During COVID-19, much excitement has surrounded the prospect of a vaccine and therapeutics. To discuss making sure as many as people who need these as possible and more, I spoke with Charles Gore, the executive director of the Medicines Patent Pool. Our conversation has been edited for length and clarity.
Could you introduce yourself and the Medicines Patent Pool (MPP) and what your aims and your goals are?
I am the executive director of the MPP, which was set up ten years ago by UNITAID. The idea was to increase access to, and facilitate development of, life-saving medicines for low- and middle-income countries (LMICs) through a very innovative approach to voluntary licensing and patent pooling. The aim is to ensure that, no matter where someone is, they can access the best new medicines (which are almost always patented) as quickly as possible and as near as possible to the time at which they become available in high-income countries.
The organisation was set up really to tackle the particular issue of making medicines for HIV affordable in LMICs, particularly those in sub-Saharan Africa. We then expanded, based on the success of that model, to hepatitis C, tuberculosis and, more recently, other essential medicines, including for noncommunicable diseases (NCDs). Also, because we have ten years of experience and expertise in this model, our board expanded our mandate to ensure COVID-19 technologies, including therapeutics and perhaps even vaccines, are available as rapidly as possible to people in LMICs.
We’re here to discuss the Medicines Patent Pool’s efforts to “accelerate global access to effective COVID-19 treatments via a pool for voluntary product licences.” This effort has been joined by eighteen pharmaceutical companies. What’s the significance of this?
Eighteen signed up initially, but another three have joined so we’re now at 21. As you may have seen, so much of the focus has been around capacity and fears that there is not enough capacity to make the technologies that we need. We are discussing this with the generic companies with whom we have a built relationship over the last ten years and are working with now. What we decided we wanted to do was to show there is this capacity there and it can be used to make new technologies and specifically therapeutics available to those in LMICs. We want to highlight the fact that this focus on capacity has perhaps taken some of the focus off voluntary licensing as a way of making sure these products are available to and affordable in LMICs.
What is different about COVID-19 compared to other global health crises, or what is similar in terms of convincing drugmakers to become involved and work together?
I think everyone probably would accept that this is unprecedented. The speed at which this has overtaken us all, in an era in which we pride ourselves on the enormous advances in health (and rightly so), caught all of us by surprise, I think it’s fair to say. What that means is that people are having to look at slightly different ways of working – namely trying to do things much quicker than before and being more collaborative.
At the same time, there are some similarities to previous health crises. We still need to convince the developers of new drugs to give us licenses. Our model is going to be similar – there’ll be a lot of tweaks, but it will be effectively the same. We get a license, then sublicense to the generic manufacturers to produce versions that are more affordable but of the same high quality. We have shown this model to work very well. In the last decade, we’ve delivered some fifteen billion doses of drugs for HIV and hepatitis C. That speaks to the scale at which our model can deliver – for COVID-19, this is an asset.
You describe this cooperation as “unprecedented” between competitors. Do you foresee such cooperation being the norm in global health crises going forward?
In a sense, yes. What will happen, I hope, is that we learn the lessons of this crisis. Because it was unexpected and we are unprepared, I hope the world learns the lesson that we cannot be unprepared like this again. This will mean examining what has worked and what hasn’t worked in this current crisis and applying those lessons to future crises.
As for this current unprecedented level of cooperation, generic drug manufacturers did enjoy some level of cooperation before this. However, we’re keen on competition in our model because it drives down prices and increases affordability for LMICs. Collaboration rather than competition may become the norm in future crises, but I don’t think it will become the norm overall. We may not want it to become the norm in normal periods!
To discuss LMICs, my question is twofold: firstly, how do you describe the importance of including them in the conversation when it comes to a COVID vaccine? Secondly, why are they so often excluded from the conversation about vital drug development?
It is extremely important to include LMICs when we talk about vaccines and therapeutics. They are going to be the recipients of, in some cases, the vast majority of these technologies if they are the areas where the need is greatest. It’s taken a long time for people affected by diseases to be included in the conversation about the development and rollout of treatments. In the past, these vaccines and therapeutics were developed without enough consultation with the people who would use them.
This is precisely the same, but at a macro level. You’re talking about countries instead of individuals. Whenever you produce a drug or a vaccine, it should be applicable, deliverable, and useful in these countries. If you design a drug or a vaccine for example that is so complex that the technology to deliver it doesn’t exist in these countries, what’s the point?
We also have this issue now of extra cold-chain requirements in some cases. How’s that going to work in LMICs? Are you going to be able to roll out the volume of therapeutics and vaccines required? So including LMIcs in the conversation can prevent mistakes being made such as suddenly finding that these great drugs that you developed actually can’t get to the people who need them because not enough thought has gone into availability.
This is something we’re really facing during COVID-19. To address the second element of that question, LMICs are often excluded from the conversation because, typically, the developers of these vaccines and drugs are focusing on the markets they see as lucrative which are high-income countries. Too often, LMICs are an afterthought because they contribute a relatively small percentage of a company’s profits.
