The US gave its authorisation last week for two Covid-19 treatments in pill form, paving the way for more green lights worldwide. A wider pool of manufacturers is expected to be involved compared to vaccines, which are more complex to produce.
But, while this could make supplies more easily available in poor countries, upper-middle income ones may be left out. Meanwhile, the success of these treatments will depend on whether countries are able to quickly diagnose and treat patients – optimally, within five days of symptoms.
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US company Pfizer’s pill, called Paxlovid, can reduce the risk of hospitalisation and death among high-risk patients by nearly 90 per cent, according to the company.
The other pill, developed jointly by US firms Merck and Ridgeback Biotherapeutics, was first authorised in Britain last month. A peer-reviewed clinical trial found it cut those risks by around 30 per cent.
In the US, only a few hundred thousand of the 10 million courses on order from Pfizer – bought by the government at around US$530 per patient – will be ready in January.
Some 3 million courses of Merck’s molnupiravir – bought at US$700 each – will be ready in the same time frame.
But unlike the vaccines, which are made by their developers and a handful of select partners, the pill treatments will be available for production by generics manufacturers for sale in poorer countries around the world. The result is expected to create a distinctly different picture to the uneven access of Covid-19 vaccinations.
Both Pfizer and Merck have signed agreements to share intellectual property for their pills with a UN-backed programme known as the Medicines Patent Pool (MPP), which acts as a middleman – issuing production licences for generic versions that can be sold in designated low- and middle-income countries.
According to the MPP, more than 100 applications have been received so far for each product from generics manufacturers, and it will offer licences to select partners before the end of January.
Ellen ’t Hoen, a former executive director of the MPP and current head of the Medicines Law & Policy project, called the deals “important agreements” that could have a quick effect.
“It will lead to large-scale, low-cost production of these medicines. That also means that you get larger production of the active pharmaceutical ingredient, which usually has a downward pressure on the price as a whole, so the benefits may be beyond the direct beneficiary countries,” said ’t Hoen, who is part of an MPP advisory body.
Around 100 low- and middle-income countries will be able to access the generic drugs made via the agreements, including India, the world’s largest producer of generic medicines.
Notably absent from these agreements, however, are populous, upper-middle income countries like Brazil, China, Malaysia, Mexico, Russia and Turkey. They are expected to buy from the developers, who have said they will offer tiered pricing schemes based on countries’ ability to afford the drugs.
Experts say this could lead to more limited access in these places, unless their governments opt to use flexibilities in intellectual property rules to make or import the generic drugs.
“The Pfizer pill is going to be made available to a large number of people with mild and moderate disease in high-income countries, and you won’t see that happening in upper-middle countries quite so easily,” said Leena Menghaney, global IP adviser for Medecins Sans Frontieres Access Campaign.
While generic production will lead to ample access in the MPP-listed countries, in the long term “millions of people in middle-income countries” that are “hands off” for generics makers will be left out, according to Menghaney.
Another question is how quickly generics makers, like those in India, can ramp up their supplies in coming months.
Working with the MPP could help producers to streamline this process, experts say, for example by easing access to samples of the original drugs for use in studies required by regulators.
Once selected, manufacturers working with MPP will need to produce the pills and gather data proving their version works identically to the original. These drug makers will then need to submit their product for approval to a stringent regulator and then register it in any markets where they hope to sell.
“We hope that this will happen quickly, but it will be well into next year before the products will be available to be procured,” said MPP head of communications Gelise McCullough, noting that the expected drug volume from these producers had yet to be worked out.
Nonetheless, medicines access advocate Achal Prabhala said it was possible generics production in these countries could lead to a situation similar to that seen during the first year of the pandemic with the intravenous treatment Remdesivir.
“[At that time], doctors in hospitals and patients were lunging for it across the world, and in the US and Europe, there was very short supply ... whereas it was relatively more easily available in places like India,” said Prabhala, India-based coordinator of the AccessIBSA medicines access project.
The difference, according to Prabhala, was that in a number of poorer countries, like India, the drug developer Gilead had granted licences to generics manufacturers for production of the treatment. Western countries, in contrast, were subject to buying from the developer.
“It’s understood the monopoly will cause problems in places like India and they do things to mitigate that by providing these licences and at the same time, because there is a monopoly in the rich countries – which are their real markets – that causes a supply shortage,” he said.
This time around, some generics manufacturers have already come online outside of MPP licences. As shipments of molnupiravir are going out from Merck – or MSD as it is known outside the US and Canada – a local pharmaceutical company in Bangladesh, for example, has already launched a generic version.
Rabbur Reza, chief operating officer of Beximco Pharmaceuticals, said his company had already supplied “a number of countries” since launching the generic in November.
In Bangladesh, where the drug has been authorised for use, Beximco has priced a full course at a maximum of US$21 for the domestic market, compared to about US$700 per course paid by the US government.
“Initially when our R&D team started developing the product, accessing the active material was difficult. However, now we have a smooth flow of ... supplies,” Reza said.
This is a sharp contrast to the supply of approved vaccines, which has been starkly uneven between rich and poor countries, despite months of advocates calling for vaccine makers to share technology and support localised production.
Only a handful of secondary vaccine manufacturers have been licensed as producers and these companies generally need more than just a patent or access to the vaccine itself to be able to recreate an identical product, unlike with the Covid-19 pills.
“Making vaccines requires a lot of proprietary know-how and specialised equipment,” said John Donnelly, a principal at Vaccinology Consulting in the US.
“Assuring the quality of vaccines requires strict control of how people behave as they work on the product, because the product is defined by the way it is made, and not just by testing.”
But while production of Covid-19 pills will not face the same limitations as Covid-19 vaccines, experts say there are other hurdles besides manufacturing that could complicate access to these medicines for parts of the global population.
“The challenge for developing countries will be how they manage the supply and deploy it in the clinic ... you wouldn’t want it to become like some antibiotics, where you can get it in the market and people take it indiscriminately,” said Donnelly, noting this could lead to antiviral drug resistance.
Another issue is that the pills will require more robust health services, which can diagnose eligible people and get them on the treatment within five days of symptoms appearing.
“The big question is, will you see governments and companies invest in [these pills], because the health care limitations in countries may limit how meaningful they would be,” said Thomas Bollyky, director of the global health programme at the Council on Foreign Relations in New York
Bollyky said there was “reason to be sober-minded” in terms of what the pills would mean for the pandemic, given their need to be accompanied by these testing and health services.
“That’s a real problem for a lot of low-resourced settings, where you’re not seeing people early in the process and testing rates have gone down considerably,” he said.
Instead, he stressed the importance of vaccines over pills in such areas. “You don’t want an intervention that needs a lot of health care infrastructure to apply and can only be harnessed once people have got sick.”
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