Select Committee on Health Written Evidence


Memorandum by the Prescription Medicines Code of Practice Authority (PI 14)


  1.  The importance the pharmaceutical industry places on its relationships with health professionals and others with regard to promotion and other activities is demonstrated by The Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry (current edition 2003) and the transparency of the complaints procedure. The ABPI Code has the support of the Medicines and Healthcare products Regulatory Agency (MHRA) and health professional organisations. Many countries have used it as a model for their own codes. Companies not in membership of the ABPI can agree to comply with it and most do so. Health professionals are aware of the Code and submit complaints as do pharmaceutical companies and others. The complaints system gives equal status to the complainant and the respondent. Both parties have the right to appeal and to attend appeal hearings. Publication of virtually a complete record of the submissions and rulings contributes significantly to effective self regulation and is a powerful sanction.


  2.  The PMCPA was established by the ABPI to administer the ABPI Code of Practice for the Pharmaceutical Industry[11] independently of the ABPI itself. The PMCPA is also responsible for providing advice, guidance and training on the Code. The PMCPA is not part of the day to day management structure of the ABPI and this is explained in Paragraph 26 below. The relationship between the ABPI and the PMCPA is set out in a Protocol of Agreement.[12] Neither the staff of the ABPI nor the ABPI Board of Management play any role in relation to the consideration of complaints. The ABPI Board has a role in relation to sanctions in serious cases once the adjudications have been made and this is explained in Paragraph 30 below. Unless additional sanctions are necessary the first notification from the PMCPA of the outcome of complaints is when consideration of the case is completed and the PMCPA circulates to the ABPI Board draft case reports prior to their publication. The PMCPA is regarded as a body that carries out a public law function and is thus subject to judicial review.

  3.  The ABPI Code covers the promotion of medicines for prescribing to health professionals and appropriate administrative staff and also covers information about such medicines made available to the general public. It also applies to a number of non-promotional areas. The ABPI Code does not cover the promotion of medicines for purchase by the general public; this is covered by codes established by the Proprietary Association of Great Britain.[13]

  4.  The ABPI Code aims to ensure that the promotion of medicines is carried out in a responsible, ethical and professional manner. It seeks to achieve a balance between the needs of patients, industry, health professionals and the general public. The ABPI Code is drawn up in consultation with the British Medical Association (BMA), the Royal Pharmaceutical Society of Great Britain (RPSGB) and the MHRA. The ABPI Code has been regularly revised since its inception in 1958, currently a new edition is agreed approximately every two years. The ongoing review of the Code and its operation will take into account a current European wide review of codes of practice and the conclusions of the Health Select Committee Inquiry.

  5.  Compliance with the ABPI Code is a condition of membership of the ABPI. About 60 companies which are not members of the ABPI have also agreed to comply with it. The ABPI Code thus covers most of the relevant companies in the UK.

  6.  The ABPI Code reflects, extends and provides detailed guidance above and beyond the UK legal requirements, which were first introduced in the Medicines Act 1968. The UK legal requirements are now based primarily on a European Directive.[14] The European Directive and UK law allow for voluntary control by self regulatory bodies and recourse to such bodies in addition to statutory control. The MHRA's stated view is that the control of medicines advertising is based on the long established system of self regulation which it sees as working successfully in the UK and that the statutory powers are to underpin and support self regulation, providing a means of enforcement should self regulation fail.[15] The role of the MHRA is restricted to the administration of UK law which covers the promotion of medicines for prescribing and the promotion of medicines for purchase by the general public. The MHRA occasionally forwards complaints to the PMCPA for consideration under the ABPI Code.


  7.  The ABPI Code applies to the activities of pharmaceutical companies and covers promotion in whatever form, whether it be printed, verbal or electronic as set out in Clause 1.2 which defines promotion as any activity undertaken by a pharmaceutical company or with its authority which promotes the prescription, supply, sale or administration of its medicines. Exemptions are also set out in Clause 1.2 and include those in the European Directive. The Code of Practice booklet includes supplementary information giving guidance on interpretation of the Code, guidelines on company procedures which represent good practice, and the Constitution and Procedure for the PMCPA, which sets out how the Code is operated together with the sanctions.

  8.  Pharmaceutical companies are required by Clause 7.1 of the Code to promptly provide health professionals and appropriate administrative staff upon reasonable request with accurate and relevant information about the products they market.

