Paragraphs 10.4, 11.3 and 12.2 of the Constitution and Procedure for the Prescription Medicines Code of Practice Authority variously authorize the Code of Practice Appeal Board or the Board of Management of the Association of the British Pharmaceutical Industry to require an audit of a company’s procedures in relation to the Code of Practice for the Pharmaceutical Industry to be carried out by the Prescription Medicines Code of Practice Authority.
Set out below are guidelines on company procedures which are regarded as representing good practice in this regard. They are minimum requirements and will need to be adapted to fit in with the arrangements at any particular company.
The guidelines also point out the most significant changes which have been made to the Code in the 2014 edition.
The guidelines do not cover all aspects of the Code and are thus no substitute for a detailed study of the Code as a whole, including all of the supplementary information.
1) Scope of the Code
It should be borne in mind that the Code covers some matters that are not necessarily related to promotion. Companies should familiarise themselves with the detail of what is covered and ensure that their procedures are such as to ensure compliance at all times. The supplementary information to Clause 1.1 gives guidance in this regard as does Clause 14.3 which details materials to be certified even if they are non-promotional in nature.
Other material issued by companies which relates to medicines but which is not intended as promotion for those medicines, such as corporate advertising, press releases, market research material, financial information for shareholders and the Stock Exchange and responses to unsolicited enquiries from the public etc, should be examined to ensure that it does not contravene the Code or relevant statutory requirements.
Account should be taken of the fact that nonpromotional material could be used or made available in such a way that it would be considered promotion and thereby come within the scope of the Code.
Adequate provision should be made in copromotion agreements and the like to ensure compliance with the Code. Where companies jointly promote the same product and the promotional material bears both company names, each company must certify the promotional material involved as the companies concerned will be held jointly responsible for it under the Code (supplementary information to Clause 14.1).
3) Breaches of the Code
In the event of a company being found in breach of the Code, procedures should provide that adequate steps are taken to ensure that relevant information about the matter is communicated internally to appropriate members of staff.
Procedures must be in place to ensure that promotional material found to be in breach of the Code, and any similar material in any format, is quickly and entirely withdrawn from use, not forgetting material stored electronically and/or in the hands of others, such as printers and agencies. It is important for the reputation of the industry that companies comply with undertakings. Inadequate action leading to a breach of undertaking is likely to be in breach of Clause 2.
Companies are advised to keep written records of the action taken to withdraw material.
Companies should bear in mind that promotional material must be up-to-date at the time that it is sent or used or, in the case of a journal advertisement, at the publication date of the journal.
Each company must have a senior employee who is responsible for ensuring that it meets the requirements of the Code (Clause 1.10).
Unless other formal arrangements have been made by a company, it will be assumed that the responsible person is the managing director or chief executive or equivalent.
To assist with compliance, companies should have a comprehensive set of standard operating procedures (SOPs) covering all aspects of the Code. SOPs should set out high standards and relevant staff should be trained and validated on their content.
5) Price Lists for Unlicensed Medicines
Price lists relating to unlicensed medicines are allowed provided that they include no product claims and make clear that the products are unlicensed (Clause 1.2 and its supplementary information). Such price lists can be sent to health professionals and appropriate administrative staff at reasonable intervals or in response to enquiries. They must not be used proactively in a manner which could be seen to be promoting unlicensed medicines, such as by displaying them on exhibition stands.
6) Abbreviated Advertisements
Abbreviated advertisements (Clause 5) must refer to a website where further information about the product can be found. This further information can consist of the prescribing information, as set out in Clauses 4.2 and 4.3, or the summary of product characteristics. Clause 5.4 sets out the information which must be given.
7) Extremes of Format
The 2014 Code added a new requirement to Clause 9.7 which previously stated that extremes of format, size or cost of promotional material must be avoided.
The reference to ‘promotional’ has been deleted and it is now required that informational or educational materials must be inexpensive, directly relevant to the practice of medicine or pharmacy and directly beneficial to the care of patients.
8) Clinical Trials
Companies must disclose details of clinical trials (Clause 13.1). The supplementary information to Clause 13.1 details how this should be done. Companies must include, on the homepage of their website, information as to where details of their clinical trials can be found.
9) Non-Interventional Studies of Marketed Medicines
A non-interventional study of a marketed medicine is a study where the medicine is prescribed in the usual manner in accordance with the terms of its marketing authorization (Clause 13.2). The assignment of the patient to a particular therapeutic strategy is not decided by a study protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.
