No Plan B

  • Posted on 15.10.2015

No Plan B


Aline Lautenberg

MedTech Europe, General Counsel - Director Legal & Compliance


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.  

•    The changing environment: we need to accept that, in today’s healthcare, direct sponsorship is already a model of the past. Phasing it out will not have the tsunami impact that some fear. Between the countries that have banned direct sponsorship, those who have restricted it with extremely burdensome rules, healthcare professionals and hospitals that are not accepting such support anymore, companies that have moved on and pressure from public opinion, the extent to which direct sponsorship is used to support independent medical education is already limited. This trend will continue in the future.

•    By proposing an open dialogue on this issue internally as well as externally before any final decision by EDMA and Eucomed members, a compliance issue became political, worthy of an episode from House of Cards.

Given all this, and even though it will be a democratic vote on a very clear question (i.e.  Do you approve or reject the draft MedTech Europe Code – as it stands today –,  which encompasses the entire framework which will regulate, as a minimum standard across Europe, all interactions between HCPs and the MedTech industry?), I do not believe that our industry has a choice between “YES” and “NO”.

It can only be “YES”. Not because we would lose face after this very public debate, but because it is the right thing to do, because of the need for better regulation, and because the world has moved on and is watching us. It can only be “YES” because if we do not do it as European-wide strict self-regulation for our industry, it will eventually creep in at national level, with all the variations that are very complicated to manage for an international industry evolving in a globalised and interconnected world.

This is why I believe this is not a choice between “YES” and “NO”, and this is why there is no plan B. 

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