Ethical and Conceptual Issues Raised by the Therapeutic Use Exemption Process

Fancy Bears, an anonymous cyber-hacking espionage group, have been responsible for hacking the World Anti-Doping Agency (WADA) and leaking confidential medical information, including details of athletes who have been granted Therapeutic Use Exemptions (TUEs) to allow them to take substances on the Prohibited List. The information published has highlighted the debate into the ethical and conceptual issues raised by the TUE process.

A greater transparency within the TUE system used by elite athletes is important to demonstrate it works in a manner that is acceptable and fair to all athletes. Importantly, complete transparency is not an expectation as this implies every detail including an athlete’s medical data, medical conditions and the substance used would be in the public domain (Cox, Bloodworth, McNamee, 2017). An individual athletes’ right to medical privacy should be heavily considered, but a move towards more transparency would hold those involved in the process to a greater account and make the TUE process both difficult to exploit and reduce perceptions of exploitation. This is important to give confidence to clean athletes and stakeholders that it does function as it is claimed to, allowing athletes with certain medical conditions to be included in sport, but that at the same time it is not being abused by those seeking a performance advantage. Those in sport should be subject to the same moral obligations as those outside, as the thrill of a competition with an unknown result is vital for people to believe in a sport. Without this, fans will stop watching, young athletes will stop playing, sports will lose investors and ultimately elite sport will collapse.

The TUE Program is defined by WADA as a “rigorous and necessary part of elite sport; which has overwhelming acceptance from athletes, physicians and all anti-doping stakeholders” (WADA, 2019, para. 1). The program is designed to allow athletes with a genuine medical issue, who have no other medical alternatives, to take a medication that is on the Prohibited List. The concept of overwhelming acceptance could be interpreted in different ways; is it because it is a system that is effective in protecting athlete’s health and clean sport? Or, does it create a loophole to allow athletes to use medication for performance enhancement? Recent cases of unethical use of the TUE process include the UK Parliamentary review into Team Sky and allegations against Alberto Salazar, Head Coach of the Nike Oregon Project, for obtaining unnecessary TUEs and altering athlete’s medical records. These examples demonstrate that although the use of a TUE is within the rules of sport, it may not always be within the spirit of sport as within the right circumstances the system can be abused.

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The TUE Process

WADA annually publishes a Prohibited List that identifies substances and methods that cannot be used by athletes in competition, out of competition and within specific sports. The Prohibited List applies to all athletes who have agreed to the World Anti-Doping Code. In 2019, over 660 sport organisations, and by default their members, are signatories to the Code. These organizations include the International Olympic Committee (IOC), the International Paralympic Committee (IPC), International Federations (IFs) and National Anti-Doping Organizations (NADOs) (WADA, 2019). Athletes, like all people, may have illnesses or conditions that require them to take a medication or undergo a procedure which is on the Prohibited List (WADA, 2019). These athletes, under narrow and well-defined conditions, can be granted a TUE to enable them to take a substance or use a method without the consequences of committing a doping offence. 

The 2021 International Standard for Therapeutic Use Exemptions (p. 10) states that an athlete will only be granted a TUE if on the balance of probabilities all the following conditions are met: 

(a) The Prohibited Substance or Prohibited Method in question is needed to treat a diagnosed medical condition supported by relevant clinical evidence.

(b) The Therapeutic Use of the Prohibited Substance or Prohibited Method will not, on the balance of probabilities, 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 medical condition.

c) The Prohibited Substance or Prohibited Method is an indicated treatment for the medical condition, and there is no reasonable permitted Therapeutic alternative.

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.

