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.
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