Posts – Page 99 – PEAH – Policies for Equitable Access to Health

EU Trade Agreements: Favouring Big Pharma over public health

In recent years, the European Union (EU) has been aggressively pushing for Intellectual Property (IP) provisions in bilateral trade agreements with emerging economies such as India and Thailand. These trade agreements are designed to ensure that developing countries who sign these agreements adopt more stringent IP laws that go much beyond the requirements of the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights agreement.

The Government of India and Thailand should ensure that negotiations that affect public health must be conducted with adequate levels of transparency and public scrutiny, and access to the negotiating texts must be increased. They should also ensure that public interest does not get overshadowed by commercial interest as failure to do so will cut have dire consequences for access to medicines for millions

EU Trade Agreements: Favouring Big Pharma over Public Health

Chalermsak Kittitrakul* and Shailly Gupta**

*Coordinator, AIDS ACCESS Foundation (Thailand)

**Policy Advocacy Officer, Médecins Sans Frontières Access Campaign (India)

The intent behind this approach is clear: Proposed EU Trade agreements seek to further consolidate and extend the monopolies of big pharmaceutical companies by blocking the production, registration and supply of affordable generic medicines.

The increased availability of affordable generic medicines played a key role in scaling up treatment of HIV/AIDS around the world, allowing for nine million people to be on treatment today. Competition among generic producers was instrumental in bringing down the price of the first generation of ARVs, and is one of the key reasons treatment could be scaled up to millions of people. Today, first-line ART is available for as little as $100 per person per year (ppy), which is a 99% decrease from 2000, when treatments still under patent were priced at more than $10,000 ppy.

In particular production of low cost, quality generic drugs by Indian manufacturers – in the absence of patent barriers – has made the country the ‘pharmacy of the developing world’ with supply of affordable essential medicines, vaccines and medical products reaching more than 100 countries. Many large non-profit organisations that procure medicines for treatment across the world, including UNICEF, UNFPA, PEPFAR, Global Fund, UNITAID and IDA [1] , largely depend on generic medicines from India. For example, over 70 percent of all pharmaceuticals and 100 percent of paediatric and second-line antiretroviral medicines (ARVs) bought by IDA are procured from Indian companies.

But the situation today is different and the progress achieved is once again under threat. With the WTO’s TRIPS agreement being implemented in key manufacturing countries and several of the newest drugs for cancer, TB, HIV and hepatitis are now patented in countries such as India and Thailand. The sort of automatic generic competition that brought prices down so dramatically for older generations of drugs will not be possible for these newer drugs.

For instance: Raltegravir, a patented HIV drug used in the needed triple-drug cocktail by MSF in its Mumbai (India) clinic to treat patients who develop resistance to first and then second regimens, costs about 1,330 euros per patient per year .

At the same time, additional threats are now emerging in the form of ongoing free trade agreement (FTA) negotiations that could choke off the production and distribution of affordable generic medicines in developing countries. The EU in particular, is currently negotiating trade agreements with several developing countries including India, Thailand, ASEAN, Malaysia and Ukraine. This article is an attempt to highlight the harmful IP provisions being negotiated by EU bilaterally with India and Thailand.

The EU India FTA negotiations, now in their sixth year, continue to include measures that could seriously restrict production of generic medicines in India. Both European Union and India are keen to ink the deal well before elections in EU and India in 2014. The draft texts of IP chapter are not made available in public and the bilateral negotiations are being carried out under complete secrecy. However, leaked draft text of India-EU FTA available in public domain reflects presence of IP and investment provisions which would impact access to medicines and greatly restrict India’s right to use TRIPS flexibilities.

The negotiations on Thailand and EU FTA began in March this year with a very short deadline for concluding the deal in less than two years. Thailand is under extreme pressure to sign this FTA by end of 2014 as the Generalized System of Preferences (GSP) for Thailand will be withdrawn by EU January 2015 resulting in depletion of its exports to Europe. There is a strong apprehension among civil society that the EU will use this pressure to push Thailand to accept TRIPS Plus IP provisions that will further undermine access to affordable generic medicines for people in Thailand.

Proposed Intellectual Property Provisions in the EU draft text

Data exclusivity: extending monopoly status

Data exclusivity would prevent a drug regulatory authority from registering a generic medicine for as long as exclusivity lasts over the clinical trial data (usually five to ten years). In addition to bio-equivalence data that is currently required, domestic producers will additionally have to submit their own safety and efficacy data to register the generic medicines. This will oblige them to repeat clinical trials – something that takes years and involves costs that the generic companies usually cannot afford. But more importantly, the repetition of clinical trials raises serious ethical concerns.

This could be applicable not just for a new drug but also for any new formulation of an old medicine, even if itâs not patented. Big multinationals can thereby enjoy market exclusivity on a large number of medicines, charging exorbitant prices, even on drugs that do not deserve a patent or where the patent has expired.

A clear example of this comes from US, where the price of colchicine, a drug that has been used to treat gout for thousands of years, rose more than 5000 percent after data exclusivity was obtained by one company who chose to take legal action to remove competitors from the market (Kesselheim, A., Solomon, D., Incentives for Drug Development â Incentives for Drug Development â The Curious Case of Colchicine, N Engl J Med 2010; 362:2045-2047).

Public outrage at the impact EU proposal on data exclusivity would have on the worldwide availability of affordable Indian generic medicines, has contributed to the removal of this provision from the EU India FTA.

However, leaked documents from Thai negotiators seen by civil society indicate that EU is going to demand five years of data exclusivity under the trade agreement with Thailand.

Extending patent term durations

A patent term extension – also known as a supplementary protection certificate – would require a trading partner to extend a patent term beyond 20 years if there is any delay in the granting of a patent or in obtaining marketing approval for the medicine. In case of the paediatric formulations, patent protection could be extended for an additional three to five years. The extra years added to the patent are years in which the patent holder can maintain a monopoly position and continue to charge artificially high prices for the drug, free from generic competition.

A recent study in Thailand projected that if a 10 year patent extension was granted as proposed under the Thai-US FTA, over the next 20 years, the price index for medicines would increase by 32 percent; spending on medicines would increase from baseline to approximately US$11.19 billion; and the domestic generic pharmaceutical industry would lose $3.37 billion.

While EU has withdrawn the text on patent term extension from the FTA negotiations with India amid public pressure, it is expected to be part of negotiation under Thai-EU FTA.

