Tractatenblad 2023, 84

83 (2005) Nr. 18

A. TITEL

Internationaal Verdrag tegen doping in de sport (met Bijlagen en Aanhangsels);

Parijs, 19 oktober 2005

Voor een overzicht van de verdragsgegevens, zie verdragsnummers 010871, 003898, 013996, 013997 en 013998 in de Verdragenbank.

B. TEKST

De Commissie van Toezicht heeft op respectievelijk 7 december 2020, 6 december 2021 en 2 november 2022 op grond van artikel 11, eerste lid, onder b, van de op 16 november 1989 te Straatsburg tot stand gekomen Overeenkomst ter bestrijding van doping (Trb. 1991, 8), wijzigingen van Bijlage I bij het Verdrag goedgekeurd. De Engelse tekst van deze wijzigingen is geplaatst in respectievelijk Trb. 2021, 11, Trb. 2022, 3 en Trb. 2023, 1.

De Conferentie van Partijen heeft op respectievelijk 15 november 2020, 15 november 2021 en 15 november 2022 op grond van artikel 34, tweede lid, van het Verdrag, de door het Uitvoerend Comité van het Mondiaal Anti-dopingagentschap aangenomen bovengenoemde wijzigingen van Bijlage I bij het Verdrag goedgekeurd.

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De Conferentie van Partijen heeft op 15 november 2022 op grond van artikel 34, tweede lid, van het Verdrag, de door het Uitvoerend Comité van het Mondiaal Anti-dopingagentschap aangenomen wijziging van Bijlage II bij het Verdrag goedgekeurd. De geconsolideerde Engelse tekst¹⁾ van Bijlage II bij het Verdrag, zoals laatstelijk gewijzigd in 2022, luidt vanaf 1 januari 2023 als volgt:

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 Prohibited 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.

  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 Markers 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 Committee, 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 the 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 International 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 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: Having 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 Analytical 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 International-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.

  Major Event Organizations: The continental associations of National Olympic Committees 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 authority 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 Athlete 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, for 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 Prohibited List.

  Prohibited Substance: Any substance, or class of substances, so described on the

  Prohibited List.

  Recreational Athlete: A natural Person who is so defined by the relevant National Anti-Doping Organization; provided, however, the 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 (if 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.

  [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 Committee (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.

• 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 annotating 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.

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.

[Comment 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 Use/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 Possessing 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 applies:

  • a) Emergency or urgent treatment of a medical condition was necessary;

  • b) There was insufficient time, 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 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 Method 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?]

• 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 disciplines 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.

  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 Athlete, 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, the information reported shall include (in English or French):

  • 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 Anti-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 Article 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

  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 (subject 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 compete (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 application 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 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 signature, 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, accompanied 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.

• 6.10 The TUEC’s decision must be communicated in writing to the Athlete and must be made available to WADA and to other Anti-Doping Organizations via ADAMS, in accordance with Article 5.5.

• 6.11 Each TUE will have a specified duration, as decided by the TUEC, at the end of which the TUE will expire automatically. If the Athlete needs to continue to Use the Prohibited Substance or Prohibited Method after the expiry date, they must submit an application for a new TUE well in advance of that expiry date, so that there is sufficient time for a decision to be made on the application before the expiry date.

  [Comment to Article 6.11: Where applicable, the duration of validity should be guided by the WADA documents titled “TUE Physician Guidelines”.]

• 6.12 A TUE will be withdrawn prior to expiry if the Athlete does not promptly comply with any requirements or conditions imposed by the Anti-Doping Organization granting the TUE. Alternatively a TUE may be reversed upon review by WADA or on appeal.

• 6.13 Where an Adverse Analytical Finding is issued shortly after a TUE for the Prohibited Substance in question has expired or has been withdrawn or reversed, the Anti-Doping Organization conducting the initial review of the Adverse Analytical Finding, in accordance with Article 5.1.1.1 of the International Standard for Results Management shall consider whether the finding is consistent with Use of the Prohibited Substance prior to the expiry, withdrawal or reversal of the TUE. If so, such Use (and any resulting presence of the Prohibited Substance in the Athlete’s Sample) is not an anti-doping rule violation.

