A new Covid pill called molnupiravir has been stamped with approval by the South African medicines regulatory body.
This means that the tablets are safe and work to reduce the chances of people becoming seriously ill with Covid. But that’s not the end of the story when it comes to launching a drug in the field.
The health department shouldn’t use the drug just because the regulatory authority has approved it. Taking medications in government clinics involves three steps.
1. Get approval from the South African Health Products Regulatory Authority (Sahpra)
Sahpra asks if a drug is safe and working.
Molnupiravir ticked both boxes and got approval.
No drug can be bought or sold in the country without first obtaining regulatory approval.
2. Get the green light from a group of experts
The National Essential Medicines List Committee on Covid-19 Therapeutics (Covid-19 NEMLC) decides whether a Covid drug would be a good option for South Africa. The advisory body goes a step further by looking at how practical it would be to launch a drug in the country.
Although molnupiravir works, it is not suitable for the South African public health sector because the pills come with too many conditions attached.
These are the conditions:
Molnupiravir has only been tested on unvaccinated people at high risk of becoming seriously ill. They were all older or had another health condition such as diabetes.
At least six out of 10 South Africans have some sort of protection against Covid, through vaccination or a previous infection.
Therefore molnupiravir cannot be used in this group of people as it has not been tested on vaccinated people.
There are concerns for pregnant women. Pregnant women cannot take the tablets.
So all women should have a pregnancy test or undergo some form of contraception before receiving treatment.
This is not feasible in South Africa and would strain the public health system.
Molnupiravir should be taken within five days of symptoms appearing.
This means that a person must be tested, get a positive result, and receive the pills within that time.
Delays at any time, especially in getting tested, could lead many people to miss the chance to take the drug.
Let’s go back to the approval processes. The last step is:
3. The National Department of Health says yes to the drug
The advisory group makes a recommendation, but the health department has the final say. It is therefore up to the provincial health departments to see if they have the necessary money for treatment available in their budget.
With molnupiravir, the NHS is following the committee’s suggestion not to buy the drug. The private health facilities will make their own request about the possible use of the pills.
This story was produced by the Bhekisisa Center for Health Journalism. Subscribe to the newsletter.