Recently, the European Union and India have been in the news for a near-final free trade agreement, as have the United States and the 10 other countries who are hammering out the Trans-Pacific Partnership (TPP). While these agreements could bolster economies that were weakened by the recession or that are struggling to emerge, they also have serious implications for global health. Both the U.S. and the EU are insisting on strict intellectual property clauses that would severely restrict the ability of pharmaceutical manufacturers in India and elsewhere to make and distribute life-saving, cheaper generic drugs.
As the Guardian Poverty Matters blog points out, India is the “pharmacy of the developing world” — exporting more than US$5 billion worth of generic drugs each year. The agreement would “make it all but impossible” for operations to continue as they do. Similarly, Doctors Without Borders (MSF) argued in an opinion piece in PLOS that with the TPP, the “U.S. is turning its back on existing commitments to promote public health in trade agreements and is undermining the sustainability of its own global health programs.” As MSF explains, more than 80 percent of donor-funded antiretroviral drugs distributed in developing countries are Indian-manufactured generics.
Of course, there is a problem with counterfeit drugs coming from China and India. In May, a much-discussed Lancet study found that almost a third of 1,300 anti-malarial drugs tested in West Africa and Asia were counterfeit. However, as an article in the Pacific Standard recently asserted, most of these fake drugs are coming from small, criminal operations — not mainstream pharmaceutical manufacturers. One solution put forward in the article was for states and pharma companies to focus on regulation instead of intellectual property concerns — while the reverse is what is currently happening. Pharmaceutical supply chains must be made more secure to protect patients from useless or even harmful drugs, but putting legitimate generic drug manufacturers out of business will only drive up drug prices, decreasing poor peoples’ access to essential medicines. At a time when donors, organizations, and countries are slashing funding to global health programs, this problem is especially dire.
Poverty Matters and MSF both argue that with these trade agreements, the “balance has tipped dangerously far away from public health protections towards protecting the profits of pharmaceutical firms,” as MSF wrote. Western Big Pharma companies have put pressure on the U.S. and EU to include aggressively restrictive patent rules in the trade agreements because it means they can continue to charge high prices for high-demand, life-saving drugs. Big Pharma companies often keep drugs from being eligible for generic manufacture through a process called “evergreening,” where they slightly change a drug so that they can re-patent it and maintain premium prices. Generic manufacturers operating within and outside of domestic and international intellectual property laws (for example, India’s generics would be illegal in the U.S. but are not currently within India) are an economic threat to Big Pharma because they can offer affordable drugs and force prices down. While India has in the past put public health concerns before pharma profits, which has been a boon for Indian manufacturers, it must be noted, the agreement with the E.U. will change that, as will also be the case in those countries who are parties to the TPP.
Generic drug manufacturing and intellectual property laws are complex, controversial topics, and both sides have strong points. Although Big Pharma has done much to contribute to better global health through partnerships with NGOs and governments and the development of countless life-saving drugs, that does not give them license to put profits over people. However, it is unrealistic to argue that pharmaceuticals should not make money. A triple bottom line (people-planet-profit) outcome is possible, but it will require changes to the ways in which the pharmaceutical industry operates. Unfortunately, I fear, this will be too big of a leap for Big Pharma and for the governments pushing these trade agreements. As usual, the biggest losers will be people who need but cannot afford patent-protected drugs throughout the developing world.