Guidance

The Health Service Products Appeals Tribunal: how to appeal

Sets out the process for pharmaceutical companies to appeal against decisions made by the Secretary of State for Health and Social Care.

From:
Department of Health and Social Care
Published
21 October 2021

The Health Service Products (Pricing, Cost Control and Information) Appeals Tribunal

The Health Service Products (Pricing, Cost Control and Information) Appeals Tribunal is an independent tribunal established under The Health Service Medicines (Price Control Appeals) Regulations 2000.

What the tribunal does

We are responsible for handling appeals against decisions made by the Secretary of State for the Department of Health and Social Care (DHSC) from pharmaceutical companies in relation to:

  • the cost of medicines to the NHS
  • the supply of medicines to the NHS
  • the use of DHSC powers on medicines, ensuring companies are correctly treated in line with legislation
  • the requirements on companies in the pharmaceutical sector and their compliance with legislation

Legislation

We are responsible for hearing appeals against the Secretary of State from pharmaceutical companies relating to:

Contact the tribunal

General enquiries:

General Regulatory Chamber (on behalf of the Health Service Products Appeals Tribunal)
HM Courts and Tribunals Service
PO Box 9300
Leicester
LE1 8DJ

Email: [email protected]

Telephone: 020 3936 8963

The appeals process

Notice of appeal

If you wish to appeal against an enforcement decision made by DHSC, you have 28 days from the date the enforcement decision was issued by DHSC to send the tribunal a notice of appeal (see forms under ‘Tribunal information’ below), stating the grounds on which you feel the decision was wrong.

You must supply any supporting evidence either:

  • with the notice of appeal
  • within 28 days of giving notice of appeal

Late appeals

If you submit a notice of appeal outside of the 28-day time limit, you must also include a statement of reasons, explaining:

  • the cause of the delay
  • why failure to extend time would cause substantial injustice

The tribunal has a discretion to extend the time limit under regulation 4(2).

Information required from you for an appeal

The notice of appeal should contain information on the grounds of the appeal stating why you consider that:

  • the enforcement decision was based on a factual error
  • the enforcement decision was legally erroneous, and/or
  • the Secretary of State’s exercise of discretion in relation to the decision was not appropriate

The supporting evidence required should include:

  • a copy of any document you have received from DHSC giving notification of the enforcement decision
  • a copy of any documents you have received explaining why DHSC has taken its decision
  • 2 copies of every other document you rely upon for the purposes of the appeal

A document stating:

  • the name, address (a telephone number and email address would also be useful) and the profession of the person (if any) representing your company, and whether the tribunal should send documents concerning the appeal to the representative instead of you
  • whether you consider that the appeal should be decided at an oral hearing
  • if, in your opinion, any other person has a direct interest in the subject matter of the appeal, the name and address of such other person

Acknowledgement

The tribunal will send you an acknowledgement letter confirming receipt of the notice of appeal.

The tribunal will also send a copy of the appeal documents to DHSC.

Amending your notice of appeal

Within the 28-day period after sending the tribunal your notice of appeal, you have the opportunity to either:

  1. amend the grounds of appeal identified in the notice of appeal
  2. withdraw or amend any of the supporting evidence supplied

You must ask permission from the tribunal if you need to make any amendments outside of this time limit.

You must send the tribunal 2 copies of any amendments.

Further information required

Once the notice of an appeal and additional material have been received by the tribunal, we may require you to provide further information. We will notify you of this in writing. You will have 14 days to send us this additional information.

Withdrawing your appeal

You may withdraw your appeal at any point within the 28-day period after sending the tribunal your notice of appeal. You will need permission from the tribunal to withdraw your appeal after this period.

