Compulsory Licence supported by WHO

Malaysia’s bold move to impose compulsory licence (CL) on the drug sofosbuvir has been heavily criticised by big pharmaceutical companies, but has the support of the World Health Organisation (WHO).
WHO advocates universal health coverage and that means access to life-saving treatment, said its head of mission and representative to Malaysia, Brunei and Singapore Dr Lo Ying-Ru.
She said Malaysia, in wanting to provide universal health coverage with limited funding, had decided to make sofosbuvir available for its healthcare systems.
Asked how WHO views the pressures Malaysia is facing after issuing a CL for the generic version of sofosbuvir, Dr Lo said: “I understand the Malaysian Government is adhering to the World Trade Organisation’s TRIPs (Trade-Related Aspects of Intellectual Property Rights) agreement.
There are about 400,000 Malaysians who are infected by Hepatitis C. However, only a fraction could afford the medication which may cost up to RM300,000 for the full course of treatment.
Malaysia is not given special pricing for the drugs by pharmaceutical companies because it is considered a middle-income country.
NGOs had lobbied the Government to issue a CL so patients could gain access to the medication.
In September 2017, the Domestic Trade, Cooperatives and Consumerism Ministry confirmed the Cabinet had issued government-use licences to enable the import of generic versions of sofosbuvir.
Since then, big pharmaceutical companies had been pressuring Malaysia to retract its position, as it discourages innovation. They claimed Malaysia risked being put on the US Watch List on IP-related trade barriers.
Recently, the Pharmaceutical Research and Manufacturers of America (PhRMA) urged the US Trade Representative (USTR) to take action “to address serious market access and intellectual property barriers” in 19 overseas markets.
It urged the Office of the USTR and other federal agencies to reverse the CL in Malaysia and end “discriminatory pricing policies” in Canada, Japan and South Korea.
However, US-based NGO Public Citizen defended the countries using CL, saying that issuing the licence does not override a patent right.
“Rather, the right reserved by the Government to make use of an invention is embedded in the initial grant of every patent,” it said.
Public Citizen also pointed out that the patent owner could still sell the medicine, and retain the exclusive right to sell to private providers and hospitals.
“The US should not criticise Malaysia for its TRIPs-compliant public health policy,” it said.
It defended Malaysia’s stand as the Hepatitis C disease burden was high and projected to rise steeply owing to limited antiviral treatment and the high cost of sofosbuvir.
The treatment price of around RM 300,000 is beyond the reach of many Malaysians.
Health director-general Datuk Seri Dr Noor Hisham Abdullah said the Government did not violate any laws or agreements when issuing the CL. “We go by the book,” he said.

/theSTAR 02-03-2018

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