[Author: Diya Jaimon, Law Student at National Law University, Delhi, India]

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Introduction

The Fancy Bears Espionage Operation of 2016, which leaked confidential data of athletes from the World Anti-Doping Agency (‘WADA’) database ignited many discussions; on player ethics, drug misuse and privacy. These heated debates hinged on the ethics and legality of what can be referred to as “the exception to the rule against doping”; Therapeutic Use Exemptions (“TUE”).

The data which showed elite athletes such as Serena Williams, Chris Froome and Simone Biles have taken TUE’s, apart from shocking fans, narrowed debates around opaque TUE grant processes and led to many asking for reform in WADA’s guidelines surrounding the TUE grant. Flash forward to 2025, not much has changed. The debates around ethics of fair play versus the privacy rights and medical rights of players continue and the process remains as opaque as ever.

This article does not purport to answer these questions, rather it engages with the current critiques and proposes to take a middle ground; the right to privacy of athletes must be protected and sensitive medical data cannot be freely published. However, the author would like to opine on the publishing of sensitive medical data of players who have been denied TUEs and been prosecuted for doping; is misuse of the process/ ignorance of the process enough to forego their right to privacy? Further, the author also vouches for greater uniformity in the TUE regime, and selective data being divulged. However, the question of valuation still remains the same; in elite competitive sport, where the future of an athlete may depend on a 0.01 second edge, can a TUE be granted so easily, considering it being prone to misuse? Does fair play consideration weigh over privacy?

Therapeutic Use Exemptions – Evolution and Framework

The rights of athletes to participate in doping free sports is upheld by WADA, through it’s World Anti-Doping Program. (‘WADP’)  Through the publication of its prohibited list, WADA aims to uphold integrity and fairness in sports, and more than 600 sports organisations are signatories to it. However, there is one exception to these criteria; it being the health necessities of the athletes. Thus, in 2004 the International Standard for Therapeutic Use Exemptions (ISTUE) was adopted (and amended multiple times, the latest in 2023).

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 antidoping organisation;

5. the process for WADA to review TUE decisions; and

6. the strict confidentiality provisions that apply to the TUE process.

The grant of a prospective TUE depends, on a balance of probability, on the factors set out in Article 4.1 of the ISTUE, which includes the necessity of using the prohibited substance, the assurance that the substance does not produce additional performance enhancing effects, the lack of an alternative as well as the necessity of usage. The ISTUE Guidelines are mandatory guidelines and must be adhered to by national and international sporting organizations. Each Anti-Doping Organization is required to establish a Therapeutic use Exemption Committee (“TUEC”) comprising of medical personnel. The Committee is responsible for reviewing the requests for grants of TUE’s and reporting the decision to the WADA’s ADAMS repository.

National and International Frameworks

The grant of a TUE happens on both a national and international level. Every National Anti-Doping Organization, International Federation, and Major Event Organizer is required to set up a Therapeutic Use Exemption Committee (TUEC). This committee is responsible for assessing whether applications for granting or acknowledging TUEs fulfil the criteria outlined in Article 4.1 of the ISTUE. An athlete who isn’t classified as an International-Level Athlete should submit their application to their National Anti-Doping Organization. However, if the athlete competes at the international level, they must apply to their respective International Federation. In cases where an athlete has already received a Therapeutic Use Exemption (TUE) from their National Anti-Doping Organization for a specific prohibited substance or method, and this TUE aligns with ISTUE standards, the International Federation is generally expected to recognize it. If an International-Level Athlete hasn’t obtained a TUE yet, they should apply directly to their International Federation as soon as the need arises. These guidelines are outlined in Article 4.4 of the WADA Code.

Issues and Challenges

Challenges to the grant as well as usage of TUE’s can be on two grounds; procedure based as well as principle based. Procedurally, the ISTUE does prescribe standards that organizations as well as states need to comply, to get a WADA recognized TUE, however, the process in which medical data is processed as well as standards that the TUEC personnel apply are not uniform. 

Principally, the abuse of TUE’s can violate rules of fairness in sports and affect the integrity of the game. The way around the same does require certain sacrifices to athletes’ rights to privacy; raising two competing principles that the Anti-Doping regime must balance.

Opaque Process v. Privacy Concerns

The opacity in the TUE process rises from firstly, the fact that there is no access to the general public, data about who has been granted a TUE. Moreover, the process of verifying a TUE, looking at the four conditions of the ISTUE and the TUEC Committee’s interpretation, are not provided in the open domain. This data is only available with WADA, and it was precisely this data that was attacked in the 2016 Fancy Bears attack.

