NICE process and methods

8 The oral appeal process

8.1 What is the timescale for an appeal?

If the lead non-executive director for appeals has decided that an oral appeal should be held, the appeal panel will aim to hold an oral appeal within 8 weeks of an appeal being lodged.

8.2 Who may attend the oral appeal?

Oral appeals are primarily held virtually and are open for observation by members of the public, stakeholders and the press. This supports NICE's commitment to openness and transparency. It enables stakeholders and the public to observe and better understand the way NICE makes its decisions.

A notice on the NICE website announces that an appeal will be heard. Registration opens for members of the public and staff to observe the appeal at least 15 working days before the hearing. The closing date for registration is usually 5 working days before the meeting and late registrations may not always be accepted. Once registration has closed, NICE will contact all registrants with the joining links, joining instructions, and weblinks to the frequently asked questions document and project documents for the technology appraisal or highly specialised technologies evaluation under discussion.

On the morning of the appeal, the appeal letter(s), scrutiny letters and appellant(s) responses to these letters are sent to the registrants along with a list of those taking part in the hearing and the anticipated order in which the appeal points will be heard. The appeal letter(s), scrutiny letters and responses to these letters are also published on the NICE website after confidential information and personal data have been removed.

Public observers are not allowed to take part in the discussions or record the appeal proceedings. The appeal panel chair may exclude anyone from the appeal if they consider that person is disrupting proceedings.

Each appellant is allowed up to 5 representatives at the hearing, including legal representation. This number may be reduced to 3 representatives if there are more than 3 appellants. Subject to the discretion of the appeal panel chair, an appeal will proceed in the absence of some or all of an appellant's representatives.

The committee and NICE (taken together) are allowed up to 5 representatives in total at the hearing. This may include a representative of the external assessment group or relevant commissioning organisations invited to attend committee meetings by NICE, or both.

The appeal panel will have its own legal adviser present to advise on any procedural or legal issues that may arise. When an appeal point under ground 1(b) raises an issue as to the interpretation of the law, any advice on that issue will be given in public (or circulated in writing beforehand).

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 NICE appeals team will invite another member of the appeal panel (of the same category) to attend. They will ensure there are no conflicts of interest with the evaluation being appealed. If it is not possible to replace the member at short notice, the appeal panel chair 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 lay representative, and that one of the health service or lay representatives is the panel chair. This agreement to proceed will be noted in the appeal panel decision.

8.3 How is the oral appeal done?

At the start of the appeal hearing, the appeal panel chair welcomes the participants and provides an oral briefing outlining the arrangements for the hearing. The appeal panel and representatives of the committee and NICE introduce themselves and confirm they do not have any undeclared interests or any conflicts of interest. The appellants introduce themselves, but they are not required to declare any interests. NICE's policy on declaring and managing interests does not apply to those representing the appellants. This is because the appellants will have a clear interest in the technology that is the subject of the appeal, often as the manufacturer, or bodies advocating the technology.

The appeal panel chair then invites each appellant (not each representative) to make a brief 5‑minute introductory statement. 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 (see section 8.4). 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 committee chair or a representative of NICE is also invited to make an introductory statement of similar length.

The appeal panel then considers and hears each appellant's appeal points. It is not possible for an appellant to comment on another appellant's appeal point unless they had a similar appeal point accepted during scrutiny.

Hearings are done in an inquisitorial rather than an adversarial style. This means that all questions must be made through the appeal panel chair; appellants and representatives for the committee and NICE may not question each other directly. Members of the appeal panel may ask appellants and the representatives for the committee and NICE questions on any relevant issue.

Points may be dealt with by questions from the appeal panel. If the appeal panel is confident it understands the arguments in the appeal submission and the position of NICE or the committee, the appeal point may not be specifically discussed. The appeal panel chair will endeavour to ensure that the appeal panel uses the hearing time strategically, so that the greatest time is devoted to the points most in need of exploration in the hearing. If a point is not taken in the hearing or taken only briefly this will not be an indication that the appeal panel has prejudged it.

The representatives for the 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.

A representative from each appellant and a representative from NICE or the committee are invited to make a brief concluding statement before the appeal hearing ends.

When there are multiple appellants and some choose not to attend an oral hearing, the appeal panel will consider the written appeal letters of those not attending. They may ask questions of the representatives for the committee arising out of those letters before determining the appeal points raised by the non-attending appellant(s).

After the hearing the appeal panel will meet in private to discuss and agree their decision on each appeal point. The appeal decision will summarise the issues discussed at the hearing, the panel's decision on each appeal point and their rationale.

8.4 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 in this section.

An appellant who intends to make confidential submissions (in a private hearing) should inform the appeals team 15 working days before the appeal date. The appellant should indicate if they agree for other appellants (but not the public) to remain during any confidential submissions. The appeal panel will be sensitive to the need to protect confidential and commercially sensitive information. But it will balance this against the fact that confidential submissions would deny the other appellants and the public 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 confidential submissions if it is satisfied that the disclosure of confidential information is necessary for an effective oral appeal. In addition, permission to make confidential submissions will only be granted for specific submissions for which that test is satisfied; any other submissions will be heard in public.

When 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 before publication to identify any confidential information and request that it should remain confidential. NICE will then assess the request and consider what should be redacted from the publicly released decision. 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 hearing, the unredacted version of the appeal decision will be circulated to the other appellants in confidence and for information purposes before publication. The redacted version of the appeal decision will be published.