The end of direct sponsorship of healthcare professionals by the medical device industry

In November 2014 we reported on the proposal of the European Diagnostics Manufacturers Association (EDMA) and the European Medical Technology Industry Association (Eucomed) to phase out direct sponsorship by their members of healthcare professionals (HCPs) at third party events by 01 January 2018 (see our previous article The end of direct sponsorship of healthcare professionals by the medical device industry?). This proposal would apply to all companies affiliated to MedTech Europe, whether directly or through associations such as the UK Association of British Healthcare Industries (ABHI).

Notwithstanding members across Europe expressing their concerns over the proposal during the last twelve months, on 02 December 2015 the members of MedTech Europe voted to adopt it as part of a revised code of conduct. This positive decision may, in part, be due to options available to MedTech Europe members, namely to approve or reject the revised code in its entirety; they could not merely object to parts of the code. This posed a dilemma as many of the other revisions to the code are helpful because they provide greater clarity to existing rules.

Notably, the revised code prohibits direct support for HCP attendance at third party organised educational events, but permits direct support to a HCP to:

• speak at a satellite symposium where engaged to do so pursuant to a consultancy contract, and
• attend third party organised procedure training.

Despite these exceptions, this change will result in a stricter position on direct sponsorship of HCPs in the medical device sector than the pharmaceutical sector in the UK (which permits direct sponsorship subject to certain requirements and disclosure of payments made). This is significant because the pharmaceutical sector has traditionally been more stringent than the medical device sector in the UK and elsewhere across Europe.

Despite some misgivings surrounding the prohibition of direct sponsorship, the ABHI, which is a member of Eucomed, voted in favour of the revised code. The change will have a significant impact on how medical device businesses in the UK conduct themselves and develop and maintain relationships with HCPs (an activity which is particularly important for an industry which relies on HCP involvement). It poses a particular concern for members operating in specialist areas who fear that the provision of a general educational grant to an institution to be used as the institution sees fit (which is permitted under the revised code) would result in that money being spent on attendance at events which are unrelated to their specialist area (as that is likely to be of interest only to a limited number of HCPs). It will be interesting to see the impact of this new rule, with one possibility being that companies will cease their membership of MedTech Europe (directly or by ceasing to be a member of an association, such as the ABHI, which is a member) in order to avoid the remit of these provisions. The significance of this change is compounded by the UK Health Secretary’s proposal to introduce “sunshine” legislation in the UK across both the pharmaceutical and medical device sectors, as well as the possible exit of the UK from the EU.

This change will not just be significant in the UK, but has implications across Europe: 

• In France, interactions with HCPs by the medical device sector are already heavily regulated by statute. Article L.4113-6 of the French Public Health Code (also referred to as the anti-gift or DMOS law) requires any agreement, invitation, sponsorship etc. between a medical device company (provided that it has at least one product reimbursed in France) and a French-registered HCP to be submitted to the relevant professional board for approval. In addition, the statutory sunshine system covers interactions between the medical device sector and HCPs, such that direct sponsorship of HCPs is visible to the public. In light of the existing controls (and considering that HCPs rely heavily on industry support for the purposes of continued medical education), some stakeholders have doubted whether the phasing out of any form of sponsorship would actually serve any significant compliance purpose, and ultimately the French representative industry association SNITEM voted against the revised code. It is now uncertain whether, and how, SNITEM will implement the code in its own guidelines by 2020, knowing that it is possible that French law (and/or the code) might change again in the interim.

• In Belgium, the Medicines Act of 25 March 1964 enables direct sponsorship of HCPs under strict conditions which include obtaining prior authorization (called Mdeon visa) for the sponsorship of scientific events lasting several calendar days. Since the existing legal framework has proven to be efficient, like in France some stakeholders have doubted whether phasing out HCP sponsorship would actually serve any significant compliance purpose. The Belgian representative industry association, UNAMEC, however voted in favour of the revised code. UNAMEC last reviewed its Ethical Code in November 2014. Modifications are therefore expected to reflect the revised code adopted by MedTech Europe phasing out certain HCP sponsorship. It is also expected that legislative steps will be taken at a federal level to prevent a situation where the UNAMEC Ethical Code imposes stricter rules than the 1964 Medicines Act. Coordinated legislative efforts should allow UNAMEC to provide sector-specific guidelines that are in line with the national law and ensure that UNAMEC members enjoy a swift transition towards new rules on direct sponsorship.

