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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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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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The Corruption Perceptions Index in 2023

February 6, 2024

Transparency International, headquartered in Berlin, it is a non-profit organization focused on anti-corruption operating internationally. Its purpose is to combat corruption and associated criminal activities.

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The Inheritance Loss due to Unworthiness

February 1, 2024

Dealing with death is never easy. Especially if it happens to someone close to us, such as a family member. Despite this, the mourning and pain for the loss of a loved one should not hinder the obligation imposed by law on executing the probate proceedings within 60 days, under penalty of a fine of 10% of the tax amount. If the delay exceeds 180 days, the fine is increased to 20%. Furthermore, the deceased taxpayer who paid taxes throughout their whole life must still witness, wherever they are, the unpleasantness of having part of their properties literally confiscated by the public authorities, under the title of cause mortis estate and gift tax (ITCMD).

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Electronic Drug Labels

January 22, 2024

The Brazilian Congress approved on May 11, 2022, Law #14,388/2022, also known as the Electronic Drug Labels Act. Its aim was to shift from paper package inserts to digital labels, resulting in amendments to Law #11,903/2009, which regulated the tracking of drug production and consumption through electronic data capture, storage, and transmission technology. In turn, this law had already been partially changed by Law #13,410/2016, which addressed the National Medicines Control System.

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The Definitive Compliance Guide for Health Care in the USA

January 15, 2024

Without much ado, the American Office of Inspector General (OIG) has published the General Compliance Program Guidance (GCPG). This guide is intended for use by several segments of the health care sector, such as hospitals, nursing homes, medical equipment suppliers, among others. Its objective is to encourage the development and use of internal control resources, in order to monitor compliance with provisions of applicable statutes, regulations, and programs.

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When Corruption Turns the Tables!

January 8, 2024

The past few years have been tumultuous, particularly for Brazilians, in the battle against corruption. Controversial judicial decisions, sparking significant debate, diminished the effectiveness of Operation Car Wash (“Lava Jato”), a landmark anti-corruption probe, in Brazil. The once unassailable figures in the fight against corruption found themselves vilified in a country prone to casting shadows on those in the spotlight.

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The Integrity Management Units, and the Brazilian Office of the Comptroller General’s Public Integrity Panel

December 26, 2023

On November 22, 2017, Decree #9,203 was drafted by the president at the time, Michel Temer, dealing with the governance policy of the Federal Government, its agencies, and foundations.

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The French Anti-Corruption Act (Sapin II): A Perspective After 7 Years in Force

December 12, 2023

The French anti-corruption act called Sapin II, number #1691/2016, is celebrating its anniversary this December 9th, after seven years of existence.

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Decisions by the Irish Data Protection Authority are undermined

December 6, 2023

The Data Protection Commission (DPC) of Ireland has been the focus of attention among data protection commissions in other European nations due to the fines they have imposed on technology giants. Despite this, the outcome of the cases leaves much to be desired.

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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

Items required for the Compliance Program are changed by New Regulation

The Brazilian government edited Decree #11,129 on this Monday, July 11, 2022, updating the regulation of the Brazilian Anti-Corruption Act (Statute #12,846 of August 1, 2013) and bringing some changes to the content of Decree #8,420 of March 18, 2015, which was responsible for such regulation.

Items required for the Compliance Program are changed by New RegulationRead Full Article

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