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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

Dark patterns in data protection

In a time where fake news is so prevalent, the topic of dark patterns has gained a lot of relevance. The term was purely academic but, in recent times, has been commonly seen in data protection regulations worldwide.

Dark patterns in data protectionRead Full Article

U.S Department of justice updates its guide to corporate compliance programs

Now under the Biden administration, the U.S. Department of Justice (DOJ) has published, on March 3, 2023, an update to its guide for evaluating compliance programs. It assists prosecutors in this task, allowing them to identify whether the program is efficient at the time of the offense and whether it is effective at the time of a charging decision or resolution.

U.S Department of justice updates its guide to corporate compliance programsRead Full Article

The EDPB publishes new guidelines for personal data protection

The European Data Protection Board (EDPB) has recently published, after a public inquiry with different segments of European society, three new guidelines related to the protection of personal data.

The EDPB publishes new guidelines for personal data protectionRead Full Article

The sponsorship ethics of pharmaceutical and medical companies for physicians speaking in conferences

This is certainly one of the most controversial topics in recent years with regard to the interaction of the medical profession with the health industry – which encompasses the pharmaceutical industry, medical and hospital products and even cosmetics and food.

The sponsorship ethics of pharmaceutical and medical companies for physicians speaking in conferencesRead Full Article

ANPD REGULATES THE APPLICATION OF ADMINISTRATIVE SANCTIONS

Administrative Sanctions Regulation on Dosimetry and Application of Administrative Sanctions, which establishes the dosimetry guidelines for sentences, especially calculating the base value for fines the agency may apply. It is an initiative of the rapporteur and director of the ANPD – Arthur Sabbat, in which he was unanimously followed by the rest of the board. Although the criteria set out below establish clear guidelines, the ANPD may depart from its methodology or review the penalty, if impaired proportionality is found between the severity of the violation and the intensity of the sanction.

ANPD REGULATES THE APPLICATION OF ADMINISTRATIVE SANCTIONSRead Full Article

Prison after conviction in appellate courts

Going to prison in Brazil is any easy task. The Brazilian procedural law, especially in criminal law, creates so many mechanisms for postponing the final and unappealable decisions that anyone having the resources to hire a lawyer or relying on an active public defender can postpone it. As such, many cases end up time-barred, although Brazilian legislation is slowly advancing in making crimes such as femicide or rape imprescriptible.

Prison after conviction in appellate courtsRead Full Article

Transparency International launches the 2022 Corruption Perceptions Index

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.

Transparency International launches the 2022 Corruption Perceptions IndexRead Full Article

ANPD launches new security incident form

In the second half of December 2022, the National Data Protection Authority (ANPD) published an amendment to the Security Incident Reporting form, to be used by all those who need to report security incidents starting January 1, 2023.

ANPD launches new security incident formRead Full Article

Why is the Whistleblower despised in the Fight against Corruption in Brazil?

While some countries are failing in the fight against corruption, Brazil has achieved a real negative milestone in recent years. The country managed to deconstruct the Car Wash Operation , the most powerful symbol of the fight against corruption ever carried out in the country and also  encouraged impunity to public agents who commit acts of administrative impropriety, by sanctioning Statute 14,230 of 03.31.2022. Since then,  public agents can no longer be held responsible for damages caused by recklessness, negligence or malpractice, since only deceit (the intention to do or not to do) characterizes impropriety in the corresponding crimes typified by law. An open door for the "I don't know" people... For those who intend to prove anything, they must manage on their own prove that the agent intentionally did the act...

Why is the Whistleblower despised in the Fight against Corruption in Brazil?Read Full Article

The ANPD Guide on Cookies and Personal Data Protection

Cookies continue to be a source of concern for authorities responsible for data protection in all countries, even more so if one considers the lack of transparency in the collection and use of much of this data. Behold, the National Data Protection Authority (ANPD) issued an orientation guide for dealing with cookies in Brazil, although the General Data Protection Law (LGPD) itself has not displayed specific rules on the subject. Even for that very reason, this ANPD guide comes at a good time to resolve doubts and serve as a basis for guiding everyone on how to deal with the issue in Brazil.

The ANPD Guide on Cookies and Personal Data ProtectionRead Full Article

USA passes Anti-Money Laundering Whistleblower Improvement Act

In Brazil the concept of the whistleblower continues to be ignored –  as having been incorporated into our legal system by former Minister Sérgio Moro's anti-crime package, approved by the National Congress underStatute 13,964 of December 24, 2019 (which utilizes the definition of informant rather than the North American definition of whistleblower) – along with the benefits that its employment could bring to the country, especially in the fight against corruption. While the United States, at the end of 2022, have just passed the Anti-Money Laundering Whistleblower Improvement Act, making significant progress in the battle against money laundering.

USA passes Anti-Money Laundering Whistleblower Improvement Act Read Full Article

The Impeachment of Authorities in Brazil explained

According to the Brazilian Constitution of 1988, the Legislative, Executive and the Judiciary Branches are balanced among themselves.

The Impeachment of Authorities in Brazil explainedRead Full Article

Brazilian Antitrust Law has been refined

Although Brazilian antitrust rules follow the example of US antitrust law, the pioneers in the subject were not them, but their Canadian neighbors, since the first known antitrust law was published in 1889, in Canada. By the way, this was the year in which Brazil ceased to be an empire, when the Republic was proclaimed on November 15, 1889, by Marshal Deodoro da Fonseca.

Brazilian Antitrust Law has been refinedRead Full Article

And speaking of Patient Support Programs...

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.

And speaking of Patient Support Programs...Read Full Article

Self-regulation in the health care area: Europe's positive example

One of the great frustrations of those who work in companies where there is a solid compliance culture is dealing with the limits imposed by their internal policies and procedures, as compared to competition that, sometimes, uses dubious and loose processes, which lead to numerous conflicts of interest, but which can translate into increased sales.

Self-regulation in the health care area: Europe's positive exampleRead Full Article