15 Case Reports

15.1 At the conclusion of any case under the Code, the parties will be advised of the outcome and a report must be published summarising the details of the case.

15.2 The respondent company and the medicine concerned will be named in the report.

In a case where the complaint was initiated by a company or by an organisation or official body, that company or organisation or official body will be named in the report. The information given must not, however, be such as to identify any individual.

Where expert assistance has been obtained by either the Panel or the Appeal Board, this will be referred to in the report.

Where a company has been required to issue a corrective statement, the report will reproduce its text and provide details of how the corrective statement was disseminated.

15.3 A copy of the report on a case must be sent to both the complainant and the respondent company prior to publication. Any amendments to the report suggested by these parties will be considered by the Chief Executive, consulting with the other party where appropriate. If either party does not accept the Chief Executive’s decision as to whether or not a report should be amended, the matter is referred to the Chair of the Appeal Board for their decision which is final.

15.4 Prior to publication, copies of all case reports must be submitted to the Appeal Board for review as part of its supervisory role in relation to the operation of the complaints process.

15.5 Copies of the reports may be sent to the Medicines and Healthcare products Regulatory Agency, the Competition and Markets Authority, the Serious Fraud Office, the British Medical Association, the Royal Pharmaceutical Society, the Royal College of Nursing and the Editors of the BMJ, The Pharmaceutical Journal and the Nursing Standard. Copies are also available to anyone on request.

15.6 Case reports must appear on the Authority’s website. The website also carries brief details of complaints which are currently under consideration but not yet resolved and the texts and modes of dissemination of any corrective statements that companies have been required to issue for at least the past twelve months. The Authority’s website also carries interim case reports in respect of cases where publication of the final report is delayed because either the Appeal Board or the ABPI Board has required an audit of the respondent company’s procedures in relation to the Code.

Access to the Authority’s website must be unrestricted.

15.7 Following publication of the relevant case reports, the Authority will advertise in the medical, pharmaceutical and nursing press brief details of cases in which companies were ruled in breach of Clause 2 of the Code, were required to issue a corrective statement or were the subject of a public reprimand. A press release is also issued to the media and other stakeholders. Such advertisements also appear on the Authority’s website. The companies concerned must contribute to the cost of the press advertisements.

A copy of the advertisement must be sent to the respondent company prior to publication. Any requested amendments to the advertisement will be considered by the Chief Executive. If the respondent company does not accept the Chief Executive’s decision, the matter is referred to the Chair of the Appeal Board for their decision which is final.