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International Standard for Therapeutic Use Exemptions
The International Standard for Therapeutic Use Exemptions was first adopted in 2004
and became effective in 2005. The enclosed represents version 3.0 that incorporates
revisions to the International Standard for Therapeutic Use Exemptions that were approved by the World Anti-Doping Agency Executive Committee on 10 May and 20
September 2008. The revised International Standard for Therapeutic Use Exemptions is effective as of 1 January 2009.
Published on 1 October 2008 by: World Anti-Doping Agency Stock Exchange Tower
800 Place Victoria (Suite 1700) PO Box 120
International Standard for Therapeutic Use Exemptions
PREAMBLE
The World Anti-Doping Code
International Standard for Therapeutic Use Exemptions (TUE) is a level 2 mandatory
International Standard developed as part of the World Anti-Doping Program.
The basis for the development of the
International Standard for TUE has been a review of various procedures and protocols of International Federations, the IOC, National Anti-Doping Organizations and relevant sections in the revised International Standard for Doping Control (ISDC). A WADA expert reference group reviewed, discussed and prepared the
document following wide consultation and consideration of submissions. The official text of the
International Standard for Therapeutic Use Exemption shall be maintained by WADA and shall be published in English and French. In the event of any conflict between the English and French versions, the English version shall prevail.
The
International Standard for TUE (version 3.0) will come into effect on 1 January 2009.
International Standard for Therapeutic Use Exemptions
TABLE OF CONTENTS
PART ONE: INTRODUCTION, CODE PROVISIONS AND DEFINITIONS. 5
3.2 Defined Terms from the
International Standard for TUEs.12
PART TWO: STANDARDS FOR GRANTING THERAPEUTIC USE
EXEMPTIONS . 13
Criteria for Granting a Therapeutic
Use Exemption .13
Therapeutic
Use Exemption Committees (TUECs).15
Therapeutic
Use Exemption (TUE) Application Process .15
8.0 Declaration of
Use Process .18
ANNEX 1: . 20
Minimal requirements for the medical file to be used for the TUE process in the
case of asthma and its clinical variants .20
ANNEX 2: . 21
Therapeutic use exemption application form.21
International Standard for Therapeutic Use Exemptions
PART ONE: INTRODUCTION, CODE PROVISIONS AND
DEFINITIONS
Introduction and Scope
The purpose of the
International Standard for TUE is to ensure that the
process of granting therapeutic
use exemptions is harmonized across sports and countries. The
Code permits
Athletes and their physicians to apply for therapeutic use exemptions (TUE) i.e. permission to use, for therapeutic purposes,
substances or methods contained in the List of
Prohibited Substances or
Methods whose
Use is otherwise prohibited. The
International Standard for
TUE includes criteria for granting a TUE, confidentiality of information, the formation of Therapeutic Use Exemptions Committees and the TUE application process.
This Standard applies to all
Athletes as defined by and subject to the
Code i.e. able-bodied
Athletes and
Athletes with disabilities. The World Anti-Doping Program encompasses all of the elements needed in
order to ensure optimal harmonization and best practice in international and national anti-doping programs. The main elements are: the
Code (Level 1),
International Standards (Level 2), and Models of Best Practice (Level 3). In the introduction to the
Code, the purpose and implementation of the
International Standards are summarized as follows:
“
International Standards for different technical and operational areas within the anti-doping program will be developed in consultation with the
Signatories
and governments and approved by
WADA. The purpose of the
International Standards is harmonization among
Anti-Doping Organizations responsible for
specific technical and operational parts of the anti-doping programs.
Adherence to the
International Standards is mandatory for compliance with
the
Code. The
International Standards may be revised from time to time by the
WADA Executive Committee after reasonable consultation with the
Signatories and governments. Unless provided otherwise in the
Code,
International Standards and all revisions shall become effective on the date specified in the International Standard or revision.”
Compliance with an
International Standard (as opposed to another alternative standard, practice or procedure) shall be sufficient to conclude that the procedures covered by the
International Standard were performed
properly. Definitions specified in the
Code are written in italics. Additional definitions specific to the
International Standard for TUE are underlined. International Standard for Therapeutic Use Exemptions
2.0 Code Provisions
The following articles of the
Code directly address the
International Standard
for
TUE:
Code Article 4.4 Therapeutic Use
WADA has adopted an
International Standard for the process of granting therapeutic use exemptions. Each International Federation shall ensure, for
International-Level Athletes or any other
Athlete who is entered in an
International Event, that a process is in place whereby
Athletes with documented medical conditions requiring the
Use of a
Prohibited Substance or a
Prohibited Method may request a therapeutic use exemption.
