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Therapeutic Use Exemptions

Therapeutic Use Exemptions
Therapeutic Use Exemptions

THERAPEUTIC USE EXEMPTION

 

1. What is a Therapeutic Use Exemption (TUE)?

A TUE is special permission to use a prohibited substance or method for a legitimate medical condition.

Riders, like everyone else, may have illnesses or condition which requires a particular medication. If a substance contained in your medication or the method used appears on the Prohibited List, you must apply for a TUE before starting the treatment. After the UCI Therapeutic Use Exemption Committee (TUEC) has reviewed your application, you may be given authorization to obtain treatment.

The UCI TUEC is composed of independent experts in the fields of clinical sports and exercise medicine. It is the CADF, independent entity mandated by the UCI to run the bulk of its anti-doping program, that provides administrative support to the TUEC,

 

2. Which riders should apply to the UCI for a TUE?

A. Riders included in the UCI Registered Testing Pool (UCI RTP)

If you are included in the UCI RTP, you must apply for a TUE directly to the UCI through ADAMS exclusively.

If you already had a TUE granted by your NADO at the time of your inclusion in the UCI RTP, you must apply for the recognition of this TUE by the TUEC through ADAMS exclusively. If that TUE meets the criteria set out in Section 4.0 of the UCI TUE Regulations, then the TUEC shall recognize it.

 

B. Riders not included in the UCI RTP but participating in an International Event

If you are not included in the UCI RTP, you shall apply for a TUE to your National Anti-Doping Organisation (NADO) in accordance with the regulations of your NADO.

However, if you are not included in the UCI RTP and wish to participate in an International Event (i.e. an event where the UCI is the ruling body), you must, prior to such participation, obtain recognition from the TUEC of the TUE already granted by your NADO. If that TUE meets the criteria set out in Section 4.0 of the UCI TUE Regulations, then the TUEC shall recognize it.

If the need for the TUE arises during the International Event Period, you may apply directly for a TUE to the TUEC.

Note: The list of International Events is published on the UCI website under each discipline.

 

C. Automatic Recognition

Please note that the UCI automatically recognizes TUEs decisions made by the following NADOs.

This means that if a rider’s TUE has been delivered by a NADO listed below, he/she does not need to apply to the UCI for recognition of that TUE, insofar as the TUE is still valid. The TUE is automatically recognised by the UCI, without further action required by the Rider.

  • NADO of the French Community of Belgium
  • Canadian Centre for Ethics in Sport
  • Agence Française de lutte contre le dopage
  • Agencia Española de Protección de la Salud en el Deporte
  • Antidoping Switzerland
  • Antidoping Denmark
  • NADO Vlaanderen
  • National Anti-Doping Agency Austria
  • Anti-Doping Norway
  • UK Anti-Doping
  • South African Institute for Drug-Free Sport Science Institute
  • United States Anti-Doping Agency
  • Swedish Sports Confederation
  • Nationale Anti Doping Agentur Deutschland
  • International Paralympic Committee
  • Australian Sports Anti-Doping Authority
  • NADO Italia
  • Sport Ireland

 

3. When shall I apply to the UCI for a TUE?

A rider who needs a TUE should apply as soon as the need arises, unless exceptional circumstances or true emergencies exist.

For substances prohibited in-competition only, the rider should apply for a TUE at least 30 days before his/her next Competition, unless exceptional circumstances or true emergencies exist.

The rider should apply to the UCI, using the TUE application form available on ADAMS. Please refer to section 6 below for further information on the TUE application process.

4. Conditions for granting TUE

Article 4.1- UCI Regulations for TUE

A rider may be granted a TUE if (and only if) he/she can show that each of the following conditions is met:

a. The prohibited substance or prohibited method in question is needed to treat an acute or chronic medical condition, such that the Rider would experience a significant impairment to health if the Prohibited Substance or Prohibited Method were to be withheld.

b. The therapeutic use of the prohibited substance or prohibited method is highly unlikely to produce any additional enhancement of performance beyond what might be anticipated by a return to the rider’s normal state of health following the treatment of the acute or chronic medical condition.

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

d. The necessity for the use of the prohibited substance or prohibited method is not a consequence, wholly or in part, of the prior use (without a TUE) of a substance or method which was prohibited at the time of such use.

[Comment to 4.1: The WADA documents titled “Medical Information to Support the Decisions of TUECs”, posted on WADA’s website, can be used to assist in the application of these criteria in relation to particular medical conditions.]

