Report 9 September 2014

2 fields, 1 goal: Protecting the integrity of science and sport

By IFPMA
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The purpose of this booklet is to provide practical guidance for identifying pipeline compounds with a potential for sports-related abuse and for sharing this information with the World Anti-Doping Agency (WADA).

The advice provided in this booklet represents current best practices and has been agreed with WADA. This includes template documents for Confidentiality Agreements and a Memorandum of Understanding to facilitate interactions between companies and WADA, which are based on several years of experience in collaboration between WADA and industry.

This booklet also applies to compounds that fail to complete all drug development stages, and do not achieve commercial viability, since these fall into a less well-controlled “grey zone.” While compounds that complete all stages of development
and are granted marketing authorization are highly visible, well documented, and
well regulated, experience has shown that those for which development is
discontinued may provide substantial doping abuse potential while having low
visibility and less control and oversight. Such compounds are particularly attractive
to “high-profile abusers” because they are thought to be unknown, hence
undetectable, and are likely to be part of a tailor-made doping regimen, thus
conferring significant competitive advantage.

To optimize the chances of adoption and implementation, any procedure developed
by a company should provide a balance between theoretical stringency and the day-to-day realities of the work in both WADA and the biotechnology and pharmaceutical
industries. Thus, the intention is to provide a simple, intuitive and transparent
process that:

  • Optimizes effectiveness and efficiency
  • Avoids undue workload
  • Protects proprietary information
  • Ensures that time, effort and resources are focused on compounds with genuine abuse potential as opposed to hypothetical “noise”
  • Avoids creation of a standalone bureaucracy.

About IFPMA

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) represents over 90 innovative pharmaceutical companies and associations around the world. Our industry’s almost three million employees discover, develop, and deliver medicines and vaccines that advance global health. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community improve the lives of people everywhere. For more information, visit ifpma.org.

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Elliot Dunster
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