5 Action on Complaints
5.1 When the Director 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 Director must assign a member of the Authority (who may be the Director) to be the case preparation manager to process the matter and, if appropriate, prepare case papers for the Panel.
The case preparation manager must not divulge to other members of the Authority details of matters being processed until the formal case papers are provided to the Panel for consideration as provided for in Paragraph 5.5 below.
The Director is responsible for ensuring that the preparation of a case and the adjudication of it are carried out by different members of the Authority and must take steps to make certain that this separation is maintained in the event of absences of those involved.
The Director may delegate to a case preparation manager one or more of his/her responsibilities under this Constitution and Procedure when he/she considers it appropriate and necessary to do so.
The case preparation manager:
- determines whether a case should go before the Panel
- 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 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 identified by the Director and the Chair of the Appeal Board, for example a former independent member of the Appeal Board, for his/her determination which is final.
5.2 The managing director or chief executive or equivalent of the company concerned is requested to 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. If the complainant is not a pharmaceutical company, the case preparation manager may suggest the clauses of the Code to be addressed.
If a complaint is received about a company other than one of those referred to in Paragraph 5.1 above, it is invited by the case preparation manager to agree to comply with the Code and accept the jurisdiction of the Authority (unless it has previously declined to do so). In the absence of such agreement, the complaint is not proceeded with and the complainant is advised to refer the matter to the Medicines and Healthcare products Regulatory Agency.
Unless the information is disclosed in the complaint, a complainant other than a pharmaceutical company is 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.
If a complaint concerns a matter closely similar to one which has been the subject of a previous adjudication, it may be allowed to proceed at the discretion of the Director if new evidence is adduced by the complainant or if 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. The Director should normally allow a complaint to proceed if it covers matters similar to those in a decision of the Panel where no breach of the Code was ruled and which was not the subject of appeal to the Appeal Board.
If a complainant does not accept a decision of the Director that a complaint should not be proceeded with because a similar complaint has been adjudicated upon previously and nothing has changed in the meantime, then the matter is referred to an independent referee identified by the Director and the Chair of the Appeal Board, for example a former independent member of the Appeal Board, for his/her determination which is final.
If, in the view of the Director, a complaint does not show that there may have been a breach of the Code, the complainant will be so advised. If the complainant does not accept that view, the matter is referred to an independent referee identified by the Director and the Chair of the Appeal Board, for example a former independent member of the Appeal Board, for his/her determination which is final.
5.3 When the complaint is from a pharmaceutical company, the complaint must be signed or authorized 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 Director 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 inter-company dialogue at a senior level in an attempt to resolve the matter, but that this offer was refused or dialogue proved unsuccessful. A formal statement detailing the actions taken must be provided. This requirement does not apply where the allegation is that a company has failed to comply with an undertaking that it has given and is in breach of Clause 29 of the Code.
If, in the view of the Director, that condition has not been met, the complainant shall be so advised. If the complainant does not accept that view, the matter is referred to an independent referee identified by the Director and the Chair of the Appeal Board, for example a former independent member of the Appeal Board, for his/her determination which is final.
Attention is drawn to the availability of conciliation prior to making a complaint as referred to in Paragraph 18.2 below. Information about conciliation is available from the Director.
5.4 Upon receipt of a complaint, the company concerned has ten working days in which to submit its comments in writing.
5.5 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 Code of Practice Panel to determine whether or not there has been a breach of the Code. If the complainant submits further evidence, then the respondent company shall be invited to comment on that further evidence before the matter is referred to the Panel.
5.6 When a company advises the Authority that it may have breached the Code, the Director will treat the matter as a complaint. The company’s response is invited. The case preparation manager may suggest the clauses of the Code to be addressed. When the response is received the procedure under Paragraph 5.5 above will be followed.
5.7 The parties must be notified that a case has been referred to the Panel.