Global Trends by Martin Khor

Monday 11 September 2017

Action at last on Hepatitis C?

The government decision to issue a government-use license to available a generic drug is a breakthrough in the fight to cure 500,000 Hepatitis C patients in Malaysia. 


A government decision to make a generic Hepatitis C medicine available is expected to drastically bring down the treatment costs and potentially cure hundreds of thousands of Malaysian patients in the years ahead.

This is the breakthrough that the public has been calling for, especially since July when The Star and media highlighted the plight of over 500,000 adult Malaysians suffering from Hepatitis C.  

According to international reports and reliable sources, the Cabinet last month made a decision to issue a government use license enabling the import of generic versions of the Hepatitis C drug Sofosbuvir. 

The drug, which is patented, has been selling at up to RM300,000 for a full treatment, according to a report in The Star. Health Minister Datuk Seri Dr S Subramaniam indicated, also in The Star (21 July), the Ministry is hoping to get a generic version of the same drug, for RM1,000 per patient. 

Clinical trials are being conducted in cooperation with the Geneva-based Drugs for Neglected Diseases initiative (DNDi) and an Egyptian generic company in a project to make available Sofosbuvir combined with another drug which will be suitable for most Malaysian Hepatitis C patients.  

Few patients have been treated with Sofosbuvir due to the exorbitant cost.  Getting the price down to RM1,000 will enable a cure for many thousands.

Since Sofosbuvir is patented, a government use license is needed to waive the monopoly right and enable the sale of generic drugs. Thus, the government decision is the key to opening the doors to affordable treatment.

Issuing such a license is provided for by the Malaysian Patents Act (Section 84) and consistent with the rules of the World Trade Organisation’s TRIPs Agreement.

Government use licenses and compulsory licenses have been issued before by many countries including Malaysia (for HIV-AIDS drugs in 2003), Thailand, Indonesia, India, Brazil, Ecuador, Ghana and Italy.

Hepatitis C causes 400,000 deaths worldwide annually.  In Malaysia, as of 2009, about 2.5% of the adult population (or half a million) is infected and most are unaware of this until it has progressed to advanced liver disease, liver failure or cancer.

The new Hepatitis C drugs known as direct acting antivirals (DAAs) including Sofosbuvir are a major advance as they have cure rates of over 90% and can be treated within three months with much less side effects than previously existing drugs.

Recently, the US company Gilead, which holds the patent to Sofosbuvir, announced Malaysia will now be included in the company’s own licensing scheme allowing some generic versions to be sold locally.

Under the scheme, Gilead signed agreements with some Indian drug companies to make and sell Sofosbuvir in about 100 countries, but Malaysia was excluded. 

The decision to issue a government use license is believed to be a main reason why the company is now including Malaysia.  It may hope that the government will now find it unnecessary to have a government use license and reverse its decision.

However giving up on the government use license would be really disadvantageous to the country. There are limits to what Malaysia can import or produce under the Gilead license and that restrict the freedom to choose the generic companies it can work with.

For example, Malaysia would have to reach agreements only with the Indian companies which have Gilead’s permission to sell the drug.  Thus this would endanger the project, already well advanced, by which DNDi and the Egyptian company can supply Malaysia with a suitable combination drug at affordable prices.        

Moreover, the Gilead scheme is dependent on conditions set by the company, which can also change them or terminate the scheme. 

With a government use license, the government will have freedom to choose which drug to buy from which company, at what prices, and with which other drugs to combine it with.

Malaysia can have both the government use license and take part in the company scheme, as one does not preclude the other.  So we can have the best of both, with maximum room to choose the policies that are most suitable.

While it is known that companies and their governments unhappy with a compulsory license may put pressure on countries that take such a measure, the Malaysian move will on the other hand win the support and admiration of many other countries, health groups and international organisations that are fighting for public health interests.

The landmark WTO Ministerial Declaration on TRIPS and Public Health not only recognized the legality but also the desirability of countries to take pro-public health measures and not let patents be in the way of people’s health interests.

The WTO Ministers asked developing countries to assert their rights to “use to the full” the provisions in the TRIPS agreement to “protect public health and provide medicines for all.”

The TRIPS agreement is the source of patent legislation in almost all countries, and issuing government use and compulsory licenses is one of the most important rights in TRIPS to protect public health. 

Thus the decision to issue a government use license for Sofosbuvir is a shining example of a country exercising its right to make medicines available to save hundreds of thousands and potentially millions of people from death and serious ailment.

The Government should now take the follow-up measures needed by issuing the government-use license, completing the clinical trials, negotiating with the Egyptian generic producer for the lowest possible prices, and rolling out the new Hepatitis C medicines.

These should be done as soon as possible.  Time is of the essence. Each day that goes by without making the medicines available bears a cost in terms of lives lost and needless suffering.