CONSTITUTION AND PROCEDURE FOR THE PRESCRIPTION MEDICINES CODE OF PRACTICE AUTHORITY PROPOSED AMENDMENTS AMENDMENT NUMBER 1 PARAGRAPH 13 – CASE REPORTS Paragraph 13.5 Current text ‘Full case reports in printed form are published each quarter by the Authority. Copies of the reports are sent to the Medicines and Healthcare products Regulatory Agency, the Office of Fair Trading, 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. Proposal Add the Serious Fraud Office to the list of those to whom the case reports are sent. Reason Arising from the cooperation between the SFO and the Authority in the light of the Bribery Act 2010. * * * * * AMENDMENT NUMBER 2 PARAGRAPH 19 – AMENDMENTS TO THE CODE OF PRACTICE AND CONSTITUTION AND PROCEDURE Paragraph 19.1 Current text ‘The Code and this Constitution and Procedure may be amended by a simply majority of those present and voting at a General Meeting of the ABPI. Notwithstanding the above, where a proposal to amend the Code or this Constitution and Procedure arises solely from the ABPI’s obligation to comply with the EFPIA Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals and/or with the EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations, both of the European Federation of Pharmaceutical Industries and Associations, then the ABPI Board may decide that formal approval at an 2 ABPI General Meeting is not necessary. ABPI member companies must, nonetheless, be consulted in relation to the proposed texts of the changes.’ Proposal Delete the second paragraph and replace by: Notwithstanding the above, where a proposal to amend the Code or this Constitution and Procedure arises solely from the ABPI’s obligation to comply with any code promulgated by the European Federation of Pharmaceutical Industries and Associations (EFPIA), then the ABPI Board may decide that formal approval at an ABPI General Meeting is not necessary. ABPI member companies must nonetheless be consulted in relation to the proposed texts of the changes.’ Reason To accommodate the new EFPIA Code on disclosure of transfers of value from pharmaceutical companies to healthcare professionals and organizations in an open ended way which will cover any future codes from EFPIA. * * * * * AMENDMENT NUMBER 3 PARAGRAPH 19 Paragraph 19.2 Current text ‘The views of the Authority and the Appeal Board must be sought on any proposal to amend the Code or this Constitution and Procedure. The views of the Medicines and Healthcare products Regulatory Agency, the British Medical Association, the Royal Pharmaceutical Society and the Royal College of Nursing must also be invited.’ Proposal Add the Serious Fraud Office and the Office of Fair Trading to the list of those to be consulted. Reason The Authority has consulted with the Serious Fraud Office since the Bribery Act 2010. The Office of Fair Trading is sent copies of the case reports and has been consulted on occasion about changes to the Code. Including it in Paragraph 19.2 will reflect this. * 26 June 2013 * * * *