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In the line of fire
One of the greatest strengths of the pharma industry is its mechanism to self audit and self-regulate. However, with leading firms such as AstraZeneca, Bayer, Roche and sanofi-aventis joining the long line of companies facing ABPI/PMCPA audits in recent years (culminating in Roche and AZ receiving public reprimands, and Roche's ultimate suspension) it's small wonder that many dread the sanction of an audit from the ABPI. An audit is conducted over one day and costs £10,000 or £11,000 depending on the company membership status. This must be paid within 22 days on completion of the audit.
In the event of the worst happening and your company facing sanction from the ABPI, such as a PMCPA audit, what do you do?
The first step is to establish where the company is on the compliance pathway. This can be done through an internal audit creating a gap analysis and a CAPA Plan (Corrective and Preventive Action).
Next, create a compliance development plan/programme based on the internal audit findings and CAPA, and establish the resources required. It is particularly important to nominate a lead driver for the plan, which may mean the introduction of a compliance officer/manager. The lead will be responsible for creating a development team comprising a member from each department as its spokesperson. Plotting your position on the 'compliance pathway' will determine what you need to do next.
Compliance is an ongoing process which must be maintained, checked and adjusted as the weeks and months move on. So rather than perceiving the process as audit preparation, you need to think of it as the development of a compliance programme, of which the PMCPA audit is then a part. Passing a PMCPA audit is not only about the SOPs, documentation, job bags and interviews, it's about showing that the company has a compliant culture and a clear manageable future plan that can be maintained.
Typically a full compliance development programme takes 6-8 months to achieve.
Effective programmes include, but are not limited to: standard operating procedure (SOP) development/revisions/updates; ABPI Code training for field and head office; validation of training; SOP training and validation and corporate/affiliate training.
The programme might also involve an affiliate policy document with regard to the ABPI Code and the use of UK HCPs by affiliates.
Internal checks must be conducted throughout the compliance development process to ensure that the programme is on track. Most, if not all, companies would be advised to complete further full reviews of active materials lists, job bags, rep expenses, sponsorships, MEGS, third party contracts and withdrawals.
To show compliance maintenance, a full year planner should be created showing dates for the internal compliance audits, ie 10 per cent random/systematic audit of rep expenses, 10 per cent random/systematic audit of sponsorships and meetings, as well as key company dates such as ITC, marketing meeting dates and PMCPA case review presentations.
Only when this is in place should you begin to prepare for the audit. The trick is to get the team sorted early. Make sure all the rooms are booked, food is ordered, material is available and staff have specific roles for the day – particularly those who will be ensuring the requested material is gathered and prepared for the auditors.
After the fact
It should also be recognised that few companies pass their first audit and so should gear themselves for a second.
Even the most diligent companies can make mistakes and all companies have breaches. The difference lies in those who can capture and manage the breaches quickly by having robust internal processes and procedures followed by effective internal actions such as SOP development, staff re-training or disciplinary procedures for those who persistently breach the SOPs and Code.
The Author
Ian Hale is director of Compliance in Practice
To comment on this article, email pm@pmlive.com
