Clause 18 - Items for Patients, Promotional Aids, the provision of Medical and Educational Goods and Services, Agreements to Benefit Patients such as Joint Working, Outcome Agreements and Patient Access Schemes

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 Council advises doctors that ‘You must act in your patients’ best interests when making referrals and when providing or arranging treatment or care. You must not ask for or accept any inducement, gift or hospitality which may affect or be seen to affect the way you prescribe for, treat or refer patients’.

The General Pharmaceutical Council is the regulatory body for pharmacists and pharmacy technicians. The Council’s Standards of conduct, ethics and performance state ‘Do not ask for or accept gifts, rewards or hospitality that may affect, or be seen to affect, your professional judgement’.

The Code of the Nursing & Midwifery Council, Standards of conduct, performance and ethics for nurses and midwives, states ‘You must not abuse your privileged position for your own ends’ and ‘You must ensure that your professional judgement is not influenced by any commercial considerations’.

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 does not prevent the offer of package deals whereby the purchaser of a particular medicine receives with it certain associated benefits, 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.

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 2009 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 then National Institute for Health and Clinical Excellence) in order to improve the costeffectiveness of a medicine and enable patients to receive access to cost- effective innovative medicines.

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 20 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 administrative staff 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 administrative staff 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.

Pharmaceutical companies cannot give diaries and desk pads etc to health professionals and appropriate administrative staff but there is nothing to prevent them being given by other parties which are not pharmaceutical companies. 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 23 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 appropriate administrative staff 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 appropriate administrative staff 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 18.4 – Provision of 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 means one that has cost the donor company no more than £6, 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 undertreatment or general health. Care must be taken that any such activity meets all the requirements of the Code and in particular Clause 23.

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 administrative staff for them to keep and then only at bona fide meetings. They cannot be provided, for example, by representatives when calling upon health professionals.

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 by one or more companies can be included in conference bags. The total cost of the items provided to an individual recipient must not exceed £6, excluding VAT. The perceived value to the recipent must be the same. The items may bear the names of the donor companies but not the name of any medicine or any information about medicines. No individual attendee should receive more than one notebook and one pen or pencil.

Clauses 18.1 and 18.4 do not prevent the provision of medical and educational goods and services. In order to comply with the Code such goods and services must be in the interests of patients or benefit the NHS whilst maintaining patient care. They must not be provided to individuals for their personal benefit.

The requirement in Clause 18.4 that medical and educational goods must not bear the name of any medicine does not apply where the goods involved consist of independently produced textbooks or journals which include as part of their texts the names of medicines.

Medical and educational goods and services may bear a corporate name. The involvement of a pharmaceutical company in such activities must be made clear to relevant health professionals and/or administrative staff receiving the service. In addition the involvement of a pharmaceutical company in therapy review services should be made clear to patients. However, if there are no materials for patients this would be a matter for the relevant health professional. If there are materials for patients the requirements for declaration of sponsorship set out in Clause 9.10 would apply.

The following guidance is intended to assist companies in relation to medical and educational goods and services.

1(i) The role of medical/generic representatives in relation to the provision of goods and services supplied in accordance with Clauses 18.1 and 18.4 needs to be in accordance with the principles set out below. In this context companies should consider using staff other than medical/generic representatives.

(ii) If medical/generic representatives provide, deliver or demonstrate medical and educational goods and services then this must not be linked in any way to the promotion of products.

In order to comply with this stipulation the representative must not carry out both activities at the same visit. Representatives may introduce a service by means of a brief description and/or delivering materials but may not instigate a detailed discussion about the service at the same time as a call at which products are promoted.

If, during a promotional visit by a representative, a change in medication to one of the company’s products is agreed, the representative may not then offer a therapy review service to facilitate the change as this would be seen as a way for the company to ensure that the agreed change would in fact be made.

(iii) The acceptability of the role of medical/generic representatives will depend on the nature of the goods and services provided and the method of provision.

(iv) The nature of the service provider, the person associated with the provision of medical and educational goods and services, is important ie is the service provider a medical/generic representative or is the service provider some other appropriately qualified person, such as a sponsored registered nurse? If the goods and services require patient contact, for example either directly or by identification of patients from patient records and the like, then medical/generic representatives must not be involved. Only an appropriately qualified person, for example a sponsored registered nurse, not employed as a medical/generic representative, may undertake activities relating to patient contact and/or patient identification. Medical/generic representatives could provide administrative support in relation to the provision of a screening service, but must not be present during the actual screening and must not discuss or help interpret individual clinical findings.

(v) Neither the company nor its medical/generic representatives may be given access to data/records that could identify, or could be linked to, particular patients.

