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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

Understand the Leniency Agreement

The Brazilian Anti-corruption Act # 12.846 of August 1, 2013, known abroad as the “Clean Company Act”, brought an important instrument to assist authorities in investigating and prospecting evidence, called a leniency agreement.

Understand the Leniency AgreementRead Full Article

The Bidding Process and the Rehabilitation of the Bidder Declared Dishonest

The Bidding Act # 8.666 / 93 - establishes in its Article 87 the sanctions that may be applicable to those who do not comply with the administrative contracts resulting from the bid object.

The Bidding Process and the Rehabilitation of the Bidder Declared DishonestRead Full Article

Data Protection and Privacy and the CPO

Despite the Covid-19 pandemic, which has attracted attention from all over the world, issues related to the personal data protection arouse the interest of many people, especially here in Brazil, due to the force of the LGPD which was postponed by Provisional Measure 959 on April 29, 2020 to May 3, 2021.

Data Protection and Privacy and the CPORead Full Article

Data Privacy Law and the Impact on the Health Care Area

On the afternoon of July 22nd, a webinar was held, ‘‘Data Privacy Law (LGPD) and the Impact on the Health Care Area”, presented by four of our attorneys at law: Alexandre Dalmasso, specialist in compliance with experience in the pharmaceutical industry; Douglas Leite, Flávio Buzanovsky,  and Ricardo Campello specialists in LGPD.

Data Privacy Law and the Impact on the Health Care AreaRead Full Article

New Version of the U.S Foreign Corrupt Practices Act (FCPA) Resource Guide

The US Department of Justice(US DOJ) and the US Securities and ExchangeCommission (SEC) have released a new version of the resourceguide on the US Anti-Corruption Act(FCPA - Foreign Corrupt Practices Act) after 8years since the publication´s first version.

New Version of the U.S Foreign Corrupt Practices Act (FCPA) Resource GuideRead Full Article

Transparency in Emergency Contracts

On the afternoon of July 8th, a webinar was held with the topic ‘‘Transparency in Emergency Contracts”, led by Guilherme France, research coordinator at Transparency International's Anti-Corruption Knowledge Center – Brazil, Alexandre Dalmasso and Ana Luisa Calil, attorneys at law at Licks Attorneys.

Transparency in Emergency ContractsRead Full Article

Use of e-mails

Lots of people are unaware that e-mails already existed when companies still used the electric typewriter. The first email, which is known, was sent in 1971 by Ray Tomlison. And the first email address created is also his: tomlison @ bbn-tenexa.

Use of e-mailsRead Full Article

10 Mistakes that affect a compliance investigation report.

Compliance investigations have increased exponentially, since compliance programs were consolidated in companies globally.

10 Mistakes that affect a compliance investigation report. Read Full Article

What drives good people to do bad things

To reflect on what can make good people do bad things, I will mention two real cases, which occurred during my career.

What drives good people to do bad thingsRead Full Article

TCU AND INTERNATIONAL TRANSPARENCY LAUNCH EMERGENCY CONTRACTING GUIDANCE

In May 2020, the Federal Court of Auditors - TCU, in partnership with the international non-governmental organization Transparency International marked a point in favor of tackling corruption and legal certainty for the federal, state and municipal public managers, by launching a booklet called “Recommendations for Transparency of Emergency Contracts in Response to COVID-19“. The booklet guides those professionals, in face of Act 13,979 / 2020, to adopt accurate and licit practices in the management of public resources in the pandemic scenario.

TCU AND INTERNATIONAL TRANSPARENCY LAUNCH EMERGENCY CONTRACTING GUIDANCERead Full Article

Health Fraud! How does the US government combat this problem

On the afternoon of May 28th, a webinar was held with the topic ‘Health Fraud! How does the US government combat this problem’, led by Alexandre Dalmasso, partner and responsible for the Ethics and Compliance Practice Group.

Health Fraud! How does the US government combat this problemRead Full Article

Data Protection and Privacy Mapping in the World

Currently, according to the UNCTAD - United Nations Conference on Trade and Development, here is the current scenario regarding the regulation of Data Protection and Privacy in the World:

Data Protection and Privacy Mapping in the WorldRead Full Article

European Data Authority - EDPB Publishes Guide With Rules For Consent

The European Data Protection Board (EDPB) issued on May 4, 2020 the Guide 05/2020 with rules applicable to the consent of the personal data, under the Data Protection Law, in force at the European Union - GDPR (General Data Protection Resolution).

European Data Authority - EDPB Publishes Guide With Rules For ConsentRead Full Article

THE UNCERTAINTY OF THE EFFECTIVE DATE OF THE GENERAL DATA PROTECTION LAW – LGPD

The gap between the issuance date of a law and the effective date is called vacatio legis. The reason, in general, for a law not to enter into force on the date of its publication is because the legislator wishes to provide society with time enough to become aware and prepared to respect its content.

THE UNCERTAINTY OF THE EFFECTIVE DATE OF THE GENERAL DATA PROTECTION LAW – LGPDRead Full Article

JOB DESCRIPTION OF A COMPLIANCE OFFICER

The compliance officer is briefly the facilitator in consolidating a culture of compliance within the organization, and should be the first to set an example, with respect to behaviors and attitudes when interacting with internal and external clients.

JOB DESCRIPTION OF A COMPLIANCE OFFICERRead Full Article