Magyar Antidopping Csoport

Therapeutic Use Exemption (TUE)

 

Athlete’s Therapeutic Use Exemption process – HUNADO


 


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).
 
HUNADO TUEs are only valid for national-level Competition and Out-of-Competition Testing.
 

 WHAT ARE THE CRITERIA FOR GRANTING A TUE?



All of the four following criteria must be met:
  • The athlete has a clear diagnosed medical condition, which requires treatment using a prohibited substance or method supported by relevant clinical evidence;
  • 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.
The granting of a TUE is based solely on consideration of the conditions set out above. It does not consider whether the Prohibited Substance or Prohibited Method is the most clinically appropriate or safe, or whether its Use is legal in all jurisdictions.
 

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 HUNADO 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 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 TUE. Remember athletes have the ultimate responsibility. Contact HUNADO TUE Committee (tuebizottsag@antidopping.hu) if you are having difficulties.
 
Then, contact HUNADO to determine your competition level and TUE application requirements.
 
National-Level Athletes:
Every at least registered Athlete, who has reached the age of 16 and who plays a sport whose International Federation is a Signatory to the Code, and:
  1. who were medalists of any national championships - in the actual Olympiad - until the last day of the Olympiad concerned;
  2. who are members of a National team in Hungary in the current year, or were members of a National team in Hungary in the preceding year - until the last day of the year concerned; 
  3. who compete at International Event held in Hungary or abroad in the current year, or competed at International Event held in Hungary or abroad in the preceding year, which is included in the competition calendar either of National Federation or the International Federation - until the last day of the year concerned;
  4. who participate in training camps funded by the state or a National Federation in the current year, or participated in training camps funded by the state or a National Federation in the preceding year - until the last day of the year concerned;
  5. who are included in the Registered Testing Pool and Testing Pool of HUNADO - until the last day of the year when they are removed from these pools;
  6. all athletes regardless of age, who are classified by HUNADO as National-level Athlete and who are notified in writing either directly or through their National Federation - for the period specified in the notification.
 
Notwithstanding to point a) to e) above, in exceptional cases, HUNADO has a right to classify registered athletes under the age of 16 as National-level Athlete if they meet with any of the criteria a) to e) above. In this case, HUNADO shall inform the minor athlete and his/her legal guardians in writing on the fact that the athlete is classified as a National-level Athlete.
 
If it is determined that you are a National-Level Athlete, you must apply to HUNADO 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. Please refer to the section “How to apply to HUNADO for a TUE?” 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 HUNADO or any other Anti-Doping Organization (ADO).
 
Important note:
 
A TUE granted by HUNADO is only valid at the national level. If you are, or become an International-Level Athlete, or compete at Major Games, that TUE 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 HUNADO’s TUE is automatically recognized by such IF or MEO.
 
HUNADO can assist you in the determination of your level and TUE application requirements, and, should the need occur, assist you in presenting your HUNADO’s TUE to an IF or MEO for recognition.

Please contact tuebizottsag@antidopping.hu.  
 

CAN I GET A RETROACTIVE TUE?


You may only apply retroactively for a TUE to HUNADO 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;
  • As per the HUNADO anti-doping rules you were not permitted or required to apply in advance for a TUE;
  • You are a lower level athlete who is not under the jurisdiction of an International Federation or National Anti-Doping Organization and were tested; or
  • 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 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 HUNADO’s decision).
 
For Athletes who are not International-Level Athletes or National-Level Athletes, the relevant Anti-Doping Organization may grant an Athlete’s application for a retroactive TUE without first consulting WADA; however, WADA may at any time review an Anti-Doping Organization’s decision to grant a retroactive TUE, and may in its absolute discretion, agree with or reverse the 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 HUNADO FOR A TUE?


HUNADO encourages to submit TUE applications via ADAMS, together with the required medical file. If you do not have an ADAMS account yet, please send an email to info@antidopping.hu to have it set up.
 
Otherwise, please download HUNADO’s TUE Application Form, and once duly completed and signed, send it together with the required medical file to tuebizottsag@antidopping.hu.
 
Your TUE 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 TUE application that is not complete or legible will not be dealt with and will be returned for completion and re-submission. Therefore, please make sure that your application is filed in a due course, but in any event, well before your competition.
 
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 TUE application process, and Medical Information to Support the Decisions of TUECs 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.
 

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 HUNADO 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 [OR REQUEST FOR RECOGNITION]?


HUNADO’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, including the required medical information. Bear in mind that the 21-day period starts on the day when the full, complete and legible application is submitted. Incomplete, or illegible applications are not deemed to be submitted, but shall be returned for re-submission.
 

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 shall 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 HUNADO, 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 TUEC.
 

WHAT IF MY HUNADO’S TUE APPLICATION IS DENIED?


A decision to deny a TUE application includes a written explanation of the reason(s) for the denial. If it is not clear to you, please contact HUNADO TUE Committee (tuebizottsag@antidopping.hu) 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. Otherwise, you may appeal the denial decision as follows: 
 
The request to review the denial of the TUE application shall be made to HUNADO within 14 days from the receipt of the TUEC decision. When a request to review is made, the Chair of the TUE Committee shall appoint 3 members (which may include the Chair) to consider the request to review. The members who have considered the original application cannot be appointed to review the contested decision. WADA shall be duly notified of such request by HUNADO.
 
The TUE Committee shall review the contested decision based on the Athlete's reasons and may amend or confirm the contested decision in its sole discretion.
  • If TUEC satisfies the Athlete's request, the Athlete may not appeal against the amended (reviewed) decision.
  • Otherwise, the Athlete may appeal the reviewed decision as specified below.
 
If HUNADO denies an application for a TUE after the review as specified above, the Athlete may appeal exclusively to the Permanent Court of Arbitration for Sport of Hungary (“Sport Állandó Választottbíróság”), in accordance with Article 13.2.2 of HUNADO Anti-Doping Rules.
 

WHAT IF MY HUNADO’S TUE IS NOT RECOGNIZED BY MY INTERNATIONAL FEDERATION?


You or HUNADO 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 to HUNADO, 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) H4Z 1B7
Canada
 
The email address to enquire and/or send the request for review is: medical@wada-ama.org
 
Pending WADA’s decision, HUNADO’s TUE remains valid for national-level competition and out-of-competition testing only. If the matter is not referred to WADA for review, HUANDO 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 HUNADO’s TUE Application Form [Insert again the link to a customized version of the TUE application template]. 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 HUNADO’s TUEC to obtain the information related to your TUE request in accordance with the Athlete’s Declaration, your TUE application will be deemed withdrawn without approval being granted.
 
Your TUE request-related information will be retained by HUNADO 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 HUNADO’s personal information practices, please contact Dr. Gergely Balázs Szabó (dpo@antidopping.hu).
 
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 with regard to TUEs, please contact: HUNADO TUE Committee (tuebizottsag@antidopping.hu).
 

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)