In the United States, widespread hope greeted the decision by the Food and Drug Administration last week to authorize the emergency use of two different oral treatments for SARS-CoV-2 infection, which could mark a new era in which pills taken at home can prevent severe COVID-19. Global health advocates are also celebrating the preauthorization decision by the two Big Pharmas producing the treatments to allow generic manufacturers to make low-cost versions accessible to poorer countries.
Each of the treatments, Pfizer’s combination of a new antiviral, nirmatrelvir, with an old one, and Merck’s molnupiravir, require 5 days of pills, which the U.S. government has purchased for $530 and $712 per treatment course, respectively. That’s far too expensive for much of the world, but both companies joined the Medicines Patent Pool (MPP) for their patented treatments. A nonprofit set up in 2010, MPP encourages Big Pharmas to voluntarily cut deals that allow generic manufacturers to produce and sell a company’s drugs or vaccines at steep discounts in agreed on regions of the world. “Everyone at the time said this will never happen, this is a crazy idea,” says attorney Ellen ’t Hoen, who helped establish MPP and remains on its expert advisory group.
Generic makers are expected to cut the cost of either treatment to as low as $20 per treatment course, while Pfizer and Merck will continue to sell the pills to wealthy countries for whatever the market will bear. (Nirmatrelvir is boosted by a second drug, ritonavir, that came to market as an HIV treatment and is widely available as an inexpensive generic.)
MPP modeled itself after a cross-licensing agreement created by the U.S. government to free patents controlled by the Wright brothers and another aviation pioneer, who tied up the entire airline industry. MPP initially set out to make lifesaving antiretrovirals for HIV more accessible to low-income countries and then later branched out to include drugs for hepatitis C and tuberculosis. “This is frankly a dream coming true that the pool is moving into all these various areas of huge need and succeeding,” says ’t Hoen, who ran the Campaign for Access to Essential Medicines for Doctors Without Borders (MSF) before starting MPP. Deals through the group have led to the supply of more than 18 billion doses of drugs.
ScienceInsider last week spoke with ’t Hoen, who now works at Medicines Law & Policy, a coalition of experts who support nonprofits that focus on access to medicines. This interview has been edited for brevity and clarity.
Q: Both MSF and Oxfam issued statements after Merck and Pfizer joined MPP that criticized the deals as too restrictive because they don’t allow generic manufacture in many countries that will need the discount to access the medicines. What do you think?
A: Those big, brand name NGOs [nongovernmental organizations] suffer a little bit from knee jerk responses to things that aren’t perfectly perfect. These license agreements were made so quickly for pipeline products that did not have regulatory approval when they obtained the license agreements. The weakness of the patent pool is always that these manufacturers will not be able to supply the entire planet. Pfizer and Merck will want to keep their high-income markets in particular. But having said that, if you read the license agreements carefully, there are no barriers to [generic manufacturers] supplying drugs in countries where patents have not been filed or have not been granted—or where governments have decided to issue a compulsory license. This is incredibly important. [The World Trade Organization allows countries to issue compulsory licenses without a patent owner’s consent for national emergencies.]
Q: What has been MPP’s biggest success to date?
A: The biggest success is the fact that it has licenses for all recommended HIV treatment regimens and it has established the norm that if you have an important product—and particularly an important medicine that is needed to treat people with HIV—you license to [MPP]. It’s almost unthinkable that you would not do that, which is the exact opposite of where we started from 10 years ago. [MPP] has saved many, many lives because these drugs became available at very low cost.
Q: How do these new agreements for Pfizer and Merck’s pills compare?
A: This went very fast and it’s very important that the pool is able to negotiate these licenses while these products are still pipeline. You don’t know at that point whether a product indeed will become very important. You see that now with molnupiravir, which in the beginning looked very promising and now people are saying wow, there are problems with it. But it doesn’t matter. It’s in there. And if you have the licenses, you don’t create further delays. It will be more likely that generic companies will go for the Pfizer product than for molnupiravir I suspect.
Q: Where has the patent pool yet to succeed with COVID-19?
A: It’s remarkable that Pfizer is licensing its therapeutics but not its [COVID-19] vaccine. Both Pfizer and Moderna have dug in their heels: They don’t want to license their vaccines. They want to keep them within their own, trusted circle of contract manufacturers. And that is a huge problem. What I’m hoping is that this experience Pfizer now has with [MPP] will lead them to take the next, and much more important, step to license its technology. And that would have to include a technology transfer package, in collaboration with the [MPP] and World Health Organization tech transfer initiatives.
Q: And the tech transfer is far more important with a vaccine than with a chemical compound like the drugs?
A: Indeed. Because otherwise, countries would have been issuing compulsory licenses left and right. But you just don’t get there with only the patents. You need a package that actually transfers the technology package.
Q: Moderna has already said it’s not going to enforce its COVID-19 vaccine patents during the pandemic. So what is it that’s needed?
A: That shows that doesn’t mean much. Patents in the vaccine area are more complex and much less important than the trade secrets. It’s the [manufacturing] know-how that needs to be transferred and you don’t find enough of that in the patent. You need the playbook.
What I would have liked to have seen, and I hope that in the future we’re going to see, is that these vaccines that are all developed with colossal public financing really become global public goods. And that governments that offer the financing say, “Here’s the money, generous money, for the research and development, but you cannot monopolize the knowledge that you create.” I hope that will be the lesson that the world will learn from what’s happening today.
Source: Science Mag