[Ip-health] The Star (Malaysia): Big pharma against CL move but WHO agrees

Thiru Balasubramaniam thiru at keionline.org
Fri Mar 2 00:22:03 PST 2018

Big pharma against CL move but WHO agrees



Friday, 2 Mar 2018


KUALA LUMPUR: 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 Organistion’s TRIPs
(Trade-Related Aspects of Intellectual Property Rights) agreement.

“It is a global agreement which all should respect.”

Last July, The Star carried a front page report highlighting the plight of
about 400,000 Malaysians who have 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, 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.

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

“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 RM300,000 is beyond the reach of many

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 in reply to The Star, adding that it was a
government’s right to do so.


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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