[Cross-posted from DRUGINFO with thanks. WB]
Hi all
The EU list is at https://www.ema.europa.eu/en/documents/other/union-list-critical-medicines-version-1_en.xlsx, with the methodology for selection described at https://www.ema.europa.eu/en/documents/other/methodology-identify-critical-medicines-union-list-critical-medicines_en.pdf
The NDOH regularly updates its Master Health Product List - the 1 December 2023 version is at https://www.health.gov.za/wp-content/uploads/2023/12/Current-Master-Health-Product-List-1-Dec-2023-1.xlsx. It includes a “VEN” classification. Of the 1175 items on the current list (which include some non-EML items on tender), 359 are classified as “vital”, 651 as “essential” and 138 as “non-essential” (27 lines are classified as “N/A”). The comparison with the EU list is not simple, as the MHPL lists packs sizes, dosage forms and strengths separately.
The EU Q&A (at https://www.ema.europa.eu/en/documents/other/questions-and-answers-union-list-critical-medicines_en.pdf)) states " Inclusion in the list does not mean that the medicine is likely to experience a shortage in the near
future. It means that the prevention of shortages is particularly important as a shortage could cause serious harm to patients or present challenges to health systems. Critical medicines will be subject to an analysis of the supply chain and where vulnerabilities in supply chains are identified, the medicines will be prioritised for EU-wide actions to strengthen their supply chain and minimise the risk of supply disruptions." It commits to these actions: " The European medicines regulatory network will closely monitor the medicines on the list and implement measures to minimise the risk of supply disruptions by leveraging existing processes and structures as defined in the mandate of EMA’s Medicine Shortages Single Point of Contact (SPOC) Working Party and EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)."
At present SAHPRA has no specified mandate in this regard, nor is there an explicit policy with regard to the procurement of “V” items in the public sector (e.g. split tenders, higher stockholding or the creation of strategic reserves). The EU document, likewise, has this to say about the meaning of the list for other stakeholders such as wholesalers and distributors: “Any potential obligations for these stakeholders are yet to be defined.”
Regards
Andy