Clause 19 - Medical and Educational Goods and Services

Clauses 18.1 and 19.1 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 19.1 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 other relevant decision makers 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 19.1 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 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 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 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 19.1 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 19.1 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.

Transfers of value in relation to medical or educational goods and services 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.

Disclosure must be carried out in accordance with Clause 24.

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 22.

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 19.2 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 24.

Disclosure for Calendar Years 2013 and 2015

For disclosures in relation to donations and grants made in calendar years 2013 and 2015, the requirements and procedures in Clause 18.6 and its supplementary information in the Second 2012 Edition of the Code continue to apply.