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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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ANPD Approves Regulation on Security Incident Reporting

May 8, 2024

The Brazilian Data Protection Authority (ANPD), a public entity created by the General Data Protection Act (LGPD), responsible for regulating, supervising, guiding, educating, and acting on security incidents involving personal data, as well as for cooperating with other similar international entities, published CD/ANPD’s Rule #15, dated April 24, 2024, in the Federal Register on April 26, 2024. Taking advantage of the last public consultation on the topic, the Rule approved the Regulation on Security Incident Reporting.

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India’s Anti-Corruption Act

April 30, 2024

While Brazil adopted its Anti-Corruption Act aimed at companies only on August 1, 2013, with Law #12,846, India adopted an Anti-Corruption Act known as “The Prevention of Corruption Act” on September 9, 1988, which typifies and penalizes bribery offenses involving both individuals (natural persons) and companies (legal entities). Now, let’s delve into the main points of this act below.

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The Balancing Test in Personal Data Protection

April 24, 2024

There are numerous situations in a business that result in a company having to deal with personal data, and obtaining the data subject's consent is not always possible or even viable. Bearing this in mind the legislator made 9 other legal bases available in the Brazilian General Data Protection Act (LGPD) so that companies, controllers or operators of such personal data can use them to classify the processing of the respective data.

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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

Dealing with ethical dilemmas in business

Ethics is a word derived from the Greek vernacular “ethos", which, in turn, means "way of life". Philosophically, ethics focuses on the behavior of a human being within a social environment.

Dealing with ethical dilemmas in businessRead Full Article

Highest award ever paid by the US Securities and Exchange Commission to a whistleblower

The United States Securities and Exchange Commission announced the payment of the highest award ever paid to a whistleblower since the awards were instituted by the Dodd-Frank Act, sanctioned in 2010.

Highest award ever paid by the US Securities and Exchange Commission to a whistleblowerRead Full Article

The controversy on data sharing between Europe and the USA

Ireland’s Data Protection Commission (DPC) has published a press release on May 22, announcing that the inquiry into Meta Ireland, the Dublin-based company that manages Facebook not only in Ireland but throughout Europe, has been concluded.

The controversy on data sharing between Europe and the USARead Full Article

The German supply chain due diligence act (LKSG)

In the previous article, the “United Nations Guiding Principles on Business and Human Rights”, created in 2011 and which still influences several laws in many countries, was highlighted.

The German supply chain due diligence act (LKSG)Read Full Article

United Nations guiding principles on business and human rights

Although ESG (which stands for Environmental, Social and Governance) is a popular topic, few are aware of the document “Guiding Principles on Business and Human Rights”. Launched in 2011 by the United Nations, the text has influenced countless laws in several countries around the world to this day.

United Nations guiding principles on business and human rightsRead Full Article

How to investigate corruption

With regard to investigations of corruption in Brazil, the police authority, the Brazilian Office of the Comptroller General (CGU), the Prosecution Office and even the Internal Affairs of various public entities are invariably involved.

How to investigate corruptionRead Full Article

Dark patterns in data protection

In a time where fake news is so prevalent, the topic of dark patterns has gained a lot of relevance. The term was purely academic but, in recent times, has been commonly seen in data protection regulations worldwide.

Dark patterns in data protectionRead Full Article

U.S Department of justice updates its guide to corporate compliance programs

Now under the Biden administration, the U.S. Department of Justice (DOJ) has published, on March 3, 2023, an update to its guide for evaluating compliance programs. It assists prosecutors in this task, allowing them to identify whether the program is efficient at the time of the offense and whether it is effective at the time of a charging decision or resolution.

U.S Department of justice updates its guide to corporate compliance programsRead Full Article

The EDPB publishes new guidelines for personal data protection

The European Data Protection Board (EDPB) has recently published, after a public inquiry with different segments of European society, three new guidelines related to the protection of personal data.

The EDPB publishes new guidelines for personal data protectionRead Full Article

The sponsorship ethics of pharmaceutical and medical companies for physicians speaking in conferences

This is certainly one of the most controversial topics in recent years with regard to the interaction of the medical profession with the health industry – which encompasses the pharmaceutical industry, medical and hospital products and even cosmetics and food.

The sponsorship ethics of pharmaceutical and medical companies for physicians speaking in conferencesRead Full Article

ANPD REGULATES THE APPLICATION OF ADMINISTRATIVE SANCTIONS

Administrative Sanctions Regulation on Dosimetry and Application of Administrative Sanctions, which establishes the dosimetry guidelines for sentences, especially calculating the base value for fines the agency may apply. It is an initiative of the rapporteur and director of the ANPD – Arthur Sabbat, in which he was unanimously followed by the rest of the board. Although the criteria set out below establish clear guidelines, the ANPD may depart from its methodology or review the penalty, if impaired proportionality is found between the severity of the violation and the intensity of the sanction.

ANPD REGULATES THE APPLICATION OF ADMINISTRATIVE SANCTIONSRead Full Article

Prison after conviction in appellate courts

Going to prison in Brazil is any easy task. The Brazilian procedural law, especially in criminal law, creates so many mechanisms for postponing the final and unappealable decisions that anyone having the resources to hire a lawyer or relying on an active public defender can postpone it. As such, many cases end up time-barred, although Brazilian legislation is slowly advancing in making crimes such as femicide or rape imprescriptible.

Prison after conviction in appellate courtsRead Full Article

Transparency International launches the 2022 Corruption Perceptions Index

Transparency International is a non-profit anti-corruption organization headquartered on Berlin that operates internationally. Its purpose is to combat corruption and criminal activities related to corrupt acts.

Transparency International launches the 2022 Corruption Perceptions IndexRead Full Article

ANPD launches new security incident form

In the second half of December 2022, the National Data Protection Authority (ANPD) published an amendment to the Security Incident Reporting form, to be used by all those who need to report security incidents starting January 1, 2023.

ANPD launches new security incident formRead Full Article

Why is the Whistleblower despised in the Fight against Corruption in Brazil?

While some countries are failing in the fight against corruption, Brazil has achieved a real negative milestone in recent years. The country managed to deconstruct the Car Wash Operation , the most powerful symbol of the fight against corruption ever carried out in the country and also  encouraged impunity to public agents who commit acts of administrative impropriety, by sanctioning Statute 14,230 of 03.31.2022. Since then,  public agents can no longer be held responsible for damages caused by recklessness, negligence or malpractice, since only deceit (the intention to do or not to do) characterizes impropriety in the corresponding crimes typified by law. An open door for the "I don't know" people... For those who intend to prove anything, they must manage on their own prove that the agent intentionally did the act...

Why is the Whistleblower despised in the Fight against Corruption in Brazil?Read Full Article