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3.4 Interpretation 3.4.1 The official text of the International Standard for Therapeutic Use Exemptions shall be published in English and French. |
In the event of any conflict between the English and French versions, the English version shall prevail. |
3.4.2 Like the Code, the International Standard for Therapeutic Use Exemptions has been drafted giving consideration to the principles of proportionality, human rights, and other applicable legal principles. |
It shall be interpreted and applied in that light. |
3.4.3 The comments annotati ng various provisions of the International Standard for Therapeutic Use Exemptions shall be used to guide its interpretation. |
3.4.4 Unless otherwise specified, references to Sections and Articles are references to Sections and Articles of the International Standard for Therapeutic Use Exemptions . |
3.4.5 Where the term “days” is used in the International Standard for Therapeutic Use Exemptions , it shall mean calendar days unless otherwise specified. |
3.4.6 The Annexes to the International Standard for Therapeutic Use Exemptions have the same mandatory status as the rest of the International Standard . |
ISTUE – January 20 23 Page 10 of 23 PART TWO: STANDARDS AND PROCESS FOR GRANTING TUES 4.0 Obtaining a TUE 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. |
[Comm ent 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 U se/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 Possessi ng 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 appl ies: a) Emergency or urgent treatment of a medical condition was necessary; b) There was insufficient t ime, 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 ISTUE – January 20 23 Page 11 of 23 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 Met hod 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?] |
ISTUE – January 20 23 Page 12 of 23 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. |
[Comment to Article 4.3: For the avoidance of doubt, retroactive approval may be granted under Article 4.3 even if the conditions in Article 4.2 are not met (although satisfaction of such conditions will be a relevant consideration). |
Other relevant factors might include, without limitation, the reasons why the Athlete did not apply in advance; the Athlete’s experience; the Education previously received by the Athlete ; whether the Athlete declared the Use of the substance or method on the Doping Control form; and the recent expiration of the Athlete’s TUE. |
In making its decision, WADA may, at its discretion, consult with a member(s) of a WADA TUEC.] |
5.0 TUE Responsibilities of Anti -Doping Organizations 5.1 Code Article 4.4 specifies (a) which Anti-Doping Organizations have authority to make TUE decisions; (b) how those TUE decisions should be recognized and respected by other Anti - Doping Organizations ; and (c) when TUE decisions may be reviewed and/or appealed. |
[Comment to Article 5.1: See Annex 1 – Code Article 4.4 Flowchart summarizing the key provisions of Code Article 4.4. |
Where national policy requirements and imperatives lead a National Anti -Doping Organization to prioritize certain sports or discipline s over others in its test distribution planning (as contemplated by Article 4.4.1 of the International Standard for Testing and Investigations), the National Anti -Doping Organization may decline to consider advance applications for TUEs from Athletes in some or all of the non- priority sports or disciplines , but in that case it must permit any such Athlete from whom a Sample is subsequently collected to apply for a retroactive TUE. |
The National Anti -Doping Organization should publicize any such policy on its website for the benefit of affected Athletes. |
ISTUE – January 20 23 Page 13 of 23 Code Article 4.4.2 specifies the authority of a National Anti -Doping Organization to make TUE decisions in respect of Athletes who are not International -Level Athletes. |
In case of dispute as to which National Anti -Doping Organization should deal with the TUE application of an Athlete who is not an International -Level At hlete, WADA will decide. |
WADA’s decision will be final and not subject to appeal.] |
5.2 For the avoidance of doubt, when a National Anti -Doping Organization grants a TUE to an Athlete, that TUE is valid at national level on a global basis and does not need to be formally recognized by other National Anti -Doping Organizations under Article 7.0 (for example, if an Athlete is granted a TUE by their National Anti -Doping Organization and then trains or competes in the country of another National Anti-Doping Organization , that TUE will be valid if the Athlete is then tested by such other National Anti -Doping Organization). |
5.3 Each National Anti -Doping Organization, International Federation and Major Event Organization must establish a TUEC to consider whether applications for grant or recognition of TUEs meet the conditions set out in Article 4.2. |
[Comment to Article 5.3: For the avoidance of doubt, the fulfilment of the conditions set out in Articles 4.1 and 4.3 may be determined by the relevant Anti -Doping Organization in consultation with a member(s) of the TUEC. |
While a Major Event Organization may choose to recognize pre-existing TUEs automatically, there must be a mechanism for Athletes participating in the Event to obtain a new TUE if the need arises. |
It is up to each Major Event Organization whether it sets up its own TUEC for this purpose, or rather whether it outsources the task by agreement to a third party. |
