In April 2011, the Association of the British Pharmaceutical Industry ("ABPI") and its Code of Practice administrative arm, the Prescription Medicines Code of Practice Authority ("PMCPA"), developed a Memorandum of Understanding with the Serious Fraud Office ("SFO") to clarify which agency is likely to be responsible for enforcement when a Code breach also involves a potential breach of the UK Bribery Act. The UK Bribery Act went into effect on July 1, 2011. The underlying premise of the memorandum is:
Self regulation should be the first means of dealing with complaints. Both the PMCPA and the SFO deal with complaints whatever their source. The SFO focus is on dealing with complaints that are not covered by the ABPI Code or other self regulatory authorities and which meet its criteria of serious fraud.
The approach of the SFO is outlined in the memorandum:
- Companies need to have in place robustly defined and implemented antibribery procedures with clear ownership from the top of the organization;
- The SFO and others agree that sensible proportionate promotional expenditure is entirely legitimate and not outlawed by the Bribery Act;
- The SFO will not routinely intervene in matters covered by the Code but reserves the right to take action if the issue is deemed serious enough to merit SFO investigation and will submit complaints to the PMCPA when appropriate;
- The SFO will not seek to prosecute unless it considers that prosecuting is in the public interest. In reaching such a decision, the SFO will take into account relevant action taken by the PMCPA and the MHRA; and
- The SFO is aware of the requirements of other industry codes, including the International Federation of Pharmaceutical Manufacturers and Associations Code of Pharmaceutical Marketing Practices.