With the COVID-19 crisis hitting the global community very hard, the South African Health Products Regulatory Authority (SAHPRA) has provided some information and guidelines on how they plan to deal with medicines and medical devices supply challenges.
As we all know, in this time of complete service delivery disruption and problematic supply chain completion, knowing when and who to call, can make a huge difference in how we manage the situation.
Availability of medicines in South Africa has been the black sheep of the family at times, with limited or complete lack of access to healthcare an ongoing theme in our socio-economic context.
SAHPRA has come up with a plan to try and prevent this from happening in a time when it is of the utmost importance for medicines and medical devices to reach those that need them.
The plan from SAHPRA includes the following:
- They are in constant communication with manufacturers, wholesalers, pharmacists and other healthcare providers to identify and respond to medicine and/or medical device shortages that may arise as a result of the COVID-19 pandemic.
- Pharmaceutical and medical device manufacturers and suppliers for both public and private sectors are requested, in terms of section 19(2) of the Medicines and related Substances Act (Act 101 of 1965) as amended, to notify SAHPRA of any anticipated disruptions in supply, any shortages of products experienced, and any planned withdrawals of products from the market. The information requested is to be reported as soon as it comes to the attention of manufacturers or suppliers. This request for mandatory supply of information will remain in force until the notice is withdrawn by SAHPRA.
- SAHPRA is working with the National Department of Health (NDoH) and industry to actively monitor the potential impact of the COVID-19 pandemic and respond to any disruptions or shortages as the public health emergency develops.
- SAHPRA in collaboration with NDoH will make every effort to ensure the uninterrupted supply of medicines, medical devices, in vitro diagnostics and medical equipment, particularly those that will be used to manage COVID-19 as well as other priority diseases. Should any shortages come to light, SAHPRA and NDoH, in collaboration with Industry, will communicate these to the relevant health sector stakeholders soon as possible via the SAHPRA website, in terms of section 22B of the Act. SAHPRA will also ensure expedited review of variation applications, where needed.
- SAHPRA is also part of a collaborative network of regulators around the world who are communicating regularly to ensure availability of safe, efficacious and quality medicines and medical devices required to manage patients affected by COVID-19. Currently, there are no antiviral medicines or vaccines which have been approved globally for the prevention or treatment of COVID-19. However, a number of vaccines are under development and some medicines are currently being assessed in clinical trials for efficacy against COVID-19 infection. When a vaccine or medicine is developed to prevent or treat COVID-19, SAHPRA will take appropriate action to ensure availability.
- Measures include fast-tracking through the:
- Scientific review of new medicines or vaccines through a priority review process
- Special Access Program for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed or are unavailable
- Expedited review of clinical trials for new vaccines, new or repurposed antivirals, or supportive therapies
SAHPRA is also quite honest about their capacity during this pandemic in that they confirm the COVID-19 outbreak has resulted in travel restrictions that will affect their ability to perform Good Manufacturing Practice (GMP) inspections of overseas manufacturers.
They are however working to ensure that these restrictions have minimal impact on the licensing and supply of medicines and other health products without compromising the quality of these products. Given the critical nature of the current situation, SAHPRA is calling on the support of business and/or applicants to inform them of any medicine and medical device shortages directly through the following contact details:
Contact Dr Shyamli Munbodh via e-mail at: shortages@sahpra.org.za
The information provided to SAHPRA when reporting medicine or medical devices supply challenges should include:
- The name of the product and Registration number / reference number if applicable
- The manufacturer of medicines / medical device, or holder of certificate of registration/Applicant
- The name of the active ingredient/s
- API source manufacturer and country
- Current availability,
- Possible stock out date/period
This is one way to ensure there is no shortage of medicines and medical devices during this COVID-19 crisis and it is clear that SAHPRA’s proactive approach will prove vital in the coming weeks.