Life Science Compliance Update

March 21, 2018

Preparing for the 2018 Ethical MedTech, APACMed, and China Codes

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The Healthcare Convention & Exhibitors Association (HCEA) presented a webinar, “Preparing for the 2018 Ethical MedTech, APACMed, and China Codes: Impact on International Attendee Participation at US Meetings.” Webinar attendees heard from several professionals on the new rules and the likely impact they will have in the coming years. Faculty included: Thomas Sullivan, President of Rockpointe and Editor of Policy & Medicine; Matthew Wetzel, JD, Vice President and Assistant General Counsel of AdvaMed; Aline Lautenberg, General Counsel and Director of Legal & Compliance, MedTech Europe; and Christine Wurster, Chief Revenue Officer of the Heart Rhythm Society.

While many of us may get frustrated at these Codes and regulations that continue to pop up, there are several reasons for them, as discussed by Thomas Sullivan. The reasons include: ensuring ethical interaction with healthcare professionals; helping independent decision making and public confidence in the medical industry; aligning compliance with international standards; and ensuring proper documentation of the interactions with professionals.

Asia – APACMed Code of Conduct

APACMed, the medical device association in Asia, has adopted a code for their members. Starting in 2018, APACMed will begin to review educational meetings for independent content, promotion of science, educational merit and an appropriate venue; and that there will be no inducements to use, recommend, purchase, or prescribe any product in return for payments. Payments will be made in the form of grants to defray the costs of the event and support the attendance of HCPs. Grants will be given to healthcare institutions and professional associations, moving away from direct sponsorship. Such direct sponsorships are prohibited as of January 1, 2018.

China – AdvaMed China Code

Matt Wetzel discussed the AdvaMed Code, largely as it relates to China, created to help guide member companies when it comes to customer interaction. AdvaMed has been in China for roughly ten years as it is an enforcement hot stop for US authorities and settlements continue to show that there is a need for adequate internal controls and a timely disclosure of misconduct. Therefore, working in China means that you have a need for strong standards and strong guidance for compliance efforts. 

The AdvaMed China Code was adopted in March 2015 and became effective on January 1, 2016. The Code – based on best practices and global compliance trends – allows for a self-regulatory approach to proactively address potential anti-bribery and anti-corruption concerns in the Chinese marketplace. It establishes baseline compliance guidelines for companies to incorporate into their policies on customer and HCP interactions and serves as a foundational document for the medical device industry operating in China.

While Mr. Wetzel encouraged everyone to spend some time with the Code to see what truly is and is not permitted, the status of sponsorships in China is unclear. The AdvaMed Code helps to clarify requirements for participating companies in China, as phasing out direct sponsorship seems to be the direction China is heading.

In that vein, the AdvaMed Code has phased out direct sponsorships of HCPs to attend third-party educational events, beginning January 1, 2018. As of the first of this year, there is no grant or donation allowed for direct travel, lodging, meals, or registration fees for individual HCPs to attend third-party educational conferences. Instead, companies can provide educational grants or donations to conference organizers to support the conference. The conference organizer or other allowable recipient can then use the grant funds to defray or underwrite HCP costs of attendance.  

Europe – MedTech Europe

Aline Lautenberg noted that much of what was covered in China is true for Europe, with slight differences. One of the newest changes is that companies will have to disclose the grant or donation they are giving to societies or conference organizers on a European platform for any countries where there is no such legislation in place. Further, there is an independent enforcement mechanism throughout Europe to help enforce legislation and regulations.

The rules to phase out direct sponsorships are similar to others found around the world, requiring that grants can only be provided to legal entities (never individuals) and require a written contract and other related documentation. Companies are also able to define the type of recipients that are eligible for the grant but can never name individual recipients that are eligible. Further, companies must have an internal and independent process based on objective criteria to assess any grant requests it receives.

Ms. Lautenberg provided several helpful visual maps to “demystify” the code, including when direct support is permitted as of January 1, 2018.

Heart Rhythm Society Approach

Christina Wurster of the Heart Rhythm Society (HRS) helps to put on frequent educational events for the Society, and was able to speak to the way HRS hosts their events with the help of industry while steering clear of any legal wrongdoings. HRS started the process to understand the regulations by meeting with their global counterparts and surveying event attendees to learn the broad impact the regulations have and to understand the impact the regulations will have on their events.

Ms. Wurster also provided some tips on how to craft your key message, including reviewing the highlights from the new regulations, considering all potential impacts to your organization and meetings, and reviewing and discussing proposed solutions. Once the message has been created, seek buy-in and provide resources to your target audiences, including exhibitors, international ambassadors, and delegates. You’ll also want to have a tactical plan in place, including mapped out communication channels and a customized level of frequency based on the audience.

Conclusion

As of January 1, 2018, these new rules have gone into effect throughout Europe, Asia and China. If you have any additional questions or concerns, a recording of the webinar can be viewed here.   

Additional Resources can be found here:

Chart Comparing the Ethical Codes

China Code

APAC MED Code

MedTech Europe Code

Ethical Medtech - Conferences

January 22, 2018

Privacy Upheaval – Exploring the Impact of the GDPR on Companies Sponsoring and Managing Global Clinical Research

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In May 2018, the new European Union (“EU”) General Data Protection Regulation (“GDPR”) will replace the familiar Data Protection Directive. In addition to significant new penalties, the GDPR requires companies to examine and rethink their data strategies, especially when working with clinical trials. This article discusses key considerations in implementing the GDPR for companies sponsoring and managing clinical trials.

With an ever-abundant list of important compliance requirements to contend with, life sciences compliance officers have no shortage of challenges. And the new year won’t offer any reprieve given the fast-approaching enforcement date for the General Data Protection Regulation (“GDPR”), the European Union’s (“EU’s”) new, comprehensive data protection law. On May 25, 2018, enforcement of the GDPR will begin, and there is much to do between now and then.

The GDPR, which replaces the Data Protection Directive 95/46/EC (“the Directive”), changes the current EU data protection framework in several significant ways. Among other things, the new framework expands the territorial scope for EU data protection obligations, applies those obligations directly to data processors, and broadens the requirements for controllers. The GDPR also includes new, quite severe penalties for non-compliance.

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December 07, 2017

HCEA To Host Webinar on New International Ethics Rules

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On Wednesday, December 13, 2017, the Healthcare Convention & Exhibitors Association (HCEA) will present a webinar entitled: “Preparing for the 2018 Ethical MeDTECH, APACMed and China Codes Impact on International Attendee Participation at US Meetings.”

As we have previously written about, beginning January 1, 2018, medical device companies in various regions of the world will no longer be able to directly sponsor participant’s travel to educational meetings. The Accreditation Council for Continuing Medical Education (ACCME) and other organizations have applauded this effort, as it furthers the independence of education and helps to align international codes with current United States standards.

However, because of financial constraints in many markets around the world, healthcare providers depend on outside support to attend US-based meetings. Therefore, it is possible that your annual meeting may see some changes in 2018 and beyond. This webinar will review the codes and explore some of the concerns expressed by medical meeting planners.

The webinar will be moderated by Policy & Medicine’s editor, Thomas Sullivan, and includes panelists: Aline Lautenberg, General Counsel and Director of Legal and Compliance at Eucomed, EDMA, and MedTech Europe; Matthew E. Wetzel, Vice President and Assistant General Counsel at AdvaMed; and Christine Wooster, Chief Revenue Officer at the Heart Rhythm Society.

Registration for the webinar is free for HCEA members and $50 for non-HCEA members. For additional information, contact Kristen Leikwold at kleikwold@hcea.org or call (703) 935-1961.

To register for the webinar, click here.

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