WADA - Guidelines on the Process for an Anti-Doping Organization to Opt Out of Automatic Recognition of TUEs

Page 1/4 ISTUE 2027 – Automatic Recognition Exemption Process ISTUE 2027 – Guidelines on the Process for an Anti-Doping Organization to Opt Out of Automatic Recognition of TUEs

1. Purpose and Objective

These guidelines establish the formal process and evidentiary requirements for an International Federation (IF), Major Event Organization (MEO), or other Anti -Doping Organization (ADO) seeking to opt out of the automatic recognition of Therapeutic Use Exemptions (TUEs) pursuant to ISTUE Article 7.2(b) and Code Article 4.4.

The overarching objective of this process is to: • Safeguard harmonization under the World Anti -Doping Code and the International Standard for Therapeutic Use Exemptions (ISTUE); • Ensure that any departure from automatic recognition preserves trust, quality, and consistency across jurisdictions; and • Maintain the highest level of medical, procedural, and ethical integrity in TUE decision-making.

Opting out of automatic recognition is considered an exception to the principle of harmonization and must therefore be justified by clear, objective, and proportionate grounds. At the outset, WADA emphasizes the discretionary nature of granting an exemption to automatic recognition under ISTUE Article 7.2(b). The following guidelines are therefore indicative only and do not constitute a set of mandatory rules; WADA reserves its right to consider any element not mentioned in the guidelines.

2. Formal Request Requirement

2.1 Submission

An ADO wishing to opt out of automatic recognition must submit a formal written request to WADA.

The request must: • Be signed by an appropriate authorized official; • Clearly specify whether the opt-out applies: o Generally (i.e., all substances and methods), or o Selectively (i.e., limited to specific substances or ADOs); • Include all necessary supporting documentation.Page 2/4 ISTUE 2027 – Automatic Recognition Exemption Process

2.2 Processing Period

o Generally (i.e., all substances and methods), or o Selectively (i.e., limited to specific substances or ADOs); • Include all necessary supporting documentation.Page 2/4 ISTUE 2027 – Automatic Recognition Exemption Process 2.2 Processing Period

An ADO must submit its request as soon as possible to allow WADA sufficient time to review it and ask for additional information, if necessary. In any event, it is unlikely that WADA will be able to render its decision in time if the request is received by WADA less than six (6) weeks prior to the date on which the ADO expects an answer.

3. Substantive Justification Requirements

Given that automatic recognition is a cornerstone of harmonization, the burden rests on the requesting ADO to demonstrate that opting out is: • Operationally justified, • Procedurally sound, and • Proportionate to the identified risk.

The submission must include objective evidence addressing the following key elements.

3.1 Demonstration of a Highly Functional TUE System

The ADO must provide evidence that it operates a robust and compliant TUE system consistent with the Code and ISTUE.

This may include: • A detailed description of the TUE Committee (TUEC) composition, including medical specialties and expertise; • Conflicts of interest and confidentiality declarations signed by TUEC members; • Internal workflow once a TUE application is received; • Quality assurance mechanisms (e.g., WADA audit , internal audits, peer review, periodic case analysis).

3.2 Demonstration of Capacity and Timeliness

The ADO should provide objective data evidencing its ability to review and process TUEs (including recognition reviews) in a timely manner.

This may include: • Details on the application process; • Evidence that urgent or competition-related requests were handled within appropriate timeframes; • Data demonstrating that previous recognition applications were handled without undue delay; • Evidence of sufficient administrative and medical staffing to handle increased workload.

This may include: • Details on the application process; • Evidence that urgent or competition-related requests were handled within appropriate timeframes; • Data demonstrating that previous recognition applications were handled without undue delay; • Evidence of sufficient administrative and medical staffing to handle increased workload.

Where available, anonymized case statistics should be included to substantiate performance claims.

3.3 Clearly Documented and Athlete-Centered Process

The ADO must demonstrate that it will mitigate as much as possible any additional burden on athletes created by opting out from automatic recognition.Page 3/4 ISTUE 2027 – Automatic Recognition Exemption Process

The submission should include: • A clearly documented workflow outlining the: o Communication timelines, and o Appeals process. • Evidence that administrative requirements are streamlined and easily accessible for athletes on the ADO’s website; • Details of how the ADO identifies Athletes requiring TUE recognition: o How does the ADO define who is an International Level Athlete; o How does the ADO ensure Athletes and other ADOs are aware and understand this definition; o What processes are in place to identify TUEs in ADAMS requiring recognition.

WADA will assess whether the proposed system preserves procedural fairness and minimizes athlete burden while maintaining medical rigor.

4. Justification for the Scope of Opt-Out

If the ADO seeks to opt out only for specific substances, classes, or specific ADOs, it must provide a clear, risk-based justification.

Acceptable grounds may include (without limitation): • Evidence of high-risk substances within that specific sport; • Documented patterns of misuse or abuse within the sport; • Medical complexity associated with certain substances requiring additional scrutiny; • Demonstrated history of incomplete or insufficient documentation for particular substances; • Evidence that TUEs for these substances regularly require additional clarification beyond standard documentation. If a specific ADO is selected , then a detailed reasoning with anonymized examples cases should be provided.

The ADO should explain why automatic recognition is insufficient to manage the identified risk and why

• Evidence that TUEs for these substances regularly require additional clarification beyond standard documentation. If a specific ADO is selected , then a detailed reasoning with anonymized examples cases should be provided.

The ADO should explain why automatic recognition is insufficient to manage the identified risk and why additional review is necessary and proportionate.

A general or speculative concern will not suffice.

5. WADA Review and Determination

Upon receipt of a complete submission, WADA will: • Conduct a substantive review of the documentation; • Assess compliance with Code and ISTUE principles; • Evaluate the proportionality and operational impact of the proposed opt-out; • Where necessary, request additional clarification or supporting evidence.

WADA may: • Approve the request; • Approve the request subject to conditions or limitations; • Reject the request with written justification; • Approval, where granted, may be time-limited and subject to periodic review.Page 4/4 ISTUE 2027 – Automatic Recognition Exemption Process

6. Monitoring and Reassessment

WADA may reassess the authorization if: • Timeliness standards deteriorate, • Inconsistencies arise, • The opt-out creates disproportionate athlete burden, • WADA reserves the right to revoke approval if the justification no longer remains valid.

7. Publication

Approved exemptions and scope are made public on WADA’s website to ensure transparency for all stakeholders.

8. Duration

Exemptions may be time-limited and are subject to review based on compliance of the ADO’s TUE system.

• Functional TUE System - Capacity &

Timeliness -Athlete Centered Process -Defined Scope & Risk Basis Send justification dossier via medical@wadaama.org

• Operational

Justification

• Procedural

Robustness

• Proportionality

Approved Not Approved

• Update

Website -Revise TUE Documentation

• Stakeholder

Communication

& Risk Basis Send justification dossier via medical@wadaama.org

• Operational

Justification

• Procedural

Robustness

• Proportionality

Approved Not Approved

• Update

Website -Revise TUE Documentation

• Stakeholder

Communication Prepare Justification Dossier

STEP 1 STEP 2 STEP 3 STEP 4 STEP 5

Submit Application to WADA

WADA Substantive Assessment

Decision Issued

Implementation (If approved)

ADO Opt-Out from Automatic Recognition