Polski
What is a therapeutic use exemption?
A Therapeutic Use Exemption (TUE) may be granted to an athlete permitting the use of a prohibited substance or prohibited method contained in the Prohibited List.
In the case of international-level athletes, TUEs are granted by a relevant international federation and in the case of national-level athletes by the national anti-doping organization (in Poland – the Commission Against Doping in Sport).
Comment: Each international federation publishes a list of international-level athletes who are included in the registered testing pool. The criteria for the inclusion of athletes in the registered testing pool are clearly defined. For example, only athletes who are ranked up to a certain place on the world ranking lists or who are members of national teams, etc. can be included in the registered testing pool.
The Commission Against Doping in Sport is the body to which TUE applications are submitted by all athletes under its jurisdiction (national-level athletes) whom their own international federation has not included in the registered testing pool.
What conditions must be met to obtain a TUE?
- The athlete should submit an application for a TUE no less than twenty one (21) days before s/he needs the approval (for instance an event).
- The athlete would experience a significant impairment to health if the prohibited substance or prohibited method were to be withheld in the course of treating an acute or chronic medical condition.
- The therapeutic use of the prohibited substance or prohibited method would produce no additional enhancement of performance other than that which might be anticipated by a return to a state of normal health following the treatment of a legitimate medical condition.
- There is no reasonable therapeutic alternative to the use of the otherwise prohibited substance or prohibited method.
- The necessity for the use of the otherwise prohibited substance or prohibited method cannot be a consequence, wholly or in part, of prior non-therapeutic use of any substance from the Prohibited List.
Each TUE will be cancelled by the granting body, if:
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The athlete does not promptly comply with any requirement or conditions imposed by the anti-doping organization granting the exemption.
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The term for which the TUE was granted has expired.
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The athlete has been advised that the TUE has been withdrawn by the anti-doping organization
TUE application process
- A TUE application is reviewed only on the basis of an application form accompanied by a complete medical dossier
TUE application forms can be downloaded from: www.wada-ama.org, www.antydoping.pl, and www.coms.pl
International-level athletes included in the registered testing pool send TUE applications to their international federations.
National-level athletes send their TUE applications to the Commission Against Doping in Sport (fax: 22 529 89 12) and by a registered letter and retain its copy.
Note: On 1 January 2009 aTUE form (abbreviated TUE form) and TUE form (standard TUE form) became obsolete and should not be used any more.
- An athlete may not apply to more than one anti-doping organization for a TUE. The application must identify the athlete’s sport and, where appropriate, discipline and specific position or role.
- The application must list any previous and/or current requests for permission to use an otherwise prohibited substance or prohibited method, the body to whom that request was made, and the decision of that body.
- The application must include a comprehensive medical history and the results of all examinations (laboratory investigations and imaging studies, etc.) relevant to the application. In the case of athletes with bronchitis asthma condition specific requirements defined below in the section entitled “Required medical file in the TUE process in the case of bronchitis asthma” apply.
- Any additional relevant investigations, examinations or imaging studies requested by the TUEC before approval are performed at the cost of the applicant or his/her national sport governing body.
- The application must include a statement by an appropriately qualified physician attesting to the necessity of the otherwise prohibited substance or prohibited method in the treatment of the athlete and describing why an alternative, permitted medication cannot, or could not, be used in the treatment of this condition.
- The dose, frequency, route and duration of administering the otherwise prohibited substance or prohibited method in question must be specified. In the case of change, a new application should be submitted.
- In normal circumstances, decisions of the TUEC should be completed within thirty (30) days of receipt of all relevant documentation and will be conveyed in writing to the athlete by the relevant anti-doping organization. In the case of a TUE application made in a reasonable time limit prior to an event, the TUEC should use its best endeavours to complete the TUE process before the start of the event.
- WADA can, on its own initiative, undertake a review of the TUE at any time.
