Introduction: The new WADA Code 2015
Day 1: The impact of the revised World Anti-Doping Code on the work of National Anti-Doping Agencies
Day 3: Proof of intent (or lack thereof) under the 2015 World Anti-Doping Code
Day 4: Ensuring proportionate sanctions under the 2015 World Anti-Doping Code
Editor's Note
Marjolaine Viret: An attorney-at-law at the Geneva bar, specialising in sports and health law. Her doctoral work in anti-doping was awarded a summa cum laude by the University of Fribourg in early 2015. She gained significant experience in sports arbitration as a senior associate in one of Switzerland’s leading law firms, advising clients, including major sports federations, on all aspects of anti-doping. She also holds positions within committees in sports organisations and has been involved in a variety of roles in the implementation of the 2015 WADC. Her book “Evidence in Anti-Doping at the Intersection of Science & Law” is scheduled for publication in 2015.
Emily Wisnosky: An attorney-at-law admitted to the California bar, she currently participates in the WADC 2015 Commentary research project as a doctoral researcher. She also holds an LLM from the University of Geneva in International Dispute Settlement, with a focus on sports arbitration. Before studying law, she worked as a civil engineer.
Introduction
Doping often results from the illegitimate use
of a therapeutic product. As a result, many Prohibited Substances and Methods
are pharmaceutical innovations that are or have been developed to serve
legitimate therapeutic purposes. Much is being done within the anti-doping
movement to coordinate efforts with the pharmaceutical industry in order to
prevent abuse of drugs that have been discontinued or are still in development
phase. Conversely, at the other end of the range, some Athletes may require
legitimate medical treatment and wish to receive that treatment without being
forced to give up their sports activities.
This post takes a cursory look at how the World
Anti-Doping Code (“WADC” or “Code”) tackles these issues and provides a summary
of the main changes that affect the modalities for Athletes to receive medical
treatment after the 2015 revision. The first part discusses the avenues open to
an Athlete to compete while under treatment, namely by applying for a
Therapeutic Use Exemption (“TUE”) or, in some cases, navigating the provisions
governing conditionally prohibited substances. The second part addresses the
consequences in case an Athlete should fail to take the proper avenues. The
post closes with observations regarding the current system in light of one of
the pillars of the anti-doping movement: the Athlete’s health.
1. Obtaining Clearance to Compete – Therapeutic Use Exemptions and Conditional
Prohibitions
Amendments to Procedural Requirements
for Granting a TUE
An Athlete undergoing medical treatment that
involves a Prohibited Substance must seek a TUE from the competent Anti-Doping
Organisation (“ADO”). The 2015 regime preserves the “national vs international”
distinction that existed under the previous rules. The basic principle is that International-Level Athletes request
TUEs from their International
Federation, while National-Level
Athletes request TUEs from their National Anti-Doping Organisation (“NADO”)[1]. During the consultation process
leading to the 2015 Code, recommendations were made for an international
independent TUE Committee that would grant TUEs in a centralised manner. No
such system has been introduced at this point, but the 2015 revision does take
steps to ease the procedural burden and enhance clarity for those Athletes
whose competition schedule would require multiple TUEs (e.g. those transitioning from national-level competition to
international-level competition). In particular the 2015 Code:
§ Provides a streamlined process for Athletes seeking international
recognition of a national-level TUE. These Athletes are now relieved from having to go through a whole
new application process if they already have the benefit of a TUE granted by
their NADO: they can have the
TUE “recognised” by the International Federation, which “must” grant such
recognition if the TUE is in compliance with the International
Standard for Therapeutic Use Exemptions (“ISTUE”).
§ Encourages the automatic recognition of TUEs. ISTUE 7.1 newly encourages
International Federations and Major Event Organizers to declare automatic
recognition of TUEs, at least in part – e.g. those granted by certain selected
other ADOs or for certain Prohibited Substances.
Another key procedural change reflected in the
2015 revision is an increased storage time for application data, in accordance
with the extended statute of limitation period for initiating anti-doping
proceedings from 8 to 10 years (revised WADC 17). During the TUE process, the
application must include the diagnosis as well as evidence supporting such
diagnosis[2]. This sensitive medical data is
newly stored for 10 years under the revised 2015 regime for the approval form
(versus 8 years under the 2009 regime). All other medical information must be
kept for eighteen months from the end of the TUE validity[3].
Amendments to Substantive Requirements for
Granting a TUE
The requirements to receive a TUE have been
slightly adapted in the revised 2015 ISTUE, but not in a manner that would
significantly alter the assessment. In short, the TUE Committee must find that
the following four criteria are fulfilled:
- Significant impairment to the Athlete’s health if the substance
or method were withheld,
- Lack of performance enhancement
beyond a return to a normal state of health through the use of the
substance or method,
- Absence of any other reasonable therapeutic
alternative, and
- Necessity for use not a
consequence of prior use without a valid TUE.
With regards to
the manner in which these criteria operate, the 2015 revision:
§
Places the burden of proof on the
Athlete. The 2015
ISTUE received an explicit addition that confirms and codifies the interpretation
of the CAS panel in the recent ISSF v.
