Johannesburg, 23rd June 2015
In response to the recent drug shortages being faced in the South African healthcare sector, the National Association of Pharmaceutical Manufacturers (NAPM) was able to use its international network to assist in increasing access to medicines, within three days of sending out a request through its international network.
Through its international connections the NAPM was exposed to a list of 13 of the medicines indicated by the National Department of Health that were proving difficult to source locally.
Using its position on the management committee of the International Generic Pharmaceutical Alliance (IGPA), the association sent out an appeal to its fellow associations and was able to identify sources of 50% of the needed medicines within three days. “We have notified the Department of Health on the availability of these specific medicines,” says NAPM – CEO Mr. Vivian Frittelli. One of the medicines is available from a local company which does not have a tender with the government.
The NAPM acknowledges the challenges the National Department of Health faces in accessing essential medicines including a shortage of the active pharmaceutical ingredients (API), which are not manufactured in South Africa; under-estimation of demand; long lead times for imported medicines; and limited local capacity among others.
With regard to the shortage of API, it often happens that an overseas supplier will cease manufacture due to decreased global demand or have technical problems. Over the past few years it has taken between one and two years for our local medicines regulatory authority to approve the registration of a second supplier.
The NAPM and its members believe that any effort to speed up both the pre and post registration procedures of medicines will lead to a dramatic increase in the availability and access to medicine. The MCC Secretariat have indicated that they will accept data from pre- qualified WHO sites for changes in API supply. The Associations believes that this should help to reduce the post- registration timelines.
“Access to safe medicines is vitally important for patients in South Africa. We have now for a long time promoted the idea of mutual recognition of regulatory processes from credible medicine regulatory authorities, which we believe will shorten the time to register medicines in our country, but uphold the principles of quality and safety, says Frittelli.