Secondly, Although the Code clearly states that members of a TUE Committee have to be either independent or impartial, there is no uniform organization validating all TUEs across sports and countries. There is no existing process for these bodies of who is eligible and independent or impartial ‘enough’ to approve a TUE. Lacking a central accreditation process will result in inconsistencies about the application of the criteria to practical decision making. This lack of uniformity, coupled with probable lack of consensus in medical fields about the best evidence- based practices in sports medicine can result in subjectivity in the assessment of TUEs.  Even though there are physician guidelines that are published by the WADA, these are not mandatorily required to be followed.

Case in Point: Retroactive TUE’s

To facilitate flexibility by appreciating the need for immediate medical treatment among athletes, the 2015 WADA amendments vested broader discretion on TUECs to retroactively grant TUEs under art 4.4.5 of the WADA Code.

A retroactive TUE may be granted where an athlete meets the standard TUE criteria set out under art 4.1, and additionally establishes art 4.3 of the ISTUE. A retroactive TUE may be granted under art 4.3 where:

“(a) Emergency treatment or treatment of an acute medical condition was necessary; or

(b) Due to other exceptional circumstances, there was insufficient time or opportunity for the Athlete to submit, or for the TUEC to consider, an application for the TUE prior to Sample collection; or

(c) The applicable rules required the Athlete or permitted the Athlete to apply for a retroactive TUE; or

(d) It is agreed, by WADA and by the Anti-Doping Organization to whom the application for a retroactive TUE is or would be made, that fairness requires the grant of a retroactive TUE.”

Excepting section (c) which permits – or does not, at least according to the regulations of the specific anti-doping organization that may be at stake – the issuance of a retroactive TUE, each of the other three are, in a sense, subjective and discretionary, at the discretion of the TUEC, that is, which of them falls within the ‘acute medical condition’, ‘insufficient time or opportunity’, and ‘fairness’ parameters. Resolving some of these issues, the Therapeutic Use Exemptions Guidelines, or model guidelines ‘intended to give clarity and additional guidance to [the Code’s] Article 4.4 and the ISTUE’, provide clarity, in relation to ISTUE Article 4.3, for subsections (a), (b), and (c) but leaves much open, particularly concerning subsection (d).

The Fairness Provision

The “fairness” provision in the grant of retroactive TUE’s has resulted in much criticism against the subjectivity that the whole process entails. It is but one example that requires the TUE process to be more transparent and streamlined. Going into the “fairness” provision and the interpretations, the same has been given by the Court of Arbitration in Sports (‘CAS’) and one can see how necessity, lack of alternatives and knowledge has been read in various ways.

Among the four exceptions for retroactive TUEs, ISTUE Article 4.3(d)’s ‘fairness’ requirement gives the athlete the slightest chance of getting a retroactive TUE. ‘Fairness’ is not defined within the ISTUE and further explanation does not exist in the Code or the TUE Guidelines about what to look for on a ‘fairness’ analysis by TUECs when making decisions regarding retroactive TUEs. That being said, at least to date, it is not possible to have a de novo review on appeal of a decision to reject a retroactive TUE application on ‘fairness’ grounds and given that this section only came into effect in 2015, there have been just a few CAS cases that have provided any insight into the meaning of the fairness provision. One major case that the author would like to analyze, that deals with the fairness provision is CAS 2014/A/3876, Stewart v. FIM, April 27, 2015.

Facts

Stewart was a professional motocross and supercross rider who was diagnosed with attention deficit hyperactivity disorder (‘ADHD’). He was prescribed Adderall for his condition in 2012.

He signed in 2014, documents agreeing to abide by and review the Fédération Internationale de Motocyclisme’s (‘FIM’) anti-doping rules, wherein Adderall was a prohibited substance that can being in Anti-Doping Rule Violations.

In January 2014, he neglected to disclose his regular use of this medication on the Medical History Form, as required by the FIM Anti-Doping Code, where he answered “No” to the question, “Do you take any medicine or drugs regularly?” The day following a drug test, however, Mr. Toribio, James Stewart’s trainer, contacted the American Motorcyclist Association (AMA), the U.S. affiliate of the FIM, to report that Stewart was currently taking Adderall. In a subsequent email exchange, Mr. Toribio was informed that Adderall contained a prohibited substance and that Stewart would need a TUE. Although Mr. Toribio believed he had submitted the necessary information for a TUE on Stewart’s behalf, no TUE was granted at that time. Later, on June 2, 2014, Stewart underwent another in-competition doping test. This time, he disclosed his Adderall use but mistakenly claimed he already had a TUE. After an unsuccessful TUE application in June, Stewart finally received approval for Adderall’s future use on October 15, 2014.

