8 May 2018

Therapeutic Use Exemption Process


“Only the dose makes the poison”
Paracelsus


Every athlete is first of all a human being and of course he(she) may have an illness or a condition that needs a particular medication. Usually, doctors prescribe treatments in accordance with the internal medical protocols, standards or others instructions. Some medications could contain prohibited substances or methods that are included in the Prohibited List, adopted annually by World Anti-Doping Agency (WADA). Any athlete who may be subject to doping control must request a Therapeutic Use Exemption before taking a prohibited substance or method.


Therapeutic Use Exemption (TUE) is a very relevant tool that ensure the athlete to take a proper medical treatment without constitute an anti-doping rule violation. To have an approved and valid TUE the athlete has to follow all the conditions and procedures reviewed into the International Standard for Therapeutic Use Exemption. 

The purpose of the International Standards for TUE is to establish:
a) the conditions that must be satisfied in order for a TUE to be granted;
b) the responsibilities imposed on International Federations and National Anti-Doping Organizations in making and communicating TUE decisions;
c) application, obtaining and recognition for a TUE process;
d) the process for WADA to review TUE decisions;
e) the strict confidentiality provisions that apply to the TUE process.

It is the athlete main responsibility to inform the doctor about his quality. The doctor should clearly understand that the person who needs a special medical treatment is an athlete and that the medicines should be specified very carefully. Any data offered by the athlete during the medical consultation is considered Personal Information and is confidential (this includes personal details and contacts, the cure of treatment or other information) and could be used only in the context of anti-doping activities, in accordance with the International Standard for the Protection of Privacy and Personal Information.

TUEs ensure that any athlete is able to obtain treatment for a legitimate medical condition – even if that treatment requires a prohibited substances or method. The TUE process avoids the risk of sanctions due to a positive test, so 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.

Each International Federations and National Anti-Doping Agencies should establish their own panels aimed to consider application for TUEs - Therapeutic Use Exemption Committee, independent entities formed by the physicians with experience in the care and treatment of athletes and a sound knowledge of clinical, sports and exercise medicine and lawyers, usually 3 or 5 members. In cases involving Athletes with impairments, at least one TUE Committee member should possess general experience in the care and treatment of Athletes with impairments, or possess specific experience in relation to the Athlete’s particular impairment(s). It is recommended that the TUE Committee does not interfere with the Anti-Doping Committee that is the Testing Authority and the Results Management Authority. In order to ensure a level of independence of decisions, at least majority of the members of a TUE Committee should have no political responsibility in the Anti-Doping Organization that appoints them. All members of the Committee must sign a conflict of interest and confidentiality declaration. Unfortunately, the TUE Committee has not been yet established, it is the WAF objective to appoint its members and to constitute this structure as soon as possible. In the same time it must be established a clear process for applying to its TUE Committee for a TUE that complies with the requirements and publish details of that process on its own website.

A TUE may be granted if (and only if) each of the following conditions is met:
a. The Prohibited Substance or Prohibited Method in question is needed to
treat an acute or chronic medical condition, such that the Athlete would
experience a significant impairment to health if the Prohibited Substance
or Prohibited Method were to be withheld;
b. The Therapeutic Use of the Prohibited Substance or Prohibited Method is
highly unlikely to 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 acute or chronic medical
condition;
c. There is no reasonable Therapeutic alternative to the Use of
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.

The main rule is that the athlete must obtain a TUE prior to Using or Possessing the substance or the method in the question. An athlete who needs a TUE should apply as soon as possible. For a substance prohibited In-Competition only, the application must be made at least 30 days before taking part in that event. As exceptions, in the following situations, a TUE may be granted retroactively:
a. Emergency treatment or treatment of an acute medical condition was necessary;
b. Due to other exceptional circumstances, there was insufficient time or opportunity for the Athlete to submit, or for the TUE Committee to consider, an application for the TUE prior to Sample collection;
c. The applicable rules required the Athlete or permitted the Athlete to apply for a retroactive TUE e.g., any individual who is not an international level athlete nor national level athlete may request a retroactive TUE for the use of the prohibited substance or a method;
d. It is agreed, by WADA and by the Anti-Doping Organization to whom the
application for a retroactive TUE is or would be made, that fairness
requires the grant of a retroactive TUE.

If the athlete is not an International Level Athlete he/she will apply for a TUE to the National Anti-Doping Organization (NADO). The International Level Athlete could also apply for a TUE to the NADO if he intends to compete just at the national level (valid at the national level only). If this Athlete intends to compete in an International Event, that TUE will not be valid for those purposes unless it is recognized by the relevant International Federation.

