Thailand Flaunts Pharmaceutical Patent Protection

Wednesday 6 March 2013, Amsterdam

Lax enforcement of patent regulations in Thailand is alienating American intellectual property laws, as the Thai government focuses on using generic pharmaceuticals to maintain low healthcare costs, states a new report by research and consulting.

The new report  states that in April 2012, Thailand was placed on the "Special 301" Priority Watch List by the Office of the United States Trade Representative (USTR), which identifies trade barriers to US companies and products caused by foreign intellectual property laws, regarding copyright, trademarks and patents.

The FDA seems unable to stop generic versions of patented pharmaceutical products being launched, and the Thai Ministry of Public Health (MoPH) has previously granted compulsory licenses for Sustiva (efavirenz) and Kaletra (lopinavir), without any prior discussions with the patent holders. Policy changes were only made regarding the granting of compulsory licenses in November 2012.

Privileges for the Government Pharmaceutical Organization (GPO) may work as a barrier to industry growth, but will help the government control healthcare costs by promoting generic drug use. GPO is a state enterprise under the MoPH, and holds exclusive rights to supply government hospitals with products on the National List of Essential Drugs (NLED). GPO generic product registration is very fast and requires minimal documentation in comparison to standard regulatory procedures. Public hospitals are legally obliged to use 60% of their budget to purchase NLED-listed and GPO-produced medicines, while hospitals attached to the MoPH must use 80% of their budget to purchase drugs from GPO, even if they are priced slightly higher than the same medicines manufactured by other pharmaceutical companies. Institutes are however allowed to buy drugs from other manufacturers if GPO is unable to fulfill the order, and GPO itself allows subcontracting to small companies if it is unable to fulfill the order.

The pharmaceutical market in Thailand was estimated at US$1.9 billion in 2006 and is expected to reach approximately US$8.9 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 11.7%.

Healthcare, Regulatory and Reimbursement Landscape – Thailand

This report provides information on the healthcare, regulatory, and reimbursement landscape of Thailand, and gives an overview of the pharmaceutical and medical device markets, including size, segmentation, and key drivers and barriers.