Medicines Patent Pool has a plan to get drugs to low-income nations fast

Medicines Patent Pool, known for its work in the generic licensing of drugs for infectious diseases such as HIV and tuberculosis, has big ambitions for the next three years. It aims to have 10 new licenses, support 10 technology transfers, and develop five new products that will reach 30 million people by 2025. The goal is to deliver medicines to low- and middle-income countries at the same time as high-income countries. “I want to get generic versions into low- and middle-income countries within a year of their launch in the developed world. That's really the aim,” Charles Gore, the executive director of MPP, told Devex ahead of the launch of the organization’s new strategy on Monday. LMICs often wait years to access new drugs already available in high-income countries. Antiretroviral drugs for HIV treatment are a classic example of this: They were already available in the United States in the late 1980s, but it took more than a decade for them to become accessible in African countries. Today, Paxlovid, Pfizer’s COVID-19 antiviral pill, which has been in use in the U.S. since December 2021, remains unavailable in many countries. MPP is now making it a mission to cut the waiting time for the drugs that it will license in the future. “COVID changed the landscape, and waiting five years for a medicine already approved in high-income countries is no longer acceptable,” Gore said. Expanding its reach To achieve its goal, MPP is eyeing early licensing, which Gore said should be part of pandemic preparedness efforts. “This model of voluntary public health licensing is something that could really be used in the next pandemic, provided we think it through now and do things earlier than we did this time [with COVID-19],” he said. MPP secured deals for the generic licensing of Pfizer and Merck’s COVID-19 antivirals, but the licenses were secured after the drugs have already received emergency use authorization in the U.S. But the organization needs to convince companies to license their drugs to MPP at the earliest stages of drug development. That is, even before they are tested for efficacy. Then they need to get generic manufacturers that are willing to start developing the drugs even without the assurance they will be effective. One way MPP can encourage generic manufacturers is by providing them incentives. But this may be easier done during a pandemic, Gore said, when funding can be available to speed up processes, which was the case in developing COVID-19 vaccines. It’s also important, he said, to include access provisions in any out-licensing deals when a company, usually a small- and mid-sized pharmaceutical company, works with another firm for further development or marketing of a product. That funders require access plans for grants to develop a drug is equally necessary. Gore said this is already happening, but “needs to happen more.” “And furthermore, when the terms do exist, they need to be enforced, and that's not always happened,” he said. MPP also wants to continue working with a diverse set of manufacturers and support local production. Before the pandemic, MPP used to work with manufacturers from a few countries, including India and China. But that changed with COVID-19, which led the organization to work with manufacturers across 16 LMICs. “The problem is that we can't give a license to somebody who doesn't apply,” he said. Gore said MPP will work with organizations seeking to improve local and regional manufacturing to identify companies that can benefit from some help to be able to take on their licenses. “COVID changed the landscape, and waiting five years for a medicine already approved in high-income countries is no longer acceptable.” -- — Charles Gore, executive director, Medicines Patent Pool Using an underutilized model MPP is known for licensing medicines for infectious diseases. But Gore said their model is also viable for medicines for noncommunicable diseases. Over the last four years since he joined MPP in 2018, the organization has been trying to get a voluntary licensing agreement for NCD drugs, he said. But it’s been difficult to get companies on board. Many of them think the MPP model only applies to infectious diseases. Others meanwhile don’t think a voluntary licensing deal would solve problems in accessing the drugs, given other barriers, such as a lack of diagnostics, doctors, and hospital equipment in countries. Governments may also not have the budget to purchase the drugs, even at reduced pricing. Gore said this is a problem they face with hepatitis C drugs, for which MPP has licensing deals. The number of patients who received treatment is much lower than expected, he said. According to the World Health Organization, of the 58 million people globally living with a hepatitis C virus infection, only 62% or 9.4 million people had been treated by the end of 2019. “The companies [say], if we give you a license, you're still not going to be able to make any difference. So there's no point in going through the hassle of giving you a license,” he said. For cancer, MPP joined a group, called the Access to Oncology Medicines Consortium, which can help address these barriers. Gore said that helped convince Novartis, which is also part of the consortium, to give MPP the licensing deal on the cancer drug nilotinib, which is used for the treatment of chronic myeloid leukemia, a type of blood cancer. However, the deal, signed in October, doesn’t cover a lot of countries, Gore said. He hopes to expand their reach and achieve the same for other NCD medicines. “I think our model is underutilized. I think it could be utilized across NCDs to make medicines affordable, where at the moment they’re simply not. They are either not available at all, or if they are available they are not affordable … across low- and middle-income countries,” he said. Staying on its lane MPP is also looking at what it can do in terms of access to vaccines, diagnostics, and antibiotics. But Gore said they’re careful in sticking to their area of expertise, that is, negotiating licenses to pave the way for access to affordable treatments in low- and middle-income countries. The organization has been involved with vaccines for COVID-19. It currently co-leads with WHO the messenger RNA vaccine technology transfer hub based in South Africa. But he’s aware that biological products such as vaccines take a lot of time to be developed. “So I don't know whether we actually get a license on a vaccine during this time. But I think we're willing,” he said. On diagnostics, Gore said they plan to do a feasibility study to see where they can help in increasing access and whether it makes sense for MPP’s work. “Because everything that we know about diagnostics suggests to us that intellectual property is not the barrier … it’s manufacturing know-how. And that’s not us,” he said. MPP may also work on antimicrobial resistance, although it isn’t discussed much in its strategy. AMR is one of the priorities of the Group of 20 leading economies this year. Gore is careful not to duplicate other organizations’ work or creep into areas where MPP doesn’t have expertise. “I think this is a very … important thing overall in the whole ecosystem of public health — trying to make sure that we don't tread on each other's toes, that we stick to what we do best and collaborate with other people who do what they do best,” he said.