Emilce Vega, Associate, Media & Technology
Shepherd and Wedderburn
What do you think is the impact of the Bribery Act on the UK pharmaceutical industry?
Pharmaceutical companies must ensure that the “adequate procedures” they have in place address those risks faced by the sector, cover a fairly standard array of topics including hospitality and gifts to promotional expenses and include adequate policies relating to the monitoring of financial relationships with healthcare professionals.
What are the main difference and similarity between the Sunshine Act and the ABPI Code of Practice?
The US Sunshine Act imposes annual legal disclosure obligations on certain manufacturers of drugs and devices, biologicals and medical supplies and non-compliance may result in hefty fines. English law does not provide for disclosure obligations equivalent to the Sunshine Act, but there are certain transparency regimes imposed by the ABPI Code of Practice. Although it does not have binding legal effect, compliance with the ABPI Code of Practice can be a relevant consideration when assessing a company’s “adequate procedures” and certain penalties are available for breach.
Do you know when the EFPIA will publish guidance for the new disclosure requirements?
n June 2012, the EFPIA announced an intention to introduce a pan-European approach for disclosure of financial relationships with healthcare professionals on an individual basis and is hoping to have this regime in place so that the first disclosures are due in 2016.