transparency

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...
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. •...
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,...
In 2008 Eucomed published its revised Code of Ethical Business Practice. We’re six years on now and we’re thinking about writing a new one. Why? Because so much has changed in the world of medtech compliance.