By Jesse Copelyn
There’s no sign that South Africa’s intellectual property laws will change anytime soon, public health experts say. That means pharmaceutical companies will keep abusing the country’s weak system — and keep the profits rolling in.
- After years of waiting, blood cancer patients in state hospitals can now get a drug that could stop their disease from getting worse. Until now, the medicine (called lenalidomide) had been too expensive for the state to buy. The price dropped when a generic version of the medicine became available.
- Cancer treatment activists in the country, however, say their job is far from over. There are six other life-saving cancer medicines that are out of the health department’s price range.
- A change in South Africa’s intellectual property laws could stop the loop activists are in, but there’s no sign that the government will do so anytime soon.
Six life-saving cancer medicines, of which only unaffordable branded versions are available in South Africa, will remain caught up in the years-long campaign that activists had to fight for access to the generic blood cancer drug lenalidomide, which became available in government hospitals in December.
Why? Paperwork and patent loopholes.
Lenalidomide helps to fight cancer cells for one of the most common forms of blood cancer, called multiple myeloma, and significantly reduces the chance of a person’s cancer getting worse if a patient starts using it as soon as they’re diagnosed. This also depends on at which stage the cancer was diagnosed.
The branded version of the drug, known as Revlimid, cost over 17 times the price of generic versions in 2016 (R729 000 for a year’s supply per patient in 2019) — but public sector patients in South Africa had to wait for decades to get access.
Now, Salomé Meyer from the advocacy organisation Cancer Alliance says, government patients who need several other unaffordable cancer drugs are also doomed to years of waiting, because South Africa’s laws make it easy for pharmaceutical companies to retain the sole right to sell their branded drugs for years.
The unavailable cancer drugs include treatments for breast, prostate, lung and some blood cancers.
What’s causing medicine access to be stuck in Groundhog Day?
In South Africa, most medicines are protected by patents. The principle of a patent is that companies that develop a new invention (for instance, a medicine or simply a novel technique for producing drugs) can get an exclusive right to market it without competition. The prospect of a legally protected monopoly gives companies more of an incentive to invest in making new medicines.
Drug companies justify their right to patents on medicines by saying that they spend millions researching and developing medicines. If generic manufacturers can apply to copy a drug’s recipe (and make cheaper versions of it) as soon as it hits the market, then it won’t be profitable for the original developers to invest in pharmaceutical research in the first place.
But according to Baone Twala, a legal researcher at public interest law centre Section 27, drug companies are able to get patents in South Africa without anyone actually evaluating how much money or time went into research.
Getting a patent awarded can be a complicated process. For instance, in Argentina, companies applying for a patent need to prove to a government-appointed examiner that they’ve developed something new and useful (along with ticking a host of other boxes).
However, South Africa’s laws make it easy for pharmaceutical companies to get a patent on a medicine because, for the most part, the government doesn’t evaluate the merit of an application. For example, unlike in Argentina, there aren’t any examiners rigorously checking whether the patent application is for a new or inventive product. Instead, the state only checks whether the documents are all filled in and that the required fee is paid, explains Twala.
Once a patent is awarded, competing companies can face legal penalties if they try to produce cheaper versions of the drug. This lasts for roughly two decades — and gives the original manufacturer a means to keep prices high.
But the system for awarding patents also creates loopholes for companies to keep extending their 20-year monopoly by making small, inexpensive but inconsequential changes to the formula (say, by adding salt to a drug recipe). This is called “patent evergreening”, and is a way for developers to keep on earning profits from old innovations without further benefits to patients.
How do you get a patent in SA?
To apply for a patent in South Africa, a company has to approach the registrar of patents, an officer who’s at the Companies and Intellectual Property Commission in the department of trade, industry and competition.
The registrar checks that the patent application form is filled in correctly before granting it — the only way that the application would ever be assessed for genuine innovation is if a competitor challenged that patent.
This kind of system is supposed to shift the responsibility (and cost) of regulating innovations onto pharmaceutical companies instead of the government. In a perfect world, such a system would give generic drug manufacturers an incentive to take originator companies to court to argue that they’ve won an unfair monopoly, says Jonathan Berger, a lawyer at Webber Wentzel.
But in reality this never happens, he explains. “It’s hellishly expensive [for generic medicines manufacturers] to litigate, and if they lose they have to pay for damages too.”
In a case like this, Berger says, the winning company can also use the courts to block the loser’s ability to ever make a generic version of a drug.
Because of what Twala calls “a very procedural system”, which requires a company simply to complete the paperwork correctly and pay the appropriate fee, South Africa granted 93% of all patent applications between 2000 and 2002, according to a 2016 analysis.
That’s far more than any of the other countries in the study. In second place was the United States, where only 61% of patents were approved. And the figure is even lower in countries with similar sized economies to South Africa. The researchers found that Argentina approved 12% of patent applications, while only 5% were approved in Brazil.
