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Standardization and cost of stem cell Treatments in Brazil

October 24, 2022

Recently, a judge in the State of California, United States, rendered a decision ruling that the Food and Drug Administration cannot regulate stem cell treatments as a medicine. Such a decision generated controversy, as there are other decisions that consider cell therapies as medicines regardless of their nature.

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Cookies remain in use, FLoC dies, Topics is born!

October 17, 2022

Since the GDPR (EU General Data Protection Regulation) came into force on May 25, 2018, the internet search giant Google, which belongs to Alphabet, started to internally and intensively work not only to adapt itself to the GDPR, but also to create tools that mitigate the misuse of personal information from third parties. Such an effort was not just a privilege of Google, but also of companies that develop internet browsers such as Safari and Mozilla Firefox,  which began to offer the option of blocking third-party cookies in their software.

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Research institutes and conflicts of interest

October 10, 2022

After the first round of elections in Brazil on October 2, 2022, which elected some governors, senators, federal and state deputies, the research institutes are the big stars among the fierce dispute over the presidency of the Republic. Research institutes managed to get the attention of society, which was, until then, debating whether the electronic voting machines were reliable or not, since, for some, they would be non-auditable; whereas for others, they would be safe as they do not even have internet connection.

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ANS' role is now Exemplary once again by Law. Read here what this means

September 26, 2022

Last Wednesday (September 21), the press trumpeted the enactment of a new law, especially the G1 news outlet, informing that healthcare providers are obliged to cover treatments outside the list of the Brazilian Supplementary Health Agency (ANS).

This is another chapter in the fierce dispute between providers and patients, mediated by the authorities. Healthcare providers claim an imbalance in their financial health, while patients denounce lack of coverage and excessive costs in their assistance.

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The ANPD Opens a Public Consultation on High-Risk Personal Data Processing

September 20, 2022

On January 27, 2022, the Brazilian Data Protection Authority (ANPD) edited Rule CD/ANPD #2 to regulate the application of the  Brazilian Data Privacy Act, (LGPD), Statute #13,709/2018 to small processing agents: micro-enterprises, small businesses, startups, legal entities governed by private law, including non-profits, as per the legislation in force, as well as natural persons and depersonalized private entities that process personal data, assuming typical controller or processor obligations.

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What is Brazil missing in the fight against corruption?

September 12, 2022

Corruption is definitely not an evil that only plagues Brazil but absolutely all countries without exception, to a greater or lesser extent. The existence of corruptors presupposes the existence of corrupts and vice versa. Therefore, focusing on fighting corruption at both extremes is essential, otherwise the effort may be in vain.

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In the US, Directors and Chief Compliance Officers will need to provide Certification

September 5, 2022

In March of this year, Assistant Attorney General Kenneth Polite, from the Criminal Division of the United States Justice Department, made a speech for his colleagues. The contents of this speech are still unknown to many executives and professionals in the legal and compliance areas, but has brought a very interesting new obligation:

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Brazilian Federal Pharmacy Council regulates the practice of Telepharmacy

August 29, 2022

On July 20, 2022, the Brazilian Federal Pharmacy Council (CFF) published Rule #727/2022, meeting a pressing need in the sector, with the rampant advancement of technology, by regulating the practice of Telepharmacy in Brazil.

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Italy issues new Transparency Law in Healthcare Sector

August 22, 2022

The interaction between the pharmaceutical and the medical devices industries and doctors has always been reason of concern for the authorities and the population, due to the potential conflict of interests that can be established with the concession of advantages given by the industry, in form of scientific support, gifts, meals, etc… which could interfere especially in the doctor's judgment in choosing the best treatment for their patient.

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The Ultimate Guide to Data Leakage

August 15, 2022

The Brazilian Computer Emergency Response Team (CERT.br) from the Brazilian Network Information Center (NIC.br) – which is the executive branch of the Brazilian Internet Steering Committee (CGI.br) – has been in charge of dealing with security incidents involving networks connected to the Internet in Brazil since 1997. With the collaboration of Brazilian Data Protection Authority (ANPD), they have published the Guide to Data Leakage with the purpose of guiding people on the potential risks of data processing in digital environments.

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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

Coportate fraud and its evidence

Fraud has been a considerable concern in every corporate sector, although the financial sector is the most affected and the one undertaking the most measures to prevent it in addition to respecting and complying with regulations by competent bodies.

Coportate fraud and its evidenceRead Full Article

National Data Protection Authority publishes Security Information Guidelines for Small Processing Agents

October 28, 2021 – The National Data Protection Authority (ANPD), which is the regulatory and supervisory body for the protection of personal data in Brazil, has published on October 4, 2021 a new guide called “Information Security Guidelines for Small Processing Agents”.

