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And speaking of Patient Support Programs...

November 14, 2022

The Patient Support Programs (PSPs) developed by the pharmaceutical industries are often controversial as to the real benefit they provide, how much they contribute to patient loyalty and the risks they bring to the companies implementing them.

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All there is to know about the Brazilian Freedom of Information ACT

September 4, 2023

To ensure greater transparency on public accounts and public services in general, especially after initiatives such as the Transparency Portal, Law 12,527 of November 18, 2011, the Brazilian Freedom of Information Act, was sanctioned. This Act aims to provide access to even the greater public to information regarding Public Administration, regulating Article 5, Item XXXIII, Article 37, Paragraph  3, II and Article 216, Paragraph 2, from Brazilian Constitution of 1988.

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Advances in Telemedicine Regulation in Brazil

May 16, 2022

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.

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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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2021 corruption perceptions index

January 31, 2022

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.

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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

Updated Mapping of Personal Data Protection Around the World

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.

Updated Mapping of Personal Data Protection Around the WorldRead Full Article

“Big Mac” vs. “Supermac's” and the Risk of Abandonment for Trademark Registration Owners

In a case involving the dispute between the trademarks “Big Mac” and “Supermac's” in the European Union, the Irish company Supermac's (Holdings) Ltd. applied in 2017 for the abandonment of registration #626381,  for the trademark “Big Mac”, owned by McDonald's International Property Co. Ltd, on the grounds of non-use.

“Big Mac” vs. “Supermac's” and the Risk of Abandonment for Trademark Registration OwnersRead Full Article

The Activities and Duties of the Data Protection Officer (DPO) are Finally Regulated

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.

The Activities and Duties of the Data Protection Officer (DPO) are Finally RegulatedRead Full Article

Legal Business in Brazil

The legal business is a kind of legal act that arises from the manifestation of a person's will, aiming to produce effects in the legal sphere of another. Therefore, a legal relationship arises between the parties, respecting the requirements established by law for its validity and effectiveness factors that will impact its production of effects.

Legal Business in BrazilRead Full Article

New Regulatory Framework for Clinical Research in Brazil

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.

New Regulatory Framework for Clinical Research in BrazilRead Full Article

ANVISA Approves the Regulation of Biosimilars

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.

ANVISA Approves the Regulation of BiosimilarsRead Full Article

European Council Approves Legislation on Artificial Intelligence

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).

European Council Approves Legislation on Artificial IntelligenceRead Full Article

ANPD Approves Regulation on Security Incident Reporting

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.

ANPD Approves Regulation on Security Incident ReportingRead Full Article

India’s Anti-Corruption Act

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.

India’s Anti-Corruption ActRead Full Article

The Balancing Test in Personal Data Protection

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.

The Balancing Test in Personal Data ProtectionRead Full Article

The Importance and Use of the Limitation of Liability Clause

Initially, it is important to highlight that a company's ability to carry out an economic operation is intrinsically linked to the analysis of several stages, with risk assessment being one of its crucial factors. After the decision to proceed with the operation, a new phase emerges: the negotiation of contractual terms. It is clear that consideration of costs, including possible compensation, is a key element in decision-making in order to avoid compromising the operations.

The Importance and Use of the Limitation of Liability ClauseRead Full Article

The Legitimate Interest in the Processing of Personal Data

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.

The Legitimate Interest in the Processing of Personal DataRead Full Article

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

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.

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

The Unpredictability and the Excessive Burden Theories

An extremely important aspect in contract management is the unpredictability theory. This theory can greatly impact the rights and obligations of one of the parties, completely unbalancing the rights and obligations between them and even making the contract unfair to the detriment of one of the parties.

The Unpredictability and the Excessive Burden TheoriesRead Full Article

Results from the US Securities & Exchange Commission Inspection in 2023

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.

Results from the US Securities & Exchange Commission Inspection in 2023Read Full Article