Global pharma health fund

Combat counterfeit medicines by providing and further developing the mobile GPHF Minilab. ,Support the development of simple screening tests for ongoing and new drug quality verification and monitoring projects. ,Support the development of multilingual manuals and training. ,Support the supply of Minilab kits at low cost. ,Collect data from Minilab users for reporting. ,

Interpol estimates that up to 30% of all medicines in developing countries are either illegal, counterfeit or of inferior quality.

Proliferation of counterfeit medicines constitutes a serious health hazard. No country is immune, but the most impacted are developing countries with weak medicines regulatory as well as weak law enforcement authorities and lacking adequate medicines testing capacities. Fake products can hardly be distinguished from genuine products merely by visual inspection.

To prevent counterfeit and substandard anti-infective medicines infiltrating drug supply organizations and priority disease programs in Malaria, TB and HIV/AIDS endemic countries, the Global Pharma Health Fund (GPHF), a charitable organisation maintained by Merck, set out to develop and supply at low cost the GPHF-Minilab, a mini-laboratory employing a set of chemical and physical tests for rapid drug quality verification and counterfeit medicines detection in low-income settings of developing countries.

GPHF-Minilabs can instantly help boost medicines testing capacities in developing countries. Currently, 85 active ingredients and essential medicines for a plethora of finished drug products can be verified on the spot to see whether they lack the purported drug compound or have considerably low concentrations of active ingredients. Drugs have been selected on the basis of prevailing prescription practices, public health interest and counterfeit case reports. The current short list consists of common antimicrobials, anthelminthics, antiretrovirals, antimalarials, antituberculosis treatments and other drugs, for example cardiovascular and antidiabetic medicines. Minilabs contain a full set of lab ware, reagents and reference standards. A particular challenge is the provision of manuals with simple test protocols in different languages. Tests may even be performed outside a laboratory environment and do not need to be carried out by a fully qualified pharmacist or chemist. Required is simply a person with analytical chemistry understanding such as a medical or pharmaceutical technician. Training is not necessarily required but may refresh laboratory skills and build confidence in assay reading. In 2016, GPHF alone or together with partners offered training courses in Kenya, Zambia, Rwanda and Mozambique.

Rolling out Minilabs on global scale for post-marketing drug quality surveillance requires intensive networking. Cooperation with local health authorities is a prerequisite for success. Minilabs are fit for screening but cannot replace further forensic testing on failed samples identified. Funding agents want to see the establishment of a reliable logistic chain for a sustainable global material supply and knowledge transfer before investing and supporting. So far, major support has come from United Nation family members (UNICEF, UNODC, WHO, RBM), the Global Fund (AMFm), the U.S. (USAID, USP/PQM, MSH/PFSCM) and Great Britain (UKAID, MeTA, PATHS2). Other support has come from Switzerland (SCIH), Germany (BMZ,GIZ, PTB) and some faith-based organisations.

Recently, the GPHF is provided with contact information of the Pharmaceutical Security Institute (PSI) asking the GPHF users to provide feedback on sample testing.

Since its introduction in 1999, more than 800 Minilabs have been supplied at low cost to health facilities in more than 90 countries across all continents. In recent years, joint drug quality monitoring projects in Southeast Asia and Africa triggered the seizure of millions of counterfeit antimalarial pills containing no active ingredients by Interpol, the World Customs Organization and national enforcement bodies. Data generated by the programme have also prompted WHO global drug alerts. Thus, thousands of lives were saved.

The method inventory of the GPHF-Minilab is constantly reviewed and extended to cover more active ingredients and to keep up with new challenges caused by changing therapeutic regimes such as the shift from single to fixed-dose combination antimalarials.