IP Enforcement

In the EU India FTA, there have been several rounds of negotiations on IP and parties are currently finalizing provisions related to intellectual property enforcement measures.

The provisions cover trade in generic medicines, as the border measures can block legitimate medicines from leaving India on their way to people in developing countries. The border measures tabled by the EU give companies the right to lodge requests with Indian customs authorities to detain, suspend the release, or destroy shipments of generic medicines on the basis of allegations of IP infringement.

Further under this provision, multinational pharmaceutical companies based on a mere allegation that their IP is being infringed upon, could claim and instigate a number of actions. Third parties – such as treatment providers like MSF - could become subject to legal action in Indian courts for simply buying or distributing generic medicines. How the Indian courts handle disputes over intellectual property rights will also be affected. The judiciary will have its hands tied and will no longer be able to balance intellectual property rights with people’s right to health.

The harsh enforcement provisions tabled by EU under India EU FTA are similar to the ones given in Anti-Counterfeiting Trade Agreement (ACTA) that was rejected by European parliament last year. EU is now trying to bring in ACTA provisions through the backdoor through the FTA negotiations.

The same provisions are likely to be included in the IP chapter of the EU Thailand FTA.

Investment measures

The draft investment chapter that the EU is now proposing in FTA negotiations poses a direct threat to health-related regulation in India. The investment provisions would expand multinational companies’ ability to sue the Indian government when it regulates health in the public interest. Investor-to-state dispute mechanisms hidden in the investment chapter can be effectively used to sue governments outside of domestic courts, with large sums of damages being claimed in investor-friendly arbitration forums (such as the ICC, ICSID, UNCITRAL)[2] to generate rulings that favour the claims of multinational companies over the government’s right and need to regulate public health.

A pharmaceutical company could use this provision to sue the government if it decide to override a medicine patent, control /regulate the prices of a patented medicine or take any other action designed to boost access to more affordable generic versions of a patented medicine. Several disputes have already been filed by corporations against developing country governments, in order to force a reversal of governmental public health policies and judicial decisions on patentability.

In 2012, US pharmaceutical company Eli Lilly & Co. started proceedings against the government of Canada through the NAFTA investor-to-state dispute mechanism (Chapter 11). It claimed that the decisions of a Canadian court to invalidate its patent on the medicine atomoxetine, violated Canada’s obligations under NAFTA and the WTO. The company is seeking $100 million in compensation.

The intellectual property rules agreed at the WTO also lay down what countries can do when patented life-saving medicines are priced out of reach for governments and therefore the vast majority of patients. This process is called issuing a compulsory licence (CL), which allows manufacturers other than the patent holder to produce generic versions of the patented medicines in question. Thailand and more recently India have issued such CLs.

Pharmaceutical companies have previously demonstrated their willingness to threaten governments for issuing CLs on the grounds of “expropriation of IP.” For instance, in 2007, when the Brazilian government issued a compulsory license for an HIV drug efavirenz, the originator company Merck issued a press release expressing “profound disappointment” and calling this an “expropriation of intellectual property “.

Globally, more and more foreign investors are challenging domestic government policy measures, including changes to domestic regulatory frameworks. UNCTAD has revealed that 62 new cases were initiated in 2012, confirming that foreign investors are increasingly resorting to investor-state arbitration to solve disputes .

Investment provisions that continue to hold governments to ransom over health and other public interest regulations, and in particular the investor-to-state dispute mechanism have drawn sharp criticism and increasing calls for a global rethink and reform. As a result, many countries including South Africa, Brazil and Australia have announced their intention to exclude investor-to-state dispute mechanisms from future international trade deals.

EU is going to push both India and Thailand to accept such harmful investment provisions in its bilateral trade negotiations.

Free Trade Agreements: Is it really a win-win situation for all?

Several studies have been done to assess the impact of TRIPS plus provisions in free trade agreements on access to medicines. All of them point to the negative consequences of such provisions on availability and affordability of essential medicines.

For example, a study forecasting the impact of the EU-ANDEAN FTA on access to medicines in Colombia showed medicine prices would increase by 46 percent and health spending would increase by up to US$1 billion annually. As a result, five million Colombians would lose access to medicines and 12,000 people living with HIV would see their life expectancy drop between 5.3 and 9.9 years.

Such trade deals only add another layer of protection to existing patent rights, which already impede access to medicines for people. Public health advocates have long emphasised the negative impacts that can emerge from FTAs and how they can damage a countryâs ability to produce, import, register and procure affordable generic drugs.

Both India and Thailand have played a huge role in providing quality, affordable, lifesaving medicines in their respective countries. Public health safeguards in Indian patent laws and policies have made affordable drugs available not just in the country but to the other developing countries. Negotiators in the EU-India FTA should ensure that all harmful IP and investment provisions that impact Indiaâs role as a key supplier of affordable medicines, are removed before signing of this agreement in the coming months.

Thailand ensured access by first setting up public sector manufacturing facilities in the late 1990s to meet the needs of its public health program and then issuing a series of compulsory licenses for the procurement of affordable versions of lifesaving drugs used in the treatment of HIV and cardiovascular diseases. Signing the trade deal with EU having TRIPS plus measures will result in escalated cost of medicines and will put the countryâs public health e program at risk of collapse.

The EU claims that it respects international agreements which balance IP protection and access to affordable medicines such as the Doha Declaration on TRIPS and Public Health. However, European Commission (EC)- the negotiating wing of the EU on international trade deals- seems to be going in completely opposite direction. EC Trade Commissioner Karel de Gucht and his team continually place pressure on developing countries like India and Thailand to accept IP provisions more stringent than internationally-agreed standards.

Aggressive IP proposals will in the long run undermine the constitutional right to life; dismantle public health safeguards enshrined in national laws, and significantly reduce the local capacity to produce price-lowering generic medicines. Yet FTAs attract little public attention, as they are negotiated in secret, despite repeated requests from public interest groups to open them to public debate and parliamentary scrutiny.

The Government of India and Thailand should ensure that such FTA negotiations that affect public health must be conducted with adequate levels of transparency and public scrutiny, and access to the negotiating texts must be increased. They should also remain firm in their resistance to such proposals in negotiating FTAs, and ensure that public interest does not get overshadowed by commercial interest as failure to do so will cut have dire consequences for access to medicines for millions.

