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PHRMA updates its code on interactions with health professionals

March 14, 2022

A very sensitive issue for the pharmaceutical industry, and for the medical and hospital products industry concerns the limits in their interaction with health professionals, especially physicians who prescribe drugs, and medical and hospital products.

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Petrobras at the Top of Brazilian Patent Applicants

February 19, 2024

According to a publication on the website of the newspaper A Gazeta, the Brazilian Patent and Trademark Office (BRPTO) has disclosed that, in 2023, 25,367 utility patents were filed in Brazil. This data was divided as follows:

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Only the US and Switzerland effectively enforce their Anti-Corruption Laws Abroad

July 31, 2023

Several countries have anti-corruption legislation, but few extend this legislation to fight corruption alongside foreign authorities outside their territory. Brazil, incidentally, is in the second group of countries having such norms in its set of laws.

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New Regulatory Framework for Clinical Research in Brazil

July 31, 2024

Law #14.874 was enacted on May 28, 2024, providing guidelines for research involving human subjects and establishing the National System of Ethics in research involving human subjects. This statutory framework is of utmost importance as it defines the rights of volunteers and outlines the responsibilities for researchers and sponsors of clinical research.

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More Sanctions Applied By The Brazilian Data Protection Authority signal that Violations of the LGPD Will Not Be Tolerated

October 23, 2023

The Brazilian Data Protection Authority (ANPD) published on October 18, 2023 their third sanction for violation of the General Data Protection Act (LGPD). Similarly to the second penalty, the infraction occurred in the public sector, not involving a private company.

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National Data Protection Authority publishes Security Information Guidelines for Small Processing Agents

November 1, 2021

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”.

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Medication Leaflets of Generic and Patented Medicines

February 29, 2024

The use of medication is undeniably crucial for extending our lives with the highest possible quality, aligning with advancements in science. As a result, medication leaflets are familiar to everyone, whether or not they are involved in the pharmaceutical sector. However, the same level of familiarity does not extend to the concepts of generic medicines and patented drugs.

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MATCHING THE LEGAL BASIS FOR THE PROCESSING OF PERSONAL DATA - THE GREAT EXAMPLE GIVEN BY THE UNITED KINGDOM'S DATA PROTECTION AUTHORITY (ICO)

September 27, 2021

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.

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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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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

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

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