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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

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