Athletes
who have
been identified as included in their International Federation’s
Registered Testing Pool may only obtain therapeutic use exemptions in accordance with the rules of their International Federation. Each International Federation shall publish a list of those
International Events for which a therapeutic use exemption from the International Federation is required.
Each
National Anti-Doping Organization shall ensure, for all
Athletes within its jurisdiction that have not been included in an International Federation
Registered Testing Pool, that a process is in place whereby
Athletes with documented medical conditions requiring the
Use of a
Prohibited Substance or a
Prohibited Method may request a therapeutic
use exemption. Such requests shall be evaluated in accordance with the
International Standard for Therapeutic Use Exemptions. International Federations and
National Anti-Doping Organizations shall promptly report to
WADA through
ADAMS the granting of any therapeutic use exemption except as regards national-level
Athletes who are not included in the
National Anti-Doping Organization's
Registered Testing Pool.
WADA, on its own initiative, may review at any time the granting of a therapeutic use exemption to any
International-Level Athlete or national-level
Athlete who is included in his or her
National Anti-Doping Organization's
Registered Testing Pool. Further, upon the request of any
such
Athlete who has been denied a therapeutic use exemption,
WADA may review such denial. If
WADA determines that such granting or denial of a therapeutic use exemption did not comply with the
International Standard for Therapeutic Use Exemptions,
WADA may reverse the decision.
If, contrary to the requirement of this Article, an International Federation does not have a process in place where
Athletes may request therapeutic use exemptions, an
International-Level Athlete may request
WADA to review the application as if it had been denied.
Presence of a
Prohibited Substance or its
Metabolites or
Markers (Article 2.1),
Use or
Attempted
Use of a
Prohibited Substance or a
International Standard for Therapeutic Use Exemptions
Prohibited Method (Article 2.2),
Possession of
Prohibited Substances
and
Prohibited Methods
(Article
2.6) or Administration or
Attempted
Administration of a
Prohibited Substance or
Prohibited Method (Article 2.8) consistent with the provisions of an applicable therapeutic use exemption issued pursuant to the
International Standard for Therapeutic Use Exemptions shall not be considered an anti-doping rule
Code Article 13.4 Appeals from Decisions Granting or Denying a
Therapeutic Use Exemption
Decisions by
WADA reversing the grant or denial of a therapeutic use exemption may be appealed exclusively to
CAS by the
Athlete or the
Anti-Doping Organization whose decision was reversed. Decisions by
Anti-Doping Organizations other than
WADA denying therapeutic use exemptions, which are not reversed by
WADA, may be appealed by
International-Level Athletes
to
CAS and by other
Athletes to the national-level reviewing body described in Article 13.2.2. If the national-level reviewing body reverses the decision to deny a therapeutic use exemption, that decision may be appealed to
CAS by
WADA.
When an
Anti-Doping Organization fails to take action on a properly submitted therapeutic use exemption application within a reasonable time, the
Anti-Doping Organization’s failure to decide may be considered a denial for purposes of the appeal rights provided in this Article.
Code Article 14.5 Doping Control Information Clearinghouse
WADA shall act as a central clearinghouse for
Doping Control Testing data and results for
International-Level Athletes and national-level
Athletes who have been included in their
National Anti-Doping Organization's
Registered Testing Pool. To facilitate coordinated test distribution planning and to avoid unnecessary duplication in
Testing by
the various
Anti-Doping Organizations, each
Anti-Doping Organization shall report all
In-Competition and
Out-of-Competition tests on such
Athletes to the
WADA clearinghouse as soon as possible after such tests have been conducted. This information will be made accessible to the
Athlete, the
Athlete's National Federation,
National Olympic Committee
or National Paralympic Committee,
National Anti-Doping Organization, International Federation, and the International
Olympic Committee or International Paralympic Committee.
