1 Prescription Medicines Code of Practice Authority

1.1 The Prescription Medicines Code of Practice Authority (the ‘Authority’) is responsible for the administration of the ABPI Code of Practice for the Pharmaceutical Industry (the ‘Code’) including the provision of advice, guidance and training on the Code. It is also responsible for arranging conciliation between companies when requested to do so and for arranging scrutiny of advertising and meetings.

1.2 The Authority also administers the complaints procedure by which complaints made under the Code are considered by the Code of Practice Panel (the ‘Panel’) and, where required, by the Code of Practice Appeal Board (the ‘Appeal Board’).

1.3 The Authority is appointed by and reports to the Board of the Association of the British Pharmaceutical Industry (ABPI) (the ‘ABPI Board’) and includes the Chief Executive, Directors and Managers.

1.4 The appointments of the Chief Executive and Directors are made by representatives from the Authority, the Appeal Board and the ABPI Board, in consultation with the Medicines and Healthcare products Regulatory Agency. These vacancies should be externally advertised.

1.5 The Chief Executive reports to the Appeal Board for guidance on the interpretation of the Code. The Appeal Board also has a supervisory role in relation to the operation of the complaints procedure. The Chief Executive must provide a regular status report to the Appeal Board on complaints submitted under the Code and details of the action taken on them. If the Appeal Board has concerns about the operation of the complaints procedure, those concerns should be raised with the Chief Executive and, at the Appeal Board’s discretion, may be escalated to the President of the ABPI through the Chair of the Appeal Board.

The Chief Executive reports to the President of the ABPI (or, where a conflict of interest is identified or the President is absent, the Vice President of the ABPI) for administrative purposes. The Chief Executive does not report to the President in relation to decisions and actions taken within the complaints procedure. The President must consult the Chair of the Appeal Board before setting any aspect of the Chief Executive’s annual performance review which relates to the operation of the complaints procedure. Feedback from the Chair of the Appeal Board must be obtained to assist the President’s consideration of the Chief Executive’s performance.

1.6 A Director is authorised to act on behalf of the Chief Executive if the Chief Executive is absent. A Manager is authorised to act on behalf of the Chief Executive if the Chief Executive and Directors are absent.

1.7 The Chief Executive may consult the Chair of the Appeal Board or the Appeal Board upon any matter concerning the Code or its administration.

1.8 Members of the Authority must declare any conflicts of interest prior to appointment to the Authority, and before involvement in a case including acting as case preparation manager or adjudicating on a complaint. Members of the Authority previously employed by a pharmaceutical company are restricted from involvement in a case as described above on a matter relating to their former employer for a minimum period of three years. Co-optees must comply with the same conflicts of interest provisions.

1.9 Matters are referred to independent referees in specific situations identified in this Constitution and Procedure. Independent referees are identified by the Chief Executive and the Chair of the Appeal Board and may be, for example, a former independent member of the Appeal Board. Independent referees must declare any conflicts of interest before involvement in a case. The determinations of independent referees are final.

Overriding Objective

1.10 The overriding objective of this Constitution and Procedure is to ensure that cases are dealt with fairly and justly while protecting patient safety. When making procedural and discretionary decisions, members of the Authority, the Appeal Board and any independent referee must act in a way they consider most likely to further the overriding objective.

All parties, including the complainant and respondent, must take all reasonable steps to assist the PMCPA and the Appeal Board to further the overriding objective.

Dealing with cases fairly and justly includes:

• dealing with each case in ways which are proportionate to the importance of the case and the complexity of the issues;

• avoiding unnecessary formality and adopting flexibility in the proceedings where appropriate;

• ensuring, so far as practicable, that the parties are able to participate fully in the proceedings; and

• avoiding delay to the case in hand and other cases, so far as compatible with proper consideration of the issues.

Case Management Directions

1.11 ‘Case management directions’ are directions as to the manner in which proceedings will be conducted. They may include, but are not limited to, directions about: (i) what material may go in front of the Panel or Appeal Board; (ii) what material may be redacted; (iii) whether a hearing is conducted remotely or in person; or (iv) providing dictation support to an individual who is unable to submit a complaint in writing.

Members of the Authority may give a case management direction at any time prior to an appeal being heard, including a direction amending, suspending, or setting aside an earlier direction.

The Chair of the Appeal Board may give a direction at any time in relation to cases which have been appealed to the Appeal Board, including a direction amending, suspending, or setting aside an earlier direction.

Set Aside for Procedural Error

1.12 The Chief Executive may give a direction at any time before an appeal has been lodged, setting aside a decision of the case preparation manager or Panel where there has been an error in complying with the procedure set out in this Constitution for dealing with cases (a ‘procedural error’). Where the Chief Executive is conflicted, such direction may be given by a Director.

The Chair of the Appeal Board may give a direction at any time before an appeal has been heard, setting aside a decision of the case preparation manager or Panel where there has been a procedural error.

The Chair of the Appeal Board may give a direction at any time setting aside a decision of the Appeal Board where there has been a procedural error.

Before making a final decision to set a matter aside, the Chief Executive or Chair of the Appeal Board must give parties an opportunity to make written submissions. Directions setting aside a decision should be given in writing with an explanation of the procedural error.

When a decision is set aside for procedural error, that decision will have no effect and the case will proceed as if that decision had not been made.

Decisions to set aside will be referred to an independent referee at the request of any party.

Non-Compliance

1.13 Failure of any party to comply with: (i) its obligation to assist the Authority and Appeal Board to further the overriding objective; (ii) any requirement in this Constitution and Procedure; or (iii) a direction issued by the Chief Executive or Chair of the Appeal Board, may be reported to the Chair of the Appeal Board.

The Chair of the Appeal Board may take such action as they consider just, in line with the overriding objective, which may include waiving the requirement, amending the direction, requiring compliance, restricting a party’s participation in the proceedings, or determining that a case should not proceed. The Chair of the Appeal Board must refer a determination that a case should not proceed to an independent referee at the request of any party.