Lack of Access to Drug-Resistant Tuberculosis Treatment: How we got here and what must change

How patent systems came to restrict access to life-saving medication for tuberculosis patients

Writers: Isis Calado, Loewe Lee, Marie Barberon and Christos Nikolaou, on behalf of UCL Friends of Médecins Sans Frontières Society
Editor: Maddie Wigmore-Sykes
Artist: Lucie Gourmet


Over eighty percent of the people suffering from drug-resistant tuberculosis cannot access a key medication, bedaquiline. Alternative treatments are largely ineffective and can cause agonizing side effects. Patent owner Johnson & Johnson is resisting  pleas for price reduction. How did the idea of patent rights as incentives for innovation transform into a colossal barrier to accessing essential medicines?

Tuberculosis (TB) is an infectious disease caused by the pathogen Mycobacterium tuberculosis. The disease mostly affects the lungs, causing severe disability if untreated and can eventually lead to death. TB can be cured with antibiotics taken rigorously over several months, but some forms of the disease have developed resistance to conventional therapy, leading to the emergence of drug-resistant tuberculosis (DR-TB). In 2018, the World Health Organisation recommended that countries adopt new, more effective treatment regimens including the newly developed drug bedaquiline. Previous regimens only cured up to half of the patients and exposed patients to side effects such as deafness and psychosis. Efforts to make the switch to the new treatment regimen have been encumbered by the price set by bedaquiline patent-owner, Johnson & Johnson. The company claims it is already offering a special price for many of the countries where TB is endemic, such as India and Russia, but in the seven years bedaquiline has been in use, only 51,000 people have had access to the drug. This is incommensurable considering over half a million people develop DR-TB annually.

We will travel back in time to the issue of the very first patent law to examine how patent systems evolved to prevent thousands from accessing live-saving medication worldwide – and why this must change.

From the first patent law to the first luxury medicine

It is no news that good ideas, such as methods to make medicines, are often attributed great commercial value. But how did we come about buying and selling our ideas? Or, in the first place, owning an idea? Ownership, of what is commonly referred to as intellectual property rights, is accomplished in Western law systems through the issue of patents. As we know them today, intellectual property laws arose in Venice in 1474, with the aim of attracting new inventors to the Republic. The logic behind this was simple: a patent grants an exclusive right for an original idea, encouraging innovation by inventors who have the power to decide whether their idea can be commercialised and by whom. These policies were gradually adopted by several other European states during the 17th and 18th centuries, leading up to the internationalization of patent policies through the Paris Intellectual Property Convention in 1883.

Therapeutic agents were not always included in the list of inventions that could be protected by patent laws. Except for the United States, most countries in Europe initially denied the issue of patents for medicines, arguing against it on moral and public health grounds. Nevertheless, the post-World War II period fuelled a steep evolution in the manufacturing techniques and demand for new drugs, which, amongst other factors, contributed to their inclusion in intellectual property law frameworks.

The urgent nature of healthcare is such that demand for drugs is often insensitive to their costs – if you need a treatment, you’ll pay for it, even if that means losing out on other goods. This allows monopolies to raise prices much above what is comfortable for their consumers. Furthermore, the development of public healthcare and insurance policies in developed countries modified the relationship between consumer and supplier, whereby patients don’t pay directly for their prescription, as these are paid through private or public health coverage. Increasing prices are thus accepted by states who are morally obliged to provide access to health care, and insurance firms fearing to lose clients. These considerations help us understand why some companies are able to charge exorbitant prices for life-saving medicines. Daraprim, a drug used to treat a parasitic infection that can be fatal in HIV patients, cost $750 per pill when its patent was bought by North American pharmaceutical company Turing in 2015; a 5500% increase from its previous price, $13.50. 

Going global

We have established how a system designed to encourage innovation allowed for unconscionable drug prices that don’t respond to “standard” economic theory. Now we turn to the question of how this same system, largely benefiting US and Europe-based pharmaceuticals, came to impede access to medicines in the rest of the world.

