Stop TB Partnership

Statement on the global supply of Hain Lifescience GenoType line probe assays and equipment

Geneva, 4th of April 2019.

The Stop TB Partnership’s Global Drug Facility (GDF) would like to alert countries and their partners of significant delays in the supply of GenoType MTBDRplus and MTBDRsl line probe assays and equipment manufactured by Hain Lifescience GmbH (Nehren, Germany).

Following the acquisition of a majority interest in the company by the Bruker Corporation (Billerica, USA) in October 2018, Hain Lifescience must follow lengthier export control processes in line with US, German and European regulations. To comply with applicable regulations, Hain-Bruker reviews the export control processes on a case-by-case basis, depending on the country and end-user.

This new process has resulted in significant delays: on average, orders for Hain Lifescience supplies are facing an additional 1-3 month delay in delivery. In exceptional cases, delivery of supplies has been delayed indefinitely. Please note, Hain Lifescience is unable to supply to countries currently under US embargo:

  • Cuba
  • Democratic People’s Republic of Korea
  • Sudan
  • Syria

The Stop TB Partnership is working closely with Hain Lifescience to resolve the situation as soon as possible and to provide greater visibility to countries on delivery timelines. In the meantime, countries are advised to submit orders to GDF as early as possible to help mitigate the risk of potential stock-outs as well as delays in implementation of drug-resistant TB treatment scale-up plans.

For more information, please contact gdf@stoptb.org.

ISO

GDF is ISO 9001:2015 certified for the provision of quality assured anti-TB drugs and related services to eligible national TB control programmes.