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Notes:

[1]United Nations Childrenâs Fund (UNICEF), United Nations Population Fund (UNFPA), the Presidents Emergency Plan for AIDS Relief (PEPFAR), and the International Dispensary Association (IDA)- world’s largest non-profit supplier of high-quality, low-cost generic drugs and medical supplies.

[2] International Criminal Court (ICC), International Centre for Settlement of International Disputes (ICSID), United Nation Commission on International Trade Law (UNCITRAL)

News Link n. 50

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

NEWS LINK 50

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Global Health and Idealism in the Age of "Voluntourism": Matching a Workforce’s Intention with Outcomes

In its present form, short-term medical trips represent a sub-optimally deployed resource. They could, however, address global health needs and issues, if we let them and if we facilitate them to do so in a socially conscious, appropriate way

Global Health and Idealism in the Age of “Voluntourism”: Matching a Workforce’s Intentions with Outcomes

by Lawrence Loh*

Adjunct lecturer at the University of Toronto’s School of Public Health, co-founder and Chief Medical Officer for The 53rd Week

In an era of social media dominated by Twitter and Facebook, it comes as no surprise that young health professionals worldwide are more aware than ever of global health issues facing our societies collectively. The idealism of youth foments individual desires to address poverty and inequality, reduce disease and disability, all while fostering wider transnational, intercultural understanding. At the same time, modern transport and communication links make it easier for them to identify opportunities and travel abroad, effectively allowing them to turn dreams into reality.

These young health professionals are deeply concerned with critical global health issues, often volunteering on a wide range of charitable activities at home and abroad. Research topics focus on various global issues, and advocacy takes place both through traditional routes as well as an ever-growing number of issue-based societies. Volunteers travel the world, providing service and skills with organizations big and small. Constantly interconnected by the web, today’s young leaders produce homemade videos to raise awareness, source donations through crowd-funding online, and lobby their leaders through the flattened world of e-mail and social media.

The impact of such efforts matches their heterogeneity, with initiatives ranging from large and readily apparent changes to potentially harmful outcomes for stakeholders. One only needs to look at the speed by which internet “memes” spread to understand how quickly information can be disseminated if the right vehicle is used. Many organizations and campaigns have successfully used the reproducibility and transferability of social media today to raise awareness of critical global health issues. At the same time, other well-meaning efforts driven by young professionals have far more questionable benefits and potential harms.

Increasing popular media coverage has focused on the impact of volunteering abroad, often called “voluntourism”, and the sometimes negative effects such well-intentioned efforts have on the receiving communities. Interested visiting volunteers from the developed world clearly gain much from these experiences, and often go with the very best of intentions. Despite this, there is growing sentiment that improperly conducted efforts come across as self-serving, given the ethical and sociocultural considerations involved, the unequal relationship between visitor and host community, and the significant draw on local resources to the resultant minimal impact of such efforts.

This growing sentiment, together with popular media anecdotes of the harms of “voluntourism”, often are simple analyses that have yet to account for a number of key considerations. Firstly, there exists a real need for skilled human resources to address critical global health issues in the developing world, which already suffers from shortages due to the outmigration of skilled workers. Secondly, global health problems continue to grow unabated in quantity and quality, and interest in addressing these problems comes from both governments and young professionals. Finally, such efforts represent huge collective investments -both in terms of finances, manpower, and intellectual effort- from volunteers, sending organisations, and local partners. It is an investment that is currently not being optimally realised.

Taking this classic puzzle in business terms, there is a clear need, a defined interest, investment and product, and suboptimal returns and outcomes. What is the market outlook? What is the context in which these operations currently occur? And finally, what are some strategies we can use to ensure these investments produce the primary and secondary outcomes we are looking for, and what are those desired outcomes?

Market outlook: need, interest, and barriers

Global health is everywhere in today’s world. Definitions abound about what constitutes a global health issue, but simply put, Koplan’s definition stands as the most simple: global health is about the issue, not where the issue is located; any health issue with transnational implications is “global” by nature. Some examples include the emerging infectious disease threats, growing non-communicable disease, climate change, the epidemic of injury, and the scourge of extreme poverty and malnutrition alongside a contemporary nadir of mental health. For young health care professionals, the need is real, and they feel a desire and capability to address challenges in the context of their diverse interests and skill sets.

Global health is valued. Experience abroad is look at favourably on resumes, institutions with global health programmes are more heavily sought after by top students, and whole local economies in the developing world rely on foreign aid and visiting team contributions to their programs. A 2011 survey of medical students in the United States found that 65% of respondents expected to participate in a global health opportunity abroad. These volunteers participate for myriad reasons; while all often intend to “do good” or “make a difference”, they often harbour personal growth goals as well.

Global health work occurs in a modern world where jet travel makes it possible to be anywhere within 36 hours; a world where a single mobile phone provides more knowledge than has ever been historically available to an ordinary citizen. At the same time, that modern world constrains the finances and times of young professionals through extensive training requirements, complex daily schedules, and limited holiday time. Short-term volunteer opportunities thus become the only viable outlet for interested young professionals looking to develop a global health interest.

The market outlook thus suggests that interest and participation in short-term global health work will continue to grow, given the continuing population health challenges coupled with expanding interest and access to various opportunities.

Context: harms, benefits, and values

Various stakeholders dictate the terms of short-term medical volunteerism’s present context. Traditional global health agencies, such as Doctors without Borders (MSF), have often attracted many global health volunteers previously. However, their extensive time and training requirements limit the ability of many young professionals to commit to their work abroad. The concept that “long term work” is the only way to do global health abroad is a holdover from a previous era, where those who wanted to “make a difference” abroad often packed up the van, moved away from the industrialised world to a less developed country for decades, and crafted a career and commitment that way.

Short-term volunteerism abroad, of which medical work is one small part, is a disruptive change that has particularly arisen in North America (but also in Australia, New Zealand, and Western Europe) since the late 1990s. Consider the proliferation of “alternative spring breaks” or “service trips” that have popped up from institutions ranging from major universities to small-sized non-governmental organisations (NGOs) and churches/community centres. A simple Google search for “medical missions” or “short-term medical trip” comes up with tens of thousands of results. These trips represent enormous numbers of volunteers being sent abroad. Leaving aside the obvious variability (particularly in their impact and ethics), the assessment of benefits and harms from these trips is critical.

