ethics

Following on the footsteps of our American colleagues , MedTech Europe would like to offer some thoughts on the issue of transparency and disclosure laws and how certain adaptations could help to frame transparency for a new reality. Over the last few years, a number of European countries have passed transparency or disclosure (sometimes also called “Sunshine”) laws which require life science industry to track and publicly report certain payments and transfers of value made to Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs) such as hospitals or medical societies. The objective of such laws is to provide patients with enhanced transparency into the relationships healthcare providers have with life science manufacturers, including medical technology companies (1) . The new MedTech Europe Code of Ethical Business Practice upholds the same objective while addressing the fragmentation created by the different national rules. More importantly, the Code goes a step further. Let us explain: the Code which entered into force this January introduces several important changes to the way the medical technology industry interacts with HCPs. One key aspect is the prohibition for our member companies to directly support HCPs to attend Third Party Organised Educational Conferences (e.g. paying for the registration fee, travel and lodging). Furthermore, the Code introduces transparency requirements for Educational Grants. They key objective is for companies to stop selecting the HCPs who receive financial support to attend such conferences. This change means that, from 1 January 2018, HCPs’ independent medical education can only be supported via Educational Grants, They will be provided to an independent third-party, such as a hospital or a scientific society, instead of taking the form of direct and unilateral transfers of value to an individual HCP (such as registration fee, travel and lodging costs). Moreover, companies will no longer be involved in the selection...
The MedTech Europe Code of Ethical Business Practice entered into force on the 1 st 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 Professionals. Our conversations happened in particular with the organisations representing them. In January, we formally interviewed a sample of Healthcare Professionals coming from different countries. This blog is about sharing the key findings of these interviews. As a background note, most aspects regulated by the Code were already covered by these previous Codes, but there is one fundamental change brought by the new Code that affects Healthcare Professionals. We are of course talking about the change in the model of support to Healthcare Professionals attending Third Party Organised Educational Conferences. The new model requires that a company provides an Educational Grant to a Healthcare Organisation (e.g. medical society, hospital), the latter selecting the Healthcare Professional(s) attending the conference. The Grant covers the costs such as travel, accommodation, and conference registration. The direct selection and support by companies of Healthcare Professionals to attend a given Conference or Congress will not be allowed anymore at the end of this year. The focus of the interviews was about this change. During our discussions with Healthcare Professionals regarding this new model of Educational Grants, one thing became clear; the majority of interviewed Healthcare Professionals were not at all against the change. In fact, a majority welcomed the changes as, according to them, it would bring more legitimacy and transparency. Some Healthcare Professionals also advocated that an independent selection by hospitals was much better than industry selecting HCPs. In their view, hospitals know better who needs training and...
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...
“All men make mistakes, but a good man yields when he knows his course is wrong, and repairs the evil. The only crime is pride.”— Sophocles, Antigone Just two decades ago, in the late ‘90s, the Institute of Medicine presented shocking statistics, comparing the death occurring from medical errors to the equivalent of a jumbo jet crashing every day. As a result, patient safety came into sharper focus and was recognised as a global challenge that requires skills and knowledge in many areas, including human factors. In Europe, the statistics are similarly worrying and fuelled by cases where surgeons implant wrong organs into the patient, or even worse – bring the wrong patient into surgery. Recognizing the significant risk to surgical patients, the topic has received attention from international organizations, such as the World Health Organisation (WHO), which published guidelines to improve patient safety in the operating theatre. A 19-item checklist was designed with the goal of reducing the rate of major surgical complications during three time-critical checkpoints: sign-in, timeout, and sign-out. Briefings carried out by operating theatre teams provide an opportunity to identify and resolve issues before a case starts. Debriefings at the end of the theatre list support reflective learning on what went well and what could be done better tomorrow. The checklist also helps to improve the reliability of essential surgical processes by prompting the surgical team to anticipate and prepare for potential problems. It forces a brief period of reflection (the ‘time out’) in which the theatre team works through a series of questions aimed at highlighting potential problems. Indeed, the checklist has contributed to the overall reduction of mortality in surgery and enhanced communication among theatre staff. From the medical device standpoint, its implementation is critical as it allows demonstrating potentially avoidable adverse events when...
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...
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. •...