Compulsory Licensing: Hepatitis C

The international community acknowledged Malaysia for being the first nation to invoke compulsory licensing allowing hepatitis C patients to gain access to affordable medicine.
The country was awarded the Leadership Award in Intellectual Property and Access to Medicines.
The Government received the award at the Global Summit of Intellectual Property and Access to Medicines in Morocco on Monday, said Health Director General Datuk Dr Noor Hisham Abdullah.
“A pride to the nation. Malaysia is a trailblazer when it comes to access to medicine for hepatitis C. Congra­tulations to Dr Salmah Bahri and team,” he said.
The summit was organised by the International Treatment Prepared­ness Coalition (ITPC).
It brings together community representatives, governments, civil society, academics, experts and international agencies to look at the impact of international trade rules on public health.
It also highlighted the role of NGOs and patients in the implementation flexibilities of Trade-Related Aspects of Intellectual Property (TRIPS).
In July, The Star carried a front page story highlighting the plight of about 400,000 Malaysians who suffered from hepatitis C, with only a fraction of whom can afford the medication that can cost up to RM300,000 for the full course of treatment.
Malaysia is not given special prices for the newer drugs by pharmaceutical companies because it is considered a middle-income country.
The Health Ministry has teamed up with the Drugs for Neglected Diseases Institute to come up with an affordable cure.
In the meantime, patients have to fork out huge sums for medication, try to get into clinical trials for other potential cures or seek treatment in other countries.
Subsequently, the Cabinet gave approval to issue a government-use licence to enable the import of generic versions of the hepatitis C drug Sofosbuvir.
Even if medicine is patented for 20 years, the Government has the right to issue compulsory licensing under the rights, flexibilities and safeguards vested to World Trade Organisation members by the agreement on TRIPS.
Governments can issue a compulsory licence to authorise a local import company to bring in the generic drug or to manufacture it itself by a local generic company.
The government-use licence is only applied for drugs to be used in government health facilities.
The Patents Act comes under the purview of the Intellectual Property Corporation of Malaysia (known as MyIPO) of the Domestic Trade, Cooperatives and Consumerism Ministry.

 /theSTAR 18-01-2018

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