  9.  Clause 3 states that medicines cannot be promoted before they have been granted a marketing authorisation which permits their sale or supply and that promotion must not be inconsistent with the summary of product characteristics (SPC). Clause 7.2 requires information, claims and comparisons to be accurate, balanced, fair, objective and unambiguous and based on an up-to-date evaluation of the evidence and reflect that evidence clearly. Material must not mislead either directly or by implication. Material must be capable of substantiation and substantiation must be provided on request from a health professional or appropriate administrative staff unless the request relates to the validity of the indications approved in the marketing authorisation (Clauses 7.4 and 7.5). When material refers to published studies references have to be cited (Clause 7.6). Data on file when used as a reference has to be supplied on request (Clause 7.7). Artwork including graphs and tables must comply with the Code (Clause 7.8). It must not be stated that a product has no side effects, toxic hazards or risks of addiction. The word safe cannot be used without qualification (Clause 7.9). There are restrictions on the use of the words "the", "unique" and "new" (Clauses 7.10 and 7.11).

  10.  Prescribing information (a succinct summary of relevant information in the SPC together with the cost and legal classification) in accordance with Clause 4.2 must be provided in all promotional material unless the material is an abbreviated advertisement (Clause 5) which is an advertisement limited in size, content and use, or the item is a promotional aid as described in Clause 18. The non-proprietary name has to appear immediately adjacent to the most prominent display of the brand name in a specified size (Clause 4.3). The Code limits journal advertising such that no journal advertisement can be more than three pages long and no issue of a journal may bear advertising for any one product on more than three pages, including inserts (Clause 6).

  11.  Extremes of format, size or cost must be avoided (Clause 9.7) and promotional material should only be distributed to those persons whose interest in the material can reasonably be assumed (Clause 12.1).

  12.  Clause 15 sets out the requirements for representatives, including that they must maintain a high standard of ethical conduct. The Code applies to what representatives say and do as well the materials they use. The Code prohibits the use of any inducement or subterfuge to gain an interview. No fee should be paid or offered for the grant of an interview. There are limits on the frequency of visits by one representative to an individual doctor. Representatives have to inform their companies about any information received which relates to the use of the medicines they promote and must carry or have available the relevant SPCs. Companies must prepare detailed briefing material for representatives on the technical aspects of their medicines and how they are to be promoted. This material is requested by the PMCPA when a complaint is made about what a representative has said.

  13.  Clause 16 sets out the training requirements. All relevant personnel must be fully conversant with the requirements of the Code and representatives must pass an examination within two years of commencing such employment.

  14.  A sample is defined in Clause 17 as a small supply of a medicine for the purpose of familiarisation and acquiring experience. The provision of samples is limited to no more than 10 samples per year per product per health professional qualified to prescribe the product. Samples can only be supplied in response to a signed and dated written request. Companies have to comply with individual hospital arrangements and have systems of control and accountability.

  15.  Clause 18 prohibits the provision or offer of any gift, benefit in kind or pecuniary advantage as an inducement to prescribe, supply, administer, recommend or buy any medicine apart from promotional aids and competition prizes. Promotional aids must be inexpensive, cost the company no more than £6 plus VAT, and be relevant to the recipient's profession or employment. Competitions must be a genuine test of skill and prizes must be few in number, relevant to the recipient's profession and each cost no more than £100 plus VAT. The ABPI Code permits the provision of medical and educational goods and services to enhance patient care or benefit the NHS but these must not be an inducement to prescribe, supply, administer, recommend or buy any medicine. Detailed guidance is given in the supplementary information to Clause 18.1.

  16.  Clause 19 covers meetings and hospitality. All meetings, including sponsorship of scientific meetings and payment of travelling and accommodation expenses in connection with such meetings, are covered. Hospitality must only be provided in association with scientific meetings, promotional meetings, scientific congresses and other such meetings. It must be secondary to the purpose of the meeting and the level must be appropriate, with the cost not exceeding that which the recipients would normally adopt when paying for themselves. Hospitality can only be provided for persons who qualify as proper delegates in their own right.

  17.  When meetings are sponsored by pharmaceutical companies this must be disclosed in all the papers relating to the meeting (Clause 19.3). Material relating to medicines and their uses, whether promotional or not, which is sponsored by a pharmaceutical company must clearly indicate that it has been sponsored by that company. There is an exemption for market research which needs to state that it is sponsored by a pharmaceutical company (Clause 9.10).

