Doctors Without Borders, HealthGAP, Oxfam, and the National Legislative Association on Prescription Drug Prices are just a few of the many public health advocates sounding the alarm about how a proposed new trade and investment pact for the Pacific Rim threatens access to medicine in the United States and throughout the globe.
If approved, the Trans-Pacific Partnership (TPP) would become the largest Free Trade Agreement in U.S. history. After more than three years and 15 major rounds of negotiations, U.S. TPP negotiators still refuse to tell Americans what they’ve been proposing in our names. That said, leaked text of both the TPP’s intellectual property chapter and its drug formularies chapter reveal the United States pushing for the TPP to (1) extend the length of drug patent monopolies and (2) provide pharmaceutical companies new tools for challenging government-run health programs’ decisions regarding medicine purchases.
According to Judit Rius Sanjuan of the Nobel Prize-winning Doctors Without Borders/Medecins Sans Frontieres, “The leaked draft intellectual property proposals by the United States for the Trans-Pacific Free Trade Agreement have confirmed our fears that the Obama administration is walking away from previous efforts to ensure that developing countries can access affordable medicines, setting a dangerous new standard that will likely be replicated in future trade agreements with developing nations.... [It is about providing pharmaceutical companies] longer monopoly rights that prevent price-lowering competition and keeping medicines out of the hands of the millions of people who need them. Our doctors who work across the developing world rely on affordable generic medicines to treat patients. For example, competition among generic manufacturers is what brought down drug prices for HIV/AIDS by 99 percent, from $10,000 per person per year to roughly $100 today.”
In addition to this critical issue of longer drug patents is the question of how countries are allowed to negotiate prices with pharmaceutical companies. While the TPP’s drug formularies text is most often viewed as a direct attack on other countries’ prescription drug programs, such as New Zealand’s Pharmaceutical Management Agency (PHARMAC) or Australia’s Pharmaceutical Benefits Scheme (PBS), it also threatens to expand costs within U.S. programs such as Medicare, Medicaid, TRICARE, the Veteran’s Health Administration and the 340B program.
As Rius Sanjuan indicates, the Obama administration’s TPP proposals are a big step backwards when it comes to public health. The leaked text reveals that U.S. trade negotiators want to reverse hard-won reforms designed to enhance access to affordable medications that were made during the George W. Bush administration.
In short, the TPP spells even higher health care costs in developed countries and a death sentence for people in developing countries with AIDS, tuberculosis. and other treatable diseases.
Extending Drug Patents
Access to affordable, generic medicine is critical to saving lives. The drastic reduction in drug prices for HIV/AIDS patients, for example, has helped to dramatically scale up the number of people throughout the world who are now receiving treatment.
With new, frontline medications not only extending patients’ lives, but also massively reducing HIV transmission rates, some public health professionals are now openly talking about an end to AIDS. However, at the moment, these new drugs remain patented. The Global Fund to Fight AIDS, Tuberculosis and Malaria, the President’s Emergency Plan for AIDS Relief, UNITAID and UNICEF all rely heavily on access to quality generic medications. For millions of people throughout the globe, delaying access to generic medications means delaying access to treatment. And, of course, HIV/AIDS is only one of many treatable diseases currently taking people’s lives.
If finalized and implemented, the U.S. intellectual property proposal would effectively extend the length of time pharmaceutical companies can continue charging monopoly prices. The proposal would accomplish this in a number of ways:
• broaden the scope of patentability by making it easier for pharmaceutical companies to patent new uses and minor variation of old medicines;
• slow the production of new generics when patents expire by expanding “data exclusivity” over clinical trials, forcing either the timely and costly replication of such trials or an additional three-year delay (beyond the current five) before such “exclusivity” ends;
• constrict safeguards against patent abuse by making it harder for public health advocates to challenge unjustified new patents;
• require new forms of drug patent policy;
• in some cases mandate that countries allow plants, animals and surgical methods to be patented.
Beyond these measures, the U.S. is also expected to request extensions beyond existing 20-year drug patents to “compensate” drug companies for time spent in regulatory approval processes. The overall effect of these proposals is clear: more time before affordable generics can make it into the hands of people who need them.
Empowering Drug Companies
Governments the world over use formularies to control health costs by listing medicines approved for government purchase or reimbursement, and negotiating with drug firms to obtain the lowest prices. Single-payer systems abroad are particularly vulnerable to changes in this common sense system, but so too are the government-run health programs in the United States.
The leaked U.S. proposal for a pharmaceutical pricing chapter restricts the use of such formularies, by requiring that countries set up new administrative and judicial appeal systems that will determine whether government programs “appropriately recognize the value” of drug patents in their reimbursement proposals. In Australia, the only country with single-payer yet to implement such systems under a trade agreement, the result has been higher drug prices.
The Trans-Pacific Partnership negotiations have not been transparent. Access to medicine has received the attention it has because the U.S. proposals for intellectual property and pharmaceutical pricing have been leaked. Neither of these chapters, nor any other negotiating texts, has been officially released. This is completely undemocratic, and also a rollback in transparency from many other international negotiations, even including those at the World Trade Organization, where draft negotiating texts are regularly published for public review. This excessive secrecy makes it difficult for civil society to comment on the negotiations in a productive way at precisely the time when such comments would be valuable: while the pact is still under negotiation.
While the public and most of civil society has been shut out, U.S. trade negotiators have granted approximately 600 corporate lobbyists special “cleared advisor” status that gives them access to the negotiating texts. This includes representatives of the Pharmaceutical Research and Manufacturers of America, as well as several individual drug companies, in addition to well-known corporations like Walmart, Cargill and Chevron.
The TPP is said to include some 29 separate chapters covering everything from banking regulations and public procurement to food safety standards and environmental protection, in addition to the health care-related chapters and the more traditional tariff and quota reductions.
Organizers argue that the best way to defeat the TPP is with the “Dracula Strategy” of exposing it to the light of day. They point out that bottom-up people’s movements have defeated past corporate power grabs like the Free Trade of the Americas and the WTO’s Millennial Round by educating the public to the threats posed by them. With the intense veil of secrecy around TPP negotiations, we have our work cut out for us.
