5 Actions on Complaints

5.1 When the Authority receives information from which it appears that a company (being either a member of the ABPI or a company which, although not a member, has agreed to comply with the Code and accept the jurisdiction of the Authority) may have contravened the Code, the Chief Executive must assign a member of the Authority (who may be the Chief Executive) to be the case preparation manager to process the matter and, if appropriate, prepare case papers for the Panel.

The Chief Executive is responsible for ensuring that the preparation of a case and the adjudication of it are carried out by different members of the Authority.

Any member of the Authority who has advised the case preparation manager in relation to a complaint must not be a member of the Panel which subsequently considers that case, nor be present when it is considered.

5.2 The case preparation manager:

• must determine whether a case should proceed through the full complaints procedure and go before the Panel, or should proceed through the abridged complaints procedure, or should not proceed

• may invite evidence from third parties when considered to be appropriate even though the primary responsibility for the provision of evidence lies with the parties to a case

• may delay processing a complaint if the facts are essentially similar to those before an external forum, such as an employment tribunal; this does not apply to matters before the Medicines and Healthcare products Regulatory Agency

• may amalgamate a complaint with an ongoing complaint or complaints at any time where two or more complaints are based on essentially the same evidence.

When a complaint is delayed or amalgamated, as above, the complainant may appeal against the delay or amalgamation to an independent referee.

5.3 If a complaint concerns a matter closely similar to one which has been the subject of a previous adjudication, the case preparation manager may direct, at any time before the complaint is adjudicated upon by the Panel, that the complaint should not proceed. In making that determination the case preparation manager must bear in mind the overriding objective, and must additionally consider whether: (i) new relevant evidence has been adduced by the complainant or: (ii) the passage of time or a change in circumstances raises doubts as to whether the same decision would be made in respect of the current complaint.

5.4 If, in the view of the case preparation manager, a complaint does not show that a company may have contravened the Code or the complainant has not provided sufficient detail to enable a company to properly respond, the case preparation manager may determine that the complaint will not proceed and the complainant will be so advised.

Complaints Not Proceeding

5.5 Where a decision is taken that a complaint will not be proceeded with in line with this Constitution and Procedure, the decision will be referred to an independent referee if any party so requests subject to the exception below.

Where a decision is taken that the matter should be dealt with by another UK authority (e.g. Advertising Standards Authority, Medicines and Healthcare products Regulatory Agency, General Medical Council, General Pharmaceutical Council), there is no right of referral to an independent referee. In such circumstances, the complainant will be provided with contact details for the relevant UK authority or, if the complainant is non-contactable, the complaint may be forwarded to the relevant UK authority.

5.6 If a complaint is received about a company other than one of those referred to in Paragraph 5.1, the case preparation manager will invite the company to agree to comply with the Code and accept the jurisdiction of the Authority (unless it has previously declined to do so within the previous year). In the absence of such agreement, the complaint will not be proceeded with and the complainant will be advised to refer the matter to the Medicines and Healthcare products Regulatory Agency. If the complainant is non-contactable, the complaint will be forwarded to the Medicines and Healthcare products Regulatory Agency if the matter is covered by UK law.

Complaints Proceeding

5.7 The case preparation manager will contact the managing director or chief executive or equivalent of the company which is alleged to have breached the Code and will request that they provide a complete response to the matters of complaint.

To assist companies in ensuring that a complete response is submitted, the case preparation manager may suggest relevant supporting material to be supplied. It is nonetheless the responsibility of the respondent to ensure that a full response is submitted.

To facilitate the complaints procedure by ensuring that the requisite information is available, the case preparation manager may request copies of any relevant material from a pharmaceutical company, including copies of the certificates authorising any such material and copies of relevant briefing material for representatives.

5.8 If the complainant is not a pharmaceutical company, the case preparation manager may identify which clauses of the Code must be addressed by the respondent company.

If the complainant has cited a clause but, in the view of the case preparation manager, the complaint does not show that the company may have breached that clause, the clause will be removed from the complaint. The complainant will be informed, with written reasons given. For cases going through the full complaints procedure, if the complainant does not agree with the case preparation manager’s decision to remove a clause, the clause will be included and provided to the company to provide a response.

5.9 Unless the information is disclosed in the complaint, a complainant other than a pharmaceutical company will be asked whether or not they have any commercial, financial or other interest in the matter of complaint or in the company concerned, such as whether the complainant is an employee or ex-employee, or in a competitor.

Such interests will be disclosed to the respondent company and will normally be included in the case report.

5.10 When a complaint is not from a pharmaceutical company, the Authority strongly encourages the complainant to be contactable to the Authority in order to fully participate in the complaints process. The Authority will not share the name or contact details of the complainant with other parties, including the respondent company. If it is considered necessary to share information which may identify the complainant with the respondent company, to enable the company to respond to the complaint, then it will only be shared with the prior permission of the complainant. Failure to give permission may result in the case preparation manager deciding that the case should not proceed under Paragraph 5.4.

Complainants are strongly encouraged, but not required, to initially attempt to resolve the complaint using the company’s internal or external whistleblowing and/or dispute resolution procedures.

5.11 When the complaint is from a pharmaceutical company, the complaint must be signed or authorised in writing by the company’s managing director or chief executive or equivalent and must state those clauses of the Code which are alleged to have been breached.

A complaint from a pharmaceutical company will be accepted only if the case preparation manager is satisfied that the company concerned has previously informed the company alleged to have breached the Code that it proposed to make a formal complaint and offered intercompany dialogue at a senior level in an attempt to resolve the matter, but that this offer was refused or dialogue proved unsuccessful (the ‘intercompany dialogue condition’). Details of the actions taken must be provided as part of the complaint. The intercompany dialogue condition does not apply where the allegation is that a company has failed to comply with an undertaking that it has given to the Authority.

If, in the view of the case preparation manager, the intercompany dialogue condition has not been met, the complainant shall be so advised. If the complainant does not accept that view, the matter will be referred to an independent referee.

Attention is drawn to the availability of conciliation prior to making a complaint. Information about conciliation is available from the Chief Executive.

5.12 Upon receipt of a complaint, the respondent company has fifteen working days in which to submit its response in writing. An extension of time to respond may be granted at the discretion of the case preparation manager.

5.13 When the respondent company’s response is received, the case preparation manager must determine whether there is a prima facie case to answer under the Code. If, in the view of the case preparation manager, no prima facie case has been established, the complainant and the respondent company are so advised. If the complainant does not accept that view, the matter is referred to the Panel to determine whether or not there has been a breach of the Code. If the complainant submits further evidence, then the respondent company may be invited to comment on that further evidence before the matter is referred to the Panel.

5.14 Companies are encouraged to make voluntary admissions by advising the Authority where they consider that they may have breached the Code. The Chief Executive will treat the voluntary admission as a complaint. The case preparation manager may identify the clauses of the Code to be addressed and the company’s response will be invited. When the response is received, the procedure under Paragraph 5.13 will be followed.

5.15 Parties must be notified when a case has been referred to the Panel.