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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

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