To enable it to serve as a clearinghouse for
Doping Control Testing data,
WADA has developed a database management tool,
ADAMS, that reflects
emerging data privacy principles. In particular,
WADA has developed
ADAMS to be consistent with data privacy statutes and norms applicable to
WADA and other organizations using
ADAMS. Private information regarding an
Athlete, Athlete Support Personnel, or
others involved in anti-doping activities shall be maintained by
WADA,
International Standard for Therapeutic Use Exemptions
which is supervised by Canadian privacy authorities, in strict confidence and in accordance with the
International Standard for the protection of privacy.
WADA shall, at least annually, publish statistical reports summarizing the information that it receives, ensuring at all times that the privacy of
Athletes is fully respected and make itself available for discussions with national and regional data privacy authorities.
Code Article 15.4 Mutual Recognition
15.4.1 Subject to the right to appeal provided in Article 13,
Testing, therapeutic use exemptions and hearing results or other final
adjudications of any
Signatory which are consistent with the
Code and are within that
Signatory's authority, shall be recognized and respected by all other
Signatories.
[Comment to Article 15.4.1: There has in the past been some confusion in the
interpretation of this Article with regard to therapeutic use exemptions. Unless provided otherwise by the rules of an International Federation or an agreement with
an International Federation, National Anti-Doping Organizations do not have “authority” to grant therapeutic use exemptions to International-Level Athletes
.]
15.4.2
Signatories shall recognize the same actions of other bodies which have not accepted the
Code if the rules of those bodies are otherwise consistent with the
Code.
[Comment to Article 15.4.2: Where the decision of a body that has not accepted the Code is in some respects Code compliant and in other respects not Code compliant, Signatories should attempt to apply the decision in harmony with the principles of
the Code. For example, if in a process consistent with the Code a non-Signatory has found an Athlete to have committed an anti-doping rule violation on account of the
presence of a Prohibited Substance in his body but the period of Ineligibility applied is shorter than the period provided for in the Code, then all Signatories should
recognize the finding of an anti-doping rule violation and the Athlete’s National Anti-Doping Organization should conduct a hearing consistent with Article 8 to determine
whether the longer period of Ineligibility provided in the Code should be imposed.]
3.0 Terms and Definitions
3.1 Defined Terms from the Code
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.
Adverse Analytical Finding: A report from a laboratory or other
WADA-
approved entity that, consistent with the
International Standard for
Laboratories and related Technical Documents, identifies in a
Sample the presence of a
Prohibited Substance or its
Metabolites or
Markers (including
International Standard for Therapeutic Use Exemptions
elevated quantities of endogenous substances) or evidence of the
Use of a
Prohibited Method.
Anti-Doping Organization: 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,
WADA, International Federations, and
National Anti-Doping Organizations
. Athlete: Any
Person who participates in sport at the international level (as
defined by each International Federation), the national level (as defined by each
National Anti-Doping Organization, including but not limited to those
Persons in its
Registered Testing Pool), and any other competitor in sport who is otherwise subject to the jurisdiction of any
Signatory or other sports organization accepting the
Code. All provisions of the
Code, including, for
example,
Testing and therapeutic use exemptions, must be applied to international- and national-level
competitors. Some
National Anti-Doping Organizations
may elect to test and apply anti-doping rules to recreational-level or masters competitors who are not current or potential national caliber competitors.
National Anti-Doping Organizations
are not required, however,
to apply all aspects of the
Code to such
Persons
. Specific national rules may be established for
Doping Control for non-international-level or non-national-level competitors without being in conflict with the
Code. Thus, a country could elect to test recreational-level
competitors
but not require therapeutic use exemptions or whereabouts information. In the same manner, a
Major Event Organization holding an
Event only for masters-level competitors could
elect to test the competitors but not require advance therapeutic use exemptions or whereabouts information. For purposes of Article 2.8 (Administration or
Attempted
Administration) 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: This definition makes it clear that all international- and national-caliber 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, respectively.
At the national level, anti-doping rules adopted pursuant to the Code shall apply, at a minimum, to all persons on national teams and all persons qualified to compete in
any national championship in any sport. That does not mean, however, that all such Athletes must be included in a National Anti-Doping Organization’s Registered
Testing Pool. The definition also allows each National Anti-Doping Organization, if it chooses to do so, to expand its anti-doping program beyond national-caliber Athletes to competitors at lower levels of competition. Competitors at all levels of
competition should receive the benefit of anti-doping information and education.]
