All UK pharma companies are governed by one of these two options:
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health and enforces the Human Medicines Regulations (2012).
The Blue Guide is a summary of the advertising regulations. Failing to comply with the regulations can result in the MHRA imposing criminal sanctions (eg, fines and/or imprisonment).
Conversely, the UK also operates a system of self-regulation through the industry’s own representative body, the ABPI (Association of the British Pharmaceutical Industry).
"Our core values are communication, empowerment, collaboration, honesty and integrity and innovation. We reflect these in the way we work with each of our stakeholders and members."
- The ABPI
The ABPI code of practice sets out how the industry self-regulates, and operates according to civil law, ie, establishing whether a breach occurred or not on the “balance of probabilities”.
The code is enforced by the PMCPA (Prescription Medicines Code of Practice Authority) who operate at arm’s length to the ABPI.
The code encompasses requirements stipulated in IFPMA and EFPIA codes, as well as reflecting and extending beyond the relevant UK law.
ABPI members must abide by the code in spirit and letter.
Non-members may voluntarily agree to abide by the code and accept the jurisdiction of the PMCPA.
Content of the 2016 version:
Clauses are backed up by supplementary information.
Company SOPs may provide detailed interpretation and strict processes.
Ruled if company has brought discredit to, and reduction of confidence in, the pharma industry.
Breaches of clause 2 are advertised in the BMJ, Pharmaceutical Journal and the Nursing Standard.
Ruled if company has not maintained high standards.
Ruled if sales representatives do not maintain a high standard of ethical conduct in the discharge of their duties.
Clause 2 can be alleged in cases relating to:
- Remove the company from the list of non-member companies which have agreed to comply with the code; and
- Advise the MHRA that responsibility for that company under the code can no longer be accepted.
The code does not apply to:
Note: this list is not exhaustive.
The code applies to:
What is promotion?
Any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines.
What can fall under the category of promotion?
Context is everything.
Context is everything.
It depends on:
Ask these key questions:
Examples of non-promotional areas include:
Each has a set of criteria to ensure activities remain compliant.
At Teva’s lunchtime meeting (December 2017) with HCPs (healthcare professionals) from a private hospital, a Pharmasure representative dropped off a substantial Christmas chocolate hamper for the HCPs.
PMCPA website - Case AUTH/3008/1/18 Teva v Pharmasure (only one aspect illustrated)
Complaint by Teva
Gift was inappropriate as not inexpensive or relevant to the practice of medicine or pharmacy.
Response by Pharmasure
Chocolate hamper was for HCP customers of supplement products, therefore outside the scope of the code. Representative visited hospital after a nurse call and dropped off hamper at same time.
Breach: because despite lack of discussion on a promoted product, hamper could be linked to a promoted medicine.
The chocolate hamper was not an acceptable item that may be provided to HCPs.
All companies should have a robust compliance programme.
All promotional material and activities must be approved.
Only some non-promotional material and activities must be approved.
Departments affected by the Code:
Who else must comply with the code?
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