The Secretary of State for Health has proposed implementing a rule requiring NHS healthcare organisations to keep registers of any gifts that their staff have received from pharmaceutical or medical device companies. The so-called “Sunshine Rule” would be intended to increase transparency around the relationship between NHS healthcare professionals and industry. It is expected that the rule will come into effect in 2016 but will be unlikely to take the form of new legislation as existing legislation already contains adequate enforcement mechanisms.
The keeping of public registers to record interests declared by NHS staff is nothing new. In 1993 the NHS Management Executive encouraged NHS bodies to operate standards of business conduct for NHS staff and many NHS bodies accordingly already operate public registers where staff declare gifts, benefits or sponsorship of any kind as well as financial and/or personal interests, such as company shares or research grants. The new rule may therefore simply re-establish the existing framework on a more formal basis, possible enforceable via NHS contracts and employment contracts. In any event, it is to be assumed that the new rule will likely result in an increased onus on healthcare professionals to make disclosures to their employers.
Industry trade associations representing the pharmaceutical and medical device industries have welcomed the government’s intentions in relation to increasing transparency in relations between industry and healthcare professionals. They have also pointed out that the industries each operate within robust governance frameworks covering interactions with healthcare professionals which are designed to increase transparency around industry dealings with healthcare providers and professionals. They have also emphasised the benefits for the NHS and for patients of collaborative partnerships with industry.
The Association of the British Pharmaceutical Industry (ABPI) stated that in 2016 it will be launching a searchable database of all transfers of value and payments made by industry to individual healthcare professionals made in 2015. The ABPI comments that the database will cover a wider range of interactions than what the new rule is expected to cover, as pharmaceutical companies must disclose payments and transfers of value made to healthcare organisations and practitioners other than those directly for R&D, such as clinical trials.
Other associations have approached transparency in different ways. The Association of British Healthcare Industries’ (ABHI) Guidelines on Interactions with Healthcare Professionals includes requirements for medical device companies to give written notification to a healthcare professional’s employer when employing that individual on a consultancy basis or making a financial contribution to that individual’s medical training.
While the transparency obligations under the respective industry association codes apply to the members of those associations (or non-members that elect to comply voluntarily), it seems the new rule will likely be directed at the healthcare providers and commissioners and their respective personnel. Pharmaceutical and medical device companies will nevertheless have to pay close attention to the implementation of any new rule, as the increased transparency requirements on healthcare providers and commissioners to report is likely to affect the ways in which NHS personnel interact with industry.
The announcement by the Secretary of State contained very little in terms of detail. We await further information on exactly what activity the new rule will apply to, how it will be enforced and how (if at all) the government intends the new rule to interact with and complement the current industry association transparency schemes.