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NEW DIRECTIONS FOR PUBLIC CIVIL ACTION IN BRAZIL

May 24, 2021

Public civil actions were endorsed by Article 129, III of the  Federal Constitution of 1988 and have become one of the Federal Prosecution Officer’s (MP) institutional functions, regulated by Law No. 7,347 / 85.  They target diffuse, collective, and homogeneous individual rights.  They are intended to prevent and prosecute violations to collective interests such as the environment, consumers, historical or cultural heritage, including administrative impropriety, economic order, urban order.

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MPF, SENACON, CADE, AND ANPD RECOMMEND WHATSAPP EXTEND THE TERM OF ITS NEW PRIVACY POLICY

May 17, 2021

When WhatsApp informed its users a few months ago that their data could be shared with Facebook, this fact generated alarm among many users who imagined that part of their WhatsApp dialogues would appear on their Facebook pages. However, WhatsApp denied that this was going to happen.

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Medication Leaflets of Generic and Patented Medicines

February 29, 2024

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.

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MATCHING THE LEGAL BASIS FOR THE PROCESSING OF PERSONAL DATA - THE GREAT EXAMPLE GIVEN BY THE UNITED KINGDOM'S DATA PROTECTION AUTHORITY (ICO)

September 27, 2021

One of the biggest challenges for a company's adequacy projects to personal data protection's legislation is matching the processing of certain personal data in any legal basis available in the law; depending on the country and, consequently, on its local law, there is not even the possibility of choosing a legal basis for matching, as occurs, for example, in the USA. However, this difficulty affects both Brazil and most European countries.

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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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LACK OF REGULATION FOR DATA PROTECTION OFFICERS GIVES RISE TO UNCERTAINTIES ON THEIR ROLE

August 30, 2021

The Brazilian General Data Protection Act (LGPD) entered into force in September 2020, introducing the role of Data Protection Officer (DPO). In the Act, the role is described as the person appointed by the controller and processor to act as a communication channel between the controller, the data subjects and the National Data Protection Authority (ANPD).

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Italy issues new Transparency Law in Healthcare Sector

August 22, 2022

The interaction between the pharmaceutical and the medical devices industries and doctors has always been reason of concern for the authorities and the population, due to the potential conflict of interests that can be established with the concession of advantages given by the industry, in form of scientific support, gifts, meals, etc… which could interfere especially in the doctor's judgment in choosing the best treatment for their patient.

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Items required for the Compliance Program are changed by New Regulation

July 18, 2022

The Brazilian government edited Decree #11,129 on this Monday, July 11, 2022, updating the regulation of the Brazilian Anti-Corruption Act (Statute #12,846 of August 1, 2013) and bringing some changes to the content of Decree #8,420 of March 18, 2015, which was responsible for such regulation.

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Israel Approves Limitation of Supreme Court Powers Amid Huge Controversy

July 25, 2023

Various news networks around the world, such as CNN and The Wall Street Journal have reported the controversial decision taken by the Israeli parliament – the Knesset, which imposes a limitation on the Israeli Supreme Court. This decision was very controversial, with some seeing it as an attack to democracy, and others as a defense.

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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

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