Young healthcare professionals clearly benefit from going abroad. Research has documented the obvious benefits - exposure to disease entities and presentations not available at home, increased clinical acumen which feeds decreased reliance on diagnostic testing, and the development of professional networks and relationships both with the community abroad and with other members of the team they join. They also develop an awareness of global health issues and the need that is out there and are better placed to act as advocates, having experienced it first-hand.

The proliferation also reflects the benefits for sending organisations. For medical schools, many faculty and medical student candidates are looking for international connections to pursue research or advocacy work. Running short-term educational experiences abroad allows these institutions to attract top candidates, gain stature, and win funding for these efforts.

The picture is less clear for the receiving communities abroad. Many short-term volunteer efforts focus on manual labour (e.g. painting schools or building houses) or downstream interventions (e.g. clinical care or surgery.) More upstream interventions that address the underlying determinants of health are less often addressed, as the length of time these trips occur within precludes a deeper examination of the issues. Together with this limited benefit, the communities experience numerous harms; they often commit limited resources to hosting such trips, and while they are developing relationships with professionals from abroad, such relationships often occur within an unequal power dynamic. More challenging is the nature of the benefits received; there is no continuity of care or follow-up to deal with complications, and the power inequality precludes the local community from dictating what their priorities might be.

The final perspective, perhaps, is to look at what short-term volunteerism offers the world. While the power dynamic is a concern, few can argue that the carrying out of these relationships does build some form of a relationship which helps to flatten the world and build bridges between communities. Such efforts provide a vehicle to increase understanding between disparate peoples and reaffirms societal values of charity and altruism. The data that arises from these trips can also be used to support research and biosecurity efforts. The harms from a world perspective include the potential expense of resources and the carbon footprint, and the ongoing perpetuation of a colonial mentality (related to the previously described power dynamic), but one can argue that breaking down boundaries between world communities is an opportunity that we shouldnât waste.

Considering the foregoing, there seems to be a sea change in values and beliefs related to global health work. Many young physicians who are interested in pursuing work abroad describe frustration with the old models and being able to build a career that allows them to contribute to meaningful initiatives. Long-term strategies, while still valuable, are less attractive to a generation that only has short-term time and finances to offer. At the same time, however, our societal values of altruism, volunteerism, and charity remain very much in place. It would seem the question should focus less on the value of such trips - that’s clear and evident right now. Rather, our question should be how we can take these deeply personal investments and make the more impactful, allowing them to retain current benefits while mitigating harms.

There is an opportunity here to make the short-term paradigm more effective, and to ensure that all these newly proliferating alternative spring breaks and medical mission efforts are not causing harm, but are recognised as valuable human resources making a genuine impact to mitigating global health needs.

Where to from here? Strategies and perspectives

Many traditional organisations have come out and identified problems with short-term medical volunteerism. One non-profit organisation, for example, has come out and called them the “worst practices” in global health. Discussions on the issue are widespread but have not kept up with the growth in interest. A 2008 paper by Maki and others found that over a quarter of a billion dollars and 6000 volunteer hours had been invested in published efforts alone, and this has likely only grown in the years since. While many global health stakeholders are aware of the issue, few people have begun to suggest viable solutions; short of closing off the airport and preventing people from going, what can the global health community do to optimise these experiences and their outcomes?

That same community is ever acutely aware of the challenges they face in the post-Millennium Development Goal that is only under a thousand days away. There have been calls by the World Health Organization to promote universal health coverage and by the World Bank to eliminate extreme poverty by 2030. These are not simple goals. They will require significant human resource and financial commitments by governments that are cash-strapped following an economic crisis. At the same time, concomitant threats in the rise of chronic disease, mental health, injury, and emerging communicable disease threats (particularly antimicrobial resistance) threaten to set back all the progress that has been made by the global health community in the past decades.

It’s time to stop ignoring short-term volunteer trips and dismissing them as “band-aid.” They are only band-aid if we let them be. If anything, they represent an opportunity to crowd source and harness the idealism and manpower of a young generation of physicians, nurses, pharmacists, and allied health professionals, as well as professionals from other disciplines. There needs to be greater grant support and research funding to help understand this phenomenon and how it can support global health work.

Could we take short-term trips and crowd-source them towards addressing the social determinants of health? Instead of going to a community for a week and handing out pills, could twenty or thirty coordinated short-term teams instead work on building a water sanitation system or professional development that supports the development of local capacity? If people are going to put their efforts into such means anyway, can we not figure out ways to make sure the means justify the ends?

The next generation is idealistic and wants to make a difference. It falls to us to train them and come up with paradigms that allow the appropriate, ethical harnessing of their passion and involvement. Done right, these trips could retain all the benefits of breaking down global barriers, while having the added of bonus of adding genuine global impact.

The old paradigm of packing up the van and moving to Africa for twenty years is less relevant today; short-term volunteerism is here to stay. It is in our interest to not ignore it, but rather challenge and understand it. In its present form, short-term medical trips represent a sub-optimally deployed resource. They could, however, address global health needs and issues, if we let them and if we facilitate them to do so in a socially conscious, appropriate way. Taking these steps today will ensure that a new generation of global health practitioners will be at the table, not just considering the hard questions of our time, but instead actively answering them and safeguarding the future of their children and our ever-changing world.

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*Dr. Lawrence Loh is a global public health and family physician based in Toronto. He serves as a medical specialist for the Public Health Agency of Canada and as an adjunct lecturer at the University of Toronto’s School of Public Health. A proud alumni of the Schulich School of Medicine at the University of Western Ontario, he completed his residency at the University of Toronto and obtained his Master of Public Health from the Johns Hopkins Bloomberg School of Public Health. He serves as co-founder and Chief Medical Officer for The 53rd Week and is committed to reducing the harms and maximising the outcomes of short-term global health experiences through awareness advocacy, innovation, and research.

To learn more about what The 53^rd Week is doing to improve short-term volunteerism abroad, visit www.the53rdweek.org

News Link n. 49

News Link 49

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News Link 48

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Final Two WTO Director Candidates Highlight Technology And IP

Of Evergreening and Efficacy: the Glivec Patent Case

An important case  was decided this month that may have a significant impact on access to medicines for patients in developing countries. India's high court rejected an appeal by the pharmaceutical company Novartis to grant a patent for its anti-cancer drug Glivec.

In the aftermath of this case, it is more likely other countries will follow India's lead.

