Multilateral trade deals—such as the Trans-Pacific Partnership touted by President Barack Obama on his recent trip through Asia—are usually of little concern or consequence to healthcare stakeholders.
But the largest regional trade agreement in history—if ratified and implemented by the dozen signatory countries—could affect pharmaceutical pricing around the globe. As a consequence, the pact is drawing fire from physician-advocates on the front lines of ensuring advanced medicines are available and affordable in developing countries.
The headlines from the president's trip spoke only about the benefits for American business and how the Trans-Pacific Partnership would get rid of 18,000 taxes that other countries place on goods from the U.S. The nations that have signed the TPP are the U.S., Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam.
But the deal's terms on cross-border intellectual property protection worry some healthcare advocates. They say the patent measures in the accord will translate into higher prices on many medications in poor countries.
The deal includes “dangerous provisions that would dismantle public health safeguards enshrined in international law and restrict access to price-lowering generic medicines for millions of people,” Doctors Without Borders, the Nobel Peace Prize-winning not-for-profit that sends doctors into some of the most impoverished regions of the globe, says on its website.
In April, Doctors Without Borders sent a letter to members of Congress, co-signed by about 50 other advocacy organizations, calling on legislators to reject the TPP in its current form. In the letter, the groups called out a number of clauses. Most alarming to the advocates was a requirement that signatory countries grant 20-year extensions to patents for existing medicines when their manufacturers demonstrate new uses.
“These provisions facilitate abuse of the patent system and extend the monopoly protection that enables patent holders to keep prices high over many more years for products that are already on the market,” according to the letter.
The pharmaceutical industry rejects those assertions. Yet it has expressed its own misgivings about one aspect of the agreement. It lost its fight to extend the U.S. policy of granting 12 years of data exclusivity for biologic medicines to other countries. Data exclusivity means another company wouldn't be able to get a product approved using the data generated by the original company during a certain period.
While Obama has expressed confidence the TPP could pass in this session of Congress, it looks increasingly unlikely. Both Democratic and Republican front-runners in the race for the White House have attacked the deal, and Congress is unlikely to take up a controversial measure in an election year. Most trade deals are not considered treaties but are congressional-executive branch agreements that must be approved by both houses of Congress.