Compliance News in Review, May 16, 2016

Medicines for Europe adds transparency requirements to its Code, Aegerion settles with the DOJ and SEC, and the interim president of Brazil addresses anticorruption.

Any doubt the summer blockbuster movie season had started were erased with the release of Captain America: Civil War. The film made a paltry $181 million in its opening weekend in North America, and is approaching the billion dollar mark in box office sales worldwide. The summer movie season has indeed started and it looks to be one packed with action, romance, drama, and comedy. Until the next blockbuster opens though, we politely ask you to silence your phone, and focus on the screen in front of you, as we debut this edition of the Compliance News in Review.

There will be no secret life for transfers of value to healthcare professionals (HCPs) and healthcare organizations (HCOs) in Europe. Medicines for Europe, a trade association of the generic drug industry, will now require its members to disclose certain payments to HCPs and HCOs. The organization added the transparency requirements in the latest edition of it Code of Conduct. Member companies will start tracking payments in 2017, and the first reports are due in 2018. Companies are required to report financial and in kind support to patient organizations and transfers of value to healthcare professionals and for consultancy and services. These disclosures are provided at an individual level (provided doing so does not violate privacy laws). The Code also requires disclosure of transfers of value to HCPs and HCOs for educational, meetings and site visits, and provides two options for how payments will be disclosed. One option requires the disclosure of the total number of events per healthcare professional supported; the other allows for the disclosure of the aggregate total of support provided per event.

Aegerion has conjured an agreement in principle with the DOJ and SEC to resolve investigations by both agencies over sales practices and disclosure statements about its drug cholesterol. In its settlement with the DOJ, the company will plead guilty to two misdemeanor charges of violating the FDCA, and under separate agreement will enter into a deferred prosecution agreement over alleged violations of HIPAA and an obstruction of justice charge. The company will also resolve civil charges over alleged violations of the False Claims Act, and will enter into a Corporate Integrity Agreement with HHS.

The interim president of Brazil, Michel Temer, may not be facing down aliens, but he did take some bold anticorruption actions in his first few days in office. Mr. Temer essentially dissolved the Comptroller General’s office, the main anticorruption enforcement agency, and replaced it with the Ministry of Transparency, Monitoring and Control. The move was part of a larger effort to streamline Brazil’s federal agencies.

The start of summer presents a great opportunity to step back and evaluate your compliance training program in preparation for the second half of 2016 and beyond. Are there glaring topics that need to be addressed? Are there courses that could use a re-boot? Is your training curriculum reaching all the right audiences? Through our Compliance Curriculum Analysis Process™, the PharmaCertify™ team will conduct a complete review of your live and online training to identify redundancies and any opportunities for improvement and provide you with actionable reports addressing pressing concerns. Contact Dan O’Connor at doconnor@nxlevelsolutions.com to learn more.

That’s all for this edition of the Compliance News in Review. Stay compliant and we’ll see you at the movies!

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