NICE process and methods

7 The oral appeal process

7.1 What is the timescale for an appeal?

Assuming that the appeal points are valid, the Appeal Panel will aim to hold an oral appeal within 8 weeks of an appeal being lodged.

7.2 Who may attend the oral appeal?

Oral appeals are open to consultees, commentators, members of the public and the press. Holding appeals in public is part of NICE's commitment to openness and transparency. It enables stakeholders and the public to better understand the way NICE makes its decisions.

To promote public attendance, NICE will publish a notice on its website announcing that an appeal will be heard, and opens the registration to attend the appeal at least 20 working days before the hearing. At this point, consultees, commentators, members of the public and press may register on the NICE website to attend the appeal as a public observer. Up to 25 places will be available, depending on the size of the venue. Once registration has closed, NICE will contact all the applicants. The successful applicants will receive an invitation to the appeal and documents related to the technology appraisal or highly specialised technology under discussion. Requests to attend are granted on a first-come, first-served basis, although priority is given to members of the public who are not employed by the appellant(s). To allow wide public access, NICE reserves the right to limit the number of representatives per organisation. Public observers are not allowed to participate in the discussions, record the appeal proceedings (video or audio), or take photographs in the premises in which the appeal is held. The Appeal Panel Chair may exclude any person from the appeal if he or she considers that person is disrupting proceedings.

Each appellant is allowed up to 5 representatives at the hearing, including legal representation if they wish. This number may be reduced to 3 representatives if there are more than 3 appellants. If appellants intend to make similar statements, the Appeal Panel will encourage them to be jointly represented, particularly if they have legal representation.

The Appeal Panel may have its own legal adviser present to advise on any procedural or legal issues that may arise.

All 5 members of the Appeal Panel must be present for the appeal. However, if a member is unable to attend or has to stand down at short notice, the Chair of the Appeal Panel will consult with the appellant(s) and NICE representatives. If all parties agree, the appeal will continue with only 4 members of the Appeal Panel, provided that there is still at least 1 representative of the life sciences industry, 1 health service representative, and 1 patient representative, and that one of the health service or patient representatives is the panel chair. This agreement to proceed will be noted in the Appeal Panel decision.

7.3 How is the oral appeal conducted?

On the morning of the appeal, the appeal letter(s), the scrutiny letters and responses to these letters are placed on the NICE website. Any confidential information and personal data are removed before publication on the website.

At the appeal, each appellant is allowed to make a brief 5‑minute introductory statement. The amount of time given to each appellant is determined by the nature of the introductory statement they wish to make and the need for the Appeal Panel to manage the appeal efficiently and fairly. Appellants' introductory statements should be relevant to the grounds of appeal, avoid repetition and be as clear and concise as possible. Appellants should not expect to be allowed to make an introductory statement in connection with every appeal point.

The order in which appellants present appeal points is at the discretion of the Appeal Panel Chair. The Appeal Panel Chair may stop appellants from making introductory statements that are irrelevant, or that repeat something already said by another appellant. Statements are made in the presence of the other appellant(s), the public and the press unless there are issues of confidentiality. Appellants are treated impartially and will each be given a fair opportunity to make their statement. Visual aids such as Microsoft PowerPoint presentations are not accepted.

The Chair of the advisory committee or a representative of NICE is also invited to make an introductory statement of similar length.

The Appeal Panel will then consider and hear each appellant's appeal points and appellants are given the opportunity to argue individual points during the appeal.

Hearings are conducted in an inquisitorial rather than an adversarial style. This means that members of the Appeal Panel may ask appellants questions on any relevant issue. All questions must be made through the Appeal Panel Chair; appellants and representatives for the advisory committee and NICE may not question each other directly.

Points may be dealt with by way of questions from the Appeal Panel or, if the Appeal Panel is confident it has understood the arguments on each side, may not be specifically raised in oral argument at all. The representatives for the advisory committee and NICE may be asked at any time to comment on the appellants' statements. Any such comments are made in the presence of the appellant and the appellant is given an opportunity to respond.

Each appellant and the representatives for the advisory committee and NICE are invited to make a brief concluding statement before the appeal ends.

7.4 Confidential submissions

If an appellant wishes to make statements that involve disclosing confidential information, the Appeal Panel will allow them to be heard in private (that is, in the absence of the other appellants, the public and the press) if they fall within the conditions set out below.

An appellant who intends to make confidential submissions should inform the appeals project manager 15 working days before the appeal date. The Appeal Panel will be sensitive to the need to protect confidential and commercially sensitive information, but will balance this against the fact that a private hearing would deny the other appellants and the public of the opportunity to listen (and in the case of any other appellants, to respond) and would reduce the transparency of the process. Appellants should not rely on confidential information in their appeal letters and statements if their appeal could be supported equally strongly by information in the public domain. The Appeal Panel will only allow a statement to be made in private if it is satisfied that the disclosure of confidential information is necessary for an effective oral appeal. In addition, a private appeal will only be granted for specific submissions for which that test is satisfied; any other submissions will be heard in public.

Where part of an appeal hearing is held in private, the appellant(s) submitting the confidential information will be given the opportunity to review the appeal decision prior to publication to identify any information that should remain confidential. If other appellants are involved in the appeal, and the appellant making the confidential submission agrees that the other appellants can remain during the private discussion, the unredacted version of the appeal decision will be circulated to the other appellants in confidence and for information purposes prior to publication. The redacted version of the appeal decision will be published.

Figure 1 Summary of the oral appeal process