Failure to reduce counterfeiting is one of a number of issues slowing healthcare regulation harmonisation in ASEAN.
The Association of Southeast Asian Nations (ASEAN) made healthcare a priority sector for fast-track integration. In doing so ASEAN hoped to make quality, affordable medicines available throughout the region but the process is a “tremendous endeavour”, according to a report.
Although Singapore and Malaysia have advanced, the commitment of Laos and Cambodia remains an issue, according to a US academic report published online by the Pharmaceutical Research and Manufacturers Association (PReMA) of Thailand.
Progress in Cambodia is hindered by poor infrastructure, “high levels of corruption, limited economic growth and prevalent anti-dumping”. Cambodia is politically stable, although this is a relatively recent development, but decision making is slow, bureaucratic and lacks transparency.
Some of these factors have allowed counterfeits to become “an enormous problem in Cambodia”. The US Pharmacopeia (USP) is fighting counterfeits in Cambodia, and believes it is making real progress , but the report says more work is needed to tackle the issue throughout the region.
Nonetheless, progress and positive efforts by Cambodia are acknowledged in the report. In contrast, the report is critical of Laos, claiming the national regulator has failed to prioritise “intellectual property, parallel importation, counterfeits, or other issues of ASEAN harmonisation”.
Overrun by counterfeiters
Counterfeit drugs are so common in Thailand the government lacks the resources needed to tackle the problem, according to the report. Furthermore, regulations are insufficient to deter counterfeiters.
“Until criminal charges against counterfeiters are universally applied and regulations are harmonised, the government will continue to fight a losing battle in the counterfeit drug war”, says the report.
Vietnam faces similar issues, with officials claiming they are incapable of stopping the growth in counterfeit trade. The report says customs and regulatory officials are understaffed “and lack regulatory backbone”.
Malaysia introduced holograms on pharmaceutical packaging but, despite this, the level of counterfeit trade remains significant. The report says lax enforcement and weak punishments, coupled to challenges posed by borders with Thailand and Indonesia, have hindered progress.
A positive element of the report is progress in Indonesia. The country has taken “a huge step” in tackling its “serious counterfeiting problem”, says the report, by setting up the National Anti-Counterfeiting Task Force.
Singapore is also praised for progress in a number of areas but concerns around parallel trade and intellectual property are raised. Despite these issues, which are downplayed by some in the report, the Singapore prescription drug market is predicted to remain stable.