A national shortage of the bimonthly injectable contraceptive Nur-Isterate is now entering its second year. According to Bhekisisa, it first received reports about contraceptive shortages from women in January 2018. The Health Department alerted clinics about stockouts four months later in April. At the time, the country was also short of the birth control tablets Oralcon, Trigestrel and Famynor.
The civil society coalition Stop Stockouts Project found oral contraception is now back on clinic shelves. But health facilities in at least five provinces — Gauteng, Free State, KwaZulu-Natal, North West and Mpumalanga — are still out of the popular bi-monthly birth control shot Nur-Isterate.
The report says in South Africa, two types of injectable contraceptives are available in the public sector: Nur-Isterate and Depo-Provera. Both use hormones to stop women’s ovaries from releasing eggs each month and thus prevent them from becoming pregnant. To avert shortages, South Africa usually gets injectable contraceptives from three pharmaceutical companies: Bayer, Pfizer and Fresenius Kabi.
But, the report says, in October 2017, both Pfizer and Fresenius Kabi did not bid for the national tender for these drugs. To cut costs, Fresenius Kabi had pulled its version of Depo-Provera from the South African market but later agreed to manufacture the contraceptive until April 2018, Mikko Tiitinen, MD at the company’s local branch, says.
Pfizer – which had repeatedly vied for the country’s Depo-Provera contract and lost – also decided not to submit a bid, national health department director for affordable medicines Khadija Jamaloodien explains. “At the time, Pfizer was unable to meet the requirements for the tender,” the company’s communications manager, Charmaine Motloung, says.
Bayer is the only company registered to supply Nur-Isterate in South Africa. But tough price negotiations between the firm and national treasury delayed the finalisation of its contract to provide the country with the shot by five months, triggering national shortages, National Treasury is quoted in the report as saying. While negotiations with Treasury dragged on, Bayer’s production plant in Germany was forced to allocate machines that would usually churn out Nur-Isterate to other medicines, the report quotes the company’s spokesperson, Tasniem Patel as saying.
When it became clear the company’s German production plant would not be able to fill the backlog caused by the delayed contract, Patel says Bayer asked for special permission from the SA Health Products Regulatory Agency (Sahpra), to start importing the Nur-Isterate from its factory in Pakistan. Before then, only the plant in Germany had gone through safety checks by South Africa’s drug regulator, Sahpra.
According to the report, Patel says that although Bayer rushed to address Sahpra’s concerns, the company is still waiting for the regulator’s report on its latest inspection of its Pakistani plant.
The Health Department’s update to Klaas explains that once Sahpra gives the go-ahead, stockouts of these contraceptives will likely go back to normal in March.
The report says Sahpra did not respond to requests for comment.Bhekisisa report