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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

Brazilian Comptroller General Launches a Handbook for Handling Conflicts of Interest

The Office of the Comptroller General (CGU) announced on June 4, 2022, the release of its newest document: the Handbook for Handling Conflicts of Interest.

Brazilian Comptroller General Launches a Handbook for Handling Conflicts of InterestRead Full Article

Sexual harassment complaints at CEF and the integrity program

On June 29, 2022, several media outlets, including the Isto É Dinheiro magazine, published revelations that, despite the political capitalization by the government's opponents, brought to light a worrying threat to the effectiveness of the integrity programs implemented in the various government entities.

Sexual harassment complaints at CEF and the integrity programRead Full Article

Information Wall – A Growing Need

On May 9, 2022, the website “Policy & Medicine” published an interesting article signed by Thomas Sullivan titled “McKinsey – Serving as a Double Agent?”. It describes that the Oversight and Reform Committee on the US House of Representatives issued a report concluding that 22 consultants from the renowned McKinsey consulting firm were assigned to work simultaneously with the US government and with opioid manufacturers.

Information Wall – A Growing NeedRead Full Article

ANPD is transformed into an Autonomous Agency

On this 13th of June, the Brazilian government issued the Executive Order #1,124, which was also published in the Federal Gazette on June 14, 2022. Containing 10 articles, it enters into force on the date of its publication.

ANPD is transformed into an Autonomous AgencyRead Full Article

ANS' List of Procedures is exhaustive, according to the Brazilian Superior Court of Justice. What does this mean for us?

On June 8, 2022, Brazil witnessed the unfolding of another chapter involving healthcare plans, patients and the Brazilian Agency of Supplementary Health (ANS), this time at the headquarters of the Brazilian Superior Court of Justice (STJ), in Brasilia.

ANS' List of Procedures is exhaustive, according to the Brazilian Superior Court of Justice. What does this mean for us?Read Full Article

The DPO is recognized in the Brazilian Classification of Occupations

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.

The DPO is recognized in the Brazilian Classification of OccupationsRead Full Article

The FDA unifies Premarket Review for Combination Products

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.

The FDA unifies Premarket Review for Combination ProductsRead Full Article

Advances in Telemedicine Regulation in Brazil

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.

Advances in Telemedicine Regulation in BrazilRead Full Article

FCPA 2021 Review - Hot Cases

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.

FCPA 2021 Review - Hot CasesRead Full Article

Does doing the right thing deserve recognition?

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.

Does doing the right thing deserve recognition?Read Full Article

How to Protect Your Personal Data

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.

How to Protect Your Personal DataRead Full Article

Lessons in Drug Promotion by the FDA

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.

Lessons in Drug Promotion by the FDARead Full Article

Changes to Legislation of the Brazilian Public Healthcare System (SUS) Bring Hope to Patients

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).

Changes to Legislation of the Brazilian Public Healthcare System (SUS) Bring Hope to PatientsRead Full Article

Interfarma updates its Code of Conduct

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).

Interfarma updates its Code of ConductRead Full Article