WADA issues updated Stakeholder guidance regarding Meldonium

important:  this notice is no longer valid. Updated guidance on reporting of meldonium was approved by the WADA Executive Committee on 17 May 2017, as part of the technical document TD2017MRPL.

• Further to results of additional urinary excretion studies for meldonium, WADA issued updated Stakeholder guidance regarding Results Management and Adjudication of meldonium cases.
• The guidance is for cases where athletes claim that the substance was taken before 1 January 2016; and, is determined by the Urine Collection Date and Urinary Concentration of meldonium found in an athlete’s sample.

On 30 June, the World Anti-Doping Agency (WADA) issued updated guidance regarding the prohibited substance meldonium to stakeholders that are primarily signatories to the World Anti-Doping Code (Code).

On 13 April 2016, WADA had issued a preliminary Notice providing guidance as to how organizations should manage meldonium cases within their respective jurisdictions. The Notice served to assist Stakeholders with the Results Management and Adjudication of meldonium cases until additional commissioned urinary excretionary studies relating to meldonium had been conducted by WADA-accredited laboratories.

Last week, WADA received study results, which enabled the Agency to provide updated guidance to organizations managing cases where athletes claim that the substance was taken before 1 January 2016. The guidance is determined by the Urine Collection Date and the Urinary Concentration of Meldonium found in an athlete’s sample.

This updated guidance confirms that from 1 March (and up until 30 September) 2016, cases with a low concentration of meldonium found in an athlete’s sample (less than 1 ?g /mL) are compatible with a no fault finding. Other cases are to be managed according to guidance by the responsible anti-doping organizations (ADOs).

The List Committee decided that meldonium needed to be added to the 2016 Prohibited List (List) based on evidence of clear abuse of the substance while it was on the List’s 2015 Monitoring Program. Typically, WADA does not commission excretion studies for substances that are added to the List as the Agency is generally able to rely on this information being provided by the manufacturer or regulatory authorities. In the case of meldonium, however, no information relating to urinary excretion was available and so once it was added to the List, WADA undertook excretion studies.  

“We are pleased that the necessary urinary excretion studies have now progressed; and that, the guidance we are now able to provide our stakeholders to help them manage meldonium cases is clear and scientifically robust,” said WADA President, Sir Craig Reedie.

 “The addition of meldonium to the Prohibited List created an unprecedented situation and therefore, during a transitional period, it warranted additional guidance for those in the anti-doping community tasked with managing cases,” said Oliver Niggli, Director General. “We place full trust in the ability of our Stakeholders to manage meldonium cases effectively, and will be on hand to assist them as necessary.”