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The DPO is recognized in the Brazilian Classification of Occupations

May 30, 2022

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.

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The FDA unifies Premarket Review for Combination Products

May 23, 2022

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.

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Advances in Telemedicine Regulation in Brazil

May 16, 2022

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.

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FCPA 2021 Review - Hot Cases

May 9, 2022

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.

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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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How to Protect Your Personal Data

April 25, 2022

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.

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Lessons in Drug Promotion by the FDA

April 18, 2022

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.

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

April 11, 2022

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).

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Interfarma updates its Code of Conduct

April 4, 2022

We have recently published two posts regarding the update made to the codes of PhRMA (Pharmaceutical Research and Manufacturers of America) and the IMC (Innovative Medicines Canada).

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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

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

More Sanctions Applied By The Brazilian Data Protection Authority signal that Violations of the LGPD Will Not Be Tolerated

The Brazilian Data Protection Authority (ANPD) published on October 18, 2023 their third sanction for violation of the General Data Protection Act (LGPD). Similarly to the second penalty, the infraction occurred in the public sector, not involving a private company.

More Sanctions Applied By The Brazilian Data Protection Authority signal that Violations of the LGPD Will Not Be ToleratedRead Full Article

Brazilian Data Protection Authority Applies Second Penalty for Violation of the Data Protection Act

After a phase where the Brazilian Data Protection Authority (ANPD) focused on regulating important provisions outlined in the General Data Protection Act (LGPD), in addition to editing several manuals and guidelines to assist the public in complying with the law, the ANPD has imposed its first penalty on July 6, 2023, targeting the company Telekall Infoservice.

Brazilian Data Protection Authority Applies Second Penalty for Violation of the Data Protection ActRead Full Article

Antitrust and anti-corruption authorities are already monitoring the 2026 World Cup

Considering the financial scandals fueled by acts of corruption involving the most recent World Cup, which led to the arrest of leaders from several countries, North American antitrust and anti-corruption authorities turned their attention to the 2026 World Cup, which will take place in three countries: United States, Canada, and Mexico. Among the arrests made, one that stood out was that of José Maria Marín, former president of the Brazilian Football Confederation (CBF) between 2012 and 2015 who was also governor of the State of São Paulo between 1982 and 1983, after the death of governor Franco Montoro.

Antitrust and anti-corruption authorities are already monitoring the 2026 World CupRead Full Article

Retaliation against non-disclosure agreements in the USA

Non-disclosure agreements are used by many companies with the purpose of guaranteeing or, at least, trying to hinder the disclosure of their confidential information by employees or former employees. Some companies require the signing of NDAs alongside the employment contract, while others require the signing of these documents upon termination of the employment contract, occasionally offering a bonus and demanding silence in exchange. If the employee violates the agreement, he or she may be forced to return the amount paid, often with interest and/or fines added.

Retaliation against non-disclosure agreements in the USARead Full Article