INTERNATIONAL CONVENTION AGAINST DOPING IN SPORT

ANNEX II

Rules for granting authorizations for use for therapeutic purposes

Paris, January 1, 2011.

EXTRACT FROM THE INTERNATIONAL STANDARDS FOR THE THERAPEUTIC USE OF THE WORLD ANTI-DOPING AGENCY (AMA), IN FORCE ON 1 JANUARY 2011

Part Two: Rules for the granting of authorizations for use for therapeutic purposes

4.0 Criteria for granting Authorizations for Therapeutic Use.

An authorization may be granted for therapeutic use (AUT) to a sportsman, allowing them to use a prohibited substance or a prohibited method. AUT applications will be evaluated by a Committee on Authorizations for Therapeutic Use (CAUT). The CAUT shall be designated by an anti-doping organization.

4.1 AUT will be granted only if the following criteria are strictly met:

(a) That the athlete has significant injury to his health if the prohibited substance or the prohibited method is not administered during the treatment of acute or chronic disease.

(b) The therapeutic use of the prohibited substance or of the prohibited method does not lead to an improvement in performance, except where it could be envisaged when returning to a normal state of health following the treatment of a confirmed disease. The use of a prohibited substance or a prohibited method to increase 'normally low' levels of an endogenous hormone is not considered acceptable therapeutic intervention.

c) That there is no reasonable therapeutic alternative that may replace the use of the prohibited substance or the prohibited method.

d) That the need for the use of the prohibited substance or the prohibited method is not a partial or total consequence of a previous use, without an AUT, of a substance or a method that was prohibited at the time of use.

4.2 AUT will be cancelled if:

a) The athlete does not comply with the requirements or conditions imposed by the anti-doping organization granting the authorization.

b) The deadline for which the AUT was granted has expired.

c) The athlete is told that the AUT has been cancelled by the anti-doping organization.

d) The AMA or the Court of Arbitration for Sport has revoked an AUT concession decision.

[Comment: Each AUT will have a specific duration as decided by the CAUT. There may be cases where an AUT has already expired or has been cancelled and the prohibited substance under the AUT continues to be present in the body of the athlete. In such cases, the anti-doping organisation carrying out the initial analysis of an adverse analytical result shall consider whether the result is compatible with the date of expiry or cancellation of the AUT.]

4.3 AUT requests for retroactive approval will not be taken into consideration except in cases where:

(a) there has been a medical emergency or the treatment of a non-chronic disease has been necessary,

(b) due to exceptional circumstances, there has not been sufficient time or possibility for an applicant to submit, or a CAUT to evaluate, the relevant application before a doping control.

[Comment: Medical emergencies or non-chronic diseases that require the administration of a prohibited substance or a prohibited method are uncommon before an AUT request can be made. Similarly, circumstances requiring that an AUT request be taken without delay due to an imminent competition are infrequent. The anti-doping organisations which grant AUT shall have internal procedures in place to enable such situations to be resolved.]

5.0 Confidentiality of information.

5.1 During the AUT processing procedure, the anti-doping organisations and the AMA will collect, archive, process, disclose and retain personal data in accordance with the provisions of the International Standard on the protection of personal data and their confidentiality.

5.2 The sportsperson applying for an AUT shall authorise in writing that such data may be transmitted, after the relevant application, to the members of any CUT who, in accordance with the Code, are competent to review the file and, where appropriate, other medical experts or independent scientists, all personnel taking part in the management, assessment or appeal of the AUTs, as well as the AMA. The applicant shall also provide his written consent that the decisions of the CAUT may be distributed to other relevant national anti-doping organisations and national federations in accordance with the provisions of the Code.

[Comment on Article 5.2: Before collecting personal data or obtaining the consent of the athlete, the anti-doping organization shall communicate to the latter the information referred to in Article 7.1 of the Standard International on the protection of personal data and their confidentiality.]

In case the help of external and independent experts is needed, all details of the application will be communicated without identifying the athlete in question.

5.3 Members of the CAUs, independent experts and the staff of the anti-doping organisation concerned shall carry out all their activities with strict confidentiality and must sign confidentiality agreements. In particular, the following shall be considered as strictly confidential:

(a) All medical information and data provided by the athlete and the physicians involved in the athlete's medical care.

b) All details of the request, including the name of the physicians participating in the process.

In case the athlete wishes to revoke the right of a CAUT to obtain any sanitary information, the athlete must notify that fact in writing to his doctor. As a result of that decision, the athlete will not be granted an AUT or the renewal of an existing AUT.

5.4 Anti-doping organisations will ensure that the personal data obtained in the AUT processing procedure is retained for a period of eight (8) years and thereafter only as long as it is necessary to comply with the obligations incumbent upon them under the Code, or when required by applicable laws or regulations, or the legal processes of mandatory compliance.