Of Evergreening and Efficacy: the Glivec Patent Case

by Ryan Abbott*

Associate Professor of Law at Southwestern Law School, Los Angeles

An important case [1] was decided this month that may have a significant impact on access to medicines for patients in developing countries. India’s high court rejected an appeal by the pharmaceutical company Novartis to grant a patent for its anti-cancer drug Glivec.

Judging by recent public comments, this will be a landmark case. On the Novartis website [2], where the company is hosting an impressive array of resources devoted to the Glivec patent case, it states that this “decision discourages innovative drug discovery essential to advancing medical science for patients.” Eric Althoff, a Novartis spokesman said, if “innovation is rewarded, there is a clear business case to move forward. If it isn’t rewarded and protected, there isn’t.” On the opposite side of the spectrum, Indian Trade Minister Anand Sharma called the ruling “a historic judgment” that reaffirmed the position of Indian law requiring substantive innovation for patent protection. The Supreme Court itself noted that the “debate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our constitutional scheme) at a minimum.”

Despite the controversy, this case won’t necessarily have a wide ranging impact. It involved some unusual elements, which require historical background in India’s patent system to understand.

At the time of India’s independence in 1947, the country’s patent regime permitted patents for pharmaceutical products. However, there was a sentiment that pharmaceutical product patents catered to multinational corporations (MNCs) at the expense of domestic companies. For example, one study found that only 10 percent of Indian patents were held by Indians or Indian companies. As a result, a series of amendments to India’s Patent Act gradually eroded patent protections for pharmaceutical products. This culminated in the passage of a new patents act which expressly excluded product patents for medicines (the Patents Act, 1970, which came into force in 1972 and replaced the Patents and Designs Act, 1911).

The rise of the domestic Indian pharmaceutical industry has been partially attributed to this scaling back of patent protection. In 1970, MNCs enjoyed a 68% market share of the Indian pharmaceutical market. In 2003, Indian companies collectively commanded a 77% market share. Moreover, this has occurred in a growing market. The domestic Indian pharmaceutical market has been projected to reach $49-74 billion by 2020. India is already the largest exporter of generic drugs in the world, and as the Supreme Court noted, India has become the “pharmacy of the world.” For instance, it supplies over 80% of HIV/AIDS medicines for the 8 million HIV-positive patents in low- and middle-income countries. India does not only export to the developing world; India’s largest export recipient is the United States.

India’s patent regime was profoundly impacted by the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which came into force on January 1, 1995. TRIPS is a comprehensive multilateral agreement that establishes minimum levels of intellectual property protection for all members of the World Trade Organization (WTO), including India. It requires that patent protection be made available for pharmaceutical products.

India, along with a number of other developing nations, was afforded a transition period to amend its patent system to comply with the requirements of TRIPS. Specifically, India was permitted to delay application of TRIPS provisions for five years until 2000, with an additional five year delay permitted for pharmaceutical product patents. However, Article 70.8 of the TRIPS Agreement required India to adopt an arrangement called “the mailbox procedure.” This allowed applicants to file product patents that would lie dormant until the expiration of the transition period. Under this system, a product patent could not be granted on a pharmaceutical product filed before 1995, while patents could be granted for applications filed from 1995-2005 that would become effective after 2005.

That is one reason why the Glivec product case is unusual; Glivec was invented during a transitional time for the Indian patent system. Novartis filed an initial patent application in the U.S. for the drug “imatinib” (in free base form) in 1992. If that drug would have been invented today, it would have enjoyed a twenty-year period of patent-based market exclusivity in India.

Cases involving the transition period are going to be less relevant in the future. Most of the countries that have domestic production capability are now committed to TRIPS, or even TRIPS-plus, patent protection. While the 2001 WTO Ministerial Declaration on the TRIPS Agreement and Public Health adopted in Doha (the Doha Declaration) extended the period for compliance with pharmaceutical provisions to 2016, this only applies to least developed countries (LDCs). LDCs generally lack significant pharmaceutical manufacturing capability.

The primary legal issue in the case, however, went beyond issues specific to the transition period and involved challenges to Section 3(d) of India’s patent act, which stipulates that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not eligible for patent protection. It is designed to prevent evergreening, a term used to label practices where a small change is made to an existing product and claimed as a new invention. When Section 3(d) was enacted in 2005, it was unique to India – there was no analogous provision in any other country.

Even if imatinib had been patented in India in 1992, that patent would have expired last year. (In point of fact, the U.S. patent did not expire last year – the patent term was extended for 586 days to “compensate” for the delay necessitated due to Food and Drug Administration [FDA] review). That is why, in an effort to extend patent protection for Glivec, Novartis filed a second patent application in 1997. The second application was for a specific variation (the beta crystalline form [it can also exist in alpha form or in amorphous form]) of the salt of imatinib (imatinib mesylate). That patent is due to expire in the U.S. in 2019 (it also received an extension). In 2001, the U.S. Food and Drug Administration approved “imatinib mesylate” for marketing. While the active ingredient of Glivec is imatinib in its free base form, capsules contain imatinib mesylate because it has percent greater bioavailability.

In the Glivec patent case, one of the central questions before the court was whether the “new” drug form qualified for a patent under Section 3(d). The court ruled that it did not.

To arrive at this conclusion, one of the more interesting issues the court had to resolve was how to define efficacy. It elected to define efficacy as therapeutic efficacy, but even within that definition the court was presented with multiple visions.

On the one hand, efficacy could be thought of as the capacity of a drug to produce an effect. That is, the property of a drug that causes a stimulus at a receptor site, as distinct from characteristics such as affinity, potency, and bioavailability. A broader conception of efficacy would include considerations such as improved safety or reduced toxicity.

Theoretically, I suspect a more holistic approach is justified. At the extreme end of the spectrum, a new drug could cure multiple sclerosis yet be so toxic it kills more patients than it helps. If a new form of the drug is discovered that is not better at treating multiple sclerosis but that doesn’t cause any side effects, it would be hard to argue that it isn’t a leap forward in efficacy.

The broader question is where in the development chain someone should be entitled to a patent. Not too long ago, the U.S. Patent and Trademark Office required significant evidence of clinical efficacy for pharmaceutical product patents to comply with the utility requirement. In re Brana (Fed. Cir. 1995) changed that, when the Court of Appeals for the Federal Circuit decided it would deter innovation to require FDA approval or even Phase II testing to find a compound useful within the meaning of the patent law. Amgen Inc. v. Hoechst Marion Roussel, Inc (Fed Cir 2006) went further and held that therapeutic utility is not dependent on a product having an effect in a living being, such as curing disease.

