Novartis and Health – An analysis


 

Rajeev Dhavan on April 11, 2013 – 1

 

The Novartis judgment has started a huge war of words. The patent drug producers are livid. They declare: “Woe is us. This is the end of invention.”  The generic drug makers say: “Well done Supreme Court.  Now we can supply life saving drugs to India and the world at cheaper prices.”

First let us understand the judgment for what it is. The drug in question is Gleevec which is used by cancer patients. The foundation for it is Imatinib Mesylate (IM) free base which was an important discovery and undoubtedly a new invention attributed to Dr. Zimmerman. IM was converted into a salt in the crystalline form known as IM Alfa which was then improved into the IM Beta crystalline form. This Beta form was claimed to be an invention because it had better flow properties, thermo stability and lower hygroscopicity – in other words it was more stable and digestible.

Was the Beta form an invention? This was not just a technical question for the chemist. It had mighty implications in terms of ground realities in two significant ways. The life of the original Zimmerman patent would be extended by 20 years. If another “improvement” was accepted as a patentable invention, it would be extended for another 20 years. In patent law and practice, this phenomenon is known as “evergreening.” The second ground reality was that a patent is a “monopoly.” There are two kinds of patent monopolies: a process patent which protects how the patent is made; and a product patent which protects the product itself. A process patent is a low level protection. If a drug has a process patent, this means that anyone can make that drug by some other process. This was India’s solution in the original Patent Act, 1970. But a product patent is a master monopoly which, with “evergreening”, means that only that corporates or their licensees can make that product to the exclusion of all others.  This also means that the owner of the product can impose any price it wants. Ofcourse, countries can impose a compulsory license if there is scarcity, but that option comes with too many restrictions. This was the Euro-American solution devised by the TRIPS (Trade Related Intellectual Property Rights) treaty in the new WTO (World Trade Organization).

The Supreme Court took the view that Gleevec did not have novelty – in that IM was in the public domain of knowledge in a Cancer Research article and other publications. Nor could it be said that there was an inventive step because a person skilled in the task with what was known would be able to discover the IM in the crystalline form with the properties claimed for Gleevec. The narrow decision in the case concerns whether the product Gleevec could be given a product patent for the improvements. The answer was unequivocal. Novartis could not get a product patent but was entitled to a process patent to protect how it was made. Effectively, the ‘evergreening’ of Gleevec was stopped.

But, the court went further beyond the confines of the Euro-American patent law model which India accepted when it capitulated to accept TRIPS in the WTO negotiations. How TRIPS ordained patent monopolies as free trade is baffling. But, there was a loophole. TRIPS left it to the each country to “determine the appropriate method of implementing the provisions of this agreement within their own legal system and practice”. (Article 1). TRIPS also envisaged each country to innovate in a manner conducive to social and economic welfare and to balance of rights and obligations (Article 7) and “adopt measures to protect public health and promote social economic development”. (Article 8). A worried Indian Parliament decided that patents would have to meet one further test of patentability. In the area of medicine and chemicals, it was indicated that any change must be significantly efficacious. (Section 3(d) Indian Patent Act). The significance of the Novartis judgment lies in its interpretation of this section. It posed a more stringent test beyond novelty and inventiveness by requiring significant improvement in efficacy. It was not enough that the drug was more stable and easier to administer and absorb. A significant step requires a therapeutic efficacy which is curative. If this interpretation had not been forthcoming, every little change would have fortified an “evergreening”.

The argument that research will suffer is simply wrong. Scientists rely on the past research of others. There are actually few ‘eureka’ moments in technical research. But patent holding companies want to increase these ‘’eureka’ moments, exacting a heavy price for their products. Research shows that the wide spectrum research cost is recovered in less than five years. There is an invisible government subsidy because research costs are tax deductible. Innovation will continue. In fact, the competition for innovation will become more intense as “patent” companies do not seek evregreening monopolies for small changes but only significant curative ones. Meanwhile competitive sales between companies will make medicine more affordable.

India’s parliament has shown the way by adding the criteria of significant change of curative dimensions. The Supreme Court has interpreted this addition valiantly and creatively. The world was waiting for decision like this. With evergreening de-monopolized, Cipla and others can now provide life saving drugs to Indians and others all over the world at much lower prices.