No signs of change in SA patent laws, experts say
South Africa’s department of trade, industry and competition has been promising to update the country’s intellectual property laws since 2018, so that patents would have to pass through a more rigorous assessment before being approved. For instance, the policy suggested hiring skilled examiners to assess whether a patent application is genuinely inventive.
A 2022 study found that when China put in place stricter checks, companies began to invest in more genuine innovation instead of making small and superficial adjustments to their products.
But in South Africa nothing has yet changed — and public health researchers and legal experts warn that the department is in no rush to do so. Instead, they say, the department is neglecting the 2018 policy entirely.
A new, unpublished draft of the Patents Amendment Bill was supposed to be sent to Cabinet in October, according to the 2022 budget vote speech of Trade Minister Ebrahim Patel. Activists hoped that the Bill would implement the recommendations of the 2018 policy, in which the department backed “urgent reform”.
October has come and gone, however, with no indication that the Bill was ever sent.
Says Twala: “As far as we know, the work that has to be done on the Patent Bill is complete. But for some reason, it hasn’t made the move from the ministry to the parliamentary processes”.
Berger is also in the dark: “There hasn’t even been a draft Bill published for comment.”
The media relations director for the department of trade, industry and competition, Bongani Lukhele, said that they were unable to respond to questions about when the draft legislation would be published.
A disappearing Bill and a collapsed committee
According to the Copyrights Act, the minister is supposed to appoint a Standing Advisory Committee on Intellectual Property Rights.
Retired judge Ian Farlam is listed as the committee’s current chairperson, but according to Farlam, his term ended years ago.
“The department had been talking about appointing a new committee. It must have happened, because we [the committee members] stopped receiving summonses to go to Pretoria [where the committee would convene] a couple of years ago.”
According to an anonymous source familiar with the process to elect a new committee, applications were called for, but it doesn’t appear that new members were ever appointed.
The department did not respond to a question about whether the committee was currently operating.
For activists like Meyer, these misunderstandings and mishaps spell bad news for South Africa’s cancer patients.
“Because certain cancer medicines are patented and expensive, patients in the public sector just don’t have access to them, and no one tells them that those medicines exist — so they may die sooner than their counterparts in the private sector”.
Here we go again: More drugs out of reach for cancer patients
The World Health Organisation (WHO) lists it as an essential medicine to treat two forms of leukaemia, a type of blood cancer.
It’s not on South Africa’s essential drug list (medicines the government is compelled to buy), though, because it’s far too pricey. A full course of the drug costs R50 616 for six months, more than five times the cost of the generic version sold in India.
That means that it’s not available at most state facilities, Meyer says.
Cost can play a big part in the National Essential Medicines List Committee’s decisions to recommend that the government should buy a drug for state patients, says Fatima Suleman, who heads the WHO’s Collaborating Centre for Pharmaceutical Policy and Evidence Based Practice at the University of KwaZulu-Natal.
She explains: “If we treat, say, five cancer patients [with expensive drugs], does that mean we will be compromising 4 000 diabetes patients?”
The reason for bendamustine being so expensive in South Africa is that it’s protected by a patent awarded to the manufacturer, Astellas. This means generic versions of the drug can’t be sold here. However, at least three other countries rejected Astellas’s applications.
Two state hospitals — Groote Schuur in Cape Town and Helen Joseph in Johannesburg — have, however, bought bendamustine for patients through the “buy-out” system. This is when government facilities purchase medicines from drug makers directly, as opposed to getting it from a centralised national tender.
Jennifer Geel, the head of the children’s cancer ward at Charlotte Maxeke Johannesburg Academic Hospital, says the drug is not available at her facility because it’s “extremely expensive”.
She continues: “The cost to treat one patient with bendamustine could be far better used to treat multiple patients with [cheaper] drugs.”
Can other drugs follow the lenalidomide route?
To get generic lenalidomide on the market in South Africa, pharmaceutical companies needed to get their drugs approved by the South African Health Products Regulatory Authority (Sahpra), who has to make sure that these alternative forms are safe.
But Celgene, the original manufacturer, still held a patent for lenalidomide in South Africa.
So the generics companies either needed Celgene’s patent to be overturned or they had to hope that the company wouldn’t defend its patent rights if they put their versions on the market.
In the end, option two prevailed.
By 2020, some pharmaceutical companies, including Eurolab, received authorisation from Sahpra to market generic lenalidomide. These companies then started supplying the drug in 2021 at a fraction of the cost of the original drug, without resistance from Celgene.
They were fortunate, Meyer reckons, because Bristol-Myers Squibb, who owns Celgene since late 2019, wasn’t litigious and didn’t take legal action against generic manufacturers for violating their patent.
According to Meyer, other companies may have behaved very differently, so simply relying on them not to sue is not a solution.
“We have to change the patent laws,” she argues “All that we want is for Ebrahim Patel to follow through on the intellectual property policy that was published way back in 2018.”