Compliance fragments – the ever-shifting landscape

  • Posted on 20.02.2014

Compliance fragments – the ever-shifting landscape


Aline Lautenberg

MedTech Europe, General Counsel - Director Legal & Compliance


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.

Looking back, if I had to qualify the year 2012 I’d say it was the year of the Conference Vetting System. 2013 was undoubtedly the year of transparency (with the 2010s shaping up to be the decade of transparency) with the US and France Sunshine Acts requiring medtech and pharmaceutical companies to report all value transfers made to Healthcare Professionals (HCPs). And with EFPIA (the European pharmaceutical trade association) publishing their own disclosure code, and the European Commission publishing their long-awaited study on corruption in the healthcare sector, the trend towards change was clearly established.

2014: The year compliance officially ‘grows up’?

With all that in mind, 2014 could be the year of maturity, due to a perfect storm of legal circumstances and business shifts that I’ll try to sum up in three points:

Firstly, it seems to me that compliance is starting to be fully integrated into business. At the highest level, member companies have moved from a legalistic approach to compliance to an integral part of how you do business.

This does not mean that company employees enjoy the ever-changing nature of  standard operating procedures, but that they probably better than ever appreciate the unattractive prospect of change is always preferable to the instability following a crisis, such as one following a FCPA (Foreign Corrupt Practices Act) prosecution. What that means in practice is that companies are building up their compliance function. However, this raises management issues, such as how to set up a global compliance function and how to set up effective controls and collaboration with business—all of which are particularly challenging when you are a smaller player with a single figure global headcount.

Secondly, the trends mentioned above, such as transparency, but also HCP sponsorship to congresses and more broadly to Continuous Medical Education (CME), and the obligation to have risk management systems of distributors and other independent third-parties are there to stay and these waters are become ever more difficult to navigate. Requirements are multiplying, in slightly different way across the EU staying hip to the changes in no easy task, in particular if they happen in smaller markets.

To take only one example in Denmark, who would know that the Ministry of Health considers to increase transparency in collaboration between HCPs and healthcare industry, including possible reporting obligations? This revision should take place during the first two quarters of 2014, meaning that companies may have new reporting obligations as early as 1 July 2014.

Thirdly, discussions on industry’s support to continuous medical education (CME) in Europe are intensifying. CME support has a compliance component, and this may have had a significant impact on how European (and maybe also international) educational conferences are organised. However, in these discussions, compliance is not the only issue. HCP organisations in countries like Ireland, Germany and Sweden have been voicing their concerns about industry’s support to medical education and with Sweden taking a firm stance to end this support altogether as of 1 January 2015.

But medical societies are only some of the stakeholders affected and considering what these discussions mean for the future of CME, and different perspectives are being voiced the (see for example UEMS-EACCME Conference  on CME-CPD and professional conference organiser MCI’s recently published paper).

See you in Barcelona?

All this and more will be discussed at the Global MedTech Compliance Conference, which will take place from 20-22 May in Barcelona. Compliance pros face significant challenges and this is where we come together to exchange the latest information and best practices, trade war stories, and hopefully help drive the future of medtech compliance. My AdvaMed counterpart Chris White and I are excited to “get the band back together’’ again this year and we hope to see you there. 

– Aline Lautenberg, MedTech Europe, General Counsel – Director Legal & Compliance

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