 

Rajeev Dhavan is a Senior Advocate of the Supreme Court.

 

 

#India-The right to food security #mustread


BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8273 (Published 10 December 2012)

Cite this as: BMJ 2012;345:e8273
  1. Veena Shatrugna, formerly deputy director, National Institute of Nutrition1,
  2. R Srivatsan, senior fellow2

Author Affiliations

  1. veenashatrugna@yahoo.com

Communities must push back against global policy decisions that fuel Third World hunger

The report from the Right to Food and Nutrition Watch published during October 2012 considered the effects of globalised food policies on populations in the Third World.1 It offered a very different perspective on food insecurity than that provided by official United Nations/World Bank documents. The authors of the report considered food security in light of social determinants of nutrition, such as food availability, agricultural policy, land transactions, cropping patterns, and agricultural finance. The report focused on the lack of accountability of large food producers that also own vast tracts of land to the people who face hunger and who have a right to food. Their damning indictment is that “the right to food of people around the planet has primacy over the need to fuel cars and economies in the European Union or North America.”

The report included a review of the progress of the Committee on World Food Security (an international body set up by the UN) after it was reformed in 2009 to include people’s organisations. The report stressed the importance of keeping the right to food as a benchmark in policy decisions. The World Trade Organization routinely takes major policy decisions that affect communities’ right to food without due consideration. Other offenders include international investment groups that negotiate the terms of bilateral trade agreements, public-private partnerships that promote directly delivered medicalised nutritional intervention, and those that engage in speculative trading in food. The report reviewed finance capital in agribusiness and outlined the devastating effects on poverty of speculative trading in food. Speculation on food prices has resulted in dangerously volatile food prices since 2007. Agribusiness trades through individual contracts and with little market transparency. The source of finance is surplus funds in the West, but speculation wreaks havoc and impoverishment in the Third World.

The report also presents several case studies that are eye openers to what happens on the ground. They illustrate, for example, how coercive land acquisition (grabbing)—a historical legacy of colonialism in the Arab Spring countries—and allocation of prime agricultural land to non-local industry cause food crises and impoverishment in agricultural communities. The increasing diversion of agricultural land away from food farming and to the cultivation of biofuels needed by Western countries is another major problem currently contributing to hunger in Africa. Widespread economic havoc has been caused in Mexico under the unfavourable North American Free Trade Agreement, which sees Mexico trading agricultural commodities with the United States.

India has had enormous growth in gross domestic product with no evidence of a trickle down effect. In 2006 it was estimated that 51.5% of Indian children were stunted and 54.9% were underweight. About 34.6% of adults reportedly had a body mass index of less than 18.5.2 It seems that there has been little recent change.

India’s long term food policies have resulted in an epidemic of stunting and decreased muscle mass in the children of poor families. Indian national policy has for decades emphasised cheap cereals as the major source of energy for its population. In a 1968 publication, nutrition experts suggested that a mixture of cheap foods like cereals, pulses, and vegetables could provide a mixture of amino acids that was very nearly as good as if animal proteins were consumed.3 This particular statement was reproduced in the 1971 edition of the Indian National Institute of Nutrition’s report Nutritive Value of Indian Foods and every reprint until the latest in 2011. Furthermore, it has influenced policies on food and wages, including the calculation and classification of the “poverty line.”

In 1970, people were regarded as being above the poverty line if they could afford to consume 10 042 kJ (2400 kcal) daily from the cheapest food source. Minimum wages were then calculated to provide this level of intake for a family of five on the assumption that they would consume cheap cereals. The famous “myth of protein gap,” based on an observation in 1971 that undernourished children (1670-2090 kJ daily deficit) could consume adequate protein (20 g/day) from cereal if only “they ate more of their usual foods,” changed the way the diets of poor adults and children were regarded.4 Promotion of a cereal-pulse vegetarian diet effectively removed animal proteins from Indian diets.3 Even consumption of pulses diminished over time. The more affluent vegetarians, a minority, consumed adequate daily protein requirements through sources such as milk and almonds.