Code: The World Anti-Doping
Code.
Competition: A single race, match, game or singular athletic contest. For
example, a basketball game or the finals of the Olympic 100-meter race in
International Standard for Therapeutic Use Exemptions
athletics. For stage races and other athletic 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.
Doping Control: All steps and processes from test distribution planning
through to ultimate disposition of any appeal including all steps and
processes in between such as provision of whereabouts information,
Sample collection and handling, laboratory analysis, therapeutic use exemptions,
results management and hearings.
Event: A series of individual
Competitions conducted together under one
ruling body (e.g., the Olympic Games, FINA World Championships, or Pan
American Games).
Event Period: The time between the beginning and end of an
Event, as
established by the ruling body of the
Event.
In-Competition: Unless provided otherwise in the rules of an International
Federation or other relevant
Anti-Doping Organization, “
In-Competition” means the period commencing twelve hours 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.
International Event: An
Event 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 designated by one or more
International Federations as being within the
Registered Testing Pool for an
International Federation.
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.
International Standard for Therapeutic Use Exemptions
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, the
management of test results, and the conduct of hearings, all at the national
level. This includes an entity which may be designated by multiple countries
to serve as regional
Anti-Doping Organization for such countries. 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 Event: A sport
Event involving international- or national-level
Athletes that is not an
International Event.
Out-of-Competition: Any
Doping Control which is not
In-Competition.
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 so described on the
Prohibited List.
Registered Testing Pool: The pool of top-level
Athletes established
separately by each International Federation and
National Anti-Doping
Organization who are subject to both
In-Competition and
Out-of-Competition Testing as part of that International Federation's or
National Anti-Doping
Organization's test distribution plan.
Each International Federation shall
publish a list which identifies those
Athletes included in its
Registered Testing
Pool either by name or by clearly defined, specific criteria.
Signatories: Those entities signing the
Code and agreeing to comply with
the
Code, including the International Olympic Committee, International
Federations, International Paralympic Committee,
National Olympic
Committees, National Paralympic Committees,
Major Event Organizations,
National Anti-Doping Organizations, and
WADA.
Testing: The parts of the
Doping Control process involving test distribution
planning,
Sample collection,
Sample handling, and
Sample transport to the
laboratory.
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.
International Standard for Therapeutic Use Exemptions
3.2 Defined Terms from the International Standard for TUEs
Retroactive TUE: Therapeutic use exemption approved by a Therapeutic
Use Exemption Committee based on a documented medical file after a
laboratory has reported an
Adverse Analytical Finding (AAF).
Therapeutic: Of or relating to the treatment of a medical condition by
remedial agents or methods; or providing or assisting in a cure.
TUE: Therapeutic use exemption approved by a Therapeutic Use Exemption
Committee based on a documented medical file before the
Use of the
substance in sports.
TUEC: Therapeutic Use Exemption Committee is the Panel established by the
relevant
Anti-Doping Organization.
WADA TUEC: WADA Therapeutic Use Exemption Committee is the Panel
established by
WADA.
International Standard for Therapeutic Use Exemptions
PART TWO: STANDARDS FOR GRANTING
THERAPEUTIC USE EXEMPTIONS
4.0 Criteria for Granting 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. An application for a TUE will be reviewed by a Therapeutic
Use Exemption Committee (TUEC). The TUEC will be appointed by an
Anti-Doping Organization. An exemption will be granted only in strict accordance with the following criteria:
[Comment: This Standard can apply to all Athletes as defined by and subject to the
Code, i.e. able-bodied Athletes and Athletes with disabilities. This Standard will be applied according to an individual’s circumstances. For example, an exemption that is
appropriate for an Athlete with a disability may be inappropriate for other Athletes.]
4.1 The
Athlete should submit an application for a TUE no less than
twenty-one (21) days before he/she needs the approval (for instance an
Event).
4.2 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.
4.3 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. The
Use of any
Prohibited
Substance or
Prohibited Method to increase “low-normal” levels of any endogenous hormone is not considered an acceptable therapeutic intervention.
4.4 There is no reasonable therapeutic alternative to the
Use of the
otherwise
Prohibited Substance or
Prohibited Method.
4.5 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.
