The White House’s last-minute compromise on drug copyright protections in a huge trade agreement appears to have pleased nobody, with liberals, conservatives, patient groups and the industry all criticizing the deal.
Negotiators resolved one of the main sticking points in the 12-nation Trans-Pacific Partnership deal by granting every nation except the U.S. five-eight years of market exclusivity for biologic drugs, which are derived from living organisms. Examples include vaccines.
Liberals, conservatives and the pharmaceutical industry chided the exclusivity period, but for different reasons. Conservatives and the pharmaceutical industry called for 12 years of exclusivity for biologics, which is the amount granted in the U.S.
“The failure of our Asian-Pacific partners to agree to a similar length of protection is remarkably short-sighted and has the potential to chill global investment,” said the Biotechnology Industry Organization, a biotech trade group representing biologic manufacturers.
Prominent conservatives were also dismayed at the deal, the text of which the White House has not made available.
“While the details are still emerging, unfortunately I am afraid this deal appears to fall woefully short,” Sen. Orrin Hatch, R-Utah, said in a statement Monday on the deal in general. Hatch is chairman of the Senate Finance Committee, which will review the final deal.
Liberal lawmakers, meanwhile, believe the deal is a “giveaway” for the drug industry and the exclusivity period should be shorter.
“It is a giveaway to Big Pharma, which wants to lock cheaper generics out of the market for eight years,” said Rep. Rosa DeLauro, D-Conn., a leading trade skeptic. “This will result in more expensive medicines, as well as slower progress toward medical breakthroughs.”
Patient advocates were also dismayed by the exclusivity period.
“The big losers in the TPP are patients and treatment providers in developing countries,” said advocacy group Doctors Without Borders.
The deal would force developing countries to change laws to “incorporate abusive intellectual property protections for pharmaceutical companies,” the group said.
U.S. Trade Representative Michael Froman defended the provision, a main sticking point that was finally hammered out over the weekend.
“There was recognition of the importance of innovation and … a recognition there may be multiple ways of achieving that,” he said during a press conference in Atlanta Monday after negotiators had reached a conclusion.
The 12-year U.S. exclusivity period was hammered out in a 2009 law for biologics.
These products are different from a regular drug derived from a chemical. A biologic is created from a living organism.
Examples of biologics include vaccines, human cells or tissues used in transplants such as for new tendons, and cellular or gene therapies, according to the Food and Drug Administration.
Biologics have exploded in popularity. By 2020, they are expected to account for more than half of sales within the top 100 prescription products, according to a recent report from the research firm Deloitte.
In the U.S., after a biologic has been on the market for 12 years, it is open for competition from low-cost biosimilars. The drugs are comparable to a generic, which is a cheap copycat of a brand-name drug.
But biosimilars are different.
The biggest difference is regulators don’t require a biosimilar to be an exact copy of the biologic it is imitating. A manufacturer only has to show that it is similar because the complexity of a biologic makes producing an exact copy difficult.
The U.S. approved its first biosimilar earlier this year, a treatment for side effects of chemotherapy, while Europe has approved more than 10.
The Trans-Pacific Partnership will go through congressional review. President Obama already scored a victory earlier this year when Congress approved “fast track” status for the trade deal, which means Congress must approve or reject it without adding any amendments.
“We will be consulting closely with congressional leadership on the next steps and the timetable,” Froman said. “We are confident that people will see this as a very strong deal.”
Once the final deal emerges, the public can review it for 60 days, with Congress not expected to vote on it until next year. The Senate Finance Committee sent out a statement Monday saying that the deal cannot take effect without congressional approval.
The other countries in the deal, which covers 40 percent of the world’s economy, are Australia, New Zealand, Canada, Japan, Vietnam, Mexico, Chile, Brunei, Malaysia, Singapore and Peru. China is not included.