In addition to widespread malnutrition and stunting, which underpins negative metabolic consequences in adulthood, more than 70% of women and children in India have anaemia and deficiencies in intakes of most vitamins and minerals.2Against this background of chronic poor nutrition, more food shortages have worsened malnutrition and hunger in the Indian population. A more recent concern in India, however, is the complex association between adult onset obesity and food insecurity. Accumulating evidence suggests that, although severe food insecurity leads to wasting, mild to moderate food insecurity is associated with obesity.5 This hunger induced morbidity pattern will continue to plague India for decades.

The Right to Food and Nutrition Watch 2012 report concludes by discussing how hungry people can regain control over those decisions that affect their food and nutritional situation. The authors highlight several successes, including the first international instrument that applied a human rights approach to agree on tenure of natural resources—the new Guidelines on Responsible Governance on Tenure of Land, Fisheries and Forests. These guidelines were adopted in May 2012 by the Committee on World Food Security after an inclusive and participatory process. They urge communities to occupy the newly created political spaces for inclusive decision making on food and nutrition.

Notes

Cite this as: BMJ 2012;345:e8273

Footnotes

  • Competing interests: Both authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Provenance and peer review: Commissioned; not externally peer reviewed.

References

  1. Right to Food and Nutrition Watch. Who decides about global food and nutrition? Strategies to regain control. 2012. www.rtfn-watch.org/fileadmin/media/rtfn-watch.org/ENGLISH/pdf/Watch_2012/R_t_F_a_N_Watch_2012_eng_web_rz.pdf.
  2. National Nutrition Monitoring Bureau. Diet and nutritional status of population and prevalence of hypertension among adults in rural areas. Technical report 24. National Institute of Nutrition, 2006. www.nnmbindia.org/NNMBReport06Nov20.pdf.
  3. Gopalan C, Rama Sastri BV, Balasubramanian SC. Nutritive value of Indian foods. National Institute of Nutrition, 2011.
  4. Gopalan C, Narasinga Rao BS. Nutritional constraints on growth and development in current Indian dietaries. Indian J Med Res1971;59:111-22.
  5. Townsend MS, Peerson J, Love B, Achterberg C, Murphy SP. Food insecurity is positively related to overweight in women. J Nutr2001;131:1738-45.

Pharma vs India: a case of life or death for the world’s poor #Health #drugs


WEB EXCLUSIVE, New International  Oct , 2012

Irekia under a CC License<br /><br />

Cases being heard in Indian courts could ‘open the floodgates’ for pharmaceutical companies to challenge generic drug production and keep prices ridiculously high, explains Nick Harvey.

It’s a worrying time for the poor and the sick. Two cases brought to India’s courts by transnational pharmaceutical companies could massively effect whether people in the Global South can access life-saving medicines. The most significant of these involves Swiss drugmaker Novartis which was refused a patent in India for its anti-cancer drug Glivec (imatinib) and is now challenging the country’s patent law.

There could be significant impact on access to medicines in countries such as India. Irekia under a CC License

‘People are already dying because they can’t get treatment and if Novartis wins things will become worse,’ says Eldred Tellis, who runs a centre for drug users and people living with HIV in Mumbai. ‘They are targeting India because many quality generic drugs are produced here for many people.’

Thanks to India’s 1970 Patents Act, around one-fifth of the world’s generic drugs – containing the same active ingredients as a patented drug but made by a different company at a fraction of the price – are made in the country. As well supplying India’s huge population, these drugs are shipped to poor countries around the world.

‘We source 80 per cent of our global HIVmedicines, as well as other medicines, from India – as do the Global Fund,’ says Michelle Childs, Director of Policy and Advocacy at Médecins Sans Frontières (MSF). ‘So what happens in India can immediately affect other countries and set a precedent for them.’

The problem with patents

Novartis is challenging a clause in the Indian law, ‘Section 3d,’ that prevents drugs being patented that are modifications of existing drugs, a tactic known as ‘evergreening’ used to extend patent periods. The company originally failed to patent Glivec in India as it was discovered before the country was forced to start patenting drugs in 2005. The latest patent application is based on a salt form of Glivec (imatinib mesylate), which, although being easier to absorb, is arguably no more effective.

