In its annual Special 301 report the USTR states that stronger actions are needed to tackle the manufacture, sale and distribution of counterfeit drugs, as well as the broader issue of substandard medicines, in a number of countries.
The report expresses concern about substandard active pharmaceutical ingredients (API) which bear counterfeit trademarks. These potentially dangerous materials, which are not made in compliance with good manufacturing practices (GMP), may enter the legitimate supply chain.
For instance, in China, domestic chemical manufacturers producing APIs can avoid regulatory oversight by not stating that the materials are intended for use in pharmaceuticals. The USTR believes this contributes to China being a major source of counterfeit APIs.
Consequently, the USTR recommends China builds on the positive steps it has taken, such as requiring manufacturers to register with the State Food and Drug Administration (SFDA), by enforcing more effective regulatory controls.
Other countries also come in for criticism by the USTR. The report states that the counterfeiting of medicines remains widespread in India and the country’s enforcement regime is ineffective.
China and India are both of the USTR’s priority watch list, in part because of the issue of counterfeiting. Other issues relating to intellectual property (IP), not just in pharmaceuticals, also contribute to their presence on the list.
The report highlights a number of positive developments, some of which have led to countries being removed from the watch list. Criminalising the manufacture and storage of counterfeits has contributed to the Czech Republic being removed. Hungary and Poland are also off the list.
Also, Bolivia has taken “notable enforcement action”, leading to the seizure of more than 30 tons of pharmaceuticals and corresponding prosecutions. Despite this, counterfeit medicines “continue to be widespread” and the USTR urges Bolivia to improve IP protection and enforcement.