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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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SEC Combats Corporate Retaliation Against Whistleblowers

September 20, 2024

Since the Dodd-Frank Act was enacted in the United States in 2010, the role of whistleblowers has proven crucial in helping authorities prevent fraud, bribery, and other legal violations. This is because the government lacks the personnel and resources to efficiently monitor the market on its own.

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The Brazilian Medical Association Intervenes in the Relationship between Physicians and the Pharmaceutical and Medical Products Industry

September 12, 2024

A significant concern in the healthcare sector is the potential conflict of interest between the pharmaceutical and medical products industry and healthcare professionals, particularly physicians. This potential conflict arises from the unique nature of the relationship: while the industry’s end customer is the patient, it is the physician who decides which product the patient will use. At the same time, patients pay physicians to prescribe the best treatment for their well-being.

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A Decision by the Brazilian Superior Court of Justice Sets Precedent in the Advertising of Medicines

August 29, 2024

The First Panel of the Brazilian Superior Court of Justice unanimously decided, under the report of Justice Regina Helena Costa, in the appellate decision on Special Appeal #2035645/DF, that Anvisa (the Brazilian FDA) does not have the regulatory authority to restrict the commercial advertising of pharmaceuticals by companies. This applies especially when its regulatory actions contradict the provisions established in Law #9,294/1996 and other legislative acts.

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The "Emprega + Mulheres" Program and the Impact on Employment Relationships

August 20, 2024

It is well-known that certain market sectors impose additional barriers when hiring women. This is often due to concerns that, during pregnancy, employees may need to take time off for childbirth, utilizing maternity leave. Complications during pregnancy can also arise, potentially weakening the workforce and prompting companies to hire temporary workers to cover the absence.

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Updated Mapping of Personal Data Protection Around the World

August 13, 2024

There is a growing global concern regarding the protection of personal data for individuals, given the rapid technological advances that geographically universalize information and could have considerable impacts on citizens' lives. Brazil, following the global trend, enacted its General Data Protection Act (LGPD) in August 2018, which came into force in September 2020, except for its penalties, which only came into force in August 2021.

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The Activities and Duties of the Data Protection Officer (DPO) are Finally Regulated

August 7, 2024

The National Data Protection Authority (ANPD) published Resolution CD/ANPD #18/2024, dated July 16, 2024, which sought to fill an important gap in detailing the activities of the Data Protection Officer and the responsibilities of data processing agents that support their activities.

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New Regulatory Framework for Clinical Research in Brazil

July 31, 2024

Law #14.874 was enacted on May 28, 2024, providing guidelines for research involving human subjects and establishing the National System of Ethics in research involving human subjects. This statutory framework is of utmost importance as it defines the rights of volunteers and outlines the responsibilities for researchers and sponsors of clinical research.

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ANVISA Approves the Regulation of Biosimilars

June 18, 2024

The Brazilian FDA, ANVISA, approved Rule RDC #875 of May 28, 2024, which provided, in an ancillary manner, for the registration of biosimilars through the comparability development route, aiming to guarantee the quality, safety, and efficacy of these products.

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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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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

Coportate fraud and its evidence

Fraud has been a considerable concern in every corporate sector, although the financial sector is the most affected and the one undertaking the most measures to prevent it in addition to respecting and complying with regulations by competent bodies.

Coportate fraud and its evidenceRead Full Article

National Data Protection Authority publishes Security Information Guidelines for Small Processing Agents

October 28, 2021 – The National Data Protection Authority (ANPD), which is the regulatory and supervisory body for the protection of personal data in Brazil, has published on October 4, 2021 a new guide called “Information Security Guidelines for Small Processing Agents”.

National Data Protection Authority publishes Security Information Guidelines for Small Processing AgentsRead Full Article

HOW WHISTLEBLOWERS ARE TREATED IN BRAZIL AND IN THE USA

Not many Brazilians are aware that Statute #13,964, of December 24, 2019, emerging from the former Justice Minister Sérgio Moro's anti-crime package, has brought a great innovation that could change the scenery of corruption  and other crimes in Brazil, especially the  "White collar” ones. It amended another Statute, #13,608, by introducing the role of the informer. Introducing protective measures therefor, such as: (i) full protection against retaliation, establishing specific sanctions for those who retaliate; (ii) exemption from civil or criminal liability in relation to a report in good faith; and (iii) identity confidentiality. Furthermore, the Statute provided for a reward of up to 5% of the amount recovered, when information results in recovery of revenue resulting from crimes against the public administration (government).

