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How data classification (or lack of it) affects your business

July 3, 2023

One of the most significant concerns in today's corporate environments is the risk of confidential information being leaked or shared without authorization. This exfiltration of confidential information is known to occur not only through unauthorized access by an external agent, but also through the actions of a malicious internal collaborator.

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How goes Personal Data Protection in the United States of America?

October 31, 2022

The entry into force of the General Data Protection Regulation (GDPR) in the European Union, in 2018, gave rise to concerns about the issue of protection of personal data in the United States of America, especially after the European Court ruled that the Privacy Shield would no longer be accepted as a guarantee for the transfer of personal data of European citizens to the US.

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HOW MUCH DOES IT COST, AND HOW MUCH DOES A COMPANY EARN WITH A COMPLIANCE PROGRAM?

June 7, 2021

A seemingly simple question, but appearances can be deceiving!

The question is much more complex than it seems. After all, it is illusory to compare different matters under the same prism.

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

June 13, 2023

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.

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How are whistleblowers treated in Europe?

March 21, 2022

Since 2010, with the enactment of the "Dodd-Frank Act", the United States introduced the whistleblower, i.e., someone who witnesses an irregularity within the following parameters:

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

September 20, 2021

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.

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FIGHTING CORRUPTION IN ITALY

September 13, 2021

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.

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

December 1, 2023

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.

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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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Everything you need to know about ISO

November 7, 2023

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.

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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

SEC has record financial penalty collection in 2024

The US Securities & Exchange Commission (SEC) announced in early December, according to The Wall Street Journal, record-breaking year for financial penalty collections in 2024.

SEC has record financial penalty collection in 2024Read Full Article

Australia to ban minors from accessing social media

One of the biggest concerns for parents in the modern world is their children's use of social media. Depending on how they are used, social media can become a huge headache for parents and their children tend to be the most vulnerable part in this unfiltered environment, where a world of discoveries is just a click away.

Australia to ban minors from accessing social mediaRead Full Article

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

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.

Do you know what the No Surprises Act is? Understanding its importanceRead Full Article

SEC Combats Corporate Retaliation Against Whistleblowers

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.

SEC Combats Corporate Retaliation Against WhistleblowersRead Full Article

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

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.

The Brazilian Medical Association Intervenes in the Relationship between Physicians and the Pharmaceutical and Medical Products IndustryRead Full Article

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

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.

A Decision by the Brazilian Superior Court of Justice Sets Precedent in the Advertising of MedicinesRead Full Article

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

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.

The "Emprega + Mulheres" Program and the Impact on Employment RelationshipsRead Full Article

The “Língua de Gato” case: trademark or synonym for product?

In recent weeks, the news about the loss of exclusivity of the “Língua de Gato” trademark has caused a great deal of buzz and raised many questions among chocolate lovers. After all, did Kopenhagen lose its rights to the “Língua de Gato” trademark?

The “Língua de Gato” case: trademark or synonym for product?Read Full Article

Deadlines and Deliveries — Logistical Challenges in Pharmaceutical Industry Contracts

In the pharmaceutical industry, strict compliance with delivery deadlines is essential. In commercial contracts between pharmaceutical companies and their suppliers, clarity and precision in stipulating delivery deadlines, as well as defining the consequences for non-compliance with these deadlines, are crucial to avoid disputes and ensure continuous supply to the market. Delays in the delivery of essential inputs can cause serious impacts, such as interruptions in medicaments production, compromises of research projects and even risks to public health. In this context, logistics plays a critical role that is amplified by the need for transportation and storage products under specific temperature and humidity conditions, in addition to complying with the regulatory standards of each country. The contracts signed between the parties must reflect this importance, establishing clauses that address the specific challenges of this area.

Deadlines and Deliveries — Logistical Challenges in Pharmaceutical Industry ContractsRead Full Article

Updated Mapping of Personal Data Protection Around the World

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.

Updated Mapping of Personal Data Protection Around the WorldRead Full Article

“Big Mac” vs. “Supermac's” and the Risk of Abandonment for Trademark Registration Owners

In a case involving the dispute between the trademarks “Big Mac” and “Supermac's” in the European Union, the Irish company Supermac's (Holdings) Ltd. applied in 2017 for the abandonment of registration #626381,  for the trademark “Big Mac”, owned by McDonald's International Property Co. Ltd, on the grounds of non-use.

“Big Mac” vs. “Supermac's” and the Risk of Abandonment for Trademark Registration OwnersRead Full Article

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

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.

The Activities and Duties of the Data Protection Officer (DPO) are Finally RegulatedRead Full Article

Legal Business in Brazil

The legal business is a kind of legal act that arises from the manifestation of a person's will, aiming to produce effects in the legal sphere of another. Therefore, a legal relationship arises between the parties, respecting the requirements established by law for its validity and effectiveness factors that will impact its production of effects.

Legal Business in BrazilRead Full Article

New Regulatory Framework for Clinical Research in Brazil

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.

New Regulatory Framework for Clinical Research in BrazilRead Full Article

ANVISA Approves the Regulation of Biosimilars

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.

ANVISA Approves the Regulation of BiosimilarsRead Full Article