The aim in each case is to ensure that Athletes competing in such Events have the ability to obtain TUEs quickly and efficiently before they compete.] |
a) TUECs should include at least three (3) physicians with experience in the care and treatment of Athletes and a sound knowledge of clinical, sports and exercise medicine. |
In cases where specific expertise is required (for example, for Athletes with impairments where the substance or method pertains to the Athlete’s impairment), at least one (1) TUEC member or expert should possess such expertise. |
One (1) physician member should act as chair of the TUEC. |
b) In order to ensure impartiality of decisions, all members of the TUEC must sign a conflict of interest and confidentiality declaration (a template declaration is available on WADA’s website) . |
5.4 Each National Anti -Doping Organization, International Federation and Major Event Organization must establish a clear process for applying to its TUEC for a TUE that complies with the requirements of this International Standard. |
It must also publish details of that process by (at a minimum) posting the information in a conspicuous place on its website . |
5.5 Each National Anti -Doping Organization, International Federation and Major Event Organization must promptly report (in English or French) all decisions of its TUEC granting or denying TUEs , and all decisions to recognize or refusing to recognize other Anti -Doping Organizations' TUE decisions, through ADAMS as soon as possible and in any event within twenty -one (21) days of receipt of the decision. |
A decision to deny a TUE shall include an explanation of the reason(s) for the denial. |
In respect of TUEs granted, t he information reported shall include (in English or French): ISTUE – January 20 23 Page 14 of 23 a) Whether the Athlete was permitted to apply for a TUE retroactively under Article 4.1 and an explanation of the reason(s) why, or whether the Athlete was permitted to apply for and was granted a TUE retroactively under Article 4.3 and an explanation of the reason(s) why; b) The approved substance or method, the dosage(s), frequency, route of Administration permitted, the duration of the TUE (and, if different, the duration of prescribed treatment), and any conditions imposed in connection with the TUE ; and c) The TUE application form (if not completed electronically in ADAMS) and the relevant clinical information establishing that the Article 4.2 conditions have been satisfied in respect of such TUE (for access only by WADA , the Athlete’s National Anti -Doping Organization and International Federation, and the Major Event Organization organizing an Event in which the Athlete wishes to compete). |
[Comment to Article 5.5: If a TUE application form is used it may be translated into other languages by Anti -Doping Organizations, but the original English or French text must remain on the form, and an English or French translation of the content must be provided. |
The full medical file, including diagnostic tests, laboratory results and values must be provided, but need not be translated into English or French. |
However, a translated summary of all the key information (including key diagnostic tests) must be entered into ADAMS, with sufficient information to clearly establish the diagnosis. |
It is strongly suggested that the summary be prepared by a physician or other person with adequate medical knowledge, in order to properly understand and summarize the medical information. |
More detailed/full translations may be required by the relevant Anti -Doping Organization or WADA, upon request.] |
5.6 When a National Anti -Doping Organization grants a TUE to an Athlete, it must warn him/her in writing that (a) the TUE is valid at national level only, and (b) if the Athlete becomes an International -Level Athlete or competes in an International Event , that TUE will not be valid for those purposes unless it is recognized by the relevant International Federation or Major Event Organization in accordance with Article 7.0. |
Thereafter, the National Anti -Doping Organization should help the Athlete to determine when they need to submit the TUE to an International Federation or Major Event Organization for recognition, and should guide and support the Athlete through the recognition process . |
5.7 Each International Federation and Major Event Organization must publish and keep updated a notice (at a minimum, by posting it in a conspicuous place on its website and sending it to WADA ) that sets out clearly (1) which Athletes under its jurisdiction are required to apply to it for a TUE , and when; (2) which TUE decisions of other An ti-Doping Organizations it will automatically recognize in lieu of such application, in accordance with Article 7.1(a); and (3) which TUE decisions of other Anti-Doping Organizations will have to be submitted to it for recognition, in accordance with Artic le 7.1(b). |
5.8 If a National Anti -Doping Organization grants a TUE to an Athlete and the Athlete subsequently becomes an International -Level Athlete or competes in an International Event , the TUE will not be valid unless and until the relevant International Federation recognizes that TUE in accordance with Article 7.0. |
If an International Federation grants a TUE to an Athlete and the Athlete then competes in an International Event organized by a Major Event ISTUE – January 20 23 Page 15 of 23 Organization, the TUE will not be valid unless and until the relevant Major Event Organization recognizes that TUE in accordance with Article 7.0. |