Studies have found the majority of global research and development (R&D) money is used to produce these minor variations, leading not only to high prices but a lack of genuinely new drugs.

‘About 85 per cent of all new drugs are proven to be little or no better, clinically, than existing drugs,’ says Donald Light, professor of comparative healthcare at the University of Medicine and Dentistry of New Jersey. ‘They are all better than placebo but they are not better than last year’s drug that was better than placebo.’

As these cases move through the Indian courts, the bottom line remains that they could significantly impact access to medicines for the world’s poor.

This is at odds with the pharmaceutical industry argument that the patent system is there to allow companies to receive more money to make new medicines. Producing new drugs is, they say, such an expensive business that only the big companies can afford to do it.

‘These are potentially dangerous substances so you really need to do a lot of research,’ says Mark Grayson, deputy vice-president of Pharmaceutical Research and Manufacturers of America (PhRMA). ‘You need to do clinical trials, even after the drug is on the market; you need production plants to be sterile, drugs need to be safe, all these costs need to be borne and they are not cheap.’

What they fail to mention is that the majority of R&D for developing new drugs is publicly funded. This was the case for Glivec, which was also awarded ‘orphan drug status’ in the US, allowing Novartis to receive tax breaks that paid for a large proportion of the clinical trials.

e-MagineArt.com under a CC license<br /><br />

‘The vast majority of the original research on Glivec came from charities and the government,’ says Jamie Love, Director of Knowledge Ecology International (KEI), an intellectual property pressure group. ‘But at the very end Novartis comes in and gets a patent on it and makes a couple of billion dollars a year.’

These mammoth profits are generated by aggressive pricing. When this court case began in 2006, Novartis sold Glivec for $2,200 per person per month, while the generic version was produced in India for a tenth of that price. That companies could be facing such huge losses to generic competition has wound up the neoliberal press in the US with the Wall Street Journal calling it a ‘drug disaster.’

Countries are allowed by the World Trade Organization to produce generic drugs if there is a major public health imperative, a practice known as compulsory licensing. India issued its first compulsory licence in March, ordering German drugmaker Bayer to allow a generic manufacturer to make its cancer drug Nexavar (sorafenib) for one-thirtieth of the usual $5,000 price tag. India’s patent controller argued that not only had Bayer failed to make the drug ‘reasonably affordable’, it had failed to supply the drug in large enough quantities, a decision Bayer is challenging in the courts.

‘With a patent comes obligations, one of which is you make your medicine available in the quantities needed,’ says Michelle Childs.

Targeting the poor

As these cases move through the Indian courts, the bottom line remains that they could significantly impact access to medicines for the world’s poor. If both Novartis and Bayer win, the floodgates could open for companies to challenge the laws and licences that allow generic drug production.

With the vast majority of profits in the pharmaceutical sector being made in wealthy countries, why are poor countries being targeted so aggressively? The answer, like so many others, relates to inequality. While not currently profitable, poorer countries are seen as ‘emerging markets’ because of their burgeoning middle classes.

Most of the people affected by high drug prices will die knowing nothing about patents, laws, licences or pharmaceutical companies

‘The drug companies see India as a market of 100 million, although that’s less than 10 per cent of the population,’ says Jamie Love. ‘These are the people they care about, as they are the ones with enough money.’

This desire to keep the Indian élite onside may be why Novartis’s chairperson Daniel Vasellareportedly donated hundreds of ancient Indian sculptures to a Mumbai museum last month. But most of the people affected by high drug prices will never visit a museum. And most will die knowing nothing about patents, laws, licences or pharmaceutical companies.

‘The people we work with on the ground have no idea what’s going on right now in the courts,’ says Eldred Tellis. ‘But we do, and we know that Novartis losing is their best chance to live.’

 

Asian countries act to get cheap drugs #rightohealth


SouthViews

No. 37, 22 October 2012
SOUTHVIEWS is a service of the South Centre to provide opinions and analysis of topical issues from a South perspective.
Visit the South Centre’s website: www.southcentre.org.

