Malaysia Issues Compulsory License for Gilead’s Sofosbuvir
Despite Licence
A much cheaper version
of a groundbreaking hepatitis C medicine is now accessible for the hundreds of
thousands of hepatitis C patients in Malaysia, as it decided to grant a
compulsory licence to sofosbuvir.. The decision comes right after the Gilead
Sciences decided to expand its voluntary licensing scheme to Ukraine, Belarus,
Malaysia, Thailand and Philippines & announce
on professional platform as follows:
According to the Malaysian
AIDS Council it is 500,000 people or
2.5 per cent of the general population are estimated to be living with
hepatitis C in Malaysia & the cost of the full hepatitis C treatment comes
to RM 300,000 per patient (US$71,300), leading to very few patients benefitting
from it.
Since Sofosbuvir is
patented, a government-use licence is needed to waive the monopoly right and
enable the sale of generic drugs. Thus, the government decision is the key to
opening the door to affordable treatment.
Issuing such a licence
is provided for by the Malaysian Patents Act (Section 84) and consistent with
the rules of the World Trade Organisation’s TRIPs Agreement.
Under the scheme, Gilead
signed agreements with some Indian drug companies to make and sell
Sofosbuvir in about 100 countries, but Malaysia was excluded then. The decision
to issue a government-use licence is believed to be the main reason why the
firm is now including Malaysia too. Previously, the company signed agreements with 11 India-based
manufacturers to make generics of its hepatitis C medicines for 91 developing
countries.
As a sequence of
Compulsory License Malaysia was first country in world to allowed Compulsory License
for import patented anti-HIV/AIDS drugs from an Indian generic makers under
fixed prices in 2004. Under the licence, Cipla was allowed to export and sell
these medicines under fixed ceiling prices to the Malaysian government for
exclusive supply to government hospitals for two years.
Compulsory Licensing in
India
On 25 June 2015, Lee
Pharma has filed an application to obtain a compulsory license for Patent No. IN
206543 covering Saxagliptin. The patent in question was originally
granted to Bristol-Myers Squibb (BMS) in 2007 before being transferred to
AstraZeneca.
IPO Grants First Indian
Compulsory License to a domestic generic drug-maker. The decision effectively
ends German pharmaceutical company Bayer AG's monopoly over an anti-cancer drug
and authorises the production of a low-cost version for the Indian market.
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