Medicines Patent Pool at 5 years: Promises kept, changes ahead – an interview with Greg Perry

INTELLECTUAL PROPERTY WATCH (IPW): Could you explain to us how the MPP licensing agreements work?

GREG PERRY (GP): We have licensing agreements which identify the countries that our sub-licensees can supply. That is called a geographical scope. The last agreement encompasses 117 countries, but it varies according to the agreement. Obviously we try to seek the maximum. The agreement also identifies where the manufacturing can be done. In most of our agreements now, the manufacturing can be covered anywhere in the world, even a European or a United States company can manufacture and supply to the defined geographical area.

Our sub-licensees are all at the moment Indian and Chinese with one American, Mylan, and we are hoping to diversify even further, certainly South Africa and other countries.

On the geographical scope, what is important to note, and is sometimes very badly misunderstood, is that we cover middle-income countries. The agreements do not just cover low income countries, this is very important. Our agreements cover between 50 and 80 percent of all middle-income countries.

Very recently again it was stated incorrectly in Vancouver that voluntary licences do not cover middle-income countries. Maybe others don’t, but ours do and it is part of our mission.

The major countries like China or Brazil we do not have agreements for. These are big emerging markets for the pharmaceutical industry and in the case of those two countries, they have access policies anyway.

There are three important points on access. The first is that we cover all high prevalence countries. We do not negotiate prices, we leave it to competition. That is very important. The second is our agreements are not exclusive. China and Brazil know how to negotiate. Maybe other countries who are less powerful can’t do that. And the third is that through our voluntary licensing agreements we are able to open up direct generic competition and that will provide access very rapidly.

Those three points are important and sometimes not appreciated. I know governments appreciate them because they do not have to go out and negotiate the price. We have three or four generic companies that could come in and then compete on the price.

Every single one of our agreements is on our website. Originators in the agreements also list patents either inside the territory or outside the territory.

We have a whole series of terms and conditions that also enable for TRIPS [World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights]. Our licensees have no restriction in responding to compulsory licences outside the territory defined in licensing agreements. It has not happened yet but can happen.

We have the ability for a number of generic companies to take up a licence, but what we do require is that those are quality generic manufacturers and have WHO [World Health Organization], FDA [United States Food and Drug Administration] or EMEA [European Medicines Agency] pre-qualification.

IPW: What is in it for the MPP?

GP: Public-health orientated licence. We don’t work for the generic industry, we don’t work for the originator industry, we work with them, we don’t work for them or against them. We want to encourage both sides to engage in this.

IPW: What’s in it for an originator company?

One of the appeals of an MPP licence for an originator company is that it only has to negotiate with us. There is also the advantage that they can sub-licence or delegate certain market areas to generics through us. They do not have to be present and operate in all countries. They have the intellectual property but they do not have to operate, so in certain circumstances they will be able to do that.

The other thing is that they get royalty payments. In our latest agreement on dolutegravir, which is a breakthrough HIV product, it covers nearly 94 percent of all people living in HIV in the world. In this agreement, for the first time royalties are tiered at 5, 7.5, and 10 percent depending on the GDP of the countries involved.

Our sub-licensees will supply the public sector and are entitled to exclusively supply the private sector at higher prices.

Without getting into the pros and cons of voluntary licensing and compulsory licences, voluntary licensing has so many public health advantages because a compulsory licence operates in one country. [By contrast] voluntary licensing can operate in 117 countries, so you can have economies of scales for companies. There will also be a large number of companies which will be able to get involved. From the originator’s point of view it makes more sense to try to carry out a voluntary licence since they have a clearer picture of the market.

On paediatrics they are no royalties. All the originators waive their royalties and the geographical scope is higher, up to 99 percent.

IPW: What’s in it for generic companies?

GP: For generic companies, they do not have to do the negotiations, and the terms and conditions that we get is better than what they can get. We assist generic companies for pre-qualification at the WHO. The disadvantage is that they have to share the market because there is no exclusivity. We are opening up a market in generics. We are making sure this is something that is open for a large number of competitors.

Originator and generic companies would like to be seen to be part of the MPP.

CS: In the past 5 years, would you say that the MPP has met its expectations?

GP: MPP has met its expectations. In the last two years we’ve had rapid development. You have to bear in mind that this was a completely novel and quite revolutionary idea to create a new system of IP management which engaged with the industry.

