PETALING JAYA: A think tank has cautiously welcomed the health ministry’s move to make treatment for hepatitis C in the country cheaper and more accessible to patients.
Health Minister Dr S Subramaniam was reported by Bernama as saying that the cabinet had approved the use of Rights of Government under Patent Act 1983 (Act 291) by exploiting the patented invention of the Sofosbuvir tablet 400mg, which had lowered the cost of treatment.
Galen Centre for Health and Social Policy chief executive officer Azrul Mohd Khalib said this was the second time Malaysia had utilised the option available to governments under the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
He said in 2003, Malaysia became the first country in the world to make use of that provision.
With this latest development, he said, Malaysia had again made history by becoming the first country to exploit the patented invention of Sofosbuvir.
“It is essential that the government ensures that this treatment programme succeeds.
“What does success look like? Success will be achieved when people come forward to get screened, treated and cured, which is not as easy as it sounds.
“The hard lessons from 2003 tell us that access to drugs must be accompanied by a long-term and sustained public awareness, prevention and screening programme.
“It is not easy, particularly with a disease which could take up to 20 years to progress,” he told FMT, adding that this would be critical in ensuring an outcome that justified the decision.
Azrul however cautioned that the government’s decision could have serious implications on all other innovations that are dependent on patent rights to protect their intellectual property, not just pharmaceuticals.
“Malaysia’s reputation in intellectual property rights will take a hit, especially as it has decided to proceed with this action despite its recent inclusion into Gilead Science’s voluntary licence programme.
“For better or for worse, Malaysia’s action will also have a ripple effect across countries in the region. We might see other countries deciding to do what Malaysia has done.”
When asked if cheaper hepatitis C treatment was a good thing, he replied in the affirmative but said it must be recognised that this was not an easy decision to make.
“It comes at a cost and most importantly, recognises the threat of hepatitis C in Malaysia.
“With more than 400,000 estimated to be living with the disease, it is absolutely necessary for the country to have the best access to life-saving treatment.
“This drastic move makes this possible as it makes treatment affordable for the government,” he added.
Meanwhile, the Drugs for Neglected Diseases initiative (DNDi), which is a non-profit research and development organisation, also welcomed the move.
“The Malaysian government has reaffirmed its strong commitment to providing access to treatments for hepatitis C,” it said.
“The decision is also a strong signal to other countries where high treatment costs act as a barrier to implementing a public health approach for hepatitis C,” its executive director Dr Bernard Pécoul said in a statement.
Pécoul said DNDi has been running clinical trials in Malaysia, in partnership with the health ministry and Egyptian drug manufacturer Pharco Pharmaceuticals, to test a pan-genotypic treatment combining Sofosbuvir with the drug candidate ravidasvir.
The clinical trial is ongoing at six hospitals with Clinical Research Malaysia, a non-profit entity owned by the ministry.
Pécoul said Pharco had agreed to set the price of the combination treatment at US$300 per 12-week course once ravidasvir was registered.
Currently, a full course of treatment is available in Malaysia for around US$70,000 (RM300,000).
Subramaniam said the decision to initiate the Rights of Government was made after the health ministry was included in the Medicine Patent Pool (MPP) and price negotiations with the patent holder.
He said the procurement of the 400mg Sofosbuvir tablet would be in accordance with current government procurement procedures.
The implementation of the Rights of Government for the 400mg Sofosbuvir tablet is for use at government facilities only, namely at hospitals of the health ministry and armed forces.