Now researchers try to patent compounds at the earliest available opportunity, a trend which is only going to intensify in the U.S. with last month’s transition from a first-to-invent system to a first-to-file system under the America Invents Act. For good reasons the pharmaceutical industry is involved in a competitive race, but there is no great philosophical reason that the finish line for patentability should be closer to the moment a new compound is generated. The proposition that a new form of a drug should be more effective to get a patent isn’t that radical. It would mean researchers would spend less time racing to invent compounds, and more time discovering what compounds do.

On a doctrinal level, the Indian Court’s decision is consistent with U.S. Supreme Court decisions that set limits on patentability and intellectual property protection. For example, just last month in Kirtsaeng v. John Wiley & Sons the U.S. Supreme Court ruled that the first-sale doctrine applies to lawfully made works manufactured abroad and imported into the U.S.

Novartis had at one point tried to argue that Section 3(d) was unconstitutional under the Indian constitution and non-compliant with TRIPS, but those arguments were rejected by the High Court at Madras in 2007. Novartis did not appeal those decisions. The High Court rejected the TRIPS claim because in India private plaintiffs may not challenge a national law based on its compatibility with an international agreement. However, the court also referred to the Doha Declaration, which affirms that “the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” This means that WTO members can set their own standards for patent protection within the bounds of TRIPS. Section 3(d) establishes a higher standard for an inventive step, which means that drugs patentable in other countries won’t necessarily be patentable in India.

Narrowly then, in India, there are a number of pre-grant opposition cases currently being appealed by pharmaceutical companies. If the Supreme Court had weakened the interpretation of Section 3(d), it could have allowed denied applications to be granted on appeal. Aside from that, it’s possible that this decision will have limited impact given that it involves issues fairly specific to India.

Yet some other countries, such as Argentina and the Philippines, have already incorporated provisions similar to Section 3(d). As a consultant for Health Research for Action in 2009, I coauthored a report [3] recommending to Caribbean nations that they adopt provisions like Section 3(d). In the aftermath of this case, it is more likely other countries will follow India’s lead.

More importantly, India’s victory in this case may be a signal regarding changing political attitudes toward the demands of MNCs. Historically, MNCs have taken a hard line against “lax” patent protection for pharmaceutical products. Even as recently at 2006 and 2007, Thailand faced retaliation after issuing compulsory licenses for two on-patent HIV/AIDS drugs and an antiplatelet drug. Abbott, the maker of one of the HIV/AIDS drugs, subsequently withdrew all applications to register medicines in Thailand. The United States Trade Representative (USTR) then placed Thailand on the 301 Report’s Priority Watch List and threatened to terminate Thailand’s export privileges.

India is becoming increasingly assertive with regards to IP protections. Last year, India’s Patent Office issued its first compulsory license to a generics manufacturer for an on-patent medicine. The Indian company Natco is now licensed to produce and sell a generic version of the Bayer anti-cancer drug Nexavar. India also revoked Pfizer’s patent for its anti-cancer drug Sutent. Both companies are appealing.

These actions may portend a shift in North-South dynamics if the pharmaceutical industry fails to significantly change its model. Glivec and Nexavar can both cost $70,000 a year in India, where the average person makes $1,500 annually. Those economics are simply unworkable, even though Novartis and Bayer both provide free distribution programs for certain cancer patients.

Roy Waldron, the Chief Intellectual Property Counsel for Pfizer, stated [4] last month that, “India has taken steps that call into question the sustainability of foreign investment and the ability of American companies to compete fairly. In fact, the Global Intellectual Property Center’s International Intellectual Property Index [the GIPC is part of the U.S. Chamber of Commerce], ranked India dead last in terms of overall protection of intellectual property. Despite being a member of the World Trade Organization, and an important global trading partner, India has systematically failed to interpret and apply its intellectual property laws in a manner consistent with recognized global standards.” He concluded the U.S. government should signal such actions are not condoned, and that the U.S. should pursue a robust trade agenda. MNCs and developed countries such as the U.S. continue to push for higher levels of intellectual property protection in bilateral and regional free trade agreements, and in multinational agreements like the Trans-Pacific Partnership Agreement (TPP).

Still, there is no way MNCs will make good on threats to withdraw innovative medicines from India. First, because with the possible exception of certain biological drugs, Indian generics companies could domestically produce just about any drug MNCs fail to introduce. Second, India’s pharmaceutical sector is booming; the domestic market is expected to experience double-digit growth this year, and it is among the top five pharmaceutical emerging markets. India’s pharmaceutical sector attracted foreign direct investments worth $4.9 billion in 2000-2011. It is unlikely that anyone’s business model will call for exiting that market on the basis of a legitimate patent law interpretation.

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* Ryan Abbott, M.D., J.D., M.T.O.M., is Associate Professor of Law at Southwestern Law School. He has served as a consultant on health care financing and regulation, intellectual property, and public health for international organizations, academic institutions and private enterprises including the World Health Organization, World Intellectual Property Organization and University of California, Los Angeles. Professor Abbott has published widely on issues associated with health care law and intellectual property protection in legal, medical, and scientific peer-reviewed journals.

Professor Abbott is a licensed physician, attorney, and acupuncturist. He is a graduate of the University of California, San Diego School of Medicine and the Yale Law School, as well as a Summa Cum Laude graduate from Emperor’s College (MTOM) and a Summa Cum Laude graduate from University of California, Los Angeles (BS). Professor Abbott has been the recipient of numerous research fellowships, scholarships and awards, and has served as Principal Investigator of biomedical research studies at University of California. He is a registered patent attorney with the U.S. Patent and Trademark Office and a member of the California and New York State Bars.

