14.3 The following must be certified in advance in a manner similar to that provided for by Clause 14.1:
- educational material for the public or patients issued by companies which relates to diseases or medicines but is not intended as promotion for those medicines
- material relating to working with patient organisations as described in Clause 27 and its supplementary information
- material relating to joint working between the NHS and the pharmaceutical industry as described in Clause 20 and its supplementary information
- material relating to patient support programmes involving the provision to health professionals of items to be passed on to patients as described in Clause 18.2 and its supplementary information
- non-promotional material for patients or health professionals relating to the provision of medical and educational goods and services, including relevant internal company instructions, as described in Clause
19.1 and paragraph 8 of its supplementary information.
27.3 Companies working with patient organisations must have in place a written agreement setting out exactly what has been agreed, including funding, in relation to every significant activity or ongoing relationship.
The supplementary information to Clause 27.3 provides information on key elements which should be in a written agreement, to clearly set out what has been agreed between the company and the patient organisation in relation to every significant activity or ongoing relationship. Companies need to define what significant means.
Many companies have a written agreement in place for all relationships and/or activities to ensure what has been agreed is documented and clear. Companies need to be able to demonstrate that all interactions are appropriate and no undue influence (financial or otherwise) has been exerted on a patient organisation.
Having a written agreement in place, signed by both parties, is a key piece of documentation. The written agreement must be certified in advance as set out in Clause 14.3.