  18.  Companies are required to formally certify promotional material in its final form before it is issued, as set out in Clause 14. Companies are also required to certify all meetings which involve travel outside the UK. Certification is undertaken by two nominated signatories, one of whom must be a registered medical practitioner and the other must be some other appropriately qualified person, often a pharmacist. The names of the signatories have to be provided in advance to the PMCPA and the MHRA. The certificate for promotional material must certify that the signatories have examined the material in its final form and that in their belief it is in accordance with the Code and the relevant advertising regulations and it is not inconsistent with the marketing authorisation and the SPC. Companies are advised to examine non-promotional material, such as press releases, market research, financial information for share holders, the stock exchange and the like to ensure that it is non-promotional. The use to which an item will be put is also an important consideration. Certificates and other details have to be preserved for not less than three years after final use of the material and be produced on request from the PMCPA and/or MHRA.

  19.  In addition to the clauses mentioned above, there are requirements that high standards must be maintained at all times and that material and activities must recognise the special nature of medicines, the professional nature of the audience and must not be likely to cause offence (Clauses 9.1 and 9.2). Clause 2 of the Code is used as a sign of particular censure. It states that activities or materials associated with promotion must never be such as to bring discredit upon or reduce confidence in the pharmaceutical industry. Any breach of the Code is seen as a serious matter, but a breach of Clause 2 is seen as a particularly serious matter.


  20.  If education for health professionals is promotional in nature then it is clearly covered by the Code. The legitimate exchange of medical and scientific information during the development of a medicine is not prohibited, provided such activity is not promotional (Clause 3).

  21.  Patient education is covered by Clause 20 which deals with relations with the general public.

  22.  Medicines must not be advertised to the general public if they are prescription only medicines or may not legally be advertised to the public. There is an exemption for vaccination campaigns approved by the Health Ministers. Companies can provide information both to patients and to the public provided it meets the requirements of Clause 20.2. Information must be factual, presented in a balanced way and must not raise unfounded hopes of successful treatment or be misleading with respect to safety of a medicine. Statements must not be made for the purpose of encouraging members of the public to ask their doctors to prescribe a specific medicine. European public assessment reports, SPCs, and package leaflets may be provided to members of the public on request and may be made available on websites. Companies can also provide materials about a medicine to patients who have already been prescribed that medicine, provided that such material is factual and non-promotional. Companies may conduct disease awareness or public health campaigns provided the purpose is to encourage members of the public to seek treatment for their symptoms while in no way promoting the use of a specific medicine. Particular care needs to be taken where a company's product, even though not named, is the only medicine relevant to the disease or symptom.

  23.  The Code also covers the Internet. Sites that are open access, ie available to all, must comply with Clause 20 of the Code ie no promotion of prescription only medicines to the general public. Websites with access restricted to health professionals may include advertising that complies with the Code.


  24.  Clinical research is comprehensively covered by law. The only relevant requirement in the Code is Clause 10 that clinical research and the like must not be disguised promotion.


Source and outcome of complaints

  25.  Complaints submitted under the ABPI Code come from three main sources: health professionals (40 (30%) of the 131 complaints received in 2003); companies (46% of complaints received in 2003) and those nominally made by the Director of the PMCPA (17% of complaints received in 2003). The Director takes up public criticisms of the industry such as published articles and the like. Companies occasionally make voluntary admissions to the PMCPA and anonymous complaints are considered. The 131 complaints received in 2003 led to 122 cases for consideration, some complaints related to matters not subject to the Code (no prima facie case) and others were withdrawn. Of the 122 cases considered in 2003, 97 (80%) were found in breach of the Code and 20% were found not to be in breach. Cases often consist of more than one allegation. In 2003, 366 allegations were considered with 208 (57%) ruled in breach and 43% ruled not in breach. In 2003, of the 65 rulings appealed 45 (69%) were unsuccessfully appealed and 20 (31%) were successfully appealed. Comprehensive information is published in the PMCPA Annual Report.[16] The PMCPA also carries out a regular scrutiny of advertisements and raises matters with companies which are usually settled without recourse to a formal complaint.


  26.  Complaints are first considered by the Code of Practice Panel, which consists of the Director of the Authority, Heather Simmonds (pharmacologist), the Secretary, Etta Logan (solicitor) and the Deputy Secretary, Jane Landles (pharmacist). The PMCPA is appointed by and reports to the ABPI Board of Management but it is not part of the day to day management structure of the ABPI. The Director of the PMCPA reports to the Code of Practice Appeal Board for guidance on the interpretation of the Code and the operation of the complaints procedure and to the President of the ABPI for administrative purposes.

