KUALA LUMPUR – Malaysia will be able to produce highly sought-after generic HIV drugs after the country inked a deal with global pharmaceutical company ViiV Healthcare and the United Nations-backed Medicines Patent Pool (MPP), said Health Director-General Tan Sri Dr Noor Hisham Abdullah today.
In a series of tweets early today, Dr Noor Hisham said Malaysia is part of the voluntary agreement with the company majority-owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi Limited as shareholders, and the MPP to enable greater access for dolutegravir (DTG) based regimens.
“Affordable versions of WHO-recommended dolutegravir-based treatment regimens are urgently needed to end the HIV crisis everywhere,” Dr Noor Hisham announced at around 2.40am in the first of four tweets related to the agreement.
“We are therefore very pleased with the MPP-ViiV Healthcare agreement signed today.”
Dr Noor Hisham said with the agreement, Malaysia will be able to provide WHO prequalified, more affordable versions of these essential medicines to people living with HIV and in need of treatment.
“We hope the competition bt (between) generic manufacturers enabled by this licence, will bring us quality medicines at lower prices.”
In a follow-up tweet, Dr Noor Hisham said: “It is not very often that we are listed under MPP & this decision marks a crucial milestone. We hope that It will open up more doors to gain rapid access to lifesaving medicine (sic). MOH wishes to thank MPP & all parties involved who have made this incredible decision a reality.”
In a press release, ViiV Healthcare and the MPP said the DTG-based regimens have been recommended by the World Health Organisation (WHO) or the US Department of Health and Human Services (DHHS) in certain upper-middle income countries (UMICs).
Malaysia was made party to the agreement that included only three other countries, Azerbaijan, Belarus, and Kazakhstan.
ViiV Healthcare and MPP said they developed this agreement to enable “increased access and affordability to generic DTG-based HIV treatment regimens, while also supporting continued investment in much-needed innovation upon recognising the specific challenges faced by these countries, and in response to feedback from the HIV community and the governments”.
“Through this novel agreement, generic manufacturers will have the opportunity to supply DTG-based regimens at a significantly reduced price compared to the current local price, in turn enabling greater access to these medicines for people living with HIV in each country,” the statement read.
MPP executive director Charles Gore said increasing access to life-saving medicines for low- and middle-income countries is “at the core” of MPP's mission.
“We have been able to achieve that over the last 10 years through strong partnerships that span industry, generics manufacturers, governments and civil society,” he said in the statement.
WHO’s director of global HIV, hepatitis and STI programmes Dr Meg Doherty said WHO recommends DTG as part of the preferred first-line and second-line regimen for HIV patients, including pregnant women and those of childbearing potential.
“WHO welcomes this licence and through our regional and country offices have worked alongside governments and MPP to ensure that this agreement responds to people’s HIV treatment needs in these countries.”
ViiV Healthcare CEO Deborah Waterhouse said the company is “100% committed” to its mission of leaving no person living with HIV behind and is proud to have built upon its existing partnership with MPP to enable improved access to DTG in the countries involved, in line with the WHO HIV treatment guideline.
“Through this agreement, we have created an innovative model that enables improved access to treatment and increased affordability while supporting continued investment in research and development of much needed innovative medicines to help ensure better long-term outcomes for people living with HIV.” – The Vibes, December 1, 2020