While disciplinary proceedings continued regarding the amphetamine found in his April 12 sample, he was issued a provisional suspension on June 17, which he immediately contested, arguing that his use of Adderall could be justified through a TUE. However, on June 26, FIM’s International Disciplinary Court (CDI) denied Stewart’s request to lift the suspension. During this suspension, he participated in several competitions organized by MX Sports Pro Racing, which is not governed by FIM or AMA regulations. Unlike the World Anti-Doping Code (WADC), MX Sports’ Substance Abuse Policy does not offer TUEs but does allow the use of otherwise banned substances if prescribed.

CDI Ban

After a hearing on October 23, 2014, the CDI confirmed Stewart had violated anti-doping rules due to the amphetamine detected in his April 12 sample. The CDI imposed a 16-month ineligibility period starting from the sample collection date and nullified his results from both the AMA Supercross FIM World Championship, where the sample was collected, and the competitions he entered during his provisional suspension that were outside FIM/AMA’s jurisdiction.

CAS Proceedings

James Stewart appealed the FIM’s decision to the Court of Arbitration for Sport (CAS), seeking either to overturn the CDI’s ruling entirely or, if not, to reduce his period of ineligibility and reinstate his disqualified results. Stewart argued that his infraction was essentially a “paperwork violation,” as he could have obtained a TUE for Adderall but didn’t due to a lack of anti-doping education and the varying rules of the competitions he entered. He claimed the sixteen-month suspension and disqualification of results were excessive and requested a lesser penalty or complete removal of the sanctions. Furthermore, he argued that the 2015 TUE regulations, which had since come into effect, would have permitted a retroactive TUE, thus voiding the infraction entirely.

This argument was rejected by the CAS panel. Stewart’s argument that if the violation has taken place in 2015, when the Retroactive TUE process would have granted him, a TUE was rejected, as the panel held that “[t]here would have been no requirement of fairness that required Mr Stewart to be granted a retrospective TUE simply because he had failed to carry out his obligations and so through ignorance to apply timeously for a TUE”.

For the panel, James Stewart’s lack of proactive commitment to comply with his anti-doping obligations and his ignorance of the TUE regime weighed in heavily in the panel’s interpretation of whether “fairness” would have required the grant of a TUE.

Another case that highlights the narrow interpretation that the panel provides to the “fairness” provision is that of Molly Beckwith-Ludlow, a field and track athlete. Ludlow, after failing to qualify for the 2016 Rio Olympics, intended to retire from track and field to focus on starting a family, although she hadn’t officially announced her decision before undergoing an out-of-competition drug test in late 2016. Her test came back positive for clomiphene metabolites, a medication she was taking under the guidance of an obstetrician to assist with family planning. Despite these circumstances, her request for a retroactive TUE was denied on grounds of fairness. Although this constituted an anti-doping violation, the United States Anti-Doping Agency (USADA) imposed only a public warning as a sanction.

These cases highlight the restrictive and narrow approach in the grant of retroactive TUEs, and have been highlighted to show a) the subjectivity that the provisions governing grant of retroactive TUEs can have and b) the opaque process leaves athletes in the dark about what criteria the panels use in granting the TUEs. This brings us to the next argument on transparency in the grant of a TUE.

Solutions to Opacity

Firstly, to combat the problems related to diverse medical best practices being used to evaluate a TUE application by the committee, an independent review process of the TUEC decisions is suggested. The Australian Anti- Doping agency, in 2017, suggested such an audit and peer review process in Australia. This system could decide on the criterias for qualification to become a TUE committee member as well. However, with regards to transparency, the discussion of TUE policy suggests that all information pertaining to the TUE procedure was publicly available. This would imply that the public would be aware of an athlete’s health information, medical issues, and the use of drugs to address those conditions. The TUE policy could only then be appropriately referred to as “transparent”. The idea that transparency will make doping through TUE processes much more difficult to exploit is one reason for this shift towards transparency. For instance, more people would have access to each TUE case if the TUE procedure were to become more public. As a result, TUE applications and approvals would be subject to more public scrutiny and accountability.

Athletes and their physicians could be less inclined to try to take advantage of the TUE process if they believe it is being closely examined. Increasing transparency could also better illustrate the beneficial effects of such a regulation by bringing attention to the fact that athletes occasionally suffer from major medical disorders that call for medical care, even when the products they use are on the prohibited list. Lastly, enhancing transparency would guarantee that those engaged in the TUE certificate issuance process continue to adhere to the pertinent TUE procedures. In conclusion, there are definite advantages to proposals for a change to a more open TUE regulation, and these calls are probably going to gain traction.