4.6 The TUE will be cancelled by the granting body, if:
a. The A
thlete does not promptly comply with any requirements or
conditions imposed by the
Anti-Doping Organization granting the
b. The term for which the TUE was granted has expired.
International Standard for Therapeutic Use Exemptions
c. The A
thlete is advised that the TUE has been withdrawn by the
[Comment: Each TUE will have a specified duration as decided upon by the TUEC.
There may be cases when a TUE has expired or has been withdrawn and the Prohibited Substance subject to the TUE is still present in the Athlete’s body. In such cases, the Anti-Doping Organization conducting the initial review of an adverse
analytical finding will consider whether the finding is consistent with expiry or
withdrawal of the TUE.]
4.7 An application for a TUE will not be considered for retroactive approval
except in cases where:
a. Emergency treatment or treatment of an acute medical condition
b. due to exceptional circumstances, there was insufficient time or
opportunity for an applicant to submit, or a TUEC to consider, an application prior to
Doping Control, or
c. the conditions set forth under 7.13 apply.
[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 expedited
consideration of an application for a TUE
due to imminent competition are infrequent.
Anti-Doping Organizations granting TUE
s should have internal procedures which
permit such situations to be addressed.]
5.0. Confidentiality of Information
5.1 The applicant must provide written consent for the transmission of all
information pertaining to the application to members of the TUEC and, as required, other independent medical or scientific experts, or to all necessary staff involved in the management, review or appeal of TUEs. Should the assistance of external, independent experts be required, all
details of the application will be circulated without identifying the
Athlete
concerned. The applicant must also provide written consent for the decisions
of the TUEC to be distributed to other relevant
Anti-Doping Organizations under the provisions of the
Code.
5.2 The members of the TUECs and the administration of the
Anti-Doping
Organization involved will conduct all of their activities in strict confidence. All members of a TUEC and all staff involved will sign confidentiality agreements. In particular they will keep the following information confidential:
International Standard for Therapeutic Use Exemptions
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)
Should the
Athlete wish to revoke the right of the TUEC or the
WADA TUEC to obtain any health information on his/her behalf, the
Athlete must notify his/her medical practitioner in writing of the fact. As a consequence of such a decision, the
Athlete will not receive approval for a TUE or renewal of an existing TUE.
6.0 Therapeutic Use Exemption Committees (TUECs)
TUECs
shall be constituted and act in accordance with the following
guidelines:
6.1 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 order to ensure a level of independence of
decisions, the majority of the members of any TUEC should be free of
conflicts of interest or political responsibility in the
Anti-Doping Organization. All members of a TUEC will sign a conflict of interest agreement. In applications involving
Athletes with disabilities, at least one TUEC member must possess specific experience with the care and treatment of
Athletes with disabilities.
6.2 TUECs may seek whatever medical or scientific expertise they deem
appropriate in reviewing the circumstances of any application for a TUE.
6.3 The
WADA TUEC shall be composed following the criteria set out in
Article 6.1. The
WADA TUEC is established to review on its own initiative TUE decisions granted by
Anti-Doping Organizations. As specified in Article 4.4 of the
Code, the
WADA TUEC, upon request by
Athletes who have been denied TUEs by an
Anti-Doping Organization, will review such decisions with the power to reverse them.
7.0 Therapeutic Use Exemption (TUE) Application
Process
TUE will only be considered following the receipt of a completed
application form that must include all relevant documents (see Annex 2 – TUE form). The application process must be dealt with in accordance with the principles of strict medical confidentiality.
International Standard for Therapeutic Use Exemptions
TUE application form(s), as set out in Annex 2, can be modified by
Anti-Doping Organizations to include additional requests for information, but
no sections or items shall be removed.
7.3 The
TUE application form(s) may be translated into other language(s)
by
Anti-Doping Organizations, but English or French must remain on the
application form(s).
7.4 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.
7.5 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.
7.6 The application must include a comprehensive medical history and the
results of all examinations, laboratory investigations and imaging studies
relevant to the application. The arguments related to the diagnosis and
treatment, as well as duration of validity, should follow the
WADA “Medical
Information to Support the Decisions of TUECs”. For asthma, the specific
requirement(s) set out in Annex 1 must be fulfilled.
7.7 Any additional relevant investigations, examinations or imaging studies
requested by the TUEC of the
Anti-Doping Organization before approval will
be undertaken at the expense of the applicant or his/her national sport
governing body.
