Healthcare workers and advocacy groups are still sceptical and wonder whether “compassionate use access” is just a renaming of the Section 21 application process the regulator currently requires to access the drug.
Durban – THE South African Health Products Regulatory Authority (SAHPRA) has granted “controlled compassionate” access to Ivermectin.
The highly controversial and much talked about drug, which is commonly used for the treatment and control of parasites in animals, came into the spotlight after SAHPRA banned it for human consumption following several social media posts claiming it “cured” people of Covid-19 in late December last year.
But in an unexpected turn of events and following mounting pressure from healthcare workers and civil society, SAHPRA has approved the use Ivermectin for emergency use even though it is not registered for human consumption in the country.
“We gave due consideration to the current context – the position of healthcare workers, the lives being lost – and we have decided that our approach going forward will allow for controlled compassionate access to Ivermectin that will enable us to monitor its use by healthcare professionals reporting to us. This process will allow us to collect the data we need to make the right decision on this treatment,” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
The health product regulator said it needed time to further consult with the sector on access protocols and would announce these in the next few days.
“This decision does not mean our position has changed. There is still not enough scientific data and scientific trails to justify and recommend the regulator to approve the use of this but we have taken into consideration the current context. We are still looking for data that will be a game-changer which is why we are undertaking this process. We still need to develop confidence in vaccines,” said Dr Boitumelo Semete-Makokotlela.
But healthcare workers and advocacy groups are still sceptical and wonder whether “compassionate use access” is just a renaming of the Section 21 application process the regulator currently requires to access the drug.
Dr Naseeba Kathrada, a GP who practices in Durban and who earlier this month wrote an impassioned plea to President Cyril Ramaphosa to approve Ivermectin use for Covid-19, said even though she was quite hopeful that SAHPRA was moving in the right direction, said she was not convinced that the process would change.
“To me it seems no different to a Section 1 application and if it is just a renaming of this process that they are doing, then there are causes for concern. I am however hopeful that it is not because the Section 21 is an 8 page document to fill in and if they want feedback per patient, that is exactly what we are fighting against. We simply do not have the time; we have to save lives and filling in an 8 page form for 60 patients a day is quite unreasonable living in these times,” said Dr Kathrada.
Dr Kathranda also said the delay in announcing the specific guidelines on how to access the drug was “also a cause for concern”.
Advocacy group South Africa Has A Right to Ivermectim (Sahari) was also not impressed at the announcement saying while the SAHPRA announcement of controlled compassionate use is step 1 in the right direction, it is inadequate in a pandemic.
“We refuse complex Section 21 applications. We refuse supply tender corruption however we will analyze guidelines and are willing to engage,” said Sahari spokesperson Shabnam Mohammed.
Meanwhile the South African Medical Association (Sama) was “extremely pleased” regarding the regulator’s decision to grant compassionate access.
“It’s important to understand that this is not the green light that can now be used over the counter. This is for use in cases where a patient is extremely ill and the Dr would like to use Ivermectim on that patient so there is still a process that needs to be followed through SAHPRA to enable them to gather the data and information on the type of patient the drug is being used on SAMA urges all medical doctors who would like to prescribe Ivermectim to their patients to go through the SAHPRA process,” said Sama spokesperson Angelique Coetzee.