Ethics

Ethics

Views on the relationship between industry and healthcare professionals and why it matters.

The new MedTech Europe Code of Ethical Business Practice (the “Code”) came in force on the 1 st 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 a good time to take stock of the situation; inquire if there are still grey areas and what are the opportunities going forward, therefore this letter. Over the last 2-3 years we tried through different means, such as the creation of an advisory group; bilateral discussions, panel discussions, etc to ensure that our partners, i.e. Healthcare Professionals (HCPs), Hospitals, Scientific Societies and Professional Congress Organisers (PCOs) are aware of the Code developments, but in order to get everyone on the same page, we thought to provide a short summary of what lies ahead for 2017: -- 1st January 2017 – the Code came into force The Code became binding for MedTech Europe Corporate Members . For Healthcare Organisations (HCOs) and Professional Congress Organisers that means that these companies have started to apply stricter rules when providing Educational Grants. -- Throughout 2017 - Outreach to European HCPs, medical societies and PCOs will continue The double objective of this outreach is for MedTech Europe to clarify any grey areas that you may still have on the new MTE Code and to ensure that going forward, the collaboration between the healthcare community and industry continues to the best interest of the patient. One event, where discussions, formal and informal, within the Healthcare Community will take place is the Global MedTech Compliance Conference (GMTCC) on 3-4 th May in Amsterdam. Please consider this as an official invitation to attend! -- Spring 2017 – Ethical MedTech Website Presently, the...
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 can stand behind-- in our industry’s case, addressing interactions to advance medical innovation and patient health. Effective, living Codes nurture a compliance community and guide business leaders and professionals through the complexities of dynamic marketplaces. While all new Codes are essential to instill confidence in medical decision making and preserve innovation, perhaps among the most meaningful industry ethics work is in China. Why China? - Market magnitude: The Chinese medical device marketplace ranks as the world’s third largest. Almost three years ago, there were about 16,000 medical device manufacturers and over 160,000 medical device distributors in China. And yet, despite these staggering numbers, recent reports show that the Chinese device marketplace is underdeveloped when compared to other countries. Demographic and other trends also contribute to growing healthcare needs: the population is aging, people are living longer and healthier lives; the middle class is rapidly growing; and public and private health care spending are increasing in response to patient demands for better and more modern medical care. - Enforcement trends and complexity: Increased scrutiny and far-reaching enforcement are accompanying rapid health sector growth. Chinese anti-corruption efforts made headlines now familiar to compliance professionals in the US and EU. Multiple ministries and national and regional authorities exercise health sector oversight. Recent pronouncements such as the New Donation Rules and The Nine Prohibitions both provide clarity and raise new questions, and it can be difficult to discern precedent in general. Based on these and other trends, an 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 across regions worldwide and being aware of all the issues that could arise. In our company, fairness is one of the core values, and we consider fairness to our customers as part of our ethos. Discussions around medical education were originally business led, with representatives from all parts of the business of our company contributing. Then compliance and legal professionals joined the conversation. As we talked and talked, we realised we had to answer the question - why do we support the medical education of Healthcare Professionals and for what reason? This helped us come up with a new, refocused educational strategy that took into account the changing environment and the modern world in which we operate. As a result we did reconfirm our intention to provide education, but we reviewed the best and most efficient way in which this could be done. The debate led us to introduce a shift from direct sponsoring of HCPs to third party organised educational events to grants. Was this tough? Yes, particularly as in some areas W.L. Gore was the first to introduce this concept. Both internally and externally some struggled with the concept. However with clear explanation and our conviction that this was the right way forward we started to see a change in attitude. We now find a system based on grants allows more forward planning, as we provide grants for a period of up to a year. Generally a broader group within the chosen institution...
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 the industry behaves in all its interactions with healthcare professionals (HCPs) in such a way that it safeguards its image and reputation. It has taken almost two years to write this new common MedTech Europe Code, discussing every point, fine-tuning every detail and eventually reaching a consensus on how each aspect of our industry’s interaction with HCPs should be regulated. Now that we are fast approaching the moment of choice, i.e. when the MedTech industry will be asked to vote “YES” or “NO” to the proposed text, I often get asked whether I think the new Code will be approved. I do not hold a crystal ball and therefore cannot predict the outcome of a democratic vote. But whether the new Code is approved or not, there are a few points I believe are worth noting: • The narrow scope of the debate: discussions have mostly focused on the so-called phase-out of direct sponsorship of HCPs to third-party organised conferences, disregarding the already existing and very-well established alternative, and by this I mean supporting independent medical education via educational grants. This debate also misses the fact that the revision of the respective EDMA and Eucomed Codes of Ethical Business Practice into a single MedTech Europe Code touches upon every single aspect of the relationship between the MedTech industry and healthcare professionals. Financial support of HCPs to third-party organised conferences is only a small part of the new Code. Yet, it gets all the attention. •...
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 replied. “We use subagents.” Needless to say, my company engaged a different distributor. But we did so in the face of a serious challenge: how do you talk seriously with distributors about compliance, and how can you expect them to respond? A lot has changed in eight years. Within a few years after the interview mentioned above, several large device manufacturers had announced settlements with the U.S. authorities under the Foreign Corrupt Practices Act, involving allegations that the manufacturers used distributors and other intermediaries to funnel improper payments to government officials. Around the same time, a medical device marketing executive was prosecuted in the United Kingdom for authorizing payments to distributors that were used to provide cash and other benefits to Greek physicians. And the Chinese government cracked down on corruption in the pharmaceutical sector, accusing companies of making improper payments to physicians through travel agents and conference organizers. In light of enforcement trends, compliance officers around the world are beefing up safeguards against corruption by third party intermediaries. For many, the task has been daunting. A large company may have hundreds or even thousands of distributors and sales agents around the world; in some cases just identifying them and implementing written contracts has been a massive undertaking. Small companies have fewer intermediaries, but also have fewer resources for managing their overseas agents and distributors. So where are we today? The task remains monumental, but companies now have much more guidance available. The US Department...
Continuous Medical Education
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 of support for the continuing medical education of HCPs. What follows is my take on the future of CME. What is the current state of continuing medical education (CME)? Is CME itself – and the way it is being delivered – truly effective? Almost everyone involved in medicine - from regulators to physicians - agree that CME is essential. Today, a significant proportion of CME takes place during medical congresses where delegates often receive direct industry sponsorship. It is this sponsorship that has attracted regulatory concern, putting CME into question. Is Continuous Medical Education itself – and the way it is being delivered – truly effective? One current concept of CME is that simply presenting scientific/clinical information (usually through long and complex PowerPoint slides) is education enough for most practicing physicians. In my experience of interacting and working with practitioners, I have found this to be neither true, nor enough. Clinicians today are looking for something that is directly applicable to their daily practice. To respond to real physician needs, the Europa Group works closely with medical societies and institutions as well as with committed groups of physicians. First to understand their needs and then to develop high-quality, effective and interactive practitioner education. Our educative solutions are the results of rigorous academic research & development with experts in adult learning. This is how it works… All sessions are run by and for physicians. When physicians are nominated by their societies to present at these sessions,...