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Are you certain of what’s now permitted when dealing with pharma reps? Heather Simmonds of the PMCPA suggests you “know the Code” [Feature article from 'Summons' Spring 2008]

DO YOU feel that you make the most of opportunities to work with pharmaceutical companies for the benefit of your patients? Or do you feel that with increased scrutiny and regulatory controls it is now more trouble than it’s worth?

Criticism of the pharmaceutical industry’s relationships with health professionals has come from various sources in recent years, ranging from the media to the Health Select Committee enquiry into the influence of pharmaceutical companies. So it is understandable that doctors and other health professionals may be wary and unsure of what can be gained from working with industry.

However, with increasing pressure to meet targets, deliver a good service to patients and keep skills up-todate it is important to look at a variety of ways to achieve your objectives. Pharmaceutical representatives can be a useful source of information on medicines and can support you in a number of other ways, including educational materials for patients. But unless you are aware of what is permitted, both you and the company could end up in hot water.

Rules of engagement

Two sets of rules govern these relationships – the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry and the General Medical Council’s guidance, Good Medical Practice. Most pharmaceutical companies operating in the UK have agreed to comply with the ABPI Code and, of course, doctors must abide by the GMC’s guidance. Both documents reflect UK law. The ABPI Code goes beyond the legal requirements.

The current version of Good Medical Practice prohibits doctors from asking for, or accepting, any inducement, gift or hospitality that affects, or could be seen to affect, their judgement. It also includes a number of requirements about conflicts of interest.

The ABPI Code has many requirements about the content of promotional material, including the need for all claims to be capable of substantiation whether made in writing or by representatives. It also places restrictions on the provision of samples, promotional aids, meetings, hospitality, subsistence, travel and accommodation. Detailed reports of all cases are published on the Prescription Medicines Code of Practice Authority’s website (the PMCPA was established by the ABPI to administer the ABPI Code at arm’s length from itself). Brief details of serious cases are advertised in the medical and pharmaceutical press.

As long as you are aware of what is and isn’t permitted and are prepared to play your part in ensuring that these relationships remain professional, ethical and above reproach, working with pharmaceutical companies can benefit, and even improve, patient care. So how can you work together?

Meetings and hospitality

Pharmaceutical companies can sponsor meetings such as presentations in GP practices, but their sponsorship must be disclosed in all papers relating to the meeting and any published proceedings. Payment may not be made to doctors or other prescribers, either directly or indirectly, for rental for rooms to be used for meetings.

It must be the scientific or educational content that attracts delegates to a meeting. Lavish or deluxe venues must not be used and companies should avoid using venues renowned for their entertainment facilities. Meetings wholly or mainly of a social or sporting nature are unacceptable.

Hospitality can only be provided in association with scientific meetings, promotional meetings, scientific congresses and other such meetings. Subsistence must be strictly limited to the main purpose of the event and secondary to it. Hospitality cannot be offered to spouses or other such people unless they qualify as a delegate in their own right.

Under the Code, companies can also sponsor delegates’ attendance at educational meetings as long as the requirements of the Code are met. Companies can only provide economy air travel when sponsoring delegates.

Gifts

No gift, benefit in kind or pecuniary advantage should be offered or given as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine. Items must not be offered for personal benefit. Promotional aids must be inexpensive – the limit is £6, excluding VAT – and of a similar perceived value as well as being relevant to the recipient’s profession.

Medical and educational goods and services

The provision of medical and educational goods and services which enhance patient care or benefit the NHS while maintaining patient care are permitted, provided they do not constitute an inducement to prescribe, supply, administer, recommend, buy or sell any medicine. Items must not bear a product name, but can bear a company name. The involvement of the pharmaceutical company must always be made clear. Therapy review programmes, which aim to ensure a patient receives optimal treatment following a clinical assessment, are permitted and can be a productive and mutually beneficial way to improve patient care by working with the pharmaceutical industry.

However, it is unacceptable for a company to assist with a switch programme where all patients on medicine A are simply switched to medicine B without any clinical assessment. Companies may promote a switch from one product to another, but must not assist in carrying it out.

Representatives

The Code applies to what representatives say as well as the materials they use. Representatives must maintain a high standard of ethical conduct and must be properly trained. All representatives have to pass an ABPI examination. Representatives must not use any inducement or subterfuge to gain an interview and no fee should be offered or paid for the grant of an interview.

Representatives can be a very useful source of information on medicines. If you are seeing a representative from a company that has products in a disease area that you are interested in, they should be able to provide information on the disease itself as well as medicines for treatment. Some companies may also have patient materials which you may find useful to distribute to patients when talking about their illness.

What to do if you have concerns

Complaints to the PMCPA are often made by doctors. Recent examples include complaints about the conduct of representatives, information or claims in advertisements and hospitality. Breaches of the Code were ruled in many of these cases. Full details are available on www.pmcpa.org.uk.

Companies ruled in breach of the Code are subject to a number of sanctions including publication of a detailed case report. Other possible sanctions include public reprimands, advertising in the medical and pharmaceutical press and possible suspension or expulsion from membership of the ABPI.

Complaints about the promotion of medicines, or the provision of information to the public should be sent to the Director of the Prescription Medicines Code of Practice Authority, 12 Whitehall, London SW1A 2DY (or by email to complaints@pmcpa.org.uk).

Further information on the Code and complaints procedure can be found at www.pmcpa.org.uk and advice on the Code can be obtained by calling 020 7747 8880. Heather Simmonds is Director of the Prescription Medicines Code of Practice Authority and has worked on the Code for over 17 years. She is responsible for the day-to-day running of the organisation and chairs the Code of Practice Panel which rules on all complaints submitted to the Authority in the first instance.

REFERENCES

1. The ABPI Code of Practice and a guide to the Code for health professionals can be accessed at www.pmcpa.org.uk. Printed copies are available free of charge by calling 020 7747 8881.

2. Good Medical Practice can be downloaded at www.gmc-uk. org.