The Legal and Compliance team of MedTech Europe

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...