An Athlete who needs to Use a Prohibited Substance or Prohibited Method for Therapeutic reasons must apply for and obtain a TUE prior to Using or Possessing the substance or method in question, unless the Athlete is entitled to apply for a TUE retroactively under Article 4.1. In both cases, the Article 4.2 conditions must be satisfied.

[Comment to Article 4.0: There may be situations where an Athlete has a medical condition and is Using or Possessing a Prohibited Substance or Prohibited Method prior to becoming subject to anti-doping rules. In that case, such prior Use/Possession does not require a TUE and a prospective TUE will be sufficient.]

4.1 A retroactive TUE provides an Athlete the opportunity to apply for a TUE for a Prohibited Substance or Prohibited Method after Using or Possessing the substance or method in question.

An Athlete may apply retroactively for a TUE (but must still meet the conditions in Article 4.2) if any one of the following exceptions applies:

a) Emergency or urgent treatment of a medical condition was necessary;

b) There was insufficient time, opportunity or other exceptional circumstances that prevented the Athlete from submitting (or the TUEC to consider) an application for the TUE prior to Sample collection;

c) Due to national level prioritization of certain sports or disciplines, the Athlete’s National Anti-Doping Organization did not permit or require the Athlete to apply for a prospective TUE (see comment to Article 5.1);

d) If an Anti-Doping Organization chooses to collect a Sample from an Athlete who is not an International-Level Athlete or National-Level Athlete, and that Athlete is Using a Prohibited Substance or Prohibited Method for Therapeutic reasons, the Anti-Doping Organization must permit the Athlete to apply for a retroactive TUE; or

e) The Athlete Used Out-of-Competition, for Therapeutic reasons, a Prohibited Substance that is only prohibited In-Competition.

[Comment to Article 4.1: The fulfillment of one of the retroactive exceptions does not mean that a TUE will necessarily be granted; it means that the Athlete’s application may be evaluated under Article 4.2 to determine if the specified TUE conditions have been satisfied.]

[Comment to Article 4.1(c), (d) and (e): Such Athletes are strongly advised to have a medical file prepared and ready to demonstrate their satisfaction of the TUE conditions set out at Article 4.2, in case an application for a retroactive TUE is necessary following Sample collection.]

[Comment to Article 4.1(e): This seeks to address situations where, for Therapeutic reasons, an Athlete Uses a substance Out-of-Competition that is only prohibited In-Competition, but there is a risk that the substance will remain in their system In-Competition. In such situations, the Anti-Doping Organization must permit the Athlete to apply for a retroactive TUE (where the Athlete has not applied in advance). This also seeks to prevent Anti-Doping Organizations from having to assess advance TUE applications that may not be necessary.]

4.2 An Athlete may be granted a TUE if (and only if) they can show, on the balance of probabilities, that each of the following conditions is met:

a) The Prohibited Substance or Prohibited Method in question is needed to treat a diagnosed medical condition supported by relevant clinical evidence.

[Comment to Article 4.2(a): The Use of the Prohibited Substance or Prohibited Method may be part of a necessary diagnostic investigation rather than a treatment per se.]

b) The Therapeutic Use of the Prohibited Substance or Prohibited Method will not, on the balance of probabilities, produce any additional enhancement of performance beyond what might be anticipated by a return to the Athlete’s normal state of health following the treatment of the medical condition.

[Comment to Article 4.2(b): An Athlete’s normal state of health will need to be determined on an individual basis. A normal state of health for a specific Athlete is their state of health but for the medical condition for which the Athlete is seeking a TUE.]

c) The Prohibited Substance or Prohibited Method is an indicated treatment for the medical condition, and there is no reasonable permitted Therapeutic alternative.

[Comment to Article 4.2(c): The physician must explain why the treatment chosen was the most appropriate, e.g., based on experience, side-effect profiles or other medical justifications, including, where applicable, geographically specific medical practice, and the ability to access the medication. Further, it is not always necessary to try and fail alternatives before using the Prohibited Substance or Prohibited Method.]

d) The necessity for the Use of the Prohibited Substance or Prohibited Method is not a consequence, wholly or in part, of the prior Use (without a TUE) of a substance or method which was prohibited at the time of such Use.

[Comment to Article 4.2: The WADA documents titled “TUE Physician Guidelines”, posted on WADA’s website, should be used to assist in the application of these criteria in relation to particular medical conditions.

The granting of a TUE is based solely on consideration of the conditions set out in Article 4.2. 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.

When an International Federation or Major Event Organization TUEC is deciding whether or not to recognize a TUE granted by another Anti-Doping Organization (see Article 7), and when WADA is reviewing a decision to grant (or not to grant) a TUE (see Article 8), the issue will be the same as it is for a TUEC that is considering an application for a TUE under Article 6, i.e., has the Athlete demonstrated on the balance of probabilities that each of the conditions set out in Article 4.2 is met?]

4.3 In exceptional circumstances and notwithstanding any other provision in this International Standard for Therapeutic Use Exemptions, an Athlete may apply for and be granted retroactive approval for their Therapeutic Use of a Prohibited Substance or Prohibited Method if, considering the purpose of the Code, it would be manifestly unfair not to grant a retroactive TUE. For International-Level Athletes and National-Level Athletes, an Anti-Doping Organization may grant an Athlete’s application for a retroactive TUE pursuant to this Article only with the prior approval of WADA (and WADA may in its absolute discretion agree with or reject the Anti-Doping Organization’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 pursuant to this Article without first consulting WADA; however, WADA may at any time review an Anti-Doping Organization’s decision to grant a retroactive TUE pursuant to this Article, and may in its absolute discretion, agree with or reverse the decision.

Any decision made by WADA and/or an Anti-Doping Organization under this Article may not be challenged either as a defense to proceedings for an anti-doping rule violation, or by way of appeal, or otherwise.

All decisions of an Anti-Doping Organization under this Article 4.3, whether granting or denying a TUE, must be reported through ADAMS in accordance with Article 5.5.