Appeal procedures

Paragraph 8.3 of the PMCPA Constitution and Procedure states that the complainant and the respondent company in a case may appeal to the Code of Practice Appeal Board against rulings made by the Code of Practice Panel.

The following is intended to assist the complainant and respondent company when lodging or responding to an appeal. The PMCPA and the Appeal Board will expect the recommendations below to be followed as closely as possible.

The numbers in brackets refer to the relevant paragraphs of the Constitution and Procedure.

Lodging an appeal

Timelines

You will be notified of the deadlines for appeal when you are sent the Panel’s ruling.

  • You must give notice of your intention to appeal within five working days of notification of the Panel’s ruling.
  • You must lodge your appeal within 10 working days of notification of the Panel’s ruling.

The appeal must state:
• which ruling(s) is/are appealed – please state the clause number
• your detailed reasons as to why the ruling is not accepted.

An extension to the five and 10 working days allowed can be granted at the discretion of the Chief Executive of the PMCPA but only in exceptional circumstances.

Complainants from outside of the pharmaceutical industry who have difficulty in responding within the time allowed (e.g. because of professional commitments or holidays) should contact the Chief Executive as soon as possible after they receive notification of the Panel’s ruling, so that alternative arrangements can be made.

Companies should note that if the company appeals some rulings but accepts others, then it must provide the requisite undertaking and assurance in respect of those rulings which it accepts within five days of notification of the ruling (8.4). In certain circumstances, the Panel may decide that, if there is an appeal, the company ruled in breach must suspend the use of the material or activity pending the final outcome (8.4).

Preparing your reasons for appeal

Appeals must be accompanied by reasons as to why the Panel’s ruling is not accepted.

When preparing an appeal, bear in mind that members of the Appeal Board will have received and read all of the prior documentation in full.

The Appeal Board will receive:
• the complaint and its attachments
• the letter from the PMCPA notifying the respondent company of the complaint
• the company’s response to the complaint and any attachments
• the Code of Practice Panel minute
• the letters from the PMCPA notifying the appellant of the Panel ruling
• the appeal and its attachments
• subsequent comments from the parties (see below)
• copies of published case reports referred to by the parties.

Please be guided by the following points when preparing your written appeal submission:

  • You should aim to provide a clear, concise exposition of the facts
  • Repetition should be avoided
  • All points should be covered in the main text, without the use of footnotes
  • If more than one ruling is appealed, matters must be dealt with in the same order as in the Panel’s ruling
  • In a multi-issue case, the appeal must follow any numbering system used by the PMCPA in its notification of the Panel’s ruling
  • You may introduce new reasons but you may not introduce new or different allegations that did not form part of the complaint
  • Bear in mind that it must have been possible to substantiate a claim on the day it was made.

Any additional material which you want the Appeal Board to consider must be submitted in writing with the written submission (4.10).

  • When a published paper is referred to, it must be provided; it is helpful to provide commentary explaining what the Appeal Board members are expected to note and where in the paper they should look
  • Websites may be cited but digital copies of the relevant webpages must be provided
  • An English translation must be provided for any materials in another language
  • When audio or audiovisual material is referred to, a transcript must be provided.

Pharmaceutical companies appealing a ruling should submit digital copies of all the documentation to be considered, including the covering letter and attachments. Wherever possible, there should be no restrictions on editing. Companies should provide good quality digital copies of the material at issue, together with copies of relevant summaries of product characteristics.

Confidentiality

If the respondent company objects to certain of its comments or materials being made available to the complainant on the grounds of confidentiality, and the matter cannot be settled by the Chief Executive, it will be referred to an independent referee (8.5 and 8.6). It should be noted that the general principle is that anything which the respondent company wishes the Appeal Board to consider must be made available to the complainant.

Commenting on an appeal

An appeal by the complainant

When an appeal is lodged by the complainant, the respondent company has five working days to comment on the reasons for the appeal (8.5). The complainant then has five working days to comment on the respondent company’s comments (8.5). The complainant’s final comments are sent to the respondent company for information, and both sets of comments go before the Appeal Board.

When responding to an appeal, pharmaceutical companies should submit digital copies of all the documentation to be considered, including the covering letter and attachments. Wherever possible, there should be no restrictions on editing. Companies should provide good quality digital copies of the material at issue, together with copies of relevant summaries of product characteristics.

The points relating to confidentiality of material, set out above, apply equally here.

An extension to the five and 10 working days allowed can be granted at the discretion of the Chief Executive of the PMCPA but only in exceptional circumstances.

An appeal by the respondent company

When an appeal is lodged by the respondent company, the complainant has five working days to comment on the reasons for the appeal (8.6). These comments are sent to the respondent company for information, and will go before the Appeal Board.

An extension to the five and 10 working days allowed can be granted at the discretion of the Chief Executive of the PMCPA but only in exceptional circumstances.

Cases appealed by both parties

When both parties to a case lodge an appeal, all of the stages described above are followed and the Appeal Board receives a composite set of papers covering both appeals.

