Straight talk with...Ellen 't Hoen

Abstract

In July, the global health financing mechanism UNITAID established an intellectual property–sharing scheme focused on scaling up access to new and lower-priced antiretroviral drugs in the developing world. The initiative—called the Medicines Patent Pool (MPP)—aims to streamline licensing processes, drive the combination of multiple HIV medicines into one pill and foster the development of drug formulations for children. In September, the US National Institutes of Health (NIH) became the first contributor to the venture, licensing a suite of patents related to protease inhibitors that are used to treat HIV. The task of bringing drug firms and other key stakeholders into the fold now falls on Ellen 't Hoen, a lawyer who became MPP's executive director last month after previously heading up Médecins Sans Frontières' Campaign for Access to Essential Medicines. Asher Mullard spoke to Hoen about the challenges of encouraging companies to share their intellectual property in a normally guarded sector.

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Why do we need the Medicines Patent Pool?

In the past, there were no patent barriers to manufacturing cheap medicines for the developing world; in India, medical product patents did not exist until 2005, for instance. But that has changed with the implementation of the trade-related aspects of intellectual property rights agreement. Unless we do something deliberate, there will be no mechanism to ensure access to new drugs. The MPP will provide such a mechanism, specifically increasing access to affordable and effective HIV medicines in developing countries. It will do so by acting as a one-stop shop for pharmaceutical companies, which can voluntarily contribute intellectual property to the pool, and for generics firms, which can then license the rights to produce cheap drugs for the developing world. And, because the licenses from different companies will be pooled together, generics companies and others can develop new combinations of products and formulations that are not needed for the Western world, such as for pediatric AIDS.

Aren't many HIV drugs already available at low cost?

Credit: ©IAS/Marcus Rose/Workers' Photos

I remember the days when the first treatments came out—they cost $10,000 per patient per year, and we had no idea how to get them to the people who needed them most. It's true that those same drugs are now available for $65 per patient per year. But it isn't only a matter of trying to get the most affordable products to people; we need to get the best possible treatments to patients. Through the MPP, we aim to provide access to the next generation of first- and second-line treatments.

How will your past experience help you in your new role?

The most important experience I had at Médecins Sans Frontières was actually seeing the difference that the availability of drugs makes to peoples' lives. I remember visiting a clinic in South Africa, outside Cape Town, when cheap HIV drugs were not available, and it was just rooms of dying people. A few months later, when the first drugs were available, I went back, and it was an entirely different environment. It was absolutely unbelievable. I've also learnt that change is possible, even when we least expect it. The MPP is in some ways a radical idea, but its beauty is that it can actually work within the existing system. All it takes is people to say, “yes, let's make this happen.”

How crucial is this first series of patents, granted to you by the NIH?

It is an important political success, because it came with strong support from the US government, and the vast majority of antiretroviral patent holders are in the US. It also marks the start of a longer collaboration with the NIH, a key investor in the development of new drugs. The practical usefulness in the short term of this particular license is not very big, however. It enables licensees to do some research with the protease inhibitor darunavir, but we still need IP from the Johnson & Johnson subsidiary Tibotec before we can issue licenses to produce darunavir, because they own patents that cover manufacturing.

When do you expect drug companies to sign up to the initiative?

We've already had very good conversations with a number of companies. We are talking with Johnson & Johnson's Tibotec, Abbott, Boehringer-Ingelheim, Merck, Gilead, ViiV, Sequoia, Roche and Bristol-Myers Squibb. But we have only just started to work on the negotiations, and we need time to work through the details before any agreements can be reached.

What is in it for these drug makers?

There is something in the MPP scheme for everybody. Most of these companies have said they want to help improve global health—this is a very concrete and very visible way of doing so. We are also looking at other incentives that can be put in place. We take the view, for instance, that companies should be remunerated, through royalties, for making licenses available.

When will the MPP's first products make it to the market?

I hope to have licenses to produce drugs within a year from now. There could then be a time lag of another one or two years, while generic companies develop their products, before any of these are available to patients. But, if we are ever going to get a drug on the market, we need to ensure that there is adequate funding to HIV programs. We can overcome as many patent barriers as we like, but it won't make a difference if there isn't enough money around to buy the drugs.