Will my patient have to apply for therapeutic use exemption?
If possible, the simplest solution for the doctor as well as the athlete is to change the treatment so that the patient will not have to use a medication that contains substances on the Prohibited List. If this approach is impossible, it will be necessary to apply for therapeutic use exemption. The application must be completed by the athlete and the doctor, and should be sent to Anti-Doping Norway, or the relevant international sports federation, for assessment by a specialist medical committee (
Box 1 For an athlete to be authorised to use a medication that contains substances on the Prohibited List, the following criteria must be met (5):
a) The athlete has a clear diagnosed medical condition which requires treatment using a prohibited substance or method.
b) The therapeutic use of the substance will not, on the balance of probabilities produce significant enhancement of performance beyond the athlete's normal state of health.
c) The prohibited substance or method is an indicated treatment for the medical condition, and there is no reasonable permitted therapeutic alternative.
d) The necessity to use that substance or method is not a consequence of the prior unauthorized use of a substance or method which was prohibited at the time of use.
If one of these criteria is not met, the medication cannot generally be approved for use in sports.
If the anti-doping regulations apply to the patient, it is necessary to establish whether the medication the patient needs contains substances on the Prohibited List. If the relevant medication is registered in Norway, this information is easy to access by searching for it in the Norwegian Pharmaceutical Product Compendium or on Anti-Doping Norway's website.
Colour-coded silhouette labels (Figure 1) alert users of the Norwegian Pharmaceutical Product Compendium to whether there are doping issues associated with specific medications.
Figure 1 A green silhouette means that the medication is permitted without any restrictions, an amber silhouette means that the medication is prohibited with certain exceptions, while a red silhouette means that the medication contains substances on the Prohibited List. Figure: Anti-Doping Norway/the Norwegian Pharmaceutical Product Compendium
Anti-Doping Norway's Medical Committee is made up of specialists in a range of fields, currently endocrinology, psychiatry, pulmonary medicine, paediatrics and sports medicine. Non-conflicting interests and independence are important qualities for Anti-Doping Norway, which is why no committee member holds a high-ranking position in any Norwegian sport. The most important argument for approval in assessments of therapeutic use exemption applications is that the four above criteria are fulfilled. Judgement is applied in each individual case, but the level of discretion is restricted by the World Anti-Doping Agency's regulations and guidance
The athlete's competing level determines when and where they need to apply for a therapeutic use exemption. If the patient is defined as an elite athlete who competes at national
(6) or international level, it is a requirement that an application is submitted as soon as a diagnosis has been made. If the patient is not defined as an elite athlete who competes at international or national level, an application for therapeutic use exemption can be submitted after a positive doping test, i.e. so-called retroactive exemption, when asked to do so by Anti-Doping Norway (7). However, all athletes must ensure that the criteria for exemption are fulfilled, whether applications are submitted prospectively or retroactively. Most Norwegian athletes can have their application assessed by Anti-Doping Norway, but some elite sports people will need to have their application assessed by international sports federations or other international bodies (such as the International Olympic Committee). In principle, decisions made by Anti-Doping Norway should be recognised by the international sports federations, but such recognition is not automatic. The various sports federations follow different rules in this respect, and the current regulations must be clarified on a case-by-case basis – with assistance from Anti-Doping Norway if required. All rulings are time-limited (7).