  27.  The Panel considers each case on written evidence only and has access to expert assistance such as a medical opinion. The parties are provided with full details including the outcome. Both the complainant and the respondent can appeal the Panel's rulings to the Code of Practice Appeal Board; both see all relevant submissions and are entitled to attend or be represented at an appeal. Appeals can however be on the basis of written documents only. The Appeal Board has two roles, to hear appeals and to supervise the activities of the Panel. The Appeal Board is made up of 19 members including an independent legally qualified Chairman, Mr Nicholas Browne QC. In addition there are six other independent members: three medically qualified; one a pharmacist; one representative of the interest of patients and one from an independent body involved in providing information on medicines. All independent members are appointed in consultation with the MHRA and, in addition, the BMA for the medical members and the RPSGB for the pharmacist member. The remaining 12 members are from pharmaceutical companies, four medical directors or equivalent and eight senior executives. All members of the Appeal Board are appointed by the ABPI Board of Management. The Appeal Board also receives details of all cases completed at the Panel level.


  28.  In each case where a breach is ruled, the chief executive of the company concerned must give an undertaking that the practice in question will cease forthwith, if it has not already ceased, and that all possible steps have been taken to avoid a similar breach in the future. This means that materials have to be recalled immediately and destroyed. Companies cannot wait until replacement material is available. Companies are required to comply with undertakings given (Clause 22). The major sanction is the publication of comprehensive reports on all completed cases in the Code of Practice Review[17] which is published quarterly, widely circulated and freely available to all. The medical and pharmaceutical press frequently publish details of cases and occasionally details appear in the national press. Additional sanctions are imposed in serious cases.

  29.  The additional sanctions available to the Appeal Board include a requirement to recover items given in connection with the promotion of a medicine and a requirement for a company to undergo an audit of its procedures in relation to the Code, together with the ability to impose requirements on the company concerned to improve its procedures. The Appeal Board rarely requires recovery of items ruled in breach, although this sanction has recently been used in relation to a complaint made in 2003. Two of the complaints received in 2003 were the subject of an audit. This involves the Director of the PMCPA and either the Secretary or Deputy Secretary conducting an in depth analysis of the company's procedures for complying with all aspects of the Code including interviews with the chief executive, medical director, registered signatories and other employees, including a representative. A detailed report with recommendations is considered by the Appeal Board which can require a reaudit to check that the recommendations are implemented.

  30.  The additional sanctions available to the ABPI Board of Management include a public reprimand, audit (as for the Appeal Board), publication of a corrective statement and suspension or expulsion from the ABPI, or, for a company not a member of the ABPI, to advise the MHRA that responsibility for that company under the Code can no longer continue to be accepted. A public reprimand takes the form of an article on the front page of the Code of Practice Review and is often reported by the medical and pharmaceutical press. Arising from the complaints considered in 2003 one company was publicly reprimanded. It is more usual for audits to be required by the Appeal Board, although in 2003 the ABPI Board of Management required a company to undergo a reaudit in relation to a complaint considered in 2002, the initial audit having taken place in 2002. The ABPI Board has never required a company to publish a corrective statement nor has a company been expelled from membership of the ABPI. Companies have been suspended from membership of the ABPI, but this sanction has not been used since 1993. Two companies have been removed over time from the list of non-member companies complying with the Code.


  31.  Administrative charges are paid by pharmaceutical companies ruled in breach of the Code and companies which make unsuccessful complaints. The charges are £1,250 per matter if a case is settled at the Panel level and £5,000 per matter if an appeal is unsuccessful. No charges are paid by complainants outside the pharmaceutical industry. Administrative charges are not regarded as being fines.

  32.  The PMCPA is self financing with its income coming from an annual Code of Practice Levy paid directly to the PMCPA by members of the ABPI, administrative charges and charges for attending seminars on the Code. Further details appear in the Annual Report and the Protocol of Agreement.

11   ABPI Code of Practice for the Pharmaceutical Industry 2003 Edition. Available from the PMCPA, 12 Whitehall, London, SW1A 2DY ( Back

12   Protocol of Agreement between the Prescription Medicines Code of Practice Authority and The Association of the British Pharmaceutical Industry. Available from the PMCPA. Back

13   Proprietary Association of Great Britain. Vernon House, Sicilian Avenue, London, WC1A 2QS ( Back

14   European Directive 2001/83/EC on the Community Code relating to medicinal products for human use, as amended. Back

15   MAIL 130 March/April 2002. Available from the MHRA ( Back

16   Prescription Medicines Code of Practice Authority Annual Report 2003. Available from the PMCPA. Back

17   Code of Practice Review. Published quarterly and available from the PMCPA. Back

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Prepared 26 April 2005