Staring with Malaysia in 2003, many Asian countries are now taking actions to promote cheaper medicines through compulsory licensing, with Indonesia being the latest case
………………………………………………………………

By Martin Khor

By Martin Khor
Recent government actions by Indonesia and India to issue compulsory licenses are extending the trend in Asia to increase access to cheaper medicines to treat serious ailments, especially HIV/AIDS, cancer and hepatitis B.

The supply of generic medicines, either through import or local production, has been the major method of reducing prices and making the drugs affordable to more people.

When the required medicines are patented, which usually results in high prices,   governments are allowed by the WTO rules to issue a compulsory license to enable themselves or private companies to import or produce generic versions, which usually cost much less.

In 2003, Malaysia became the first developing country to issue a compulsory license to a local firm to import drugs to treat HIV-AIDS from India.  The cheaper generic drugs enabled the government to treat many more patients within the same budget.

Following this, Indonesia in 2004 issued a Presidential decree enabling the production of a some HIV-AIDS drugs while Thailand in 2007 issued compulsory licenses for several HIV-AIDS and cancer drugs.

In March this year, India approved its first compulsory license enabling a local company to produce a generic version of an anti-cancer drug, which could reduce the price of treating kidney and liver cancer from US$5,200 a month (the price of the branded product) to $160 a month (the price of the generic product).

The latest measure was taken on 3 September by Indonesian President Dr. Susilo Bambang Yudhoyono who issued a decree which has the effect of a compulsory license.  It enables local manufacturers to make, import and sell generic versions of seven patented drugs used for treating HIV-AIDS and hepatitis B.

The decree said that in line with the urgent need to control HIV/AIDS and Hepatitis B in Indonesia, “it is necessary to continue and expand the access policies to provide access to antiviral and anti-retroviral medicines still protected by patent.”

This is the third time Indonesia has issued a set of compulsory licenses. The latest decree stated that the 2004 and 2007 decrees were no longer sufficient to implement the policies.

The compulsory license is aimed at significantly reducing the prices of these life-saving medicines and making them accessible to thousands more Indonesian patients.

“We will ensure the availability of good-quality, safe and effective generic versions of anti-retroviral and anti-viral drugs,” said HM Subuh, infectious disease control director at the Indonesian Health Ministry, as quoted in the Jakarta Post of 19 October.

According to the decree, the generic companies would have to pay a royalty of 0.5% of the net sales value of the generic drugs to the companies that own the patents, such as Merck, Glaxo SmithKline, Bristol Myers Squibb, Abbott and Gilead.

The first decree in 2004 enabled cheaper generic medicines that provided HIV-infected patients with first-line anti-retroviral therapy.  However, these have become ineffective or less effective because of increasing resistance or the lower safety of the drugs.

The latest decree enables the supply of generic anti-retroviral products for not only better first but also second-line anti-retroviral therapy.

“With the 2012 regulation, we obviously can improve access to quality but affordable drugs,” Maura Linda Sitanggang, the Health Ministry’s Director General for Pharmaceuticals and Medical Equipment, told The Jakarta Post. “We’re using this mechanism concerning public interest on the production of quality but affordable medicines to treat HIV and HBV.”

The seven medicines which are the subject of the compulsory license (known in this case as for “government use”) are efavirenz, abacavir, didanosin, lopinavir + ritonavir combination, tenofovir, tenofovir + emtricitabine, and tenofovir + emtricitabine + efavirenz.

All the drugs are used to treat HIV-AIDS.  The drug tenofovir (brand name Viread produced by patent holder Gilead) is also used to treat hepatitis B, which affects 13 million people in Indonesia.  It had been approved in the United States for treating HIV-AIDS in 2001 and for treating chronic Hepatitis B in 2008.

The combination drug tenofovir + emtrisitabin (brand name Truvada, produced by Abbot) is taken in a single dose once a day.  It has been used to treat HIV-AIDS and in July 2012 it also became the first drug approved by the US Food and Drug Administration for use as a preventive measure, to reduce the risk of HIV infection to people at high risk of infection including those who may engage in sex with HIV infected patients.

