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The controversy on data sharing between Europe and the USA

June 5, 2023

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.

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The German supply chain due diligence act (LKSG)

May 29, 2023

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.

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United Nations guiding principles on business and human rights

May 22, 2023

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.

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How to investigate corruption

May 15, 2023

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.

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Dark patterns in data protection

May 8, 2023

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.

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

May 2, 2023

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.

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The EDPB publishes new guidelines for personal data protection

April 11, 2023

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.

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

March 20, 2023

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.

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ANPD REGULATES THE APPLICATION OF ADMINISTRATIVE SANCTIONS

March 7, 2023

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.

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Prison after conviction in appellate courts

February 23, 2023

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.

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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

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

European Council Approves Legislation on Artificial Intelligence

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).

European Council Approves Legislation on Artificial IntelligenceRead Full Article

ANPD Approves Regulation on Security Incident Reporting

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.

ANPD Approves Regulation on Security Incident ReportingRead Full Article