The Privacy Conundrum and Selective Application

WADA has published its  International Standard for the Protection of Privacy and Personal Information  (‘ISPPPI’). WADA has also stated that the right to keep medical information confidential is a fundamental human right. This is also bolstered through the standards, where the privacy requirements are a minimum standard to be applied to all testing agencies, which can change according to national legal frameworks. The WADA  has also provided an expansive reading to what constitutes personal information in its Article 3.3. With such a robust data protection system in place, requiring that the athletes’ information on TUEs are publicly available might go against the code. There are other issues too with regards to greater transparency.  Assume that the TUE policy changed to become more open. It is reasonable to assume that the illnesses and medical records of athletes would be made public. Athletes’ privacy would be at risk because they would have little to no control over who would have access to this personal data. Furthermore, it is possible that some medical situations are more susceptible than others. Determining which of these requirements, if any, may legitimately be made public would be an unsurmountable ethical and intellectual barrier. Athletes may suffer additional unjustified harms, such as athlete dropout, marginalisation, humiliation, and loss of income, if private medical issues were made public under the potential of more openness.

Another argument against implementing a more open TUE regulation is to the competition itself and the possibility that openness would change how athletes compete in sports. Let’s say that the TUE policy changed to become more open. Competing athletes may create game plans or tactics that focus on the weaknesses in their athletic ability brought on by the illness. Pete Sampras, the tennis player, did not want this to occur during his career.

These arguments against making the TUE process more transparent raise the question of balance; when two competing claims of athlete privacy and abuse of the TUE process are laid out, which one should be prioritized? Can there be a potential balance where sensitive medical data is not compromised for the principles of fair play?

The potential model suggested by the Australian Anti-Doping agency where there is an independent review process can be taken up. However, the opacity with respect to how the process gets carried out still remains.

WADA’s argument on privacy being the cornerstone, seems to be a tactic to avoid accountability, due to the fact that athlete’s privacy is negated when it comes to doping violations and refusal of TUE processes. There, you can see the athlete’s entire medical history and sensitive personal information being published in the decisions and appeals column of the WADA, national organizations, etc.  Annex A of the ISPPPI, allows the data on TUE rejections and appeals process to be published, according to the necessity/ proportionality principle.

Considerations for a Transparent Process

Throughout this article, the Author has tried to lay out different loopholes and moral concerns that may weigh in when TUEs are granted. Firstly, there is an opacity of process. There is also subjectivity in the grant of TUEs, especially evident from the decisions surrounding Retroactive TUEs.

This is accompanied with no universal agreement on medical best practices or treatments of a particular disease. The author has not delved into medical professionals’ integrity and the possibility of faking diseases to obtain TUEs.

There also remains larger questions about whether TUEs may grant an athlete the competitive edge that, in elite sports, is enough to let them win the game. This would raise questions about whether TUEs should be granted in the first place, and the need for its strict monitoring. After the Fancy bears data leak and top athletes being discovered as using TUEs, public’s perception about their legitimacy has certainly taken a hit. A possible solution to the same would be to monitor the process on a larger level and maintain transparency. However, this raises concerns about athletes right to privacy and data protection, which the WADA too, claims to uphold.

Conclusion

In a study conducted on Danish athletes, 51% of them believed that the TUEs granted to their co-athletes and in the sport were unnecessary. However, a WADA study from 2016 – 2022 on Olympic and Paralympic athletes reveal that the prevalence of usage of TUEs is less than 1% and 3%, respectively. Low usage can mean low abuse of the TUE process, however, that cannot be said conclusively, after elite Athletes’ usage of TUEs being public after the fancy Bears Scandal.

In elite sports, the stakes are high and the margin to win are miniscule. This raises concerns about even the slightest amount of performance enhancement in sports. Considering the opacity and uncertainty surrounding the misuse of the TUE system, it is the need of the hour to ensure that a process that was brought in to ensure fairness to all, to eliminate barriers to elite sports and to uphold the right to health is not misused to gain competitive edges. Losing public perception in the fairness of the sports industry and the win being “legitimate” will only hurt the industry in the long run, with disgruntled fans and loss of sponsorship. Hence, it is imperative that the WADA comes up with a process that can balance all the competing considerations at play; privacy, fairness and the right to health.

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[For feedback or query, please reach out to the Author at diya.jaimon21@nludelhi.ac.in]

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Preferred Citation: Diya Jaimon, “Challenges Surrounding the Therapeutic Use Exemption Framework in Anti-Doping” Sports Law Review India, available at: https://sportslawreviewindia.blog/2025/02/26/challenges-surrounding-the-therapeutic-use-exemption-framework-in-anti-doping/ Published on 26 February 2025.