TWN Info Service on Intellectual Property Issues (Aug17/03)
9 August 2017
Third World Network

Dear friends and colleagues,

The urgent need to ensure access to affordable treatment for Hepatitis C surfaced strongly again on World Hepatitis Day on 28 July.

As Martin Khor of South Centre emphasises in a Malaysian news column: “The situation where 500,000 Malaysians are infected with Hepatitis C but cannot afford treatment when a total cure is available is not acceptable, so urgent action is now needed.”

A version of the article below was first published in The Star (Malaysia) on 31 July.

With best wishes,
Third World Network

The Star, Monday 31 July 2017

Action needed now on Hepatitis C

The situation where 500,000 Malaysians are infected with Hepatitis C but cannot afford treatment when a total cure is available is not acceptable, so urgent action is now needed.

By Martin Khor (Executive Director, South Centre)
 

World Hepatitis Day fell on 28 July, last Friday. So it was timely the alarming situation of Hepatitis C in Malaysia has been highlighted.  A solution is in sight but must be implemented soon as so many lives are at stake.

The Star on 28 July revealed that over 500,000 Malaysians aged 15 to 60 are infected with Hepatitis C, but most are unaware because there are no early symptoms. Hepatitis C can seriously damage the liver especially when it leads to cirrhosis (serious scarring) and cancer.

What is more alarming is the high incidence and its recent rate of increase.  In 2009, the Hepatitis C incidence rate was 3.71%, and this shot up to 8.57% in 2016, said the Health Minister Datuk Seri Dr S Subramaniam on 20 July. That indicates one in 12 adult Malaysians have Hepatitis C.  The incidence rate for Hepatitis B also rose from 2.13% to 12.6% in the same period. Combined, that’s a very high rate of hepatitis.

The good news is that a new cure for Hepatitis C is now available.  The bad news is that it is very expensive for Malaysians, though much cheaper in other countries. And the hopeful news is that we might get a good treatment at a cheap rate by next year, if all goes well.

The year 2013 saw a breakthrough in Hepatitis C treatment with new direct acting antivirals (DAAs) which may cure up to 95% of cases, a higher success rate with much less toxic side effects than current treatments.

In the new regime, the main drug is Sofosbuvir (produced by Gilead) which is often combined with another drug to make it more effective.   

The big problem is that the original price of Sofosbuvir was fixed at US$1,000 per pill or US$84,000 for a 12-week treatment course in the US.

In Malaysia, the cost may be up to RM300,000 for the full treatment, according to The Star report of 28 July.  Last November, the Consumers Association of Penang reported that a patient in a private hospital had been charged RM385,000 for a 24-week course a few years ago.

Even though prices may have fallen since, “life-saving Hepatitis C treatment is beyond the reach of most Malaysians,” said CAP President S M Mohamed Idris.

Gilead has entered agreements allowing some Indian drug companies to produce and sell Sofosbuvir in about 100 low and middle income countries, and the cost has gone down to about US$200 to US$300 for them. But Malaysia is one of the 41 middle-income countries excluded, including China and Thailand.

In countries which have not patented the drug, generic versions of Sofosbuvir were available for a 28-day course selling for US$15 in Pakistan, US$51 in Egypt, US$108 in India and US$197 in Bangladesh in 2016, according to World Health Organization (WHO) data.

In countries where Gilead holds the patent, the originator branded product (Sovaldi) was selling for US$2292 in Brazil, US$16,368 in Romania and the launching price of US$28,000 in 2013 in the US for a 28-day supply.

The company has been criticised for making super profits through charging as much as the market can bear, and excluding the majority who need treatment.

Worldwide hepatitis C causes 700,000 deaths each year.  “It can be completely cured with direct acting antivirals (DAAs) within 3 months. However, as of 2015, only 7% of the 71 million people with chronic hepatitis C had access to treatment,” said WHO.  

In Malaysia, the situation is bad, as very few of the infected are able to get treatment. The Health Minister said on 21 July that “it currently costs RM30,000 to RM40,000 per person for 12 weeks of treatment”.   But he also indicated that “we hope to bring it down to RM1,000; if we do that it will be a major success.”

The Health Ministry is cooperating with Drugs for Neglected Diseases initiative (DNDi), a Geneva-based non-profit research and development organisation to do clinical trials for a combination of Sofosbuvir and Ravidasvir drugs.  According to DNDi executive director, Bernard Pecoul, DNDi had agreed with Pharco, an Egyptian drug company, to provide treatment for Malaysians for around US$300. 

One issue is that Sofosbuvir is patented in Malaysia, unlike Egypt which had rejected the patent application. If a product is patented, rival brands are not allowed to be sold.

However, the WTO and national patent laws allow governments to issue “compulsory licenses” or “government use orders” on various grounds.

Malaysia is no stranger to this.  In 2003 the government issued a government use order to enable import of two combination HIV-AIDS drugs from an Indian generic company, which resulted in great savings as the cost fell by 68% to 83% and three times more patients could be treated.

Malaysia earned praise for this action, with other countries following suit, including Thailand and Indonesia. Today it is quite common for countries to issue compulsory licenses.

In the case of Hepatitis C, there are potentially half a million Malaysians suffering from the very serious ailment and who just cannot afford the treatment.  If the price can be brought down from the original RM400,000 and the present RM40,000 to only RM1,000, imagine the massive savings to the government and country and most important the joy to the patients where the light at the end of the tunnel can finally be sighted.

On this year’s Hepatitis Day, it is thus imperative that all necessary measures are pursued, including concluding the clinical tests, working with DNDi and Pharco to set the right treatment regime and getting a good bargain on the cost the government has to pay for the combination drugs, and issuing the compulsory license or government use order to enable the treatment to proceed.