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ISTUE – January 20 23 Page 2 of 23 International Standard for Therapeutic Use Exemptions The World Anti -Doping Code International Standard for Therapeutic Use Exemptions is a mandatory International Standard developed as part of the World Anti-Doping Program.
It was developed in consultation with Signatories, public authorities and other relevant stakeholders.
The International Standard for Therapeutic Use Exemptions was first adopted in 2004 and came into effect on 1 January 2005.
It was subsequently amended seven times, the first- time effective January 2009, the second effective January 2010, the third effective January 2011, the fourth effective January 2015, the fi fth effective January 2016, the sixth effective January 2019 , the seventh effective January 2021 .
This revised version was approved by the WADA Executive Committee on 23 September 2022 and is effective as of 1 January 2023 .
Published by: World Anti -Doping Agency Stock Exchange Tower 800 Place Victoria (Suite 1700) PO Box 120 Montreal, Quebec Canada H4Z 1B7 www.wada -ama.org Tel: + 1 514 904 9232 Fax: + 1 514 904 8650 E-mail: code@wada- ama.org ISTUE – January 20 23 Page 3 of 23 TABLE OF CONTENTS PART ONE: INTRODUCTION, CODE PROVISIONS, INTERNATIONAL STANDARD PROVISIONS AND DEFINITIONS ............................................................................................................................... 4 1.0 Introduction and Scope .............................................................................................................. 4 2.0 Code Provisions ......................................................................................................................... 4 3.0 Definitions and Interpretation ...................................................................................................... 4 PART TWO: STANDARDS AND PROCESS FOR GRANTING TUES ............................................... 10 4.0 Obtaining a TUE ....................................................................................................................... 10 5.0 TUE Responsibilities of Anti-Doping Organizations .................................................................. 12 6.0 TUE Application Process .......................................................................................................... 15 7.0 TUE Recognition Process ........................................................................................................ 17 8.0 Review of TUE Decisions by WADA ......................................................................................... 18 9.0 Confidentiality of Information .................................................................................................... 19 ANNEX 1: Code Article 4.4 Flowchart .............................................................................................. 21 ISTUE – January 20 23 Page 4 of 23 PART ONE: INTRODUCTION, CODE PROVISIONS, INTERNATIONAL STANDARD PROVISIONS AND DEFINITIONS 1.0 Introduction and Scope 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 .
Terms used in this International Standard that are defined terms from the Code are italicized.
Terms that are defined in this or another International Standard are underlined.
2.0 Code Provisions The following articles in the 2021 Code are directly relevant to the International Standard for Therapeutic Use Exemptions ; they can be obtained by referring to the Code itself: • Code Article 4.4 Therapeutic Use Exemptions ("TUEs") • Code Article 13.4 Appeals Relating to TUEs 3.0 Definitions and Interpretation 3.1 Defined terms from the 2021 Code that are used in the International Standard for Therapeutic Use Exemptions ADAMS : The Anti -Doping Administration and Management System is a Web -based database management tool for data entry, storage, sharing, and reporting designed to assist stakeholders and WADA in their anti -doping operations in conjunction with data protection legislation.
Administration : Providing, supplying, supervising, facilitating, or otherwise participating in the Use or Attempted Use by another Person of a Pr ohibited Substance or Prohibited Method.
However, this definition shall not include the actions of bona fide medical personnel involving a Prohibited Substance or Prohibited Method Used for genuine and legal therapeutic purposes or other acceptable justification and shall not include actions involving Prohibited Substances which are not prohibited in Out -of-Competition Testing unless the circumstances as a whole demonstrate that such Prohibited Substances are not intended for genuine and legal therapeutic purposes or are intended to enhance sport performance .
ISTUE – January 20 23 Page 5 of 23 Adverse Analytical Finding: A report from a WADA -accredited laboratory or other WADA - approved laboratory that, consistent with the International Standard for Laboratories, establishes in a Sample the presence of a Prohibited Substance or its Metabolites or Marker s or evidence of the Use of a Prohibited Method .
Anti-Doping Organization: WADA or a Signatory that is responsible for adopting rules for initiating, implementing or enforcing any part of the Doping Control process.
This includes, for example, the International Olympic Committee, the International Paralympic Committ ee, other Major Event Organizations that conduct Testing at their Events , International Federations, and National Anti -Doping Organizations.
Athlete : Any Person who competes in sport at the international level (as defined by each International Federation) or the national level (as defined by each National Anti -Doping Organization).
An Anti-Doping Organization has discretion to apply anti -doping rules to an Athlete who is neither an International -Level Athlete nor a National -Level Athlete, and thus to bring them within the definition of “ Athlete”.
In relation to Athletes who are neither International -Level nor National -Level Athletes , an Anti-Doping Organization may elect to: conduct limited Testing or no Testing at all; analyze Samples for less than th e full menu of Prohibited Substances ; require limited or no whereabouts information; or not require advance TUEs .
