Action at last on Hepatitis C?

The decision to issue a government-use licence to make a generic drug available 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 other 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 licence 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 in July that 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 Genevabased Drugs for Neglected Diseases initiative (DNDi) and an Egyptian generic company in a project to make available Sofosbuvir, combined with another drug.

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

Issuing such a licence 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 licences and compulsory licences have been issued before by many countries, including Malaysia (for HIV-AIDS drugs in 2003).

Hepatitis C causes 400,000 deaths worldwide annually. In Malaysia, as of 2009, about 2.5% of the adult population (or half a million) were 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 fewer side effects than previously existing drugs.

Recently, US company Gilead, which holds the patent to Sofosbuvir, announced that 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 then.

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

However, giving up on the government-use licence would be disadvantageous. There are limits to what Malaysia can import or produce under the Gilead licence and that restricts the freedom to choose the generic firms 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. 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 licence, the Government will have freedom to choose which drug to buy from which firm, at what prices, and with which other drugs to combine it.

Malaysia can have both the government-use licence 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 licence 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 recognised the legality but also the desirability of countries taking pro-public health measures and not letting patents be in the way of people’s health interests.

Thus, the decision to issue a government-use licence 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 licence, completing the clinical trials, negotiating with the Egyptian generic producer for the lowest possible prices, and rolling out the new Hepatitis C medicines.

Each day that goes by without making the medicines available bears a cost in terms of lives lost and needless suffering.

Martin Khor (director@south centre.org) is executive director of the South Centre. The views expressed here are entirely his own.