Public health licensing to increase access and facilitate innovation: the Medicines Patent Pool model

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Marie-Paule Kieny, Chair of the Medicines Patent Pool Governance Board, gives an introduction of an article “Public health licensing to increase access and facilitate innovation: the Medicines Patent Pool model” authored by Philippe Douste-Blazy; Charles Gore; Lelio Marmora; and Marie-Paule Kieny, published in Medium. They review the impact of the Medicines Patent Pool and how its model can be adapted to other disease areas.

The Medicines Patent Pool Foundation (MPP) has been striving to scale-up access to quality-assured generic HIV medicines in low- and middle-income countries (LMICs) for almost a decade. Philippe Douste-Blazy; Charles Gore; Lelio Marmora; and Marie-Paule Kieny review the impact of the foundation and how its model can be adapted to other disease areas.

At the Sixty-first World Health Assembly in 2008, the World Health Organization (WHO) called to “examine the feasibility of voluntary patent pools…to promote innovation of and access to health products and medical devices.”[1] At this time, patent pools in public health did not exist. New, safe and effective patented therapies were mostly out of reach of LMICs’ populations. While the concept of patent pools had been previously discussed by WHO Member States, it was not certain that such a model could effectively accelerate access to treatment.

In 2010, Unitaid took on the challenge of creating and investing in the MPP, the world’s first patent pooling initiative in public health. Unitaid was the natural place for exploring the establishment of an innovative mechanism such as a patent pool. Relying on pioneering funding approaches (receiving most of its resources via levies on airline tickets), Unitaid had begun to play a central role in addressing market challenges in the treatment commodities for HIV/AIDS, malaria and tuberculosis.

At this time, the HIV challenge in sub-Saharan Africa was daunting. Most countries could only access generic antiretroviral (ARVs) regimens of the first generation, which generally contained stavudine, rather than the more effective — and safer — tenofovir (TDF). Stavudine had a range of documented side effects and, in 2010, the WHO guidelines for ARV therapy had recommended that countries progressively reduce its use because of “well-recognised toxicity.”[2]

Yet newer or improved regimens were slow to scale up in LMICs, one of the key reasons being significant affordability barriers. It was over 10 years before TDF moved from originator approval to being widely available in developing countries. And for those developing resistance to first-line treatment, second-line treatments were often out of reach.

The MPP aimed to change this. Concentrating on HIV, the foundation began negotiating public health driven voluntary licences with patent holders (later expanding to hepatitis C and tuberculosis).

Now, eight years on, the MPP has been able to dramatically reduce time to access treatment. In the case of new HIV therapies such as dolutegravir (DTG), the timescale has more than halved. New licences have also facilitated the development of the fixed-dose combinations which are better suited for resource-limited settings or for use in children. The WHO-recommended first-line treatment tenofovir/lamivudine/DTG was developed by MPP licensees, thanks to licences from patent holder ViiV Healthcare, and is now available for USD 75 per patient per year in over 100 countries. Overall, the MPP has provided 17 million patient-years of treatment through generic partners, from January 2012 to December 2017, by enabling generic manufacturers to ramp up production.

The extraordinary scale-up of antiretroviral treatment was driven in part by price reductions facilitated by the MPP. Since 2010, concerted action by many partners — including Unitaid, WHO, PEPFAR, and many others — has reduced AIDS-related deaths from 1.5 million in 2010 to under one million in 2017[3] with sharp declines seen in many of the countries most afflicted by the disease.

In 2016, the WHO recommended the expansion of the MPP to “all disease areas, and for all patented essential medicines on the WHO Essential Medicines List (EML).” Following a feasibility study[4], the MPP’s remit was extended, with an initial focus on small molecules currently included in the WHO EML and those with strong likelihood for inclusion. While expanding the model will not be without its challenges — and we expect many of the same questions to be raised — the potential is there for significant public health impact.

As we’ve seen with the release of the Access to Medicine Index 2018[5], many companies are now including access strategies as part of new product launches. Based on our first-hand experience, we firmly believe in the potential for win-win-win scenarios, brought about by close partnership working with the research-based and the generic pharmaceutical industry, to benefit people needing urgent access to treatments no matter where they live. Just under 10 years ago, the MPP’s model was a novel and untested concept. We now hope that, for essential medicines of public health importance in LMICs, it will become standard practice.