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PHRMA updates its code on interactions with health professionals

March 14, 2022

A very sensitive issue for the pharmaceutical industry, and for the medical and hospital products industry concerns the limits in their interaction with health professionals, especially physicians who prescribe drugs, and medical and hospital products.

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Petrobras at the Top of Brazilian Patent Applicants

February 19, 2024

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:

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Only the US and Switzerland effectively enforce their Anti-Corruption Laws Abroad

July 31, 2023

Several countries have anti-corruption legislation, but few extend this legislation to fight corruption alongside foreign authorities outside their territory. Brazil, incidentally, is in the second group of countries having such norms in its set of laws.

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

October 23, 2023

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.

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National Data Protection Authority publishes Security Information Guidelines for Small Processing Agents

November 1, 2021

October 28, 2021 – The National Data Protection Authority (ANPD), which is the regulatory and supervisory body for the protection of personal data in Brazil, has published on October 4, 2021 a new guide called “Information Security Guidelines for Small Processing Agents”.

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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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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

The action plan for Portugal's digital strategy

The digital age is not just an option but an inescapable reality, redefining societies, economies, and governments. Recognizing this, Portugal has reinforced its commitment to digital transformation, culminating in the approval of Council of Ministers Rule #214/2025 on December 29, 2025. This legal instrument is far more than a bureaucratic formality; it is the cornerstone of a future where technology serves as a catalyst for progress and well-being. Through this Resolution, Portugal has approved the 2026-2027 Action Plan of its National Digital Strategy (EDN – Estratégia Digital Nacional), as reported by the news outlet Sapo.pt. This plan is an ambitious yet pragmatic roadmap designed to achieve significant goals by 2030, with one clear objective: to position the country among Europe's leaders in digital transformation. The goal is to promote a transition that is not only technologically advanced but also deeply inclusive, sustainable, and ethical.

The action plan for Portugal's digital strategyRead Full Article

The Railway Statute in Brazil

The Brazilian railway sector, historically challenged by inadequate infrastructure, bureaucratic hurdles, and an overreliance on road freight transport, has long needed a regulatory framework to unlock its true potential. Statute #14,273 of December 23, 2021, governing rail transport, represents a watershed moment. Known as the “New Railway Statute,” it emerged from extensive debate in the National Congress with a promise to modernize the sector's legal foundations, attract substantial private investment, and spur the development and expansion of the national rail network.

The Railway Statute in BrazilRead Full Article

The European Commission's adequacy decision for Brazil

The protection of personal data has become a central issue in the global legal and technological landscape. With the increasing digitalization of the economy and the cross-border flow of data, harmonizing legislation and recognizing equivalent levels of data protection between countries are fundamental steps to ensure legal certainty and the smooth operation of international commerce. The European Union's recent decision to recognize Brazil as a country with a level of personal data protection “essentially equivalent” to its own represents a significant milestone in this regard.

The European Commission's adequacy decision for BrazilRead Full Article

Regulation of artificial intelligence in law

Artificial intelligence (AI) represents one of the most profound technological revolutions in recent history, with the potential to redefine society, the economy, and human interactions. Its ability to process large volumes of data, identify complex patterns, and perform tasks once exclusive to the human mind has generated transformative impacts across multiple sectors. From medicine, with more accurate diagnoses, to industry, with process optimization, AI is reshaping the way we live and work. At the epicenter of this transformation, the legal sector stands out as a particularly fertile ground for AI applications and, consequently, for AI regulation.

Regulation of artificial intelligence in lawRead Full Article

European Union decision reignites debate over illegal content on social media

Last Friday, October 24, The Guardian published an article alleging that Meta Platforms Inc. had violated European Union (EU) law. The story was significant not only because it involved one of the world's largest companies, which controls giants like Facebook, Instagram, and WhatsApp, but also because it reignited the debate over social networks' responsibility to control illegal content on their platforms.

European Union decision reignites debate over illegal content on social mediaRead Full Article

Brazil’s Superior Court of Justice ratifies joint and several liability in Brazilian Anti-Corruption Act

The Brazilian Anti-Corruption Act (Law #12,846/2013) represents a fundamental milestone in Brazil's fight against corruption by establishing, among other provisions, the objective liability of legal entities for acts harmful to the public administration.

Brazil’s Superior Court of Justice ratifies joint and several liability in Brazilian Anti-Corruption ActRead Full Article

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