MedTech Europe Code of Ethical Business Practice and its implementation at European level

Published on 21st Nov 2018

MedTech Europe establishes a 2020 roadmap for member companies and national associations to adopt the standards established in its code of ethical business, existing varying degrees of response to date.

The European association of the medical technology industry, MedTech Europe ("MedTech"), decided to modify its Code of Ethical Business (the "Code"), in 2015, in order to design more efficient processes in terms of compliance. Thenceforth, the different operators of the sector (member companies, on the one hand, and national associations, on the other) began their path towards the adoption and transposition of these standards, each at a different pace.

The race for the adjustment was initiated by member companies at the beginning of 2017, which had to adapt the rules of the Code to their internal policies gradually. Thus, on January 1, 2018, when the more rigorous rules in terms of relations between industry and health professionals came into force, direct support to health professionals for attending events and educational conferences organized by third parties came to an end.

The national associations will be the last ones obliged to transpose the rules of the Code. By January 1, 2020, they would have implemented all the MedTech regulations to their national codes so that they become binding at the local level.

Notwithstanding the period granted by Medtech to the national associations, Spain, through the Spanish Federation of Healthcare Technology Companies (FENIN, in Spanish), has been pioneering in adopting the Code by approving a new code of ethics on January 1, 2018. Known as "Fenin Code", it's been set to replace the previous code of good practice, in force since 2009.

The content of the new Fenin Code is the same as that of the Code, in essence. It embeds the most relevant novelties of the Code, such as the prohibition of direct aid to health professionals for attending events and educational conferences organized by third parties, the limitation of donations, new rules relating to transparency and the creation of a conference vetting system for the validation of events organized by third parties ("CVS").

It should be noted that, since the Fenin Code came into force, CVS is fully operational and has already evaluated more than 1,300 events within a year. Through this platform it is possible to determine if a congress conforms to the regulations of the Fenin Code, with the companies adhering to the federation only sponsoring events -organized by third parties- that have been positively assessed by CVS.

In certain countries, such as Italy or France, national associations still do not show signs of adapting to the Code or are in the approval stage within the internal organization, at best (SIDIV and Assobiomedica). On the contrary, German (BVMed, Spectaris) and British associations (ABHI, BIVDA) have already agreed on the transposition of the Code in their relevant regulations and, to date, they are even mandatory in their respective territories.

In short, it can be said that the associations of the health technology sector -both at European and national level- are successfully moving forward, with significant improvements in transparency and independence of healthcare professionals. All the same, their progression to adapt the Code will have to be followed up to its ultimate implementation in 2020.

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* This article is current as of the date of its publication and does not necessarily reflect the present state of the law or relevant regulation.

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