INTERNATIONAL CONVENTION AGAINST DOPING IN SPORT

ANNEX II

Rules for granting authorizations for use for therapeutic purposes

Paris, January 1, 2009.

Excerpt from international standards for the World Anti-Doping Agency (AMA) therapeutic use authorizations, in force on 1 January 2009

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, thus allowing him to use a prohibited substance or a prohibited method listed in prohibited substances and methods. AUT applications will be examined by an Authorizations Committee for Therapeutic Use (CAUT). The CAUT will be designated by an anti-doping organization. Only strict compliance authorisations will be granted with the following criteria:

[Comment: These rules can be applied to all athletes according to the definition of the Code and according to the provisions of the Code, that is, trained athletes and athletes with disabilities. These rules will be applied according to the circumstances of each individual. For example, an authorization that is appropriate for a disabled athlete may not be appropriate for other athletes.]

4.1 The sportsman must submit an AUT application at least twenty-one (21) days before needing approval (for example, to participate in an event).

4.2 The sportsman would suffer significant damage to his health if the banned substance or the prohibited method were not administered during the treatment of a serious or chronic disease.

4.3 The therapeutic use of the prohibited substance or the prohibited method would not lead to an additional improvement in performance, except where the return to a normal state of health after the treatment of a disease could be expected. checked. 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.

4.4 There is no reasonable therapeutic alternative to the use of the prohibited substance or prohibited method.

4.5 The need for the use of the prohibited substance or prohibited method cannot be a consequence, in whole or in part, of a prior non-therapeutic use of a substance included in the list of substances and methods prohibited.

4.6 The AUT will be cancelled by the granting body if:

a) The athlete does not immediately meet 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 informed that the AUT has been withdrawn by the anti-doping organization.

[Comment: Each AUT will have a specified duration as decided by the CAUT. There may be cases where an AUT has expired or has been withdrawn and the prohibited substance under the AUT is still present in the body of the athlete. In such cases, the anti-doping organization conducting the initial analysis of an adverse analytical finding shall consider whether the finding is in accordance with the expiration or withdrawal of the, AUT.]

4.7 The retroactive approval AUT requests will not be taken into account, except in cases where:

a) An emergency treatment or treatment of a serious illness is necessary,

b) Due to exceptional circumstances, there was neither time nor sufficient opportunity for an applicant to present, or a CAUT to study, an application prior to an anti-doping control, or

c) The conditions defined in section 7.13 are met.

[Comment: medical emergencies or serious illnesses 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 that grant AUT shall have internal procedures to allow for the solution of such situations.]

5.0 Confidentiality of information.

5.1 The applicant should provide written consent for the transmission of all information relating to the application to the members of the CUT and, as appropriate, to other independent medical or scientific experts, or to all necessary staff involved in the management, examination or appeal of the AUTs.

In case the help of external and independent experts is needed, all the details of the application will be communicated without identifying the athlete in question. The applicant must also provide written consent for the decisions of the CAUT to be distributed to other relevant anti-doping organisations in accordance with the provisions of the Code.

5.2 The members of the CAUT and the administration of the anti-doping organization concerned shall carry out all their activities with strict confidentiality. All members of a CUT and all staff involved will have to sign confidentiality agreements. In particular, they shall keep the following information 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 the CAUT or the CAUT of the AMA to obtain any health information on his behalf, the athlete must notify his doctor in writing. As a result of that decision, the athlete will not receive the approval of an AUT or the renewal of an existing AUT.

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 CAUT must 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 AMA's CAUT is established to analyze, by its own initiative, the AUT decisions granted by the anti-doping organizations. As specified in Article 4.4 of the Code, the EAC of the AMA, at the request of the athletes to whom an anti-doping organisation has refused an AUT, shall re-examine such decisions and shall have the power to revoke them.

7.0 Request Procedure for a Therapeutic Use Authorization (AUT).

7.1 The grant of an AUT will only be considered after receipt of a completed application form which should include all relevant documents (see Annex 2-Form AUT). The application procedure must be performed in accordance with the principles of strict medical confidentiality.

7.2 The AUT application form, as indicated in Annex 2, may be modified by anti-doping organizations to include requests for additional information, but no sections or points may be removed.

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

7.4 A sportsman will not be able to address more than one anti-doping organisation to apply for an AUT. The application shall indicate the sport of the athlete and, where appropriate, the discipline and the specific position or role.

7.5 The application must indicate previous and/or current applications for permission for use of a prohibited substance or a prohibited method, the body to which the application was made, and the decision of that body.

7.6 The application should include a complete medical history and the results of all examinations, laboratory investigations and graphic studies relevant to the application. The arguments relating to diagnosis and treatment, as well as the duration of validity, should be adjusted to the "Medical information to support the decisions of the CAUT of the AMA". For asthma, the specific requirements as defined in Annex 1 must be met.

7.7 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 or his/her national sports body.

7.8 The application must 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 or she cannot A medication allowed in the treatment of the disease should be used.

