What Is A Therapeutic Use Exemption (TUE)?

Athletes may have illnesses or conditions that require them to take medications or undergo procedures. If the medication or method an athlete 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 athlete the authorization 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 athlete has a clear diagnosed medical condition which requires treatment using 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 athlete’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?

Athletes who are subject to anti-doping rules would need a TUE to take a prohibited substance or use a prohibited method. You should verify with WAKO to know to whom you need 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 may also use a ‘check your medication’ online tool or ask your NADO if it has one.

You have a responsibility to inform your physician(s) that you are an Athlete bound to anti-doping rules. You and your physician(s) should check the Prohibited List for the substance/method you are prescribed. If the substance/method is prohibited, discuss non-prohibited alternatives, if there are none, apply for a TUE.  Remember Athletes have the ultimate responsibility. Contact your NADO or WAKO if you are having difficulties.

Then, contact WAKO Antidoping Officer at gianlorenzo.daniele@yahoo.it to determine your competition level and TUE application requirements.

If it is determined that you are an International-Level Athlete:

WAKO Definition of International Level Athlete is as follows:

  1. An Athlete who is National Champion in that given year and subsequent years where he/she is the official national Champion as recognized by the WAKO National Governing Body.
  2. An Athlete who has competed in a WAKO World Cup, or A/B class event in the last two years as defined in the WAKO Calendar.

You must apply to WAKO in advance, as soon as the need arises, unless there are emergency or 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) apply.

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

If you already have a TUE granted by your National Anti-Doping Organization (NADO):

National level athletes must apply for a TUE to the NADO of their home country. WAKO will automatically recognize any TUE granted by any NADO declared compliant by WADA, in accordance with Article 7.1 (a) of World Antidoping Code.

In such case, please notify WAKO that you have a TUE granted by your NADO.

If your existing TUE does not fall under a category of decision described above, you must submit a request for recognition to WAKO. Please refer to the section “How to submit a request for recognition of your NADO’s TUE to WAKO?” below.

TUE granted by a Non-compliant NADO will have to be submitted to WAKO for recognition, in accordance with Article 7.1(b).

Your NADO’s TUE is only valid at the national level, and you must submit a request for recognition to WAKO. Please refer to the section “How to submit a request for recognition of your NADO’s TUE to WAKO?” below.

If you are NOT an International-Level Athlete and you have been tested by WAKO, WAKO recognizes a valid TUE granted by your NADO (i.e., it satisfies the 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 WAKO, you must apply for a retroactive TUE to WAKO.

Can I Get a Retroactive TUE?

You may only apply retroactively for a TUE to WAKO 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 athlete who is not under the jurisdiction of WAKO or NADO and were tested.
  • You tested positive after using a substance Out-of-Competition that is only prohibited In-Competition (for example 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 WAKO’s 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 WAKO for a TUE?

WAKO encourages to submit TUE applications via ADAMS, together with the required medical information. If you do not have an ADAMS account yet, please contact gianlorenzo.daniele@yahoo.it to have it set up.

Otherwise, please download the WAKO TUE Application Form, and once duly completed and signed, send it together with the required medical file to WAKO Antidoping Officer – gianlorenzo.daniele@yahoo.it

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

The medical file must include:

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

Any cost related to TUE Application will fall under Athlete’s responsibility including any required additional medical examinations, tests, imaging studies, etc.

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

To assist you and your doctor in providing the correct medical documentation, we suggest consulting the WADA’s Checklists for TUE applications for guidance and support, and TUE Physician Guidelines for 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 WAKO?

Your request for recognition should be submitted to WAKO in writing quoting your ADAMS TUE reference number.

Keep a complete copy of the proof that your request for recognition has been sent to WAKO.

What happens at major events?

A Major Event Organization (MEO) requires athletes to apply for the recognition of their TUE if they wish to use a prohibited substance or method in connection with the Event.

If you have a TUE granted by WAKO and you will be competing at a Major Event e.g., the Olympic Games, you should contact the MEO for information on their recognition process.

When will I receive a decision on my TUE application?

WAKO’s TUEC’s 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].

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, route or duration of administration, you should contact WAKO, 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 physician in the TUE application and would usually be accepted by the ADO TUEC.

What if my WAKO’s 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 WAKO to understand exactly why the TUE was denied. Sometimes, there may be a critical piece of information, diagnostic test, laboratory results missing, etc. In which case, you should re-apply to us.

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

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

It should be noted 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 recognized by WAKO?

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 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 on-line method unless sending by registered mail.

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 process: and in the WAKO TUE Application Form. All members of the TUEC and any other authorized 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 WAKO’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.

Your TUE request-related information will be retained by WAKO and any other authorized 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 any further information and questions in relation to WAKO’s personal information practices, please contact WAKO’s Data Protection Officer at v.cocca@crclex.com

If you have a doubt as regards to which organization you should apply for a TUE, or as to the recognition process, or any other question about TUEs, please contact WAKO Antidoping Officer at gianlorenzo.daniele@yahoo.it

Other useful links: 

WADA International Standard for Therapeutic Use Exemptions (ISTUE)

WADA Checklists for TUE Applications

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

WADA Anti-Doping Education and Learning (ADEL)

International Standard for the Protection of Privacy and Personal Information (ISPPPI) | World Anti Doping Agency (wada-ama.org)