[1] http://www.scribd.com/doc/133343411/Novartis-patent-Judgement

[2] http://www.novartis.com/newsroom/product-related-info-center/glivec.shtml

[3] http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1909978

[4] http://waysandmeans.house.gov/uploadedfiles/pfizer_testimony31313.pdf

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Investors’ IP Rights Unbound: The Danger of Investment Clauses to Access to Medicines

Although access to medicines activists have been wise to focus our attention intently on convincing low- and middle-income countries to adopt and use all possible TRIPS-compliant flexibilities and to oppose the TRIPS-plus IP chapters in free trade agreements, we have neglected to interrogate another chapter in free trade agreements and bilateral investment treaties that perhaps pose an even greater threat to our collective access to medicines’ investment chapters

Investors’ IP Rights Unbound: The Danger of Investment Clauses to Access to Medicines

by Prof. Brook K. Baker*, Policy Analyst Health GAP, Northeastern U. School of Law, Program on Human Rights and the Global Economy, Honorary Research Fellow, University of KwaZulu Natal

April 20, 2013

Access-to-medicines activists have recently had much to celebrate. In India, the Supreme Court upheld India’s strict standards of patentability and rejected an “evergreening” patent on Glivec, an important cancer medicines that Novartis sells for $70,000 per year [i]. Earlier last year, the Indian Comptroller of Patents issued India’s first compulsory license on a Bayer cancer medicine, Nexavar, to Natco, thereby shaving the price by 97%. The Intellectual Property Appellate Board of India affirmed that decision which is now on appeal to the High Court [ii]. On the trade front, India health activists succeeded in convincing the Indian government to reject European demands in EU-India trade negotiations that would have imposed data monopolies and extended the length of patent monopolies [iii]. Fortunately, India is not acting alone; Indonesia also quietly issued compulsory licenses on seven hepatitis and HIV antiretroviral medicines last year [iv], and Argentina recently adopted proactive guidelines to restrain secondary patents on minor modifications to existing medicines[v]. Last summer, the over-reaching Anti-Counterfeiting Trade Agreement was rejected by the generally pro-IP European Parliament [vi] and Europe was forced to reconsider its draconian border measures that had resulted in the seizure of lawful in-transit medicines in the Netherlands and elsewhere [vii].Even the U.S. is reconsidering its willingness to patent isolated genes[viii] while Canada is accelerating its rejection of patents on medicines that fail to make required disclosures, e.g., Pfizer’s Viagra [ix].

We could wish that the tide was irreversibly turning against the excesses of patent and data monopolies on medicine that erect ever-higher and stronger exclusivity barriers that price poor people and poor countries from accessing life-saving public goods. But anyone who thinks that Big Pharma is sitting still and that their allies in European and US trade offices have found a new religion is dangerously wrong. We’ve know for a decade and a half that Big Pharma and its rich-country trade rep allies have been seeking to ratchet-up longer, stronger, and broader patent and data monopolies in a string of bilateral and plurilateral free trade agreements such as US-CAFTA and EU-Caricom [x]. Those efforts are intensifying in the TRIPS-plus demands that the US and EU are putting forth in current negotiations, e.g., the Trans-Pacific Partnership Agreement [xi] and the EU-India FTA. In these trade negotiations, the US and EU typically seek patent term extensions, eased standards of patentability, restrictions on patent opposition procedures and patent revocations, data exclusivity [xii], and greatly enhanced enforcement powers in terms of “deterrent” damages, mandatory injunctions, enhanced border enforcement, and expanded criminal enforcement [xiii]. This IP-maximalist agenda is pursued not only in secret free trade agreement negotiations, but through diplomatic pressure, threats of sanctions found in IP/trade assessments (like the U.S. Special 301 Watch List), biased technical assistance and training to IP examiners and judges, and a thorough-going disinformation campaign that casts intellectual property rights as irreducible and irreplaceable, as the only engine for innovation and creativity, and as the prime fount of foreign direct investment, technological advancement, and development more broadly [xiv].

Under investment chapters, foreign IP investors, like Novartis and Bayer, are recognized as “investors” who have made “investments” involving expenditures and expectations of profit [xv]. Suddenly intellectual property rights, already hugely protected, are given another mantle of protection, namely protections as investments. In addition, investors are given rights to bring claims for private arbitration directly against governments whenever their expectations of IP-based profits are frustrated by government decisions and policies. Decisions of these private arbitral tribunals consisting of three international trade lawyers are not subject to judicial review, but are reducible into court judgments that can be levied against government property.

Using loose and imprecise standards addressing “minimum standards of treatment,” “indirect expropriation,” and “national treatment,” multinational pharmaceuticals might claim that denying patents, granting oppositions, revoking patents, issuing compulsory licenses, and registering generics while referencing clinical data or doing so before patent expiration all violate their legitimate expectations for profit. Although the “minimum standards of treatment” clause was originally designed to prevent grossly abusive and discriminatory courtroom adjudications totally outside the bounds of normative due process, it has morphed to decisions with a much more lenient standard that rewards investors even when they have been given a full panoply of due process safeguards. The expropriation standard, originally adopted to deter nationalization of businesses and seizures of real property has similarly morphed to prevent indirect expropriations, what we call regulatory takings in the U.S., where changes in government regulations - many designed to protect public health, environment, and other legitimate public interests - are challenged as having diluted the investor’s expectations of profit. Finally, the national treatment standard, though originally adopted to ensure that foreign investors are treated equivalently to domestic investors, is also morphing in new directions.

Threats like these with respect to pharmaceutical IPRs used to be theoretical, but the theoretical has now become real. In November of 2012, Eli Lilly sued the government of Canada for $100 million under NAFTA’s investment chapter because Canada invalidated a Bayer patent on a medicine used to treatment attention deficit disorders [xvi]. Courts in Canada, including its Court of Appeals, reviewed the patent in depth as part of an invalidation case initiated by Teva. The patent was declared invalid pursuant to requirements in Canadian patent law that an applicant must satisfy its “promise of utility” (more commonly called industrial applicability) by disclosing evidence pointing to a claimed benefit as an inventive medicine. Eli Lilly objected because the promise doctrine had been developed judicially and that it had been clarified only after Bayer had filed its common patent application in the format authorized by the Patent Cooperation Treaty, of which Canada was a member.

Eli Lilly didn’t like this ruling, so it is seeking to greatly expand the accepted meanings of minimum standards of treatment, indirect expropriation, and national treatment to argue that Canada should not be able to modify any of its patent standards or even to have a patent standard on utility and disclosure of utility that is any higher than that currently practiced in the US and EU. It argues further that it should not have to disclose information needed to satisfy patent requirements in Canada that is above and beyond what is required in patent applications filed pursuant to the Patent Cooperation Treaty, even thought the PCT clearly covers procedures for filing patent applications, not substantive requirements of patentability enforced as a sovereign rights by each country. It is important to note that Eli Lilly is pursuing a patent invalidation claim despite an express provision in the NAFTA investment chapter that purports to exclude NAFTA-compliant patent granting, revocation, and compulsory license decisions from investor dispute resolution [xvii].