WADA award (Article 4.1, in initio):
“An Athlete may be granted a TUE if (and only if) he/she
can show that each of the following conditions is met” (emphasis added).
While a welcome addition for legal predictability, the hurdle for the Athlete
to overcome is high and can lead to nearly insurmountable evidentiary situations, such as in ISSF v. WADA regarding beta-blockers in
shooting and lack of additional performance-enhancement[4].
§
Remains silent as to the standard of proof. The requisite standard of proof to establish these substantive
criteria is still not explicitly stated. Although the issue was left undecided
in ISSF v. WADA, the
solution most in line with the WADC and general principles of evidence seems
the “balance of probability”-standard, as per the general provision for
establishing facts related to anti-doping rule violations (WADC 3.1)[5].
§ Newly allows retroactive TUEs for “fairness” reasons. As a rule, TUEs must be obtained
prior to using the Prohibited Substance or Method (ISTUE 4.2). Exceptionally, a
TUE may be granted with retroactive effect, which mostly concerns lower-level
Athletes for whom the applicable anti-doping rules accept such possibility
(WADC 4.4.5), or for emergency situations (ISTUE 4.3). The 2015 ISTUE contains
a new possibility to grant a retroactive TUE if WADA and the relevant ADO agree
that “fairness” so requires. The scope of this new exception remains unclear. A
recent award rejected an Athlete’s plea that (s)he did
not “timeously” request a TUE based on ignorance of the system[6]. One may wonder whether fairness related reasons could offer a
solution for situations of venire contra
proprium factum, i.e. when the Athlete received assurance from a competent
ADO that the substance or method was not prohibited[7] and the latter could thus reasonably be considered estopped from
pursuing a violation based on a subsequent positive test.
Transparency for Conditionally Prohibited Substances
Only minor changes were made in the 2015
revision in the context of conditionally prohibited substances. Some categories
of Prohibited Substances are widely used to treat minor conditions, including in
the context of sports medicine. Moreover, their effects on the Athlete may
depend on the mode of use. Thus, the Prohibited List prohibits the following
substances only conditionally:
§ Beta-2 agonists (class S.3) – e.g. Salbutamol, the active ingredient
of “Ventolin” –widespread against asthma in endurance sports. “Limits of use”
have been determined that are deemed to reflect an acceptable therapeutic use
of the substance[8].
§ Glucocorticoids (class S.9)[9],
which have been the subject of debates for their use in sports medicine, are
prohibited only when administered by certain routes (oral, intravenous,
intramuscular or rectal). A contrario
all other routes of application are permitted.
These categories require adjustments for
establishing an anti-doping rule violation compared to the standard regime, as the
finding of a violation calls for information beyond the mere detection of the
substance. Unless a distinctive trait for dosage or route of administration can
be identified directly during Sample analysis[10],
the information must be gathered during results management and generally
supposes explanations from Athletes regarding the causes that led to the
findings. In particular, for these types of substances, the 2015 Code:
§ Applies a different burden of proof. Whereas the burden is on the Athlete to show that the criteria for a
TUE are realised (see above), or to demonstrate the origins of the analytical
findings to obtain a reduced sanction (WADC 10), for S.3 and S.9 substances
proving dosage and/or route of administration is part of the requirements for a
violation. A specific allocation of the burden to the Athlete is only provided
in the Prohibited List for findings of Salbutamol and Formoterol above a
certain Threshold. In all other situations, it ought to be sufficient for the
Athlete to present credible explanations (e.g.
listing the substance on the Doping Control form[11]) that the Prohibited Substance originated from an authorised Use. The
burden of proof ought then to be on the ADO to convince the hearing panel to a
comfortable satisfaction (WADC 3.1) that a prohibited Use occurred.
§ Prefers short-cut procedures and transparency. The International Standard for Laboratories (“ISL”) introduces the
“Presumptive Adverse Analytical Finding” to promote procedural economy by
allowing a laboratory to enquire with the Testing Authority whether a TUE
exists prior to the confirmation step of the A Sample for a S.3 or S.9 class
substance (normally the presence of a TUE is determined after report of the
Adverse Analytical Finding, during the initial review by the ADO). The revised 2015 regime maintains
this pragmatic solution, but seeks to foster transparency in order to avoid
this short cut from being abused by ADOs to stop cases from going forward. The
2015 ISL makes it explicit that any such communication and its outcome must be
documented and provided to WADA (ISL 5.2.4.3.1.1)[12].
2. Sanctions for Legitimate Medical Treatment without a TUE
An Athlete who is undergoing legitimate medical
treatment that involves a Prohibited Substance, but does not have a TUE might –
if tested – return an Adverse Analytical Finding. As mentioned above, an
anti-doping violation cannot be invalidated for reasons of legitimate medical
treatment, save in exceptional circumstances where the system allows for a
retroactive TUE or for authorized Use of S.3 & S.9 class substances. Thus,
Athletes will typically first turn to the options in the sanctioning regime to
reduce or eliminate the sanction for Fault-related reasons. The success of this
effort varies considerably from case-to-case, with no clear pattern emerging in
the CAS jurisprudence.
