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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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ANPD Approves Regulation on Security Incident Reporting

May 8, 2024

The Brazilian Data Protection Authority (ANPD), a public entity created by the General Data Protection Act (LGPD), responsible for regulating, supervising, guiding, educating, and acting on security incidents involving personal data, as well as for cooperating with other similar international entities, published CD/ANPD’s Rule #15, dated April 24, 2024, in the Federal Register on April 26, 2024. Taking advantage of the last public consultation on the topic, the Rule approved the Regulation on Security Incident Reporting.

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India’s Anti-Corruption Act

April 30, 2024

While Brazil adopted its Anti-Corruption Act aimed at companies only on August 1, 2013, with Law #12,846, India adopted an Anti-Corruption Act known as “The Prevention of Corruption Act” on September 9, 1988, which typifies and penalizes bribery offenses involving both individuals (natural persons) and companies (legal entities). Now, let’s delve into the main points of this act below.

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The Balancing Test in Personal Data Protection

April 24, 2024

There are numerous situations in a business that result in a company having to deal with personal data, and obtaining the data subject's consent is not always possible or even viable. Bearing this in mind the legislator made 9 other legal bases available in the Brazilian General Data Protection Act (LGPD) so that companies, controllers or operators of such personal data can use them to classify the processing of the respective data.

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The Legitimate Interest in the Processing of Personal Data

April 15, 2024

Since the creation of the Brazilian General Data Protection Act (LGPD) on August 14, 2018, the comparison with the European GDPR was inevitable, after all, the Brazilian LGPD was greatly influenced by the similar law published just over two years earlier in Europe. While the LGPD had ten legal bases to support the processing of personal data, the GDPR had only six legal bases.

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CGU's Lilac Guide to Combating Moral Harassment, Sexual Harassment, and Discrimination in the Public Service

April 8, 2024

The ongoing battle waged by companies and governments to address moral harassment, sexual harassment, and discrimination among employees, whether in the private or public sector, is nothing new. A poignant illustration of this perpetual struggle was the resignation of the president of the Brazilian Savings Bank (Caixa Econômica Federal – CEF) on June 29, 2022, following allegations of sexual harassment made by CEF employees.

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Results from the US Securities & Exchange Commission Inspection in 2023

April 1, 2024

Many people wonder why the US Securities & Exchange Commission (SEC) has been so successful, which has anequivalent agency in Brazil. The reason for its effectiveness is not hard to understand: the agency does not hesitate to investigate and impose penalties to curb irregularities that impact the day-to-day operations of the US stock market, including instances of corruption.

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When Supporting Gender Equality Conflicts with Privacy Rights

March 15, 2024

At a time in history when the topics of diversity and inclusion are more and more relevant, a federal law enacted in 2023 is causing great controversy, even forcing a rush to the courts to ensure its compliance.

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The Fight Against Corruption in Singapore

March 6, 2024

Corruption poses anever-present concern for democracies on every continent. It is no different inAsia, especially in Singapore, which alongside New Zealand and Scandinaviancountries stand out as examples of best practices in infrastructure and legal frameworkemployed to combat corruption.

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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

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

Innovative Medicines Canada (IMC) updates its Code of Ethical Practices

The Innovative Medicines Canada (IMC) was founded on April 23, 1914, by representatives of 10 pharmaceutical and toilet products companies under the name “Canadian Association of Manufacturers of Medicinal and Toilet Products”. In 1915, the association changed its name to “Canadian Pharmaceutical Manufacturers Association”, while in 1965, the association again changed its name to the “Pharmaceutical Manufacturers Association of Canada (PMAC)”.

Innovative Medicines Canada (IMC) updates its Code of Ethical PracticesRead Full Article

How are whistleblowers treated in Europe?

Since 2010, with the enactment of the "Dodd-Frank Act", the United States introduced the whistleblower, i.e., someone who witnesses an irregularity within the following parameters:

How are whistleblowers treated in Europe?Read Full Article

PHRMA updates its code on interactions with health professionals

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.

PHRMA updates its code on interactions with health professionalsRead Full Article

When gifts become a problem

Could a simple gift be a nuisance to a company? Depending on the situation and the parties involved, it certainly can!

When gifts become a problemRead Full Article

UNODC'S best practices in the fight against corruption

In a memorable initiative, the United Nations Office on Drugs and Crime (UNODC) developed, in 2007, the Best Practices in the Fight Against Corruption project, of which several countries took part, including Brazil.

UNODC'S best practices in the fight against corruptionRead Full Article

When friendship drags you down

Professor Robert Henry Srour from the University of São Paulo (USP), who I respectfully admire as one of the greatest and best thinkers on ethics in Brazil, describes in his magnificent work “Ética Empresarial” an interesting scene from the movie The Devil's Own, 1997.

When friendship drags you downRead Full Article

Data protection rules in the states of Virginia and Colorado, USA

Although the United States is at the forefront when it comes to innovation and technology, the same cannot be said when it comes to privacy and data protection, since state statutes focus solely on the commercialization of personal data from individuals. Due to its form of government, the US allows States to decide on the rules for the protection of personal data.

Data protection rules in the states of Virginia and Colorado, USARead Full Article

Brazilian Data Protection Authority (ANPD) regulates personal data protection for small business

The Brazilian Data Protection Authority (ANPD), the body responsible for the promotion and control of the General Data Protection Law (LGPD) in Brazil, started 2022 by publishing CD/ANPD Resolution #2 on January 27, 2022, which approves the regulation implementing the LGPD – Statute #13.709/2018 for small processing agents.

Brazilian Data Protection Authority (ANPD) regulates personal data protection for small businessRead Full Article

2021 corruption perceptions index

The Transparency International is a non-profit anti-corruption organization headquartered on Berlin that operates internationally. Its purpose is to combat corruption and criminal activities related to corrupt acts.

2021 corruption perceptions indexRead Full Article

Third-Party Due Diligence

In the early 2000s, when a company was asked if there was a compliance program in force, the answer would be the existence of a Code of Ethics or Conduct. If that was the case and there was a compliance program, the company could boast this as a hallmark.

Third-Party Due DiligenceRead Full Article

VIRTUAL VOICE ASSISTANTS AND PERSONAL DATA PROTECTION

While Brazil's National Data Protection Authority (ANPD) struggles to meet its General DataProtection Act (LGPD) regulatory schedule for the two-year period of 2021 and2022, Europe is making strides in regulating and guiding various aspects of the GeneralData Protection Regulation (GDPR), as shown below.

VIRTUAL VOICE ASSISTANTS AND PERSONAL DATA PROTECTIONRead Full Article

Why you should not ignore risk assessment

Considering the hardships the world is going through, recently paralyzed by one of the biggest pandemics in history which, claimed the lives of millions of people millions of companies that could not bear the burden of shutdowns and were not prepared for working remotely, it has become necessary to draw attention to something that many companies despise: the habit of performing risk assessments.

Why you should not ignore risk assessmentRead Full Article

Ethics and Democracy

After moments of great suffering when not only Brazil but the world was faced with a lethal pandemic resulting in the death of millions, life begins to return to normal. The economic issues caused by the pandemic in addition to the health injuries of citizens show the dramatic social abyss, which is engulfing mainly the lower-middle classes in Brazil. Economic markers, GDP below the target, and galloping inflation demonstrate that the ghost of recession is more realistic than we'd like.

Ethics and DemocracyRead Full Article

Relationships between co-workers and conflicts of interest

The recurring theme of romantic relationships between co-workers has been around the corporate world for quite some time and often leaves the field of Human Resources or even Compliance in difficult situations.

Relationships between co-workers and conflicts of interestRead Full Article