Managing primary care patients with personality disorder
With more GPs forming links with drug companies to meet new contract targets, Dr Nicholas Norwell of the MDU offers advice on the legal pitfalls to bear in mind
Dr Nicholas Norwell of the MDU offers advice on the legal pitfalls to bear in mind
A number of GPs have contacted the MDU recently for advice about their relationships with pharmaceutical companies. Their queries have covered a wide range of issues such as taking part in research sponsored by pharmaceutical companies and what their stance should be towards financial and other incentives offered to them or to their practice, such as industry-sponsored nurses.
GPs want to know what the current ethical and professional guidelines are and contractual obligations governing GPs' relationship with pharmaceutical firms. GPs also want to know how they can ensure any incentives they are offered do not skew clinical decision-making that is not in the patient's best interest and could leave them open to GMC criticism.
Remember the doctor's duty
Doctors 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. Clearly this means 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. The box on the right outlines the GMC guidance for doctors entering a commercial agreement.
Drug company regulation
The pharmaceutical industry also has to adhere to guidelines in its dealings with doctors. The Association of the British Pharmaceutical Industry produces ethical guidance on gifts and inducements for its representatives.
It states that no 'gift, benefit in kind or pecuniary advantage shall be offered or given to members of the health care professions or to administrative staff as an inducement to prescribe, supply, administer, recommend or buy any medicine'.1
The only exceptions to this are promotional aids and prizes, whether related to a particular product or of general use. These may be distributed to members of the health professions and to appropriate administrative staff. The only proviso is that they must be inexpensive and of relevance to the practice of their profession or employment.
The GMC reiterates this point with the following advice: 'You should not ask for or accept any material awards, except those of insignificant value, from companies that sell or market drugs or appliances. You must not ask for or accept fees for agreeing to meet sales representatives.'
The new contract
Under the terms of the new GMS contract2 GPs are also obliged to declare any gift worth
more than £100. The contract itself obliges practices to 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 in connection with the new contract, which could include pharmaceutical companies.
The contract clauses (493-498) apply to the contractor, for example the GP principal (including any partners within a partnership), their employees or locums and extend to the spouses or same-sex partners of those people.
Although the regulations do not apply to gifts of less than £100 in value, or to a gift where there are reasonable grounds to believe that it is unconnected with services provided (or to be provided) by the contractor, the MDU advises that it may be prudent to interpret the regulations widely to avoid future difficulties or criticism where pharmaceutical companies provide benefits or hospitality to either the practice or individuals that may exceed £100, for example.
GPs' dealings with pharmaceutical companies are no different from their dealings with any commercial organisation with which they have a relationship. While these relationships may be beneficial to both parties, GPs and their staff must be able to demonstrate that their clinical decision-making is not influenced by any external influence.
Any GP who has concerns that their ethical position might be compromised by their relationship with a pharmaceutical company should contact their medical defence organisation, professional body or the GMC for advice.
Nicholas Norwell is a medicolegal adviser
at the MDU
The GMC's Good Medical Practice guidance for doctors in their financial dealings
Practice guidance for doctors
in their financial dealings
"You must be honest in financial and commercial dealings with employers, insurers and other organisations or individuals."
"You must act in your patients' best interests when making referrals and providing or arranging treatment or care. So you must not ask for or accept any inducement, gift or hospitality, which may affect
or be seen to affect your judgment. You should not offer such inducements to colleagues."
"If you have a financial or commercial interest in.... pharmaceutical or other biomedical companies, these must not affect the way you prescribe or refer patients."
1 Association of the British Pharmaceutical Industry Code of Practice, 2003, Clause 18
2 Standard General Medical Services Contract can be found at: www.dh.gov.uk/assetRoot/04/07/51/59/04075159.pdf