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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

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

The right of the subject to access their personal data and the nightmare this creates for businesses

The General Data Protection Law (LGPD) – Law 13.709 / 2018 – was designed to standardize the protection of personal data handled by third parties (individuals, companies, or the government) for commercial purposes.

The right of the subject to access their personal data and the nightmare this creates for businessesRead Full Article