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The FDA unifies Premarket Review for Combination Products

May 23, 2022

In January 2022, the Food and Drug Administration (FDA) published an interesting guide, called Principles of Premarket Pathways for Combination Products, which establishes the unification of premarket review of combination products.

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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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FCPA 2021 Review - Hot Cases

May 9, 2022

For this week's Licks Attorneys Compliance Blog, we will re-air the webinar “FCPA Review 2021 – Hot Cases”, hosted by our partner Alexandre Dalmasso.

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Does doing the right thing deserve recognition?

May 2, 2022

Successful compliance programs typically take place in organizations with examples coming from the top. There is no doubt about the fundamental factor for success in such programs: top management engagement, or a culture of example. There is no way for a compliance program to prosper otherwise.

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How to Protect Your Personal Data

April 25, 2022

On August 14, 2018, the Brazilian General Data Protection Act (LGPD) – Statute #13,709 established general rules for the protection of every individual's personal data – something that, until then, lacked safeguards and limits on third-party use.

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Lessons in Drug Promotion by the FDA

April 18, 2022

The Food and Drug Administration (FDA) is the American agency responsible for protecting and promoting public health through the control and supervision of food safety, medicines and the like, a role similar to that performed by ANVISA in Brazil.

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Changes to Legislation of the Brazilian Public Healthcare System (SUS) Bring Hope to Patients

April 11, 2022

One of the greatest Brazilian achievements is undoubtedly the Brazilian Public Healthcare System (SUS). Provided for by Article 196 of the 1988 Brazilian Constitution, it establishes that health is a right for all and a duty of the State, and guarantees to every Brazilian access to public health, regardless of payment to the Brazilian Social-Security Administration (INSS).

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Interfarma updates its Code of Conduct

April 4, 2022

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).

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

March 27, 2022

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)”.

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How are whistleblowers treated in Europe?

March 21, 2022

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:

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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