As a result, if the International Federation or Major Event Organization (as applicable) declines to recognize that TUE , then (sub ject to the Athlete’s rights of review and appeal) that TUE may not be relied upon to excuse the presence, Use, Possession or Administration of the Prohibited Substance or Prohibited Method mentioned in the TUE vis-à-vis that International Federation or Major Event Organization. |
6.0 TUE Application Process 6.1 An Athlete who needs a TUE should apply as soon as possible. |
For substances prohibited In-Competition only, the Athlete should apply for a TUE at least thirty (30) days before their next Competition , unless it is an emergency or exceptional situation. |
6.2 The Athlete should apply to their National Anti-Doping Organization, International Federation and/or a Major Event Organization (as applicable), online or using the TUE application form provided. |
Anti-Doping Organizations shall make the application form or process they want Athletes to use available on their websites. |
If an application form is used, it must be based on the “TUE Application Form” template available on WADA’s website. |
The template may be modified by Anti-Doping Organizations to include additional requests for information, but no sections or items may be removed. |
[Comment to Article 6.2: In certain situations, an Athlete may not know which National Anti - Doping Organization they should apply to for a TUE. |
In such circumstances, the Athlete should consult the National Anti-Doping Organization of the country of the sport organization for which they com pete (or with which they are a member or license holder), to determine if they fall within that National Anti -Doping Organization’s TUE jurisdiction, according to their rules. |
If that National Anti -Doping Organization refuses to evaluate the TUE applicati on because the Athlete does not fall within its TUE jurisdiction, the Athlete should consult the anti-doping rules of the National Anti-Doping Organization of the country in which they reside (if different). |
If the Athlete still does not fall within that National Anti -Doping Organization’s TUE jurisdiction, the Athlete should then consult the anti -doping rules of the National Anti-Doping Organization of their country of citizenship (if different from where they compete or reside). |
Athletes may contact any of the above- referenced National Anti -Doping Organizations for assistance with determining whether the National Anti -Doping Organization has TUE jurisdiction. |
In the event that none of the above- mentioned National Anti -Doping Organizations have TUE jurisdiction, where there is an Adverse Analytical Finding, the Athlete should ordinarily be permitted to apply for a retroactive TUE from the Anti -Doping Organization that has Results Management authority. |
See also the summary flowcharts on “Where to Apply?” in the medical section of WADA’s website.] |
6.3 An Athlete may not apply to more than one (1) Anti -Doping Organization for a TUE for the Use of the same Prohibited Substance or Prohibited Method for the same medical condition. |
Nor may an Athlete have more than one (1) TUE at a time for the Use of the same Prohibited Substance or Prohibited Method for the same medical condition (and any such new TUE will supersede the previous TUE, which should be cancelled by the relevant Anti -Doping ISTUE – January 20 23 Page 16 of 23 Organization). |
6.4 The Athlete should submit the TUE application to the relevant Anti-Doping Organization via ADAMS or as otherwise specified by the Anti -Doping Organization . |
The application must be accompanied by a comprehensive medical history, including documentation from the original diagnosing physician(s) (where possible) and the results of all relevant examinations, laboratory investigations and imaging studies. |
The application must include the physician’s si gnature, in the designated area. |
[Comment to Article 6.4: The information submitted in relation to the diagnosis and treatment should be guided by the relevant WADA documents posted on WADA’s website.] |
6.5 The Athlete should keep a complete copy of the TUE application and of all materials and information submitted to their Anti-Doping Organization. |
6.6 A TUE application will only be considered by the TUEC following the receipt of a properly completed application, accompani ed by all relevant documents. |
Incomplete applications will be returned to the Athlete for completion and re-submission. |
6.7 The TUEC may request from the Athlete or their physician any additional information, examinations or imaging studies, or other information that it deems necessary in order to consider the Athlete’s application; and/or it may seek the assistance of such other medical or scientific experts as it deems appropriate. |
6.8 Any costs incurred by the Athlete in making the TUE application and in supplementing it as required by the TUEC are the responsibility of the Athlete. |
6.9 The TUEC shall decide whether or not to grant the application as soon as possible, and usually (i.e., unless exceptional circumstances apply) within no more than twenty -one (21) days of receipt of a complete application. |
Where a TUE application is made in a reasonable time prior to an Event , the TUEC must use its best endeavors to issue its decision before the start of the Event . |
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