TUEs are necessary in sport which has a strict liability policy. For inclusivity the TUE concept is “both sound and essential” (Fitch, 2019, para 2). The concept of inclusivity in sport is “pro-active behaviours, options and actions for make all people feel welcome and respected. Being inclusive is about following best practice for what sport should be so that everyone can get the most out of it” (Play by the Rules, 2019). A complete removal of the TUE system would mean athletes who have certain medical conditions requiring a substance of method on the Prohibited List would be excluded and unable to participate in competitive sport. For athletes with a long-term medical need this would be absolute, for athletes with a short-term medical condition there would be questions about how long an athlete should be ineligible to compete. However, there are some criticisms of the TUE system. These include whether there is a limited therapeutic need for a substance and symptoms have been fabricated by an athlete or medical professional, whether an athlete abuses the conditions of their TUE by taking higher doses than required, or whether a TUE is required, but the drug is also performance enhancing. As stated by Pike (2017) “TUEs are a creative way to prevent the unfair exclusion of athletes with a chronic condition, and they have the potential to be the least bad option. But they cannot be competitively neutral” (p. 1). This lack of neutrality applies both in practice and how they are perceived. As stakeholders in clean sport it is important to question whether a “least bad option” is morally good enough, or whether the TUE system needs to be amended.

Blurring the line

The line between the use of substances or methods for medical reasons and doping can be blurred. Manipulation of the TUE system potentially presents an opportunity for athletes to exploit the process to gain an advantage within a grey area, that is somewhere between the black line of cheating and what may be considered the morally correct action a normal person might undertake. It is within the rules of sport, yet potentially against the spirit of sport. The spirit of sport is defined by WADA as the essence of Olympism, the pursuit of human excellence, through the dedicated perfection of each person’s natural talents. It is how we play true (WADA, 2019). It could be argued that the TUE system does not lend itself to the spirit of sport, which is one of the central concepts of anti-doping policy. As Pike (2017) has identified, medical science will never be specific enough to identify exact dosages of substances to return an athlete to a normal level with no potential performance advantage. Even when there is a medical requirement if an athlete has any potential advantage from a substance does the TUE system support natural talent or playing true?

What is important to consider in this discussion is whether sport is a direct reflection of society or whether sport, and those involved, should be subject to the same moral obligations. When medals are central to the concept of high-performance sport, the value of the gold so great and the margin between winning and losing is so small, can those in sport really be held to the same account of morality as those outside? Should we reconsider the ethical line as per society to encompass what in reality high-performance sport is all about – doing whatever can be done without crossing the black line of cheating to achieve the goal?  Shane Sutton, former technical director of Team Sky has stated that TUEs were a legitimate way of finding the celebrated concept of marginal gains, within the anti-doping rules. If this is the prevailing attitude amongst sport leaders, then the concept of the spirit of sport is largely irrelevant.

A 2013 Danish study has shown TUE exploitation is perceived to be happening in practice. 645 Danish elite athletes from 40 sports completed a questionnaire about their experience and perceptions of TUEs. The data collected showed that 51% of athletes believed athletes within their sport had received an unnecessary TUE and 53% considered that being given permission to take a substance via the TUE process was of importance for their “(hypothetical) wish to try out doping” (Overbye & Wagner, 2013, para 3). 4% of athletes within the study believed it would be acceptable to receive a TUE without a genuine medical need. The results themselves are ethically problematic as the TUE process is designed to allow athletes to bring their health to a ‘normal’ level, not to provide them with a sporting advantage. As problematic is the athlete’s distrust of the system and that this distrust increases once the athlete has engaged with the process. This leads to the question as to whether the process needs to be more rigorous and transparent to ensure athletes are only being granted a TUE for a genuine medical need and whether this would give more confidence in the fairness of the policy. 

Inconsistencies

Currently, the WADA regulations state that IFs, NADOs and MEOs must have a clear process that is easily available for an athlete to request a TUE. The 2019 International Standard for Therapeutic Use Exemptions states that “in order to ensure a level of independence of decisions, at least a majority of the members of a TUEC should have no political responsibility in the Anti-Doping Organization that appoints them. All members of the TUEC must sign a conflict of interest and confidentiality declaration” (WADA, 2019, p 13). In the 2021 International Standard for Therapeutic Use Exemptions this clause has been removed and now states that “in order to ensure impartiality of decisions, all members of the TUEC must sign a conflict of interest and confidentiality declaration” (WADA, 2021, p 13). This amendment identifies that the concept of true independence in practice is difficult to achieve, especially in countries where the sporting community is small and there is little investment in the clean sport movement. 

