The seminar “Be ready for transparency: public disclosure requirements and IT systems in the pharmaceutical Industry” organised by BMI SYSTEM and hosted by Law firm Shepherd and Wedderburn, at their London office, outlined the recent regulatory changes concerning the disclosure of financial support in the pharmaceutical industry and illustrated how well-designed IT solutions can facilitate regulatory compliance.
UK Bribery Act 2010
Emilce Vega, Associate at Shepherd and Wedderburn, began the seminar with an outline of the requirements of the UK Bribery Act 2010, which necessitates that all UK private and public companies implement adequate procedures to prevent bribery in the UK and globally, through affiliates. Facilitation payments are a particular area of concern and pharmaceutical companies should be careful in their relationship with healthcare professionals (HCPs)and patient organisations, where payments are given to public officials: notable areas of exposure include clinical research and clinical trials, consultancy agreements, donations and grants.
In the UK there are no set laws for transparency requirements, however, the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice sets out requirements for the promotion of prescription only medicines (including the provision of samples, gifts, hospitality and entertainment) to HCPs and administrative staff, whilst prohibiting any promotion to the public and patient organisations. The code was amended last year to include recent changes to European and international codes and now stipulates that all payments, including grants and sponsorships, made in January 2012 need to be declared by the end of the financial year for all members.
ABPI Code of Practice – the information that will need to be publicly available by the end of each member’s financial year, starting 31st March 2013:
Clauses 18.6: All grants, donations and sponsorship; including amounts and the names of the recipients.
Clause 19.3 and 19.4: The monies paid to UK health professionals attending meetings organised by third parties (registration and accommodation and travel fees: total amounts paid and the number of attendances, but names are not necessary).
Clause 20.2: Fees paid to consultants for services such as speeches, training and advisory boards.
Clause 20.3: Market research and payments for consultants’ accommodation and travel inside and outside the UK.
Clauses 23.8 and 23.9: The amount of financial or significant non-financial support given to patient organisations at a national and European level. Although names do not currently need to be disclosed, the number of organisations needs to be recorded.
“The new Edition of the ABPI Code introduces the concept of non-financial support for patient organisations, however it is sometimes hard to give a value to this,” explained Emilce Vega. “Although disclosure can be presented in the form of documentation, it is cheap and easy to set up a website to allow the public to have easy access to this information. Breeches of the APBI Code are taken very seriously by the Industry, so it is important to have a database to store all your data that can be easily updated.”
Anna Feros, Partner at Shepherd and Wedderburn, explained how the changes to the ABPI Code of Practice follow recent legislative changes in the US. The ‘Sunshine Act’ forms part of the 2010 US Patient Protection and Affordable Care Act and introduces two distinct disclosure obligations. Firstly disclosure of all information regarding payments to physicians and teaching hospitals and, secondly, information regarding the ownership or investment interest in a manufacturer held by a physician or family member. Published in February this year, the final rule of the Act stipulates that data collection must commence on the 1st of August for data release on a public website by 30th June 2014.
The estimated costs for industry compliance with the Sunshine Act has been given as $270 million in the first year and $180 million annually and companies face severe fines if they fail to record payments. Anna Feros gave some important advice to delegates concerning the redefinition of contracts with HCPs to fit in with the new disclosure requirements. “The disclosure of names is an area for open debate, and the new transparency requirements will spell an end to vague contracts and retainers, which will now have to give detailed accounts of services and the estimates of monies to be paid”, she explained.
IT solutions to aid transparency
Laurent Clerc, Regulatory Affairs Expert at BMI SYSTEM, explained how the company’s experience with IT systems for transparency comes from working with the 2012 ‘Loi Bertrand’, which defines the relationship of French pharmaceutical companies with HCPs and HCOs. According to him, “UK companies should think ahead and anticipate future requirements for nominative disclosure, which includes the names of HCPs. When implementing an IT system, a process approach is recommended, to give a global view of all the decisions made. Our tools provide an audit trail allowing retrieval of all monetary data plus the mentioned decisions; any claims from HCPs can also be kept in the same system.”
The tailor-made solutions offered by BMI SYSTEM are a real investment for a company wishing to avoid the significant monetary and credibility costs of not complying with the APBI’s Code of Practice. In order to minimise legal risks and avoid conflicts of interest Laurent Clerc suggested having a unique ‘identifier’ for each HCP and a step in the process to identify as soon as possible how much money a consultant has already received.” BMI SYSTEM IT solutions are equipped to deal with the often tricky calculation of non-financial support, and can build an interface to collect information from different sources, in particular, from different countries: combining local requirements with a global view.”
Francis Geysermans, Chief Technical Officer at BMI SYSTEM, presented the NAYA GRC 2013 platform to delegates. “Our robust IT systems facilitate pharmaceutical companies’ efforts to meet changing legal obligations whilst simultaneously improving processes and managing risks,” he explained.