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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

THE COMPLIANCE POLICY FOR FINANCIAL INSTITUTIONS ACCORDING TO THE NATIONAL MONETARY COUNCIL

The National Monetary Council (CMN) has regulated – through the CMN Resolution 4,595, of August 28, 2017 - the compliance policy applicable to financial institutions authorized to operate in Brazil by the Central Bank, but not applicable to consortium administrators and payment institutions.

THE COMPLIANCE POLICY FOR FINANCIAL INSTITUTIONS ACCORDING TO THE NATIONAL MONETARY COUNCILRead Full Article

EUROPEAN BODIES APPROVE JOINT PROPOSAL TO PROHIBIT THE USE OF AI FOR AUTOMATED RECOGNITION

The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) announced on June 21st, 2021 that they have approved a joint opinion on the European Commission's Proposal for a Regulation laying down harmonised rules on artificial intelligence (AI).

EUROPEAN BODIES APPROVE JOINT PROPOSAL TO PROHIBIT THE USE OF AI FOR AUTOMATED RECOGNITIONRead Full Article

THE NATIONAL REGISTRY OF INELIGIBLE AND SUSPENDED COMPANIES (CEIS) AND THE NATIONAL REGISTRY OF PUNISHED COMPANIES (CNEP)

Brazil published its Anti-Corruption Law - Law 12. 846, on August 1, 2013, whereby companies were committed to administrative and civil liability, with regard specifically to acts related to corruption, fraud in tenders and creating impeding circumstances for investigation or inspection. Unfortunately, the Brazilian legislator missed a great opportunity to criminalize companies’ operation and conduct, as is already the case in some countries.

THE NATIONAL REGISTRY OF INELIGIBLE AND SUSPENDED COMPANIES (CEIS) AND THE NATIONAL REGISTRY OF PUNISHED COMPANIES (CNEP) Read Full Article

COOKIES, UNDERSTAND IT ONCE AND FOR ALL!

There are many definitions out there for cookies, but the one I like the most is found on the Positivo website, as well as some other websites, which clarifies that cookies are simple text files sent by the website to the browser the first time you visit it. A simple and effective definition. It’s there so that when the user visits the website again, their browser sends the data collected by the cookie, depending on its goal.

COOKIES, UNDERSTAND IT ONCE AND FOR ALL!Read Full Article

Webinar LGPD – Data Leaks and first decisions

On the afternoon of April 22, the webinar ‘Data Leaks and first decisions’ was presented by partner Douglas Leite and Attorneys at Law and data protection specialists Flávio Buzanovsky and Angela Fonseca.

Webinar LGPD – Data Leaks and first decisionsRead Full Article

Webinar ‘FCPA Review 2020 – Hot Cases’

On the afternoon of April 8th, the webinar ‘FCPA Review 2020 – Hot Cases’ was presented by partner Alexandre Dalmasso.

Webinar ‘FCPA Review 2020 – Hot Cases’Read Full Article

NEW GOVERNMENT PROCUREMENT RULES ARE ENACTED IN BRAZIL

President Jair Messias Bolsonaro just signed the new Government Procurement Act into law, converting the Bill (PL) 4.253 / 2020 into Law 14.133 of April 1, 2021.

NEW GOVERNMENT PROCUREMENT RULES ARE ENACTED IN BRAZILRead Full Article

THE DISPOSAL OF PERSONAL DATA

Recently, the Federal Supreme Court (STF) positioned itself against the right to be forgotten versus the media's right to report certain facts. In this specific case, the STF ended up endorsing the thesis recognizing a right to be forgotten would be an act of censorship, given the media's right to report news for society's knowledge accurately.

THE DISPOSAL OF PERSONAL DATARead Full Article

CNIL INTRODUCED NEW RULES FOR THE USE OF COOKIES IN FRANCE IN 2020

In October 2020, the Commission Nationale de l’Informatique et des Libertés (CNIL), the French body that regulates the protection of personal data in that country, published two documents, one designated “guidelines” and the other called “recommendations,” establishing rules and good practices, concerning the use of cookies on the internet.

CNIL INTRODUCED NEW RULES FOR THE USE OF COOKIES IN FRANCE IN 2020Read Full Article

AN ANALYSIS OF THE SANCTIONS APPLIED BY THE WORLD BANK IN 2020

The World Bank published its Annual Sanctions Report for 2020, highlighting the institution’s concern with the projects it finances globally and potential risks of fraud and corruption.

AN ANALYSIS OF THE SANCTIONS APPLIED BY THE WORLD BANK IN 2020Read Full Article

THE FRENCH ANTICORRUPTION AGENCY (AFA) PUBLISHES NEW GUIDELINES FOR PUBLIC AND PRIVATE ORGANIZATIONS

On January 12, 2021, the French Anti-Corruption Agency (AFA) published new guidelines for companies in the public and private sectors, laying out recommendations in order to ensure compliance with the French Anti-Corruption Law (Sapin II) sanctioned since the end of 2016.

THE FRENCH ANTICORRUPTION AGENCY (AFA) PUBLISHES NEW GUIDELINES FOR PUBLIC AND PRIVATE ORGANIZATIONSRead Full Article

COMPLIANCE PROGRAM REQUIREMENTS FOR BIDS IN THE STATE OF PERNAMBUCO ARE POSTPONED

Following the states of Rio de Janeiro, Espírito Santo, Santa Catarina, and the Federal District, the State of Pernambuco signed a law that compels the implementation of a compliance program (called an ‘integrity program’ in the public sector) by private companies that wish to contract with the state government. I am referring to State Law 16,722, enacted on December 9, 2019.

COMPLIANCE PROGRAM REQUIREMENTS FOR BIDS IN THE STATE OF PERNAMBUCO ARE POSTPONEDRead Full Article

USFDA PUBLISHES GUIDELINES FOR MANUFACTURERS NAMING NEW MEDICINES

The US Food and Drug Administration (FDA) has just published new guidelines for manufacturers regarding the choice of names for their medicines. The guide focuses on how the trust and distinction of other existing medication may be transmitted to end-users, that is, to patients.

USFDA PUBLISHES GUIDELINES FOR MANUFACTURERS NAMING NEW MEDICINES Read Full Article

Judicialization of medicines: USA x Brazil’

On February 9th, webinar Judicialization of medicines: USA x Brazil’ was presented by partner Alexandre Dalmasso. Dalmasso discussed the access both Brazil and USA have to medicines as well as the legal and financial impact.

Judicialization of medicines: USA x Brazil’ Read Full Article

Statistical results of General Data Protection (GDPR) enforcement in 2020

The year 2020, plagued by the Covid-19 pandemic, has passed. European countries suffered amid the coronavirus's spread, with Italy, Spain, the United Kingdom, and France most negatively affected in the first wave. Subsequently, during the second wave, the United Kingdom and Portugal ended up leading in infection rates and discovering a new yet more contagious strain.

Statistical results of General Data Protection (GDPR) enforcement in 2020Read Full Article