The Indonesian decree was the second compulsory license in Asia this year.

In India, the Patent Office in March approved the country’s first compulsory license to a local firm Natco Pharma to make a generic version of the cancer drug sorofenib tosylate (brand name Nexavar, produced by Bayer).

It was argued that at the high price of 2.8 lakh rupees (US$5,200) for a month’s dosage of Nexavar, only 200 patients were treated in India in a year.  Natco said that 8,000 people would need the drug, and it could supply a generic version at 8,800 rupees (US$160) for a month’s treatment.

The drug is used to treat advanced kidney and liver cancer.  According to the terms of the license, Natco would pay Bayer royalties of 6% of its net sales.

Bayer challenged the compulsory license and on 16 September the Intellectual Property Appellate Board rejected its petition, ruling that “If a stay is granted it will jeopardise the interests of the public who are in need of the drug.”

Other developing regions have also been making use of the compulsory license option in the WTO’s intellectual property treaty known as TRIPS.  They include Brazil and Ecuador in Latin America and Kenya, Zambia and Zimbabwe in Africa.

In 2001, the WTO’s Ministerial Conference in Doha adopted a TRIPS and Public Health Declaration that asserted that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health.

It affirmed that the Agreement should be interpreted in a manner supportive of the right to health and access to medicines for all.

The Declaration clarified:  “In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.”

Table: Active Substance Name, Name of Patent Holder, Patent Number, and Duration of Patents for Antiviral and Antiretroviral Medicines
 

NO. NAME OF ACTIVE SUBSTANCES NAME OF PATENT
HOLDERS
PATENT NUMBER DURATION OF
PATENT
1. Efavirenz Merck & Co., INC ID 0005812 Until the end of patent period,
August 7, 2013
2. Abacavir Glaxo Group
Limited
ID 0011367 Until the end of
patent period, May 14, 2018
3. Didanosin Bristol – Myers
Squibb Company
ID 0010163 Until the end of
patent period, August 6, 2018
4. Combination Lopinavir and
Ritonavir
Abbott
Laboratories
ID 0023461 Until the end of
patent period, August 23, 2018
5. Tenofovir Gilead Sciences,
Inc.
ID 0007658 Until the end of
patent period, July
23, 2018
6. Combination Tenofovir and
EmtrisitabinCombination Tenofovir, Emtrisitabin and Evafirenz
Gilead Sciences, Inc. ID P0029476 Until the end of
patent period, 3
November 2024

 

The EU-India Free Trade Agreement: is it the end of the world as we know it?


European Union

Image via Wikipedia

This week, Indian and European Union (EU) trade negotiators in New Delhi will most likely announce that they have reached a preliminary agreement on a trade pact that will forge a new commercial relationship between the two economies. The EU wants the pact to include new intellectual property (IP) rules that go beyond current requirements under international law. These new IP rules would serve the interests of multinational pharmaceutical companies in Europe, while drastically increasing medicines prices for millions of poor people in India and other developing countries.

If India accepts the new rules, the impact on public health would be severe, especially for the poorest people in India who buy medicines out of pocket. The Government has found that 80% of all out of pocket expenses for health care are medicines, meaning people are highly sensitive to any rise in medicine prices. If the Indian Government caves in to EU demands, it may force Indian households to forego life-saving treatment in the future, or to make difficult choices between medicines and other basic necessities. Some States in India have recognized the negative impact of people paying out of pocket for medicines and provide free medicines instead. Such a scheme is working particularly well in Rajisthan for example. However, such progressive programs could be put at risk if medicine costs rise as a result of this trade agreement.

Compounding these concerns is India’s role as the ‘pharmacy of the developing world’. India produces over two-thirds of all of the generic medicines (identical copies of originator medicines) used in low and middle income countries, including over 80% of all medicines used to treat HIV and AIDS. Competition in the Indian marketplace is fierce, and producers continuously innovate new ways to reduce the cost of making quality medicines, both simple and complex. Competition from Indian generics has reduced the cost of providing treatment for a range of illnesses through multilateral and government programs, in addition to making quality medicines more accessible for patients who must buy them out of pocket. The price of medicines to treat HIV and AIDS fell drastically, from 10,000 USD per patient per year, to less than 80 USD, thanks in large part to robust generic competition amongst manufacturers in India.