7.8 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.
7.9 The dose, frequency, route and duration of administration of the
otherwise
Prohibited Substance or
Prohibited Method in question must be
specified. In case of change, a new application should be submitted.
7.10 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 case of a TUE application made in a reasonable time limit prior to an
Event the TUEC should use its best endeavors to complete the TUE process before
the start of the
Event. Where a TUE
has been granted to an
Athlete in the
Anti-Doping Organization Registered Testing Pool, the
Athlete and
WADA will
be provided promptly with an approval which includes information pertaining
to the duration of the exemption and any conditions associated with the TUE.
7.11 a. Upon receiving a request by an
Athlete for review, the
WADA TUEC
will, as specified in Article 4.4 of the
Code, be able to reverse a decision on a
International Standard for Therapeutic Use Exemptions
TUE denied by an
Anti-Doping Organization. The
Athlete shall provide to the
WADA TUEC all the information for a TUE as submitted initially to the
Anti-Doping Organization accompanied by an
application fee. Until the review process has been completed, the original decision remains in effect. The process should not take longer than thirty (30) days following receipt of all the information by
WADA.
b.
WADA can, on its own initiative, undertake a review at any time.
7.12 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.
7.13 The
Use of inhaled Beta-2 Agonists:
- The
Use of inhaled formoterol, salbutamol, salmeterol, terbutaline
reflects current clinical practice. The
Use of these substances should be declared on
ADAMS where reasonably feasible and in accordance with the
Code as soon as the product is used and must as well be declared
on the
Doping Control form at the time of
Testing. Failure to declare will be taken into account in the result management process in particular in case of application for a Retroactive TUE.
-
Athletes using the substances listed above by inhalation must have a
medical file justifying this
Use and meeting the minimum requirements
Depending upon the category of the Athlete, the medical file will
be evaluated as follows:
- For all
Athletes included in an International Federation
Registered
Testing Pool a regular TUE approved before the
Use of the substance.
- For
Athletes participating in an
International Event but who are not
included in an International Federation
Registered Testing Pool either a
TUE, or a Retroactive TUE in the case of an
Adverse Analytical Finding, in accordance with the rule of the International Federation or of the
Major Event Organization.
- For national-level
Athletes who are not included in an International
Federation
Registered Testing Pool, whether or not they are part of a national
Registered Testing Pool, either a TUE, or a Retroactive TUE in the case of an
Adverse Analytical Finding, in accordance with the rules of the
National Anti-Doping Organization.
- No Retroactive TUE will be granted if the requirements of Annex 1 are
not met meaning that any
Adverse Analytical Finding reported by the
International Standard for Therapeutic Use Exemptions
laboratory in these circumstances will result in an anti-doping rule violation.
- Any
Athlete may apply for a TUE at any time if they wish.
- Any A
thlete who has applied for a TUE or a Retroactive TUE and who
was denied such TUE may not use the substance without the prior granting of a TUE (no Retroactive TUE will be permitted).
8.0 Declaration of Use Process
8.1 It is acknowledged that some substances included on the List of
Prohibited Substances are used to treat medical conditions frequently
encountered in the athlete population. For monitoring purposes, these
substances, for which the route of administration is not prohibited,
will
require a simple declaration of use. These are strictly limited to :
Glucocorticosteroids used by non systemic routes, namely intraarticular,
periarticular, peritendinous, epidural, intradermal injections and inhaled
route.
8.2 For the mentioned substances, the declaration of
Use should be done
through
ADAMS where reasonably feasible and in accordance with the
Code
by the
Athlete at the same time as the
Use starts. This declaration should mention the diagnosis, the name of the substance, the dose undertaken, the name and the contact details of the physician.
In addition, the
Athlete must declare the
Use of the substance in question on
the
Doping Control form.
9.0 Clearinghouse
9.1 Anti-Doping Organisations
are required to provide
WADA with all
TUEs
approved for
Athletes who are part of a national or international
Registered
Testing Pool, and all supporting documentation, in accordance with section 7.
9.2 The declarations of use should be available to
WADA (
ADAMS).
9.3 The clearinghouse shall guarantee strict confidentiality of all the
10.0 Transitional provision
Abbreviated Therapeutic Use Exemptions (ATUEs) delivered prior to
December 31, 2008 shall remain governed by the 2005 TUE Standard.
