Information on Therapeutic Use Exemptions

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).

National Anti-Doping Organizations Therapeutic Use Exemptions (TUE) are only valid for national-level Competition and Out-of-Competition Testing.

WHAT ARE THE CRITERIA FOR GRANTING A THERAPEUTIC USE EXEMPTION?

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 the 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 THERAPEUTIC USE EXEMPTION? WHERE AND WHEN TO APPLY?

Athletes who are subject to anti-doping rules would need a Therapeutic Use Exemption to take a prohibited substance or use a prohibited method. You should verify with the Oceania Regional Anti-Doping Organization (ORADO) 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.

Helpful resource: check your medication database link globaldro.com

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 whatever substance/method you are prescribed. If the substance/method is prohibited, discuss non-prohibited alternatives, if there are none, apply for a apeutic Use Exemption. Remember athletes have the ultimate responsibility. Contact the ORADO if you are having difficulties.

Contact ORADO to determine your competition level and Therapeutic Use Exemption application requirements.

If it is determined that you are a National-Level Athlete, you must apply to the ORADO 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 Therapeutic Use Exemption at least 30 days before your next competition. Please refer to the section “How to apply for a Therapeutic Use Exemption?” below.

If your level is lower than the “National-Level” as defined above you are entitled to apply for a retroactive TUE after being tested by your National Anti-Doping Organization or any other Anti-Doping Organization (ADO).

Important note:

A Therapeutic Use Exemption granted by the ORADO is only valid at the national level. If you are, or become an International-Level Athlete, or compete at Major Games, that Therapeutic Use Exemption will not be valid unless it is recognized by the relevant International Federation (IF) or Major Event Organization (MEO). It is your responsibility to check if the ORADO Therapeutic Use Exemption is automatically recognized by such IF or MEO.

The ORADO can assist you in the determination of your level and Therapeutic Use Exemption application requirements, and, should the need occur, assist you in presenting the ORADO TUE to an IF or MEO for recognition.

CAN I GET A RETROACTIVE TUE?

You may only apply retroactively for a Therapeutic Use Exemption to your National Anti-Doping Organization 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 Therapeutic Use Exemption application, or having it evaluated, before getting tested.
As per our anti-doping rules you were not permitted or required to apply in advance for a Therapeutic Use Exemption.
You are a lower-level athlete who is not under the jurisdiction of an International Federation or National Anti-Doping Organization and were tested.
You tested positive after using a substance Out-of-Competition that was only prohibited In-Competition (for example glucocorticoids).

In rare and exceptional circumstances and notwithstanding any other provision in the International Standards for Therapeutic Use Exemption, 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 Therapeutic Use Exemption.

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

Important note: Using a prohibited substance or method without a Therapeutic Use Exemption could result in an Anti-Doping Rule Violation.

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

HOW TO APPLY FOR A THERAPEUTIC USE EXEMPTION?

Through ADAMS or paper format / electronic Therapeutic Use Exemption form

We encourages to submit Therapeutic Use Exemption applications via ADAMS, together with the required medical file. If you do not have an ADAMS account yet, please contact your the ORADO to have it set up.

Otherwise, please download the below Therapeutic Use Exemption Application, once duly completed and signed, send it together with the required medical file to the ORADO , email quintyn@oceanianoc.org

Your Therapeutic Use Exemption application must be submitted in a legible form using 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 Therapeutic Use Exemption 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 during the Therapeutic Use Exemption application process, and TUE Physician Guidelines for guidance on specific common medical conditions, treatments, substances, etc.

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

WHAT HAPPENS AT MAJOR EVENTS?

A Major Event Organization requires athletes to apply for the recognition of their Therapeutic Use Exemption if they wish to use a prohibited substance or method in connection with the Event.

If you have a Therapeutic Use Exemption granted by the ORADO and you will be competing at a Major Event e.g., the Olympic Games, you should contact the Major Event Organization for information on their recognition process.

WHEN WILL I RECEIVE A DECISION ON MY THERAPEUTIC USE EXEMPTION APPLICATION?

TUEC’s must render a decision as soon as possible, and usually within 21 days from the date of receipt of the complete Therapeutic Use Exemption application, including the required medical information.

WHAT IF I NEED TO RENEW MY THERAPEUTIC USE EXEMPTION?

Each Therapeutic Use Exemption 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 Therapeutic Use Exemption 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 Therapeutic Use Exemption.

Important note: The presence (following sample collection), use, possession or administration of the prohibited substance or method shall be consistent with the terms of your Therapeutic Use Exemption. Therefore, if you require a materially different dosage, frequency, route or duration of administration, you should contact the ORADO, as you may be required to apply for a new Therapeutic Use Exemption. 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 Therapeutic Use Exemption application and would usually be accepted by the ORADO Therapeutic Use Exemption Committee.

WHAT IF MY THERAPEUTIC USE EXEMPTION APPLICATION IS DENIED?

A decision to deny a Therapeutic Use Exemption application includes a written explanation of the reason(s) for the denial. If it is not clear to you, please contact the ORADO to understand exactly why the Therapeutic Use Exemption 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 the ORADO. Otherwise, you may appeal the denial decision by writing to your National Anti-Doping Organization or the Oceania Regional Anti-Doping Organization advising why you feel the wrong decision has been reached. The TUEC has 21 days to respond to your appeal.

WHAT IF THE OCEANIA REGIONAL ANTI-DOPING ORGANIZATIONS THERAPEUTIC USE EXEMPTION IS NOT RECOGNIZED BY MY INTERNATIONAL FEDERATION?

You or the ORADO have 21 days to refer the matter to WADA for review after notification of the non-recognition. You should send the same information that you submitted the ORADO and on which their TUEC based their decision, 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) H3C 0B4
Canada

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

Pending WADA’s decision, the ORADO Therapeutic Use Exemption remains valid for national-level competition and out-of-competition testing only. If the matter is not referred to WADA for review, the ORADO must determine whether the original Therapeutic Use Exemption 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 Therapeutic Use Exemption application including the supporting medical information, and any other information related to the evaluation of your Therapeutic Use Exemption request is kept strictly confidential and treated in accordance with the Athlete’s Declaration contained in the ADAMS Therapeutic Use Exemption process. All members of the Therapeutic Use Exemption Committee and any other authorized recipients of your Therapeutic Use Exemption 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 ORADO Therapeutic Use Exemption Committee to obtain the information related to your Therapeutic Use Exemption request in accordance with the Athlete’s Declaration, your Therapeutic Use Exemption application will be deemed withdrawn without approval being granted.

Your Therapeutic Use Exemption request-related information will be retained by the ORADO Therapeutic Use Exemption Committee 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 the ORADO's personal information practices, please contact the ORADO.

If you have a doubt as regards to which organization you should apply for a Therapeutic Use Exemption, or as to the recognition process, or any other question concerning Therapeutic Use Exemption’s, please contact the ORADO.