THERAPEUTIC USE EXEMPTIONS | Federation Internationale de l'Automobile

THERAPEUTIC USE EXEMPTIONS

WHAT IS A THERAPEUTIC USE EXEMPTION (TUE)?

Drivers may have illnesses or conditions that require them to take medications or undergo procedures. If the medication or method a driver is required to use to treat an illness or condition is prohibited as per the World Anti-Doping Agency’s (WADA) Prohibited List, a TUE may give that driver the authorisation to use that substance or method while competing without invoking an anti-doping rule violation (ADRV) and applicable sanction. Applications for TUEs are evaluated by a panel of physicians, the TUE Committee (TUEC).

 

WHAT ARE THE CRITERIA FOR GRANTING A TUE?

All of the four following criteria must be met (for more details, please refer to the WADA International Standard for Therapeutic Use Exemptions (ISTUE) Article 4.2):

  • The driver has a clear diagnosed medical condition which requires treatment involving a prohibited substance or method;
  • The therapeutic use of the substance will not, on the balance of probabilities, produce significant enhancement of performance beyond the driver’s normal state of health;
  • The prohibited substance or method is an indicated treatment for the medical condition, and there is no reasonable permitted therapeutic alternative;
  • The necessity to use that substance or method is not a consequence of the prior use (without a TUE) of a substance or method which was prohibited at the time of use.

 

WHO SHOULD APPLY FOR A TUE? WHERE AND WHEN TO APPLY? 

The FIA has delegated responsibility for all TUE applications to the International Testing Agency (ITA). This means that the ITA is now fully responsible for the TUE application process for all international-level Drivers who fall under the FIA’s jurisdiction.

Drivers who are subject to anti-doping rules will need a TUE to take a prohibited substance or use a prohibited method. You should check with the ITA on how to apply and if you can apply retroactively.

First, check if the required medication or method you intend to take or use is prohibited as per the WADA Prohibited List.

You can also check your medication online via a website such as globalDRO (https://globaldro.com) or ask your National Anti-Doping Organization (NADO) if it has one (the list of NADOs is available at https://www.wada-ama.org/en/code-signatories#GovernmentFundedOrganizations). 

You are responsible for informing your doctor(s) that you are an athlete bound to anti-doping rules. You and your doctor(s) should check the Prohibited List for the substance/method you are prescribed. If the substance/method is prohibited, discuss non-prohibited alternatives, and if there are none, apply for a TUE. Remember that Drivers have the ultimate responsibility. Contact your NADO or the ITA if you are having difficulties in assessing the status of a substance. 

Then, check your status below, to determine your competition level and TUE application requirements:

International-Level Drivers Definition

(a) Drivers taking part in any competition registered on the FIA International Sporting Calendar, which is published at the following link: https://www.fia.com/international-sporting-calendar;

(b) Drivers included in the FIA Registered Testing Pool, the FIA Testing Pool or any other Pool established by the FIA.

  • If it is determined that you are an International-Level Driver, you must apply to the ITA in advance, as soon as the need arises, except in the event of an emergency or in exceptional circumstances.

For substances prohibited in-competition only, you should apply for a TUE at least 30 days before your next competition, unless one of the exceptions on retroactive TUEs (see below) applies.

Please refer to the section “How to apply to the ITA for a TUE?” below.

If you already have a TUE granted by your NADO:

The ITA’s TUEC will automatically recognise it for the purpose of an international-level competition without the need to review the relevant clinical information.

  • If you are NOT an International-Level Driver and you have been tested by the FIA, the ITA’s TUEC recognises a valid TUE granted by your NADO (i.e., it satisfies the International Standard for Therapeutic Use Exemptions (ISTUE) criteria for granting a TUE), unless you are required to apply for recognition of the TUE because you are competing in an international event.

If you are NOT a National-Level Athlete as defined by your NADO and you have been tested by the FIA, you must apply for a retroactive TUE to the ITA.

 

CAN I GET A RETROACTIVE TUE?

You may only apply retroactively for a TUE to the ITA’s TUEC if:

  • You required emergency or urgent treatment of a medical condition.
  • There was insufficient time, opportunity or other exceptional circumstances that prevented you from submitting the TUE application, or having it evaluated, before getting tested.
  • You are a lower level driver who is not under the jurisdiction of the FIA or NADO and were tested. 
  • You tested positive after using a substance out-of-competition that is only prohibited in-competition (e.g. glucocorticoids). 

In rare and exceptional circumstances and notwithstanding any other provision in the ISTUE, you may apply for and be granted retroactive approval for a therapeutic use of a prohibited substance or method, if considering the purpose of the Code, it would be manifestly unfair not to grant a retroactive TUE.

This unique retroactive TUE will only be granted with the prior approval of WADA (and WADA may in its absolute discretion agree with or reject the ITA’s TUEC decision).

Important note:

Using a prohibited substance or method without a TUE could result in an Anti-Doping Rule Violation.

In case an application for a retroactive TUE is necessary following sample collection, you are strongly advised to have a medical file prepared and ready to submit for evaluation. 

 

HOW TO APPLY TO THE ITA FOR A TUE?

The FIA encourages TUE applications to be submitted via ADAMS, together with the required medical information. If you do not have an ADAMS account yet, contact tue@ita.sport to set one up.

Alternatively, download the TUE Application Form (also available at https://ita.sport/TUE), and once duly completed and signed, send it together with the required medical file to tue@ita.sport.

Your TUE application must be submitted in legible capital letters or completed electronically.

The medical file must include:

  • A comprehensive medical history, including documentation from the original diagnosing doctor(s) (where possible);
  • The results of all examinations, laboratory investigations and imaging studies relevant to the application.

