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Clause of concern?

The changes to Clause 18 of the Code, governing promotional items, may have more significant implications than it first appears

A magnifying glass analysing a contractMany people will be aware of the recent PMCPA (Prescriptions Medicines Code of Practice Authority) consultation on the proposed changes to the Code of Practice, to be finally determined at the Association of the British Pharmaceutical Industry's (ABPI) Autumn Conference. But are they equally au fait with the potential consequences of some of these proposals, which are after all quite detailed?

Ethical Medicines Industry Group (EMIG) members have indicated that the proposals likely to have the greatest impact on their businesses relate to Clauses 18.2, 18.3 and 18.4: 'Promotional Items'. A summary of the changes follows:

• All brand reminders (that is, anything bearing a brand name) will be prohibited
• Items that are to be passed on to patients, are part of a formal patient support programme and are fully certified can be provided. These items can carry a company name but must cost less than £6 excluding VAT and the perceived value to the healthcare professional (HCP) and the patient must be similar. A brand name can be added only if this is essential for the proper use of the item
• Company branded notebooks, pens or pencils can be provided to HCPs and admin staff, but only at bona fide meetings. The total cost of such items provided to an attendee must be less than £6 and perceived to be similar
• Textbooks will no longer be allowed to be used as promotional aids but can be provided as Medical and Educational Goods and Services (MEGS) under clause 18.4. However, textbooks cannot be provided to individuals; presumably this means the donation must be made to the clinic or surgery
• MEGS will continue, but must not be provided to individuals for their personal benefit. (What would be the implication of this for a single-handed GP?) MEGS must be in the interests of patients or benefit the NHS while maintaining patient care. Companies should continue to consider using staff other than medical representatives to provide MEGS and they should not be linked in any way to the promotion of products or provided during a promotional visit, unless this is a brief description and/or delivering materials.

EMIG surveyed its 79 pharmaceutical member companies regarding the aspects of these proposed changes that members perceived as having greatest practical impact on their businesses and which are therefore the most contentious. The focus of the survey was on measuring support or otherwise for the proposed new Clauses 18.2, 18.3 and 18.4. Of those companies that voted, around 60 per cent opposed the inclusion of the new Clauses 18.2, 18.3 and 18.4.

Consistently, companies made the following observations:

• The wording of the proposed new Clause 18 ignores the wishes of these ABPI member companies for clarification of what types of promotional items were to be excluded from the proposed ban (before a final opinion be expressed). It also ignores the wish for a rejection of the previous proposal that the distribution of allowable promotional items be separated from the role of the medical representative. If this point is not addressed, the impact will be felt particularly heavily by small and medium sized companies
• Under the new Pharmaceutical Research and Manufacturers of America (PhRMA) Code, US regulations allow for product-branded educational items to be delivered by a promotional medical representative, who is also allowed to deliver a product sales message during the same call. The major move by the US industry to provide educational items that benefit patient care has been very well received by HCPs; early feedback has been that the image of the industry and, specifically, the role of the representative have been enhanced. The new Clause 18 attempts to prevent this and this is rejected
• RPCs are a way of securing invited call requests from customers (indeed, it is the customer that completes them) and the net effect is to reduce the number of cold calls. Abolishing this system would not be acceptable and in fact would force companies to rely on unsolicited calls, which is a definite step back. If these new clauses are accepted and enacted, it will arguably make the UK market the most restricted promotional environment for pharmaceuticals. This will place smaller and medium sized companies with the majority of their turnover in the UK at a considerable disadvantage compared with similar companies abroad.

There is no evidence that these proposals will enhance trust between HCPs and industry. Indeed, many doctors could react negatively to the suggestion that the provision of inexpensive branding items might influence their prescribing behaviour.

EMIG believes there is no justification for mandatory imposition, particularly because of the strength of feeling against the proposals. We recommend that, if the belief is so strong that its customers will feel more trust in the industry because they are no longer provided with promotional items, then the decision should be that a voluntary withdrawal is called for. Time will prove whether this is valid and, if borne out over a two-year period by those companies that choose to set an example, the rest of industry will follow.

However, if the changes are instituted as currently set out, EMIG believes this will undermine self-regulation in the longer term, as well as pose a serious threat to the industry at an already commercially challenging time.


Leslie GallowayThe Author
Leslie Galloway is chairman of the Ethical Medicines Industry Group (EMIG)

To comment on this article, email

13th October 2010


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