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THERAPEUTIC USE
EXEMPTIONS
GUIDELINES
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January 2007
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TABLE OF CONTENTS
Introduction and scope ........................................................... 4
Definitions ............................................................................. 5
Defined terms from the Code ......................................................... 5
Defined terms from the International Standard for TUE...................... 7
1. TUE procedure .................................................................... 8
1.1. What is a TUE ....................................................................... 8
1.1.1. What is an Abbreviated TUE (ATUE)? .................................. 8
1.1.2. What is a standard TUE? ................................................... 9
1.2. What are the criteria for granting a TUE .................................... 9
1.3. Deadline for TUE submission and retroactive approvals ..............10
2. Documentation/information ............................................... 11
2.1. What is sufficient?.................................................................11
2.2. Who decides what is sufficient?...............................................12
2.3. Incomplete TUE applications...................................................12
2.4. TUE application forms............................................................12
2.5. TUE application received by e-mail or fax by ADO......................12
2.6. Renewing a TUE ...................................................................13
2.6.1. Full application or not?.....................................................13
2.6.2. Renewal option in ADAMS.................................................13
2.6.3. Automatic continuation?...................................................13
2.7. Duration ..............................................................................13
3. Who grants TUE? ............................................................... 13
3.1. Deadline to request a TUE ......................................................14
3.2. International Federations (IFs) for International-Level athletes....14
3.3. National Anti-Doping Organizations (NADOs) and National
Federations (NF) for National-Level athletes....................................14
3.4. What does a National-Level athlete need to do if she/he becomes
an International-Level athlete?......................................................15
4. IF and NADO duties ........................................................... 15
4.1. TUEC constitution .................................................................15
4.1.1. Non-conflict of interest and confidentiality issues .................16
4.2. 30-day deadline....................................................................16
4.3. Notification to athlete ............................................................16
4.4. Non-compliance with the International Standard for TUE ............16
4.5. Testing pool .........................................................................16
4.5.1. Communication of Testing Pools ........................................16
4.5.2. Team Sports...................................................................17
5. Validity of TUEs and Mutual recognition ............................... 17
5.1. Mutual recognition and WADC.................................................17
5.2. TUEs granted by IFs vs. TUEs granted by NADOs and NFs...........17
5.3. Recognition by IFs of TUEs granted by NADOs ..........................18
6. Reporting system .............................................................. 18
6.1. NADO duties ........................................................................18
6.2. IF duties..............................................................................19
7. WADAs role ..................................................................... 19
7.1 TUE monitoring role ...............................................................19
WADA- World Anti-Doping Program
TUE Guidelines
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Definitions
Defined terms from the Code
Adverse Analytical Finding: A report from a laboratory or other
approved Testing entity that identifies in a Specimen the presence of a
Prohibited Substance or its Metabolites or Markers (including elevated
quantities of endogenous substances) or evidence of the Use of a
Prohibited Method.
Anti-Doping Organization (ADO): a Signatory that is responsible for
antidoping 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: For purposes of Doping Control, any Person who participates in
sport at the International-Level (as defined by each International
Federation) or National-level (as defined by each NADO) and any
additional Person who participates in sport at a lower level if designated
by the Persons NADO. 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.
Code: The World Anti-Doping Code.
Event: A series of individual Competitions conducted together under one
ruling body (e.g., the Olympic Games, FINA World Championships, or Pan
American Games).
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.
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1. TUE procedure
An athlete, like any other person, may have illnesses or conditions that
require the use of particular medications as treatment. But, Substances an
athlete is required to take as a treatment may fall under the Prohibited
List. In such a case, a Therapeutic Use Exemption (TUE) may, under strict
conditions, provide an athlete with the authorization to take the needed
medicine, all the while competing in sport, with no resulting doping
offence.
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2.
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4.
on
reasonable
and
therapeutic
referenced
alternatives
medications
are
must
be
Only valid
alternative.
considered
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treatment
or
treatment
of
an
acute
medical
2. Documentation/information
2.1. What is sufficient?
A TUE application should be considered as sufficient if it allows the ADO to
render a reasoned decision in accordance with the criteria set in the
International Standard for TUE.
