Clause 18 - Prohibition on Inducements and Inappropriate Payments, the Provision of Items for Patients, Health Professionals and Other Relevant Decision Makers, Agreements to Benefit Patients such as Outcome Agreements and Patient Access Schemes

Clause 18.1 Health Professionals’ Codes of Conduct

The General Medical Council is the regulatory body for doctors and is responsible for giving guidance on standards of professional conduct and on medical ethics. In its guidance, the GMC advises doctors that ‘You must not allow any interests you have to affect the way you prescribe for, treat, refer or commission services for patients’ and ‘You must not ask for or accept – from patients, colleagues or others – any inducement, gift or hospitality that may affect or be seen to affect the way you prescribe for, treat or refer patients or commission services for patients. You must not offer these inducements’.

The General Pharmaceutical Council is the regulatory body for pharmacists and pharmacy technicians. The Council’s Standards for pharmacy professionals includes that they must use their professional judgement and must behave in a professional manner. They are expected to “declare any personal or professional interests and manage these professionally”.

The Code of the Nursing & Midwifery Council, Professional standards of practice and behaviour for nurses and midwives states “You must act with honesty and integrity in any financial dealings you have with everyone you have a professional relationship with, including people in your care”.

In a joint statement, the Chief Executives of statutory regulators of health and care professionals (which refers to individuals regulated by one of nine regulators overseen by the Professional Standards Authority, including those referred to above) expect health and social care professionals to “Ensure their professional judgement is not compromised by personal, financial or commercial interests, incentives, targets or similar measures” and to “Refuse all but the most trivial gifts, favours or hospitality if accepting them could be interpreted as an attempt to gain preferential treatment or would contravene your professional code of practice”.

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 1.2) 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 18.1 Package Deals

Clause 18.1 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. The transaction as a whole must be fair and reasonable and the associated benefits must be relevant to the medicine involved.

The supplementary information to Clause 1.10 exempts package deals relating to ordinary course purchases and sales of medicines from the requirement to disclose. Transfers of value made in the course of other package deals would need to be disclosed in accordance with Clause 24.

Companies can provide genetic testing or other biomarkers/specific testing in relation to the rational use of one 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 18.1 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 conformity with its requirements.

The 2014 Pharmaceutical Price Regulation Scheme describes 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 apply in the devolved nations.

The outcome of discussions regarding the next pharmaceutical Price Regulation Scheme will be available in 2019.

Donations to charities made by companies in return for health professionals’ attendance at company stands at meetings are not unacceptable under this clause provided that the level of donation for each individual is modest, the money is for a reputable charity and any action required of the health professional is not inappropriate. Any donation to a charity must not constitute a payment that would otherwise be unacceptable under the Code. For example, it would not be acceptable for a representative to pay into a practice equipment fund set up as a charity as this would be a financial inducement prohibited under Clause 18.1. Donations to charities in return for representatives gaining interviews are also prohibited under Clause 15.3.

Any offer by a company of a donation to a charity which is conditional upon some action by a health professional must not place undue pressure on the health professional to fulfil that condition. At all times the provisions of Clauses 2 and 9.1 must be kept in mind.

Any payment to an individual for an activity that is ruled in breach of Clause 12.2 and/or Clause 23 is likely to be viewed as an unacceptable payment and thus in breach of Clause 18.1.

The requirements of Clause 18.1 cannot be avoided by providing health professionals or practices etc with items on long term or permanent loan. Such items will be regarded as gifts and subject to the requirements of this clause.

The use of competitions, quizzes and suchlike, and the giving of prizes, are unacceptable methods of promotion.

This does not preclude the use at promotional meetings of quizzes which are intended to gauge attendees’ knowledge of the subject matter of the meetings, provided that such quizzes are non-promotional in nature and are bona fide tests of skill that recognise the professional standing of the audience and no prizes are offered. To be acceptable a quiz must form part of the meeting’s formal proceedings. Exhibition stands must not be included in any way in the conduct of a quiz.

A promotional aid is defined as a non-monetary gift made for a promotional purpose. Promotional aids may be given to health professionals and other relevant decision makers only in accordance with Clause 18.3. Health professionals may, however, be provided with items which are to be passed on to patients in accordance with Clause 18.2.

Items to be passed on to patients may bear the name of a medicine and/or information about medicines only if such detail is essential for the proper use of the item by patients.

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

Gifts such as coffee mugs, stationery, computer accessories, diaries, calendars and the like are not acceptable. Gifts of 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. Items such as toys and puzzles intended for children to play with while waiting must not be provided. Gifts of items for use in the home or car are unacceptable.

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, booklets and textbooks 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 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 18.1 does not preclude the provision to health professionals and other relevant decision makers of inexpensive DVDs etc which bear educational or promotional material compliant with the Code, provided that they cannot be used by the recipient to store other data.

Clause 18.1 does not preclude the provision to health professionals and other relevant decision makers of inexpensive memory sticks which bear educational or promotional material compliant with the Code, provided that their storage capacity is commensurate with the amount of data to be stored.

Textbooks must not be given to health professionals as promotional aids. In appropriate circumstances independently produced medical/educational publications such as textbooks could be given for health professionals to use in accordance with Clause 19.1 – Medical and Educational Goods and Services – but they must not be given to individuals.

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.

Patient support items 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, for example on reply paid cards.

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, perhaps for obese patients.

Provided that they have been appropriately documented and certified in advance as required by Clause 14.3, in limited circumstances patient support items 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. This is where their purpose is to allow patients to gain experience in using their medicines whilst under the supervision of a health professional. 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.

Items which may be made available to patients, for example by completing a request card enclosed with a medicine, should be inexpensive and related to either the condition under treatment or general health. Care must be taken that any such activity meets all the requirements of the Code and in particular Clause 26.

No item for use by patients must be given for the purpose of encouraging patients to request a particular medicine.

Companies cannot run or sponsor competitions or quizzes for patients if prizes are offered to individuals. A competition for patients where the prizes were health related and were given to a clinic or similar might be acceptable.

Notebooks, pens and pencils are the only items that can be provided to health professionals and other relevant decision makers for them to keep and then only at bona fide meetings.

They cannot be provided, for example, by representatives when calling upon health professionals. No individual attendee should receive more than one notebook and one pen or pencil.

The total cost to the donor company of all such items provided to an individual person attending a meeting must not exceed £6, excluding VAT. The perceived value to the recipient must be similar.

Notebooks, pens and pencils must not be given out from exhibition stands.

Notebooks, pens and pencils provided at company organised meetings may bear the name of the donor company but not the name of any medicine or any information about medicines.

Notebooks, pens and pencils included in conference bags at third party organised meetings may not bear the names of the donor companies or the name of any medicine or any information about medicines.