American Lobbyists Are Fighting to Halt the Availability of Affordable Medicine to the 3rd World

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India, when allowed to be left to its own devices, has done an incredible job at keeping medicine cheap enough so people in the country can afford it. It avoids handing out patents for drugs unless they are completely new or have some sort of therapeutic advantage over already available treatments, meaning that the vast majority of life-saving medicines are open to being copied and sold by other companies.

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One example is that in 2012, German Big Pharma company Bayer was charging $4500 per month for a liver and cancer medicine. Deeming that price too high for a country where the average yearly wage is about a quarter of that, the Indian government granted a license to generic manufacturer Natco, as long as they paid some royalties to Bayer. As a result of this deal, the price of the medicine decreased by a whopping 97%.

Just to be clear, ‘generic’ medicines are basically copies of branded medicines that have the same therapeutic or clinical benefit as the original. We are not talking about crappy Dr. Dre Beats knock-offs or paper thin Levi’s doppelgängers made in a Thai sweat-shop: all of these ‘generic’ medicines are legit, quality approved products that people use everyday to treat their illnesses.

Rohit Malpani from Doctors Without Borders gave me some more background on the situation: “India started to encourage the development of the generics industry in the 1970s, and since then has seen over 10,000 companies emerge to develop generic medicines. So it’s a highly competitive market place between all of these companies, and they’ve become really good at finding the cheapest way to produce quality assured medicines.”

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But now aggressive lobbying from US pharmaceutical companies is set to change all of that. They are seeking to change intellectual property laws in the country, meaning that many drugs for treatments will have to be purchased from US imports rather than domestically produced copies.

Once a drug has been developed and a first patent filed and granted, pharmaceutical companies then engage in a practice called ‘evergreening’, where pharmaceutical companies undermine access to affordable medicines by using a variety of tactics to extend the monopoly protection on drugs beyond the initial 20-year patent period. For example, companies obtain multiple secondary patents – often for trivial modifications – on a single drug so that even when patents on the original compound expire, the product is protected for years by a cluster of patents that prevents production of more affordable generic versions, and generic competition is what drives down the cost of medicines.

Indian generic companies have been able to produce affordable versions of medicines as Indian patent law prevents evergreening. But India is now under significant pressure from the US government and drug companies to water down its patent law to allow evergreening and tighten the companies’ hold on drug monopolies.

But what really matters is that the low cost generic medicines that Doctors Without Borders use and patients need just won’t be affordable. If the prices of these drugs were to go up, people in India simply won’t be able to afford to pay for medicines, meaning they would have to go into severe poverty in an effort to find enough cash for pay for them, or go without treatment all together. Either way, your life is going to suck.

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However, it’s just not those who need medical care in India who should be worried about this aggressive lobbying. India is referred to, by those in the business, as ‘the pharmacy of the developing world’, with medicines for the world’s poorest countries being purchased from India, not just for the low cost but also because they don’t have the capacity to produce any themselves.

We aren’t just talking about paracetamol and basic painkillers here. India produces treatments for really dangerous diseases, such as hepatitis C and even HIV. Even a tiny alteration in the law “would have enormous impacts on public health systems sub-Saharan Africa, Latin America and South East Asia,” Rohit stressed, “even though they obviously can’t have an influence upon how India’s patent laws are written.” Better-off countries such as Brazil wouldn’t be immune to the effects either.

The face-palming irony of the whole thing is that the vast majority of medicines that people take in the US, and those used by US AIDS programmes, are of the generic variety, a lot of which are developed by Indian manufacturers.

So that’s Indians, US aid agencies, Doctors Without Borders, the world’s most poor and vulnerable AND US citizens that pharmaceutical companies such as Pfizer are going to be screwing over with this change in law, assuming that it happens.

According to the letter sent to President Obama written by Rep. Paulsen, Rep. John Larson and 170 other members of Congress , they are “deeply concerned about the growing trade imbalance between the United States and India,” which is due to Indian government favouring domestic production of medicines over US imports. They say that India is “harming” US industry, “jeopardizing jobs and innovation here at home” and having “a negative impact on […] investment in the United States.”

You’d been forgiven for thinking that these were the words of a stereotypical right-wing, venture capitalist. But Rohit pointed out that the support is “decidedly non-partisan.” In fact, “we don’t see any empathy or understanding of the measures that the Indian government or other governments are taking to ensure affordable medicine prices. In some ways, we often see very little space between the approaches of either political party.”

Paulsen and Co. are also worried that other countries may get a similar idea to India and start producing medicine domestically for the benefit of its people, because “it is a thought leader among emerging countries.”

The attack’s focus is on the illegality of the Indian government’s actions. However, Rohit told me that “every sort of impartial legal expert has validated India’s measures as being consistent with global trade rules.”

Rather than just take Rohit’s word for it, I had a look at a report written by the World Health Organisation. It stated that Member States should “consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights, including those recognized by the Doha Declaration on the TRIPS Agreement and Public Health and the WTO decision of 30 August 2003”

These flexibilities in the law include compulsory licenses, just like the one awarded for kidney treatment mentioned earlier.

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After approaching Pfizer, one of the main pharmaceutical companies behind this lobbying, and being bounced between multiple media departments, I wasn’t provided comment but instead forwarded testimony that Chief Intellectual Property Counsel Roy Waldron delivered to the House of Representatives back in June. He stated that India’s actions lower their ability to “provide faster access to life-saving medicines”, and that the country was a “hostile innovation and investment environment.”

I was also kindly directed to one of the many think-tank websites that have been set up to push the anti-India initiative. The ‘Alliance for Fair Trade with India’, which isn’t just concerned with the pharmaceutical industry but also technology and other sectors, is full of useful information detailing how India is being “unfair” and is practising “discrimination” against US traders.

As for what needs to be done to counter all of this political pressure and PR hotair: “the Indian government must continue to do what it has,” Rohit continued, “which is to very carefully and continually defend these measures they have taken as legal.” Rohit also said that it’s crucial that governments spread “knowledge and understanding amongst people in the country, to understand how these very technical changes to the patent law will have an impact on their lives and well as the lives of others,” and that the Indian government should collaborate with other pressured countries to fight back.

There is a wider problem of virulence towards the generic medicine trade in general. With the evergreening of drugs, especially those for cancer, the price for treatment remains incredibly high for everyone around the world. This is from a speech of the Director General of the WHO:” The costs of many new medical products are becoming unsustainable for even the wealthiest countries in the world. Last year, the US Food and Drug Administration approved 12 drugs for various cancer indications. Of these 12, 11 were priced above US$ 100 000 per patient per year. This price is unaffordable, for most patients, most health budgets, and most insurance companies. These are problems for all countries, not just the developing world. I can assure you, after more than two decades of efforts, there are no easy solutions.”