This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: How to create and maintain an ethical culture, Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Progress and new challenges after 10 years of collaboration, Distributors play key role in compliance, New industry code must safeguard independent medical education and Health data can transform our lives- but must be used wisely
The recent winter Olympics have offered a thrill of competition along with a wonderful opportunity to connect for a short time with the world beyond our borders through this remarkable athletic event.
The Olympics motto, “Citius, Altius, Fortius” – swifter, higher, stronger – resonates with us as we think about the pace of technological progress in the medical sector, and the Olympic ideals of friendship, solidarity and fair play remind us that we need to work together to achieve the highest standards of business ethics as our companies pursue success in the rapidly evolving medtech field.
The Legal & Compliance teams at AdvaMed and MedTech Europe are particularly proud of how innovative companies with global perspectives and worldwide markets have come together to collaborate to promote business ethics, corporate compliance and patient centricity on the global stage.
The MedTech industry has had a stringent code of ethics for a number of years now– because patients everywhere deserve confidence in the integrity of medical decision making. One high-priority area for these codes has been setting a framework for interactions with health care professionals (HCPs) both through the Code of Ethics of AdvaMed and the one of MedTech Europe. These interactions are a key component of medical technology research and development, and they are critical to ensure that HCPs have the latest information about safe and effective use of these technologies, ultimately for the benefit of patients.
Over the last two years, MedTech industry organizations across the world have been focusing on ways to enhance their policies for interaction with HCPs. In particular, there is an international commitment to phase out the practice of “direct sponsorship” of HCPs at training and educational events. Under these new guidelines, instead of a MedTech company selecting individual HCPs whom they will support to attend educational events (e.g., paying registration, travel, and accommodation costs), companies now will provide educational grants to third-party health care institutions or professional associations to cover such costs. The third party entities in turn will select the appropriate HCPs to receive the medical education support. In many countries, including European nations, China, Middle East, and South Africa, adoption of the new guidelines became effective January 1, 2018. This safeguard is intended to support independent decision making in educational programs while enabling vital medical technology information exchanges to continue.
This kind of globally-coordinated compliance policy initiative is made possible by ongoing contact among international MedTech compliance professionals– particularly through the annual Global MedTech Compliance Conference (GMTCC). Several aspects of the direct sponsorship policy have been discussed at the last few annual meetings, such as: (1) best practices from companies and countries that have already stopped direct sponsorship; (2) concerns of stakeholders such as medical societies and professional conference organizers; and (3) potential policy convergence with other life sciences industry associations (the voting results from a previous “Code Convergence” session are available here).
The next GMTCC is scheduled for May 2 -4, 2018 in Paris. The conference will continue the dialogue on best practices in educational grants – and address many other significant compliance issues facing MedTech companies.
“One topic on the agenda that has been of particular interest to me is value-based healthcare, with a focus on legal and compliance implications. I firmly believe that we will never meet the true full potential of value-based healthcare unless MedTech companies can be full participants – and that will require removing archaic legal barriers to arrangements that are good for both patients and payers.”, says Christopher White, Chief Operating Officer, General Counsel, Association Executive, AdvaMed. More information here
“I will be excited to discuss how our compliance strategies will be keeping up with the fast-moving innovative nature of our industry where we talk more widely about artificial intelligence in healthcare and find patients more and more in the center of innovative medical technologies. I am curious to further discover how GDPR will change our lives in such an environment and how we will be adapting our compliance practices not only for today but also for tomorrow.”, says Ceren Aral Desnos, Interim Director Legal & Compliance, MedTech Europe
A new topic at GMTCC this year is public-private partnerships. Government authorities are increasingly seeking to engage MedTech companies in providing comprehensive solutions to local health care needs, which can include building, equipping, and even managing hospitals. One of the GMTCC sessions will look at lessons learned to date, along with legal and compliance risks of such public-private arrangements.
The comprehensive GMTCC conference will also feature sessions on such issues as:
- Risks in distributor relationships with MedTech companies
- New compliance issues for health technologies (e.g. databases, applications, services, mobiles, wearables)
- Assessing the value of compliance (an issue I touched on in a recent blog post)
We look forward to the opportunity to exchange ideas with other compliance professionals across the globe as we strive to meet our shared goal of effectively promoting ethics and compliance and hope to see many colleagues there!