Clause 15 - Representatives

All provisions in the Code relating to the need for accuracy, balance, fairness, good taste etc apply equally to oral representations as well as to printed and electronic material. Representatives must not make claims or comparisons which are in any way inaccurate, misleading, disparaging, in poor taste etc, or which are outside the terms of the marketing authorization for the medicine or are inconsistent with the summary or product characteristics. Indications for which the medicine does not have a marketing authorization must not be promoted.

Attention is drawn to the provisions of Clause 9.9 which prohibit the use of the telephone, text messages, email, telemessages and facsimile etc for promotional purposes, except with the prior permission of the recipient.

Companies employing or using contract representatives are responsible for their conduct and must ensure that they comply with the provisions of this and all other relevant clauses in the Code, and in particular the training requirements under Clauses 15.1, 16.1 and 16.3.

Attention is drawn to the requirements of Clauses 18 and 22 which prohibit the provision of any financial inducement for the purposes of sales promotion and require that any hospitality provided is secondary to the purpose of a meeting, is not out of proportion to the occasion and does not extend beyond members of the health professions or other relevant decision makers.

Meetings organised for groups of doctors, other health professionals and/or other relevant decision makers which are wholly or mainly of a social or sporting nature are unacceptable.

Representatives organising meetings are permitted to provide appropriate hospitality and/or to meet any reasonable, actual costs which may have been incurred. For example, if the refreshments have been organised and paid for by a medical practice the cost may be reimbursed as long as it is reasonable in relation to what was provided and the refreshments themselves were appropriate for the occasion.

Donations in lieu of hospitality are unacceptable as they are inducements for the purpose of holding a meeting. If hospitality is not required at a meeting there is no obligation or right to provide some benefit of an equivalent value.

Donations to charities in return for representatives gaining interviews are prohibited under Clause 15.3.

Reply paid cards which refer to representatives delivering items to health professionals or other relevant decision makers should explain that there is no obligation to grant the representative an interview when the items are delivered. This is to avoid the impression that there is such an obligation, which would be contrary to Clause 15.3 which prohibits the use of any inducement or subterfuge to gain an interview.

The General Medical Council, the General Pharmaceutical Council and the Code of the Nursing & Midwifery Council, set out requirements for doctors, pharmacists, pharmacy technicians, nurses and midwives. Further details are given in the supplementary information to Clauses 18.1 and 22.

The number of calls made on a doctor or other prescriber and the intervals between successive visits are relevant to the determination of frequency.

Companies should arrange that intervals between visits do not cause inconvenience. The number of calls made on a doctor or other prescriber by a representative each year should not normally exceed three on average. This does not include the following which may be additional to those three visits:

• attendance at group meetings, including audio-visual presentations and the like
• a visit which is requested by a doctor or other prescriber or a call which is made in order to respond to a specific enquiry
• a visit to follow up a report of an adverse reaction.

Representatives must always endeavour to treat prescribers’ time with respect and give them no cause to believe that their time might have been wasted. If for any unavoidable reasons, an appointment cannot be kept, the longest possible notice must be given.

When briefing representatives companies should distinguish clearly between expected call rates and expected contact rates.Contacts include those at group meetings, visits requested by doctors or other prescribers, visits in response to specific enquiries and visits to follow up adverse reaction reports. Targets must be realistic and not such that representatives breach the Code in order to meet them.

The requirement to provide a copy of the summary of product characteristics can be met by the provision of an electronic copy if the recipient agrees.

If discussion on a medicine is initiated by the person or persons on whom a representative calls, the representative is not obliged to have available the information on that medicine referred to in this clause.

The detailed briefing material referred to in this clause consists of both the training material used to instruct medical representatives about a medicine and the instructions given to them as to how the product should be promoted.