• 6.14 In the event that, after their TUE is granted, the Athlete requires a materially different dosage, frequency, route or duration of Administration of the Prohibited Substance or Prohibited Method to that specified in the TUE, they must contact the relevant Anti-Doping Organization, who will then determine whether the Athlete needs to apply for a new TUE. 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.

  [Comment to Article 6.14: It is recognized that for certain medical conditions, dosages may fluctuate, particularly during the early stages of the establishment of a treatment regime or for a condition such as insulin-dependent diabetes. Such potential fluctuations should be accounted for in the TUE. However, in the event of a change that is not accounted for in the TUE, the Athlete must contact the relevant Anti-Doping Organization to determine whether a new TUE is required.]

7.0 TUE Recognition Process

• 7.1 Code Article 4.4 requires Anti-Doping Organizations to recognize TUEs granted by other Anti-Doping Organizations that satisfy the Article 4.2 conditions. Therefore, if an Athlete who becomes subject to the TUE requirements of an International Federation or Major Event Organization already has a TUE, they should not submit an application for a new TUE to the International Federation or Major Event Organization. Instead:

  • a) The International Federation or Major Event Organization may publish notice that it will automatically recognize TUE decisions made pursuant to Code Article 4.4 (or certain categories of such decisions, e.g., those made by specified Anti-Doping Organizations, or those relating to particular Prohibited Substances), provided that such TUE decisions have been reported in accordance with Article 5.5. 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, they do not need to take any further action. The TUE may not be subject to further review by the Anti-Doping Organization once automatically recognized.

    [Comment to Article 7.1(a): Automatic recognition of TUE decisions can ease the burden on Athletes. Nevertheless, International Federations and Major Event Organizations should carefully select the Anti-Doping Organizations and/or substances for which they will automatically recognize. If an International Federation or Major Event Organization is willing to grant automatic recognition of TUE decisions, it should publish on its website and keep updated a list of Anti-Doping Organizations whose TUE decisions it will recognize automatically, and/or a list of those Prohibited Substances for which TUE decisions will be recognized automatically.]

  • b) In the absence of such automatic recognition, the Athlete shall submit a request for recognition of the granted TUE to the International Federation or Major Event Organization in question, via ADAMS or as otherwise specified by that International Federation or Major Event Organization.

    [Comment to Article 7.1(b): Recognition is based solely on satisfaction of the Article 4.2 conditions. Accordingly, TUE duration alone is not a reason to deny recognition (unless it relates to satisfaction of the Article 4.2 conditions). Where applicable, TUE duration should be guided by the WADA TUE Physician Guidelines.]

• 7.2 Incomplete requests for recognition of a TUE will be returned to the Athlete for completion and re-submission. In addition, 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 request for recognition of the TUE; and/or it may seek the assistance of such other medical or scientific experts as it deems appropriate.

• 7.3 Any costs incurred by the Athlete in making the request for recognition of the TUE and in supplementing it as required by the TUEC are the responsibility of the Athlete.

• 7.4 The TUEC shall decide whether or not to recognize the TUE 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 request for recognition. Where the request is made a reasonable time prior to an Event, the TUEC must use its best endeavors to issue its decision before the start of the Event.

• 7.5 The TUEC’s decision will be notified in writing to the Athlete and will be made available to WADA and to other Anti-Doping Organizations via ADAMS. A decision not to recognize a TUE must include an explanation of the reason(s) for the non-recognition.

• 7.6 If an International Federation chooses to test an Athlete who is not an International-Level Athlete, it must recognize a TUE granted by that Athlete’s National Anti-Doping Organization unless the Athlete is required to apply for recognition of the TUE pursuant to Articles 5.8 and 7.0, i.e., because the Athlete is competing in an International Event.

8.0 Review of TUE Decisions by WADA

• 8.1 Code Article 4.4.6 provides that WADA, in certain cases, must review TUE decisions of International Federations, and that it may review any other TUE decisions, in each case to determine compliance with the Article 4.1 and 4.2 conditions. In relation to the Article 4.2 conditions, WADA shall establish a WADA TUEC that meets the requirements of Article 5.3 to carry out such reviews. In relation to the Article 4.1 conditions, these can be reviewed by WADA (which may, at its discretion, consult with a member(s) of a WADA TUEC).

