Ethics

Each fall the two of us meet to discuss global healthcare legal and compliance developments and to assess implications on the medical technology industry, patient care and innovation. When we first began collaborating the iPhone was just invented (healthcare apps were unimaginable) and, since that time, quite a bit has changed! When we annually meet, […]

As a medtech lawyer, my focus naturally gravitates to assessing “downstream” relationships and risk; that is, analysis of the legal arrangements between manufacturers, distribution agents, and health care providers that together bring medical technologies to the patient’s bedside. These relationships can be complex, as are the legal issues they raise. But ensuring ethical standards in these relationships […]

The MedTech Europe Code of Ethical Business Practice entered into force on the 1st January 2017, with the phase-out of direct sponsorship that needs to be implemented in less than a year from now. The Code has been the topic of many conversations. However, until recently, we did not have the opinion of individual Healthcare […]

The new MedTech Europe Code of Ethical Business Practice (the “Code”) came in force on the 1st January 2017 and replaces the Eucomed Code of Ethical Business Practices and the EDMA Code of Ethics. The Code allows for an additional year to phase out direct sponsorship by the entire medtech industry but this may be […]

As a compliance professional, it’s exciting to witness new Codes of Ethics take root worldwide.  Voluntary industry Codes of Ethics serve several important functions.  A credible Code demonstrates industry’s ability to self-regulate, in turn fostering consumer and governmental trust and confidence.  A Code centers stakeholders on the most meaningful business principles that the entire industry […]

At W.L. Gore we took the decision to review our educational strategy well before the recommendation of the EDMA and Eucomed Boards to phase-out direct sponsorship of Healthcare Professionals (HCPs) to third party organised educational events was announced. We did this as our business leaders were getting increasingly concerned about the complexities of doing business […]

If the activities of the medical technology industry are viewed through the prism of either corruption or honesty, then the draft MedTech Europe Code of Ethical Business Practice could be considered as an endeavor to dissociate the industry from the former.  The draft code does so by providing a clear and stringent framework, ensuring that […]

Eight years ago, I was interviewing executives of a prospective Chinese distributor for my employer, a publicly-traded medical device company based in California. “We understand that it is hard to do business in China without paying kickbacks to physicians and hospital administrators” I observed. “How do you handle this?” Without hesitating, one of the executives […]

Yesterday, EDMA and Eucomed announced recommendations to respective members on how to improve their Codes of Ethical Business Practice. Chief among their recommendations are a phase out of direct sponsorship and stricter guidelines for indirect sponsorship of healthcare professionals to attend third-party organised conferences. They’ve also committed to working with stakeholders to elaborate new models […]