Thailand gets nod to make HIV/Aids drug
The World Health Organisation (WHO) has certified the Government Pharmaceutical Organization’s (GPO) to produce the antiretroviral drug Efavirenz, in a move likely to reduce the cost of the drug in the region.
“Being certified means the GPO is able to produce the drug cheaply. And that highlights the country’s achievement in reducing the number of HIV/Aids transmissions from mother to child, together with other forms of controlling the disease,” Dr Sopon Mekthon, the chairman of GPO’s board said in a press conference yesterday.
Efavirenz is the first drug set to be produced in Thailand and Asean to pass the WHO Prequalification Program (WHO PQ) and be included in the list.
“As a result, international health organisations such as the Global Fund and Unicef can order the medication for use in underdeveloped countries,” he said.
The WHO in August approved GPO’s request to register the drug on its list after the GPO first submitted the application in 2016.
A team of inspectors visited to examine the manufacturing plant based in Pathum Thani province to oversee procedures at the plant and ensure they are in line with WHO requirements.
The period of this certification’s validity is three years.
“Efavirenz is the medication first prescribed to all HIV-infected people when they are diagnosed with the virus,” Dr Sopon said.
Efavirenz is often prescribed in combination with tenofovir/emtricitabine (Truvada) in adults and adolescents and children.
Efavirenz is also used in combination with other antiretroviral agents as part of an expanded post-exposure prophylaxis regimen to reduce the risk of HIV infection in people exposed to a significant risk.
Mukdavan Prakobvaitayakit, deputy managing director of the GPO, said the organisation had taken 16 years to develop the infrastructure to produce the drug.
“Our work is how to build up the country’s drug production capabilities. We can’t rely on buying drugs from overseas. We need to be able to produce our own drug at a reasonable cost,” she said.
The locally made product is marketed at 180 baht per bottle of 30 600mg tablets, while the imported product retails at more than 1,000 baht per bottle, she said.
“After the WHO certification, many countries have asked the GPO to take steps to sell its version of the drug in their territories,” Ms Mukdavan said.
She cited the Philippines and countries in the Caribbean as examples. The Philippines plans to order about 300,000 bottles at a cost of 51 million baht, she said.
“The GPO will produce 42 million Efavirenz tablets this year. This amount accounts to only 2.5% of the total capacity of the GPO,” she said.
Meanwhile, Kanikar Kijtiwatchakul, former Access Campaigner of Medecins Sans Frontieres (Thailand), said that it is one of three drugs that the country is now able to produce having cited Compulsory Licensing (CL).
Compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself. It is one of the flexibilities in the field of patent protection included in the WTO’s agreement on intellectual property — the Trips (Trade-Related Aspects of Intellectual Property Rights) Agreement.
GPO has produced drugs serving around 300,000 people living with HIV/Aids under the Universal Health Coverage or Gold Card scheme.