 

5. Particular information with regard to Glucocorticoids, Beta-2 Agonists against Asthma and Injections (“No Needle Policy”)

A. Glucocorticoids

Authorised routes of administration

The following routes of administration (i.e. how the medication is administered or taken) are authorised and hence do not require a TUE for the use of glucocorticoids :

• Dermatological – on the skin;
• Auricular - in or on the ear;
• Buccal – inside the mouth (without swallowing);
• Gingival - on the gums;
• Nasal - inside the nose, either by topical application or nasal spray;
• Ophthalmic – on or in the eye;
• Perianal – on or around the anus;
• Inhalation – through the mouth via an inhaler or “puffer”;
• Intradermal injection – into the skin;
• Epidural injection – into the spine;
• Intra-articular injection – into a joint capsule;
• Periarticular injection – around a joint;
• Peritendinous injection – around a tendon.

 

Prohibited routes of administration - systemic administration

You must complete a full TUE application before taking glucocorticoids by any of the following systemic routes:
• Orally – through the mouth, usually in the form of pills or tablets or syrup or drops;
• Intravenous injection – injection into a vein;
• Intramuscular injection – injection into a muscle;
• Rectally – into the rectum usually in the form of a suppository or rectal application of a cream.

Local injection of glucocorticoids - “8-days rest period”

In case of a local injection of glucocorticoids, which is subject also to the Anti-Doping Rules and the Prohibited List, the rider must rest and is prevented from competing for 8 days (article 13.3.055 of the UCI Regulations).

B. Beta-2 agonists for asthma

Whether or not you need to apply for a TUE before using a beta-2 agonists for the treatment of asthma depends on the medication. Please pay utmost attention to the substance which is included in your inhaler.

Salmeterol /Salbutamol/Formoterol

Inhaled salbutamol (maximum 1600 micrograms over 24 hours), inhaled formoterol (maximum 54 micrograms over 24 hours) and inhaled salmeterol in accordance with the manufacturers’ recommended therapeutic regimen are not prohibited and therefore do not require a TUE.

You must obtain a TUE only if you need to inhale more than 1600 μg per day of salbutamol.
You must obtain a TUE only if you need to inhale more than 54 μg per day of formoterol.
You must obtain a TUE if you take salmeterol, salbutamol and/or formoterol by any other routes of administration.

Terbutaline or other Beta-2 agonist

If you take terbutaline or any other beta-2 agonist for the treatment of asthma, you must submit a TUE request for asthma and your full medical file through ADAMS to confirm the diagnosis of asthma and/or its clinical variants.
The medical file should include:
- A detailed medical history and clinical review;
- Lung function test with spirometry;
- Bronchodilator response;
- Bronchial provocation tests.

To assist your doctor in completing the correct tests, and providing the correct medical information, we suggest that he or she consults the WADA Guidelines on Asthma.

C. Injections – “No Needle” Policy

We remind you that the use of injections to administer drugs or substances without a clear and recognised medical indication is prohibited. This applies to any substance that is injected whether endogenous or exogenous, prohibited under the UCI Anti-Doping Rules (ADR) or not, and to any type of injection (article 13.3.052 of the UCI Regulations).

Accordingly, the injection that falls under the "No Needle Policy" must be reported immediately and in writing not later than 24 hours afterwards to the UCI Doctor (via email medical@uci.ch).

 

6. How to apply for a TUE to the UCI?

If you need to take any substance or method which is included in the Prohibited List or to have your TUE granted by your NADO recognised, you must apply for a TUE to the UCI, using exclusively the TUE application form available on ADAMS. The completed TUE application form and a comprehensive medical file must be submitted to the UCI via ADAMS.

All TUE applications must be submitted in legible French or English. Written medical reports must also be submitted in legible French or English, although results of tests may be in the original language.

If you need a TUE, you should apply as soon as the need arises. For substances prohibited in-competition only, the rider should apply at least 30 days before his/her next competition, unless exceptional or true emergencies exist.
To assist your doctor in providing the correct medical documentation we suggest that you consult the WADA website to access the medical information required to support TUE application for treatments of several common medical conditions.

If you are a rider whose doctor has a medical ADAMS account, your team doctor can undertake this task on your behalf through ADAMS.

 

7. Contact Info

If you do not have access to ADAMS, please request an ADAMS user account from adams@cadf.ch
Please contact tue@cadf.ch if you need assistance in applying for a TUE.

Declaration in the scope of the “No Needle Policy” (article 13.3.052 of the UCI Medical Rules) must be reported to UCI Doctor via email (medical@uci.ch).

 

8. Number of TUEs granted annually by the UCI

 

Year TUEs granted
2009 239
2010 97
2011 55
2012 46
2013 31
2014 25
2015 13
2016  15 

 

9. Rules and Procedure

The UCI TUE Regulations can be accessed here.
Part 13 Medical Rules of the UCI Cycling Regulations can be accessed here.
Anti-Doping Rules and Procedure can be accessed here.

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