Rohit Malpani is a campaigns advisor at Oxfam and leads the organization’s access to medicines campaign. Oxfam’s response to Progressive Economy’s “Trade Fact of the Week” 11/28/12 is cross posted from the Progressive Economy blog.

Oxfam disagrees with the analysis set out in your November 28 article about patent protection for medicines. The article incorrectly explains the TRIPS Agreement, and we do not believe there was ever a global consensus in support of the intellectual property (IP) approach promoted by USTR, as implied in your article.

The TRIPS Agreement sets out minimum standards for IP protection, and explicitly includes a series of exceptions and limitations to IP rights that may be used by governments in order to achieve public policy objectives, including improvement of health outcomes. We have long been puzzled by efforts to portray compulsory licensing as a legal tool that may only be used during health “crises” or “emergencies”. Put simply, this interpretation is unsupported by the text of the Agreement itself. Similarly, the Doha Declaration confirms the right of countries to use all IP flexibilities in TRIPS “especially”—not “only”—in relation to health emergencies and pandemics.

We question the “policy calm” that you state has existed for 10 years in relation to patented medicines. In fact, that “policy calm” has never existed. Instead, there have been on-going tensions due to the endless efforts of the USTR, under pressure by the multinational pharmaceutical industry, to renegotiate the terms and conditions of the TRIPS Agreement through other means, and especially to strip away the public health limitations and exceptions that were included in the TRIPS Agreement in 1994. Developing countries are finding increasingly that they must endure against these tensions and challenge the pressure because many patients in their countries cannot obtain the medicines they need – especially newer treatments that are still under patent protection, which tend to be out of reach. Certainly governments in poor countries should allocate more money to health care, but the exorbitant prices of many patented medicines, an increasingly familiar problem in the United States, are an absolute barrier to health care coverage in resource-deficient countries.

Together with other humanitarian groups, we have documented a persistent, severe lack of access to new treatments and quality health care across developing countries, with the lowest income groups most affected. Upgrading health infrastructure is a crucial part of the solution, as is use by governments of all the policy options available to them, including IP flexibilities, to promote the availability of quality, low-cost versions of new treatments for their populations.

Medicines, including but not only “essential medicines” as identified by the WHO, are an important component of healthcare. Depending on their affliction, patients need access to quality, effective treatments regardless of whether these are on the WHO essential medicines list (EML). Moreover, medicines are selected for inclusion in the EML based on a range of factors, including affordability; because patent-protected treatments are more expensive, they are generally not included in the list. This is a critical flaw in the papers cited in your analysis, which found—unsurprisingly—that many medicines on the EML are off-patent.

Health care also does not only refer to AIDS, TB and malaria. To say that India has a “relatively small patient population” with cancer and other non-communicable diseases is wrong. Today, the World Health Organization notes that 80 percent of all non-communicable diseases (cancer, heart disease, diabetes) are in low-income countries, especially as life-styles and eating habits undergo a dramatic shift. By some projections, there are up to 2.5 million cases of cancer in India today. Likewise, by 2025, India will have over 75 million cases of diabetes. These are not problems which can be addressed through charity and insurance. They require serious, Marshall-Plan like investments by governments to both prevent development of these diseases and, inevitably, to provide treatment to ensure that their own citizens can lead healthy lives.

Improving health outcomes in the developing world will require substantial investments in health infrastructure, services, and medicines. At the same time, we urge governments to use policy tools available to them to promote availability of quality, effective treatments at the lowest possible cost.

Cross posted from Global Health Check and written by Rohit Malpani and Mohga M Kamal-Yanni. Rohit Malpani is a campaigns advisor at Oxfam and leads the organization’s access to medicines campaign. Mohga M Kamal-Yanni works for Oxfam as a Senior Health & HIV Policy Advisor.

Last week, the Indian Patent Office took a major step to decrease the price of a previously unaffordable life-saving medicine by issuing a ‘compulsory license’ on Sorafenib, a medicine used for the treatment of kidney and liver cancers. But such welcome action is unlikely to be repeated if the EU and Novartis have their way.

Up until now Sorafenib has been sold exclusively by Bayer, the German drug firm, at a very high price that nearly no one in India could afford. The new compulsory license permits Indian pharmaceutical manufacturers to make and sell low-cost copies of the medicine while paying royalties to Bayer, the patent owner.

The Indian Patent Office stated that Bayer had failed to make the medicine “available to the public at a reasonable price”. Through the manufacture of generic versions, the price of the medicine will fall drastically and ensure it is more affordable. News reports suggest that only about 49 patients were placed on treatment last year. So the impact will be significant.

A compulsory license is a basic safeguard, enshrined in global trade rules, whereby a country can override a drug patent to enable production or importation of a generic medicine needed for public health purposes in the country (and to a limited extent, for export). Although drug prices have been shown to be consistently too high in developing countries, and in spite of the increased public health demand for new medicines to address diseases, very few countries have issued compulsory licenses to date. This is due mostly to political and corporate pressure placed on developing country governments.

For example, Thailand issued a number of compulsory licenses for medicines to treat HIV, cancer and heart disease in 2006 and 2007. In response, both the EU and the US sent strong messages to the Thai government requesting they cancel its compulsory licenses. At the same time, Abbott, a drug company, withdrew registration of seven medicines, including a critical, heat-stable version of an HIV and AIDS medicine, to retaliate against the Thai Government. It was an unprecedented action.

Pharmaceutical companies, supported by rich nations, have tried to also stem (or even abolish!), the use of compulsory licensing to very limited circumstances (e.g. only to address an epidemic or emergency or to only treat HIV and AIDS). Yet WTO rules make clear that compulsory licensing should be a tool available for all medicines needed for the benefit of public health. With an ever growing burden of cancer and other non communicable diseases (NCDs) in developing countries [about 70% of all cancer deaths in 2008 occurred in low- and middle-income countries and NCDs are responsible for 53% of all deaths in India] it is crucial to ensure that effective new treatment is available and affordable to patients in these countries.

Given the disappointing number of compulsory licenses issued to date, India has clearly made an important step in the right direction. Yet the good fortune for India’s people may be short-lived. Through the rest of 2012, the Indian government will face at least two serious challenges from rich countries and drug companies that could threaten the country’s ability to manufacture affordable generic medicines. Firstly, the EU is putting enormous pressure on India to introduce new IP rules through a free trade agreement whose negotiations should be completed this year.

At the same time, and for the second time since 2005, the drug company Novartis has hauled the Indian Government through its own court system to force changes to the country’s intellectual property law – alleging that in its current form it is not compliant with global trade rules. The Indian law being challenged was introduced in 2005 and plays a critical role in keeping down the price of medicines by discouraging the practice of ever-greening. To take action on the Novartis case visit: http://sumofus.org/campaigns/novartis-lawsuit/

Despite meeting all its obligations under global trade rules, India faces tremendous pressure to tighten its intellectual property rules. If either the EU or Novartis gets its way the impact will be catastrophic, blocking access to affordable medicines for millions of people in India and across other developing countries.

India’s actions, whether it be issuing a compulsory license, or pushing back against the aggressive pressure of the EU and Novartis, are especially important because India is considered the ‘pharmacy of the developing world’. Since India has stuck out its neck to issue a compulsory license, hopefully others will follow suit. Conversely, if the Indian government cedes to the pressure of the EU and Novartis it will be a huge set back to other countries fighting for affordable medicines.

Let’s hope India keeps taking steps in the right direction.