Despite strict rules already governing the healthcare sector, questions still arise about how pharma companies and healthcare professionals (HCPs) interact; whether payments, gifts, hospitality or conference funding exert an inappropriate influence on HCP prescribing behaviours and treatment decisions.
To address these concerns, the European Federation for Pharmaceutical Industries and Associations (EFPIA) have implemented the Transparency Disclosure Code; legislation which, like 2010’s US Sunshine Act, requires companies to capture and publicly report all HCP spend. The new rules have been in effect since 2015 and are due to publish their first data for public viewing in 2016. It’s hoped that having healthcare’s financial dealings open to such scrutiny will eradicate the possibility of excessive payments that could be construed as a bribe.
From an agency perspective, this changes life notably, with a whole new level of details demanding attention.
Where meetings take place, it’s now our job to keep track of lunches, accommodation, pens and pencils, who walks and who catches the bus – any ‘transfer of value’ between sponsor and delegate – down to an individual level. Simple items such as pens and pads will also become increasingly difficult for EFPIA members to sponsor, as the value of these to the HCP is hard to judge.
For an industry with such an impact on people’s lives, this level of regulation is reasonable and responsible but, on a nation-by-nation basis, it could also be remarkably difficult to apply. EFPIA code needs to be obeyed but so do the laws and codes of the HCP’s home country (and privacy laws trump a transparency code). It follows then that, although the pharma company is legally required to report transactions, they’ll need the HCP’s permission to do so.
It’s a maze of regulation that we must navigate carefully. The stakes for a misstep are high; penalty fines, legal fees, even the risk of criminal prosecution. On top of this, we risk bringing both the pharma industry and HCPs into disrepute. However, to protect our clients and their customers we must open them to an almost-uncomfortable level of scrutiny – quite a challenge for healthcare agencies whose role it is to help companies and brands build relationships. 2016 looks like it’s going to keep us on our toes…