However, if an Article 2.1, 2.3 or 2.5 anti -doping rule violation is committed by any Athlete over whom an Anti -Doping Organization has elected to exercise its authority to test and who competes below the international or national level, then the Consequences set forth in the Code must be applied.
For purposes of Article 2.8 and Article 2.9 and for purposes of anti-doping information and Education, any Person who participates in sport under the authority of any Signatory , government, or other sports organization accepting the Code is an Athlete .
[Comment to Athlete: Individuals who participate in sport may fall in one of five categories: 1) International -Level Athlete, 2) National -Level Athlete, 3) individuals who are not International or National -Level Athletes but over whom the Inter national Federation or National Anti-Doping Organization has chosen to exercise authority, 4) Recreational Athlete, and 5) individuals over whom no International Federation or National Anti -Doping Organization has, or has chosen to, exercise authority.
All International and National -Level Athletes are subject to the anti -doping rules of the Code, with the precise definitions of international and national level sport to be set forth in the anti-doping rules of the International Federations and National Anti -Doping Organizations.]
Attempt: Purposely engaging in conduct that constitutes a substantial step in a course of conduct planned to culminate in the commission of an anti -doping rule violation.
Provided, however, there shall be no anti-doping rule violation based solely on an Attempt to commit a violation if the Person renounces the Attempt prior to it being discovered by a third party not involved in the Attempt .
CAS : The Court of Arbitration for Sport.
Code: The World Anti -Doping Code.
Competition : A single race, match, game or singular sport contest.
For example, a basketball game or the finals of the Olympic 100-meter race in athletics.
For stage races and ISTUE – January 20 23 Page 6 of 23 other sport contests where prizes are awarded on a daily or other interim basis the distinction between a Competition and an Event will be as provided in the rules of the applicable International Federation.
Education: The process of learning to instill values and develop behaviors that foster and protect the spirit of sport, and to prevent intentional and unintentional doping.
Event : A series of individual Competitions conducted together under one ruling body (e.g., the Olympic Games, World Championships of an International Federation, or Pan American Games).
In-Competition : The period commencing at 11:59 p.m. on the day before a Competition in which the Athlete is scheduled to participate through the end of such Competition and the Sample collection process related to such Competition.
Provided, however, WADA may approve, for a particular sport, an alternative definition if an International Federation provides a compelling justification that a different definition is necessary for its sport; upon such approval by WADA , the alternative definition shall be followed by all Major Event Organizations for that particular sport.
[Comment to In- Competition: Ha ving a universally accepted definition for In -Competition provides greater harmonization among Athletes across all sports, eliminates or reduces confusion among Athletes about the relevant timeframe for In -Competition Testing, avoids inadvertent Adverse An alytical Findings in between Competitions during an Event and assists in preventing any potential performance enhancement benefits from substances prohibited Out -of-Competition being carried over to the Competition period.]
International Event : An Event or Competition where the International Olympic Committee, the International Paralympic Committee, an International Federation, a Major Event Organization, or another international sport organization is the ruling body for the Event or appoints the technical officials for the Event .
International -Level Athlete : Athletes who compete in sport at the international level, as defined by each International Federation, consistent with the International Standard for Testing and Investigations.
[Comment to International -Level Athlete: Consistent with the International Standard for Testing and Investigations, the International Federation is free to determine the criteria it will use to classify Athletes as International -Level Athletes, e.g., by ranking, by participation in particular International Events, by type of license, etc.
However, it must publish those criteria in clear and concise form, so that Athletes are able to ascertain quickly and easily when they will become classified as Internat ional -Level Athletes.
For example, if the criteria include participation in certain International Events, then the International Federation must publish a list of those International Events.]
International Standard: A standard adopted by WADA in support of the Code.
Compliance with an International Standard (as opposed to another alternative standard, practice or procedure) shall be sufficient to conclude that the procedures addressed by the International Standard were performed properly.
International Standards shall include any Technical Documents issued pursuant to the International Standard.
ISTUE – January 20 23 Page 7 of 23 Major Event Organizations: The continental associations of National Olympic Committee s and other international multi -sport organizations that function as the ruling body for any continental, regional or other International Event .
National Anti -Doping Organization: The entity(ies) designated by each country as possessing the primary author ity and responsibility to adopt and implement anti-doping rules, direct the collection of Samples , manage test results and conduct Results Management at the national level.
If this designation has not been made by the competent public authority(ies), the entity shall be the country’s National Olympic Committee or its designee.
National -Level Athlete: Athletes who compete in sport at the national level, as defined by each National Anti -Doping Organization, consistent with the International Standard for Testing and Investigations.
Out-of-Competition: Any period which is not In -Competition.
Possession: The actual, physical Possession , or the constructive Possession (which shall be found only if the Person has exclusive control or intends to exercise control over the Prohibited Substance or Prohibited Method or the premises in which a Prohibited Substance or Prohibited Method exists); provided, however, that if the Person does not have exclusive control over the Prohibited Substance or Prohibited Method or the premises in which a Prohibited Substance or Prohibited Method exists, constructive Possession shall only be found if the Person knew about the presence of the Prohibited Substance or Prohibited Method and intended to exercise control over it.
