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

October 7, 2024

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.

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SEC Combats Corporate Retaliation Against Whistleblowers

September 20, 2024

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.

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

September 12, 2024

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.

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

August 29, 2024

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.

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

August 20, 2024

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.

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Updated Mapping of Personal Data Protection Around the World

August 13, 2024

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.

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

August 7, 2024

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.

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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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ANVISA Approves the Regulation of Biosimilars

June 18, 2024

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.

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European Council Approves Legislation on Artificial Intelligence

May 29, 2024

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).

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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 DISPOSAL OF PERSONAL DATA

Recently, the Federal Supreme Court (STF) positioned itself against the right to be forgotten versus the media's right to report certain facts. In this specific case, the STF ended up endorsing the thesis recognizing a right to be forgotten would be an act of censorship, given the media's right to report news for society's knowledge accurately.

THE DISPOSAL OF PERSONAL DATARead Full Article

CNIL INTRODUCED NEW RULES FOR THE USE OF COOKIES IN FRANCE IN 2020

In October 2020, the Commission Nationale de l’Informatique et des Libertés (CNIL), the French body that regulates the protection of personal data in that country, published two documents, one designated “guidelines” and the other called “recommendations,” establishing rules and good practices, concerning the use of cookies on the internet.

CNIL INTRODUCED NEW RULES FOR THE USE OF COOKIES IN FRANCE IN 2020Read Full Article

AN ANALYSIS OF THE SANCTIONS APPLIED BY THE WORLD BANK IN 2020

The World Bank published its Annual Sanctions Report for 2020, highlighting the institution’s concern with the projects it finances globally and potential risks of fraud and corruption.

AN ANALYSIS OF THE SANCTIONS APPLIED BY THE WORLD BANK IN 2020Read Full Article

THE FRENCH ANTICORRUPTION AGENCY (AFA) PUBLISHES NEW GUIDELINES FOR PUBLIC AND PRIVATE ORGANIZATIONS

On January 12, 2021, the French Anti-Corruption Agency (AFA) published new guidelines for companies in the public and private sectors, laying out recommendations in order to ensure compliance with the French Anti-Corruption Law (Sapin II) sanctioned since the end of 2016.

THE FRENCH ANTICORRUPTION AGENCY (AFA) PUBLISHES NEW GUIDELINES FOR PUBLIC AND PRIVATE ORGANIZATIONSRead Full Article

COMPLIANCE PROGRAM REQUIREMENTS FOR BIDS IN THE STATE OF PERNAMBUCO ARE POSTPONED

Following the states of Rio de Janeiro, Espírito Santo, Santa Catarina, and the Federal District, the State of Pernambuco signed a law that compels the implementation of a compliance program (called an ‘integrity program’ in the public sector) by private companies that wish to contract with the state government. I am referring to State Law 16,722, enacted on December 9, 2019.

COMPLIANCE PROGRAM REQUIREMENTS FOR BIDS IN THE STATE OF PERNAMBUCO ARE POSTPONEDRead Full Article

USFDA PUBLISHES GUIDELINES FOR MANUFACTURERS NAMING NEW MEDICINES

The US Food and Drug Administration (FDA) has just published new guidelines for manufacturers regarding the choice of names for their medicines. The guide focuses on how the trust and distinction of other existing medication may be transmitted to end-users, that is, to patients.

USFDA PUBLISHES GUIDELINES FOR MANUFACTURERS NAMING NEW MEDICINES Read Full Article

Judicialization of medicines: USA x Brazil’

On February 9th, webinar Judicialization of medicines: USA x Brazil’ was presented by partner Alexandre Dalmasso. Dalmasso discussed the access both Brazil and USA have to medicines as well as the legal and financial impact.

Judicialization of medicines: USA x Brazil’ Read Full Article

Statistical results of General Data Protection (GDPR) enforcement in 2020

The year 2020, plagued by the Covid-19 pandemic, has passed. European countries suffered amid the coronavirus's spread, with Italy, Spain, the United Kingdom, and France most negatively affected in the first wave. Subsequently, during the second wave, the United Kingdom and Portugal ended up leading in infection rates and discovering a new yet more contagious strain.

Statistical results of General Data Protection (GDPR) enforcement in 2020Read Full Article

Is there potential for excessive rigor in data protection?

The General Data Protection Law (LGPD), created in 2018, finally came into force in Brazil in 2020. The National Data Protection Agency (ANPD) was structured accordingly to begin managing and controlling the effective protection of personal data. However, to date, the ANPD has not yet started to standardize obscure aspects of the law and address gaps that need regulation.

Is there potential for excessive rigor in data protection?Read Full Article

The ANPD and the challenge of enforcing the LGPD

The recently formed National Data Protection Authority (ANPD) has a challenging mission to standardize or regulate various situations that require more detailed regulation by the primary authority responsible for personal data in Brazil.

The ANPD and the challenge of enforcing the LGPDRead Full Article

How Canada combats spam!

Recently, in an article on this website, the USA’s 2003 CAN-SPAM law that helped regulate spam was mentioned (Sending and Posting Advertisement in Mass, translated into Portuguese as ““Enviar e Postar Publicidade em Massa,” or Stupid Pointless Annoying Messages, which translates into Portuguese as “Mensagens Perturbadoras, Estúpidas e Sem Noção”).

How Canada combats spam!Read Full Article

Can a collection company call indebted consumers once the General Data Protection Law is in force?

Under the General Data Protection Law (LGPD) now in force, a frequently asked question is whether collection companies contracted by financial institutions, retail chains, or other lending organizations can continue to call individuals – allegedly using their personal data shared by the companies which contracted the service and, therefore, creditors of the vindicated amount – or not.

Can a collection company call indebted consumers once the General Data Protection Law is in force?Read Full Article

CONAR launches a guide for digital influencers

The National Council for AdvertisingSelf-Regulation (CONAR) launched the Guide for Digital Influencers in November2020 to establish standards and ethical criteria in advertising to be carriedby the channels used by such influencers.

CONAR launches a guide for digital influencersRead Full Article

And how about the privacy and protection of personal data in the United States of America?

In this unique year of 2020, the significant milestone in the area of privacy and protection of personal data in the United States of America (USA) remains undoubtedly the CCPA - California Consumer Privacy Act, which started to protect the citizens of the State of California against commercial use of their personal data without their consent. But does privacy and protection of personal data in the US come down to the CCPA only?

And how about the privacy and protection of personal data in the United States of America?Read Full Article

São Paulo State Government prohibits pharmacies and drugstores from requiring a CPF to grant discounts to their customers

The Governor of the State of São Paulo, João Agripino da Costa Doria Junior – better known as João Doria – sanctioned State Bill # 1212/2019 on December 1, 2020. The bill was authored by State Deputy Alex de Madureira as he is known, since his name is Alexander Muniz de Oliveira, being born in Piracicaba, SP, and affiliated with the Social Democratic Party (PSD).

São Paulo State Government prohibits pharmacies and drugstores from requiring a CPF to grant discounts to their customersRead Full Article