Question NW4054 to the Minister of Health

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25 November 2022 - NW4054

Profile picture: Ismail, Ms H

Ismail, Ms H to ask the Minister of Health

By what date will the critical shortages of (a) contraceptives and (b) 1 500 other essential medicine supplies, including dosages of Metformin, Betagesic, Nepamol, Ponstan paediatric suppositories and pain patches and/or options to treat severe pain, be addressed as the shortages are putting persons’ lives at risk?

Reply:

a) The supply constraints related to contraceptives have been resolved. Currently, there are no challenges related to the availability of contraceptives. As on 04 November 2022, availability of contraceptives across all facilities in the public sector was 91.3%.

b) It is the Departments of Health’s policy to ensure equitable access to quality healthcare through availability of safe, effective and cost-effective medicines at the appropriate level of care. The National Department of Health manages contracts of approximately 1 200 essential medicine items. Contracts are awarded to suppliers (manufacturers) following an open tender process in accordance with the Public Finance Management Act. Provinces procure medicines directly from contacted suppliers. Note that the public sector services the healthcare needs of 84% of South Africa’s population.

The NDOH continuously engages with the contracted 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

With regard to:

  • Metformin – there were no supply challenges in the public sector.
  • Betagesic – i.e. ibuprofen. There were no supply challenges as contracts were awarded to four different suppliers to ensure security of supply of ibuprofen.
  • Napamol – i.e. paracetamol 500 mg tablets. There were no supply challenges as contracts were awarded to four different suppliers to ensure security of supply of paracetamol.
  • Ponstan – i.e. mefenamic acid. This medicine is not an essential medicines and therefore there is no contract for this item.

The availability of ibuprofen and paracetamol at facility level as on 04 November 2022 was 92% and of metformin, 91.2%.

The question from the Honourable Ismail is reflective of stock outs experienced in the private sector over which the Department has no control. Private sector services the healthcare needs of only 16% of South Africa’s population.

Private sector pharmacies procure medicines from wholesalers based on Single Exit Price. In this context, there is no aggregation of demand. Furthermore, availability is dependent on market forces based on supply and demand. The situation makes the private sector vulnerable to supply challenges.

However, with the implementation of National Health Insurance, in the context of one health system, these supply challenges will also be addressed.

 

END.

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