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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

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