Category: Health and Medicine

Compulsory licensing is one of those euphemisms that hide a whole raft of issues. By definition – it is “authorisation to a government or company to make and sell a pharmaceutical drug without the permission of the patent holder”, which makes the intent clear.

In its most obvious form, compulsory licensing is what occurs when a government allows a third party to produce a patented product or process without the consent of the patent owner. At first glance, it would seem to be nothing more than infringement of intellectual property rights. After all, one cannot imagine companies agreeing to a legal compulsory licensing system for music, movies, or even software. Of course, that’s the point, the breach of the patent becomes legal when a government says it is. So, if it seems unethical and immoral from the point of view of the companies, is there any justification, or compulsory licensing simply piracy at the national level?

Compulsory licensing seems to be an implicit flexibility in patent protection included in the WTO agreement on intellectual property, the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, and applies to public health only. But, we’re not talking about movies, music, and software. This flexibility is about allowing the developing world to develop healthily and the sidestepping of patents on pharmaceutical and other medical products.

Fundamentally, compulsory licensing overrides the patent protection a pharmaceutical company may have for its product and legalises the manufacture of generics for the benefit of that nation’s poor and sick. Usually, it is reserved for drugs that are simply too expensive for developing world countries to afford. Despite the cost, these are essential for treating the very diseases, such as malaria and HIV/AIDS, with which the poorer nations are worst afflicted.

Indian lawyers, Sagarika Chakraborty and Angira Singhvi, writing in a forthcoming issue of the International Journal of Intellectual Property Management, suggest that compulsory licensing has not yet been used extensively in the developing world as an instrument of public policy and in some instances has simply been a tool of economic abuse. However, used properly compulsory licensing could promote widespread health improvements, they say, and might allow the term ‘developing’ to become ‘developed’ in many parts of the world.

They argue that developing nations are not the primary markets for drug companies. Moreover, they currently represent a very small proportion of sales. Even in the absence of compulsory licensing that TRIPS should have little detrimental impact on profits. Of course, India has a burgeoning middle class and as it develops could begin to represent a vast untapped market for the pharmaceutical industry. If the pharmaceutical industry were to ignore compulsory licensing during this period of development it could find its potential markets compromised as wealth accrues in such countries. Conversely, working with developing nations now could accumulate goodwill for the future.

But, given that drug companies have essentially neglected so-called third-world diseases for decades, seeing no billion-dollar blockbusters in regions such as Africa, South America, and Asia, they have little ammunition to now enforce their patents in those places. It is likely that as that middle class emerges, they will have grown entirely accustomed to pharmaceutical generics that they may never accede to purchasing the expensive patent-protected versions.

Some companies are facing the issue of compulsory licensing head on. They are already taking tiny steps to circumvent TRIPS by offering discounts to developing nations on select drugs and essentially becoming generics manufacturers of their own products. In 2000 Pfizer offered fluconazole to South Africa for free to treat opportunistic infection in AIDS sufferers. This kind of action could counteract the putative market loss as nations develop, providing much needed publicity and branding.

Cynically speaking, these steps have perhaps been spurred on by the philanthropic actions of the likes of the The Bill & Melinda Gates Foundation and their promise to tackle malaria. They may have been triggered by the work of prescription drug retrieval charities like Intercare, and others which collects returned prescription medicines and supplies them free of charge to a network of health centres in Africa. Alternatively, various national changes, such as Brazil’s AIDS control program that breaks the patent on Merck’s AIDS drug Efavirenz, the Doha-enforcing amendments to Chinese Patent Law in December 2008, Thailand’s Foreign Business Act and international condemnation of the industry position may also have acted as a spur to push the compulsory licensing debate forward.

“A lot of drug companies are getting increasingly nervous about the ability of developing countries to override their patent rights in the interest of public health,” says SpicyIP. “The biggest worry for drug companies, however, is that countries will abuse compulsory licenses, employing them in the absence of any public health crisis, simply because the government wants to pay less for drugs.” Similar concerns are reported by Intellectual Property Watch.

TRIPS and the WTO’s DOHA Declaration, essentially allows developing and underdeveloped countries to sidestep patent law and “use without authorisation of the right holder”. Unfortunately, the Declaration does not clarify key terms, such as “public health”, say Chakraborty and Singhvi, which means the field remains open to interpretation that might the pharmaceutical industry and developed countries rather than those it aims to help.

Patent and IP pundit Tom Giovanetti recently highlight the issue of compulsory licensing and how it might affect the American motor industry and the development of green technologies. “Those who argue against patents inevitably are disingenuous about the innovation of the patent system itself,” he says.

“The true genius of the patent system is that, in exchange for your temporary market power, you must disclose your invention. In other words, a patent does not lock knowledge away. In fact, patents are the ultimate tools for technology transfer. Everyone gains immediate access to the knowledge–they just don’t get to copy the invention. They can build on it, they can improve it, but they cannot immediately copy it,” adds Giovanetti. That perhaps simply adds another brace to the argument put forward by Chakraborty and Singhvi for pharmaceuticals in the developing world.

Drug firms have argued that giving away free drugs is detrimental to R&D. R&D costs hundreds of millions of dollars, takes ten to fifteen years to bring a product to market, and patent protection is therefore vital for company survival.