The Appeal Board hearing

The members of the Appeal Board

The Appeal Board comprises:
• an independent, legally qualified Chair
• three independent registered medical practitioners
• two independent registered pharmacists
• one independent registered senior nurse practitioner
• one independent member representing the interests of patients
• one independent lay member
• four industry members who are registered medical practitioners
• four industry members who are directors or senior executives of pharmaceutical companies (3.1)

Not all members will necessarily be present at any particular meeting. The Chair and seven members constitute a quorum. Independent members, including the Chair, are always in a majority (4.2).

In advance of the meeting, the parties are advised of the membership of the Appeal Board (including potential co-opted members) and are asked if they have any objections to particular members and the grounds for such objections. The Chair will determine whether objections are valid. Where there are valid objections, the member must withdraw from the Appeal Board while it considers the case (4.8).

A member of the Appeal Board who is concerned in a case, either as complainant or respondent, is not sent the papers and withdraws before consideration commences. Other members are required to declare any interest in a case before it is considered. Having consulted the parties (if present), the Chair will determine whether it is appropriate for a particular member to remain for the consideration of the case (4.8).

Appearing or being represented at the hearing

When an appeal is considered by the Appeal Board, both the complainant and the respondent company entitled to appeal or be represented (4.11). Neither party is obliged to attend, although respondent companies are usually represented. Although the Appeal Board considers it extremely helpful if the appellant attends, cases can be dealt with on the basis of written submissions.

Advance notification of the names and job titles of those who will be representing the parties should be given to the PMCPA. Where there is more than one representative from a party, it is helpful if someone is clearly designated as the leader and that this is made known to the Chair of the Appeal Board.

A company may not be represented before the Appeal Board by a representative who is also a member of the Appeal Board, except with the consent of the Chair. Such consent may be given only if the Chair is satisfied that no other person within the company can properly represent it in the case in question (4.11).

Other people present at the hearing

The PMCPA’s Operations and Governance Manager provides administrative support to the Appeal Board and will be present during the meeting.

For the Appeal Board’s consideration of an appeal, members of the PMCPA may be present only at the invitation of the Chair and with the agreement of the party or parties involved. The purpose of attendance is to understand as observers the work of the Appeal Board (4.3). They will normally observe the meeting via video link from a separate room.

What happens during the hearing?

Appeals are heard by the Appeal Board in the offices of the PMCPA or an appropriately chosen venue. Members of the Appeal Board are identifiable by nameplates. The parties are seated opposite the Chair. If both parties are represented, they are seated on either side of the screen on which presentations will be shown.

If both parties are present or are represented, the hearing proceeds as follows:
1. The appellant is invited to make the first presentation
2. The appellant responds to questions from the Appeal Board
3. The other party is invited to make a presentation if they wish
4. The other party responds to questions from the Appeal Board
5. The appellant can make brief closing comments

Where there is an appeal by both parties, the points appealed by the complainant are taken first.

If more than one point is appealed, they will be taken in the same order as in the Panel’s rulings.

If necessary, the Chair can be asked to adjourn the hearing for a few minutes so that the representatives of a party can consult between themselves.

It is not obligatory to make a presentation, although it is customary to do so; sometimes, representatives just answer any questions that members of the Appeal Board may have.

Presentations should be concise, clear and to the point. Presentations should normally last no longer than 15 minutes. If it is considered that 15 minutes will not be long enough, then this should be raised with the Chief Executive as far in advance of the hearing as is possible.

It should be borne in mind that members of the Appeal Board will already have read the papers in the case. New material, i.e. material which has not been included in the papers submitted in relation to the case, cannot be introduced at the hearing (4.10). If there is a possibility that a presentation introduces new material, the relevant party will be asked to identify where in the submitted papers the information can be found. If the information cannot be found in the submitted papers, the relevant party will be asked to remove it from the presentation.

PowerPoint projection facilities are available. If they are to be used, the numbered slides, to which no subsequent amendments can be made, must be emailed to the PMCPA at least three working days before the hearing.

Although there is no obligation, the Chair of the Appeal Board considers it appropriate for each party to have advance sight of any slides that the other party intends to show. When the PMCPA has received both sets of slides, it exchanges them between the parties.

If either of the parties at a hearing has any concerns or questions about the Appeal Board’s procedures, they are best raised with the Chair at the time, rather than after the hearing.

The appeal outcome

When the hearing has been completed and the representatives have left the meeting, the Appeal Board determines whether the appeal in relation to each ruling has been successful.

The Appeal Board will also consider whether additional sanctions may be appropriate.

Informal notification of the result is given by telephone soon after the hearing. Formal written notification follows in due course after the minutes of the meeting have been agreed by the Chair.

Withdrawing an appeal

Notice of appeal may be withdrawn at any time. If the appeal is from a pharmaceutical company (as complainant or respondent) and notice is given after the papers relating to the appeal have been circulated to the Appeal Board, the higher administrative charge will be payable (17.2 and 17.3).