The dilemma in the model is that regardless of whether the Code states that members of a TUE Committee have to be either independent or impartial there is no consistent organization approving all TUEs across sports and countries. There is no current accreditation process for these organisations as to who is eligible and independent or impartial ‘enough’ to approve a TUE. With no central accreditation process there will be inconsistencies as to how the criteria are applied in practice to decision making. As per the current and 2021 International Standard, information for every granted TUE should be submitted to WADA through the World Anti-Doping Administration & Management System (ADAMS) for review by WADA’s Medical Director and the TUE-Expert Group to provide some form of oversight and quality control.

There is little available information as to the volume of granted TUEs received or whether all IFs, NADOs and MEOs do submit complete information to WADA in practice. If this information is unavailable it is difficult to confidently say the process is fair, as it is unclear as to whether the WADA Medical Director and TUE Expert-Group have the capacity to review each case against the criteria. WADA cite the principle of strict medical confidentiality (WADA, 2019, 9.3) with regards to all TUE information, which is an understandable position as it complies with the International Standard for the Protection of Privacy and Personal Information. However, the perceived secrecy behind the TUE process and rumours that circulate amongst sporting communities about certain athletes or groups of athletes does not assist the identified lack of trust. 

Athlete health

The overwhelming consideration when addressing what potentially harms an athlete’s health is that given the nature of elite sport, with athletes driving their bodies to the absolute limit, the sport itself presents a risk to athlete health (Kayser, Mauron & Miah, 2007). Anti-doping policy is often framed by its advocates as a vital part of promoting athlete health but, the potential harm to athlete heath clause within the Code may be a contradiction to what athletes are already doing. Research by Kayser & Smith (2008) and Lentillon-Kaestner, Hagger & Hardcastle (2012) extend this showing that some elite athletes view doping as a way to maintain their health whilst training and competing.  

There are several ways in which the TUE process could be exploited by an athlete for a performance advantage which could be a risk to their health. Strategies could include finding a doctor who is willing to write prescriptions for unnecessary medical conditions, to fake symptoms of an illness or injury, or to manipulate the results of a diagnostic tests (Dimeo & Moller, 2017). This could be done on an individual level or systematically. A 2011 study on elite Swiss cyclists confirms this is happening in practice, as athletes obtain a TUE by feigning illness or injury. Corticosteroids were perceived as commonly used by some riders, were believed to be easy to obtain via doctor’s prescription and were an inexpensive form of doping (Lentillon-Kaestner, Hagger & Hardcastle, 2012). Within this sample of cyclists, the potential health risks did not influence most decisions to use banned substances. Using an unnecessary TUE to gain a performance advantage may be a cultural issue within some sports. It allows athletes to legitimize a form of cheating. It is beyond the purpose of the TUE in that it takes an athlete beyond a ‘normal’ level.

Privacy

To overcome the distrust in the TUE process Overbye & Wagner (2013) suggest increased transparency within the regulations. However, an ethical concern with increased transparency comes a decrease in privacy. Medical privacy should usually trump all else with regards to information that is publicly available. Elite athletes regularly have their private medical information shared amongst wider members of their support teams without a valid consent process, which suggests lack of privacy may be a norm at this level. Former Team Sky Doctor, Fabio Bartalucci commented in the media with regards to discussing riders with a wider support team “to be honest their presence annoyed me because of the importance of medical secrecy. I don’t think information concerning the health of the riders should be discussed outside of the group of team doctors. Rider health should not be open to possible debate” (Farrand, 2018, para 37). A consideration is that perhaps by default choosing to be an elite athlete means you all also waive some of your right to medical privacy. Sports and athletes have somewhat created this situation for themselves, doping scandals of the past and present, rumours of TUE abuse and athletes operating in a grey area, have made it hard for fans to really believe what they are seeing in terms of great performances. Secrecy is turning away fans that sustain our elite sports.

