Intercompany dialogue

The following guidance provides details of the process a pharmaceutical company should undertake in an attempt to resolve an alleged breach of the Code with another pharmaceutical company prior to making a formal complaint to the PMCPA.

Background

The Constitution and Procedure for the Prescription Medicines Code of Practice Authority (Paragraph 5.11) requires intercompany dialogue in advance of any complaint from a pharmaceutical company being accepted. Complaints can only proceed if the case preparation manager is satisfied that the complainant company informed the respondent company 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 was refused or dialogue proved unsuccessful. Details of the actions taken must be provided as part of the complaint. In addition, a complaint from a company must be signed or authorised by the chief executive and state the clauses of the Code alleged to have been breached.

The requirements for intercompany dialogue in the Constitution and Procedure do not apply where failure to comply with an undertaking given to the Authority in a previous case is alleged.

The industry recognises the contribution that intercompany dialogue makes to robust, effective self-regulation which relies upon companies making fully informed responses to complaints as well as upon the transparency and openness of both parties.

Recommended process

Initial complaint

Normally, a telephone call is made first to alert the respondent company to a complaint and to outline the basis of that complaint. This should be followed by written details of the specific points considered to be in breach of the Code, including the relevant clauses.

Communication should be between appropriate levels of relevant departments of the companies concerned. This will vary given the size and resources available within each company, but ideally those responsible for certifying the material, activity, etc. under the Code should be involved in the initial contact.

The respondent company should normally be given ten working days to respond to the complaint. A shorter period of time could be negotiated, particularly if a public health or safety issue is involved, or if there is a pressing and growing media issue resulting from a press release. Longer periods of time could also be agreed. Parties are expected to act within the spirit of the Code when agreeing timelines.

Initial response

The response should address all of the points raised and include any proposed amendments or actions and timelines. The amendments, actions and timelines should be treated with the same importance as when an undertaking is given to the PMCPA following a ruling of a breach of the Code. If no response is received within a reasonable time, then a complaint can be submitted to the PMCPA on the basis that intercompany dialogue has been refused. The success of intercompany dialogue should be judged on whether and to what extent it achieved the action sought, and not on why the respondent complied.

It is not necessary for a respondent company to admit that an item or activity is in breach of the Code for it to be amended in the course of intercompany dialogue.

Complaints should not be made by the respondent in its response. New complaints should be made separately.

Follow-up by complainant

The complainant should provide written comments to the respondent stating clearly its position with respect to all points originally raised. This should normally be within ten working days of receipt of the response.

If all points are accepted, intercompany dialogue can be seen to have successfully concluded and should be documented as such. If some or all points are outstanding this should be made clear to the respondent with restatement of the issues, rationale and relevant clauses where necessary.

Subsequent dialogue

If progress is being made, parties are encouraged to continue the dialogue. If, however, no progress is made and the likelihood of such seems remote, then a complaint may be submitted to the PMCPA.

At any stage, face-to-face meetings and teleconferences are encouraged to allow debate and resolution of differences wherever possible. Formal minutes agreed by both parties with appropriate timescales are helpful. Those taking part in such discussions should be sufficiently senior to be able to agree on actions going forward.

Written correspondence or minutes of meetings should clearly state the outcome to avoid differences of opinion as to each party’s position. Where agreement has been reached it is advisable to agree timescales for any changes to be made.

Further guidance

Should a company fail to honour its commitment to withdraw or amend material or practices, further intercompany dialogue is encouraged, although a complaint to the PMCPA could be submitted on the basis that intercompany dialogue was unsuccessful.

Where intercompany dialogue has reached a satisfactory conclusion, companies should not resurrect any issue at a later date as part of a complaint to the PMCPA without first attempting further intercompany dialogue.

A senior manager of each company must be involved in the last round of intercompany dialogue prior to finalising a formal complaint to the PMCPA. Depending on the subject matter, it is often helpful if this is at medical director level.

Submitting a complaint to the PMCPA

Companies should submit a wholly separate and complete letter of complaint to the PMCPA and attach copies of all relevant intercompany correspondence to demonstrate that Paragraph 5.11 of the Constitution and Procedure has been followed.

The complaint must be signed or authorised by the chief executive and state the clauses of the Code alleged to have been breached.

The complainant should inform the respondent at the same time as submission of the complaint to the PMCPA.

If the requirements of Paragraph 5.11 of the Constitution and Procedure are not satisfied, the case preparation manager will so advise the complainant company and the complaint will not proceed. This could happen either when the PMCPA receives the complaint or when the response to the complaint is received. If the complainant company does not accept the case preparation manager's decision, the matter is referred to an independent referee identified by the Chief Executive and the Chair of the Code of Practice Appeal Board, for example a former independent member of the Appeal Board, for their decision which is final.

It is not unusual in intercompany complaints for the respondent company to claim that the requirements of Paragraph 5.11 have not been met. Parties are reminded that for the process of self-regulation to be efficient, it is important to comply with both the letter and the spirit of the Constitution and Procedure in this regard. Thus, complainant companies must be consistent in their citation of clauses of the Code. If intercompany dialogue has been about Clause 6.1, the PMCPA will not accept a complaint about the same matter which cites Clause 14.4. However, complaints to the PMCPA do not have to use identical language to that used in intercompany dialogue, providing that the formal complaint is not inconsistent with, and does not change the substance of, previous discussions.