(vi) Sponsored health professionals should not be involved in the promotion of specific products. Registered nurses, midwives and health visitors are required to comply with the Nursing & Midwifery Council Code - Standards of conduct, performance and ethics for nurses and midwives.

2 The remuneration of those not employed as medical/generic representatives but who are sponsored or employed as service providers in relation to the provision of medical and educational goods and services must not be linked to sales in any particular territory or place or to sales of a specific product or products and, in particular, may not include a bonus scheme linked to such sales. Bonus schemes linked to a company’s overall national performance, or to the level of service provided, may be acceptable.

3 Companies must ensure that patient confidentiality is maintained at all times and that data protection legislation is complied with.

4 Service providers must operate to detailed written instructions provided by the company. These should be similar to the briefing material for representatives as referred to in Clause 15.9. The written instructions should set out the role of the service provider and should cover patient confidentiality issues. Instructions on how the recipients are to be informed etc should be included. The written instructions must not advocate, either directly or indirectly, any course of action which would be likely to lead to a breach of the Code.

5 Service providers must abide by the principle set out in Clause 15.5 that in an interview, or when seeking an appointment, reasonable steps must be taken to ensure that they do not mislead as to their identity or that of the company they represent.

6 A recipient of a service must be provided with a written protocol to avoid misunderstandings as to what the recipient has agreed. The identity of the sponsoring pharmaceutical company must be given. For example, a general practitioner allowing a sponsored registered nurse access to patient records should be informed in writing of any data to be extracted and the use to which those data will be put.

7 Any printed material designed for use in relation to the provision of medical and educational goods and services must be non-promotional. It is not acceptable for such materials to promote the prescription, supply, sale or administration of the sponsoring company’s medicines. Nor is it acceptable for materials to criticise competitor products as this might be seen as promotional. All printed materials must identify the sponsoring pharmaceutical company.

8 Material relating to the provision of medical and educational goods and services, such as internal instructions, external instructions, the written protocol for recipients and other printed material, including material relating to therapy reviews, etc, must be certified by the Code of Practice signatories within companies to ensure that the requirements of the Code are met as required by Clause 14.3.

A copy of the materials must be made available to the Prescription Medicines Code of Practice Authority on request.

9 Companies are recommended to inform relevant NHS or other organisations of their activities where appropriate. This is particularly recommended where companies are proposing to provide medical and educational goods and services which would have budgetary implications for the parties involved. For example the provision of a screening service for a limited period might mean that funds would have to be found in the future when company sponsorship stopped. Another example might be the provision of diagnostic or laboratory services and the like, which the relevant organisation would normally be expected to provide.

Clauses 18.1 and 18.4 prohibit switch services paid for or facilitated directly or indirectly by a pharmaceutical company whereby a patient’s medicine is simply changed to another. For example it would be unacceptable if patients on medicine A were changed to medicine B, without any clinical assessment, at the expense of a pharmaceutical company promoting either or both medicines. It would be acceptable for a company to promote a simple switch from one product to another but not to assist a health professional in implementing that switch even if assistance was by means of a third party such as a sponsored nurse or similar. Such arrangements are seen as companies in effect paying for prescriptions and are unacceptable.

A therapeutic review is different to a switch service. A therapeutic review which aims to ensure that patients receive optimal treatment following a clinical assessment is a legitimate activity for a pharmaceutical company to support and/or assist. The result of such clinical assessments might require, among other things, possible changes of treatment including changes of dose or medicine or cessation of treatment. A genuine therapeutic review should include a comprehensive range of relevant treatment choices, including non-medicinal choices, for the health professional and should not be limited to the medicines of the sponsoring pharmaceutical company. The arrangements for therapeutic review must enhance patient care, or benefit the NHS and maintain patient care, and must otherwise be in accordance with Clause 18.4 and the supplementary information on the provision of medical and educational goods and services. The decision to change or commence treatment must be made for each individual patient by the prescriber and every decision to change an individual patient’s treatment must be documented with evidence that it was made on rational grounds.

he Department of Health defines joint working between the NHS and the pharmaceutical industry as situations where, for the benefit of patients, one or more pharmaceutical companies and the NHS pool skills, experience and/or resources for the joint development and implementation of patient centred projects and share a commitment to successful delivery.

Each party must make a significant contribution and the outcomes must be measured. Treatments must be in line with nationally accepted clinical guidance where such exists. Joint working between the pharmaceutical industry and the NHS must be conducted in an open and transparent manner. Joint working must be for the benefit of patients but it is expected that the arrangements will also benefit the NHS and the pharmaceutical company or companies involved. Joint working differs from the situation where pharmaceutical companies simply provide funds for a specific event or programme.