In the mid-20th century, the vast majority of the world’s population did not have access to state or private health coverage and relied on the low prices of generic (patent-free) drug companies to access medication. At this point in time, the steep rise of the globalization of trade made the pharmaceutical sector understand that they would benefit even more from intellectual property rights if their patents were valid across the globe. In the 1980s, European, American and Japanese pharmaceutical companies began to push for an international trade agreement on intellectual property laws to be formalized between World Trade Organisation (WTO) members, giving origin to the TRIPS (Trade-Related Aspects of International Property Rights). Finalized in 1995, the agreement “harmonized” intellectual property regulations by dictating the level of protection a country must give to other WTO members. In other words, every country who signed TRIPS had to change its own domestic law to protect patent rights of pharmaceuticals of fellow signatory countries. By impeding the production of generic medications in developing countries through giving exclusive rights to foreign pharmaceuticals, TRIPS would build severe barriers to healthcare access among these populations.

Like similar multilateral agreements, TRIPS incorporates multiple subtleties which make it look less like a barrier to accessing essential medicines. For example, Article 31 of the agreement dictates that states can authorize a generic manufacturer to produce copies of a needed medicine without the consent of the patent owner, provided that appropriate remuneration is paid to the original manufacturer. However, the generic manufacturing was restricted to the country issuing the compulsory license, which meant that this “flexibility” was of little use for countries with no capacity to produce the necessary drugs.

A few years after TRIPS was signed, intense protests from groups advocating for access to medicines resulted in the Doha Conference (2001), which produced a declaration aimed at “clarifying” the relationship between TRIPS and public health objectives. The declaration reinstated that countries can and should use the flexibilities enclosed in TRIPS and allowed for imports under compulsory licensing, attenuating the problem of production capacity. Nevertheless, these flexibilities are not self-executing, and developing countries are often pressured into avoiding them. Even before the implementation of TRIPS, the US pressured Thailand to adopt stricter intellectual property policies, limiting their use of compulsory licensing. Ultimately, TRIPS’ flexibilities and the Doha Conference’s clarifications crumble under political pressure and do not provide enough support for developing countries to nurture their national generics industry, which would ensure sustainable medicine supplies.

Making medicines in the dark

Protected by the globalized intellectual property law system, the pharmaceutical industry justifies the high prices it charges with the risks associated with investing in drug development. The cost of developing and producing a medicine is subject to extensive debate, as there is a wide disagreement on what should be factored in. These companies insistently present large “cost of failure” estimates – the money lost in developing drugs which never make it to the market, but with little transparency on how these costs are calculated. Additionally, many fail to acknowledge the contribution of public funds – university research, tax exemptions – towards the development of new medicines. Overall there is a failure to recognise that drug monopolies contravene the collective efforts put into developing them.

The price currently charged by patent-owner Johnson and Johnson for bedaquiline – $2 a day – makes the DR-TB regimen (which contains other drugs too) cost nearly $2000 over 18 months, with bedaquiline being the main driver of the price. Researchers have calculated that bedaquiline can be produced and sold at as little as $0.25 a day. As with many other medicines, the development of bedaquiline received the contributions of several national and academic institutions, including  University College London. Given the colossal barrier price imposes on access to medication, it is absurd that Johnson & Johnson insists on maintaining the current bedaquiline price.

The demands

Over the last few years, Médecins Sans Frontières (MSF) has coordinated a global campaign demanding Johnson & Johnson to half the price of bedaquiline. #NoMoreTears reclaims the company’s famous shampoo ad slogan to hold the pharmaceutical company accountable for the avoidable suffering it is inflicting on the TB patient community, pushing them to excruciating, cheaper treatments or no treatment at all. Furthermore, the campaign demands Johnson & Johnson to issue a license to the Medicines Patent Pool, a system created to allow sub-licensing of key medicines to low and middle-income countries in order to foster production of copies by local generic companies.

So far, Johnson & Johnson has ignored these appeals. Instead, they filed further applications to prolong bedaquiline monopoly beyond the year which their patent expires, 2023. Medicines aren’t like any other product. We can’t wait until they get cheaper. While bedaquiline isn’t made widely available, thousands of TB patients will be consumed and killed by the disease. We support MSF’s demands for reducing bedaquiline price and allowing for the knowledge on how to make it to be used by local generic manufacturers. Owning an idea only makes sense when it can be shared with those who need it the most.

Learn more about how you can join MSF’s #NoMoreTears campaign: https://nomoretears.msfaccess.org/why-should-johnson-johnson-listen-us

References

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