A company involved in non-interventional studies must have a scientific service to deal with their approval and supervision as required by Clause 22.2.
Companies must publish the summary details and results of non-interventional studies of marketed medicines completed on or after 1 May 2011 (Clause 13.3). This applies to studies with which a UK company has had any involvement. The 2008 Code encouraged companies to publish this information and this still applies to studies completed prior to 1 May 2011.
Clause 13.4, which sets out the criteria with which non-interventional studies must comply, applies to studies completed on or after 1 July 2008, though companies are encouraged to comply in relation to studies completed prior to that date.
10) Certification of Promotional Material
Procedures must ensure that:
Each certificate should bear a reference number with the same reference number appearing on the promotional material in question so that there can be no doubt as to what has been certified. A particular reference number should relate to only one item of promotional material.
Different sizes and different layouts of a piece of promotional material should be separately certified and each should have its own unique reference number.
A change in the certification requirements made in the 2014 Code allows pharmacists registered in the UK to certify all material in lieu of a medical practitioner. Previously they could certify all materials other than those covered by Clause 14.3.
11) Certification of Representatives’ Briefing and Training Materials
The certification requirements of Clause 14 apply also to briefing material prepared for representatives in accordance with Clause 15.9. Briefing material includes the training material used to instruct medical representatives about a medicine and the instructions given to them as to how the product should be promoted. Procedures must ensure that no such material is used or issued prior to certification.
12) Certification of Items to be Passed on to Patients
Items which are provided to health professionals for them to pass on to patients must be certified (Clauses 14.3 and 18.2). Such items must be part of a formal patient support programme, the details of which must be appropriately documented and certified in advance.
13) Certification of Other Material
Clause 14.3 lists other material which needs to be certified and companies should familiarise themselves with what is covered. Additionally, Clause 14.2 requires the certification of all meetings which involve travel outside the UK. The Code now allows only very limited provision to health professionals of promotional aids for them to keep and these must be certified (supplementary information to Clause 18.3 and Clause 14.1).
14) Representatives’ Expenses
There should be a clearly laid down procedure for approval and payment of representatives’ expenses and expenditure on meetings and hospitality and the like. A system should be in place for an audit on a systematic or random basis which will check the nature of the expenditure which has been incurred and assess whether that expenditure was in accordance with the requirements of the Code.
15) Representatives’ Training
Representatives should be provided with written instructions on the application of the Code to their work even if they are also provided with an actual copy of it. It is recommended that each representative is given their own copy of the Code. Their instructions should cover such matters as the company’s policies on meetings and hospitality, and the associated allowable expenditure, and the specific requirements for representatives in Clause 15. It should be made clear how reporting to the ‘scientific service’ of the company is to be carried out in relation to information about the medicines which they promote which comes to their notice, particularly reports of adverse reactions (Clause 15.6).
It should be made clear to representatives as to whether, and in what circumstances, they can themselves write letters (or prepare other written materials) which mention particular medicines and are thus almost certain to be considered promotional material.
Such items must be certified, either in advance by way of proforma letters or by certifying each individual letter or other item, and must bear prescribing information in accordance with Clause 4.1.
It should be ensured that all relevant personnel, including representatives and members of staff (including persons retained by way of contract with third parties) concerned in any way with the preparation or approval of promotional material or of information to be provided to members of the UK health professions or to appropriate administrative staff or of information to be provided to the public and recognised patient organisations, are fully conversant with the requirements of the Code and relevant legal requirements (Clause 16.1).
Appropriate arrangements should be in place for training on the requirements of the Code. These may be internal arrangements for appropriate staff members but it is recommended that key personnel attend one of the seminars organised by the Prescription Medicines Code of Practice Authority.
It should also be ensured that all personnel (including persons retained by way of contract with third parties) are fully conversant with pharmacovigilance requirements relevant to their work and that this is fully documented (Clause 16.2).
Adequate arrangements should be in place to ensure that any information as to changes to the Code etc, including reports of decided cases, are circulated to relevant personnel.
Companies should consider making knowledge of, and compliance with, their obligations in relation to both the Code and pharmacovigilance requirements part of the annual appraisal process for relevant employees.