[The MPP just published a document [pdf] on progress and achievements of the Medicines Patent Pool 2010-2015]

What we’ve done at the Medicines Patent Pool is being able to get companies to share their IP for public health purposes and it worked! The second thing where we have gone beyond expectations is paediatrics. We have created the PHTI (Paediatric HIV Treatment Initiative) with DNDi (Drugs for Neglected Diseases initiative). We created a partnership not only to share the IP in paediatrics but to enhance the development and the distribution of the products as they are developed.

I really do not believe that IP can work in a silo. What we do is about development of new products and innovation, so we wanted to link up with other groups to ensure that when we get companies to share their IP there is actually an immediate knock-on effect. We now have two working groups that are set up and are working on identifying the correct formulation of the fixed dose combinations and then we will bring in generic companies.

Paediatrics are an extremely high priority area. There are no appropriate formulations for children and it is a gap area. The number of children that are being supplied in HIV is about 25 percent. Children are being left behind in the HIV fight. That is an area that was not identified at the beginning.

We are also looking at the development of fixed-dose combinations, which is important for developing countries.

Something important to note is that all of our agreements allow for the use in combination.

IPW: What are the prospects for MPP in the next 5 years?

GP: As you know, we had our financing and mandate approved by UNITAID for HIV in December last year. The approval by UNITAID itself was an endorsement of the success of the model they had invested in.

Within that we have identified new products in the pipeline and are identifying new technologies, for example, injectables or the use of nanotechnology. We see that as the future of treatment. This adds to the development of fixed-dose combinations and the development of paediatrics products.

On HIV, we are continuing our core work and we have done feasibility studies on tuberculosis (TB) and hepatitis C, which are available on our website [pdf]. They have been reviewed internally and we now have a consultation process. There is an online consultation process on both and we are undertaking consultations in the areas of TB and hepatitis C. There are a variety and diversity of groups interested in particular for hepatitis C and we are seeking to listen to everybody. This is very important.

We know there is a lot of interest from various stakeholders for us to get involved in these areas through the public health community and we know that because of our success in HIV and because we have established a professional working relationship based on public health with the industry, the industry is open to us in hepatitis C and TB. They have made no commitments, of course. We are working with a number of TB organisations and developing certain new concepts for research. So I expect in one form or another, I can’t give the details because we have a process to go through. We have to see if UNITAID will finance us. I would imagine in some shape or form the Medicines Patent Pool will be an expanded and slightly different animal than it is at the moment.

I believe that because of the success in HIV the model can be transferred to other areas. How and to what extend we have to see over the next six months.

What is happening at the MPP is part of the change that is happening in public health with PDP (product development partnerships) for example. A decade ago in Geneva discussions at the WHO were very technical. Now when you come here it is actually very dynamic because there are so many things happening with organisations such as DNDi, the Gavi Alliance, UNITAID, the Global Fund, and the Medicines for Malaria Venture. We are part of that change in trend that is happening, where people from all sides of public health, and that includes the industry, want to find ways forward. It is about innovation and about to making sure that innovation is accessible to as many people as possible. If innovation is not there, for example in fixed-dose combinations and paediatrics, we will seek to stimulate that particularly if there is an IP issue to be addressed, where IP needs to be shared.

In the case of TB we would probably be working much more upstream, which is trying to create collaboration in IP or get IP holders, whether they are companies or universities to have more public health orientated agreements. TB is a very different area than HIV it is a smaller market, it is fragmented and there is not a lot of investment and even if you sell in developing countries at a lower rate you are not going to get much of a better situation in developed countries. In HIV you can segment, you can say I will sell this price in HIV in the developed world then I tiered price in a second group and then I will voluntary licence in the third group and you can sustain your model through this.

When we looked at the extension, TB came up immediately because TB is related to HIV co- infection. In Africa, the majority of people who die from HIV actually die from a TB-related infection. We are already in discussions with the TB Alliance, the Stop TB Partnership, MSF [Médecins Sans Frontières] on how we can create a collaboration to try to stimulate research in that area.

Hepatitis C is also a co-infection issue. That is how we came in with the idea of addressing hepatitis C, because it is a co-infection with HIV and we saw that as an extension of our mandate in HIV.

IPW: Thank you.

Source: Intellectual Property Watch