South Africa's medicines regulator finds middle ground to authorise 'compassionate use' of ivermectin, whilst still stating that there is not yet sufficient evidence for full registration.
This afternoon Boitumelo Semete-Makokotlela, CEO of the South African Health Products Regulatory Authority (SAHPRA) announced that it would "facilitate a controlled compassionate access programme" to the drug ivermectin for use for patients with Covid-19.
"Very detailed guidelines of this programme" will be announced "in coming days" that would build in the principles that are used to inform and grant s21 authorisations under the Medicines Act and would be "open to all patients". A s21 authorisation is a mechanism used by SAHPRA for medicines that are not registered in South Africa, but which are known to be safe and efficacious and in use in other countries. In the past, how and when these authorisations have been granted has itself been a bone of contention, for example, overuse of generic drugs for cancer or HIV whose originals are excessively priced.
According to Semete-Makokotlela, applications would need to be made by health professionals so as to ensure they took responsibility for safety and monitor efficacy. "There's a large responsibility we are placing on health professionals," she said....