No matter who you are or where you live, it’s time to pay attention to the Trans-Pacific Partnership (TPP) trade deal. If signed in its current form, the TPP will lock in high, unsustainable drug prices, delay the availability of less expensive generic medicines, and price millions of people out of the medical care that they need.
Today, AARP and Doctors Without Borders/Médecins Sans Frontières (MSF) express our deep concerns about the TPP’s impact on drug prices. Intellectual property provisions being proposed by the U.S. put too much emphasis on drug industry priorities at the expense of consumer and patient needs.
Various provisions in the TPP would delay the introduction of lower-priced drugs and worsen an already failing system of research and development that awards patents and other monopolies to companies for producing ‘me-too‘ medicines that provide little to no therapeutic benefits over existing treatments.
More troubling are demands by the U.S. to mandate 12 years of data exclusivity for biologic medicines, which include vaccines and drugs used to treat conditions like cancer and multiple sclerosis. Data exclusivity blocks competing firms from using previously generated clinical trial data to gain approval for generic versions of these drugs and vaccines.
With annual prices that can reach $400,000, the high cost of biologic drugs not only has negative effects on consumers and patients, but also on health care payers, including programs like Medicare and Medicaid, as well as children in developing countries who are most vulnerable to dying from vaccine-preventable diseases.
It is noteworthy that the proposed 12 years of data exclusivity, or when clinical trial data are protected, goes well beyond the monopoly protections already provided in the U.S. Today, biologic drug manufacturers receive four years of data exclusivity that runs concurrently with 12 years of market exclusivity, or when the FDA is blocked from approving generic versions of a brand name product.
The Obama administration has made it clear that it disapproves of these protections by repeatedly proposing in its federal budgets to reduce the market exclusivity period to seven years. This puzzling contradiction raises the question: Why is the U.S. pushing for even more monopoly protections in the TPP? Twelve years of data exclusivity is unprecedented in any previous trade agreement and is not the law in any of the other TPP negotiating countries.
If pharmaceutical companies get their way, brand-name biologic drugs would not face direct competition for excessively long periods of time while patients, medical providers like MSF, and taxpayer-funded government programs endure unnecessarily high prices. AARP and MSF strongly believe the final trade agreement should not bind the U.S. or other negotiating countries to a 12-year data exclusivity period for brand-name biologic drugs.
In its current form, the TPP could negatively affect the health and lives of millions of people who rely on access to affordable medicines, and fundamentally contradicts and undermines the U.S. government’s own commitments and investments in both domestic and global health. Global health programs supported by U.S. taxpayers like the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), Gavi, the Vaccine Alliance, and the Global Fund to Fight AIDS, Tuberculosis and Malaria all heavily rely on the availability of price-lowering competition in medicines and vaccines to effectively run their programs.
AARP, MSF, and many other organizations, including public health experts, Nobel Prize winners, and civil society groups, have communicated their concerns publicly and directly to the U.S. Trade Representative on numerous occasions.
The only ones supporting 12 years of data exclusivity are pharmaceutical companies and the patient groups they fund. There is now an organized campaign of op-eds and letters to scare the public into believing that the breakthroughs of tomorrow can only be guaranteed by blocking access to affordable medicines for at least 12 years. There is simply no good evidence for this; on the contrary, the Federal Trade Commission finds that 12 years is unnecessary to promote innovation in biologic drugs.
Relying on monopoly pricing to promote innovation leaves us with higher-cost programs, higher out-of-pocket costs, and generally unaffordable medicines, often with very little to show in terms of true innovation.
As TPP negotiations continue, it is essential that the U.S. and other negotiating countries work to protect existing public health safeguards and to promote a public health-driven biomedical innovation system. We strongly believe that consumer and patient needs, not drug industry profits, should be the U.S. government’s primary concern as it finalizes the TPP.
LeaMond is AARP’s chief advocacy and engagement officer. Delaunay is executive director of Doctors Without Borders/Médecins Sans Frontières (MSF), USA.