• In the Netherlands, the Medical Devices Act does not currently restrict direct sponsorship of HCP’s. However, on 29 October 2015, the Minister of Health proposed changing the Medical Devices Act to prevent any “undesired influences” between industry and HCPs by implementing a general clause prohibiting favouritism, but allowing activities similar to those permitted for medicines, which are set out in the medical device industry code (the GMH Code) eg requiring services agreements and sponsoring agreements to be concluded in writing. In light of these proposed changes, it is not clear whether the prohibition to direct sponsorship under the MedTech Europe code is really required to strengthen compliance. Importantly, the requirements in Netherlands apply equally to HCPs and industry, so if a financial relationship existed between a Dutch HCP and a foreign medical device company, the HCP would still have to comply with the transparency requirements under Dutch law. At the time of publication of this paper, it is not publicly known how the Dutch industry associations voted in respect of the adoption of the proposed MedTech Europe code.

• In Spain, direct sponsorship of HCPs is currently permitted provided that such sponsorship complies with the requirements of the Best Practices Code (Code) of the Spanish Federation of Healthcare Technology Companies (FENIN), which entered into force in 2005 and was updated in 2009. The Code is based in the following four principles: separation, transparency, honesty and legality. These requirements include that: (i) the events shall be organized by recognized entities and have a scientific interest; (ii) sponsorship shall be limited to the payment of the event registration fee and travel, meals and accommodation expenses during the days of the event; and (iii) the medical and scientific aspects of the event should be the primary focus of the event, with hospitality during the event always being secondary in focus and reasonable. At the time of publication, it is not publicly known how FENIN voted in respect of the adoption of the proposed MedTech Europe code. However, as FENIN has been promoting its relationship with scientific societies recently with a view to smoothing the way for the introduction of changes to the Code as a result of European guidelines, it may be that FENIN has been gearing up to adopt the new code.

• In Italy, direct sponsorship of HCPs by medical device companies is currently permitted, subject to strict rules set out in the Code of Ethics of the Italian industry association “Assobiomedica”, which represents more than 90% of Italian medical device companies. Assobiomedica members criticised the revised MedTech Europe Code arguing that the existing rules were sufficiently strict to guarantee a clear and transparent relationship between companies and HCPs and that, without financial contributions from companies, the Italian National Healthcare System would risk being unable to support the requisite continuing medical education of HCPs. At the time of publication, it is not publicly known how Assobiomedica voted in respect of the adoption of the proposed MedTech Europe code.

• In Germany, national law permits direct sponsorship of HCPs subject to conditions. In January 2015, the German Federal Medical Technology Association (Bundesverband Medizintechnologie or BVMed) adopted its revised Medical Devices Code (Kodex Medizinprodukte) reflecting the requirements of the aforementioned national law. This code contains four basic principles (separation, transparency, documentation and equivalence) guiding interaction between the industry and HCPs and mirrors the position at law in Germany - it does not impose stricter requirements, such as those envisaged by MedTech Europe. Given the existing controls, BVMed (along with Spectaris, another German member association of Eucomed) voted against the phase out of direct sponsorship and the revised MedTech Europe Code. German stakeholders, in particular direct corporate members of Eucomed/EDMA, will still have to deal with the implications of the adopted MedTech Europe Code.

Corporate members of Eucomed will have one year to put internal systems in place to give effect to its provisions and a further year to phase out direct sponsorship of third party organised educational events - timelines which may prove challenging. The ABHI anticipates that it will have updated its code of practice by the January 2017, but full implementation of a revised ABHI code is unlikely to occur until January 2019.