If the decision regarding the granting of a TUE is reversed by WADA upon review, the reversal shall not apply retroactively and shall not disqualify the athlete's results during the period that the TUE had been granted and shall take effect no later than fourteen (14) days following notification of the decision to the athlete.
What is retroactive TUE?
Retroactive TUE is therapeutic use exemption approved by the Therapeutic Use Exemption Committee based on a documented medical file after a laboratory has reported an adverse analytical finding. In such a situation the TUE application is submitted by the athlete after the use of the prohibited substance. This is possible in strictly defined situations:
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Emergency treatment was necessary, or
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Due to exceptional circumstances there was insufficient time or opportunity for an application to submit, or a TUEC to consider, an application prior to doping control, or
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In the case when drugs belonging to the ß-2 agonists group have been used to treat bronchitis asthma (see below: Procedure for an athlete with a bronchitis asthma condition)
Comment: Medical emergencies or acute medical situations requiring administration of an otherwise prohibited substance or prohibited method before an application for a TUE can be made, are uncommon. Similarly, circumstances requiring the expedited consideration of an application for a TUE due to imminent competition are infrequent.
Declaration of use process
There are no longer substances or methods on the Prohibited List that require a Declaration of Use and therefore it is not necessary to file a Declaration of Use.
Athletes with a bronchitis asthma condition
Bronchitis asthma is treated with medications on the Prohibited List:
- Beta-2 agonists (formoterol, salbutamol, salmeterol, terbutalina)
- Glucocorticosteroids (budesonide, beclometasone, cyclesonide, fluticasone, etc.)
The World Anti-Doping Agency (WADA) permits the use of medications in these two groups by the inhaled route by athletes with bronchitis asthma condition provided that they present their medical file (see: “Required medical file in the TUE processes in the case of bronchitis asthma”).
Depending on the athlete category, the medical file should be prepared and submitted as follows:
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In the case of international-level athletes included in the registered testing pool of the international federation – regular TUE completed by the athlete’s physician, submitted to the international federation prior to the use of the prohibited substance.
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In the case of athletes taking part in international events, who are not included in the registered testing pool of the international federation – TUE or Retroactive TUE in the case of an adverse analytical finding, pursuant to the regulations of the international federation or organizer of an important event.
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In the case of national-level athletes - TUE or Retroactive TUE in the case of an adverse analytical finding.
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A Retroactive TUE is not granted if the conditions describing the required medical file (see: “Required medical file in the TUE processes in the case of bronchitis asthma”) have not been met, which means that any adverse analytical finding announced by the laboratory under such circumstances is treated as a doping rule violation.
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Each use of the prohibited substance must be declared on the doping control form at the time of control.
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When only glucocorticosteroids are used by the inhaled route, the use of the prohibited substance must be declared (it is not necessary to submit a TUE application or a Retroactive TUE application).
Explanation: The World Anti-Doping Agency (WADA) permits a situation in which a national level athlete with a bronchitis asthma condition uses prohibited medications belonging to the beta-2 agonists and glucocorticosteroids by the inhaled route without prior consent (i.e. without TUE). In the case of a positive analytical finding during doping control the Commission Against Doping in Sport notifies the athlete, who must submit a Retroactive TUE application with the required medical file.
Required medical file in the TUE processes in the case of bronchitis asthma:
The file must reflect the current best medical practice to include:
1. A complete medical history
2. A comprehensive report of the clinical examination with specific focus on the respiratory system
3. A report of spirometry with the measure of the Forced Expiratory Volume in 1 second (FEV1)
4. If airway obstruction is present, the spirometry will be repeated after inhalation of a short acting Beta-2 Agonist to demonstrate the reversibility of bronchoconstriction
5. In the absence of reversible airway obstruction, a bronchial provocation test is required to establish the presence of airway hyperresponsiveness
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Provocation test with methacholine or histamine
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Exercise provocation test
6. Exact name, address (including telephone, e-mail, fax) of examining physician.
Downloadable forms
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