Ellen ’t Hoen is the executive director of the Medicines Patent Pool Foundation and was the Senior Advisor on Intellectual Property for UNITAID, a global health funding agency hosted by the World Health Organization (WHO) in Geneva. She was also the former Director of Policy Advocacy for the “Campaign for Access to Essential Medicines” by Médicins Sans Frontières

What is your general assessment of the global situation regarding the availability and development of treatments against HIV?

“If you look at HIV there has been tremendous progress. The fact that today five million people have access to HIV treatment is phenomenal. That is good news. (…) However, at some point most people being treated for HIV will have to switch to newer generation medicines, so-called second or third-line medicines [due to side-effects or HIV drug-resistance]. This creates a “treatment time bomb”, because people that are on treatment today will need to have access to newer medicines that are either currently not available, not available at prices they can afford, or not available in formulations that would be best to use in resource-poor settings (…). It’s not only second-line treatments [that are not going to be readily available], it’s also that today the vast majority of people on HIV medication in the developing world are actually using a regimen that is no longer recommended. There are now better medicines that are not getting out on a large enough scale. Another issue is that that there are many more people who need treatment today [than in the past]. The WHO has recently revised its guidelines and now recommends starting treatment much earlier [in the disease course], which has added a significant number of people in need of treatment. So, there is a risk because of the tremendous success (…)[;] it would be dangerous to now become complacent and say ‘OK, we’ve solved this treatment issue and we can now move on to the next issue’ because very soon, huge problems will occur with trying to get newer drugs to more people. So there is huge progress but there is also now a need to take deliberate action to make sure that progress doesn’t get lost.”

In your opinion, what are the biggest obstacles to adequate drug coverage worldwide?

“There are a number of things that need to be put in place. First of all, drugs need to be affordable. Cost of medicines is an issue (…). If the price goes up, access goes down. Second is funding to pay for these medicines, and of course the [global] financial crisis is unfortunately affecting the amount of money that is available for HIV treatment. Third, there isn’t really a deliberate effort to develop adapted medicines [specifically for use in developing countries]. What we are trying to do today is take the medicines that have been developed for use in sophisticated medical environments in rich countries, and make them work in developing countries. We need a much more targeted development of products that would meet the needs of people in developing countries. One example of that is medicines for children. Pediatric AIDS is a disease of the [global] South, it almost is not existent in rich countries anymore. Therefore as a market it doesn’t exist. Unless something deliberate is done, adapted medicines for children will not exist.”

When and by whom was the Medicines Patent Pool created?

“The history of the Patent Pool goes back to 2002 when several groups proposed it at the Barcelona AIDS conference. The actual creation of the Patent Pool (…) was done last July [] by UNITAID, which is a financing mechanism for the procurement of HIV, tuberculosis and malaria medicines.”

What are the Patent Pool’s goals?

“Our objective is to establish a licensing mechanism for HIV medicines, contribute to solutions with regards to price, development of adapted formulations, and specifically, development of medicines for children. The thinking behind the Patent Pool is driven by the need to respond to the change in the intellectual property environment. In the past, there has been availability of low-cost generic [non-brand name, unpatented] AIDS drugs, because these medicines were not patented in many countries and in particular in countries where they could be produced at low cost. India, for example, has been called the “pharmacy of the developing world” [because it could to serve as a base for generic drug makers] (…). That is no longer possible because the World Trade Organization now requires all countries to implement a minimum set of patenting practices, including patents for pharmaceuticals lasting at least 20 years. So the only way to get new-generation generic medicines is if there are licences available. We are trying to persuade those [groups] holding patents to voluntarily make licences for those patents to help make them available for the field of HIV and for use in developing countries.”

How is the Patent Pool funded?

“We are funded by UNITAID (…). The vast majority of the funding from UNITAID comes from an airline ticket levy that the countries that participate in UNITAID have implemented. It’s an innovative financing mechanism that can guarantee a constant stream of money. It’s kind of a solidarity levy.”

Is the Medicines Patent Pool the first initiative of its kind?

“There actually are many different patent pools in many different areas of technology and for many different reasons but this is the first patent pool related to medicines.”

How does the Patent Pool function and how does it hope to meet its goals?

“Through a dialogue with the pharmaceutical industries and other entities holding patents related to HIV. In particular, the NIH [National Institutes of Health] is very important, and has become the first licensor to [join] the Medicines Patent Pool. The fact that our first licence is from the US government is (…) very exciting because it comes with very strong political support. That is important because most of the relevant patent holders are US-based. We are now in the process of working out the terms and conditions under which private companies would be prepared to join the Patent Pool. There is, at this stage, no guarantee of success, because it is a voluntary pool. We have no means by which to force the companies to collaborate with us. At the end of the day, they will have to make that decision themselves. This is why (…) the more people know about it the better. Universities, researchers and students have been very important in the past. It was really a student movement that kick-started that debate about the need for licensing about a decade ago.”

So far, is the NIH the only licensor of the Patent Pool or have others joined?

“The NIH is so far the first and the only licensor, which, considering our short existence, is not at all a small achievement. We hope that in 2011 we’ll be able to have company licences as well.”

What are the incentives for for-profit pharmaceutical companies and drug-makers to join the Patent Pool?

“There are a number of reasons why they might join. First of all, it is (…) a very visible way of showing that you take your corporate responsibility very seriously. Second, (…) we’re not asking the companies to give up their patents. There will be royalty payments over the sales of the products that go back to the patent holder. Third, companies that look at the longer-term strategy for the provision of these medicines know that millions and millions of people will need access to these medicines, and very few companies will want to be the only one responsible for producing all those drugs, so sharing the production of those drugs is sound business.”

Are you seeking patents for drugs that already exist, ones that are in clinical trial or candidate compounds that might be tested?

“We are interested in all HIV-related medicines, including those that have not yet been tested or have not led to a product because our objective is a double one: we want to contribute to access and also to further development.”

What are fixed-dose combination medicines and how might the Patent Pool affect their availability?

“Fixed-dose combinations are very important because the treatment of HIV always requires multiple medicines. In developing countries, it’s very difficult to implement a treatment were you need to use several different pills several times a day and often in different combinations. So the development of a treatment combined in one pill is very important (…). There isn’t a single WHO-recommended treatment for which one company owns all the different components, so if you want to develop a fixed-dose combination pill you will need to bring the intellectual property together. So that is something where we can play a role.”

What are your hopes for the future of the Medicines Patent Pool and what it might achieve?

“I really think that the Patent Pool has the potential to have a long-term effect on access to HIV medicines and in particular to new medicines. It is important that licensing become the norm rather than the exception. If the Medicines Patent Pool does not succeed, we will really be faced with a very, very difficult situation in the near future. Having said that, we’ve so far had good responses and we’re having good conversations with the companies, so I’m confident that we’ll be able to succeed. But support from others is absolutely crucial. Support from the universities, students and researchers [helps] increase the demand on the companies to collaborate and is key to our success.”

Interview conducted November 27th, 2010

–  Nadia Cohen is at Harvard Medical School

For more information:

Stop AIDS Campaign (UK) Patent Pool Animation