• 8.2 Each request for review must be submitted to WADA in writing and must be accompanied by payment of the application fee established by WADA, as well as copies of all of the information specified in Article 6.4 (or, in the case of review of a TUE denial, all of the information that the Athlete submitted in connection with the original TUE application). The request must be copied to the Anti-Doping Organization whose decision would be the subject of the review, and to the Athlete (if they are not requesting the review).

• 8.3 Where the request is for review of a TUE decision that WADA is not obliged to review, WADA shall advise the Athlete as soon as practicable following receipt of the request whether or not it will review the TUE decision. Any decision by WADA not to review the TUE decision is final and may not be appealed. However, the TUE decision may still be appealable, as set out in Code Article 4.4.7.

• 8.4 Where the request is for review of a TUE decision of an International Federation that WADA is obliged to review, WADA may nevertheless refer the decision back to the International Federation (a) for clarification (for example, if the reasons are not clearly set out in the decision); and/or (b) for re-consideration by the International Federation (for example, if the TUE was only denied because medical tests or other information required to demonstrate satisfaction of the Article 4.2 conditions were missing).

  [Comment to Article 8.4: If an International Federation refuses to recognize a TUE granted by a National Anti-Doping Organization only because medical tests or other information required to demonstrate satisfaction of the Article 4.2 conditions are missing, the matter should not be referred to WADA. Instead, the file should be completed and re-submitted to the International Federation.]

• 8.5 Where a request for review is referred to the WADA TUEC, the WADA TUEC may seek additional information from the Anti-Doping Organization and/or the Athlete, including further studies as described in Article 6.7, and/or it may obtain the assistance of other medical or scientific experts as it deems appropriate.

• 8.6 WADA shall reverse any grant of a TUE that does not comply with the Article 4.1 and 4.2 conditions (as applicable). Where the TUE reversed was a prospective TUE (rather than a retroactive TUE), such reversal shall take effect upon the date specified by WADA (which shall not be earlier than the date of WADA’s notification to the Athlete). 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.

• 8.7 WADA shall reverse any denial of a TUE where the TUE application met the Article 4.1 and 4.2 conditions (as applicable), i.e., it shall grant the TUE.

• 8.8 Where WADA reviews a decision of an International Federation that has been referred to it pursuant to Code Article 4.4.3 (i.e., a mandatory review), it may require whichever Anti-Doping Organization “loses” the review (i.e., the Anti-Doping Organization whose view it does not uphold) (a) to reimburse the application fee to the party that referred the decision to WADA (if applicable); and/or (b) to pay the costs incurred by WADA in respect of that review, to the extent they are not covered by the application fee.

• 8.9 Where WADA reverses a TUE decision that WADA has decided in its discretion to review, WADA may require the Anti-Doping Organization that made the decision to pay the costs incurred by WADA in respect of that review.

• 8.10 If applicable, WADA shall communicate the reasoned decision of the WADA TUEC promptly to the Athlete and to their National Anti-Doping Organization and International Federation (and, if applicable, the Major Event Organization).

9.0 Confidentiality of Information

• 9.1 The Processing of Personal Information during the TUE process by Anti-Doping Organizations shall comply with the International Standard for the Protection of Privacy and Personal Information. Anti-Doping Organizations shall ensure that they have a valid legal authority or basis for such Processing, in accordance with the International Standard for the Protection of Privacy and Personal Information and applicable laws.

• 9.2 Anti-Doping Organizations shall communicate in writing the following information to Athletes as well as any other relevant information in accordance with Article 7.1 of the International Standard for the Protection of Privacy and Personal Information in connection with an Athlete’s application for the grant or recognition of a TUE:

  • a) All information pertaining to the application will be transmitted to members of all TUECs with authority under this International Standard to review the file and, as required, other independent medical or scientific experts, and to all necessary staff (including WADA staff) involved in the management, review or appeal of TUE applications;

  • b) The Athlete must authorize their physician(s) to release to any relevant TUEC upon request any health information that any such TUEC deems necessary in order to consider and determine the Athlete’s application; and

  • c) The decision on the application will be made available to all Anti-Doping Organizations with Testing authority and/or Results Management authority over the Athlete.