7.9 The 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.

7.10 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 an event, the CAUT will do its utmost to complete the process of processing the AUT prior to the commencement of such event. Where an AUT has been awarded to a sportsman of the selected group of athletes subject to controls by the anti-doping organisation, the athlete and the AMA shall immediately obtain an approval including information relating to the duration of the authorization and the conditions associated with the AUT.

7.11.a) When you receive a request from a sportsperson for review, the AMA's CAUT, as specified in Article 4.4 of the Code, may revoke a decision on an AUT denied by an anti-doping organization. The athlete will provide the AMA CAUT with all the information corresponding to an AUT that has been initially given to the anti-doping organization, and will also pay a request fee. Until the review process is complete, the original decision remains in effect. The process should not take more than thirty (30) days after the receipt of all information by the AMA.

b) The AMA can perform a review at any time on its own initiative.

7.12 If the decision on the award of an AUT is revoked by the AMA after the review, the revocation will not be applied retroactively and will not disqualify the results of the athlete during the period in which the AUT has been granted, and shall be valid fourteen (14) days, at the latest, after notification of the decision to the athlete.

7.13 Use of beta-2 agonists by inhalation: The use of formoterol, salbutamol, salmeterol and terbutaline by inhalation corresponds to the current clinical practice. The use of such substances shall be declared in the ADAMS system, where reasonably practicable and in accordance with the Code, as soon as the product is used, and shall also be declared on the anti-doping control form during the control. The absence of a declaration shall be taken into account in the process of managing the results, in particular when a retroactive AUT is requested.

Athletes using the above substances by inhalation must have a medical file to justify their use and to meet the minimum requirements as defined in Annex 1.

Depending on the category of the athlete, the medical file must contain the following assessment elements:

For sportspersons who are part of the selected group of athletes subject to controls by an international federation, an ordinary AUT approved prior to the use of the substance.

For sportspersons participating in an international event, but not part of the selected group of athletes subject to controls by an international federation, an AUT or a retroactive AUT in case of a result adverse analytical, in accordance with the rules of the international federation or the organisation responsible for major sporting events.

For national athletes who are not part of the selected group of athletes subject to controls by an international federation, whether or not they are included in a selected group of athletes submitted to national controls, an AUT or a retroactive AUT in the event of an adverse analytical result, in accordance with the rules of the national anti-doping organisation.

Only retroactive AUT will be granted if the requirements listed in Annex 1 are met, so any adverse analytical result communicated by a laboratory in such circumstances will result in the violation of a standard antidoping.

Athletes will be able to request an AUT at any time, if they so wish.

When a sportsman has requested an AUT or a retroactive AUT and has been denied it, you will not be able to use the substance without previously obtaining an AUT (no retroactive AUT will be authorized).

8.0 Usage declaration procedure.

8.1 It is recognized that certain substances included in the list of prohibited substances and methods are used for the treatment of diseases that frequently affect sportsmen and women. For the purposes of control, a simple declaration of the use of those substances shall be required, for which the route of administration is not prohibited and which are strictly limited to the following: glucocorticoids administered by non-systemic routes; know, intra-articular, periarticular, peritendinose, peridural, intradermal injections, and inhalation.

8.2 For the aforementioned substances, the sportsman shall make the declaration of use by the ADAMS system, where reasonably practicable and in accordance with the Code, as soon as the use begins. The declaration shall indicate the diagnosis, the name of the substance, the dose ingested and the name and address of the doctor. In addition, the athlete must declare the use of the substance in question on the anti-doping control form.

9.0 Information Center.

9.1 Anti-doping organisations must provide the AMA with all AUTs approved for athletes who are part of a selected group of athletes under national or international control and all of them. supporting documentation, as provided for in Section 7.

9.2 Usage declarations must be communicated to the AMA (ADAMS).

9.3 The Information Center will ensure the strict confidentiality of all medical information.

10.0 Transient Disposition.

Abbreviated therapeutic use authorizations (AUTA) issued before December 31, 2008 will be governed by the 2005 AUT Standards.

Those AUTA will remain valid after 1 January 2009 at least until:

(a) The date on which they are cancelled by the Competent CAUT after a review pursuant to Article 8.6 of the Rules for AUT 2005.

b) The expiration date indicated on them.

c) On December 31, 2009.

ANNEX 1

Minimum requirements for the medical file to be used in the AUT processing process in the case of asthma and its clinical variants

The case should be based on the best current medical practice and contain:

1) A complete medical history.

2) A comprehensive clinical examination report, which relates especially to the respiratory system.

3) A spirometry report with the measure of the forced expiratory volume in a second (VEF 1).

4) In case of airway obstruction, spirometry will be repeated after inhalation of a fast-acting beta-2 agonist to demonstrate the reversibility of bronchospasm.

5) In the event of irreversible airway obstruction, a bronchial provocation test will be performed to establish the presence of airway hyperreactivity.

6) The exact name, specialty, and sign (including phone, email, and fax) of the physician performing the test.

What is made public for general knowledge.

Madrid, May 27, 2009. -Secretary General of the Ministry of Foreign Affairs and Cooperation, Antonio Cosan Pérez.