A HIGHLY effective drug which can cure Hepatitis C hit the market in 2013 but five years later, over 70 million people around the world are still not getting the needed treatment.
In Malaysia, that was initially the fate of an estimated 400,000 patients for this disease, amid intense debates whether the cheaper generic version of drugs should be made available to more people.
One major reason for the untreated millions of people was the prohibitive price.
When the direct acting anti-viral medicine (DAA) sofosbuvir was first introduced in the United States, it cost US$84,000 (RM324,000) for a full 12-week treatment course.
The pharmaceutical company was criticised for making obscene profits and disregarding the majority who needed the treatment. The high cost was beyond the means of developing as well as developed countries.
Last year, The Star reported that Malaysia was not given special pricing for the drug by pharmaceutical companies because it is considered a middle-income country, even though the disease is a major public health threat.
Negotiations with the drug company failed after it gave its last offer at RM50,000 for a 12-week full-course treatment, said Health Minister Datuk Seri Dr S. Subramaniam recently.
The Government then defied the odds and became the first in the world to gain access to the generic version of sofosbuvir through compulsory licence (CL), an authorisation that allows access to generic products at a much lower cost while the patent is still underway.
It is part of the flexibility provided under the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. It brought the cost down to RM1,000 for the full-course treatment in combination with daclatasvir.
This led to the wrath of big pharmaceutical companies which pressured Malaysia to retract its position, saying that the decision discouraged innovation. They even got the US government to intervene.
Meanwhile, in developed countries, governments could only provide a limited number of treatments a year due to the high cost.
In the United States, 18 lawmakers wrote in February to the Department of Health and Human Services to consider issuing CL for expensive Hepatitis C treatments.
They argued that rationing current treatment only to those with advanced forms of the disease is harming public health in the country.
The number of people worldwide who have not been treated is a staggering 71 million, according to the latest World Health Organisation (WHO) 2018 progress report on access to Hepatitis C treatment.
The number of those who initiated DAA-based treatment for Hepatitis C was negligible, with an increase from about one million in 2015 to 1.5 million in 2016, it said.
This is despite the fact that 95% of people with Hepatitis C can be completely cured within two or three months.
While pharmaceutical companies want their intellectual property rights to be recognised, governments and civil society are asking if astronomical pricing of drugs is justified.
It is important to recognise that it is costly to develop drugs, including the cost of clinical trials. Pharmaceutical companies also have to answer to shareholders. But how much profit is too much and what is the value of human lives?
Gilead Sciences’ representative said it does not wish to comment for now.
However, the US Senate investigation of Gilead Sciences revealed that Pharmasset had initially considered a price of US$36,000 (RM138,900) for sofosbuvir.
But Gilead Sciences, which had acquired Pharmasset, set the market price at US$84,000 (RM324,000), according to The BMJ journal report.
The report, “Betting on Hepatitis C: How Financial Speculation in Drug Development Influences Access to Medicines” on July 27, 2016, said the price was set “after internal deliberation over multiple factors, including an evaluation of the high prices of previous drugs and how much health systems could bear”.
“The resulting cycle of profit accumulation, speculation, and higher prices deepens the problem of affordable access to medicines,” it said.
It also said that by the first quarter of 2016, Gilead had accumulated over US$35bil in global revenue from Hepatitis C medicines since its launch in December 2013.
The revenue was more than triple the cost of the initial acquisition of Pharmasset and nearly 40 times the cost of Gilead and Pharmasset’s combined reported costs for developing sofosbuvir-based medicines, it said.
It brings into question the purpose of a new discovery or innovation. It is supposed to bring progress and better health to mankind. But what purpose does it serve when millions are unable to afford it?
A lot of rethinking is needed if the world is to achieve better health outcomes with Hepatitis C.
The WHO report urged governments to scale up treatments by procuring the more affordable generic DAAs, which have become available through voluntary licensing or local production.
Drugs for Neglected Diseases initiative (DNDi) South-East Asia regional office head Jean-Michel Piedagnel said pharmaceutical companies should cover their R&D cost and make some profit but they should also base their profit on volume rather than a small market to enable the disease to be tackled from a public health approach.
“When cost is prohibitive, only a limited number of people will be treated and Hepatitis C infection will still be transmitted.
“Malaysia using CL in making drugs affordable and tackling Hepatitis C through public health approach is a game changer.
“The approach could eliminate Hepatitis C,” he said.
Third World Network programmes director Chee Yoke Ling said the misuse of patents includes the issue of “ever greening” – the use of various strategies to file many patents around a medicine which can increase the market monopoly beyond the normal term of 20 years for the first patent.
In Malaysia, patients in public hospitals started receiving DAAs treatment last month following the CL move.
The move had also led to Gilead Sciences announcing on Aug 24 to include Malaysia in the Hepatitis C generic licensing agreement with several Indian manufacturers.
The granting of a sofosbuvir voluntary licence (VL) meant that it will be possible for lower-cost generic versions of the drug to be made available. The price before the VL was US$30,000 (RM128,115) per person.
While WHO has called on countries to step up its fight against Hepatitis C, pharmaceutical companies too need to be more conscionable and introduce a business model that provides the support needed for nations, instead of purely maximising profit.