Almost 4 million people living with HIV in low and middle-income countries have access to crucial anti-viral medications because of voluntary licensing agreements facilitated by the Medicines Patent Pool.
In an exclusive interview with Patent Strategy, Charles Gore, executive director of MPP, says this achievement and many others are due to the organisation’s unique model, which teams ‘big pharma’ with generics companies around the world to bring essential medicines to the poorest patients.
Founded in 2010, MPP was established by the World Health Organization (WHO) to speed up access to medication for HIV, tuberculosis and hepatitis-C. While the organisation accomplishes many of the same goals as an international public health NGO, Gore says it is not simply a charity.
“Innovators tend to see our actions as philanthropy. But what we want is a solid business case to give licences. We can arrange royalties for the innovators and give them an income stream. But there are other things we can do too; innovators’ rankings on the access to medicines index goes up, for example,” explains Gore.
“The whole point of our model is it creates a win-win situation. Compulsory licensing is a threat to pharma companies, which is why we are not about that. We are a voluntary scheme and we are only talking about essential medications.”
As an example of how innovators are recognised for their contributions, GSK earned the top spot in the access to medicine index last year, partly because of its contributions to MPP via ViiV Healthcare, the company’s subsidiary focusing on HIV medicines.
ViiV contributed dolutegravir, an antiretroviral drug for HIV, to MPP in 2014. The access index ranks the top 20 pharmaceutical companies on their efforts to increase global access to medication based on several factors including pricing and R&D.
Deborah Waterhouse, CEO of ViiV Healthcare, said in a press release: “Enabling access to dolutegravir is an integral part of ViiV Healthcare’s commitment to ensuring no person living with HIV is left behind.”
The MPP model starts with the WHO and MPP drawing up a list of essential medicines that are needed in lesser-developed countries. MPP then negotiates the patents with the pharma innovators and holds a bidding war with generics companies.
Gore says: “What is unique about our model is that by giving a licence to multiple companies at once we can foster competition. When a pharma company gives a licence, they usually go to just one generic company and that doesn't bring the price down too far.
“With us, these are public health licences. We want them to be sustainable but we want the price to be as low as possible so as many people as possible can get access to life saving medications.”
MPP currently works with more than 20 generics companies in lower income countries. They are able to bring prices down to affordable levels because they can produce the drugs at high volumes.
Another advantage of the pooling scheme is that generics companies can combine different medications into single doses to come up with better medicines. The licensing agreement with ViiV Healthcare allowed generics companies to combine dolutegravir with Gilead’s tenofovir, for example, to create a fixed-dose single medication.
“Because of the pooling with different generics companies, there could be a situation where people in the developing world are getting better drugs. This is a perfect example of something happening in lesser developed countries that isn’t happening in the developed world,” says Gore.
“The point about pooling is that you can get licences from more than one originator and then the generic companies can combine them.”
The road ahead
Getting access to on-patent essential medications quickly and cheaply has been challenging in the past for countries with high rates of HIV. Before MPP, under-developed countries had to negotiate directly with pharma originators for essential medicines, or resort to compulsory licences under the TRIPS amendment.
Now with the voluntary scheme to pool patents, 13 generics companies are developing versions of dolutegravir and nearly 37 million packs of anti-retroviral medication were delivered between 2017 and 2018.
Speed of access to medication has also improved. It took less than four years after FDA approval of dolutegravir to bring a generic version to market for adults living with HIV in the developing world.
But while solid progress has been made, Gore says there is more to be done. MPP currently collects patents for HIV, tuberculosis, and hepatitis C. With diseases like diabetes and hypertension becoming more prevalent, Gore would like to increase the patent portfolio.
A big hurdle in future plans, however, is diagnosis.
“There are certain diseases that require a clinical test for diagnosis. If you only have one doctor in the country who can run the test, our model won’t work because most people with the illness will remain undiagnosed,” he says.
“We are going to approach pharma companies for a few drugs that will work with our model. There is no point for us to get a licence for a country where they can't use it. Some countries may not have the diagnostic capabilities.”
MPP also issued a patent report for long acting medications to major diseases that affect the developing world. The report on the patent landscape concluded that due to the complexity of protection on the medications themselves, and on the manufacturing processes, there are many freedom to operate challenges that can prevent generics companies from getting the medications to patients quickly.
“There is huge potential for long acting technologies to make a substantial difference to treatment adherence in low- and middle-income countries, for diseases including HIV, hepatitis C and tuberculosis. But this won’t happen by itself,” says Gore.
“Much collaboration is still required to develop them and then ensure affordable access. This report, by mapping the patent landscape for these technologies, will help accelerate this process.”
While more can and should be done to improve access in the developing world to essential medications, the 4 million people living with HIV who now receive affordable access to antiretrovirals have a new lease of life.