Clause 16.3 sets out the requirements relating to the need for representatives to pass an appropriate examination. Examination status is enquired into when a complaint is received about a representative. Companies should have appropriate procedures in place to ensure that representatives enter for the examination on the earliest practicable date.
Representatives must take the examination in their first year of such employment and must pass it within two years of starting such employment.
A significant change made in the 2014 Code is that the examinations will have to be accredited to at least Level 3 by an external awarding body recognised by Ofqual. The ABPI will offer accredited examinations by January 2014 and will cease to offer its unaccredited examinations at the end of 2015. Examinations may also be offered by providers other than the ABPI (Clause 16.3).
Representatives commencing such emplyment on or after 1 October 2014 must take an accredited examination. It is recommended that representatives commencing such employment on or after 1 January 2014 but on or before 30 September 2014 also take an accredited examination. There is more detail in the supplementary information to Clause 16.3.
17) Provision of Medicines and Samples
Companies should ensure that their procedures are such as to ensure compliance with Clause 17. They should be clear as to the distinctions between samples, identification samples, titration packs and free goods etc which are described in the supplementary information to Clause 17.
Electronic signatures are now acceptable in relation to requests for samples.
Not more than four samples of a particular medicine may be provided to an individual health professional during the course of a year (Clause 17.2).
A significant change was made in the 2014 Code. Previously samples of medicines launched prior to 1 January 2012 could be provided only until 31 December 2013. That restriction has been removed and samples of any medicine can now be provided to a health professional, but only for two years after that health professional first requests samples of it. There is a special provision for the sampling of new medicines which are extensions of existing medicines (Clause 17.2).
Clause 17.9 requires companies to have adequate systems of control and accountability for samples and for all medicines handled by representatives. Similarly, there should be an adequate system to control the number of samples of a particular product given to a particular health professional (Clause 17.2).
Samples must not be given for the sole purpose of treating patients (Clause 17.12).
Starter packs are not permitted (supplementary information to Clause 17). Starter packs were small packs designed to provide sufficient medicine for a primary care prescriber to initiate treatment in such circumstances as a call out in the night.
18) Items for Patients and Promotional Aids
The traditional forms of promotional aid, such as coffee mugs, stationery and calendars, cannot be given to health professionals and nor can items for use in a clinic or treatment room, such as surgical gloves, tongue depressors, tissues and the like (supplementary information to Clause 18.1). Toys and puzzles for children to play with cannot be provided either.
Items intended to be passed on to patients can be provided to health professionals if these are part of a patient support programme, the details of which have been appropriately documented and certified in advance (Clause 18.2). They must cost no more than £6, excluding VAT, and the perceived value to the health professional and the patient must be similar. They must directly benefit patient care. Such items can be provided to health professionals by representatives during the course of a promotional call but they must not be given out from exhibition stands.
In limited circumstances, patient support items can be provided to health professionals when they are not to be passed to patients for them to keep (supplementary information to Clause 18.2). 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 are inhalation devices devoid of active ingredients and devices to assist patients to learn how to self- inject.
The only items that can be provided to health professionals for them to keep are notebooks, pens and pencils for use at bona fide meetings and conferences etc. The total cost of such items provided to an individual must not exceed £6, excluding VAT, and the perceived value to the recipient must be similar. They must not bear the name of a medicine or any information about medicines but may bear the name of the company providing them (Clause 18.3). They must not be provided by representatives when calling upon health professionals. They must not be given out from exhibition stands.
The 2014 Code stipulates that memory sticks and DVDs provided in accordance with the supplementary information to Clause 18.1 must be inexpensive.
There is much detail in the supplementary information to Clauses 18.1, 18.2 and 18.3 and it is essential that companies familiarise themselves with it.
19) Medical and Educational Goods and Services
The provision of medical and education goods and services must be carried out in compliance with Clause 18.4 and must be certified in accordance with Clause 14.3.
20) Agreements to Benefit Patients such as Joint Working, Outcome Agreements and Patient Access Schemes
Joint working between the NHS and the pharmaceutical industry is dealt with in the Code in some detail (Clause 18.5 and its supplementary information). An executive summary of a joint working agreement must be made public in relation to joint working projects starting on or after 1 May 2011 or on-going on that date. Material relating to joint working must be certified (Clause 14.3).