6.0 Committees on Authorizations for Therapeutic Use (CAUT).

CAUs will be constituted and acted in accordance with the following guidelines:

6.1 The CAUs shall include at least three (3) physicians experienced in the medical care and treatment of athletes and with good knowledge of clinical, sports and exercise medicine. In order to guarantee the level of independence of the decisions, the majority of the members of the CAUT must not have any conflicts of interest or any political responsibility in the anti-doping organization. All members of the CAUT shall sign an agreement on conflicts of interest. In applications for athletes with disabilities, at least one member of the CUT shall have specific experience in assisting and treating athletes with disabilities.

6.2 CAUs may request the assistance of medical or scientific experts they consider appropriate to analyze the circumstances of an AUT request.

6.3 The EAC of the AMA shall be composed by applying the criteria set out in Article 6.1. The EAC of the AMA is established to analyze the grant or refusal of AUT to athletes of international level, athletes registered in an international competition, as indicated in Article 7.1 (b), or athletes who are part of the group selected from athletes subject to controls by the national anti-doping organisation, in accordance with Article 4.4 of the Code. Under normal circumstances, the AMA CAUT shall issue a decision within thirty (30) days following receipt of all requested information.

7.0 Responsibilities of international federations and national anti-doping organizations.

7.1 International federations should:

a) Constituting a CUT, in accordance with the provisions of Article 6.

b) Publish a list of international competitions for which an AUT granted in accordance with the rules of the international federation is required.

c) Establish and publish an AUT processing procedure, whereby a sportsman who is part of the selected group of sportspersons subject to controls by the international federation or who is enrolled in an international competition, as referred to in Article 7.1 (b), and has a documented medical history requiring the use of a prohibited substance or a prohibited method, may request an AUT. This procedure shall be in accordance with Article 4.4 of the Code, these International Standards and the International Standard on the protection of personal data and their confidentiality.

d) Publish the rules under which the international federation will accept AUTs granted by other anti-doping organizations.

e) Immediately communicate to the AMA, through the ADAMS system, the granting of all AUTs, including the substance or method, the dose, frequency and route of administration that have been approved, the duration of the AUT, the conditions imposed in relation to the AUT and its complete file.

f) Immediately communicate to the national anti-doping organisation and the relevant national federation the grant of an AUT.

g) At the request of the AMA, immediately transmit the complete file of any AUT that has been denied.

7.2 National anti-doping organisations should:

(a) Constituting a CAUT in accordance with the provisions of Article 6.

b) Specify and publish categories of sportspersons under their authority and must obtain an AUT before using a prohibited substance or a prohibited method. They shall include at least all the athletes who are part of the selected group of athletes subject to controls by the national anti-doping organisation and other national athletes, in accordance with the provisions laid down by the national anti-doping organisation.

[Comment on Article 7.2 (b): National anti-doping organisations will only grant AUT to athletes who are part of the selected group of sportspersons subject to controls by an international federation when in the rules of the latter the national anti-doping organisations are recognised or enabled to grant AUT to such sportsmen.]

c) Create and publish an AUT processing procedure whereby a sportsman who is part of the selected group of athletes subject to national anti-doping controls, or is listed among the referred to in Article 7.2 (b) and which has a documented medical history requiring the use of a prohibited substance or a prohibited method, may request an AUT. This procedure shall be in accordance with Article 4.4 of the Code, these International Standards and the International Standard on the protection of personal data and their confidentiality.

(d) Immediately communicate to the AMA, through the ADAMS system, the granting of an AUT to an athlete who is part of his/her selected group of athletes subject to controls, and where appropriate, to an athlete who is part of the selected group of athletes subject to controls by an international federation or registered in an international competition, as referred to in Article 7.1 (b), including the substance or method, the dose, the frequency and the route the duration of the AUT, the conditions imposed in relation to the with the AUT and its complete file.

e) At the request of the AMA, immediately transmit the complete file of any AUT that has been denied.

f) Immediately communicate to the national federation and the relevant international federation the award of an AUT when the rules of the international federation authorize the national anti-doping organizations to grant AUT to international athletes.

g) Recognize the AUTs granted by international federations to athletes who are part of the selected group of athletes subject to controls by an international federation or who are registered in a competition international, as referred to in Article 7.1 (b).

[For the purposes of Article 7, the term "publish" means the following: Anti-doping organizations will publish information by placing it in a visible place on their website and sending it to national federations that are subject to their rules.]

8.0 Request procedure for an AUT.

8.1 Unless the rules of an international federation provide otherwise, the following sportspersons will obtain an AUT from their international federation:

(a) Athletes who are part of the selected group of athletes subject to international federation controls.

(b) Athletes participating in an international competition for which an AUT granted in accordance with the rules of the international federation is required.

8.2 Athletes who are not mentioned in Article 8.1 will obtain an AUT by addressing their national anti-doping organization.

[Comment on paragraphs 1 and 2 of Article 8: Unless the rules of an international federation provide otherwise, the athlete who holds an AUT of a national anti-doping organization, but subsequently passes to be part of the selected group of athletes subject to controls by the international federation or intend to participate in an international competition for which the international federation considers that an AUT is required for her, you will get a new AUT from the international federation.

