Do representatives have to report adverse events for competitor products?

  • Clause 17 (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 authorisation for the medicine or are inconsistent with the summary of product characteristics. Indications for which the medicine does not have a marketing authorisation must not be promoted.

  • Clause 17 (15) Contract Representatives

    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 Clause 9.

  • Clause 17.3 (15.3) Hospitality and Payments for Events/Meetings

    Events/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 events/meetings are permitted to provide appropriate hospitality and/or to meet any reasonable, actual costs which may have been incurred. For example, if the subsistence (food and drink) has 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 subsistence itself was appropriate for the occasion. The requirements of Clause 10 apply.

    Donations instead of hospitality are unacceptable as they are inducements for the purpose of holding an event/meeting. If subsistence is not required at an event/meeting, there is no obligation or right to provide some benefit of an equivalent value.

  • Clause 17.3 (15.3) Items Delivered by Representatives

    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 17.3, which prohibits the use of any inducement or subterfuge to gain an interview.

  • Clause 17.3 (15.3) Health Professionals’ Standards of Conduct

    The General Medical Council, the General Pharmaceutical Council and the Nursing & Midwifery Council set out requirements for doctors, pharmacists, pharmacy technicians, nurses and midwives. Further details are given in the supplementary information to Clause 10.1.

  • Clause 17.4 (15.4) Frequency and Manner of Calls on Doctors and Other Prescribers

    The number of calls made on doctors and other prescribers and the intervals between successive visits are relevant to the determination of frequency.

    Companies should arrange that the frequency of visits does 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 events/meetings, including audiovisual 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’ and others’ 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 events/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.

  • Clause 17.8 (15.8) Provision of the Summary of Product Characteristics

    An electronic copy of the summary of product characteristics can be provided. 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.

  • Clause 17.9 (15.9) Briefing Material

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

Pharmaceutical companies must ensure that their staff are trained including on relevant pharmacovigilance requirements. If a representative is advised of an adverse event with a competitor medicine they should as a minimum advise the health professional that this should be reported via the yellow card scheme. Clause 9.2