Lenacapavir (LEN), a groundbreaking, long-acting antiretroviral, has prevented nearly all HIV infections in clinical trials. LEN could be the answer to responding to the global HIV crisis, if it becomes widely accessible through compulsory licenses, say HIV researchers and advocates.
Currently, patents on LEN make it inaccessible in many middle-income countries, which are not included in Gilead’s voluntary license (VL).. These countries are not eligible for affordable generic versions of LEN; instead, they must pay whatever Gilead demands for the drug. Gilead currently charges over USD $40,000 per person, per year for LEN, although the projected cost for profitably mass-producing generic versions of LEN is between USD $40 to $100 per person, per year.
In a forthcoming editorial, Dr. Andrew Hill from the Department of Pharmacology and Therapeutics at the University of Liverpool, Mark J. Siedner from the Massachusetts General Hospital and Harvard Medical School, and Francois Venter, from the University of the Witwatersrand Faculty of Health Sciences, suggest that countries excluded from Gilead’s VL declare a public health emergency to pursue compulsory licensing, which would enable them to import or manufacture generic versions of the drug, and thereby, effectively reduce new HIV infections.
Make Medicines Affordable (MMA) sat down with HIV researcher Dr. Andrew Hill to delve into this possibility and what it would mean for people living with HIV. The following is a slightly edited and condensed transcript of our conversation.
MMA: Why does lenacapavir have the potential to be groundbreaking?
Hill: Lenacapavir is an injection that people can take once every six months that almost completely stops HIV transmission….it is the closest we’ve ever been to an HIV vaccine. I’ve been working on HIV for over 30 years. I’ve never seen anything like this before.
I spoke to researchers in Eswatini, and they were talking about giving lenacapavir to all the women in the country, because the risk of HIV infection is so great. In Eswatini, 40% of young women have HIV by the time they’re 30 years old.
A lot of people who are at risk of HIV are embarrassed about taking pills to protect themselves, because other people might think they already have HIV or that they’re promiscuous or sinful. With lenacapavir, people can quietly take this injection as part of something else, like hormonal injections or an antenatal visit, and it can be done confidentially.
MMA: Gilead’s voluntary license has been widely criticized, as it excluded nearly half of all countries in the world. Why else is this voluntary license problematic?
Hill: The problem with Gilead’s voluntary license for lenacapavir is it has a lot more restrictions than a normal voluntary license, and it excludes parts of the world where HIV is growing the fastest. It only includes countries where 67% of HIV infections happen. It has a lot of restrictions because the countries who make the drugs have to restrict the sale of the drug to a small group of countries and also need to report information [to Gilead] on what would normally be confidential data.
MMA: You suggest that countries excluded from the voluntary license use a compulsory license instead. What is compulsory licensing, and how can it be utilized in this circumstance?
Hill: With a compulsory license, the country may decide that it will use patents or patent applications without authorisation from a patent owner on a ground that country defined in its legislation, for example to protect public health,. They use the drug company’s patent and say, ‘You have no choice. We will license this whether you like it or not’, and that’s why it’s called a compulsory license.
It’s the legal right of a country to issue a compulsory license to protect public interest as opposed to private interests of the patent owner. One example is the case of a public health emergency. After 9/11, anthrax was sent to politicians and journalists in the United States, which considered this a public health emergency and threatened to issue a compulsory license for the drug to treat anthrax. During the COVID-19 pandemic, Israel considered the epidemic a public health emergency and issued a compulsory license on a potential treatment for COVID-19. The European government has passed legislation to allow it to issue compulsory licenses if there is a pandemic. In the past, Brazil, Colombia,Thailand, and Uruguay have issued compulsory licenses.
During the compulsory license, a country will start making the drug themselves, or they will import the generic drug from a country that is making it. That is a perfectly legal mechanism to make sure that people can access a medicine at an affordable price, and that is what can be done with lenacapavir.
MMA: You’ve stated that some countries are hesitant to issue a compulsory license due to fear of economic sanctions or facing non-preferential treatment in trade negotiations. Tell us about these risks.
Hill: There have been examples of threats from the U.S. department of trade against countries which issue compulsory licenses, but the long term analysis of those countries showed that it hasn’t actually impacted their trading potential. There is currently a legal action from GlaxoSmithKline against Colombia, after they issued a compulsory license on an HIV drug, so this does happen. However, the TRIPS Agreement is very clear. It is legal for a country to issue a compulsory license.
If we look at HIV versus COVID, 41 million people have died of HIV so far. About 15 million people died worldwide of COVID-19. You could argue that HIV is more of a public health emergency than COVID ever was, and that we need to have emergency-style measures put into place. Otherwise, the epidemic just carries on.
MMA: What must happen for a compulsory license to become a reality?
Hill: Ultimately, it’s the decision of a government to issue the compulsory license. There might need to be pressure from civil society, from non-governmental organizations to make it happen. Once it does happen, you then need a mechanism to get the drug into the country. You’d have the building blocks of the drug being exported from countries that were already making it, and the drug would then either be made inside the country [that issued the compulsory license] or made in a country where it was legal to do so [either in the absence of a blocking patent or with the enforcement of a CL or VL].
MMA: Why is it critical for countries who are excluded from the voluntary license to pursue a compulsory license or, at the very least, consider this?
Hill: With the current timelines for voluntary licensing, it could take another three years before Gilead’s generic route comes to fruition, and that is a huge amount of time. In that time, we would expect, if current infection rates continue, another four million people will acquire HIV. We have another two million dying from HIV-related illnesses. That, for me, is a public health emergency. Doing nothing means we continue to see an HIV infection every 24 seconds and an HIV-related death every minute.
MMA: What do you believe is the role of organizations such as UNAIDS, given that they set the global targets on HIV eradication, in helping push for compulsory licensing of lenacapavir?
Hill: An organization like UNAIDS should show leadership on how these goals can be achieved. If they say infections need to fall below 350,000 per year, they need to show the mechanism which will make this possible. If the mechanism of voluntary licenses is failing, then the next logical conclusion is compulsory licenses. So you would expect UNAIDS to support countries that issue compulsory licenses and say that this is a way forward.
We need to realize how much of a moment this is [the success of lenacapavir] to shut down HIV transmission. We’ve never been in this position before. Governments have many different priorities for many different diseases, but if they could concentrate on HIV, and then they could be given a vision where young women get an injection every six months and don’t get HIV, it could be groundbreaking. I think governments need to really be shown what a breakthrough this [drug] is, and given a guide to how they could get there. This ability to import the drug legally under compulsory license could stop HIV transmission. It would be huge. If one or two countries could take this on [compulsory licensing] and demonstrate to the world that HIV transmission can be stopped, it would send shock waves.
