WADA CODE : INTERNATIONAL STANDARD FOR THERAPEUTIC USE EXEMPTIONS

The International Standard for Therapeutic Use Exemptions is a mandatory International Standard developed as part of the World Anti-Doping Program. The purpose of the International Standard for Therapeutic Use Exemptions is to establish

(a) the conditions that must be satisfied in order for a Therapeutic Use Exemption (or TUE) to be granted, permitting the presence of a Prohibited Substance in an Athlete’s Sample or the Athlete’s Use or Attempted Use, Possession and/or Administration or Attempted Administration of a Prohibited Substance or Prohibited Method for therapeutic reasons;

(b) the responsibilities imposed on Anti-Doping Organizations in making and communicating TUE decisions;

(c) the process for an Athlete to apply for a TUE;

(d) the process for an Athlete to get a TUE granted by one Anti-Doping Organization recognized by another Anti-Doping Organization;

(e) the process for WADA to review TUE decisions; and

(f) the strict confidentiality provisions that apply to the TUE process.

The following articles in the 2015 Code are directly relevant to the International Standard for Therapeutic Use Exemptions:

Code Article 4.4 Therapeutic Use Exemptions (“TUEs”).

4.4.1 The presence of a Prohibited Substance or its Metabolites or Markers, and/or the Use or Attempted Use, Possession or Administration or Attempted Administration of a Prohibited Substance or Prohibited Method shall not be considered an anti-doping rule violation if it is consistent with the provisions of a TUE granted in accordance with the International Standard for Therapeutic Use Exemptions.

4.4.2 An Athlete who is not an International-Level Athlete should apply to his or her National Anti-Doping Organization for a TUE. If the National Anti-Doping Organization denies the application, the Athlete may appeal exclusively to the national-level appeal body described in Articles 13.2.2 and 13.2.3.

4.4.3 An Athlete who is an International-Level Athlete should apply to his or her International Federation.

4.4.3.1 Where the Athlete already has a TUE granted by his or her National Anti-Doping Organization for the substance or method in question, if that TUE meets the criteria set out in the International Standard for Therapeutic Use Exemptions, then the International Federation must recognize it. If the International Federation considers that the TUE does not meet those criteria and so refuses to recognize it, it must notify the Athlete and his or her National Anti-Doping Organization promptly, with reasons. The Athlete or the National Anti-Doping Organization shall have 21 days from such notification to refer the matter to WADA for review. If the matter is referred to WADA for review, the TUE granted by the National Anti-Doping Organization remains valid for national-level Competition and Out-of-Competition Testing (but is not valid for international-level Competition) pending WADA’s decision. If the matter is not referred to WADA for review, the TUE becomes invalid for any purpose when the 21-day review deadline expires.

4.4.3.2 If the Athlete does not already have a TUE granted by his or her National Anti-Doping Organization for the substance or method in question, the Athlete must apply directly to his or her International Federation for a TUE as soon as the need arises. If the International Federation (or the National Anti-Doping Organization, where it has agreed to consider the application on behalf of the International Federation) denies the Athlete’s application, it must notify the Athlete promptly, with reasons. If the International Federation grants the Athlete’s application, it must notify not only the Athlete but also his or her National Anti-Doping Organization, and if the National Anti-Doping Organization considers that the TUE does not meet the criteria set out in the International Standard for Therapeutic Use Exemptions, it has 21 days from such notification to refer the matter to WADA for review. If the National Anti-Doping Organization refers the matter to WADA for review, the TUE granted by the International Federation remains valid for international-level Competition and Out-of-Competition Testing (but is not valid for national-level Competition) pending WADA’s decision. If the National Anti-Doping Organization does not refer the matter to WADA for review, the TUE granted by the International Federation becomes valid for national-level Competition as well when the 21-day review deadline expires.

