compliance

This year, GMTCC is fully part of the MedTech Forum. By joining forces to build synergies between the business and compliance communities , the industry is sending a clear message: compliance is part of the business! I have always been in favour of having the compliance officer seen as a true business partner. Indeed, compliance programmes are not just a set of rules and policies drafted by an army of lawyers. On the contrary! A compliance programme will only be effective if it’s designed strategically by taking into account how the business is structured and what are the areas of risk. To be successful compliance must be embedded in the business activities. By adopting this common agenda, the medical device industry is leading by example, which is the right thing to do. Actually, the real surprise would have been if the industry had taken any other approach. This year, again, there were several scandals involving our industry. First of all, the Implant Files. This investigation conducted by a consortium of independent journalists around the world tried to denounce the fact that some medical devices (implants in particular) were improperly put on the market and abusively prescribed by certain HCP. The investigation received a lot of media attention but none of these allegations finally revealed illegal behaviours from the medical device companies. The healthcare system is certainly not perfect and further transparency shall be encouraged, in particular in the system of complaints reporting. It will be the case with the implementation of the Medical Device Regulation as from May 2020. But it should not be forgotten that the medical device industry is not the sole player in the health system and healthcare professionals and healthcare organizations have some responsibilities as well. In the future, the main risk in terms of compliance...
In an era where transparency is expected, the healthcare industry has been at the centre of attention from the public and from authorities. We can see this in how governments around the world – notably the US and France – have developed ‘Sunshine Acts’ to mandate disclosure of industry support for healthcare institutions and professionals. These transparency laws can take differing approaches, posing challenges to companies. On the other hand, Europe’s medtech industry is committed to self-regulation as means of building public trust. We believe that by notably setting a high and common standard for transparency, we can meet public expectations. So, what have we achieved so far? We are pleased to report that our industry has taken several steps forward to improve transparency and enhance our reputation as an ethical business. We have embraced a Code of Ethical Business. A key element of the Code is the ban on direct sponsorship of health professionals. We have shifted towards a model of educational grants, which reinforces our commitment to supporting medical education, whilst providing transparency, as these educational grants are subject to disclosure on a Europe-wide platform . In devising this approach, we learned some lessons from the experience of the pharmaceutical industry which discloses all transfers of value to healthcare professionals on companies’ own websites. Under the pharma model, companies are required to secure health professionals’ consent to disclose information and, in the absence of a European-wide platform, it can be cumbersome for the public to access information on transfers of value. In medtech, we have removed the burden of handling consent management and reduced the burden for the public by making information available in one place. But the lack of convergence between these two approaches poses challenges. For a start, it is difficult to explain to the public...
Healthcare is a complex system in which many actors and interests play a role. Unfortunately, the representation of some prevails over others, quite often even over patients' interest, despite the fact that the whole system's aim is to work for their well-being and safety. In mental health, in particular, industry and healthcare professionals have had a long-standing dual relationship too often qualified by a lack of transparency. This has led to over-reliance on a very narrow biomedical approach to mental healthcare and over-prescription of medication with little scope for users to make informed choices about their care. To ensure the adequate balance of interests in the system, we need more transparency at various levels. But how does transparency fit this picture, and does it matter at all to patients? I believe that patients and users are truly interested in and have a right to know who their providers cooperate with and where they get their knowledge from. Even if not directly by consulting public registers or companies' websites – they always look for the best quality of care for themselves and their relatives and the highest possible competencies of medical staff. Patients and users are growingly becoming aware of the existing conflicts of interest in the medical practice and the ways they can affect the quality of care they receive. However, I think their right to assess and evaluate possible barriers to the full enjoyment of the highest quality of care is not exercised enough. Some legislative steps can be taken in order to improve this. In Europe, nine countries have already decided to introduce legally binding sunshine laws - in various forms. All this is done not to add to the current administrative burden for the companies, but to answer legitimate public concerns about the undue impact of industrial...
By combining the GMTCC with the annual European MedTech Forum, the medtech industry is signalling that compliance is moving centre-stage, writes Nancy Travis, Vice President, International Compliance & Governance, AdvaMed For more than a decade, MedTech Europe and AdvaMed have jointly organised the key event on compliance professionals’ calendars. The Global MedTech Compliance Conference (GMTCC) is an annual gathering of the international healthcare compliance community. Over the years, it has grown into a forum where to share ideas, discuss challenges and promote best practices. Some people say compliance is a lonely profession, as the compliance department often-times is a department of one in smaller companies or for local offices in new markets. But compliance officers attending this conference will find a peer group ready to engage, an experience that can be enormously valuable and rewarding – and create a network that will live on after the event concludes. I’m particularly excited about this year’s GMTCC because it’s a little different from previous years. The 2019 conference will be held in parallel with the European MedTech Forum (May 14-16) – an event that has traditionally focused on business operations – for the first time. This shows that ethics is no longer a side-line to the business; it’s not a nice-to-have. Ethics and compliance are mainstream features of good business practice. More than that, compliance is a business enabler. As a relative newcomer to the field, I have been struck by the rapid transition of compliance from the periphery to an industry priority. As Bronwen Taylor said when closing last year’s GMTCC, compliance departments have moved from being perceived the ‘Department of No’ to become the ‘Department of ‘How’. In tandem with this shift, I’ve seen a strong appreciation from the business side for following ethical business practices. In many leading medtech...
Health data can transform our lives – but must be used wisely
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: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage, 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 and New industry code must safeguard independent medical education There is considerable hype around the potential of big data to change healthcare. Much of this is justified: large datasets and increased computing power are combining to make healthcare more personalised, more precise and more predictable. This revolution draws on the skills and knowhow of engineers, biologists, data scientists, lawyers and others, and is changing the life sciences industry in the process. However, all actors working in this space – from industry titans to newcomers with roots in the tech sector – must prioritise compliance. In particular, it is essential that we take data privacy seriously. From the R&D stage through to direct consumer interactions, we must think carefully about how we collect, store and use data. That is why security and privacy by design are essential to companies like Verily. The company’s history as the life sciences division of Google means data security is woven into its DNA. Indeed, Verily is a member of AdvaMed, and its compliance program follows highest standards of the medtech industry. Getting data privacy right We are at a crucial moment in the history of health data - we have a unique opportunity to transform the diagnosis and treatment of ill-health. Getting this right is critical to the future we envision to empower patients with the information they need to stay well,...
New industry code must safeguard independent medical education
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: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage, 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 and Health data can transform our lives – but must be used wisely The MedTech Code was designed by industry to ensure compliance with the highest ethical and legal standards. However, dialogue with professional medical societies is essential if we are to avoid unintended negative consequences for the quality and accessibility of education. It’s time to explore new models of collaboration Continuing medical education (CME) is a life-long commitment for clinicians. Through independently developed courses, they stay up to date with the latest scientific and technological advances in their field. Keeping doctors’ knowledge current directly benefits patients and helps developers of innovative technologies and techniques to disseminate information. CME has been successfully provided for decades through professional bodies at annual congresses and specialised seminars. As a past-President of the European Society of Cardiology and member of the Alliance for Biomedical Research in Europe ( BioMed Alliance ) – a network of 29 research-driven biomedical societies with more than 400,000 members – I have seen first-hand how professional societies support education. Congresses have attracted support from industry in a number of ways, including through unrestricted grants, and where companies cover the registration and travel costs of individual doctors. Income from these events have allowed congresses to grow; to cover a wide range of disease areas (including rare conditions); and to redeploy any surplus to other key activities...