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European Council Approves Legislation on Artificial Intelligence

May 29, 2024

In contrast to Mercosur, which struggles to evolve from an economic bloc to a political and monetary union due to challenges in socio-political integration caused by alternating conservative and progressive governments, the European Union continues to demonstrate efficiency in integrating its member countries. Despite the United Kingdom's departure, the EU remains committed to regulating fundamental issues related to the incorporation of new technologies, which will significantly impact personal, educational, and professional relationships. We are specifically discussing Artificial Intelligence (AI).

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Ethics and Democracy

December 20, 2021

After moments of great suffering when not only Brazil but the world was faced with a lethal pandemic resulting in the death of millions, life begins to return to normal. The economic issues caused by the pandemic in addition to the health injuries of citizens show the dramatic social abyss, which is engulfing mainly the lower-middle classes in Brazil. Economic markers, GDP below the target, and galloping inflation demonstrate that the ghost of recession is more realistic than we'd like.

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EUROPEAN BODIES APPROVE JOINT PROPOSAL TO PROHIBIT THE USE OF AI FOR AUTOMATED RECOGNITION

July 12, 2021

The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) announced on June 21st, 2021 that they have approved a joint opinion on the European Commission's Proposal for a Regulation laying down harmonised rules on artificial intelligence (AI).

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ESG for laymen!

August 23, 2021

In the corporate world of finance, ESG is “in”. Indeed, ESG is an acronym of three words in English, meaning environmental, social, and governance.

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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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Do you know what the No Surprises Act is? Understanding its importance

October 7, 2024

The No Surprises Act is a prime example of legislation in a country where the legal system is based more on case law than statutes. While Brazil’s legal system originates from Civil Law, the United States follows Common Law. However, U.S. laws are often very well-drafted, especially in terms of their applicability. In this context, it is important to consider the role of the judiciary, which operates under the punitive principle, unlike Brazil's compensatory system, which is less effective.

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Does doing the right thing deserve recognition?

May 2, 2022

Successful compliance programs typically take place in organizations with examples coming from the top. There is no doubt about the fundamental factor for success in such programs: top management engagement, or a culture of example. There is no way for a compliance program to prosper otherwise.

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Discussing the conflict of interest in the federal government

June 27, 2023

Today, after reading an article authored by the renowned legal scholar Wálter Maierovitch, I was taken aback by the way some authorities handle conflicts of interest.

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DISCOUNT ON MEDICATION - A SOURCE OF CONCERN FOR THE PHARMACEUTICAL SECTOR

August 16, 2021

In May 2021, the State of Arkansas in the United States published the HB1709 bill prohibiting manufacturers from offering discount on any product containing insulin, with the exception of the discount provided directly to the end user in the form of a pharmaceutical manufacturer discount coupon and which can be obtained through the National Council for Prescription Drug Programs e-prescribing service.

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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

Items required for the Compliance Program are changed by New Regulation

The Brazilian government edited Decree #11,129 on this Monday, July 11, 2022, updating the regulation of the Brazilian Anti-Corruption Act (Statute #12,846 of August 1, 2013) and bringing some changes to the content of Decree #8,420 of March 18, 2015, which was responsible for such regulation.

Items required for the Compliance Program are changed by New RegulationRead Full Article

Brazilian Comptroller General Launches a Handbook for Handling Conflicts of Interest

The Office of the Comptroller General (CGU) announced on June 4, 2022, the release of its newest document: the Handbook for Handling Conflicts of Interest.

Brazilian Comptroller General Launches a Handbook for Handling Conflicts of InterestRead Full Article

Sexual harassment complaints at CEF and the integrity program

On June 29, 2022, several media outlets, including the Isto É Dinheiro magazine, published revelations that, despite the political capitalization by the government's opponents, brought to light a worrying threat to the effectiveness of the integrity programs implemented in the various government entities.