If you withdraw your appeal:

  • you cannot make a fresh appeal for the same enforcement decision
  • any interim orders or directions given by the tribunal will no longer be valid

DHSC response

DHSC has up to 28 days from the date it receives the notice of appeal and additional material to submit its response to the appeal. The response document should state:

  • whether or not DHSC intends to uphold its original enforcement decision (and if not, the appeal must be allowed)
  • the name, address (a telephone number and email address would also be useful) and the profession of the person (if any) representing DHSC, and whether the tribunal should send documents concerning the appeal to the representative instead of DHSC
  • the name and address of any other persons DHSC considers has a direct interest in the subject matter of the appeal

If DHSC does intend to uphold its decision, it should also provide:

  • a statement summarising DHSC’s answer to each ground of appeal supplied by the appellant
  • 2 copies of every document DHSC used to support their appeal
  • a statement indicating whether DHSC requests that the appeal should be decided at an oral hearing

The tribunal will send you DHSC’s response documents.

Representatives and experts

Any representatives you or DHSC have declared who will be involved in the appeal will be sent all the relevant documents for both parties and will be asked to provide their input to the appeal within 21 days.

Both parties will be sent the response from the representative and have 7 days to add any additional comments.

The tribunal may also call on expert representation and will send both parties any subsequent written reports by such experts.

Setting the tribunal hearing date

Once your appeal notice and supporting material and DHSC’s response have been received by the tribunal, both parties will then be sent written confirmation of the time and venue of the hearing.

When setting the date, we will take into consideration the complexity of the case, the availability of all parties and whether there is a need for a pre-hearing review. If both parties and the tribunal agree, the tribunal may also decide the hearing without an appeal.

Information about the procedure of the hearing and what to expect on the day will also be provided.

You must reply at least 2 weeks before the hearing date, indicating whether you, and/or your representative will be in attendance.

Change of hearing date or venue

The date, time or venue of the hearing can be re-scheduled by the tribunal with the consent of both parties. We will contact you as soon as possible explaining this change and the alternate hearing details.

Pre-hearing review

Where required the pre-hearing review is a hearing that takes place before the main tribunal hearing, in order to address something other than the substantive issues of the case.

The aim of a pre-hearing review is to allow the tribunal to understand the case and put in place the necessary arrangements to prepare for the final hearing. It can also be used to address any stand-alone points that it makes sense to resolve before a full hearing.

We will notify you of the date and venue of the pre-hearing review.

All parties will be informed of any outcomes made following the pre-hearing review as soon as practicable.

Hearing venue

Currently, due to COVID-19 restrictions, it is anticipated that cases are not heard face to face, but virtually on the Cloud Video Platform (CVP).

Tribunal decision

By the end of the hearing, the tribunal must come to a decision, either unanimously or by a majority verdict, as to whether the enforcement decision was justified on the evidence given, and also what, if any enforcement or other action should be taken.

The recorded decision of the tribunal can be made and communicated either at the end of the hearing, or within 7 days of the hearing.

Both you and DHSC will be sent a copy of the decision which must include a statement of the reasons as to why the tribunal came to their verdict.

Publication of the decision

The tribunal will publish the decisions of the appeal on GOV.UK. The tribunal will ensure any information which is considered confidential and not in the public interest be redacted from the published document.

Paying costs to someone else involved in the case

The tribunal can decide whether to make an order that a party must pay all or part of the costs of the other side in relation to proceedings we control, unless the persons involved have agreed who should pay. We may decide that the losing side should pay all the costs of both sides. This will not always happen because we must take account of all the circumstances and try to do what is fair in each case.

Disagree with the decision

If you disagree with the tribunal’s decision, you can appeal within 3 months of the decision being made on a question of law to the High Court:

  • The High Court in England and Wales
  • The High Court Justice in Northern Ireland
  • Court of Session in Scotland

To do this please contact the General Regulatory Chamber (GRC) team:

General Regulatory Chamber (on behalf of the Health Service Products Appeals Tribunal)
PO Box 9300
Leicester
LE1 8DJ

Email: [email protected]

Telephone: 0300 123 4504

DHSC has the same right to appeal within the same time limits.

Tribunal information

Notice of appeal form (T98). This page also includes the guide to completing the notice of appeal or application (T97).

How to join a Cloud Video Platform (CVP) hearing

General Regulatory Chamber cases listed for hearing

The Health Service Medicines (Price Control Appeals) Regulations 2000

Updates to this page

Published 21 October 2021

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