This is true, say Chakraborty and Singhvi, but not in the developing world, where R&D for “third-world” diseases is minimal. ‘We argue that compulsory licensing is a fundamental tool that developing countries may use in certain conditions to ensure that poor people have access to necessary medicines,’ the say.

Sagarika Chakraborty, Angira Singhvi (2009). Compulsory licensing for access to medicines in the developing world Int J Intellectual Property Management, 3 (2), 110-126

Following on from Monday’s post about health information on twitter, it seemed a nice coincidence that I came across a research paper focusing on healthcare information available in the developing world.

The web is still relatively young and yet many people can barely remember a time when they could not simply click a mouse and gain access to health and medical information. Apparently, hundreds of millions of people regularly access the internet for the sole purpose of finding healthcare information, news about the latest medicines, and advice on every ailment and illness you can imagine and some you can’t.

According to Mahinda Kommalage and Anoj Thabrew, of the Faculty of Medicine at the University of Ruhuna in Sri Lanka, most research into such internet use has focused on health information in developed countries. There have been thousands of scientific papers published on this topic by Western researchers, but a mere handful of results on PubMed cite locations such as Sri Lanka, Nepal, and Bangladesh in keyword searches together with the word “internet”. Moreover, of the six results for “Sri Lanka and Internet”, just one study from 1999 is actually about a health website.

Kommalage and Thabrew suggest that given the enormous growth of Internet usage across the globe almost irrespective of geography, it is quite surprising that so little research into medical and health information sites in developing countries has been carried out. This is particularly worrying given the almost total lack of controls and regulations on medical information on the web.

The researchers have focused on health education websites in Sri Lanka in a survey of what is available. Their first discovery relates to the size of the website most (almost 90%) have fewer than 100 pages, which is barely enough to cover the basics. Moreover, while the quality of local non-commercial sites was higher than those owned by businesses fewer than one in ten provided health education content for the general public.

The notion that the internet might help the developing world improve its health status is not new. As long ago as 2000, the British Medical Journal published an article from WHO scientist Tessa Tan-Torres Edejer entitled “Disseminating health information in developing countries: the role of the internet”. A rare few related papers can be found with a little Googling, including one from Johns Hopkins’ Madhav Goyal and colleagues writing in JAMA who lament the fact that in poor nations invaluable healthcare information rarely reaches those who need it most.

I asked Gabriel Guimaraes a Physician at ASEFE in Brazil about the issue and he points out that the internet does reduce the differences. “This question has so many possible answers,” she says, “We could either talk about the evidence based medicine and everything related to it (MedLine, NCBI and Cochrane’s Metanalysis), which in Latin America would also relate to SCIELO database, or health record software which would relate for example to Health Informatics Societies (like SBIS), or about telemedicine. Anyway there is not much difference between developing and developed because we are talking about recent technology which has almost simultaneously started for every country.”

But, his conclusions do not bear up to the scrutiny of Kommalage and Thabrew, at least for Sri Lanka.

“The total number of websites has not increased compared to the increase in internet usage in Sri Lanka during the last few years,” the researchers say. If their findings apply to the wider developing world then the internet represents a massively underutilised health education resource in parts of the world where improved health education could be used to reduce significantly the incidence of many lethal diseases, such as malaria, HIV/AIDS, and parasitic infections.

For anyone interested in what is being done to redress the balance, check out antropologi.info blog and Health Information for all 2015. The raison d’être is the following fact:

Tens of thousands of people die every day, often for the simple reason that the parent, carer or health worker lacks the information and knowledge they need to save them.

Somewhat related to this post but more about scientific research than information is SciDev.net. Also of interest: Uneca, science with Africa.

Mahinda Kommalage, Anoj Thabrew (2008). The use of websites for disseminating health information in developing countries: an experience from Sri Lanka Int. J. Electronic Healthcare, 4 (3/4), 327-338

UPDATED UPDATE: Two men have been served a death sentence for their involvement in China’s melamine contaminated milk scandal. The former boss of the Sanlu dairy at the centre of the scandal was given life imprisonment. 19 other sentences handed down by the court in northern China, where Sanlu is based, are of lower severity.

More than 200 families whose babies were hospitalised after drinking infant milk formula tainted with the industrial chemical melamine are taking their case to China’s highest court after being repeatedly ignored by lower courts, according to an AP report.

An earlier report revealed that the parents of an infant who died after drinking melamine milk have been paid 200,000 yuan (about $30,000) in compensation by the dairy company at the heart of the scandal, New Zealand owned Sanlu.

A report from Reuters says that the contaminated milk powder killed at least six children and sickened almost 300,000 last year. Many parents whose children were affected are hoping those responsible for the contamination will face the death penalty.

Now that the scandal is not so prominent in the media, investors are moving back in on China, Farming UK reports that Henry George Roberts company KKR & Co intend to invest US$100 million into the dairy industry in China. “Investing in China’s largest producer and distributor of fresh milk, the American company are gambling on the recent melamine scandal being behind them,” the magazine says. “The recent scandal in China over the use of melamine in milk, to raise the protein levels, has seen the values in the industry plummet.”

Reuters and others report that China now plans to impose production controls on melamine so that the melamine in milk scandal may never happen again. At the height of the debacle hundreds of products, not just infant formula, on supermarket shelves across the globe were tainted with the “Made in China” label. Thousands of visitors to the Sciencebase site over the last few months have arrived to get more information as the story unfolded. I will report on any subsequent developments as soon as they happen.