If the International Federation refuses to recognize a TUE granted by a National Anti-Doping Organization only because medical records  or other information are missing that are needed to demonstrate satisfaction with the criteria in the International Standard for Therapeutic Use Exemptions, the matter should not be referred to WADA. Instead, the file should be completed and re-submitted to the International Federation.
If an International Federation chooses to test an Athlete who is not an International-Level Athlete, it must recognize a TUE granted to that Athlete by his or her National Anti-Doping Organization.

4.4.4 A Major Event Organization may require Athletes to apply to it for a TUE if they wish to Use a Prohibited Substance or a Prohibited Method in connection with the Event. In that case:

4.4.4.1 The Major Event Organization must ensure a process is available for an Athlete to apply for a TUE if he or she does not already have one. If the TUE is granted, it is effective for its Event only.

4.4.4.2 Where the Athlete already has a TUE granted by his or her National Anti-Doping Organization or International Federation, if that TUE meets the criteria set out in the International Standard for Therapeutic Use Exemptions, the Major Event Organization must recognize it. If the Major Event Organization decides the TUE does not meet those criteria and so refuses to recognize it, it must notify the Athlete promptly, explaining its reasons.

4.4.4.3 A decision by a Major Event Organization not to recognize or not to grant a TUE may be appealed by the Athlete exclusively to an independent body established or appointed by the Major Event Organization for that purpose. If the Athlete does not appeal (or the appeal is unsuccessful), he or she may not Use the substance or method in question in connection with the Event, but any TUE granted by his or her National Anti-Doping Organization or International Federation for that substance or method remains valid outside of that Event.

The CAS Ad Hoc Division or a similar body may act as the independent appeal body for particular Events, or WADA may agree to perform that function. If neither CAS nor WADA are performing that function, WADA retains the right (but not the obligation) to review the TUE decisions made in connection with the Event at any time, in accordance with Article 4.4.6.

4.4.5 If an Anti-Doping Organization chooses to collect a Sample from a Person who is not an International-Level or National-Level Athlete, and that Person is Using a Prohibited Substance or Prohibited Method for therapeutic reasons, the Anti-Doping Organization may permit him or her to apply for a retroactive TUE.

4.4.6 WADA must review an International Federation’s decision not to recognize a TUE granted by the National Anti-Doping Organization that is referred to it by the Athlete or the Athlete’s National Anti-Doping Organization. In addition, WADA must review an International Federation’s decision to grant a TUE that is referred to it by the Athlete’s National Anti-Doping Organization. WADA may review any other TUE decisions at any time, whether upon request by those affected or on its own initiative. If the TUE decision being reviewed meets the criteria set out in the International Standard for Therapeutic Use Exemptions, WADA will not interfere with it. If the TUE decision does not meet those criteria, WADA will reverse it.

WADA shall be entitled to charge a fee to cover the costs of (a) any review it is required to conduct in accordance with Article 4.4.6; and (b) any review it chooses to conduct, where the decision being reviewed is reversed.

4.4.7 Any TUE decision by an International Federation (or by a National Anti-Doping Organization where it has agreed to consider the application on behalf of an International Federation) that is not reviewed by WADA, or that is reviewed by WADA but is not reversed upon review, may be appealed by the Athlete and/or the Athlete’s National Anti-Doping Organization, exclusively to CAS.

In such cases, the decision being appealed is the International Federation’s TUE decision, not WADA’s decision not to review the TUE decision or (having reviewed it) not to reverse the TUE decision. However, the time to appeal the TUE decision does not begin to run until the date that WADA communicates its decision. In any event, whether the decision has been reviewed by WADA or not, WADA shall be given notice of the appeal so that it may participate if it sees fit.

A decision by WADA to reverse a TUE decision may be appealed by the Athlete, the National Anti-Doping Organization and/or the International Federation affected, exclusively to CAS. A failure to take action within a reasonable time on a properly submitted application for grant/recognition of a TUE or for review of a TUE decision shall be considered a denial of the application.

 

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