The 2015 WADC
has not improved the clarity of the situation for violations involving
legitimate medical treatment, unless contamination is involved. In the 2009
WADC, if Athletes were
“fortunate” enough to have inadvertently Used a Specified Substance then the
Panel had the flexibility to settle on a sanction ranging from a reprimand and
no period of Ineligibility, up to a two-year period of Ineligibility; if the
Prohibited Substance was non-Specified, the shortest period of Ineligibility
available was one year. This raises questions of fairness, since violations
under similar factual circumstances, and with similar levels of fault are
punished with very different sanctions.[13] The 2015 WADC remedied this
disparate treatment when the violation involves a Contaminated
Product.[14] No analogous exception to receive a facilitated reduction in the
case of legitimate medical treatment is available, even though similar policy
arguments could also be lodged in this context.
Before Athletes can seek to establish a
Fault-related reduction, newly under the 2015 WADC they must first avoid a
finding that the violation was committed “intentionally”. This prospect poses
interpretational issues for medications[15]. According to the definition in WADC
10.2.3, “the term ‘intentional’ is meant to identify those Athletes who cheat.”
However, the core of the definition defines “intentional” conduct as
encompassing both knowing and reckless behaviour[16]. Since the violations considered in
this post involve the knowing administration of a medication, it can be
expected that Athletes will rely on the reference to “cheating” to argue that
their conduct falls outside of this definition[17]. If they were to succeed with this
line of argumentation before hearing panels, then their basic sanction starts
at a two-year period of Ineligibility that is subject to further reduction for
Fault-related reasons[18]. If they
were to fail, they face
a strict four-year period of Ineligibility, which would
inevitably raise proportionality concerns for this type of violation.
The Fault-related reductions in the 2015 WADC,
like those in the 2009 WADC, rest in an interpretive grey area for violations
arising from legitimate medical use. A sanction can be reduced for
Fault-related reasons if the Athlete can establish a factual scenario that is
accepted to reflect No Fault or Negligence, or No Significant Fault or
Negligence. On one hand, it is well-established that medications often contain
Prohibited Substances, thus panels expect a high-level of diligence from an
Athlete to avoid a violation arising from medications. Thus, these types of
violations often are committed with a high level of negligence at least
bordering on “significant” and at times approaching “reckless”[19]. As to the level of Fault, CAS
panels are not consistent. One CAS panel found that a legitimate medical Use of
a Prohibited Substance that could have been (and eventually was) excused by a
TUE can implicate only a low-level of Fault[20], whereas others have come to the
opposite conclusion, holding that the (alleged) “legitimate therapeutic use” of
a medication was “irrelevant”, and contributed to the Athlete’s significant
level of Fault[21]. In light of these different
characterisations, it is difficult to predict how a panel would sanction these
violations under the 2015 Code.
Conclusion – Remember
Health Considerations behind Anti-Doping
Athletes do not have it easy when it comes to
reconciling necessary medical treatment with high-level competition in sport.
The conditions for claiming the right to compete despite Use of a Prohibited
Substance or Method are stringent, and the procedure at times burdensome. There
is no doubt that the system must strictly monitor any possible abuse of medical
treatment as a cover up for doping attempts. Nevertheless, this system should
not escalate into penalising Athletes who had a legitimate need for treatment
and resorted in good faith to such treatment, especially since in many cases
the performance-enhancing effects of the Use of a Prohibited Substance or
Method are hypothetical at most.
The current system requires considerable
Athlete transparency in matters related to their health. The TUE process is not
the only context in which Athletes may have to reveal information about medical
conditions and/or ongoing treatment for these conditions. Apart from the
disclosure of medication and blood transfusion that Athletes are required to
make on the Doping Control form, the anti-doping proceedings themselves may
bring to light information about medical conditions affecting the Athlete. This
may occur either because the Athlete is bound to reveal information to build a
defence, or because the detection system itself may uncover collateral data
indicating a pathology – known or unknown to the Athlete[22].
In return for these expectations, the
anti-doping movement must keep in mind one of its key stated goals – the
protection of the Athlete’s health – when regulating matters implicating
legitimate medical treatment. This protection must include efforts to avoid the
Athlete inadvertently committing an anti-doping rule violation while under
therapeutic treatment, which may include more systematic labelling of
medication with explicit warnings. The attentiveness to the Athlete’s health,
however, could go beyond these efforts and exploit the data collected as part
of Doping Control also for the benefit of the Athlete. The current regime
already allows for suspected pathologies detected on the occasion of Doping
Control to be communicated to the Athlete on certain specific aspects[23]. As Athletes agree to disclose
large parts of their privacy for the sake of clean sport, it might be desirable
to explore paths through which clean sport might wish to pay these Athletes
back by providing them and their physicians with an additional source of data
on health matters, an aspect of Athlete’s lives that is always on the brink of
being endangered in elite sports.