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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

Medication Leaflets of Generic and Patented Medicines

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.

Medication Leaflets of Generic and Patented MedicinesRead Full Article

Petrobras at the Top of Brazilian Patent Applicants

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:

Petrobras at the Top of Brazilian Patent ApplicantsRead Full Article

The Corruption Perceptions Index in 2023

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.

The Corruption Perceptions Index in 2023Read Full Article

The Inheritance Loss due to Unworthiness

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).

The Inheritance Loss due to UnworthinessRead Full Article

Electronic Drug Labels

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.

Electronic Drug LabelsRead Full Article

The Definitive Compliance Guide for Health Care in the USA

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.

The Definitive Compliance Guide for Health Care in the USARead Full Article

When Corruption Turns the Tables!

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.

When Corruption Turns the Tables!Read Full Article

The Integrity Management Units, and the Brazilian Office of the Comptroller General’s Public Integrity Panel

On November 22, 2017, Decree #9,203 was drafted by the president at the time, Michel Temer, dealing with the governance policy of the Federal Government, its agencies, and foundations.

The Integrity Management Units, and the Brazilian Office of the Comptroller General’s Public Integrity PanelRead Full Article

The French Anti-Corruption Act (Sapin II): A Perspective After 7 Years in Force

The French anti-corruption act called Sapin II, number #1691/2016, is celebrating its anniversary this December 9th, after seven years of existence.

The French Anti-Corruption Act (Sapin II): A Perspective After 7 Years in ForceRead Full Article

Decisions by the Irish Data Protection Authority are undermined

The Data Protection Commission (DPC) of Ireland has been the focus of attention among data protection commissions in other European nations due to the fines they have imposed on technology giants. Despite this, the outcome of the cases leaves much to be desired.

Decisions by the Irish Data Protection Authority are underminedRead Full Article

FDA innovates with new guide for drug approval in the United States

The American agency Food and Drug Administration (FDA) innovated once again by creating a new guide on real-world evidence (RWE) and real-world data (RWD) to support drug approval.

FDA innovates with new guide for drug approval in the United StatesRead Full Article

Artificial intelligence and its regulation in Brazil

On March 29, 2023, “The New York Times” published an article regarding an open letter signed by more than a thousand leaders in the technology sector, including Elon Musk, president of Tesla, Space X, and X (formerly Twitter). The letter requested a stop in the development of artificial intelligence above GPT-4, developed by OpenAI, considering the potential risk of threatening the very existence of society as we know it and even humanity.

Artificial intelligence and its regulation in BrazilRead Full Article

The Fight Against Fake News Around the World

The advancement of technology is overwhelming and inevitable. However, while it revolutionizes communication on a global scale, enabling easy access to information and taking progress to previously inaccessible places, it can have the opposite effect, with a hidden purpose perpetrated by those who maliciously convert a lie into a truth. In fact, as Joseph Goebbels, minister of Nazi propaganda, said, “a lie told a thousand times becomes the truth”.

The Fight Against Fake News Around the WorldRead Full Article

Everything you need to know about ISO

Although the headquarters of the International Organization for Standardization (ISO) is located in Geneva, Switzerland, few people are aware that the organization was founded after a meeting that took place in London, England, in 1946, shortly after the end of the Second World War. At said meeting, 65 representatives from 25 countries sought to discuss the future of international standardization in several areas.

Everything you need to know about ISORead Full Article

How to Implement ERM

ERM, short for enterprise risk management, plays a fundamental role in identifying, preventing, and managing potential risks that may impact business and influence a company's results, ensuring its long-term viability.

How to Implement ERMRead Full Article