National Data Protection Authority publishes Security Information Guidelines for Small Processing AgentsRead Full Article

HOW WHISTLEBLOWERS ARE TREATED IN BRAZIL AND IN THE USA

Not many Brazilians are aware that Statute #13,964, of December 24, 2019, emerging from the former Justice Minister Sérgio Moro's anti-crime package, has brought a great innovation that could change the scenery of corruption  and other crimes in Brazil, especially the  "White collar” ones. It amended another Statute, #13,608, by introducing the role of the informer. Introducing protective measures therefor, such as: (i) full protection against retaliation, establishing specific sanctions for those who retaliate; (ii) exemption from civil or criminal liability in relation to a report in good faith; and (iii) identity confidentiality. Furthermore, the Statute provided for a reward of up to 5% of the amount recovered, when information results in recovery of revenue resulting from crimes against the public administration (government).

HOW WHISTLEBLOWERS ARE TREATED IN BRAZIL AND IN THE USARead Full Article

MATCHING THE LEGAL BASIS FOR THE PROCESSING OF PERSONAL DATA - THE GREAT EXAMPLE GIVEN BY THE UNITED KINGDOM'S DATA PROTECTION AUTHORITY (ICO)

One of the biggest challenges for a company's adequacy projects to personal data protection's legislation is matching the processing of certain personal data in any legal basis available in the law; depending on the country and, consequently, on its local law, there is not even the possibility of choosing a legal basis for matching, as occurs, for example, in the USA. However, this difficulty affects both Brazil and most European countries.

MATCHING THE LEGAL BASIS FOR THE PROCESSING OF PERSONAL DATA - THE GREAT EXAMPLE GIVEN BY THE UNITED KINGDOM'S DATA PROTECTION AUTHORITY (ICO) Read Full Article

GUIDE TO ASSESS THE INTERFERENCE OF FOREIGN COUNTRIES IN PERSONAL DATA PROTECTION

In February 2020, the European Data Protection Board released a recommendation guide on essential guarantees for surveillance measures implemented under the European General Data Protection Regulation – GDPR.

GUIDE TO ASSESS THE INTERFERENCE OF FOREIGN COUNTRIES IN PERSONAL DATA PROTECTIONRead Full Article

FIGHTING CORRUPTION IN ITALY

The fight against corruptionin Italy has always been a great challenge, considering the difficulties inconfronting organized crime, especially the mafia, which has received differentnames depending on the region, such as the Camorra in Naples, the Cosa Nostrain Sicily, and the 'Ndrangheta in Calabria.

FIGHTING CORRUPTION IN ITALYRead Full Article

BRAZILIAN POWER SUPPLY CRISIS AND COMPANY STANCES

Brazil is currently going through the most severe water shortage in the last 91 years, according to CNN. This impacts the power supply crisis, leading to notice after notice  on increases in the consumer's electricity bill, determined by the Brazilian Electricity Regulatory Agency (Aneel), as more expensive energy sources such as thermoelectric plants need to be activated or have their production increased to compensate for the limitations imposed on hydroelectric power plants, as they have no input material.

BRAZILIAN POWER SUPPLY CRISIS AND COMPANY STANCESRead Full Article

LACK OF REGULATION FOR DATA PROTECTION OFFICERS GIVES RISE TO UNCERTAINTIES ON THEIR ROLE

The Brazilian General Data Protection Act (LGPD) entered into force in September 2020, introducing the role of Data Protection Officer (DPO). In the Act, the role is described as the person appointed by the controller and processor to act as a communication channel between the controller, the data subjects and the National Data Protection Authority (ANPD).

LACK OF REGULATION FOR DATA PROTECTION OFFICERS GIVES RISE TO UNCERTAINTIES ON THEIR ROLE Read Full Article

ESG for laymen!

In the corporate world of finance, ESG is “in”. Indeed, ESG is an acronym of three words in English, meaning environmental, social, and governance.

ESG for laymen! Read Full Article

DISCOUNT ON MEDICATION - A SOURCE OF CONCERN FOR THE PHARMACEUTICAL SECTOR

In May 2021, the State of Arkansas in the United States published the HB1709 bill prohibiting manufacturers from offering discount on any product containing insulin, with the exception of the discount provided directly to the end user in the form of a pharmaceutical manufacturer discount coupon and which can be obtained through the National Council for Prescription Drug Programs e-prescribing service.

DISCOUNT ON MEDICATION - A SOURCE OF CONCERN FOR THE PHARMACEUTICAL SECTORRead Full Article

THE LACK OF PROPORTIONALITY IN THE GENERAL DATA PROTECTION LAW

The General Data Protection Law (LGPD) established 10 (ten) principles that must be observed in the activities of processing personal data.

THE LACK OF PROPORTIONALITY IN THE GENERAL DATA PROTECTION LAWRead Full Article

THE COMPLIANCE POLICY FOR FINANCIAL INSTITUTIONS ACCORDING TO THE NATIONAL MONETARY COUNCIL

The National Monetary Council (CMN) has regulated – through the CMN Resolution 4,595, of August 28, 2017 - the compliance policy applicable to financial institutions authorized to operate in Brazil by the Central Bank, but not applicable to consortium administrators and payment institutions.

THE COMPLIANCE POLICY FOR FINANCIAL INSTITUTIONS ACCORDING TO THE NATIONAL MONETARY COUNCILRead Full Article