The Medicines Patent Pool is a public health organisation based in Geneva but with offices also in India. What we were set up to do was to ask the pharmaceutical industry to give us licenses on their new patented drugs that we could then sub-licence to generic manufacturers to produce high quality but affordable versions of these new patented drugs for low- and middle-income countries to make sure that people there could have rapid access to them and not have to wait 20 years until patents expire.
Can you take us through the process of negotiating a voluntary licence?
Obviously one of the issues is how do we persuade, first of all, the pharmaceutical industry to give us a licence and then when we do how we negotiate them. So when we are negotiating there are certain key terms that we want to make sure are in the licence. These are what we call public health terms. We want to make sure that our licences cover as broad a territory as possible but obviously we have to take into account the commercial interests of the pharmaceutical company that we’re licensing from. We want to make sure that they are aligned with other potential access mechanisms like TRIPS flexibilities and so on. We want to make sure that there is nothing in the licence that will make it slow or difficult for generic companies to develop and then market and sell the products as quickly as possible because, as I said, what we’re aiming for is speed.
What we want is that, in as far as possible, people in low- and middle-income countries get access pretty much at the same time as people in high-income countries to the newest drugs. So licensing and what it takes, the actual negotiations can take a while because trying to tie all this down, make sure that we’re in agreement on this, making sure that, as I said, we balance the commercial interests of the innovators with making sure there is a sustainable market for the generic companies. Because the whole point of our model is that it is sustainable, it’s not like a donation programme. This is designed to be money-making for generic companies, albeit with fairly slim profits to make sure that the prices are as low as possible. Then also balancing those two against the public health needs.
What motivates a pharmaceutical company to offer a voluntary licence to the MPP?
Pharmaceutical companies may give us licences for a whole range of reasons. It may be, for example, that they just want to make sure that their product reaches as many people as possible and they may not have the experience or the offices or simply the human resources to go out and register and then market in a couple of hundred countries at the same time. But there may also be other elements involved, for example, public relations. COVID has really focussed attention on access and equity. I think it’s becoming increasingly difficult for companies not to look at this because they’ve seen what happens – if you don’t do that everybody shouts at you.
So, from a PR perspective, it’s really good to make sure that you have a good access programme. The Medicines Patent Pool model has been shown to be one of the best and we are rated extremely highly in the Access to Medicines Index. But there may also be financial considerations so it’s perfectly possible for our licences to include royalties, some of them do, some of them don’t, and these can be commercially significant. At the same time, from a point of view of retention of staff, employment of staff, very often companies realise that the more they do on access, the more successful they are likely to be in those areas because people, for example, involved in R&D want to make sure that if they discover some fantastic life-changing product it doesn’t just go to a quarter of the world, it goes to the whole world. So there are many reasons why a pharmaceutical company may want to give us a licence.
What is the biggest misconception about licensing a medicine?
There’s some feeling that complex products, for example, are too difficult to licence, so vaccines, biological therapeutics. Also actually, to be honest, up until right now there has been a misconception that you can’t do licensing in non-communicable diseases. With this new licence we’ve shown that you can. But also in terms of the more complex products, generic companies are getting much better at knowing how to develop them; regulators are becoming much more amenable to having shortened pathways to make sure that they are available quickly.
So the biggest misconception about licensing is you can’t do it. It’s in different areas that people bring this out, saying, ‘Oh, you can’t do it for that. You can’t do it for this.’ We are absolutely convinced that in almost every case you can do licensing and we should stop asking ourselves can we do it and ask ourselves how can we do it.
How do you prioritise which medicines to license?
We have a sophisticated prioritisation mechanism because clearly we cannot look at everything. What we are primarily focussed on is is there a public health need, and specifically in low- and middle-income countries? Are there people in those countries who really need this drug? Then are there existing access challenges which might be price, they might be other things? Then can the MPP model solve those access challenges? If the answer to all those is yes, it’s a big problem, yes, there are access problems and, yes, we can solve them then that’s a medicine we will go for.
How is the partnership with the ATOM Coalition important to your work in pursuing MPP facilitated voluntary licensing?
The partnership with ATOM is absolutely essential. What we realised from our work in HIV and hepatitis and other areas is that there are certain very specific things in those areas, and in particular in HIV, where you have large international investment so that you have the money and you have procurement organised by, for example, the Global Fund. This makes things much easier.
In NCDs, and particularly cancer, we really don’t have that. We have governments with small budgets, not necessarily willing to spend on cancer drugs, and we have a lot of access challenges aside from the availability of the medicines. So there may not be diagnostics, for example, in place or at least they might need a lot of scaling up. If we have generic medicines there may not be much medical education going on that we would need to address. The whole infrastructure may need strengthening. There may need to be more adjuvant treatments. The willingness of government to pay for these. All of these need to be addressed.
Realising this, we went to UICC and suggested a memorandum of understanding about how we might be able to work together. UICC said, ‘This is a good idea but it’s not big enough. Actually what we need to do is to put together a whole consortium.’ And that’s how ATOM was born. It’s a consortium that is trying to address all these different access challenges in a holistic way.
Why is the first MPP licence for an NCD treatment such a milestone?
This is the first public health licence in the NCD space. As I said earlier, a lot of people said, ‘Oh, this can’t be done. It’s not appropriate.’ We’ve really believed that it is appropriate, it is a really good way of providing access. We’ve been talking to companies for quite a long time and it’s been slow but at last here we are and that’s why it’s such a milestone. This is different, this is new and, as such, it’s really a fantastic licence for us. It changes or will change the perception of the world and particularly of pharmaceutical companies about what is possible. As I said earlier, it’s not ‘Can you do it?’ it’s ‘How can you do it?’ and we’ve shown this is how you can do it.
How did this NCD licence for nilotinib with Novartis come about?
It came about, we had been discussing with Novartis about licences generally for a number of years. Then when ATOM was formed this really gave Novartis the comfort to know that these other challenges that I talked about are being addressed. So suddenly they had much more impetus in discussing this with us. Also the idea that through the royalties they could then be providing funding for these activities through ATOM really was a very compelling argument for them.
How will this licence impact cancer patients with chronic myeloid leukaemia?
What this is going to do is to provide affordable access to a second line drug that is really important in leukaemia. A number of patients find that imatinib, after a while, does not work for them and so they badly need a second line treatment. Nilotinib provides exactly that. Hopefully this will be at a price that’s really affordable, we don’t know the pricing yet, but our model relies on competition driving down the price and that has worked very well in our other licences. What we think is suddenly something that was unaffordable will become affordable for patients throughout low- and middle-income countries that are covered by the licence.
What lessons have you learned over the years that are helping to inform the licensing process for cancer medicines?
What we have learned about licensing is that there’s no one size fits all. Almost all of our licences, each one, essentially, is different from the last one in some respect. We negotiate them on a bespoke basis with the pharmaceutical company involved depending on the product, depending on the market, depending on where we are in public health. One thing we’ve learned that I’d like to stress is flexibility. We have to be flexible. So this licence is different from some of our HIV licences, different from our COVID licences, for example. In this particular licence we’ve concentrated on countries where ATOM is going to be providing the support and the answer to the other access challenges to really make this a success.