The drug purchasing facility UNITAID recently agreed to move forward, in principle, with a proposal to establish a patent pool that could have a dramatic impact on the affordability and availability of much needed treatments for people living in developing countries, such as combinations of expensive newer AIDS medicines and formulations appropriate for children.
The ‘patent pool’ is not a new concept – the idea has been used to stimulate innovation in a variety of fields, but applying it to the field of medicines is new. MSF has welcomed this initiative that could help to fill some of the desperate gaps in treatments for our patients.
Ellen ‘t Hoen, Policy Advocacy Director of MSF’s Campaign for Access to Essential Medicines, outlines here how the mechanism would work and what benefits it could bring.
What is a patent pool and how does it work?
A patent pool is a mechanism whereby patent owners put their patents in a ‘pool’ and allow others who need access to those patents to use them in exchange for a royalty payment. Patent pools have, in fact, been used to drive forward innovation in many different fields of technology, for example in the development of recording equipment, where you need multiple patents to be able to produce a certain product.
So the driving principle is a sharing of knowledge, for which the originating inventors are, however, still rewarded?
Yes, that is the beauty of it. It’s not a matter of donating your patents – the patent owners who collaborate with the pool get royalties from those who use their patents.
And in the field of developing new medical products, which may be a rather specialized field, how could a patent pool be useful?
A patent pool can help encourage innovation in areas where it’s not happening today. Take HIV/AIDS, for example: we desperately need the development of new fixed-dose combination drugs that combine multiple compounds into one pill, especially for the newer drugs. These simplify treatment for people living with AIDS and are also used for pediatric AIDS treatment. But being able to produce such combinations means we need to overcome the patent barriers, because when you want to combine three separate products together into one pill, you may have to deal with three different patent owners, and every single company that needs to have access to these patents has to deal with the three different patent owners. This makes coming to an agreement very difficult. But if you accomplish all this in one place, such as the patent pool, you have a streamlined ‘one-stop shop’ process for both the patent owners and the companies that need access to these patents.
And how could the patent pool help us address the problem of lacking drug formulations for children with AIDS?
AIDS in children has almost disappeared in wealthy countries, so for Western pharmaceutical companies, developing products for pediatric AIDS is not a priority, even though there are many, many children in the world that are living with HIV/AIDS and desperately need appropriate treatment. Generic companies have in fact been the ones that have been interested and willing to develop and produce the needed adapted tablet formulations of AIDS medicines for children. But there are patent barriers to doing so, particularly if you look at the newer drugs. However, if those patents were in a pool, anyone interested in developing fixed-dose combinations or pediatric formulations could do it, using those patents.
Beyond helping foster innovation in needed products, such as fixed-dose combinations and pediatric formulations, how would a patent pool help with affordability?
A patent pool would help bring prices down by speeding up the development of generic products. Today, when generic producers are faced with a patent in a given country, they have to wait 20 years until the patent term runs out. A patent pool can speed that up, because as soon as the patent is in the pool, generic companies can go to the pool, pay the royalties and develop generic versions of the product – so you end up with competition much earlier than otherwise, and competition is the single most important force that drives prices down.
Specifically for MSF’s work treating people with AIDS, can you give some examples of treatments we urgently need but can’t access at affordable prices?
Sure, for example, the improved first-line triple drug combination that contains tenofovir (TDF). It is very expensive despite company discount offers, because there aren’t enough producers. Another example is heat-stable second-line regimens containing lopinavir or atazanavir, boosted with ritonavir to treat people who develop resistance to their first set of medications.
What indication is there so far that patent holders are willing to sign up to this initiative?
We have been encouraged by their initial responses. The companies have called the proposal “very interesting.” We take that as a very positive signal. However, it is not only about the patent owners. There also needs to be buy-in from those that will use the patents, so generic pharmaceutical companies will also need to be at the table. It is important that the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property calls on countries to explore the use of patent pools for public health purposes.
How wide an impact do you think a patent pool is going to have in terms of generating innovation for the medical tools that we so desperately need here at MSF?
I think if the UNITAID patent pool succeeds, the effects could be really phenomenal, both in the area of access, namely bringing prices down, and in the area of developing desperately needed combinations and pediatric formulations. But success will depend on everybody collaborating.