    [Comment to Article 9.2: Where Anti-Doping Organizations are relying upon the Athlete’s consent to Process Personal Information in connection with the TUE process, the Athlete applying for the grant or recognition of a TUE shall provide written and explicit consent to the foregoing.]

• 9.3 The TUE application shall be dealt with in accordance with the principles of strict medical confidentiality. The members of all relevant TUECs, any consulted 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 provided by the Athlete and physician(s) involved in the Athlete’s care; and

  • b) All details of the application, including the name of the physician(s) involved in the process.

• 9.4 Should the Athlete wish to revoke the right of a TUEC to obtain any health information on their behalf, the Athlete shall notify their physician in writing of such revocation; provided that, as a result of that revocation, the Athlete’s application for a TUE or for recognition of an existing TUE will be deemed withdrawn without approval/recognition having been granted.

• 9.5 Anti-Doping Organizations shall only use information submitted by an Athlete in connection with a TUE application to evaluate the application and in the context of potential anti-doping rule violation investigations and proceedings.

ANNEX 1:
CODE ARTICLE 4.4 FLOWCHART

1. TUE procedure if Athlete is not an International-Level Athlete when need for TUE arises

2. TUE procedure if Athlete is an International-Level Athlete (and so subject to the International Federation's TUE requirements) when need for TUE arises

3. Athlete enters Event for which Major Event Organization (or “MEO”) has its own TUE requirements

D. PARLEMENT

De wijzigingen van respectievelijk 15 november 2020, 15 november 2021 en 15 november 2022 van Bijlage I bij het Verdrag en de wijziging van 15 november 2022 van Bijlage II bij het Verdrag behoeven ingevolge artikel 7, onderdeel f, van de Rijkswet goedkeuring en bekendmaking verdragen niet de goedkeuring van de Staten-Generaal.

G. INWERKINGTREDING

De wijziging van 15 november 2020 van Bijlage I bij het Verdrag is ingevolge artikel 34, derde lid, op 1 januari 2021 in werking getreden voor alle partijen bij het Verdrag, waaronder het Koninkrijk der Nederlanden.

De wijziging van 15 november 2021 van Bijlage I bij het Verdrag is ingevolge artikel 34, derde lid, op 1 januari 2022 in werking getreden voor alle partijen bij het Verdrag, waaronder het Koninkrijk der Nederlanden.

De wijziging van 15 november 2022 van Bijlage I bij het Verdrag is ingevolge artikel 34, derde lid, op 1 januari 2023 in werking getreden voor alle partijen bij het verdrag, waaronder het Koninkrijk der Nederlanden.

Wat betreft het Koninkrijk der Nederlanden, gelden de wijzigingen van Bijlage I bij het Verdrag, evenals het Verdrag, voor het gehele Koninkrijk.

De wijziging van 15 november 2022 van Bijlage II bij het Verdrag is ingevolge artikel 34, derde lid, op 1 januari 2023 in werking getreden voor alle partijen bij het Verdrag, waaronder het Koninkrijk der Nederlanden.

Wat betreft het Koninkrijk der Nederlanden, geldt de wijziging van Bijlage II bij het Verdrag, evenals het Verdrag, voor het gehele Koninkrijk.

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In overeenstemming met artikel 19, tweede lid, van de Rijkswet goedkeuring en bekendmaking verdragen heeft de Minister van Buitenlandse Zaken bepaald dat de wijziging van 15 november 2022 van Bijlage II bij het Verdrag zal zijn bekendgemaakt in het gehele Koninkrijk op de dag na de datum van uitgifte van dit Tractatenblad.

Uitgegeven de twintigste juli 2023.

De Minister van Buitenlandse Zaken, W.B. HOEKSTRA

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1) De Franse tekst is niet opgenomen.