How are your customers directed to work with you?

As well as your ABPI code of conduct, the directives include

· Commercial Sponsorship – Ethical standards for the NHS. Nov 2000.

· GMC 1995 "Duties of a doctor."

· Guidance for R&D managers in NHS Trusts and Clinical Research Departments in the Pharmaceutical Industry – 2003.

· NHS income generation guidance.

These are usually more recently supplemented by a Trust policy on working with the pharmaceutical industry.(The word Trust includes all types of NHS Trust throughout this article.) Other policies such as data protection, corporate governance and patient confidentiality come into the picture too.

With so many documents to refer to, one might think there are clear guidelines but in many cases there is variation in interpretation, leading to uncertainty. For example the phrase "Sponsorship arrangements should be at a corporate rather than individual level" in some Trusts will mean that your company should not write cheques for speaker fees to individual doctors but to their department. In other Trusts it also means you have to bring branding items to a central pool and register them in a logbook. This accommodates the Trust need for transparency, accountability, probity and openness. A register of sponsorship is kept by most Trusts and presented annually to their Audit Committee.

Prescribing costs are a significant part of most Trust budgets and the Commission for Health and Audit improvement clearly comments on overspend which will impact star ratings. Thus Trusts feel a greater need to control the activities of medical representatives.

Several PCTs have banned their practices from taking even pens and sticky pads from Medical Representatives. This causes significant changes in stationary costs for many practices though in many cases the PCT will still provide the items from a central pool. However the practice then ends up thanking the PCT rather than you!

Many hospitals now require all Medical Representatives to report to Pharmacy on arrival to the hospital to state who they are going to visit and why. Pharmacists are vigilant that your messages will not conflict with medicines management efforts and in particular, with budget management efforts.

One kind of sponsorship that is usually still very acceptable is sponsorship of medical meetings set up by the Trust or a practice and therefore within their programme of work. (However, you should be aware that sponsorship or provision of training that is not directly related to your therapy area is not usually best use of your time or budget.)

This can include funding of training, room hire and provision of speakers and meals, though the meals should not be excessively lavish. However do not depend on getting a list of attendees from the organizers any more because many now refuse to supply this. It is seen as a breach of the data protection act.

The NHS Information Authority is clearly uncomfortable with the idea of pharmaceutical companies auditing patient information for medicine switches or other reasons. However many Trusts are still glad of the service as it helps meet some of their targets. However a clear contract for the audit should be drawn up to meet legal and ethical standards and must include

Ø A process for seeking the consent of all patients whose data are used in the audit,

Ø Clear indication of the level of patient identifiable information to which the auditor has access.

Ø The purpose for which the information will be used. Use of the information for any purpose not stated in the agreement (e.g. quoting the cost saving made to another customer) constitutes breach of the data protection act.

It is usually more acceptable if a nurse or nurse advisor carries out the audit as they have professional codes of conduct regarding use of patient information.

If you provide training to a Trust, the Training and Development Manager will be trained to check that the content of your programme does not conflict with their programme of work and that you have appropriate professional indemnity and public liability insurance cover. They will usually check the hospitality arrangements to ensure they are secondary to the content of the training.

It is usually a mistake to offer branding items to a member of a formulary committee. Well presented clinical papers and accurate cost data presented with a knowledge of the particular context and needs of the relevant Trust are the best tools for influence here. Even showing excessive friendliness with a consultant sponsor of your product such as calling them by first name is a mistake. It undermines credibility of the sponsor and creates suspicion that they are "bought" by the industry.

The NHS is also well aware that it is a major client of the Pharmaceutical and has made conscious efforts to exert power as the major purchaser in the UK. NHS supplies contracts terms and conditions over ride the terms and conditions of any supplier. European directives mean more tendering, often at Purchasing and Supplies Agency level. Purchasing decisions are usually based on cost.

While at first glance this combination of initiatives to regulate NHS interaction with the pharmaceutical industry might seem likely to make life more difficult for Sales Representatives, in fact it can also create an environment where the Representative is seen more as a professional with useful knowledge and information to contribute rather than a meal ticket.

The Author

Miriam George is Managing Director of PDC Healthcare, a consultancy that provides a range of services to the NHS and to pharmaceutical companies. Tel 01530 459761. E-mail Miriam@the-pdc.com. The team includes several pharmacists and frequently assists companies with formulary and tender response projects. Miriam identified the need for an article such as this when hearing from NHS clients that many failures to gain formulary inclusion were due to errors made by Medical Representatives when interacting with NHS clients