Possible ways the Therapeutic Use Exemptions system can be improved to prevent abuse

On 13 September 2016, a group of hackers calling themselves “Fancy Bears”, began to leak onto the Internet¹ confidential athlete data relating to, among other things, “Therapeutic Use Exemptions” (TUEs – explained below) for certain drug consumption. Fancy Bears’ claimed that they obtained the data by hacking into the World Anti-Doping Agency’s (WADA) Anti-Doping Administration and Management System (ADAMS). This has been subsequently confirmed by WADA.²

While the legality of the hack cannot be condoned, the upshot is that it has thrown TUEs under the spotlight. The public seems surprised at the number of TUEs granted to athletes,³ and there is a growing suspicion in some corners that athletes may be using TUEs unscrupulously⁴ to take drugs that are otherwise classified as performance enhancing and banned under the WADA Code. WADA has tried to reassure the community, with the WADA TUE Expert Group releasing this statement⁵ on 30 September. However, questions remain about the ethical use, integrity and principles of the TUE regime.⁶  

Accordingly this article examines the TUE regime, asking whether it is open to abuse and, if so, how it could be improved. Specifically it looks at:

• Background to TUEs
• The International Standard for Therapeutic Use Exemptions
• The application process
• Prevalence of TUEs and possible abuse of the process
• Possible reforms
• Concluding comments

BACKGROUND TO TUEs

The International Standard for Therapeutic Use Exemptions (ISTUE),⁷ first adopted in 2004, was created with the understanding that, due to illness or a medical condition, an athlete may require the use of medications or treatments on WADA's Prohibited List.⁸ A TUE is granted to an athlete under narrow, well-defined conditions contained within the ISTUE. In simple terms, the TUE enables the athlete to take necessary medication while competing in sport events, without the consequences and ramifications of committing a doping offence.

Between January 2015 and March 2016, UK athletes were granted 159 TUEs, with 12 rejected. Of these, the UK Anti-Doping Agency approved 116 and rejected six while international federations approved 43 and rejected six⁹. The strict criteria for one to be granted are detailed below.

The last three WADA reports indicate a rise in TUEs worldwide across all sports generally. In 2013, there were 636 approved TUEs, 897 in 2014 and 1330 in 2015. That is an increase of more than 100% in just two years¹⁰. 

The International Standard for Therapeutic Use Exemptions¹¹  

The purpose of the ISTUE is to establish:

1. the conditions that must be satisfied in order for a TUE to be granted;
2. the responsibilities imposed on anti-doping organisations in making and communicating TUE decisions;
3.  the process for an athlete to apply for a TUE;
4. the process for an athlete to get a TUE granted by one anti-doping organisation recognised by another anti-doping organisation;
5. the process for WADA to review TUE decisions; and
6. the strict confidentiality provisions that apply to the TUE process¹².

An athlete may be granted a TUE if (and only if) he/she can show, on a balance of probability, that each of the following conditions in Article 4.1 of ISTUE is met (all definitions not otherwise defined hereinafter shall have the same meaning as within ISTUE):

1. The Prohibited Substance or Prohibited Method in question is needed to treat an acute or chronic medical condition, such that the Athlete would experience a significant impairment to health if the Prohibited Substance or Prohibited Method were to be withheld.
2. 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 Athlete's normal state of health following the treatment of the acute or chronic medical condition.
3. There is no reasonable Therapeutic alternative to the Use of the Prohibited Substance or Prohibited Method.
4. 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 the substance or method which was prohibited at the time of such Use¹³.

Unless one of the exceptions set out in Article 4.3 applies, e.g. emergency treatment or treatment of an acute medical condition was necessary; or due to other exceptional circumstances, there was insufficient time or opportunity for the Athlete to submit, or for the Therapeutic Use Exemption Committee (TUEC) to consider an application for the TUE prior to sample collection; the athlete must obtain a TUE prior to using or processing the Prohibited Substance or Prohibited Method in question¹⁴.

THE APPLICATION PROCESS