Football players who have either physical symptoms or disease after injury may need to be treated with specific medicines that are on the list of prohibited substances. Therapeutic use exemption may be granted to such players, in accordance with strictly defined criteria—these are presented in this article. Procedures of how to request for an abbreviated or a standard therapeutic use exemption are explained, and data on therapeutic use exemptions (UEFA and FIFA, 2004 and 2005) are also presented

Dvorak, J.

Kirkendall, D.

Vouillamoz, M.

Carolina Digital Repository

SUPPLEMENTTherapeutic use exemptionJ Dvorak, D Kirkendall, M Vouillamoz. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .See end of article forauthors’ affiliations. . . . . . . . . . . . . . . . . . . . . . .Correspondence to:Professor J Dvorak,Chairman, FIFA MedicalAssessment and ResearchCentre, Department ofNeurology, SchulthessClinic, Lengghalde 2,8008 Zurich, Switzerland;jiri.dvorak@kws.ch. . . . . . . . . . . . . . . . . . . . . . .Br J Sports Med 2006;40(Suppl I):i40–i42. doi: 10.1136/bjsm.2006.027490Football players who have either physical symptoms or disease after injury may need to be treated withspecific medicines that are on the list of prohibited substances. Therapeutic use exemption may be grantedto such players, in accordance with strictly defined criteria—these are presented in this article. Proceduresof how to request for an abbreviated or a standard therapeutic use exemption are explained, and data ontherapeutic use exemptions (UEFA and FIFA, 2004 and 2005) are also presented.Afootball player who has physical symptoms and signsor acute or chronic disease following an injury mayneed to be treated with a medicine that is on the list ofprohibited substances. A therapeutic use exemption (TUE)permitting the use of such a substance or method that is onthe prohibited list, may be granted to the player, dependingto the clinical situation.An exemption will be granted only in strict accordancewith the following criteria1:N The player shall submit an application for TUE no lessthan 21 days before participating in an event.N The player would experience a significant impairment tohealth if the prohibited substance or method were to bewithheld in the course of treating an acute or chronicmedical condition.N The therapeutic use of the prohibited substance or methodwould produce no additional enhancement of perfor-mance other than that which might be anticipated by areturn to a state of normal health following the treatmentof a legitimate medical condition. The use of anyprohibited substance or method to increase ‘‘low-normal’’levels of any endogenous hormone is not considered anacceptable therapeutic intervention.N There is no reasonable therapeutic alternative to the use ofthe otherwise prohibited substance or method.N The necessity for the otherwise prohibited substance ormethod cannot be a consequence, wholly or in part, orprior non-therapeutic use of any substance from theprohibited list.N The TUE will be cancelled by the granting body, if:– The player does not promptly comply with anyrequirements or conditions imposed by the FIFA[Fédération Internationale de Football Association]Doping Control Sub-Committee granting the exemp-tion.– The term for which the TUE was granted has expired.– The player is advised that the TUE has been withdrawnby the FIFA Doping Control Sub-Committee.N An application for a TUE will not be considered forretroactive approval except in cases where:– Emergency treatment or treatment of an acute medicalcondition was necessary, or– Due to exceptional circumstances, there was insuffi-cient time or opportunity for an applicant to submit, orthe granting body to consider, an application prior todoping control.N Confidentiality of information: The applicant shall providewritten consent for the transmission of all informationpertaining to the application to members of the FIFAgranting body and, as required, other independent medicalor relevant scientific experts. If the assistance of external,independent experts is required, all details of the applica-tion will be circulated without identifying the playerinvolved in the doctor’s care. The applicant shall also givewritten consent to the decisions of the FIFA granting bodyto be distributed to the involved medical personnel ofother relevant anti-doping organisations under the provi-sions of the FIFA Doping Control Regulations. Themembers of the granting body involved will conduct allof their activities in strict confidence according to theHippocratic Oath and the medico-legal and ethical rules ofconfidentiality.FIFA proposes using the standard application forms for the TUEapplications as described in the ‘‘International Standard forTUE’’2 (downloadable from WADA website (www.wada-ama.org/rtecontent/document/standard.pdf and www.wada-ama.org/rtecontent/document/simplified.pdf) or FIFA forms(downloadable from www.fifa.com/documents/fifa/regulations/FIFA_Standard%20TUE%20form_E.pdf and www.fifa.com/documents/fifa/regulations/FIFA_Abbreviated%20TUE%20form_E.pdf).As a result of the agreement between the World Anti-Doping Agency (WADA) and FIFA to implement therequirements of the WADC, in March 2004, FIFA and allother football confederations immediately introduced a TUEprocess for all national and international players participatingin the different competitions. The WADA TUE-committee isinformed about any approval and rejection and FIFA willdisclose any information to the medical staff of WADA onrequest.Abbreviations: TUE, therapeutic use exemption, WADA, World Anti-Doping Agency; WADC, World Anti-Doping Codei40www.bjsportmed.comIn agreement with FIFA, and according to article 4.4 of theWADA code,3 the TUE applications procedure has been putinto operation for football players as shown in table 1. Toavoid misunderstandings, players and team doctors havebeen told that a TUE request may be submitted to only onebody at a time. The same TUE request may NOT be submittedto several different bodies. To deal with these TUE requests,FIFA and the confederations have created, according to theWADA International Standard, their own panels of indepen-dent doctors, called therapeutic