Publication: Magyar Közlöny
Issue: MK-2009-67 (Year: 2009, Number: 67)
Era: 2004-2010
Section: szóló 267/2006. (XII. 20.) Korm. rendelet
Paragraph Index: 398

2. § Az Egyez mény II. mel lék le te mó do sí tá sá nak hi te les an - gol nyel vû szö ve ge és an nak hi va ta los ma gyar nyel vû for - dí tá sa a kö vet ke zõ: „INTERNATIONAL CONVENTION AGAINST DOPING IN SPORT Annex II – Standards for Granting Therapeutic Use Exemptions Paris, 1 January 2009 Extract from the INTERNATIONAL STANDARD FOR THERAPEUTIC USE EXEMPTIONS, 1 January 2009 of the World Anti-Doping Agency (WADA) PART TWO: STANDARDS FOR GRANTING THERAPEUTIC USE EXEMPTIONS 4.0 Cri te ria for Gran ting a The ra pe u tic Use Exemp - ti on 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. 2009/67. szám 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 Athlete does not promptly comply with any requirements or conditions imposed by the Anti-Doping Organization granting the exemption. (b) The term for which the TUE was granted has expired. (c) The Athlete is advised that the TUE has been withdrawn by the Anti-Doping Organization. [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 was necessary, or (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 TUEs 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: (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) involved in the process. 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 The ra pe u tic Use Exemp ti on Com mit te es (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 7.1 A 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. 7.2 The 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. 2009/67. szám 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 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

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