The new UK anti-bribery law and its implication for the pharmaceutical industry
The Bribery Act came in force last July in the UK after several delays. It is regulated by the SFO (Serious Fraud Office) which is in charge of its application and will investigate and prosecute any offender. The Act only concerns bribery Pharmaceutical industries have been named as being “very obvious targets” for the SFO by the law firm Thomas Eggar (PharmaTimes, October 2011, p. 36). However the SFO respects the self-regulation operating in the pharmaceutical industry and this is why a memorandum has been issued to clarify the situation between the different regulatory agencies and the new Bribery Act 2010.
The Bribery Act 2010
The Bribery Act came in force last July in the UK after several delays. It is regulated by the SFO (Serious Fraud Office) which is in charge of its application and will investigate and prosecute any offender. The Act only concerns bribery.
Bribery consists in offering/giving/receiving a financial or any other advantage, intending to induce or reward improper performance; or knowing or believing that acceptance would in itself be improper.
One of the biggest issues with this Act is its jurisdictional reach; indeed the SFO can investigate and prosecute any entity having an activity in the UK wherever the company is based in the world.
The Act also issues in its section 7 the “failure of commercial organisation to prevent bribery”, in this case an organisation must make sure it has established clear dispositions to prevent bribery with all its employees but also with any associated person (supplier or distributor).
Pharmaceutical industries have been named as being “very obvious targets” for the SFO by the law firm Thomas Eggar (PharmaTimes, October 2011, p. 36). However the SFO respects the self-regulation operating in the pharmaceutical industry and this is why a memorandum has been issued.
Memorandum of understanding between the ABPI, the PMCPA and the SFO
Issued in April 2011, the Memorandum of understanding between the ABPI, the PMCPA and the SFO is aimed to clarify the situation between the different regulatory agencies and the new Bribery Act 2010.
The main point of this memorandum is to establish the fact that the SFO recognizes and values the self-regulation of the industry. By doing so it wants to encourage complaints to be reported at first directly to the PMCPA then in case it cannot be settled directly by the Agency the SFO or the MHRA will deal with it.
A number of provisions of the ABPI Code of Practice have the potential to overlap with the requirements of the Bribery Act 2010. The MHRA and the SFO will retain discretion at all times over which cases they choose to pursue and when, but unless there are good reasons for doing otherwise, the SFO’s approach is to delegate matters which are covered by the ABPI Code.
New ABPI Code 2011
Published in January last year, the new ABPI Code deals mainly with transparency issues and the incorporation of the new regulations established by the Bribery Act 2010. The main changes of the 2011 revision can be found on the PMCPA website (the agency in charge of the application of the ABPI Code, www.pmcpa.org.uk). One of the main changes is the redefinition of “promotional aids”, most items distributed in the past can no longer be, now every item must have a direct use for the physician in the fields of his work and must not have a price above 6£ (VAT incl.).
Other changes concern the disclosure requirements that have to be made publicly available from May 2011 in a first time, then January 2013 in a second time:
- Financial support to patient organisations
- Non-interventional studies
- Sponsorship of institutions
- Sponsorship of attendance at third party meetings
- Use of consultants
Meetings and Hospitality for HealthCare Professionals
The introduction of the Bribery Act and the revision of the ABPI Code are going to change the way pharmaceutical companies are to deal with HealthCare Professional (HCPs).
The clause 19 of the ABPI Code defines what can be tolerated during meetings, hospitality or sponsorship by any pharmaceutical company.
It clearly states the new resolution which tends to make publicly available financial details of sponsorship of UK health professionals and appropriate administrative staff in relation to attendance at meetings organised by third parties (Clause 19.4: Sponsorship in this context includes registration fees, costs of accommodation (both inside and outside the UK) and travel outside the UK).
The Bribery Act should not change, in theory, the usual practices of hospitality in the pharmaceutical industry since the rules established by the ABPI code are more constraining. However the SFO could decide to investigate for cases arising outside the UK.
NAYA and the ABPI
NAYA Compliance 2012 is fully compliant with the new UK regulation. Modules such as NAYA Grants and Donations, NAYA Transparency or NAYA HCP Relationships make of NAYA Compliance the only software solution to answer all your needs concerning compliance with the ABPI Code and the Bribery Act. All modules are available on a single web platform.