Clause 19 Prohibition on Inducements and Inappropriate Payments and the Provision of Items to Health Professionals and Other Relevant Decision Makers

For information on health professionals’ standards of conduct refer to the supplementary information to Clause 10.1.

Measures or trade practices relating to prices, margins and discounts which were in regular use by a significant proportion of the pharmaceutical industry on 1 January 1993 are outside the scope of the Code (see Clause 1.17) and are excluded from the provisions of this clause. Other trade practices are subject to the Code. The terms ‘prices’, ‘margins’ and ‘discounts’ are primarily financial terms.

Schemes which enable health professionals to obtain personal benefits, for example gift vouchers for high street stores, in relation to the purchase of medicines are unacceptable even if they are presented as alternatives to financial discounts.

Clause 19.1 does not prevent the offer of package deals which are commercial arrangements whereby the purchase of a particular medicine is linked to the provision of certain associated benefits as part of the purchase price, such as apparatus for administration, the provision of training on its use or the services of a nurse to administer it. Transfers of value made in the course of these package deals would need to be disclosed in accordance with Clause 28. The transaction as a whole must be fair and reasonable and the associated benefits must be relevant to the medicine involved.

Clause 1.25 exempts package deals solely relating to ordinary course purchases and sales of medicines from the requirement to disclose transfers of value.

Companies can provide genetic testing or other biomarkers/specific testing in relation to the rational use of its medicines.

Where the use of a medicine requires specific testing prior to prescription, companies can arrange to provide such testing as a package deal even when the outcome of the testing does not support the use of the medicine in some of those tested.

Clause 19.1 does not preclude the use of outcome or risk sharing agreements where a full or partial refund of the price paid for a medicine, or some other form of recompense, is due if the outcome of the use of the medicine in a patient fails to meet certain criteria. That is to say, its therapeutic effect does not meet expectations. Clear criteria as to when a refund or other recompense would be due must be settled in advance and set out in the agreement. Any refund or recompense must always go to the relevant NHS or other organisation and never to individual health professionals or practices etc.

Patient access schemes are acceptable in principle under the Code but they must be carried out in a manner compatible with its requirements.

The 2014 Pharmaceutical Price Regulation Scheme described patient access schemes as schemes proposed by a pharmaceutical company and agreed with the Department of Health (with input from the National Institute for Health and Care Excellence) in order to improve the cost-effectiveness of a medicine and enable patients to receive access to cost-effective, innovative medicines. Corresponding arrangements applied in the devolved nations.

The 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) also refers to the Department of Health and Social Services, the ABPI and NHS England understanding of the benefits that clinically and cost-effective medicines can bring and refers to patient access schemes in relation to commercial flexibilities offered by the health service in England. VPAS states that the scheme represents an opportunity to further expand the commercial flexibility offered by the health service in England. The governments of Scotland, Wales and Northern Ireland may agree similar arrangements.

A promotional aid is defined as a non-monetary item given for a promotional purpose. Promotional aids may be given to health professionals and other relevant decision makers only in accordance with Clause 10.4. Health professionals may, however, be provided with items which are to be passed on to patients in accordance with Clause 19.2.

Items for the personal benefit of health professionals or other relevant decision makers must not be offered or provided.

Coffee mugs, stationery, computer accessories, diaries, calendars and the like and items for use in the home or car are not acceptable. Items for use with patients in the clinic, surgery or treatment room etc, such as surgical gloves, nail brushes, tongue depressors, tissues and the like, are also not acceptable. Toys and puzzles intended for children to play with while waiting must not be provided.

Advertisements for prescription medicines must not appear on any items, such as diaries and desk pads, which pharmaceutical companies could not themselves give.

Literature such as leaflets and booklets about medicines and their uses, which is intended for patients, can be provided to health professionals for them to pass on. They are not considered to be promotional aids but they must comply with the relevant requirements of the Code, in particular Clause 26 and its supplementary information. A story book for young patients about a product or a disease could be provided for relevant patients.

Clause 19.1 does not preclude the provision to health professionals and other relevant decision makers of inexpensive data storage devices such as memory sticks and the like which bear educational or promotional material compliant with the Code, provided that their storage capacity is commensurate with the amount of data to be provided.

Textbooks must not be given to individual health professionals or other relevant decision makers as promotional aids. In appropriate circumstances, independently produced medical/educational publications such as textbooks could be given for health professionals and other relevant decision makers to use in accordance with Clause 23.1, Donations and Grants, but they must not be given to individuals.

The requirements of Clause 23 cannot be avoided by providing health professionals or practices etc with items on long term or permanent loan.

Although items which are to be passed on to patients may not be given out from exhibition stands, they may be exhibited and demonstrated on stands and requests for them accepted for later delivery.

Items for patient support may be provided to health professionals by representatives during the course of a promotional call and representatives may deliver such items when they are requested by health professionals. Examples of items which might be acceptable include a peak flow meter as part of a scheme for patients to regularly record readings or a pedometer as part of a scheme to encourage exercise.

Provided that they have been appropriately documented and certified in advance as required by Clause 8.3, items for patient support which allow patients to gain experience in using their medicines whilst under the supervision of a health professional, may be made available for the use of health professionals even though they are not to be passed on to patients for them to keep. Examples include inhalation devices (with no active ingredient) and devices intended to assist patients to learn how to self-inject.

An ‘inexpensive’ item for patient support means one that has cost the donor company no more than £10, excluding VAT. The perceived value to the health professional and the patient must be similar.

Information regarding material and items made available directly to patients is set out in Clause 26 and its supplementary information.