While the Trans-Pacific Partnership is usually described as a trade agreement, it includes a number of provisions that have little to do with promoting international trade. One of the most important examples: provisions championed by big pharmaceutical companies that would delay the introduction of low-cost, generic versions of life-saving medicines. That could have significant and potentially dangerous ramifications for global public health.
A new report from the prominent AIDS research group amfAR argues that these changes would drive up the price of some drugs that are desperately needed in the developing world. The group says that would hamper the global fight against AIDS (and other diseases) in a way that would ultimately cost lives.
When a drug company invents a new drug, it is granted a patent monopoly — usually around 20 years — on the drug to help it recoup its research and development costs. After the patent expires, other companies are free to make competing versions of the drug, known as generics.
Generic drugs are especially important for low- and medium-income countries because they tend to be dramatically cheaper than name-brand pharmaceuticals. Generic drugs are also heavily used by international public health groups such as Doctors without Borders because lower prices allow their donors dollars to go further. From amfAR's report:
Developing countries, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNITAID, and other global HIV programs have been and will remain dependent on generic medicines to scale up treatment to the millions more who need it today.
The global community would never have achieved its successes in addressing the HIV epidemic if the terms of the proposed TPP were the international standard in 2001.
How the TPP could delay generics and raise drug prices
We don't know exactly what will be in the TPP, because the current text is a closely guarded secret. But a version of the treaty released by WikiLeaks last year provided some insight on the deal's contents. And amfAR argues that several provisions in that draft would hamper the global fight against AIDS.
Most of these changes are modeled on US law, so the immediate impact on the United States would be limited. However, the treaty would have the effect of locking in America's pro-pharma laws, which would make it harder for Congress to reform those laws in the future. And it would have bigger effects in other countries, many of which have laws that allow more competition than those in the United States.
- The TPP is expected to expand what could be patented. It could require countries to offer patent protection for plants and animals, which had been specifically excluded from previous trade agreements.
- It would also allow pharmaceutical companies to patent "new uses or methods of using a known product," which could allow drug companies to extend the effective term of patent protection by getting multiple patents on the same drug.
- If generic manufacturers or public interest groups believe a patent goes too far, they can go to court to have it invalidated. But the TPP would tilt the playing field in favor of drug companies. A "presumption of validity" would require challengers to prove the patent is invalid, rather than asking drug companies to prove their patents are consistent with the law.
- The TPP is expected to require countries to extend patent protections to compensate for delays in drug approval. The amfAR report states, "Such terms have been common in [free trade agreements] in the past, but the TPP weakens the required justification for what constitutes an 'unreasonable delay,' making it easier for pharmaceutical companies to demand longer patent extensions and further delay the entrance of generic competition."
- In what might be the most controversial requirement, the TPP could bar the makers of certain types of generic drugs from using data from incumbents drug companies' clinical trials to demonstrate the safety and efficacy of their own products. Known as "data exclusivity," this rule forces generic drug companies to perform their own expensive, time consuming, and unnecessary clinical trials. US law currently grants data exclusivity for 12 years, and Obama trade representatives are reportedly pushing to require other TPP countries to adopt the same requirement. That's surprising because the president's own 2016 budget proposed reducing the period of data exclusivity in the United States to seven years.
In short, the TPP could lead to significant delays in the introduction of generic drugs. That, in amfAR's view, will "impede access to affordable generic medicines" needed to fight AIDS.