As mentioned on the TUE application form and in accordance with the
International Standard for TUE the following documents must be attached
to the duly filled-in application form in support of a standard TUE request:
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2.7. Duration
As mentioned earlier, a TUE should always be granted for a limited period
of time even if the use of the Substance is chronic. The use of the
Substance shall be followed-up by a Physician on a regular basis. The TUE
will be renewed consequently.
For specific guidance regarding duration of TUEs, please refer to the
Medical Information to support TUEC decisions.
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5.2. TUEs granted by IFs vs. TUEs granted by NADOs and NFs
TUEs delivered by a NADO or NF are not necessarily recognized at the
International-Level while TUEs delivered by an IF are valid at the national
level.
On the one hand, TUEs delivered by an IF are valid at the national level.
As such, an athlete participating in National Events who has previously
received a TUE from an IF, and whose TUE is still valid and has been
reported to the NADO, does not need to obtain a TUE from the NADO.(see
WADA, Models of Best Practice for NADOs Article 4.6).
On the other hand, in order to ensure equal treatment for athletes
competing in a same international event, IFs will not automatically
recognize TUEs granted at the national level since international
competitions are not within NADOs authority. IFs can decide to recognize
TUEs from certain NADOs (or NFs), see 5.1.4. In that case the IF endorses
the decision and the TUE. A prerequisite for this recognition is that the
procedure and decision of the National TUEC strictly complied with the IFs
procedure. In all other cases, a National-Level athlete who becomes an
WADA- World Anti-Doping Program
TUE Guidelines
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6. Reporting system
This section is meant to clarify what information needs to be reported to
which body.
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6.2. IF duties
IFs must report all granted TUEs (Abbreviated and Standard) to the
athletes NADO and NF (see Article 8.4 sub b of TUE Standard). This
eliminates a duplication of work as TUEs granted by IFs should be
recognized and respected by the NADO.
IFs must report ATUEs and TUEs to WADA. The following instructions
apply to all relevant communications:
TUEs and ATUEs have to be sent to WADA separately (e.g. group all the
TUEs in a separate folder). All TUEs have to be sent by postal mail to:
World Anti-Doping Agency
Maison du Sport International
Av. De Rhodanie 54
1007 Lausanne
ATUEs can be sent by postal mail, e-mail or fax:
E-mail: tue@wada-ama.org
Confidential fax: 001 514 904 1400
7. WADAs role
WADA has three main roles in the TUE process as explained hereafter: a
monitoring role, a reviewing role upon request of an athlete and a role in
the management of data through ADAMS.
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7.3. ADAMS
7.3.1. What is ADAMS?
The Anti-Doping Administration and Management System (ADAMS) is an
internet-based database management tool. It is a centralized system that
allows data entry and storage, as well as data-sharing and reporting to
take place in a highly secure environment that restricts access to all but
relevant and authorized parties. It is designed exclusively to assist
stakeholders and WADA in their anti-doping operations with full
compliance with the WADC.
8. Language issues
8.1. Application forms
English or French must figure on all forms that have been customized by
ADOs in addition to the national language(s). Moreover, all copies of
applications sent to WADA must be in English or French.
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9. Data protection
9.1. Agreement with athlete
The athlete shall provide written consent for the transmission of all
information pertaining to the application to members of the TUEC and, as
required, to other independent medical or scientific experts, as well as to
all necessary staff involved in the management, review or appeals of
TUEs. The athlete shall also provide written consent for the decisions of
the TUEC to be distributed to other relevant ADOs under the provisions of
the Code and for data to be stored in and transferred to the WADA
Clearinghouse (ADAMS).
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Therapeutic Use Exemption has been granted, or (b) there is any apparent
departure from the International Standards for Testing or Laboratory
Analysis that undermines the validity of the Adverse Analytical Finding.
(Article 7.1 WADC)
10.5. No TUE
If the athlete has not been granted a TUE in accordance with the
International Standard for TUE, then the ADO shall follow its results
management regulations with respect to the Adverse Analytical Finding.
