The new provisions to the Association of British Pharmaceutical Industry (ABPI)’s Code of Conduct are now fully effective, which means that since the 1st of May, direct or indirect transfers of value to healthcare professionals (HCPs) and healthcare organisations (HCOs) must be publicly disclosed.
It is worth reminding ourselves of the key parts of Clause 24 from the Code, which will mean that from now on pharmaceutical companies will need to have robust systems in place to collate and record their data for public access.
Definition of a transfer of value
“The term ‘transfer of value’ means a direct or indirect transfer of value, whether in cash, in kind or otherwise, made, whether for promotional purposes or otherwise, in connection with the development or sale of medicines.” It is important to understand the difference between a direct and an indirect transfer of value – direct transfer of value is one made directly by a company for the benefit of a recipient. Whereas, an indirect transfer of value is one made by a third party on behalf of a company for the benefit of a recipient – this only applies however if the identity of the company is known to, or can be identified by, the recipient.
Recipients and consent
Where a transfer of value is taking place, companies are encouraged to include a contract which can be signed by the recipient giving their consent to disclose the information about them. The Code now makes it the onus of the company to ensure that they have appropriate arrangements in place to lawfully disclose information about transfers of value. When recipients cannot be named for legal reasons, the amount of money given must be disclosed on an aggregate basis. In addition the Code states that “The number of recipients involved must be stated together with the percentage of all recipients that they represent and the aggregate amount attributable to transfers of value to such recipients.”
How and when to record
Payments to the same HCP can be aggregated but itemised data must be available on request. For HCOs, payments are required to be disclosed for each individual activity. According to the ABPI Code, there will be a central platform for UK disclosure: companies are obliged to use this. A template for data submission is also available to download from the Prescription Medicines Code of Practice Authority (PMCPA) website. Disclosures must occur annually and be in the first six months after the end of the calendar year in which the transfers of value were made. For five years after disclosure, companies must keep all their records.
Each company must publish a note summarising the methods that have been used to calculate transfers of value and how they have identified each category of payment. It must be made clear by the pharmaceutical company how multi-year contracts, VAT and other tax aspects, alongside currency issues are dealt with. It is also vitally important that to ensure that companies remain compliant with this self-regulatory code. Sanctions can be imposed by the PMCPA if companies are in breach of the code, including an audit of the company, a public reprimand and suspension or expulsion from membership of the ABPI. Bringing any transgressions to light remains an important part of the process to ensure the growth of this culture of transparency seen in the past few years throughout the pharmaceutical industry.
Ruth Knowles is a freelance science writer who has written articles and press releases on a range of life science and health topics. She received her MSc in Science Communication from the University of the West of England, Bristol.