IPASA | How do we ensure access to life-saving medication without crippling innovation? Let’s talk about voluntary licensing.

14 Dec How do we ensure access to life-saving medication without crippling innovation? Let’s talk about voluntary licensing.

Posted at 07:46h in Ipasa News by DrBoss

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To address the need for affordable and accessible life-saving medical interventions, the Medicines Patent Pool has become the saving grace for countless patients, writes Dr Mothobi Godfrey Keele, Head of Government Affairs and Policy at IPASA.

As of 2021, more than 38.4 million people globally were living with HIV, with as many as 1.5 million people infected with the virus last year alone¹. While global prevalence amongst adults has levelled since 2001² and new infections among children have declined by 41% since 2010, more is needed to increase accessibility to life-saving medications. Especially as insights suggest that only 54% of children living with the virus receive treatment³.

As we commemorate World AIDS Day on 1 December⁴, we are reminded of the opportunity to unite against HIV, show support for those living with the virus and remember those who have succumbed to it. It is also a moment to reflect on the enormous effort scientists have expended on researching and developing treatments to control the virus and keep patients as healthy as possible.

While there is no cure for AIDS, medical treatments against HIV effectively combat complications arising from the virus, reduce the viral load of HIV in the body and keep the immune system as healthy as possible⁵. Treatments against HIV can be expensive, and often more than an average person can afford⁶. In addition, pharmaceutical companies with registered intellectual property rights over the chemical composition of their medications can often dictate their asking price as they seek to recoup costs incurred during the Research and Development (R&D) phase and still deliver strong returns to investors who fund expensive long-term explorations that don’t always result in the creation of effective medication.

It is for this reason that organisations such as the Medicines Patent Pool (MPP) were established to accelerate access to affordable, quality treatment for low- and middle-income countries. This is achieved through voluntary licensing agreements and patent pooling which see generic manufacturers given the green light to manufacture medications whose patent rights remain enforceable by pharmaceutical innovator companies⁷.

One example of the success of the Medicines Patent Pool in benefitting developing nations with an adequate supply of affordable quality medications is evidenced in the rollout of the HIV medicine dolutegravir (DTG) in South Africa in late 2019⁸.

DTG-based treatments have demonstrated a favourable rapid virologic and immunological response within four to eight weeks of use, as well as good compliance and an improved side effects profile⁹. So much so that the World Health Organization (WHO) recommends DTG-based treatments as the preferred first- and second-line regimen for those living with HIV⁸.

The access to the DTG medication came after extensive public health licensing agreements between the Medicines Patent Pool and South African generic manufacturers for the medication’s technology transfer from global generic HIV treatment specialist pharmaceutical company, ViiV Healthcare⁸.

The agreement, signed in 2014, accelerated the access to quality and affordable versions of DTG medications as well as its combinations, including TLD⁸ – a combination of tenofovir disoproxil, lamivudine and dolutegravir¹⁰.

With the largest HIV treatment programme in the world by way of public procurement, South Africans have benefited greatly from this exchange⁸ that has seen as many as 60% of the 5,4 million citizens on antiretroviral treatments as of June this year, receiving the first-line DTG treatment regimen¹¹.

To this end, all South Africans who have been newly diagnosed with HIV, those who were previously prescribed TEE (a combination of tenofovir, emtricitabine, and efavirenz), and patients who were virally suppressed for at least six months will be offered the new combination of TLD⁸. Furthermore, this has provided equitable medication access to patients throughout the country, even those who depend on the State for their healthcare needs.

The collaborative efforts of the Medicines Patent Pool, the South African government and ViiV Healthcare have resulted in the country being recognised as a leader in HIV response and treatment, and the saving grace for many South Africans living with the virus and intent on living a healthy and productive life for many years to come.

[ENDS]

References:

11. González LL. World’s largest HIV treatment programme could shift almost entirely to WHO-preferred first line regimen [Internet]. aidsmap.com. [cited 2022 Nov 23]. Available from: https://www.aidsmap.com/news/jun-2022/worlds-largest-hiv-treatment-programme-could-shift-almost-entirely-who-preferred