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24th August 2015

Sunshine Rule – Anything to declare?

Sunshine rule - anything to declare?

The Health Secretary, Jeremy Hunt, has today announced that all NHS organisations will have to declare all gifts and hospitality staff receive from drug companies or face unlimited prosecution, and even imprisonment, under new rules from next year. Based on the Sunshine Act, which is law in America, the ‘Sunshine rule’ will be mandatory and all members of staff will have to keep a register of hospitality and gifts from pharmaceutical firms to crackdown on corruption in the NHS.

Medical Regulations

The Human Medical Regulations 2012 clearly state that a “person may not, in connection with the promotion of medicinal products to persons qualified to prescribe or supply them, supply, offer, or promise any gift, pecuniary advantage or benefit” unless it is cheap and relevant to medicinal practice. Such actions, of course, may constitute bribery, which is a crime and defined by Black's Law Dictionary as ‘the offering, giving, receiving or soliciting of any item of value to influence the actions of an official or other person in charge of a public or legal duty.’

The sun ain't gonna shine anymore

For those who aren’t familiar with the Sunshine Act, it was passed into US law in 2010 as part of President Obama’s Patient Protection and Affordable Care Act (PPACA) and was implemented in August 2013. There has been a lack of cohesion and clarity as to what should and should not be reported, including the medical writing support provided by pharmaceutical companies to authors of clinical studies, but Mr Hunt wants new government rules to ensure that it is very clear. The Association of British Pharmaceutical (ABPI) has welcomed the announcement, which aims to improve transparency in the relationships between healthcare professionals and the pharmaceutical industry.

Abuse of their position

It appears that part of the problem is just how many sales reps are targeting hospitals in particular, with 65 reps on site at any one time according to a recent report. Mr Hunt said: “Disturbing evidence has come to my attention that small numbers of NHS staff have tried to influence NHS purchasing decisions in turn for payment, gifts or hospitality from pharmaceutical firms and medical device manufacturers. This is a complete abuse of their position and will be shocking to the vast majority of staff who want the best for patients. The NHS is indirectly paying for every one of those reps, through staff and the amount paid for drugs and products.”

Anti-bribery policy and procedure

To ensure you are fully covered by the prospect of any potential bribery claims, the QCS management system has an Anti-Bribery Policy and Procedure which outlines what constitutes a bribe, hospitality, and charitable contributions.

Alison Lowerson – QCS Expert GP Practice Manager Contributor

Topics: GPs

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