These ATUEs shall remain valid after January 1, 2009 until the earliest of: International Standard for Therapeutic Use Exemptions
(i) The date on which they are cancelled by the competent TUEC following review in accordance with art. 8.6 of the 2005 TUE Standard ; (ii) Their expiry date as mentioned on the ATUE ; (iii) December 31, 2009.
International Standard for Therapeutic Use Exemptions
ANNEX 1:
Minimal requirements for the medical file to be used for the
TUE process in the case of asthma and its clinical variants
The file must reflect current best medical practice to include:
1)
A comprehensive report of the clinical examination with specific focus
A report of spirometry with the measure of the Forced Expiratory Volume in 1 second (FEV1)
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 hyper-
Exact name, speciality, address (including telephone, e-mail, fax) of examining physician.
International Standard for Therapeutic Use Exemptions
ANNEX 2:
Therapeutic use exemption application form
Identification of Anti-Doping Organization
Therapeutic Use Exemptions
Please complete all sections in capital letters or typing
1. Athlete Information
………………………………………….
Female
Male
Date of Birth(d/m/y)………………………………………
Address: …………………………………………………………………………………………
City: . Country: . Postcode: ………….
Tel.:…………………………………. ………………
………………………………………………………………….
(with international code)
Sport:……… . Discipline/Position: …………….
International or National Sport Organization:
……………………………………………………………………….
If athlete with disability, indicate disability: ………………………………………….
International Standard for Therapeutic Use Exemptions
2. Medical information
Diagnosis with sufficient medical information (see note 1)
: …………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………….
………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………….
If a permitted medication can be used to treat the medical condition, provide clinical
justification for the requested use of the prohibited medication
……………………………………………………………………………………………………………………………………………………….
……………………………………………………………………………………………………………………………………………………….
……………………………………………………………………………………………………………………………………………………….
Prohibited substance(s):
Frequency
Generic name
Intended duration of
treatment:
(
Please tick appropriate box)
or duration (week/month): …………………………………
Have you submitted any previous TUE application: yes
no
For which substance?
…………………………………………………………………………………………………………………
whom?…………………………………………………………………….When?……………………………………………… Decision: Approved Not approved
International Standard for Therapeutic Use Exemptions
I certify that the above-mentioned treatment is medically appropriate and that the
use of alternative medication not on the prohibited list would be unsatisfactory for
this condition.
Name:
…………………………………………………….
Medical specialty:
…………………………………………………………………………………
Address:
…………………………………………………………………
Tel.:
…………………………………………………………………….
Fax:
………………………………………………………………….…
E-mail:
…………………………………………………………………
Signature of Medical Practitioner:
…………………………… Date:
……………….
5. Athlete’s declaration
I, …………………………………………………………………………………. certify that the information under 1. is accurate and that I am requesting approval to use a Substance or Method from the WADA Prohibited List. I authorize the release of personal medical information to the Anti-Doping
Organization (ADO) as well as to WADA staff, to the WADA TUEC (Therapeutic Use Exemption Committee) and to other ADO under the provisions of the Code. I understand that if I ever
wish to revoke the right of these organizations to obtain my health information on my behalf, I must notify my medical practitioner and my ADO in writing of that fact.
Athlete’s signature: .
Date: …………….
Parent’s/Guardian’s signature: .
Date: …………….
(if the athlete is a minor or has a disability preventing him/her to sign this form, a parent or guardian
shall sign together with or on behalf of the athlete)
International Standard for Therapeutic Use Exemptions
Note 1
Diagnosis
Evidence confirming the diagnosis must be attached and forwarded with this application. The medical evidence should include a comprehensive medical history and the results of all
relevant examinations, laboratory investigations and imaging studies. Copies of the original reports or letters should be included when possible. Evidence should be as objective as
possible in the clinical circumstances and in the case of non-demonstrable conditions independent supporting medical opinion will assist this application.
Incomplete Applications will be returned and will need to be
resubmitted.
Please submit the completed form to the ADO and keep a copy for your
records.
International Standard for Therapeutic Use Exemptions
Source: http://www.stv-fsg.ch/fileadmin/user_upload/stvfsgch/dokumente/ausbildung_gesundheit/praevention/antidoping/TUE_Standard_2009_Final_031008.pdf
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