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The therapeutic use exemption: step by step

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Andriy Melnyk · 9 min read
The therapeutic use exemption: step by step

Anyone can fall ill, athletes included. Bronchial asthma, diabetes mellitus, ADHD, inflammatory bowel diseases — treating them often requires preparations from the WADA Prohibited List. So that treatment does not turn into disqualification, there is the therapeutic use exemption (TUE). The editorial team explains how to obtain it step by step and why most refusals are linked to poor documentation.

What a TUE is and the four criteria

A TUE is an official permission from an anti-doping organisation to use a specific prohibited substance or method in a defined dose, by a defined route of administration and for a defined period. With a valid TUE, detection of this substance in a sample is not a violation. The rules are governed by the International Standard for Therapeutic Use Exemptions (ISTUE) and Article 4.4 of the World Anti-Doping Code.

An exemption is granted only when four criteria defined by the ISTUE are met simultaneously. None of them can be «compensated» by another: if at least one is not met, the application will be rejected.

  1. The substance or method is needed to treat a diagnosed condition confirmed by clinical data.
  2. The therapeutic use is highly unlikely to produce any additional improvement in performance beyond a return to normal health.
  3. There is no reasonable permitted alternative.
  4. The need for the treatment is not a consequence of prior use of a prohibited substance without a TUE.

The fourth criterion is especially important for our blog's topics. For example, hypogonadism that developed after the use of anabolic steroids does not confer the right to a TUE for testosterone, because the condition is a consequence of prior abuse.

A TUE is not a «privilege» or an exception to the rules. It is a mechanism that allows people with chronic illnesses to compete on an equal footing with others without giving up justified treatment.

Steps 1–2: whether an exemption is needed and where to apply

The first step is to check whether the preparation is really prohibited. Important details: the prohibition may apply permanently or only in competition, and may depend on the route of administration or the dose. For example, glucocorticoids are prohibited in competition when administered systemically (orally, intravenously, intramuscularly, rectally, and since 2022 — also as any injections), whereas topical forms are permitted.

Another example is beta-2 agonists. Inhaled salbutamol is permitted without a TUE within the limits set by the Prohibited List (no more than 1600 mcg over 24 hours in divided doses and no more than 600 mcg over 8 hours), while for other substances of this group their own limits or a mandatory TUE apply. Check the exact wording each year in the current List.

Athlete levelWhere to submit the applicationComment
International level (as defined by the IF)International federationA national TUE may be recognised by the IF or require a new application
National levelNational anti-doping organisationValid for national competitions and NADO testing
Participant in a major event (Olympic Games, etc.)The event organiser (under its rules)Often recognises already valid TUEs
Lower levelDepends on the NADO's rulesA retroactive application after testing is possible

The rules of the international federation and the NADO help determine your level. If in doubt, it is worth writing to both organisations in advance: a mistake about the addressee can cost weeks.

It is also useful to use the medicine-checking tools offered by some NADOs (for example, the Global DRO databases in a number of countries). They allow you to quickly find out the status of a specific preparation, taking the route of administration into account.

Дозвіл на терапевтичне використання: покроково — ілюстрація
Photo:Siborey Sean/Unsplash

Steps 3–4: documents and submitting the application

The quality of the documentation is the main factor of success. The TUE Committee (TUEC) consists of doctors who do not see the athlete; they assess only the submitted papers. So the application must convincingly confirm the diagnosis, not merely state it.

  • The application formof the prescribed template, completed and signed by the doctor and the athlete.
  • Medical history: when and how the diagnosis was made, symptoms, course.
  • Objective data: results of tests, functional tests, imaging (for example, spirometry with a bronchodilator test for asthma, hormone tests for endocrine conditions).
  • Justification, of why permitted alternatives are unsuitable or did not work.
  • The preparation: name, dose, frequency, route of administration, duration of treatment.
  • Translationof the documents into English, if the application is submitted to an international federation.

WADA publishes TUE Physician Guidelines for common conditions: asthma, ADHD, diabetes mellitus, male hypogonadism, inflammatory bowel diseases and others. They state directly which examinations the committee expects to see. A doctor should review the relevant document before filling in the application.