Provided, however, there shall be no anti - doping rule violation based solely on Possession if, prior to receiving notification of any kind that the Person has committed an anti -doping rule violation, the Person has taken concrete action demonstrating that the Person never intended to have Possession and has renounced Possession by explicitly declaring it to an Anti -Doping Organization.
Notwithstanding anything to the contrary in this definition, the purchase (including by any electronic or other means) of a Prohibited Substance or Prohibited Method constitutes Possession by the Person who makes the purchase.
[Comment to Possession: Under this definition, anabolic steroids found in an Athlete 's car would constitute a violation unless the Athlete establishes that someone else used the car; in that event, the Anti -Doping Organization must establish that, even though the Athl ete did not have exclusive control over the car, the Athlete knew about the anabolic steroids and intended to have control over them.
Similarly, in the example of anabolic steroids found in a home medicine cabinet under the joint control of an Athlete and spouse, the Anti -Doping Organization must establish that the Athlete knew the steroids were in the cabinet and that the Athlete intended to exercise control over them.
The act of purchasing a Prohibited Substance alone constitutes Possession, even where, f or example, the product does not arrive, is received by someone else, or is sent to a third- party address.]
Prohibited List : The list identifying the Prohibited Substances and Prohibited Methods .
Prohibited Method : Any method so described on the Prohibit ed List .
Prohibited Substance: Any substance, or class of substances, so described on the Prohibited List .
ISTUE – January 20 23 Page 8 of 23 Recreational Athlete: A natural Person who is so defined by the relevant National Anti - Doping Organization; provided, however, t he term shall not include any Person who, within the five (5) years prior to committing any anti-doping rule violation, has been an International - Level Athlete (as defined by each International Federation consistent with the International Standard for Testing and Investigations) or National -Level Athlete (as defined by each National Anti-Doping Organization consistent with the International Standard for Testing and Investigations), has represented any country in an International Event in an open category or has been included within any Registered Testing Pool or other whereabouts information pool maintained by any International Federation or National Anti -Doping Organization.
[Comment to Recreational Athlete: The term “open category” is meant to exclude competition that is limited to junior or age group categories.]
Results Management : The process encompassing the timeframe between notification as per Article 5 of the International Standard for Results Management , or in certain cases (e.g., Atypical Finding, Athlete Biological Passport , Whereabouts Failure ), such pre- notification steps expressly provided for in Article 5 of the International Standard for Results Management , through the charge until the final resolution of the matter, including the end of the hearing process at first instance or on appeal (i f an appeal was lodged).
Sample or Specimen : Any biological material collected for the purposes of Doping Control .
[Comment to Sample or Specimen: It has sometimes been claimed that the collection of blood Samples violates the tenets of certain religious or cultural groups.
It has been determined that there is no basis for any such claim.]
Testing : The parts of the Doping Control process involving test distribution planning, Sample collection, Sample handling, and Sample transport to the laboratory.
Therapeutic Use Exemption (TUE) : A Therapeutic Use Exemption allows an Athlete with a medical condition to use a Prohibited Substance or Prohibited Method, but only if the conditions set out in Article 4.4 and the International Standard for Therapeutic Use Exemptions are met.
Use: The utilization, application, ingestion, injection or consumption by any means whatsoever of any Prohibited Substance or Prohibited Method.
WADA: The World Anti -Doping Agency.
3.2 Defined terms from the International Standard for the Protection of Privacy and Personal Information Personal Information: Information, including without limitation Sensitive Personal Information , relating to an identified or identifiable Participant or other Person whose information is Processed solely in the context of an Anti -Doping Organization’s Anti -Doping Activities .
ISTUE – January 20 23 Page 9 of 23 [Comment to Personal Information: It is understood that Personal Information includes, but is not limited to, information relating to an Athlete’s name, date of birth, contact details and sporting affiliations, whereabouts, designated TUEs (if any), anti -doping test results, and Results Management (including disciplinary hearings, appeals and sanctions).
Personal Information also includes personal details and contact information relating to other Persons, such as medical professionals and other Persons working with, treating or assisting an Athlete in the context of Anti -Doping Activities.
Such information remains Personal Information and is regulated by this International Standard for the entire duration of its Processing, irrespective of whether the relevant individual remains involved in organized sport.]
Processing (and its cognates, Process and Processed) : Collecting, accessing, retaining, storing, disclosing, transferring, transmitting, amending, deleting or otherwise making use of Personal Information .
3.3 Defined terms specific to the International Standard for Therapeutic Use Exemptions Therapeutic : Of or relating to the treatment of a medical condition by remedial agents or methods; or providing or assisting in a cure.
Therapeutic Use Exemption Committe e (or "TUEC") : The panel established by an Anti - Doping Organization to consider applications for TUEs .
WADA TUEC: The panel established by WADA to review the TUE decisions of other Anti - Doping Organizations.