Industry group PhRMA late last week urged the Office of the United States Trade Representative (USTR) to designate Canada, Korea and Malaysia as “Priority Foreign Countries,” which is a designation reserved for countries with what PhRMA considers to be “the most onerous and egregious intellectual property or market access” practices that have the greatest impact on US products.
“Government price controls in Canada, Japan, Korea and other markets are non-tariff barriers to trade that substantially eliminate incentives to invest in the development of new medicines for patients,” the report says.
The report also criticizes the Malaysian government for allowing a government use license for a medicine.
“This action could cause serious harm to a U.S. manufacturer that was engaged in ongoing negotiations with the Government of Malaysia on a voluntary license at the time this compulsory license was unilaterally issued,” the report says.
Regulatory Approval Delays
PhRMA notes that China is reforming and strengthening its regulatory framework, but remains an outlier in the drug approval process compared to other regulatory authorities, "with new medicines typically taking three to five years longer to reach the China market than other major markets.”
Other markets with complex and lengthy regulatory approval processes include Korea, Russia and Turkey.
In Mexico, the report adds, “excessive regulatory approval delays are compounded by consolidated procurement processes that lack transparency and are applied inconsistently.”
Regulatory Data Protection
Many US trading partners – including Argentina, Brazil, China, Egypt, India and Turkey – also do not provide regulatory data protection (RDP), PhRMA says, noting that parties should be required to protect regulatory test data submitted as a condition of obtaining marketing approval against both disclosure and unfair commercial use.
“For example, Mexico provides RDP for small-molecule treatments, but not for biologics. In Chile, RDP is not made available for new uses, formulations, compositions or dosage forms. Canada passed legislation in 2014 that gives the Health Minister broad discretion to share undisclosed test data without safeguards to protect against unfair commercial use. Other countries provide RDP in a manner that discriminates against foreign innovators. For example, Saudi Arabia and other countries assert that they provide RDP but have allowed local companies to rely on data submitted by U.S. innovators during the period of protection,” the report says.
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2018