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 why two large components of the healthcare industry are taking different approaches.
In addition, the merits of the medtech model have not yet been embraced by the public. We have a sense that, as an industry, we have not communicated the rationale for our risk-based approach well enough. As the tone of recent articles on the ‘Implant Files’ have made clear, public trust is still not where we want it to be. Clearly, challenges still remain to improve our reputation.
So where to next? We must ask ourselves whether we need to go a step further by addressing the issue of collaboration with HCPs, which requires tackling the thorny issues of consent management that this would bring.
We must also do a better job of communicating to patients why we all share the same interest in health professionals being equipped with the latest knowledge and skills to achieve the best outcomes.
We welcome the fact that in the medtech industry we are making progress with other regions, including the US, Asia and the Middle East, to achieve global alignment.
We feel it is vitally important to engage with other healthcare industry actors.
This blog is part of the MedTech Forum blog series. Pascale Schmidt will be speaking at the MedTech Forum and Global MedTech Compliance Conference 2019. You can follow the conversation under #MTF2019 and find more details at medtechforum.eu.
