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Science and Society Patents: how the profit machine costs lives

Despite miraculous trial results showing new treatment could halt transmission, corporate greed and patent laws condemn millions to preventable infection and death, write ROX MIDDLETON, LIAM SHAW and MIRIAM GAUNTLETT

DECIDING a particular year when a scientific discovery or advance took place is often an arbitrary decision. Archimedes is said to have leapt from his bathtub and shouted “Eureka!” when he realised that the volume of any object, no matter how complicated, could be found by placing the object in water and measuring the volume of water it displaces.

But even that eureka moment is of dubious authenticity. It is rare for scientific research to advance in a glorious instant of revelation.

So when the journal Science named the HIV/AIDS drug lenacapavir as its “breakthrough of the year,” it shouldn’t be surprising that its story began far earlier.

The drug was first approved for use in the EU and the US two years ago and was patented a decade ago, to say nothing of the research in the years before that made it possible. And yet, it is fair to say that this year marked an amazing discovery.

In recent years, the potential of some treatments for pre-exposure prophylaxis (PrEP) of HIV/AIDS has become clear. PrEP means giving medicines to people before they have acquired HIV, which results in far fewer people acquiring it in the first place.

That drives a positive cycle, since fewer new cases means fewer subsequent cases. PrEP is effective not only because of the underlying science, but because it provides real health improvement that corresponds to need, rather than blaming people for simply living their normal lives.

An imperfect analogy might be something like installing airbags in cars: it reduces the number of deaths by investing in safety ahead of time, rather than only treating accident victims and rebuking people for owning cars.

However, existing treatments for PrEP have to be taken extremely frequently, meaning it is often not possible for people to continue. The need for new drugs is urgent, because every year, 1.3 million people newly acquire HIV. This year, a clinical trial of an injectable form of lenacapavir, an antiretroviral medication, in more than 5,000 HIV-negative cisgender women and adolescent girls produced an amazing result.

Half of the participants were treated with one injection of lenacapavir every six months, the others with daily doses of another oral PrEP drug (each group also received a placebo version of the other treatment). There were 55 new infections of HIV — but none in those who had received lenacapavir.

Using lenacapavir for PrEP could drive new HIV infections down because an injection every six months is far more achievable than daily dosing. This news really was something of a eureka moment.

Unfortunately, lenacapavir is not only a medicine but also a product. The company that patented it, Gilead Sciences, did not invest in the research out of benevolence. The structure of a corporation dictates that they maximise value for their shareholders.

On approval of lenacapavir in 2022, their share price increased by 50 per cent, and on the positive results this year, it grew again. Depending on the region, a year’s treatment with lenacapavir for one person costs between $25,000 and $45,000. Those prices mean millions of people who could benefit from the drug will not get it.

The true cost of a medicine is not nothing. Medicines cannot be summoned out of thin air, and there are real costs involved in pharmaceutical manufacturing and distribution. But crucially, these are economies of scale. In the case of lenacapavir, as with other medicines, allowing other suppliers to manufacture the drug would lead to massive reductions in cost. Research led by Dr Andrew Hill at Liverpool University with other HIV researchers calculated that lenacapavir could be mass-produced for under $100 — and still leave a profit of 30 per cent.

But legally, this is immaterial. Until Gilead’s patent expires, they are lawfully at liberty to enforce their monopoly. The lenacapavir patent will only expire in 2034 — and they could even attempt to extend it for longer using common industry tactics. HIV can be safely managed through taking antiretroviral therapy, which ensures a negligible viral load and very little reduction in life expectancy.

However, this again relies on access to licensed drugs. As a result, hundreds of thousands of people die every year from HIV-related illness. The results of the monopoly on lenacapavir are what Engels would have called social murder, as documented for a previous generation of HIV/Aids drugs in the 2013 documentary Fire in the Blood.

Under current global trade agreements, countries agree to respect the intellectual property laws of other countries. This means that the intellectual property regime of wealthy countries such as the US dictates global pharmaceutical production and distribution, directly leading to high prices and huge delays in lifesaving medicines reaching people who need them.

The status quo was enshrined in 1995 with the notorious “TRIPS” trade agreement. Economist Joseph Stiglitz has said that trade ministers who signed it were “in effect signing the death warrants on thousands of people in sub-Saharan Africa and elsewhere.” Profits are prioritised over lives.

On rare occasions, legal systems within countries do simply refuse to recognise patent claims. In 2013, the Supreme Court in India rejected a patent application for an anti-cancer drug on the grounds that it was a modified version of a previous drug, so was “obvious.” The result was drastic: the price of the drug fell from over $2,000 for a month’s treatment to less than $100. But such cases are outliers.

More normal are deals, struck between the patent-holder and other companies. In September of this year, the HIV/Aids activist group ACT UP protested outside Gilead to demand they license other companies to produce it at a lower cost. Activists rang a bell every 24 seconds to mark a new person acquiring HIV.

In October, Gilead announced royalty-free voluntary licensing agreements to increase access to lenacapavir. But the deal excludes many countries, including Brazil and Mexico. Some activists believe they should issue compulsory licenses anyway, using a legal mechanism to suspend Gilead’s patent.

These access agreements, limited as they are, wouldn’t have happened without activists. The groundwork for this mitigation was laid by those who campaigned for the Medicines Patent Pool, which the UN backed in 2010.

A 2022 analysis by economist Lucy Xiaolu Wang found that this mechanism has indeed worked to increase the share of generic drugs supplied to low and middle-income countries. Unfortunately, that increase was only by 7 per cent.

More must be done. The current patent regime is killing people. The evidence from this year’s study is clear: everyone in the world deserves access to lenacapavir. That would mark the real breakthrough.

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