On Tuesday, May 12, public health organizations around the world breathed a sigh of relief as the U.S. Senate voted against the motion to grant the president trade promotion authority (TPA) -- only to find this relief replaced by frustration and anxiety as the Senate announced, only 24 hours after its initial decision, that the body will reconsider the TPA. TPA, or fast track, removes Congress's right to amend or negotiate the Trans Pacific Partnership (TPP), a trade agreement between 12 countries controlling 40 percent of the world's economy, and allows the president to expedite completion of the deal. While President Obama has touted the TPP as "the most progressive trade agreement in history," citing the labor and environmental regulations incorporated in the document, he fails to acknowledge the severe impact that the TPP will have on human rights and welfare globally.
Namely, the TPP, as currently written, threatens to block access to life-saving medicines around the world. The agreement includes provisions on intellectual property, enabling pharmaceutical companies to extend their patents on existing medications by up to 20 years based on minor modifications, such as new doses or delivery mechanisms, without any proof of increased efficacy -- a practice known as "evergreening." Moreover, the TPP requires that all member countries grant data exclusivity on expensive biologic drugs for 12 years. Data exclusivity prohibits drug companies from accessing and using the patent holder's clinical trial data to accelerate approval of biosimilar drugs (which are, in simplified terms, generic versions of biologic drugs). Together, these provisions halt progress in the development, approval, and accessibility of affordable generic small-molecule and biosimilar drugs.
Proponents of the TPP and, in particular its provisions on pharmaceuticals, argue that intensified intellectual property regulations are necessary to incentivize innovation. They argue that without such protections, the costs and time required to develop complex biologic drugs and complete the intense regulatory approval process would deter research of these therapies. Yet these arguments are highly contestable. In 2009, the U.S. Federal Trade Commission (FTC) concluded that data exclusivity periods for biologics were not justifiable, as other incentive structures such as patent protection and market-based pricing were more than sufficient to spur innovation in the field. The FTC's analyses were based on the projected research and development costs for biosimilars, which would drive down prices significantly, but not as dramatically or quickly as seen in the generic drug market. Even President Obama's administration has pushed for the reduction of data exclusivity for biologics from 12 years to seven within the U.S. We must acknowledge that if the U.S. itself has not reached consensus on this issue, we cannot justify exporting such strong protections abroad at the expense of patient lives.
Why does this matter? Because the TPP stipulations on biologics would extend to such life-saving drugs as vaccines and treatments for chronic diseases, including diabetes, cancer, and cardiovascular disease, and put them out of reach for patients both in high, and low and middle-income countries (LMICs). While LMICs claim almost 80 percent of the disability adjusted life years lost worldwide to cancer, these countries only have an estimated of 5 percent of global cancer resources. In 2001, the WHO reported availability of anti-cancer drugs in only 22 percent of African countries, 43 percent of South East Asia, and 57 percent of countries in the Americas, compared to 91 percent in Europe. In recognition of these disparities, which still persist today, the World Health Organization added 16 anti-cancer medications among other biologic drugs to its Model Essential Medicines List just last week. The purpose of the list is to indicate which medicines should be made available and affordable at all times, and thereby guide public procurement.
Progress toward mitigating these disparities has been accelerated through generics production. Many generic cancer medications are available for less than $100 per treatment course, as opposed to the thousands of dollars charged for branded medications. In Brazil, generics competition was able to reduce price of certain cancer medications by 90 percent. In India, generic companies were able to cost imatinib, a leukemia drug, at approximately $167, as opposed to roughly $3,000 and over $2,000 for the branded drug (Gleevec) in the United States and India, respectively. India's booming generics industry not only supplies the Indian market, but also exports its more affordable formulations around the world - including the U.S., where India accounts for approximately 40 percent of generic drug imports, and generics have saved the health system $239 billion over their branded counterparts. Regardless of whether more countries are added to the TPP in the future, the stipulations on intellectual property would impede generic drug companies from such countries as India from gaining access to external markets and improving access to life-saving and essential medicines. Thus, the TPP threatens to work against public interest as defined last week by the World Health Organization's Essential Medicines List.
The Senate's deal with the White House is to reconsider the TPA after voting on bills surrounding concerns on customs enforcement, trade preference to sub-Saharan African countries, and Trade Adjustment Assistance. But the legislative body made no mention of the key provisions that will threaten decades of global health progress. We must stand against the fast track in order to buy Congress the time and ability to revise the provisions on biologics and patent protection. And if we successfully stop the fast track, we must learn from these last few days that complacency is not an option. We do not want a short-lived sigh of relief, but to be able to breathe easy after changing the TPP stipulations on medicines. We, the Young Professionals Chronic Disease Network, stand with Doctors Without Borders, OXFAM, and amFAR, among other human rights organizations, to fight for access to medicines around the world, and the prioritization of human life over excessive and unjustifiable financial interests.
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