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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

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

Data Protection and Privacy and the CPO

Despite the Covid-19 pandemic, which has attracted attention from all over the world, issues related to the personal data protection arouse the interest of many people, especially here in Brazil, due to the force of the LGPD which was postponed by Provisional Measure 959 on April 29, 2020 to May 3, 2021.

Data Protection and Privacy and the CPORead Full Article

Data Privacy Law and the Impact on the Health Care Area

On the afternoon of July 22nd, a webinar was held, ‘‘Data Privacy Law (LGPD) and the Impact on the Health Care Area”, presented by four of our attorneys at law: Alexandre Dalmasso, specialist in compliance with experience in the pharmaceutical industry; Douglas Leite, Flávio Buzanovsky,  and Ricardo Campello specialists in LGPD.

Data Privacy Law and the Impact on the Health Care AreaRead Full Article

New Version of the U.S Foreign Corrupt Practices Act (FCPA) Resource Guide

The US Department of Justice(US DOJ) and the US Securities and ExchangeCommission (SEC) have released a new version of the resourceguide on the US Anti-Corruption Act(FCPA - Foreign Corrupt Practices Act) after 8years since the publication´s first version.

New Version of the U.S Foreign Corrupt Practices Act (FCPA) Resource GuideRead Full Article

Transparency in Emergency Contracts

On the afternoon of July 8th, a webinar was held with the topic ‘‘Transparency in Emergency Contracts”, led by Guilherme France, research coordinator at Transparency International's Anti-Corruption Knowledge Center – Brazil, Alexandre Dalmasso and Ana Luisa Calil, attorneys at law at Licks Attorneys.

Transparency in Emergency ContractsRead Full Article

Use of e-mails

Lots of people are unaware that e-mails already existed when companies still used the electric typewriter. The first email, which is known, was sent in 1971 by Ray Tomlison. And the first email address created is also his: tomlison @ bbn-tenexa.

Use of e-mailsRead Full Article

10 Mistakes that affect a compliance investigation report.

Compliance investigations have increased exponentially, since compliance programs were consolidated in companies globally.

10 Mistakes that affect a compliance investigation report. Read Full Article

What drives good people to do bad things

To reflect on what can make good people do bad things, I will mention two real cases, which occurred during my career.

What drives good people to do bad thingsRead Full Article

TCU AND INTERNATIONAL TRANSPARENCY LAUNCH EMERGENCY CONTRACTING GUIDANCE

In May 2020, the Federal Court of Auditors - TCU, in partnership with the international non-governmental organization Transparency International marked a point in favor of tackling corruption and legal certainty for the federal, state and municipal public managers, by launching a booklet called “Recommendations for Transparency of Emergency Contracts in Response to COVID-19“. The booklet guides those professionals, in face of Act 13,979 / 2020, to adopt accurate and licit practices in the management of public resources in the pandemic scenario.

TCU AND INTERNATIONAL TRANSPARENCY LAUNCH EMERGENCY CONTRACTING GUIDANCERead Full Article

Health Fraud! How does the US government combat this problem

On the afternoon of May 28th, a webinar was held with the topic ‘Health Fraud! How does the US government combat this problem’, led by Alexandre Dalmasso, partner and responsible for the Ethics and Compliance Practice Group.

Health Fraud! How does the US government combat this problemRead Full Article

Data Protection and Privacy Mapping in the World

Currently, according to the UNCTAD - United Nations Conference on Trade and Development, here is the current scenario regarding the regulation of Data Protection and Privacy in the World:

Data Protection and Privacy Mapping in the WorldRead Full Article

European Data Authority - EDPB Publishes Guide With Rules For Consent

The European Data Protection Board (EDPB) issued on May 4, 2020 the Guide 05/2020 with rules applicable to the consent of the personal data, under the Data Protection Law, in force at the European Union - GDPR (General Data Protection Resolution).

European Data Authority - EDPB Publishes Guide With Rules For ConsentRead Full Article

THE UNCERTAINTY OF THE EFFECTIVE DATE OF THE GENERAL DATA PROTECTION LAW – LGPD

The gap between the issuance date of a law and the effective date is called vacatio legis. The reason, in general, for a law not to enter into force on the date of its publication is because the legislator wishes to provide society with time enough to become aware and prepared to respect its content.

THE UNCERTAINTY OF THE EFFECTIVE DATE OF THE GENERAL DATA PROTECTION LAW – LGPDRead Full Article

JOB DESCRIPTION OF A COMPLIANCE OFFICER

The compliance officer is briefly the facilitator in consolidating a culture of compliance within the organization, and should be the first to set an example, with respect to behaviors and attitudes when interacting with internal and external clients.

JOB DESCRIPTION OF A COMPLIANCE OFFICERRead Full Article