The 2014 Code requires public disclosure of transfers of value in connection with joint working. This applies to transfers of value made in 2015 and each calendar year thereafter (Clause 18.5 and its supplementary information). Disclosure of 2015 data will be required in 2016. Clause 21 sets out the requirements in relation to transfers of value.
The supplementary information to Clause 18.1 deals with outcome or risk sharing agreements, patient access schemes and package deals.
21) Donations and Grants to Institutions, Organisations and Associations
The 2011 Code required pharmaceutical companies to make publicly available details of grants and donations made to institutions, organisations and associations in accordance with Clause 18.6. This applied to donations and grants made in 2012 and each calendar year thereafter.
The 2014 Code introduces requirements for public disclosure which differ from those in the Second 2012 Code (Clause 18.6 and its supplementary information). The new requirements apply to transfers of value made in 2015 and each calendar year thereafter. Disclosure of 2015 data will be required in 2016. Clause 21 sets out the requirements in relation to transfers of value.
For disclosures in relation to 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 2014 Code requires public disclosure of transfers of value in relation to contracts under which institutions etc provide services to pharmaceutical companies (Clause 18.7 and its supplementary information). This will apply to data for 2015 and each calendar year thereafter. Disclosure must be carried out in accordance with Clause 21.
22) Meetings and Hospitality
A company must have a written document that sets out its policies on meetings and hospitality and the associated allowable expenditure and must ensure that all meetings that it plans are checked to see that they comply with Clause 19.
Clause 19.2 of the 2014 Code stipulates that the cost of a meal (including drinks) provided by way of subsistence must not exceed £75 per person excluding VAT and gratuities. The supplementary information to Clause 19.2 sets out futher details.
Meetings held outside the UK are not necessarily unacceptable but there have to be valid and cogent reasons for the use of a venue outside the UK (supplementary information to Clause 19.1).
Meetings which involve travel outside the UK must be formally certified as set out in Clause 14.2.
A company’s procedures should cover its own meetings, those which it sponsors and the sponsorship of attendance at meetings.
Companies should remind their affiliates that the ABPI Code of Practice must be complied with if UK health professionals attend meetings which they organise regardless of whether such meetings occur in the UK or abroad.
23) Sponsorship to Attend Meetings
A change made in the 2011 Code was that financial details of sponsorship of UK health professionals and appropriate administrative staff to attend meetings organised by third parties must be made publicly available (Clause 19.4 and its supplementary information).
The information had to be made publicly available in respect of sponsorship to attend meetings in 2012 and each calendar year thereafter.
The 2014 Code introduces different requirements which apply to both meetings organised by third parties and those organised by pharmaceutical companies (Clause 19.5 and its supplementary information). The previous requirements in the Second 2012 Code applied only to meetings organised by third parties. Disclosure will be of attendance at meetings in 2015 and each calendar year thereafter. Disclosure of 2015 data will be required in 2016. Disclosure must be carried out in accordance with Clause 21.
For disclosure in relation to calendar years 2013 and 2014 the requirements and procedures in Clause 19.4 and its supplementary information in the Second 2012 Edition of the Code still apply.
24) The Use of Consultants
Health professionals and appropriate administrative staff may be used as consultants and advisors for services such as speaking at and chairing meetings, involvement in medical/scientific studies, clinical trials or training services, participation at advisory board meetings, and participation in market research where such participation involves remuneration and/or travel. The arrangements which cover these genuine consultancy or other services must, to the extent relevant to the particular arrangement, fulfil the criteria set out in Clause 20 and procedures should ensure that the requirements of that clause are complied with.
Changes were made in relation to the use of consultants in the 2011 Code. In particular, public disclosure of fees paid to consultants in the UK for certain services would be required for payments made in 2012 and each calendar year thereafter (Clause 20.2). No disclosure was required in relation to payments for research and development work, including the conduct of clinical trials. Additional information would have to be disclosed in relation to certain payments made in 2013 and each calendar year thereafter (Clause 20.3).
The 2014 Code has made significant changes in relation to transfers of value to consultants (Clauses 20.2 and 20.3 and their supplementary information). Transfers of value in relation to research and development work (including the conduct of clinical trials) are now included but are to be disclosed on an aggregate basis.
The new requirements apply to data for 2015 and each calendar year thereafter. The data for 2015 will be disclosed in 2016. Disclosure must be carried out in accordance with Clause 21. There is much detail in the supplementary information to Clauses 20.2 and 20.3.
