Why doesn’t SA use this bargaining chip when it makes deals with drugmakers?

• A two-monthy HIV prevention injection could be too expensive for the department of health to buy even though the country participated in drug trials to test the medicine.
• In the past, this situation has played out with medications for HIV, tuberculosis, and most recently Covid. SA’s clinical trial rules allow for some participants to get the drugs, but these authors argue it’s not enough.
• Instead, SA must adapt these rules to make sure that access to new medicines is available for everyone in the country.

SA’s diversity makes it the ideal place for pharmaceutical companies to test how well their new medicines work on different groups of people. This is a crucial bargaining chip that the country’s government continually underplays in deliberations with drug corporations for access to medication that have been trialled locally.

And it comes at a huge cost to our people.

Take the HIV prevention injection, long-acting cabotegravir (CAB-LA), to which 74 heavyweight researchers and activists demanded cheaper access in July in a letter released shortly before the 24th International Aids Conference, which started in Montreal today.

“New long-acting medicines could reach those who need them most, first,” they wrote to ViiV Healthcare, the manufacturer of the injection. “Or they could roll out slowly, reach only a portion of those who could benefit, and have limited impact on the Aids pandemic.” 

The authors had good reason for their plea, especially in the case of SA, one of the countries with the largest number of people infected with HIV in the world.

One study found that the two-monthly jab, which is loaded with the antiretroviral drug cabotegravir, works three times better than the oral, daily version of the medicine in men and transgender women. A second trial showed the injection also worked better than the pill in cisgender women (women whose gender identity matches the sex they were born with).

In fact, in practice, CAB-LA works so well that it virtually nullifies someone’s risk of contracting HIV through sex.

So where does SA come into the picture?  

The two previously mentioned clinical trials that revealed the efficacy of CAB-LA were both run, in part, in the country. But ViiV Healthcare now plans to sell the injection to lower-income countries at a price activists calculated as “100 times more expensive than gold” — a cost far beyond what SA’s public health sector can afford.

A year’s CAB-LA injections for one person would cost R4,500: four times as much as what the health department pays for a person to get 12 months’ worth of Truvada, the HIV prevention pill, which the country started to roll out in 2016.  

For SA to be able to afford CAB-LA, it can’t cost any more than double what the HIV prevention pill, also referred to as oral PrEP, costs, estimates a March preprint (so not peer-reviewed) costing study.

What can be done to prevent a repeat?

Once a trial is over, rules set by the country’s medicines regulator, the SA Health Products Regulatory Authority (Sahpra), allow people who were part of the study to get the medicine that was tested. But it’s not enough — everyone in the country who needs the tested drug should have the right to access it at an affordable price. 

This is where the health department should be pushing the envelope: change the rules to include all people in SA at a reasonable rate.

Anything less is unethical given how much tax money goes into running such trials. In 2018, the government paid 47% of all the research & development (R&D) in the country.

Plus, history proves that Big Pharma can’t be relied on to be generous. It happened with tuberculosis, antiretrovirals and HIV prevention pills. And now it’s happening again.

ViiV has been slow to share its CAB-LA technology with generic drugmakers, which will keep the medicine out of reach for millions of people for another four or five years because of how long it will take for generic makers to go get their recipes and manufacturing plants ready, according to estimates from the Clinton Health Access Initiative.

ViiV did, however, announce in April that it was working with the Medicines Patent Pool, an organisation that works with drug companies to make medicines more affordable, to help generic manufacturers to make the jab cheaply. On Thursday, the company’s CEO, Deborah Waterhouse, announced in Montreal that this effort is on track. ViiV will sell CAB-LA without profit to countries in Sub-Saharan Africa until generics are available. She didn’t say what this price would be exactly, only that it would be “tens, not hundreds” of dollars per person.

But even if ViiV shares its know-how today, Sahpra has yet to register CAB-LA for use in SA. The manufacturer applied with Sahpra in December, according to Sahpra CEO Boitumelo Semete, shortly after the US regulator, the Food & Drug Administration, approved the injection. 

Can Big Pharma change?

Some might say that the drug industry proved its benevolence during the Covid pandemic.

The Covid vaccine by Johnson & Johnson (J&J) was tested in SA, and in November 2020 the company struck a deal with a local generic manufacturer, Aspen, to “fill and finish” the jab locally.

But that didn’t mean J&J shared all of its trade secrets, rather that Aspen can import the ingredient that makes the vaccine work and just complete the steps after that.

It ended up being piecemeal.

Millions of vaccines were sent from East London to the EU — at a time when SA desperately needed the jabs and had a vaccination rate much lower than the EU. Why? The agreement with J&J gave Aspen no power to decide how the vaccines would be distributed.

After facing wide criticism about the move, J&J and the EU sent the shipment back to the AU. J&J has since signed a new, adjusted agreement with Aspen, but the run of events does illustrate the nature of some of these contracts where powerful corporations can impose restrictive conditions that stifle the independence of smaller manufacturers.

SA cannot allow this type of deal to play out again. It should instead be a standard requirement that any drug company that wants to test its inventions in the country must also opt in to giving the country’s people access to it at a reasonable price.

This must be built into the R&D process as early as possible (when a medicine is still in the trial phase) to ensure that the fruits of innovation are benefiting the greatest number of people.

That’s what should have happened with CAB-LA.

Patients volunteering for clinical studies make a significant contribution to science. They deserve to have their voices heard in decisions made about data and results sharing — especially with whom the data is shared and under which terms they can get access to health technology being trialled.

* This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.

* Waterhouse is the regional advocacy co-ordinator & head of operational support unit at Doctors Without Borders (MSF) Southern Africa; Kobola is an intern at Doctors Without Borders (MSF).