Medicolegal - Dealing with pharmaceutical firms

GPs must keep a register of gifts and not be swayed by incentives, says Dr Nicholas Norwell of the MDU.

GPs have a professional and ethical duty to prescribe drugs and recommend treatments based on their judgment of a patient's clinical needs and the effectiveness of the treatment.

This means that GPs cannot allow themselves to be influenced by incentives to prescribe one drug or treatment over another. To do so would undermine the trust patients place in GPs.

One of the roles of the pharmaceutical industry is to keep doctors informed about the latest advances in medicine and the management of illness.

The relationship between GPs and the pharmaceutical industry works effectively when each party follows the strict professional code of practice.

Hospitality and gifts
GPs cannot allow gifts or inducements from pharmaceutical firms or anyone else to bias their clinical judgment. In Good Medical Practice the GMC states: 'You must be open and honest in financial and commercial dealings with employers, insurers and other organisations or individuals.'

It continues: '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.'

Under the provisions of the Medicines (Advertising) Regulations 1994, GPs may be subject to summary conviction if they accept any gift, pecuniary advantage, benefit in kind, hospitality or sponsorship that is prohibited by the regulations.

In Good Practice in Prescribing Medicines, the GMC says: 'If you have financial or commercial interests in organisations providing healthcare or in other biomedical companies, these interests must not affect the way you prescribe for, treat or refer patients'.

Recognising the benefits that can be gained from the relationship between the pharmaceutical industry and the NHS, the DoH has recently published some best practice guidance on joint working for NHS staff. This stresses that these relationships must work for the benefits of patients.

This guidance applies to joint working arrangements, but the principles it outlines can be applied more widely. For example, funding agreements can be recorded and monitored.

Contract regulations
Under the terms of the GMS contracts regulations, GPs are obliged to declare any gift worth more than £100.

GP practices must keep a register of all gifts made by patients, relatives or any person who provides or wishes to provide services for either the contractor, or its patients.

The rules apply to all GPs in a practice, their employees or locums and extends to the spouses or partners of those people.

Regulations do not apply to gifts worth less than £100 or gifts that are unconnected with services provided (or to be provided in the future) by the GP.

It may be prudent to apply the regulations widely to avoid future criticism and include in the register any hospitality offered by and accepted from pharmaceutical representatives.

Industry guidance
The pharmaceutical industry also has guidelines covering its dealing with doctors. The Association of the British Pharmaceutical Industry (ABPI) produced new, stricter ethical guidance on gifts and hospitality for its medical representatives in 2006.

This states that: 'No gift, benefit in kind or pecuniary advantage shall be offered or given to members of the health professions or to administrative staff as an inducement to prescribe, supply, administer, recommend (or) buy or sell any medicine'.

Promotional aids, costing no more than £6 excluding VAT, may be distributed provided they are relevant to the recipient's profession. Gifts are more likely to be acceptable if they benefit patient care.

Sponsorship
There is also guidance for GPs attending conferences and meetings sponsored by pharmaceutical firms.

The GMC, in its guidance on Conflicts of Interest (2007) says GPs who are sponsored by a pharmaceutical company at an educational meeting should announce which organisation they are sponsored by and disclose this in all published papers related to the meeting.

The ABPI code says that pharmaceutical companies should not cover subsistence expenses for doctors except in association with scientific meetings or similar, and that this expenditure must be secondary to the purpose of the meeting and not out of proportion.

For example, economy class air travel can be provided for delegates attending international meetings, and lavish venues must not be used.

GPs' dealings with pharmaceutical companies are the same as their dealings with any commercial organisation with which they have a relationship, in that GPs and their staff must be able to demonstrate that their clinical decision-making is not influenced by any external pressure.

Members should contact their medical defence provider for further advice.

Dr Norwell is an MDU medico-legal adviser

Contact Sharon Pickett at GP Education on (020) 8267 4512 or email GPregistrar@haymarket.com

Learning points

1. GPs must be able to demonstrate that their clinical decision-making is not biased by incentives from the pharmaceutical industry.

2. GPs who solicit or accept any gifts or hospitality prohibited by the regulations may be subject to summary conviction.

3. A register recording any gifts to the practice worth more than £100 must be kept. It is also worth recording all hospitality accepted from pharmaceutical representatives.

4. If you are sponsored by a pharmaceutical company to attend a meeting, you must declare details of the sponsorship in all related published papers.

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