Question NW3732 to the Minister of Health

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28 October 2022 - NW3732

Profile picture: Hlengwa, Ms MD

Hlengwa, Ms MD to ask the Minister of Health

Whether, considering that contraceptives is the most common medicine that was out of stock at public healthcare facilities in 2022, which may be catastrophic for some of the most vulnerable women in the Republic, and noting that the Stop Stockouts Project (SSP) acknowledges the significant efforts of his department to address such stockouts of all medicines (details furnished), his department has considered the recommendations of the SSP (details furnished); if not, (a) why not and (b) what alternatives have been considered to address the negative impacts of the specified stockouts; if so, what are the relevant details?

Reply:

The National Department of Health (NDOH) welcomes the initiative by SSP to investigate stockouts in the provinces and has considered the recommendations made in the SSP report. It should be noted that the overall medicine availability has improved significantly over the years, since 2014. In any supply chain, supply challenges do arise from time to time.

In the April to June 2022 period, the reporting period of the SSP report, contracted suppliers reported challenges impacting on the supply for some contraceptives. These challenges included Active Pharmaceutical Ingredient (API) shortages, production delays and quality control issues which affected the manufacture of both tablets and implants. Additionally, the contract for the implants was ceded from one supplier to another, which resulted in interruptions in supply until the process was complete.

The NDOH continuously engages the suppliers to identify any possible supply challenges, to adjust the demand forecast (where necessary) and to work together to mitigate the risks. Furthermore, the NDOH established a decision-making forum where all provinces are represented; to identify interventions aimed at addressing any medicine supply challenges, to improve medicine availability and to reduce the potential impact of stock outs.

Where supply constraints are identified, the NDOH works with the provinces to identify and implement interventions to minimize stock outs and impact on patients. These interventions are informed by the cause of the supply challenge:

• Where the supply constraint is due to operational matters e.g., machine breakdown, labor unrest, theft, post importation testing, etc. the NDOH would source products from alternative local suppliers with registered products using the quotation process.

• Should the supply constraint result in a longer term supply challenge, such as regulatory matters including amendments to the dossier that requires approval from South African Health Products Regulatory Authority (SAHPRA), including a change/addition of an active pharmaceutical ingredient source and/or manufacturing site, the transfer of ownership of dossiers which results in a change of marketing authorization, delays in the issuing of the permits for imported medicines, manufactured products requiring additional quality checks by SAHPRA, etc. and no alternative local suppliers with registered products are available; an application would be made to SAHPRA for the acquisition of unregistered medicines for human use in South Africa Act use in terms of Section 21 of the Medicines and Related Substances Act. For example, when the Medroxyprogesterone injection was unavailable, Section 21 was sourced to minimize impact on patients.

Since the publication of the report, the supply of all contraceptives has stabilized and the NDOH is not aware of any supply constraints for contraceptives at present. The overall medicine availability indicates that there is sufficient stock to meet the patient demand and is currently at 90.5%.

END.

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