16 March 2018

WADA update regarding Berlinger security bottles

Following our media release of 9 March, the World Anti-Doping Agency (WADA) is now in a position to provide fresh information to stakeholders intended to maintain the integrity of global doping control programs, after Berlinger Special AG announced last week its decision to halt production of its human doping control kits and its intention to withdraw from the market.

The update is as follows:

  • Berlinger has between three-six months of stock available.
  • To date, WADA has received no reports of cracked Berlinger bottles following freezing from any accredited laboratory, Anti-Doping Organization (ADO) or sample collection provider.
  • WADA is actively exploring alternative sources of sample collection kits, in collaboration with the Institute of National Anti-Doping Organizations (iNADO) and a number of ADOs.
  • To that end, a meeting took place on 7 March with an existing doping control kit manufacturer, Versapak, which is developing a new urine kit. At the meeting, Versapak presented a prototype to some ADOs, a WADA-accredited laboratory, a number of Doping Control Officers and WADA. Versapak received feedback on the prototype, which they are now addressing and preparing for production in April 2018. More information is available on Versapak’s website.
  • WADA has also had preliminary discussions with three other organizations which are at various stages of development of new sample collection equipment:
  1. Secure Doping Control, which has been developed in partnership between the US Anti-Doping Agency and Major League Baseball. More information is available here
  2. LOCKCON, represented by Roger Sabat and Monika Egli. More information is available here.
  3. Prof. Arne Ljungqvist’s Anti-Doping Foundation. More information is available here.
  • Some of these four companies and organizations will be present at the WADA Symposium in Lausanne on 21-23 March and ADOs should feel free to contact them to further discuss their products and timing of production.
  • A specific topic on this issue has been added to the agenda of day two of the WADA Symposium on 22 March in Lausanne to provide a further update.
  • WADA will continue gathering information from all interested parties including other potential manufacturers in order to propose solutions that will maintain the integrity of the doping control process.

Useful background information:

On 19 January, WADA was informed by the WADA-accredited laboratory in Cologne, Germany, that security bottles of the new generation ‘BEREG-KIT Geneva’, introduced in September 2017 by Berlinger, may potentially be susceptible to manual opening without evidence.

Upon being informed of this potential integrity issue by the Cologne laboratory, WADA immediately launched an inquiry and reached out to the laboratory and Berlinger to ascertain the facts.

On 27 January, WADA announced that preliminary results of the inquiry into the issue would soon be available and recommended to ADOs and laboratories appropriate measures required to maintain the integrity of the doping control process. WADA continued to follow up with the manufacturer to clarify the testing protocols and results as they became available.

On 31 January, WADA announced that its inquiry had confirmed that a proportion of the ‘BEREG-KIT Geneva’ security bottles were susceptible to manual opening without evidence of tampering (whether they have been frozen or not – initially it had been thought that only frozen bottles were susceptible to opening without evidence). At that point, WADA recommended to the International Olympic Committee (IOC) that, for the Winter Games in PyeongChang, it continue to use the earlier model BEREG-KIT, which was first released in 2016 and which reported no such issues as observed in the ‘Geneva’ model.

At that time, WADA also wrote to all ADOs and WADA-accredited laboratories around the world to update them on the latest situation and recommended that they, too, should continue to use the 2016 model of bottle, of which Berlinger agreed to restart production.

On 2 March, WADA was advised by Berlinger that feedback from one of its customers had raised fresh concerns over the integrity of some of its bottles and that it had initiated an examination. Specifically, the customer reported that a limited number of bottles had cracked when frozen. This cracking was noticed mainly in the discontinued ‘BEREG-KIT Geneva’ model and, to a much lesser extent, in the latest batch of the ‘BEREG-KIT’ model.

WADA immediately sought to collect more information from Berlinger as to the specifics and scale of the alleged integrity issues in order to ensure an effective and quick solution was developed by Berlinger for its clients that served the global anti-doping program. With the same intention, WADA also reached out to a sampling of the accredited laboratories and the Institute of National Anti-Doping Organizations (iNADO) to determine whether the laboratories or National Anti-Doping Organizations had experienced any such incidences. None had.

On 7 March, in an effort to identify new suppliers, representatives from WADA and a number of ADOs, met with existing doping control kit manufacturer Versapak to learn more about a new kit that the company is planning to introduce.

On 9 March, Berlinger announced it was withdrawing from the doping control business. WADA immediately issued a statement noting Berlinger’s decision and WADA also issued an advisory to all ADOs, labs and sample collection agencies, including the International Olympic Committee and the International Paralympic Committee, on the latest state of play along with instructions on how to proceed.

At every stage, it was made clear that Berlinger, along with other manufacturers of security bottles, are responsible for the development, testing, distribution and monitoring of the equipment they produce and provide to their clients. It is up to each ADO to decide which sample collection equipment they use provided they meet the requirements of Article 6.3.4 of the International Standard for Testing and Investigations (ISTI). The ISTI, along with other WADA International Standards, will undergo a revision through stakeholder consultation starting in June this year, in parallel to the ongoing revision of the World Anti-Doping Code.