More than half of a total population of 5 billion people in developing countries rely on less than $2 per day. Patent protection has been criticized for hampering non-discriminatory access to medicines by delaying competition from generic versions of drugs and extending unaffordable monopoly prices for brand-name products.
High-quality, cheap medicines for tuberculosis, malaria and HIV – also as combination treatments – are currently being manufactured in India. Since such drugs from India (as well as South Africa and elsewhere) serve as a lifeline to resource-limited countries, it is a priority that their production is safeguarded.
As a World Trade Organization member, India has an obligation to enforce patent protection rules. However, its drug programs – and the export of medicine to developing countries in Africa and elsewhere – may be jeopardized by free trade agreements and intellectual property enforcement agendas that go beyond the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS.
These policies are under consideration at a time when many Indian drug companies are being taken over by multinational corporations eager to gain control of the country’s market. The brand industry, indeed, is increasingly looking to emerging markets in the Asia-Pacific area, where a number of well-off elites (300 million people in India, at least 800 million in China) can afford out-of-pocket spending on health care, and the rising wealth is contributing to increased rates of chronic diseases.
Things might change now that Southern drug industries, with their high-level skills in innovation, manufacturing and marketing, are increasingly engaged in South-South commercialization partnerships and in North-South outsourcing ventures for research and development.
As a premise for health gains by resource-limited populations, these moves match with pro-access initiatives by the World Health Organization, European Union, World Intellectual Property Organization, U.S. President’s Emergency Plan for AIDS Relief, Medicines Patent Pool, the William J. Clinton Foundation, UNITAID and the Global Fund, as well as with some choices by emerging economies to ward off TRIPS-plus monopolies based on practices beyond TRIPS levels. These choices include enforced compulsory licenses and patent offices’ resistance to “evergreening” patent applications, a strategy whereby a manufacturer extends exclusivity of a drug by filing for multiple patents of slightly changed versions of a drug over time.
While such opportunities for better health could fall short of their potential without a suitable geopolitical context. And a new balance of power in the Asia-Pacific region is now emerging in the wake of rekindled interest of the United States in the region.
The China-India-United States power block
The United States is looking to India as a key partner in maintaining a mutually profitable balance of power in the Asia-Pacific region. India is indeed an interested party in a geopolitical system that brings together America’s principal partners (Japan, Australia and South Korea) with perhaps its main competitor, China. Inherently, India is a natural counterweight to China since it is growing rapidly.
In many ways, India is playing the United States and China off each other, with a resulting balance of power centered on a triangular relationship that mixes cooperation and competition. While the United States tries to draw India closer, China cajoles India to keep it from getting too close to the United States. Meanwhile, countries like Singapore, Indonesia, Malaysia, Vietnam, Taiwan, the Philippines and Thailand want to preserve the current order in the Asia-Pacific region; China seems eager to change the status quo in its favor.
Courtship of India by the United States may mean, for Indian drug makers, more profitable conditions in deals with U.S. enterprises. On these grounds, India may step up existing partnerships for drug clinical trials with high-tech, fast-growth developing countries to gain inexpensive regulatory approvals, expand its market and cut the costs for the development of medicines.
This context could lead the Indian government to become more prone to rejecting intellectual property obligations that may hinder its trade with affordable and high-quality medicines.
Additionally, this context could pave the way for the Indian government to enforce a proposal to require foreign companies seeking more than 49 percent ownership in any Indian drug firm to first get an approval by the Indian government.
Furthermore, courtship of India by the United States could imply far more exploitation of Indian medicines in PEPFAR.
TPP and access: promises and concerns
The Trans-Pacific Partnership, or TPP, talks began in March 2010, promoted by the United States to deepening free trade in the Pacific realm. The talks address issues such as the implications for the multilateral trade system and the different economic levels and needs of the nine countries currently involved.
A plan for medicines, known as Trade Enhancing Access to Medicines, or TEAM, was introduced by U.S. negotiators at the eighth round of TPP talks in Chicago Sept. 9-15, 2011. While the U.S. administration did not disclose the plan’s contents, a U.S. white paper released Sept. 12 outlined its aims. According to this paper, TEAM will set up a “TPP access window” to accelerate access to medicines, get rid of tariffs on medicines and medical devices, and step up legal certainty for manufacturers of generic medicines. The paper also urged TPP parties to reaffirm their commitment to the Doha Declaration on the TRIPS Agreement and Public Health.
However, many public interest groups and non-governmental organizations are opposing TEAM, also in the light of a leaked draft which led Médecins Sans Frontières to allege that the TPP chapter on intellectual property would encompass TRIPS-plus measures including:
Making it easier to patent new forms of old medicines that offer no added therapeutic efficacy for patients (“evergreening”).
Restricting “pre-grant opposition,” which allows a patent to be challenged before it is being granted.
Enforcing intellectual property beyond what TRIPS requires, allowing customs officials to impound shipments of drugs on mere suspicion of IP infringement, including “in transit” products that are legal in origin and destination countries.
Expanding data exclusivity, although the exact terms are unknown; this may lead to a requirement for generic drug manufacturers to independently carry out safety and efficacy tests and goes beyond WTO’s request for data protection against unfair commercial use.
Extending patent lengths beyond 20-year TRIPS requirements.
Preventing drug regulatory authorities from approving new drugs if they may infringe existing patents.
More recently, at an Oct. 25 meeting of the WTOTRIPS Council, India raised concerns that the TEAM approach at the TPP September round in Chicago would delay access to affordable generic medicines.
Room for hope
On the Asia-Pacific chessboard, a compromise is needed among stakeholders. In this respect, whatever the final terms of the TPP deal may be, for the United States, a robust dialogue with India and Japan will be key. Note that on Nov. 11, at the U.S.-hosted APEC summit in Honolulu, Japan asked to join TPP talks.
TPP will probably lead the United States to strengthen ties with India and South Africa and step up efforts in sub-Saharan Africa to counteract China’s rising influence there. Inherently, the United States can rely on an already established India-South Africa collaboration, including on health matters and R&D and drug distribution and marketing.
These prospects would reinforce each other while speeding up access to medicines for Africans.
So, after all is said and done, TPP may add to opportunities for health in the current Asia-Pacific context and bring substantial gains to developing countries by addressing calls by several U.S. key partners in the Asia-Pacific region and beyond for non-discriminatory access to medicines.
This would make a huge difference for global health and the millions of people in Africa and beyond who now do not have access to needed medicines.
Want to read more about innovative financing for development? Check out Busannovate, a blog brought to you by Devex in partnership with the United Nations Foundation, and launched with a thought-provoking guest opinion by Nobel Peace Prize winner Muhammad Yunus.