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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 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

Drugmaker launches litigation against the US government to enable co-payments

According to Reuters, Pfizer Inc. filed a lawsuit on June 26, 2020, to make it possible to help beneficiaries of the federal healthcare program - Medicare - pay for two drugs to treat a rare and sometimes fatal heart disease, and that cost $225,000 a year.

Drugmaker launches litigation against the US government to enable co-paymentsRead Full Article

Corruption and the criminal liability of companies

Corruption is a topic that always attracts the attention of the media and society.  In some ways, it resembles a kind of metastatic societal cancer, in which a cell released into the bloodstream may burst like a new tumor, anytime, anywhere.

Corruption and the criminal liability of companiesRead Full Article

ABNT Security Certification Diverges from the European Authority's Position on Privacy and Data Protection

A TV commercial recently broadcast to promote a vehicle hire application informed viewers that it was the first and only company in the sector security certified by the Brazilian Association of Technical Standards (ABNT).

ABNT Security Certification Diverges from the European Authority's Position on Privacy and Data ProtectionRead Full Article

Risk assessment - Is yours up to date?

Is your risk assessment up to date?  This is a question that should regularly be asked within any financial institution.  Unfortunately, in most cases, the answer is postponed or even ignored, up until the moment when a government agent needs to evaluate that company's compliance program.

Risk assessment - Is yours up to date?Read Full Article

United States government announces largest healthcare and opioid enforcement action in history

The US Department of Justice (USDOJ) announced a historic nationwide enforcement action against healthcare fraud.  This unprecedented initiative involves 345 charged defendants in 51 federal districts, including more than 100 doctors, nurses, and other licensed medical professionals.

United States government announces largest healthcare and opioid enforcement action in historyRead Full Article

Compliance in the financial market

Ordinance BACEN 3,978 of January 23, 2020, which was created for the purpose of regulating the policy, procedures and internal controls to be adopted by institutions authorized to operate by the Central Bank of Brazil (BACEN) with a view to preventing the use of financial system for the practice of crimes of “laundering” or concealment of assets, rights and values, as set out in Law 9,613, of March 3, 1998, and of terrorism financing, provided for in Law 13,260, of December 16, March 2016, would come into force on July 1, 2020. However, Ordinance BACEN 4,005, dated April 16, 2020, changed the effective date to October 1, 2020.

Compliance in the financial marketRead Full Article

The role of the European Union's Data Protection Officer (Encarregado)

The position of ‘Data Protection Officer’ – established initially under the terms of the EU’s General Data Protection Regulation (GDPR) – has been imported into Brazil’s equivalent General Data Protection Law (LGDP) with the slightly peculiar title of  “Encarregado.”

The role of the European Union's Data Protection Officer (Encarregado)Read Full Article

Rules to protect whistleblowers in the European Union

In April 2018, the European Union launched a proposal to create a Directive standardizing whistleblower protection rules and clarifying the proper protection to be given to those reporting a company's misconduct.

Rules to protect whistleblowers in the European UnionRead Full Article

The concept of the foreign public official under the Usa's Foreign Corrupt Practices Act

The definition of the 'foreign public official,' according to the USA's anti-corruption law – the Foreign Corrupt Practices Act (FCPA) – has always been a sui generis aspect of the regulation, considering its breadth in comparison with similar standards in other countries.

The concept of the foreign public official under the Usa's Foreign Corrupt Practices ActRead Full Article

The principles of the General Data Protection Law - LGDP

The General Data Protection Law (LGPD), Law 13,709 of August 14, 2018, was enacted after the president's sanction, on September 18, 2020,  converting the Provisional Measure 959/2020 into law, and regulating the protection of personal data of individuals, with a level of detail never before achieved by any other local law.

The principles of the General Data Protection Law - LGDPRead Full Article

FCPA Review 2019

On the afternoon of August 27th, webinar ‘FCPA Review 2019’ was presented by partner Alexandre Dalmasso.

FCPA Review 2019Read Full Article

LGPD – Lessons learned from the European GDPR

On the afternoon of August 25th, webinar ‘LGPD – Lessons learned from the European GDPR’ was presented by three of our attorneys at law: Alexandre Dalmasso, partner; Douglas Leite and Flávio Buzanovsky, specialists in LGPD.

LGPD – Lessons learned from the European GDPRRead Full Article

The French Anti-Corruption Agency - Gifts and entertainment guide - AFA

The French Anti-Corruption Agency - AFA published, approximately 1 year ago, a guide on gifts and entertainment in order to guide companies, foundations and associations to establish safe rules on this topic.

The French Anti-Corruption Agency - Gifts and entertainment guide - AFARead Full Article