TWN Info Service on Health Issues (Aug17/01)
By Martin Khor
This article was first published in The Star (Malaysia, 31 July).
WORLD Hepatitis Day fell on July 28. So it was timely that 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 revealed last Friday 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 Health Minister Datuk Seri Dr S. Subra¬maniam on July 20.
That indicates one in 12 adult Malaysians has 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 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 which may cure up to 95% of cases.
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$84,000 (RM359,436) for a 12-week treatment course in the United States.
In Malaysia, the cost may be up to RM300,000 for the full treatment, according to The Star report.
Last November, the Consumers Associa¬tion 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 (RM855 to RM1,283) for them.
But Malaysia is one of the 41 middle-income countries excluded.
In countries which have not patented the drug, generic versions of Sofosbuvir are available for a 28-day course at prices ranging from US$15 (RM64) in Pakistan to US$197 (RM842) 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 prices ranging from US$2,292 (RM9,807) in Brazil to the launching price of US$28,000 (RM119,812) 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 three 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 July 21 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 the 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 Dr Bernard Pecoul, DNDi had agreed with Pharco, an Egyptian drug company, to provide treatment for Malaysians for around US$300 (RM1,283).
One issue is that Sofosbuvir is patented in Malaysia, unlike Egypt which rejected the patent application. If a product is patented, rival brands are not allowed to be sold.
However, the WHO and national patent laws allow governments to issue “compulsory licences” or “govern¬ment 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 licences.
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 the joy of the patients.
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 licence or government use order to enable the treatment to proceed.
> Martin Khor (firstname.lastname@example.org) is executive director of the South Centre. The views expressed here are entirely his own.