CODE OF PRACTICE REVIEW PRESCRIPTION MEDICINES CODE OF PRACTICE AUTHORITY CODE OF PRACTICE REVIEW NUMBER 27 FEBRUARY 2000 PRESCRIPTION MEDICINES The Prescription Medicines Code of Practice Authority was established by The Association of the British Pharmaceutical Industry (ABPI) in CODE OF PRACTICE AUTHORITY 1993 to operate the ABPI Code of Practice for the Pharmaceutical Industry independently of the Association itself. The Prescription Medicines Code of Practice ● the provision of information to the Making Authority was established by The general public either directly or Number of complaints Association of the British Pharmaceutical indirectly complaints and Industry (ABPI) in 1993 to operate the Code ● all other sales promotion in whatever of Practice for the Pharmaceutical Industry in 1999 down on 1998 responding to form, such as participation in at arm’s length from the ABPI itself. exhibitions, the use of audio-cassettes, them Compliance with the Code is obligatory for films, records, tapes, video recordings, There were 127 complaints under the Code of Practice in 1999 as ABPI member companies and, in addition, electronic media, interactive data compared with 144 in 1998. There were 145 in 1997 and 102 in 1996. Inter-company complaints are often more than sixty non member companies systems, the Internet and the like. The number of cases usually differs from the number of complaints accompanied by previous have voluntarily agreed to comply with the Complaints submitted under the Code are because some complaints involve more than one company and because correspondence between the parties. Code and to accept the jurisdiction of the considered by the Code of Practice Panel While this is helpful, the provision of Authority. some complaints do not become cases at all, usually because no prima which consists of the three members of the such correspondence should not be a facie breach is established. There were 128 cases in 1999 as compared substitute for clearly setting out the The Code covers the advertising of Code of Practice Authority acting with the with 138 in 1998. medicines to health professionals and assistance of independent expert advisers matters complained of in the actual administrative staff and also covers where appropriate. Both complainants and For only the second time, the number of complaints from other letter of complaint. The Authority information about such medicines made respondents may appeal to the Code of pharmaceutical companies exceeded the number of complaints from cannot be expected to try to tease out available to the general public. Practice Appeal Board against rulings made health professionals, 48% coming from companies and 38% from health from inter-company correspondence the issues which remain unresolved. by the Panel. The Code of Practice Appeal professionals. This was also the pattern in 1996. Usually the greatest It covers: Similarly, responses which are Board is chaired by an independent legally number of complaints come from health professionals. The remainder ● accompanied by previous journal and direct mail advertising qualified Chairman, Mr Philip Cox QC, and of the complaints in 1999 came from a member of the public, from includes independent members from correspondence should deal with all of ● the activities of representatives including various organisations and from the Director of the Authority. outside the industry. the matters complained of in the actual detail aids and other printed material Since the Authority was established in 1993, there have been wide but letter of response. used by representatives In each case where a breach of the Code is ruled, the company concerned must give an unexplainable variations in the number of complaints received each When multi-issue complaints are made, ● the supply of samples undertaking that the practice in question year, ranging from 92 in 1993 to 145 in both 1994 and 1997. it is helpful if the issues are numbered in a logical fashion in the letter of ● the provision of inducements to has ceased forthwith and that all possible February 2000 prescribe, supply or buy medicines by steps have been taken to avoid a similar complaint and if the same numbering the gift, offer or promise of any benefit breach in the future. An undertaking must system is used by the respondent. or bonus, whether in money or in kind be accompanied by details of the action The co-operation of companies on these taken to implement the ruling. Additional 145 145 144 ● the provision of hospitality points will assist the Authority in the sanctions are imposed in serious cases. resolution of complaints. ● the organisation of promotional 127 Complaints about the promotion of meetings medicines should be sent to the Director of ● the sponsorship of scientific and other the Prescription Medicines Code of Practice 104 102 meetings including payment of Authority, 12 Whitehall, London SW1A 2DY 92 Changes to signatories travelling and accommodation expenses (telephone 0171-930 9677 Companies