If the athlete has no TUE or it is not valid the following procedure applies:
If the initial review does not reveal an applicable Therapeutic Use
Exemption of departure from the International Standard for Testing or the
International Standard for laboratory analysis in force at the time of
Testing or analysis that undermines the validity of the Adverse Analytical
Finding, the ADO shall promptly notify the athlete of: (a) the Adverse
Analytical Finding; (b) the anti-doping rule violated , or, in a case under
Articles 7.1.8 or 7.1.9 of the IF Models of Best Practice, a description of
the additional investigation that will be conducted as to whether there is
an anti-doping rule violation; (c) the athletes right to promptly request
WADA- World Anti-Doping Program
TUE Guidelines
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the analysis may be deemed waived; (d) the right of the athlete and/or
the athletes representative to attend the B Sample opening and analysis
if such analysis is requested; and (e) the athletes right to request copies
of the A and B Sample laboratory documentation package which includes
information as required by the International Standard for Laboratory
Analysis. (Article 7.2 WADC.)
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The review process will start upon receipt by WADA of the payment and
the full documentation.
On reception of a complete review request, WADA will establish and
coordinate the WADA TUEC which will review the case and render a
decision in no later that 30 days. WADA shall inform all relevant parties of
its decision.
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elements in the TUE application file that CAS could deem that a TUE
Committee wrongfully refused a TUE request (CAS 2004/A/769).
In addition, CAS cannot rule on facts and evidence that have not been
submitted to the appropriate TUE Committee along with the TUE
application. In fact, it is in principle inadmissible for an athlete to
request CAS to rule on facts and evidence that have not been submitted
to the appropriate TUE Committee along with the TUE application (CAS
2004/A/769). As mentioned in section 11.1, (whether in the case of a
review by WADA or in the case of an appeal before CAS), no additional
medical data/information can be provided. The review/appeal has to
be judged on the same documents as the first decision.
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References
WADA, 2003, World Anti-Doping Code.
WADA, International Standard for Therapeutic Use Exemptions, In force
January 1st 2005
WADA, 2003, Models of Best Practice for International Federations.
WADA, 2004, Models of Best Practice for NADOs.
WADA, TUE Q&As Leaflet.
CAS, Statutes of the Bodies Working for the Settlement of Sports-related
Disputes.
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APPENDIX
DECLARATION OF CONFIDENTIALITY AND NON-CONFLICT OF INTEREST
As a member of the [name of organization] TUE Committee, I
____________________________________________,
declare
and
accept that, by executing this Declaration, I am bound by its terms.
I understand that the nature of my involvement as a member of the above
Committee is such that I will have knowledge of, or become aware of,
sensitive and confidential information.
I do swear or solemnly affirm that as a member of the [name of
organization] TUE Committee, I will comply with all the requirements
pertaining to the confidentiality of the information received by me or that
comes to my knowledge, in any other way, in the course of my duties and
tasks during and after the term of my involvement.
Except as required by law, or as authorized in the course of my duties, or
as expressly authorized by [person in charge at your organization], I will
not disclose or give to any person whatsoever, including in particular
members of the media, any confidential information or document that
comes to my knowledge or possession either directly or indirectly through
my involvement as a member of the [name of the organization] TUE
Committee, except for the information which has already been publicly
disclosed or in my possession independently from [name of the
organization]. I will not use my title of member of the Committee to make
any public statement.
I hereby acknowledge that [name of the organization] has all rights to
possession of and title to all Materials and any copies, extracts and
summaries and other confidential information originating during the
course of my involvement as a member of the [name of the organization]
TUE Committee.
Furthermore, I understand that breach of my obligation of confidentiality
may result in possible legal action against me and in immediate
termination of my involvement with the [name of the organization] TUE
Committee.
In case of a conflict of interest with a party involved in a Therapeutic Use
Exemption application process to be dealt with by the [name of the
organization] Therapeutic Use Exemption Committee, I will immediately
inform the [person in charge at the organization] and abstain from taking
part in the decision process for that specific case.
_________________________________________
(SIGNATURE)
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