Kuala Lumpur, 21 September 2017 – Yesterday’s formal announcement by the Health Minister that the Government has decided to utilise Section 84 under the Patent Act 1983 (Act 291) to provide for the production of a generic version of Sofosbuvir to treat Hepatitis C needs to be viewed as an act of necessary action undertaken in the public interest and as a last resort.

Commenting on the announcement, Azrul Mohd Khalib, Chief Executive of the Galen Centre for Health and Social Policy, said, “This decision was obviously not taken lightly, comes at a great 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.”

“It is essential that we ensure that this treatment programme succeeds. This is the second time Malaysia has initiated this option available to governments under the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In 2003, Malaysia became the first country in the world to make use of that provision. With this development, Malaysia again makes history by being the first country to exploit the patented invention of Sofosbuvir.”

“What does success look like? Success will be 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 drug access 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. This will be critical in ensuring a health outcome which justifies this decision,” he emphasised.

“Unfortunately, we must also acknowledge that this development could have serious implications towards all innovations, not only pharmaceuticals, which are dependent on patent rights to protect their intellectual property. Malaysia’s reputation in intellectual property rights will take a hit. Malaysia’s action will also have a ripple effect across countries in the region. We might see others decide to do what Malaysia has done,” Azrul concluded.

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