive Compliance Guide for Health Care in the USA

January 15, 2024

Without much ado, the American Office of Inspector General (OIG) has published the General Compliance Program Guidance (GCPG). This guide is intended for use by several segments of the health care sector, such as hospitals, nursing homes, medical equipment suppliers, among others. Its objective is to encourage the development and use of internal control resources, in order to monitor compliance with provisions of applicable statutes, regulations, and programs.

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When Corruption Turns the Tables!

January 8, 2024

The past few years have been tumultuous, particularly for Brazilians, in the battle against corruption. Controversial judicial decisions, sparking significant debate, diminished the effectiveness of Operation Car Wash (“Lava Jato”), a landmark anti-corruption probe, in Brazil. The once unassailable figures in the fight against corruption found themselves vilified in a country prone to casting shadows on those in the spotlight.

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ABOUT US

Licks Attorneys Compliance’s Blog provides regular and insightful updates about Ethic and Compliance. The posts are authored by Alexandre Dalmasso, our partner. Licks Attorneys is a top tier Brazilian law firm, specialized in Intellectual Property and recognized for its success handling large and strategic projects in the country.

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Licks Attorneys' COMPLIANCE Blog

USA passes Anti-Money Laundering Whistleblower Improvement Act

In Brazil the concept of the whistleblower continues to be ignored –  as having been incorporated into our legal system by former Minister Sérgio Moro's anti-crime package, approved by the National Congress underStatute 13,964 of December 24, 2019 (which utilizes the definition of informant rather than the North American definition of whistleblower) – along with the benefits that its employment could bring to the country, especially in the fight against corruption. While the United States, at the end of 2022, have just passed the Anti-Money Laundering Whistleblower Improvement Act, making significant progress in the battle against money laundering.

USA passes Anti-Money Laundering Whistleblower Improvement Act Read Full Article

The Impeachment of Authorities in Brazil explained

According to the Brazilian Constitution of 1988, the Legislative, Executive and the Judiciary Branches are balanced among themselves.

The Impeachment of Authorities in Brazil explainedRead Full Article

Brazilian Antitrust Law has been refined

Although Brazilian antitrust rules follow the example of US antitrust law, the pioneers in the subject were not them, but their Canadian neighbors, since the first known antitrust law was published in 1889, in Canada. By the way, this was the year in which Brazil ceased to be an empire, when the Republic was proclaimed on November 15, 1889, by Marshal Deodoro da Fonseca.

Brazilian Antitrust Law has been refinedRead Full Article

And speaking of Patient Support Programs...

The Patient Support Programs (PSPs) developed by the pharmaceutical industries are often controversial as to the real benefit they provide, how much they contribute to patient loyalty and the risks they bring to the companies implementing them.

And speaking of Patient Support Programs...Read Full Article

Self-regulation in the health care area: Europe's positive example

One of the great frustrations of those who work in companies where there is a solid compliance culture is dealing with the limits imposed by their internal policies and procedures, as compared to competition that, sometimes, uses dubious and loose processes, which lead to numerous conflicts of interest, but which can translate into increased sales.

Self-regulation in the health care area: Europe's positive exampleRead Full Article

How goes Personal Data Protection in the United States of America?

The entry into force of the General Data Protection Regulation (GDPR) in the European Union, in 2018, gave rise to concerns about the issue of protection of personal data in the United States of America, especially after the European Court ruled that the Privacy Shield would no longer be accepted as a guarantee for the transfer of personal data of European citizens to the US.

How goes Personal Data Protection in the United States of America?Read Full Article

Standardization and cost of stem cell Treatments in Brazil

Recently, a judge in the State of California, United States, rendered a decision ruling that the Food and Drug Administration cannot regulate stem cell treatments as a medicine. Such a decision generated controversy, as there are other decisions that consider cell therapies as medicines regardless of their nature.

Standardization and cost of stem cell Treatments in BrazilRead Full Article

Cookies remain in use, FLoC dies, Topics is born!

Since the GDPR (EU General Data Protection Regulation) came into force on May 25, 2018, the internet search giant Google, which belongs to Alphabet, started to internally and intensively work not only to adapt itself to the GDPR, but also to create tools that mitigate the misuse of personal information from third parties. Such an effort was not just a privilege of Google, but also of companies that develop internet browsers such as Safari and Mozilla Firefox,  which began to offer the option of blocking third-party cookies in their software.

Cookies remain in use, FLoC dies, Topics is born!Read Full Article

Research institutes and conflicts of interest

After the first round of elections in Brazil on October 2, 2022, which elected some governors, senators, federal and state deputies, the research institutes are the big stars among the fierce dispute over the presidency of the Republic. Research institutes managed to get the attention of society, which was, until then, debating whether the electronic voting machines were reliable or not, since, for some, they would be non-auditable; whereas for others, they would be safe as they do not even have internet connection.

Research institutes and conflicts of interestRead Full Article

ANS' role is now Exemplary once again by Law. Read here what this means

Last Wednesday (September 21), the press trumpeted the enactment of a new law, especially the G1 news outlet, informing that healthcare providers are obliged to cover treatments outside the list of the Brazilian Supplementary Health Agency (ANS).

This is another chapter in the fierce dispute between providers and patients, mediated by the authorities. Healthcare providers claim an imbalance in their financial health, while patients denounce lack of coverage and excessive costs in their assistance.

ANS' role is now Exemplary once again by Law. Read here what this meansRead Full Article

The ANPD Opens a Public Consultation on High-Risk Personal Data Processing

On January 27, 2022, the Brazilian Data Protection Authority (ANPD) edited Rule CD/ANPD #2 to regulate the application of the  Brazilian Data Privacy Act, (LGPD), Statute #13,709/2018 to small processing agents: micro-enterprises, small businesses, startups, legal entities governed by private law, including non-profits, as per the legislation in force, as well as natural persons and depersonalized private entities that process personal data, assuming typical controller or processor obligations.

The ANPD Opens a Public Consultation on High-Risk Personal Data ProcessingRead Full Article

What is Brazil missing in the fight against corruption?

Corruption is definitely not an evil that only plagues Brazil but absolutely all countries without exception, to a greater or lesser extent. The existence of corruptors presupposes the existence of corrupts and vice versa. Therefore, focusing on fighting corruption at both extremes is essential, otherwise the effort may be in vain.

What is Brazil missing in the fight against corruption?Read Full Article

In the US, Directors and Chief Compliance Officers will need to provide Certification

In March of this year, Assistant Attorney General Kenneth Polite, from the Criminal Division of the United States Justice Department, made a speech for his colleagues. The contents of this speech are still unknown to many executives and professionals in the legal and compliance areas, but has brought a very interesting new obligation:

In the US, Directors and Chief Compliance Officers will need to provide CertificationRead Full Article

Brazilian Federal Pharmacy Council regulates the practice of Telepharmacy

On July 20, 2022, the Brazilian Federal Pharmacy Council (CFF) published Rule #727/2022, meeting a pressing need in the sector, with the rampant advancement of technology, by regulating the practice of Telepharmacy in Brazil.

Brazilian Federal Pharmacy Council regulates the practice of TelepharmacyRead Full Article

Italy issues new Transparency Law in Healthcare Sector

The interaction between the pharmaceutical and the medical devices industries and doctors has always been reason of concern for the authorities and the population, due to the potential conflict of interests that can be established with the concession of advantages given by the industry, in form of scientific support, gifts, meals, etc… which could interfere especially in the doctor's judgment in choosing the best treatment for their patient.

Italy issues new Transparency Law in Healthcare SectorRead Full Article