are reminded that changes in connection therewith facsimile 0171-930 4554). to the signatories who certify promotional material in accordance with Clause 14 of the Code of Practice have to be notified promptly to both the Authority and the Advertising Unit of the Post Licensing Division of the Medicines Control Agency. Some companies have notified no 1993 1994 1995 1996 1997 1998 1999 changes for years and it may be that changes have been made but never notified. Complying with undertakings CODE OF PRACTICE TRAINING Training seminars on the Code of Practice, open to all comers, are From time to time, claims which have run by the Code of Practice Authority on a regular basis at the previously been ruled in breach of the Royal Society of Medicine in London. Code pop up later in other formats, such as on a forgotten exhibition stand. These seminars comprise a full day course offering lectures on the Companies are reminded that once they Code and the procedures under which complaints are considered, have accepted that a claim etc is in discussion in syndicate groups on case studies and the opportunity breach of the Code they must ensure to put questions to the Code of Practice Authority. that it is removed promptly from all promotional material in whatever form. Forthcoming Code of Practice seminar dates on which places remain If representative materials are involved, available are: representatives must be given appropriate instructions in writing to Tuesday, 18 April ensure that items in breach do not Monday, 22 May continue to be used by them and that inappropriate oral statements are not Friday, 9 June made. Journal advertisements already Short training sessions on the Code or full all day seminars can be booked must be cancelled unless it is too late to prevent their further arranged for individual companies, including advertising and public appearance, in which case full details of relations agencies and member and non member companies of the future appearances must be given on ABPI. Training sessions can be tailored to the requirements of the the form of undertaking and assurance. individual company. For further information regarding any of the above, please contact Jean Rollingson for details (020 7930 9677 extn 1443). How to contact the Authority Direct lines can be used to contact Our address is: members of the Authority. Prescription Medicines Heather Simmonds: 020 7747 1438 Code of Practice Authority Etta Logan: 020 7747 1405 12 Whitehall Jane Landles: 020 7747 1415 London SW1A 2DY The above are available to give Telephone: 020 7930 9677 informal advice on the Facsimile: 020 7930 4554 application of the Code of Practice. Copies of the Code of Practice for the Pharmaceutical Industry The Authority rather than the and of this Review can be ABPI is the contact point for obtained from Lisa Matthews information on the application of (020 7930 9677 extn 1473). the Code. CASE AUTH/879/5/99 HOSPITAL PHARMACIST v SERVIER Breach of undertaking A hospital pharmacist complained about the fourth issue of a The Appeal Board considered that an undertaking journal entitled ‘Highlights from … The European was an important document. The Appeal Board Cardiologist – Journal by Fax’ sent to him by Servier. He had noted that the company had taken steps to comply previously complained about the first issue of this journal with the undertaking but the amendments to the which had been ruled in breach of the Code (Case material had not been sufficient. The Appeal Board AUTH/721/6/98). Once again his first impression was that the considered that the company’s failure to comply articles appearing in the publication were taken from a well- with its undertaking brought discredit upon and known journal called ‘The European Cardiologist Journal’ of reduced confidence in the pharmaceutical industry. which articles contained therein were available by fax on The Panel’s rulings were all upheld. request. This did not appear to be the case. There was a well A hospital pharmacist complained about a mailing known periodical called ‘The European Journal of sent by Servier Laboratories Ltd. The mailing Cardiology’ which was now called ‘The International Journal consisted of a journal entitled ‘Highlights from …The of Cardiology’. The publication by Servier appeared to be European Cardiologist – Journal by Fax’. The Servier some sort of promotional newsletter. The only difference logo and company name, together with the statement between it and the one at issue before was that the ‘Provided as a service to medicine by Servier advertisement for Coversyl no longer appeared on the back Laboratories’ were given on the front cover. This was page, but on a sleeve that enclosed the publication. The issue number 4 in the series. The inside front cover complainant believed that the presentation of articles in this consisted largely of a ‘Dear Colleague’ letter from the way still did not clearly indicate that the highlights did not Assistant Project Manager – Cardiovascular Products.