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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 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

Is there potential for excessive rigor in data protection?

The General Data Protection Law (LGPD), created in 2018, finally came into force in Brazil in 2020. The National Data Protection Agency (ANPD) was structured accordingly to begin managing and controlling the effective protection of personal data. However, to date, the ANPD has not yet started to standardize obscure aspects of the law and address gaps that need regulation.

Is there potential for excessive rigor in data protection?Read Full Article

The ANPD and the challenge of enforcing the LGPD

The recently formed National Data Protection Authority (ANPD) has a challenging mission to standardize or regulate various situations that require more detailed regulation by the primary authority responsible for personal data in Brazil.

The ANPD and the challenge of enforcing the LGPDRead Full Article

How Canada combats spam!

Recently, in an article on this website, the USA’s 2003 CAN-SPAM law that helped regulate spam was mentioned (Sending and Posting Advertisement in Mass, translated into Portuguese as ““Enviar e Postar Publicidade em Massa,” or Stupid Pointless Annoying Messages, which translates into Portuguese as “Mensagens Perturbadoras, Estúpidas e Sem Noção”).

How Canada combats spam!Read Full Article

Can a collection company call indebted consumers once the General Data Protection Law is in force?

Under the General Data Protection Law (LGPD) now in force, a frequently asked question is whether collection companies contracted by financial institutions, retail chains, or other lending organizations can continue to call individuals – allegedly using their personal data shared by the companies which contracted the service and, therefore, creditors of the vindicated amount – or not.

Can a collection company call indebted consumers once the General Data Protection Law is in force?Read Full Article

CONAR launches a guide for digital influencers

The National Council for AdvertisingSelf-Regulation (CONAR) launched the Guide for Digital Influencers in November2020 to establish standards and ethical criteria in advertising to be carriedby the channels used by such influencers.

CONAR launches a guide for digital influencersRead Full Article

And how about the privacy and protection of personal data in the United States of America?

In this unique year of 2020, the significant milestone in the area of privacy and protection of personal data in the United States of America (USA) remains undoubtedly the CCPA - California Consumer Privacy Act, which started to protect the citizens of the State of California against commercial use of their personal data without their consent. But does privacy and protection of personal data in the US come down to the CCPA only?

And how about the privacy and protection of personal data in the United States of America?Read Full Article

São Paulo State Government prohibits pharmacies and drugstores from requiring a CPF to grant discounts to their customers

The Governor of the State of São Paulo, João Agripino da Costa Doria Junior – better known as João Doria – sanctioned State Bill # 1212/2019 on December 1, 2020. The bill was authored by State Deputy Alex de Madureira as he is known, since his name is Alexander Muniz de Oliveira, being born in Piracicaba, SP, and affiliated with the Social Democratic Party (PSD).

São Paulo State Government prohibits pharmacies and drugstores from requiring a CPF to grant discounts to their customersRead Full Article