I hope that, in the future, it will broadly be the case that when drugs are developed, the manufacturers will want to get them to all the people who could benefit. What I think we’re seeing now and will see over time is increased focus on access, with drug developers having a plan to make these available and affordable to everybody who needs them at the start and not as an afterthought. Whether you live should not depend on where you live. In the 21st century, it is unacceptable to leave people behind. That’s what drives the Medicines Patent Pool.
MPP works, in the organisation’s own words, with “civil society, governments, international organisations, industry, patient groups and other stakeholders, to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.” Why is it important that there is a multisectoral approach to ensuring access to a COVID vaccine and therapeutics?
We’re a very small organisation of 25 people approximately. To have facilitated fifteen billion doses of drugs over the last ten years shows we cannot achieve this by ourselves. We work with so many different players as there are so many different players involved in making drugs available. We have to work with those who own the intellectual property and persuade them that our model is beneficial to them in helping them deliver their products to people in countries where they may not have a footprint.
Then of course we work with other partners who prioritise medicines and write guidelines for essential medicines and help establish drugs on countries’ essential medicines list to convey these are the medicines they should buy for their population. That may involve working with civil society groups who will be working with the governments in-country to make sure they buy these important drugs. There’s no point having them if nobody’s actually going to buy them and deliver them to the people who need them.
Then there are often procurement agencies involved who may be buying on behalf of countries. The Global Fund is an example. Then, of course, in the lattice, are the generic companies. We need to go to them and ask them – would they like a license to develop the drug? We want to make sure that we have enough generic companies to provide competition, but not so many that the market is so swamped that it’s not sustainable. Our model is very much based on this idea that generics make enough profit to continue to do it, but not so much that it raises the prices. So it’s a delicate balance to find.
Unlike other access models for example that involve giveaways, which aren’t really sustainable in the long run, ours is particularly designed in this way.
What is the biggest obstacle to multisectoral approaches and collaborations within the pharmaceutical industry in health crises such as the pandemic?
We’re certainly trying to get the vaccines ultimately to just about everyone in the world, and certainly therapeutics to at least all the far corners of the world. We do have to try not to look at things sequentially – even though it may be logistically sensible to do that, we must find a way to do things in parallel. That is the challenge: doing things that you would ordinarily do sequentially in parallel and this unfortunately is going to mean there’s a certain amount of waste. That’s a sacrifice that I think we’re having to put up with.
As an example, we could be given a license for a drug that is not proven to be effective yet. And we might already be sublicensing to companies that might start investing in the production and then at the last minute the drug just doesn’t prove to be efficacious enough. And in fact, and this is happening right now in vaccines. People are investing in hugely increased manufacturing capacity for vaccines not yet proven. We’re all enormously encouraged by the fact that a couple of them have shown much better than expected efficacy. Maybe we’ll be tremendously lucky and everything will prove out but it’s unlikely. So the investment won’t pay off if the vaccine doesn’t work. We have to do these things in parallel and there’s a risk involved in that, but the risk of delaying is just so much greater, because it’s the risk of people dying all the time in the extraordinary numbers that we’re seeing.
About Charles Gore
Charles Gore is the Executive Director of the Medicines Patent Pool. He took up the post in July 2018 following a career in patient representation and public health advocacy. In under two years he has advanced the work of the MPP in HIV and Hepatitis and is opening up further opportunities for the MPP model of voluntary licensing to be used for patented medicines on the World Health Organization (WHO) essential medicines list.
Charles was diagnosed with hepatitis C in 1995 and cirrhosis in 1998. In 2000, he set up The Hepatitis C Trust in the UK, that he ran for 18 years. In 2002, he was treated and cured of for his hepatitis C. He helped create the European Liver Patients Association and was its first President in 2004. In 2007, Charles organised a meeting of hepatitis patient organisations from around the world to agree on co-ordinated global action. From this emerged the decision to hold an annual World Hepatitis Day and to create a new NGO, The World Hepatitis Alliance, of which Charles was the President from 2007 until the end of 2017. As a result of advocacy by the Alliance and its members, WHO adopted successive viral hepatitis resolutions in 2010, 2014 and 2016, making World Hepatitis Day an official day, celebrated on 28 July every year, and endorsing the first Global Health Sector Strategy on viral hepatitis with the goal of eliminating hepatitis B and C by 2030.
In addition to direct advocacy with over 50 Ministries of Health, Charles has led on advising countries on finding sustainable domestic financing for hepatitis programmes, including health system elements such as infection control and blood and injection safety. Charles also sits on a number of national and international advisory bodies, including the WHO Director-General’s Strategic and Technical Advisory Committee for Viral Hepatitis and has been a member of all the WHO guideline development groups on testing and treating viral hepatitis.
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