Medtech Europe represents the medical technology industry in Europe. It is the alliance of the two leading medical technology industry associations, EUCOMED (which represents the European medical devices industry) and EDMA (which represents respectively the European in vitro diagnostic industry). In the context of their alliance EUCOMED and EDMA adopted on 2 December 2015 a new common Code of Ethical Business Practice, replacing the EUCOMED and EDMA respective Codes of Ethics. The new common code sets the minimum standards appropriate to the various types of activities carried out by its Members and will become binding on January 2017. A transition period during which specific provisions will apply is also foreseen. Respectively, Member Associations -Association of Health Research and Biotechnology Industry (SEIV), in particular, in Greece- are expected to transpose the Code at national level by January 1st 2020.
Important provisions of the Code
The new common Code aims to regulate in the most effective way the activities carried out by Medtech members, including mainly guidelines on the interactions with HCPs, company events, third party educational events, grants and donations – as well as transparence obligations and compliance with national laws.
- First of all, the MedTech Code of Ethics introduces a series of new guidelines regarding the interactions with HCPs and HCOs. In particular, the Code sets a new obligation for its Members who shall no longer be allowed to provide direct financial or in kind support to individual Healthcare Professional Professionals to cover costs of their attendance at Third Party Organized Educational Events with the exception of Third Party Organized Procedure Training meetings or pursuant to a consulting agreement with a Health Care Professional Speaker engaged by a Member to speak at a satellite symposium. The latter obligation will become binding for its Members on December 31st, 2017 and from that date on Μember Companies may only provide financial or in kind support through educational grants or other types of funding in accordance with the Code’s stipulations. In such cases, the Healthcare Organization receiving the grant for the support of HCPs’ attendance, shall be solely responsible for the selection of participants.
During the transition period which will last until the full application of the above rule, Member Companies will be allowed to provide direct financial or in kind support to HCP in order to cover the cost of their participation under specific conditions. In particular, Member Companies must at all times comply with the general criteria for such events, as set out in the Code, these concerning the event programme which should directly relate to the specialty of the HCP, the choice of venue (centrally located, ease of access, appropriate location etc) as well as reasonable hospitality and travel costs. Moreover, Members must ensure that the Event has been approved via the Conference Vetting System.
- Furthermore, the Code sets out a series of criteria regarding consulting agreements between members and HCPs. The Code underlines the necessity of documenting such arrangements in writing, specifying the nature of the provided services as well as the payment basis for the provided services – one of the most important criteria which must be fulfilled.
- Εducational items and gifts granted by Companies to HCPs are also regulated via the new Code of Ethics. Such gifts must always be modest in value and directly related to the HCP’s specialty along with a few other guidelines which must be followed. Moreover, Member Companies are also permitted under the Code to provide a reasonable number of samples at no charge to HCPs and HCOs in order to familiarize themselves with the offered products and to acquire experience regarding their safe and effective use. However, the quantity of the samples provided must not exceed the amount which is reasonably necessary in order to acquire adequate experience to use the offered product.
It is worth noting, finally, that the new Code’s content is in accordance with the respective articles in Advamed’s Code of Ethics. Advamed, representing 80% of medical companies doing business in the US, has implemented a similar series of rules, some of which are slightly stricter than the ones adopted by MedTech, aiming to efficiently regulate all interactions between its Members and HCPs and HCOs. In particular and according to Advamed’s Code of Ethics, gifts to HCPs must strictly serve educational purposes while Public Sector HCPs must not be offered in any case gifts, meals or even refreshments by Member Companies.
Our law firm’s comment:
It becomes clear, that the promotion of business ethics especially when it comes to interacting with HCPs and HCOs has become one of the primary goals of the leading associations in the medical device industries, both in Europe and the US.
The new MedTech Code of Business Ethics sets out a series of harmonized rules which efficiently promote the essence of ethics, especially in the competitive and rapidly changing medical technology industry. Nevertheless, each Member must take into account that the Code sets the minimum standards which must be followed by Member Companies as well as their Member Associations when interacting with HCPs and HCOs. This means that national/local laws which may be stricter will apply first, therefore binding all Members, who must comply with the stricter legislation. This is of particular importance, especially when it comes to transparency obligations which differ from country to country.