HOW WHISTLEBLOWERS ARE TREATED IN BRAZIL AND IN THE USARead Full Article

MATCHING THE LEGAL BASIS FOR THE PROCESSING OF PERSONAL DATA - THE GREAT EXAMPLE GIVEN BY THE UNITED KINGDOM'S DATA PROTECTION AUTHORITY (ICO)

One of the biggest challenges for a company's adequacy projects to personal data protection's legislation is matching the processing of certain personal data in any legal basis available in the law; depending on the country and, consequently, on its local law, there is not even the possibility of choosing a legal basis for matching, as occurs, for example, in the USA. However, this difficulty affects both Brazil and most European countries.

MATCHING THE LEGAL BASIS FOR THE PROCESSING OF PERSONAL DATA - THE GREAT EXAMPLE GIVEN BY THE UNITED KINGDOM'S DATA PROTECTION AUTHORITY (ICO) Read Full Article

GUIDE TO ASSESS THE INTERFERENCE OF FOREIGN COUNTRIES IN PERSONAL DATA PROTECTION

In February 2020, the European Data Protection Board released a recommendation guide on essential guarantees for surveillance measures implemented under the European General Data Protection Regulation – GDPR.

GUIDE TO ASSESS THE INTERFERENCE OF FOREIGN COUNTRIES IN PERSONAL DATA PROTECTIONRead Full Article

FIGHTING CORRUPTION IN ITALY

The fight against corruptionin Italy has always been a great challenge, considering the difficulties inconfronting organized crime, especially the mafia, which has received differentnames depending on the region, such as the Camorra in Naples, the Cosa Nostrain Sicily, and the 'Ndrangheta in Calabria.

FIGHTING CORRUPTION IN ITALYRead Full Article

BRAZILIAN POWER SUPPLY CRISIS AND COMPANY STANCES

Brazil is currently going through the most severe water shortage in the last 91 years, according to CNN. This impacts the power supply crisis, leading to notice after notice  on increases in the consumer's electricity bill, determined by the Brazilian Electricity Regulatory Agency (Aneel), as more expensive energy sources such as thermoelectric plants need to be activated or have their production increased to compensate for the limitations imposed on hydroelectric power plants, as they have no input material.

BRAZILIAN POWER SUPPLY CRISIS AND COMPANY STANCESRead Full Article

LACK OF REGULATION FOR DATA PROTECTION OFFICERS GIVES RISE TO UNCERTAINTIES ON THEIR ROLE

The Brazilian General Data Protection Act (LGPD) entered into force in September 2020, introducing the role of Data Protection Officer (DPO). In the Act, the role is described as the person appointed by the controller and processor to act as a communication channel between the controller, the data subjects and the National Data Protection Authority (ANPD).

LACK OF REGULATION FOR DATA PROTECTION OFFICERS GIVES RISE TO UNCERTAINTIES ON THEIR ROLE Read Full Article

ESG for laymen!

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

ESG for laymen! Read Full Article

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

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.

DISCOUNT ON MEDICATION - A SOURCE OF CONCERN FOR THE PHARMACEUTICAL SECTORRead Full Article

THE LACK OF PROPORTIONALITY IN THE GENERAL DATA PROTECTION LAW

The General Data Protection Law (LGPD) established 10 (ten) principles that must be observed in the activities of processing personal data.

THE LACK OF PROPORTIONALITY IN THE GENERAL DATA PROTECTION LAWRead Full Article

THE COMPLIANCE POLICY FOR FINANCIAL INSTITUTIONS ACCORDING TO THE NATIONAL MONETARY COUNCIL

The National Monetary Council (CMN) has regulated – through the CMN Resolution 4,595, of August 28, 2017 - the compliance policy applicable to financial institutions authorized to operate in Brazil by the Central Bank, but not applicable to consortium administrators and payment institutions.

THE COMPLIANCE POLICY FOR FINANCIAL INSTITUTIONS ACCORDING TO THE NATIONAL MONETARY COUNCILRead Full Article