Recommendations

The TUE process highlights a clear difference between the rules of sport and the spirit of sport. In reality, no process will ever function perfectly within this sphere. A division in the Code between elite and club level athletes may “improve the credibility of WADA, NADOs and governing bodies as they acknowledge the differing circumstances in which substance use occurs” (Henning, 2017, para 30).  The highly competitive nature of elite sport and the significant awards from winning mean there will always be those who try and gain as much advantage as possible. To prevent the TUE system from being used for unethical purposes the following recommendations for elite athletes could be implemented:

Data

Elite athletes have to be willing to be part of the solution to regain respect for their sport by consenting to their anonymous data being published. TUE information should be publicly available to better hold sport stakeholders to account. There should be annual statistics published with regard to federation, sport and substance to give clean sport stakeholders confidence that the system is not being abused. This can be done while maintaining an athlete’s right to privacy as personal information will be redacted. This may reduce the self-perpetuating problem of an athlete believing they need to, and that it is acceptable, to operate in an ethically questionable area. Without WADA published data it is unclear as to how many elite athletes use the TUE system and for what substances. The insinuation that an athlete has to abuse the TUE system to enable a level playing field or no competitive disadvantage may actually be incorrect. Published data could prevent athletes from harming themselves by using unnecessary medication and then the subsequent harm to others within this cycle. If Code signatories are not compliant with entering complete data into ADAMS, then they should be deemed non-compliant. The greater harm would be to continue with the current process whereby athletes can take advantage by abusing medication for performance gains and the lack of transparency. Clean athletes may be the victims of those have previously bent the rules, but for elite sport to regain its respect a major cultural shift is required.  

Education

The variance in education across countries and sports is wide, due to both the unequal investment in anti-doping and the amount allocated into educating athletes. It is the responsibility of WADA, NADOs and the sports themselves to ensure they appropriately educate all levels of athlete to both protect clean sport and athletes, at a minimum, have an understanding of the Prohibited List and steps that should be taken if a substance or method on the list is medically required. Education is of vital importance within anti-doping and the TUE process. The 2021 WADA Code updates the guidelines for education to an International Standard for Education. Education will be mandatory as part of compliance for Federations and Sports to maintain their eligibility for international events. Ethically and conceptually this is an important step forward as all athletes that are members of a sport which is a signatory to the World Anti-Doping Code are subject to the rules, yet often, if education is not consistently available. Greater work needs to be done to engage with athletes. Often, the consent process is an athlete ticking a Terms and Conditions box, of which the anti-doing rules are one part of the wider membership regulations. This is not an ethical process without making education available to every person to whom the rules apply.

Accreditation System

To build trust within the process WADA could create an accreditation system for physicians to ensure they are competent to grant a TUE. Every athlete would know they are subject to the same decision-making criteria as their competitors. UK Anti-Doping have created a robust oversight system with regards to their TUE system. They hold an annual meeting where they invite external medical professionals to provide a critical assessment of a selection of TUEs the committee have approved. This information is useful to check for consistency and reliability, and to provide recommendations for the future. This oversight system could be expanded to operate on a global level whereby WADA should facilitate relationships between NADO, IF and MEO TUE Committees to critically assess others’ decisions to work towards consistent international standards.

Conclusion

Sport is part of the wider society in which it is embedded, for sport to maintain its fans and participants the anti-doping system needs to be effective and transparent. Those who break the rules or abuse any potential loopholes should be appropriately sanctioned. The TUE system has suffered from the wider distrust of the ability of WADA to protect clean athletes. At the 2019 World Conference on Doping in Sport David Gerrard stated that less than 1% of elite athletes had a TUE, yet this information conflicts with perceptions of the athletes in the Danish study. It is likely the perception of TUE abuse is greater than actual abuse. Regaining trust in the anti-doping system is vital for the fight against clean sport. The TUE system, although potentially more robust than is perceived by athletes, has to become more transparent at elite level, although without a doubt this has to be balanced with an athlete’s right to medical privacy.

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