Any costs incurred by the driver in relation to the TUE application and in order to supplement it as required by the TUEC are the responsibility of the driver.

Any TUE application that is not complete or legible will be returned for completion and re-submission.

To assist you and your doctor in providing the correct medical documentation, we suggest consulting WADA’s Checklists for TUE applications for guidance and support, and Medical Information to Support the Decisions of TUECsfor guidance on specific common medical conditions, treatments, substances, etc. 

Keep a complete copy of the TUE application form and all medical information submitted in support of your application, and proof that it has been sent.

 

HOW TO SUBMIT A REQUEST FOR RECOGNITION OF MY NADO’S TUE TO THE ITA?

The ITA’s TUEC will automatically recognise your TUE for purposes of international-level competition without the need to review the relevant clinical information. If the TUE is correctly entered in ADAMS, there is no need to contact us. Nevertheless, should you require confirmation, you can submit your request to the ITA in writing, specifying your ADAMS TUE reference number.

You can download your TUE certificate directly from ADAMS.

 

WHEN WILL I RECEIVE A DECISION ON MY TUE APPLICATION (OR REQUEST FOR RECOGNITION)?

The ITA’s TUEC must render a decision as soon as possible, and usually within 21 days from the date of receipt of the complete TUE application, or request for recognition, unless in exceptional circumstances. 

 

WHAT IF I NEED TO RENEW MY TUE?

Each TUE has a specific duration, at the end of which it expires automatically. Should you need to continue to use the prohibited substance or method, it is your responsibility to submit a new application for a TUE with updated medical information ahead of the expiry date, so that there is sufficient time for a decision to be made prior to the expiry of the current TUE.

Important note:

The presence (following sample collection), use, possession or administration of the prohibited substance or method must be consistent with the terms of your TUE. Therefore, if you require a materially different dosage, frequency, routeor duration of administration, you should contact the ITA, as you may be required to apply for a new TUE. Some substances and dosages, e.g. insulin, are often modified during treatment and these possible fluctuations should be mentioned by the treating doctor in the TUE application and are typically accepted by the ITA’s TUEC. 

 

WHAT IF MY TUE APPLICATION IS DENIED?

A decision to deny a TUE application will include a written explanation of the reason(s) for the denial. If it is not clear to you, please contact the ITA to understand exactly why the TUE was denied. Sometimes, there may be a critical piece of information, diagnostic test, laboratory results, etc. missing. In which case, you should resubmit your application. 

You and/or your NADO may refer the matter to WADA for review no later than 21 days after notification of the ITA’s TUEC decision. You should send the same information that you submitted to the ITA, and on which the decision to deny the TUE was based, via a secure online method or by registered post to:

WADA Medical Department
World Anti-Doping Agency

Stock Exchange Tower

800 Place Victoria (Suite 1700)

P.O. Box 120

Montreal (Quebec) H4Z 1B7

Canada

The email address to enquire and/or send the request for review is: medical@wada-ama.org

Please note that WADA is not obliged to proceed with a request for a review. In that case, you and/or your NADO may appeal to the Court of Arbitration for Sport (CAS).

 

WHAT IF MY NADO’S TUE IS NOT RECOGNISED BY THE FIA?

You and/or your NADO have 21 days from the date of decision to refer the matter to WADA for review. The email address to enquire and/or send the request for review is: medical@wada-ama.org. Alternatively, you may send it to: 

WADA Medical Department
World Anti-Doping Agency
Stock Exchange Tower

800 Place Victoria (Suite 1700)

P.O. Box 120

Montreal (Quebec) H4Z 1B7

Canada

The same information that was provided to your NADO should be submitted to WADA. Please use a secure online method unless sending by registered post. 

Pending WADA’s decision, your NADO TUE remains valid for national-level competition and out-of-competition testing only.

If the matter is not referred to WADA for review, your NADO must determine whether the original TUE that was granted should remain valid for national-level competition and out-of-competition testing. 

 

WILL MY MEDICAL INFORMATION BE TREATED IN A CONFIDENTIAL MANNER?

All the information contained in a TUE application, including the supporting medical information and any other information related to the evaluation of your TUE request is kept strictly confidential and treated in accordance with the Athlete’s Declaration contained in the ADAMS TUE and in the TUE application form which can be found here. All members of the TUEC and any other authorised recipients of your TUE request and related information (as described in the Athlete’s Declaration) are subject to a professional or contractual confidentiality obligation.

Please review the terms of the Athlete’s Declaration carefully. In particular, note that should you wish to revoke the right of the ITA’s TUEC to obtain the information related to your TUE in accordance with the Athlete’s Declaration, your TUE application will be deemed withdrawn without approval (or recognition) being granted.

Information related to your TUE request will be retained by the FIA, ITA’s TUEC and any other authorised recipients for no longer than necessary for the purposes stated in the Athlete’s Declaration, in accordance with the International Standard for the Protection of Privacy and Personal Information.

 

CONTACT INFORMATION

For further information and questions in relation to personal information practices, please contact the ITA at privacy@ita.sport or the FIA at dpo@fia.com.

If you have any doubts regarding which organisation you should send a TUE request to, or the recognition process, or any other question about TUEs, please contact: tue@ita.sport.

 

OTHER USEFUL LINKS: 

WADA International Standard for Therapeutic Use Exemptions (ISTUE)

WADA Q&A on Therapeutic Use Exemptions

WADA Checklists for TUE Applications

WADA Guidelines for the 2021 International Standard for Therapeutic Use Exemptions (ISTUE) 

WADA Anti-Doping Education and Learning (ADEL)