Yet India’s role as pharmacy of the developing world is already eroding. Today, India is a member of the World Trade Organization (WTO) and therefore already plays by certain trade rules, including in relation to intellectual property. For instance, it must provide patents, which confer a time-limited monopoly, to innovative companies to reward them for developing new products including medicines. Indian companies must wait for a patent to expire before they can produce identical, quality copies of innovator medicines for use in India and for export to poor patients around the world. From 2005, India started granting patents for medicines, meaning delays to provide generics are increasing.

It hasn’t been all bad news until now. An important feature of these global trade rules is they do not prevent countries from addressing public health concerns, including high medicine prices. Countries have recourse to a set of policy tools that can be used to keep medicine prices from rising, and to ensure that competition can be stimulated to bring down prices. The right of countries to use these tools was affirmed in 2001, when WTO members unanimously agreed to the Doha Declaration on TRIPS and Public Health, which stated that the rules must be applied in a way that promotes public health and, in particular, access to medicines for all. Having entered trade negotiations with the EU, the Indian Government is under immense pressure from EU trade negotiators to accept stricter IP rules that contradict the Doha Declaration and to give up these tools and provisions that can safeguard the health of millions of people in India and other developing countries. Such strict new rules can be extremely damaging when implemented in low and middle-income countries.

Oxfam has observed over time a measurable, negative impact on access to medicines in those countries that have implemented stricter IP rules along the lines of those proposed by the EU. For instance, a 2007 Oxfam study in Jordan found that medicines prices rose by 20% following implementation of a 2001 trade agreement with the United States, with the cost of medicines to treat heart disease and cancer, the two leading causes of death in Jordan, rising markedly. A second study published in Health Affairs in 2009 found a similar impact in Guatemala following implementation of its 2005 trade deal with the United States.

Why do costs keep going up as IP rules get stricter? When armed with patent monopolies on new medicines, innovator pharmaceutical companies charge the highest price a market will bear, even if this means the product is unaffordable for government health programs and poor people. Competition from generics producers brings down prices for medicines that have gone off-patent – but new treatments remain unaffordable during the monopoly patent period. The innovator companies argue they are changing their pricing policies for new products which are under monopoly protection, and, indeed, some companies appear to be trying to find ways to improve access for patients in poorer countries. Oxfam has applauded some of these changes. Overall, however, our assessment is that this is an industry that is still failing to put access to medicines at the heart of its business model. Indeed, the cost of new medicines under patent, even when companies say they have tried their best, remains too high.

The dangers of high medicine prices are relevant for communicable diseases, such as HIV/AIDS, and also for non-communicable diseases like cancer and diabetes.The World Health Organization estimates that over 80 percent of all deaths from non-communicable diseases now occur in low-income countries. Less than six months ago, the United Nations issued a landmark political declaration on Non-Communicable Diseases, calling attention to the enormous challenges faced by rich and poor countries alike in addressing NCDs in the coming decades. Like HIV/AIDS, treatment for cancer, heart disease, and diabetes often requires extended treatment, making the cost of medicines a crucial factor as to whether patients can receive health care.

Today, in an era of economic crisis and austerity, ensuring that foreign assistance is effective means the global community must find every way possible to save money, including keeping down the price of medicines.The European Union has done much to provide effective aid in the health sector. It has harmonized its aid through budget support, and it has invested in effective multi-lateral institutions such as the Global Fund. However, these efforts are countered by an EU trade agenda that would harm public health in poor countries.

Civil society groups and public health experts around the world will hold their collective breath next week as the final deal is announced and finalized. As in any negotiation, both sides must make trade-offs in order to reach a final agreement. One hopes that India will recognize that public health, both of millions of Indians and millions of people in other developing countries, should not be traded off. Rohit Malpani is a campaigns advisor at Oxfam and leads the organization’s access to medicines campaign.

Rohit Malpani is a campaigns advisor at Oxfam and leads the organization’s access to medicines campaign

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