For disclosures in relation to calendar years 2013 and 2014, the requirements and procedures in Clauses 20.2 and 20.3 and their supplementary information in the Second 2012 Edition of the Code still apply.
Contracts or agreements with consultants entered into or renewed on and after 1 May 2011 must include provisions regarding their obligation to declare the arrangement whenever they write or speak in public about the subject of the agreement or any issue relating to the company (Clause 20.1). Companies are encouraged to renegotiate existing contracts to include such provisions at their earliest convenience.
25) Transfers of value
The most significant change made in the 2014 Code relates to the public disclosure of transfers of value to health professionals and healthcare organisations (Clause 21). The term ‘transfer of value’ is defined in Clause 1.8 and the supplementary information to Clause 1.8 lists a number of matters which are not transfers of value for the purposes of the Code. Clause 21.2 lists transfers of value covered by Clause 21.1. Transfers of value to patient organisations are not covered by Clause 21. These transfers of value continue to be covered by Clauses 24.7 and 24.8.
The matter is complicated as far as the Code is concerned by the fact that it already has disclosure requirements, some of which will be superseded in due course by the new requirements which are derived from the new EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations.
The new requirements involve the disclosure of 2015 data in 2016. The existing requirements relate to the disclosure of 2012 and 2013 data onwards and these requirements will continue to apply until the new requirements supersede them.
References to the new requirements are made at relevant places in these Guidelines. Disclosures must be made in accordance with Clause 21.
Companies should take steps to ensure that they will be able to readily source the information to be publicly disclosed.
26) Scientific Services
Companies must ensure that they have an identifiable scientific service to compile and collate all information, from medical representatives or any other source, about the medicines which they market (Clause 22.1). Where relevant, they must also have a scientific service to deal with the approval and supervision of non-interventional studies (Clause 22.2). There can be one scientific service in charge of both responsibilities or separate services with clearly delineated duties.
27) Relations with the Public and the Media
Prescription only medicines must not be advertised to the public but information about them can be provided either directly or indirectly. The provision of information to the public about prescription only medicines must be in accordance with Clause 23.
An important change made in the 2014 Code is that any material which relates to a medicine and which is intended for patients taking that medicine must include a statement relating to the reporting of side effects. If the medicine is one which is subject to additional monitoring, then the material must include an inverted black equilateral triangle and an additional statement (Clause 23.3).
28) Relationships with Patient Organisations
Pharmaceutical companies can interact with patient organisations or any user organisation such as disability organisations, carer or relative organisations and consumer organisations to support their work, including assistance in the provision of appropriate information to the public, patients and carers.
When working with patient organisations, companies must ensure that all of the arrangements comply with the Code. This includes the prohibition on advertising prescription only medicines to the public (Clause 23.1). The requirements of Clause 19, which covers meetings for health professionals and appropriate administrative staff, also apply to pharmaceutical companies supporting patient organisation meetings.
Companies must ensure that the requirements of Clause 24 are complied with when working with patient organisations. In particular, written agreements must be in place in respect of every significant activity or ongoing relationship (Clause 24.3) and there has to be public disclosure of financial support or indirect/non financial support. The published information must include the monetary value of financial support and of invoiced costs (Clause 24.7). For significant non-financial support that cannot be assigned a meaningful monetary value, the published information must describe clearly the non-monetary value that the organisation receives.
Companies must ensure that their support is clearly acknowledged from the outset. The wording of a declaration of sponsorship must accurately reflect the nature of a company’s involvement.
Contracts under which patient organisations provide consultancy or other services to companies are subject to the Code and Clause 24.8 specifies the criteria which contracts for such services must meet, to the extent relevant to the particular arrangement. A list of patient organisations that have been engaged to provide significant contracted services must be published and updated at least once a year.
Companies should ensure that such contracts comply with the criteria in Clause 24.8.
Hospitality can be provided in certain circumstances to patient carers (supplementary information to Clause 24.2).
29) The Internet
Companies should ensure that all relevant requirements of the Code, including Clause 25, are complied with in relation to promotional material for prescription only medicines which is provided on the Internet and directed to a UK audience.
If access to such material is not limited to health professionals and appropriate administrative staff, a pharmaceutical company website or a company sponsored website must provide information for the public as well as promotion to health professionals with the sections clearly separated and the intended audiences identified.
Material intended for the public which is provided on the Internet must comply with Clause 23.2.