The Department of Health has issued Best practice guidance on joint working between the NHS and pharmaceutical industry and other relevant commercial organisations. The Department of Health and the ABPI have jointly issued Moving beyond sponsorship: interactive toolkit for joint working between the NHS and the pharmaceutical industry.

The ABPI has produced guidance notes on joint working between pharmaceutical companies and the NHS and others for the benefit of patients. The ABPI Guidance refers to the requirements of the Code but goes well beyond them.

When considering joint working, companies should take account of the guidance which has been issued by the ABPI and the Department of Health. Joint working is acceptable in principle provided that it is carried out in conformity with the Code. In particular, it must not constitute an inducement to health professionals or administrative staff to prescribe, supply, recommend, buy or sell any medicine. It must therefore always be ensured that any and all of the benefits of joint working which are due to the NHS, go not to individuals or practices but to an NHS or other organisation.

A joint working agreement can be based on the use of a particular medicine of a company party to the agreement, but only if the requirements below are complied with and only if the parties have satisfied themselves that the use of the medicine will enhance patient care. Goods and services provided by the company as part of the joint working agreement must be relevant to the medicines involved and the agreement as a whole must be fair and reasonable. Any goods and services provided by the company must themselves contribute to patient care.

The written agreement must cover the following points:

• the name of the joint working project, the parties to the agreement, the date and the term of the agreement
• the expected benefits for patients, the NHS and the pharmaceutical company; patient benefits should always be stated first and patient outcomes should be measured
• an outline of the financial arrangements
• the roles and responsibilities of the NHS and the pharmaceutical company and how the success of the project will be measured, when and by whom; all aspects of input should be included
• the planned publication of any data or outcomes
• if a pharmaceutical company enters into a joint working agreement on the basis that its product is already included in an appropriate place on the local formulary, a clear reference to this should be included in the joint working agreement so that all the parties are clear as to what has been agreed
• contingency arrangements to cover possible unforeseen circumstances such as changes to summaries of product characteristics and updated clinical guidance; agreements should include a dispute resolution clause and disengagement/exit criteria including an acknowledgement by the parties that the project might need to be amended or stopped if a breach of the Code is ruled
• publication by the company of an executive summary of the joint working agreement, for example on a clearly defined website or section of a website, such as on the company’s or companies’ website; the NHS organisation should also be encouraged to publish this.

The requirement to make the executive summary public applies to joint working projects started on or after 1 May 2011 or ongoing on that date.

Attention is drawn to the certification requirements set out in Clause 14.3 which apply to material prepared in relation to joint working including the joint working agreement.

Clause 18.6 is relevant to a joint working agreement between a pharmaceutical company and the NHS which does not involve the use and purchase of any of the company’s medicines. Although the ABPI Guidance is aimed principally at joint working between pharmaceutical companies and the NHS, it also covers joint working conducted though third party service providers and/or with suppliers of private healthcare.

More detail as to the requirements for joint working is provided in the ABPI Guidance which should be consulted when joint working is contemplated.

Joint working should be distinguished from straightforward sales where medicines are simply sold and there are no accompanying goods and services etc and from package deals and outcome or risk sharing agreements as defined in the supplementary information to Clause 18.1.

The information required by Clause 18.5 as to transfers of value must be publicly disclosed in relation to transfers of value made in 2015 and each calendar year thereafter, giving in each case the financial amount or value and the name of the recipient.

Companies must ensure that the amount spent on joint working projects is made public irrespective of whether the value is transferred to a healthcare organisation or some other funding model is used.

Disclosure must be carried out in accordance with Clause 21.

Donations and grants to individual health professionals are not covered by this clause. Company sponsorship of health professionals to attend events is covered by Clause 19.

Details of each grant, donation or benefit in kind (transfer of value) must be publicly disclosed, giving in each case the financial amount or value and the name of the recipient institution, organisation or association. Companies are also encouraged to ask recipients to make such funding public.

Fees and agreed expenses should be disclosed separately.

The information required by Clause 18.6 must be publicly disclosed in respect of donations, grants and benefits in kind made in 2015 and each calendar year thereafter.

Disclosure must be carried out in accordance with Clause 21.

Disclosure for Calendar Years 2013 and 2014

For disclosures in relation to donations and grants made in calendar years 2013 and 2014, the requirements and procedures in Clause 18.6 and its supplementary information in the Second 2012 Edition of the Code continue to apply.

The information required by Clause 18.7 must be publicly disclosed in relation to transfers of value made in 2015 and each calendar year thereafter, giving in each case the financial amount or value and the name of the recipient institution, organisation or association.

Fees and agreed expenses should be disclosed separately.

Disclosure must be carried out in accordance with Clause 21.