use exemption committees(TUECs)). These committees review each request and themedical evidence before granting a TUE.WADA has designed two TUE forms—abbreviated andstandard—one of which is selected and used depending onthe treatment needed by the player (table 2).ABBREVIATED TUEAbbreviated TUE requests are valid as soon as FIFA, or aconfederation, or a member association’s TUEC has receivedthe request. Treatment may start immediately after thereceipt is confirmed. However, the TUEC has the right to askfor additional information should the applied indication forglucocorticosteroids or b2 agonists appear doubtful. FIFA hasalso decided that for a b2 agonist TUE, following a clinicaldiagnosis of exercise induced or allergic asthma the results oflung function tests have to be submitted to substantiate theclinical diagnosis. This decision of the FIFA MedicalCommittee clearly stresses the importance of sound clinicaldiagnosis following state of the art assessment to avoidmisuse of b2 agonists in the absence of clear clinicaldiagnosis. In this respect FIFA endorses the May 2001statement of the IOC (International Olympic Committee)Medical Committee workshop on asthma and b2 agonists.4STANDARD TUEIn the case of a standard TUE application for which specialistexpertise is required, the TUE committee appoints externalindependent experts for a second opinion to justify thedecision. Standard TUE requests are valid as soon as FIFA ora confederation has sent the player a certificate of approval,except in rare cases of an acute life threatening condition, forwhich retroactive approval may be considered.DATA ON USE OF CURRENT PROCEDUREThe process of application for a TUE was introducedsystematically within the FIFA member associations andconfederations after the introduction of the WADC in 2003.FIFA receives applications for TUEs from players participat-ing in international competitions, such as qualifying matchesfor world cups (male and female and different age groups)and for the final competition of the world cups. The Union ofEuropean Football Associations (UEFA), on the other hand,receives applications for confederation competitions, such asTable 1 Procedure for therapeutic use exemption (TUE)For TUE application to be addressed to Request made byNational players participating in domestic FIFA member association, a national Player and clubcompetitions only (this includes friendly anti-doping organisation, or a competent doctormatches abroad) public authority or associationInternational players called up to FIFA/confederations Player and nationalparticipate in international team team doctorcompetitions and international friendlymatchesInternational players participating in club FIFA/confederations Player and clubcompetitions doctorInternational players called up by memberassociation in FIFA competitions (that is,2006 World Cup qualifiers) FIFA Player and nationalteam doctorTable 2 Indications for abbreviated and standardtherapeutic use exemption (TUE)Abbreviated TUE Standard TUEUse the abbreviated TUE form onlyfor glucocorticosteroids administeredby non-systemic routes (locally) and forb2 agonists (formoterol, salbutamol,salmeterol, and terbutaline) by inhalationUse the standard TUE formfor any treatment involving asubstance or method on theProhibited List that is notadmissible for anabbreviated TUEDermatological glucocorticosteroidsdo NOT require a TUE anymoreGranted automatically upon receiptof the completed application by therelevant organisation (a check bythe TUEC may be carried out at anytime during the duration of the TUE)Will be examined by theTUECTable 3 Documentation of approvedtherapeutic use exemptions (TUEs): FIFA andUEFAYearAbbreviated TUEs Standard TUEsUEFA FIFA UEFA FIFA2004 251 140 14 232005 299 101 20 11What is already knownTUEs are indispensable for improving medical cover ofathletes with health impairments while avoiding anti-dopingviolations. However, many physicians are still unaware of therequirements and procedures for applying for a TUE.What is newThe article summarises the criteria for granting a TUE,describes the correct procedure to be followed whenrequesting a TUE, and explains the differences between anabbreviated and standard TUE request.Therapeutic use exemption i41www.bjsportmed.comEuro 2004, and international club competitions, such as theChampions League. The total number of approved abbre-viated and standard TUEs issued by the FIFA and UEFA in2004 and 2005 are summarised in table 3.The application process operates in a way that there ismutual recognition of the approval by member associations,the confederations, and FIFA. However, FIFA, if informed,reviews the application and decision of the member associa-tion, and FIFA has the right of appeal. Once a TUE has beenapproved, the confidential medical information is filed atFIFA and a copy of the approval is sent to WADA accordingthe WADC international standard for therapeutic useexemption.Authors’ affiliations. . . . . . . . . . . . . . . . . . . . .J Dvorak, FIFA Medical Assessment and Research Centre, andDepartment of Neurology, Schulthess Clinic, Zurich, SwitzerlandD Kirkendall, FIFA Medical Research and Assessment Centre, andDepartment of Orthopaedics, University of North Carolina, Chapel Hill,NC, USAM Vouillamoz, UEFA Anti Doping Unit, Nyon, SwitzerlandCompeting interests: None declaredREFERENCES1 FIFA. Doping Control Regulations. Available at www.fifa.com/documents/fifa/regulations/dopingreglement_06_e.pdf (accessed 3 May 2006).2 World Anti-Doping Code 2003. Available at: www.wada-ama.org/WorldAnti-Doping Agency. International Standard for therapeutic use exemptions,2005. www.wada-ama.org/rtecontent/document/international_standard.pdf (accessed 3 May 2006).3 World Anti-Doping Code. Available at: www.wada-ama.org/rtecontent/document/code_v3.pdf (accessed 3 May 2006).4 International Olympic Committee press release. Available atwww.olympic.org/uk/news/media_centre/press_release_uk.asp?id = 439(accessed 3 May 2006).i42 Dvorak, Kirkendall, Vouillamozwww.bjsportmed.com

Therapeutic use exemption

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Therapeutic use exemption

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