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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

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

ANPD RELEASED GUIDELINES ON DATA PROCESSING AGENTS

The National Data Protection Authority (ANPD) released a Guidance Guide for the Definitions of Personal Data Processing Agents and the Data Protection Officer on May 27, 2021.

ANPD RELEASED GUIDELINES ON DATA PROCESSING AGENTSRead Full Article

THE LIFE OF CRACKERS HAS BECOME MORE DIFFICULT

The Senate news agency reported on May 28, 2021 that the president finally signed Bill 4554/2020, passing Law 14,155 of May 27, 2021, which modified the penal code to specifically deliberate on cybercrime, focusing on:

THE LIFE OF CRACKERS HAS BECOME MORE DIFFICULTRead 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

HOW MUCH DOES IT COST, AND HOW MUCH DOES A COMPANY EARN WITH A COMPLIANCE PROGRAM?

A seemingly simple question, but appearances can be deceiving!

The question is much more complex than it seems. After all, it is illusory to compare different matters under the same prism.

HOW MUCH DOES IT COST, AND HOW MUCH DOES A COMPANY EARN WITH A COMPLIANCE PROGRAM?Read Full Article

COVID-19 IN THE WORKPLACE

More than a year after news of the spread of the pandemic in Brazil broke, and despite the death of more than 350 thousand people in the country, media coverage continues to focus on the irresponsibility of individuals: those attending indoor parties, the stubbornness of others in not wearing a mask and the selfishness of many who seem to care little for the life of others, a close relative or not.

COVID-19 IN THE WORKPLACERead Full Article

NEW DIRECTIONS FOR PUBLIC CIVIL ACTION IN BRAZIL

Public civil actions were endorsed by Article 129, III of the  Federal Constitution of 1988 and have become one of the Federal Prosecution Officer’s (MP) institutional functions, regulated by Law No. 7,347 / 85.  They target diffuse, collective, and homogeneous individual rights.  They are intended to prevent and prosecute violations to collective interests such as the environment, consumers, historical or cultural heritage, including administrative impropriety, economic order, urban order.

NEW DIRECTIONS FOR PUBLIC CIVIL ACTION IN BRAZILRead Full Article

MPF, SENACON, CADE, AND ANPD RECOMMEND WHATSAPP EXTEND THE TERM OF ITS NEW PRIVACY POLICY

When WhatsApp informed its users a few months ago that their data could be shared with Facebook, this fact generated alarm among many users who imagined that part of their WhatsApp dialogues would appear on their Facebook pages. However, WhatsApp denied that this was going to happen.

MPF, SENACON, CADE, AND ANPD RECOMMEND WHATSAPP EXTEND THE TERM OF ITS NEW PRIVACY POLICYRead Full Article

THE RUSSIAN ANTI-CORRUPTION LAW

The Russian anti-corruption law, federal law No. 273, dated December 25, 2008, was enacted during the term of the president and jurist, Dmitri Anatolievitch Medvedev, whose term lasted from 2008 to 2012.  The law was designed to curb potential shady relationships between the private sector and the Russian government.

THE RUSSIAN ANTI-CORRUPTION LAWRead Full Article

THE WHISTLEBLOWER IN BRAZIL

On October 22, 2020, the US Securities & Exchange Commission (SEC) announced the largest reward payment ever made to a whistleblower in the United States, of US$ 114 million, more than R$ 650 million at current values. Much more than the often dreamed of mega-sena lottery in Brazil. Since its first award, the SEC has paid $ 676 million to 108 whistleblowers.

THE WHISTLEBLOWER IN BRAZILRead 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

ANTI-SPAM LAWS AROUND THE WORLD

With the development of digital marketing, many commercial initiatives have adopted forms of e-mail promotion, using a mailing list, but without observing any of the restrictions imposed by anti-spam legislation.

ANTI-SPAM LAWS AROUND THE WORLDRead 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