The technical assistance programme (TAP) will provide agencies in Ethiopia, Ghana, Kenya, Senegal and Sierra Leone with anything from reference standards to technical documents and training as USP spokesperson Laura Provan explained.
“Official medicines control groups in each country will decide what reference and documentary standards in the USP-NF best meet their needs. While we expect that drugs for infectious diseases such as malaria, TB, and HIV/AIDS, as well as antibiotics, will be frequently requested, USP will not limit access to standards.”
And, she continued, while Government agencies will be the main focus the USP may also work with any local contractors “if a government had contracted with an organization to help them in medicines quality control.”
The success of the 12-month pilot scheme will be assessed using metrics ranging from straightforward quality assessments and counterfeit detection levels to more complex factors like improved access to medicines.
The TAP is an expansion of the USP’s promoting the quality of medicines programme (PQM), which is focused on the identification and removal of substandard and counterfeit medicines from various markets worldwide.
The PQM is already established in four of the five countries covered by the TAP, which was an important factor in choosing to launch the programme in this region according to Provan.
“We felt that in a pilot program it would be best to work with people and organizations who were familiar with USP and our local staff,” she explained, adding that regulators in the one non PQM country, Sierra Leone, had asked to take part.
And, she continued, if TAP is successful the USP may launch the scheme elsewhere in 2011, adding that: “The USP is already in discussions with Egypt, India, and several of the less developed ASEAN countries.”
TAP into emerging markets
In addition to its obvious benefits for public health, the TAP pilot is also likely to benefit USP as it will further establish the organisation as the leading pharmaceutical quality and standards body, particularly in increasingly important new markets as Provan explained.
“More than half our sales of standards come from outside the US and most of that is from countries like India and China that are the pre-eminent suppliers of drugs and ingredients to emerging markets. “