As a general rule, the application is submitted at least 30 days before the moment when the exemption will be needed, for example before a competition. The exception is emergency situations, when treatment cannot be postponed.

1. Statusof the preparation 2. Identifythe organisation 3. Gatherdocuments 4. Submit(≥30 days) 5. Decision,recognition schematically; deadlines and submission channels depend on the organisation
Fig. 1. The five steps to obtaining a therapeutic use exemption (schematically).

Submission usually takes place through ADAMS or by email to the relevant organisation. Keep a copy of the entire application and confirmation of dispatch.

Step 5: decision, recognition and appeal

The committee makes a decision after reviewing the documents and, if necessary, requesting additional data. The ISTUE requires the decision to be made as quickly as possible, usually within 21 days of receiving a complete application. An incomplete application «stops the clock», so completeness is important.

If approved, the athlete receives a written exemption specifying the substance, dose, route of administration and period of validity. Any deviation, for example a different route of administration or a higher dose, is not covered by the exemption. Before the TUE expires, a new application must be submitted.

The Code provides for mutual recognition: a TUE issued by a NADO may be recognised by an international federation, but not automatically. Some federations publish lists of conditions for which recognition takes place in a simplified way; in other cases a separate application is needed.

A refusal can be appealed. A decision of an international federation may be reviewed by WADA at the athlete's request, and a decision regarding national-level athletes — by the national appeal body. WADA may also review issued TUEs on its own initiative.

Retroactive TUE and typical mistakes

A retroactive TUE, that is one issued after the fact, is possible only in clearly defined situations: emergency medical care, lack of time or opportunity to submit an application in advance, a lower-level athlete from whom a prior TUE was not required, or use of a substance out of competition when it is prohibited only in competition. Hoping to «sort it out later» in an ordinary situation is not advisable.

The most common reasons for refusals: lack of objective confirmation of the diagnosis, prescribing a prohibited preparation without trying permitted alternatives, incomplete documents, a request for doses exceeding usual clinical ones, and conditions caused by prior use of prohibited substances.

Another mistake is to think that a medical prescription is in itself an exemption. A prescription confirms treatment but does not replace a TUE. An athlete with a prescription and without a TUE will, in case of a positive test, face a case, although medical documents may influence the assessment of fault.

Athletes also often forget that a TUE has a period of validity. Treatment of a chronic illness lasts for years, but the exemption does not. It is worth setting a reminder two months before the expiry of the term.

Important.This article is for information only. Treatment decisions are made by a doctor; clarify questions about obtaining a TUE with your anti-doping organisation. Do not start taking substances prohibited in sport without medical indications and a valid exemption.

Editorial conclusions

A TUE is a lawful and predictable mechanism for athletes who need treatment with prohibited preparations. It rests on four strict criteria, and the key one is an objectively confirmed diagnosis.

The sequence of actions is simple: check the preparation's status, identify the organisation, gather evidentiary medical documentation, submit the application at least 30 days in advance and keep track of the exemption's period of validity.

Most problems arise from haste and incomplete documents. Cooperation with a sports doctor familiar with WADA's guidelines substantially increases the chances of approval.

We also recommend reading our articles on the rules for carrying medicines across the border, on prohibited supplements and on the work of the national anti-doping agency.

References

  1. World Anti-Doping Agency. International Standard for Therapeutic Use Exemptions (ISTUE). Montreal: WADA; чинна редакція.
  2. World Anti-Doping Agency. World Anti-Doping Code 2021 (Article 4.4). Montreal: WADA; 2021.
  3. World Anti-Doping Agency. The Prohibited List. Montreal: WADA; чинна редакція.
  4. World Anti-Doping Agency. TUE Physician Guidelines: Asthma. Montreal: WADA.
  5. World Anti-Doping Agency. TUE Physician Guidelines: Male Hypogonadism. Montreal: WADA.
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Andriy Melnyk

A strength-sports coach and author of programs for beginner and intermediate levels. Writes about training planning.

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