The phrase "Unless the rules of an international federation have anything else" takes into account the fact that, through its rules, some international federations are willing to recognize the AUTs granted by national anti-doping organisations and do not require a new AUT to be requested from the international federation. Where such standards exist, the athlete shall obtain an AUT from his national anti-doping organisation.]

8.3 The sportsman will submit the AUT application at least thirty (30) days before it needs approval (for example, for a competition).

8.4 The grant of an AUT will only be considered after receipt of a completed application form which must include all relevant documents (see Annex 1-AUT form). The application procedure shall be carried out in accordance with the principles of strict medical confidentiality.

8.5 AUT application forms, as indicated in Annex 1, may be modified by anti-doping organizations to include requests for additional information, but no section or section may be removed. Article.

8.6 AUT application forms may be translated into other languages by anti-doping organizations, but the English or French text must remain on the application forms.

8.7 The application shall indicate the level of the athlete (for example, if he is part of the selected group of athletes subject to international federation controls), sport and, where appropriate, discipline and post or specific paper.

8.8 The application shall indicate the prior and/or current requests of AUT, the body to which the application was made, the decision of that body and the review or appeal decisions issued by any other body.

8.9 The application must include a complete medical history and the results of all examinations, laboratory investigations and graphic studies relevant to the application. The arguments regarding diagnosis and treatment, as well as the duration of validity, should be based on the "Medical information to support the decisions of the AMA CAUT".

8.10 Any relevant investigation, examination or further graphic study requested by the CAUT of an anti-doping organisation prior to approval shall be carried out on behalf of the applicant.

[Comment on Article 8.10: In some cases, the applicant's national federation may choose to pay for such expenses.]

8.11 The application shall include a statement by a suitably qualified physician certifying the need for the prohibited substance or the method prohibited in the treatment of the athlete and describing why he/she cannot or a medication allowed in the treatment of the disease should not be used.

8.12 The substance or method, dose, frequency, route and duration of administration of the prohibited substance or prohibited method should be specified. In case of change, a new application must be submitted.

8.13 In normal circumstances, the decisions of the CAUT shall be completed within thirty (30) days after receipt of all relevant documentation, and shall be transmitted in writing to the athlete by the relevant anti-doping organisation. In the event that an AUT application has been submitted within a reasonable time before a competition, the CAUT will do its utmost to complete the process of processing the AUT before the start of the competition.

[Comment on Article 8.13: When an anti-doping organization has not ruled on an athlete's AUT request within a reasonable time, the athlete may ask the AMA to review it as if it were denied.]

9.0 Statement of Use.

9.1 The list of prohibited substances and methods no longer contains substances or methods whose use requires a declaration of use and therefore no declaration of use is necessary.

10.0 Review by the AMA of the AUT decisions.

10.1 The AMA of the AMA may at all times review the award of an AUT to an athlete who is part of the selected group of athletes subject to controls by an international federation, which is registered in a international competition, as referred to in Article 7.1 (b), or which forms part of the selected group of athletes subject to controls by a national anti-doping organisation. In addition to the information to be provided in accordance with Article 7 (1) and (2), the AMA's CAUT may also request additional information from the athlete, including the additional studies referred to in the Article 8.10. If a decision on the award of an AUT is revoked by the AMA after the review, the revocation shall not apply retroactively and shall not disqualify the results of the athlete during the period for which the AUT has been granted, and shall have Fourteen (14) days, at the latest, after notification of the decision to the athlete.

10.2 A sportsman who is part of the selected group of sportspersons subject to controls by an international federation, who is registered in an international competition, as referred to in Article 7.1 (b), or who forms part of the selected group of athletes under the control of a national anti-doping organisation may ask the AMA to review the decision to refuse an AUT, submitting a written review request to the AMA within a period of time. of 21 days from the date of the refusal. The athlete who submits that application for review to the AMA shall pay an application fee set by the AMA and provide the AMA CAUT with copies of all the information it has submitted to the anti-doping organisation in relation to the request for a AUT. The AMA's CAUT will assess the application on the basis of the file provided to the anti-doping organisation which has refused the AUT, although in order to clarify the situation, it may request additional information from the athlete, including the studies additional referred to in Article 8.10. The first refusal decision of AUT will continue to be refused until the AMA completes the review procedure. If the AMA annuls the decision to refuse an AUT, it shall enter into force immediately in accordance with the conditions laid down in the AMA decision.

10.3 An appeal against the WADA decisions in which it confirms or revokes the AUT decisions of an anti-doping organisation before the Court of Arbitration for Sport, in accordance with the Article 13 of the Code.

11.0 Previously granted abbreviated Therapeutic Use Authorizations.

11.1 All abbreviated Therapeutic Use Authorizations previously granted that have not expired or have been cancelled, will expire on December 31, 2009.

This Amendment will enter into force in general and for Spain on 1 January 2011.

What is made public for general knowledge.

Madrid, 22 December 2010.-The Technical Secretariat of the Ministry of Foreign Affairs and Cooperation, Rosa Antonia Martínez Frutos.