or method included on the Prohibited List, WADA must consider
whether the substance or method is performance enhancing and/or
harmful and/or whether its use is contrary to the spirit of sport, alter-
natively, whether it could mask the use of a prohibited substance or
method. But the Code does not confer on WADA a discretion to
determine which substance or method WADA deems performance
enhancing or harmful.
The drafters of the Code sought to make the process of determining
which substances and/or methods should be included on the prohibit-
ed list, more transparent by providing objective standards according to
which the determination must be made. These standards are mostly
scientific. Both article 4.3.1.1 and article 4.3.1.2 require WADA to con-
sider scientific or medical evidence or pharmacological effect to deter-
mine whether a substance or method is or could be performance enhanc-
ing or harmful, as the case may be. This seems somewhat tautologous
as both medicine and pharmacology are also sciences and evidence on
these grounds would also constitute “scientific evidence”.
In other words, the Code imposes a duty on WADA to determine
whether there is medical or other scientific evidence, pharmacological
effect or experience which indicates that the substance or method is or
could be performance enhancing or harmful. Article 4.3 of the Code
therefore imposes on WADA a duty to make a determination in accor-
dance with the relevant evidence, rather than a discretionary compe-
tence to weigh the various factors and make up its own collective mind
on the matter.
There is an apparent problem with this formulation. Even though
we live in the golden age of science and we strive towards the discovery
of exact scientific conclusions through the application of proper scien-
tific method, medicine and pharmacology, like the law, are not certain
and precise. Scientific and medical evidence relating to the impact which
substances and methods have on the human body, are often inconclu-
sive and sometimes contradictory. There are innumerable variables that
could at different times and in different studies impact in various ways
on the eventual results. Vagelos and Galambos
explains this succinct-
ly when they recall
[m]edicine, I suddenly realised, is not an exact science. It could not
be learned and applied by rote, even from a body of knowledge as
comprehensive as Loeb’s. Once the disease was understood, the physi-
cian could treat the patient in a variety of ways, using similar drugs
and solutions on the basis of the blood sugar level, the amount of
dehydration, the concentration of certain salts in the patient’s blood,
and so forth. Harvard medicine was different from Columbia med-
icine in that it was more flexible and left more to be determined by
a thoughtful physician. It required more intellectual input. I was
free to think, to use my understanding of the basic disease process,
and to explore the ‘art’ of medicine.
Molzone
also explains that the interface between medicine and phar-
macology, where clinical trials are conducted to determine whether any
particular substance or method has a favourable effect, no effect or an
adverse effect, is equally uncertain. Most often, substances do not pro-
vide miraculous results. Their effects are often much more subtle and
often difficult to qualify and quantify. Substances may have various
effects on the human body by relieving symptoms, altering clinical meas-
urements and influencing physiological processes. Because of differ-
ences in physiological make-up, different people react differently to the
same substance. Furthermore, the reaction which an individual may
have towards a particular substance may also differ from time to time.
In addition, the so-called “placebo-effect” means that the ability of a
substance to enhance performance depends also on psychological fac-
tors, which in turn are affected by the socio-economic and cultural envi-
ronment.
Scientific and medical evidence, therefore, seemingly pro-
vides an inadequate standard for determining whether a substance or
method should be included on the Prohibited List.
The standard of pharmacological effect is no less problematic. The
pharmacological effect of a substance depends on various factors, includ-
ing the exact composition of the preparation or solution which contains
the substance, the mode of ingestion, genetic and biological variables,
as well as the medical history and history of drug use of an individual.
The amount of a substance which is ingested and the period over which
it is ingested, could also have an impact on the pharmacological effect.
For example, in small quantities below 60 micrograms ingested over a
short term, clanbuterol is a decongestant and bronchodilator. If you
increase the dosage somewhat and it is used over a longer period, clan-
buterol becomes a nonsteroidal anabolic and metabolic accelerator which
improves muscle protein synthesis. In doses above 120 micrograms, the
stimulating and thermogenic effects of clanbuterol often cause trem-
bling, headaches and dizziness. In addition, after prolonged use with-
out interruption, the pharmacological effect of clanbuterol dissipates
so that it eventually has no effect.
Because the science seems to be so uncertain, WADA would appar-
ently be hard-pressed to justify the inclusion of any substance or method
on the Prohibited List. It is arguably for this reason that the drafters of
the Code added an alternative standard for determining whether a sub-
stance or method meets the requirements in article 4.3.1.1 and/or arti-
cle 4.3.1.2. WADA may also rely on “experience” which shows that a
substance or method is or could be performance enhancing or harm-
ful. This is a misguided attempt at resolving the difficulties relating to
scientific, medical and pharmacological evidence. This alternative stan-
dard poses many questions: Whose experience is considered? How is
the experience established? How much or how little experience is
required? Etcetera. Molzone
warns that
[d]rawing a conclusion about whether a medication or other treat-
ment works based on anecdotes is logically flawed. The reason is that
there are numerous alternatives, other than the treatment, that could
explain anecdotal findings (these are called ‘confounding variables’).
If called upon to justify the inclusion of a substance or method on the
Prohibited List based on this standard, WADA would be even more
hard-pressed to find convincing arguments.
As a result, the way in which article 4.3 of the Code is drafted, it leaves
no discretion and demands that WADA make a determination based
on evidence, which could be medical, scientific, pharmacological or
anecdotal. This could expose WADA to attack and lead to challenges
of the Prohibited List. For instance, category S0 in the Prohibited List
refers to non-approved substances and provides:
Any pharmacological substance which is not addressed by any of the
subsequent sections of the List and with no current approval by any
governmental regulatory health authority for human therapeutic use
(e.g drugs under pre-clinical or clinical development or discontin-
ued, designer drugs, veterinary medicines) is prohibited.
However, article 4.3 of the Code only allows WADA to consider “a sub-
stance or method” for inclusion on the list; Article 4.3 does not allow
WADA to list categories of substances or methods. As a result, the inclu-
sion of this blanket category is ultra vires. Furthermore, on what med-
ical or other scientific evidence, pharmacological effect or experience
could WADA possibly have relied to determine whether any particular
substance within this category should be included in the Prohibited List
when, at least at the time when WADA made its determination, it would
have been impossible to compile a comprehensive list of these substances?
As a result, WADA did not adhere to Article 4.3 of the Code when it
included category S0 in the list of Prohibited Substances. Clearly, then,
the inclusion of category S0 in the Prohibited List would not survive
judicial scrutiny if it should be challenged in court.
3. Can the Prohibited List be Challenged?
It seems that WADA may have anticipated challenges to the Prohibited
List and sought to pre-empt any challenge by providing in article 4.3.3
that WADA’s determination that a substance or method should be
included on the Prohibited List cannot be challenged. However, this
4
2012/1-2
12 Medicine, Science and Merck (2004) 27.
13 In O’Donnel and Ahuja Drug Injury:
Liability, Ananlysis and Prevention (2005)
61.
14 Hanson, Venturelli and Fleckenstein
Drugs and Society 11 ed (2011) 1, 155.
15 Hanson, Venturelli and Fleckenstein
(2011) 1, 5, 155 et seq.
16 http://www.clenbuterol.net accessed on 6
May 2012. See also Kearns et al “Chronic
administration of therapeutic levels of
clenbuterol acts as a repartitioning agent”
2001 Journal of Applied Physiology 2064.