Responding to a complaint

The overriding objective of the PMCPA’s Constitution and Procedure is to ensure that cases are dealt with fairly and justly while protecting patient safety.

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.

Preparing your response

The PMCPA is not an investigatory body. All complaints are judged on the evidence provided by the parties.

Respondent companies must ensure that all the necessary and relevant information is included in their response.

When submitting a response, companies should ensure that all the documents requested by the case preparation manager have been provided. This is likely to include, among other things:

• copies of all references cited in support of any claims in the materials at issue

• copies of any other references cited in your response

• a copy of the SPC for the relevant medicine(s)

• copies of the certificates approving the materials/activities relevant to the complaint.

If it is not clear what information is required, the company should contact the member of the PMCPA who made the request.

As a respondent, you should try to put yourself in the Code of Practice Panel’s position and consider what questions it would want answered and what documents it would want to see with regard to resolving the complaint at issue.

• When submitting emails as evidence, it is helpful if they are submitted in chronological order, annotated to clearly show which company or organisation the correspondents represent. It would also be helpful to include the correspondents’ job titles. Contact details can be redacted

• If providing written agreements or invoices as evidence, contact and bank details can be redacted

• When submitting audio or audiovisual material, a transcript must be provided.

Consider asking someone who is not familiar with the matters at issue to read your submission to ensure that it sets out a comprehensive and well-reasoned argument in response to the complaint and provides all the necessary supporting documentation.

Confidentiality and anonymity

The PMCPA accepts anonymous complaints. However, complainants are strongly encouraged to provide contact details so that they can participate fully in the process, and relevant information about their interests in the matter of complaint.

The PMCPA keeps the names of complainants from outside the pharmaceutical industry confidential. In exceptional circumstances it may be necessary for a company to know the identity of the complainant so that the matter can be properly investigated. In these circumstances, the complainant’s name will only be disclosed to the company with the complainant’s permission.

We ask complainants to provide information about any commercial, financial or other interest they have in the matter of complaint or in the company concerned. Such interest might include being an employee, ex-employee or in a competitor. Such interests will be disclosed to the respondent company and will normally be included in the published case report.

Your response to the complaint may be shared with the complainant. If the Panel rules no breach of the Code, the complainant will be sent a copy of the company’s original response to the complaint, including its enclosures. If you regard any of the material included in your submission as being confidential, please indicate this clearly within your response letter, along with reasons. Please redact any personal information, such as names, email addresses or telephone numbers, that is not relevant to the case. Please be aware that a version of your response will also appear in the published case report.

Non-compliance

Failure of any party to comply with:

• its obligation to assist the PMCPA and Appeal Board to further the overriding objective

• any requirement in the PMCPA’s Constitution and Procedure

• a direction issued by the Chief Executive or Chair of the Appeal Board
may be reported to the Chair of the Appeal Board.