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 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 of 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.
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Clause 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 Clauses 15.1, 16.1 and 16.3.
15.1 Representatives must be given adequate training and have sufficient scientific knowledge to enable them to provide full and accurate information about the medicines which they promote.
15.2 Representatives must at all times maintain a high standard of ethical conduct in the discharge of their duties and must comply with all relevant requirements of the Code.
15.3 Representatives must not employ any inducement or subterfuge to gain an interview. No fee should be paid or offered for the grant of an interview.
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Clause 15.3 Hospitality and Payments for Meetings
Attention is drawn to the requirements of Clauses 18 and 19 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 appropriate administrative staff.
Meetings organised for groups of doctors, other health professionals and/or appropriate administrative staff 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.
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Clause 15.3 Donations to Charities
Donations to charities in return for representatives gaining interviews are prohibited under Clause 15.3.
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Clause 15.3 Items Delivered by Representatives
Reply paid cards which refer to representatives delivering items to health professionals or appropriate administrative staff 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.
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Clause 15.3 Health Professionals’ Codes of Conduct
The General Medical Council is the regulatory body for doctors and is responsible for giving guidance on standards of professional conduct and on medical ethics. In its guidance, the Council advises doctors that ‘You must act in your patients’ best interests when making referrals and when providing or arranging treatment or care. You must not ask for or accept any inducement, gift or hospitality which may affect or be seen to affect the way you prescribe for, treat or refer patients’.
The General Pharmaceutical Council is the regulatory body for pharmacists and pharmacy technicians. The Council’s Standards of conduct, ethics and performance state ‘Do not ask for or accept gifts, rewards or hospitality that may affect, or be seen to affect, your professional judgement’.
The Code of the Nursing & Midwifery Council, Standards of conduct, performance and ethics for nurses and midwives, states ‘You must not abuse your privileged position for your own ends’ and ‘You must ensure that your professional judgement is not influenced by any commercial considerations’.
15.4 Representatives must ensure that the frequency, timing and duration of calls on health professionals, administrative staff in hospitals and NHS and other organisations, together with the manner in which they are made, do not cause inconvenience. The wishes of individuals on whom representatives wish to call and the arrangements in force at any particular establishment, must be observed.
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Clause 15.4 Frequency and Manner of Calls on Doctors and Other Prescribers
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.
15.5 In an interview, or when seeking an appointment for one, representatives must at the outset take reasonable steps to ensure that they do not mislead as to their identity or that of the company they represent.
15.6 Representatives must transmit forthwith to the scientific service referred to in Clause 22.1 any information which they receive in relation to the use of the medicines which they promote, particularly reports of adverse reactions.
15.7 Representatives must be paid a fixed basic salary and any addition proportional to sales of medicines must not constitute an undue proportion of their remuneration.
15.8 Representatives must provide, or have available to provide if requested, a copy of the summary of product characteristics for each medicine which they are to promote.
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Clause 15.8 Provision of Summary of Product Characteristics
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.
15.9 Companies must prepare detailed briefing material for medical representatives on the technical aspects of each medicine which they will promote. A copy of such material must be made available to the Medicines and Healthcare Products Regulatory Agency and the Prescription Medicines Code of Practice Authority on request. Briefing material must comply with the relevant requirements of the Code and, in particular, is subject to the certification requirements of Clause 14.
Briefing material must not advocate, either directly or indirectly, any course of action which would be likely to lead to a breach of the Code.
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Clause 15.9 Briefing Material
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.
15.10 Companies are responsible for the activities of their representatives if these are within the scope of their employment even if they are acting contrary to the instructions which they have been given.
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