Newsletter

Register your email and receive our updates

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

FOLLOW US ON SOCIAL MEDIA

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.

SEE MORE

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.

SEE MORE

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.

SEE MORE

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.

SEE MORE

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.

SEE MORE

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.

SEE MORE

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.

SEE MORE

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).

SEE MORE

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).

SEE MORE

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.

LINKEDIN FEED

Newsletter

Register your email and receive our updates -

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

FOLLOW US ON SOCIAL MEDIA

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