The International Federation may choose to:
- set up its own TUE Committee for this purpose;
- to recognize pre-existing TUEs automatically, e.g., those made by specified Anti-Doping Organizations, or those relating to particular Prohibited Substances. If the Athlete’s TUE falls into a category of TUEs that are automatically recognized in this way at the time the TUE is granted, he/she does not need to take any further action;
- or rather whether it outsources the task by agreement to a third party (such as Sport Accord or the new International Testing Agency).

The TUE application form and the relevant clinical information will be translated into English or French. All additional costs regarding the submission of the TUE application form and completion of the application will be supported by the athlete.

The athlete should submit the TUE application form to the relevant Anti-Doping Organization via ADAMS or as otherwise specified by the Anti-Doping Organization. The form must be accompanied by:
a. a statement by an appropriately qualified physician, attesting to the need for the athlete to Use the Prohibited Substance or Prohibited Method in question for Therapeutic reasons; and
b. a comprehensive medical history, including documentation from the original diagnosing physician(s) (where possible) and the results of all examinations, laboratory investigations and imaging studies relevant to the application.

The athlete should keep a complete copy of the TUE application form and of all materials and information submitted in support of that application in the case of any further dispute.

Any member of the TUE Committee may ask from the athlete and his doctor any additional information regarding the examinations, imaging studies, analysis, or even experts assistance that he/she deems necessary to examine the request for a TUE.

All the TUE application form will be examined by the TUE Committee within no more that 21 days of the receipt of a complete application. If one of the members of the TUE Committee has a particular point of view he will indicate it in the decision. The TUE Committee’s decision must be communicated in writing to the Athlete. All decisions of the TUE Committee granting or denying TUEs, and all the decisions to recognize or refusing to recognize other Anti-Doping Organizations’ TUE decisions will be reported via ADAMS. So, WADA will be able to review all these decisions.

The TUE application shall be dealt with in accordance with the principles of strict medical confidentiality. The members of the TUE Committee, independent experts and the relevant staff of the Anti-Doping Organization shall conduct all of their activities relating to the process in strict confidence and shall sign appropriate confidentiality agreements. In particular they shall keep the following information confidential: 
a. All medical information and data provided by the Athlete and physician(s) involved in the Athlete’s care;
b.  All details of the application, including the name of the physician(s) involved in the process.


A decision to grant a TUE must specify the dosage(s), frequency, route and duration of administration of the Prohibited Substance or Prohibited Method in question that the TUE Committee is permitting, reflecting the clinical circumstances, as well as any conditions imposed in connection with the TUE. A decision to deny a TUE application must include an explanation of the reason(s) for the denial.

Each TUE has a specified duration, at the end of each the TUE will expire automatically. To continue to use the Prohibited Substance or Method, the athlete must submit a new TUE application form. That should be made in advance of that expiry date, so that there will be sufficient time for a decision to be made. If the presence, Use, Possession or Administration of the Prohibited Substance or Prohibited Method is not consistent with the terms of the TUE granted, the fact that the Athlete has the TUE will not prevent the finding of an anti-doping rule violation.

If the athlete does not meet the conditions described in the decision the TUE may be withdrawn at any time before the expiry date. Also, a TUE may be reversed upon review by WADA or on appeal.

WADA may review any TUE decision made by International Federations or any other Anti-Doping Organization in order to determine if the decision meets the conditions of the compliance. The reversal shall not apply retroactively and the Athlete’s results prior to such notification shall not be Disqualified. Where the TUE reversed was a retroactive TUE, however, the reversal shall also be retroactive. WADA may require the Anti-Doping Organization that made the decision to pay the costs incurred by WADA in respect of that review. WADA shall communicate the reasoned decision of the WADA TUE Committee promptly to the Athlete and to his/her National Anti-Doping Organization and International Federation.

It is recommended to present the decision of granting TUE or the copy to the Doping Control Officer (DCO) during the sample collection, if not to send as soon as possible via e-mail to your Testing Authority. The athlete will fill in the Comments box of the Doping Control Form the mention of TUE.

All other relevant details and special provisions about the TUEs submission or recognition will be shared by the National Anti-Doping Organizations. The conventional role of the National Anti-Doping Organizations is to guide, to inform, to explain and to support their athletes during this entire process.

/ Mihail Grumeza