Sexual harassment complaints at CEF and the integrity programRead Full Article

Information Wall – A Growing Need

On May 9, 2022, the website “Policy & Medicine” published an interesting article signed by Thomas Sullivan titled “McKinsey – Serving as a Double Agent?”. It describes that the Oversight and Reform Committee on the US House of Representatives issued a report concluding that 22 consultants from the renowned McKinsey consulting firm were assigned to work simultaneously with the US government and with opioid manufacturers.

Information Wall – A Growing NeedRead Full Article

ANPD is transformed into an Autonomous Agency

On this 13th of June, the Brazilian government issued the Executive Order #1,124, which was also published in the Federal Gazette on June 14, 2022. Containing 10 articles, it enters into force on the date of its publication.

ANPD is transformed into an Autonomous AgencyRead Full Article

ANS' List of Procedures is exhaustive, according to the Brazilian Superior Court of Justice. What does this mean for us?

On June 8, 2022, Brazil witnessed the unfolding of another chapter involving healthcare plans, patients and the Brazilian Agency of Supplementary Health (ANS), this time at the headquarters of the Brazilian Superior Court of Justice (STJ), in Brasilia.

ANS' List of Procedures is exhaustive, according to the Brazilian Superior Court of Justice. What does this mean for us?Read Full Article

The DPO is recognized in the Brazilian Classification of Occupations

The first step towards recognizing the profession of Data Protection Officer (DPO) in Brazil, which was introduced by the definition contained in Article 5, VIII of the Brazilian Data Privacy Act (LGPD) – Statute #13,709/2018. This step was taken with its inclusion in the Brazilian Classification of Occupations (CBO), created by Ordinance #397 of October 10, 2002.

The DPO is recognized in the Brazilian Classification of OccupationsRead Full Article

The FDA unifies Premarket Review for Combination Products

In January 2022, the Food and Drug Administration (FDA) published an interesting guide, called Principles of Premarket Pathways for Combination Products, which establishes the unification of premarket review of combination products.

The FDA unifies Premarket Review for Combination ProductsRead Full Article

Advances in Telemedicine Regulation in Brazil

Up until now, telemedicine in Brazil had been regulated by Law 13,989 of April 15, 2020, which provided for the use of telemedicine during the crisis caused by the coronavirus (SARS-COV-2). That is, apparently there was only regulation approved in Congress, after the country faced a national emergency, because of the pandemic that was expanding and causing deaths and sequelae wherever it arrived, forcing social isolation. In fact, social isolation was the driving force for services, such as those resulting from the use of telemedicine.

Advances in Telemedicine Regulation in BrazilRead Full Article

FCPA 2021 Review - Hot Cases

For this week's Licks Attorneys Compliance Blog, we will re-air the webinar “FCPA Review 2021 – Hot Cases”, hosted by our partner Alexandre Dalmasso.

FCPA 2021 Review - Hot CasesRead Full Article

Does doing the right thing deserve recognition?

Successful compliance programs typically take place in organizations with examples coming from the top. There is no doubt about the fundamental factor for success in such programs: top management engagement, or a culture of example. There is no way for a compliance program to prosper otherwise.

Does doing the right thing deserve recognition?Read Full Article

How to Protect Your Personal Data

On August 14, 2018, the Brazilian General Data Protection Act (LGPD) – Statute #13,709 established general rules for the protection of every individual's personal data – something that, until then, lacked safeguards and limits on third-party use.

How to Protect Your Personal DataRead Full Article

Lessons in Drug Promotion by the FDA

The Food and Drug Administration (FDA) is the American agency responsible for protecting and promoting public health through the control and supervision of food safety, medicines and the like, a role similar to that performed by ANVISA in Brazil.

Lessons in Drug Promotion by the FDARead Full Article

Changes to Legislation of the Brazilian Public Healthcare System (SUS) Bring Hope to Patients

One of the greatest Brazilian achievements is undoubtedly the Brazilian Public Healthcare System (SUS). Provided for by Article 196 of the 1988 Brazilian Constitution, it establishes that health is a right for all and a duty of the State, and guarantees to every Brazilian access to public health, regardless of payment to the Brazilian Social-Security Administration (INSS).

Changes to Legislation of the Brazilian Public Healthcare System (SUS) Bring Hope to PatientsRead Full Article