If Eli Lilly can file this kind of expansive, topsy-turvy claim in Canada with respect to its decision to revoke a patent, what would prevent Novartis and Bayer from filing comparable claims against India because it too has adopted strong protections against evergreening in section 3(d) of its Patents Act and has allowed compulsory licensing in section 84? India has international investment agreements with 82 countries and has been subjected to 17 known investor-state claims [xviii]. Although no claims to date have been brought based on pharmaceutical IPRs, these are exactly the kinds of claims that a major international corporate law firm, Jones Day, is urging companies to file under existing investment clauses that India has ill-advisedly entered into [xix].

Novartis and Bayer, and the rest of Big Pharma, are relentless in their search for monopoly rights and monopoly profits. The right to sue governments directly when their unquenchable thirst for profits is thwarted is a dangerous escalation of corporate power. These kinds of investor cases are expensive to defend (average cost to governments over $8 million/case) and have cost taxpayers globally nearly $3 billion and counting. Five hundred and eighteen known investor-state cases have been filed, of which only 244 have been concluded [xx]. The pace of new cases is escalating (62 new cases filed in 2012 alone), as is the rate of investor wins (70% of investors claims decided on the merits in 2012 were favorable to claimants). When investors win, they can win a lot, like the $1.77 billion, plus compounded interest, costs, and attorneyâs fees, awarded to Occidental in its claim against Ecuador. But even when they don’t win, investors can coerce settlements on favorable terms (approximately 27% of case are settled). Once the pharmaceutical floodgate is unlocked, the number of claims and taxpayer exposure will expand as well.

India and other trade negotiators should heed the entreaties of trade, IP, and health activists who are warning against the inclusion of an Investment Clause in the EU-India FTA [xxi], the Trans-Pacific Partnership Agreement, and in the many other trade agreements that are underway or soon-to-be initiated. Preferably, investment chapters will be rejected in their entirety, as they are becoming a corporate sword of Damocles that hangs over the head of rich and poor governments alike. At the very least, IP should be totally defined out of “investments” and no investor claims whatsoever should be available for alleged frustration of IP-based expectations. IP right holders already have multiple forms of enforcement including private lawsuits, border seizures, criminal prosecution, and state-state dispute resolution. Enough is enough. Expanded and unbound investment rights for Big Pharma under the cover of underscrutinized investment chapters is a grave threat - a threat with deadly consequences to millions of patients who rely on governments’ rights to regulate IPRs and to use any and all TRIPS-compliant flexibilities to ensure affordable access to medicines for all.

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[i] Novartis cancer drug patent bid rejected by Indian court in landmark ruling, The Guardian (April 1, 2013).

[ii] Patent board rules in favour of Natco in cancer drug case; Bayer to challenge decision, CNN-IBN Live (March 5, 2013).

[iii] India-EU FTA won’t hit generic drugs industry: EU envoy, Business Standard (April 13, 2013).

[iv] Indonesia to override patents for life-saving medicines, IRIN News (March 25, 2013).

[v] Argentina adopts new guidelines to examine patent applications for pharmaceuticals, Don’t trade our lives away (May 31, 2012).

[vi] European Parliament rejects ACTA piracy treaty, The Telegram (July 4, 2012).

[vii] India Ministry of Commerce and Industry, India EU Reach an Understanding on the Issue of Seizure of Indian Generic Medicines in Transit (July 28, 2011); see Brook K. Baker, Settlement of India/EU WTO Dispute re Seizures of In-Transit Medicines: Why the Proposed EU Border Regulation Isn’t Good Enough, PIPIF Research Paper Series (2012).

[viii] Justices Consider Whether Patents on Genes are Valid, New York Times (April 14, 2013).

[ix] Canadaâs Supreme Court strips Viagra Patent from Pfizer, Reuters (Nov. 8, 2012).

[x] Baker, B. and Avafia, T., (2011), The Evolution of IPRs from Humble Beginnings to the Modern Day TRIPS-plus Era: Implications for Treatment Access. Working Paper prepared for the Third Meeting of the Technical Advisory Group of the Global Commission on HIV and the Law, 7-9 July 2011.

[xi] Sean M. Flynn, Brook Baker, Margot Kaminski & Jimmy Koo, The U.S. Proposal for an Intellectual Property Chapter in the Trans-Pacific Partnership Agreement, 28 Am. U. Intâl L. Rev. 105, 149-184 (2012).

[xii] Id.

[xiii] Id. at 183-200.

[xiv] Brook K. Baker, Debunking IP for Development: Africa Needs IP Space, Not IP Shackles (draft 2013).

[xv] Trans-Pacific Partnership, Intellectual Property Rights Chapter September 2011 Draft (Selected Provisions), available at http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificIP1.pdf. See Brook K. Baker, Corporate Power Unbound: Investor-State Arbitration of IP Monopolies â Eli Lilly and the TPP (draft 2013).

[xvi] The investor-state claim is Eli Lilly and Company v. The Government of Canada, Notice of Intent to Submit a Claim to Arbitration under NAFTA (Nov. 7, 2012), available at http://italaw.com/sites/default/files/case-documents/italaw1172.pdf. See Public Citizen, U.S. Pharmaceutical Corporation Uses NAFTA Foreign Investor Privileges Regime to Attack Canadaâs Patent Policy, Demand $100 Million for Invalidation of a Patent (2013).

[xvii] NAFTA, Article 1110(7).

[xviii] Biswajit Dhar, Reji Joseph & T.C. James, India’s Bilateral Investment Agreements: Time to Review, 52 Economic & Political Weekly 113-122 (2012).

[xix] Jones Day Commentary, “Treaty Protection for Global Patents: A Response to a Growing Problem for Multinational Pharmaceutical Companies,” 3 (October 2012).

[xx] UNCTAD, Recent Developments in Investor-State Dispute Resolution (2013).

[xxi] Does the EU/India free trade agreement spell the end of cheap drugs for poor countries?, The Guardian (February 10, 2013).

*Brook K. Baker is a law professor at Northeastern University School of Law (US) and an affiliate of its Program on Human Rights and the Global Economy. He is also an honorary research fellow at the University of KwaZulu Natal, Faculty of Law, South Africa. He is a policy analyst for Health GAP (Global Access Project) and writes frequently on IP, trade, and access to medicines issues.