University patents limit access to medicine. These students want to change that.

November 22, 2013

Last weekend, Universities Allied for Essential Medicines held its annual conference at Case Western Reserve University. More than 150 undergraduate, medical, and law students from nearly 100 academic institutions converged in Cleveland to discuss how to expand access to life-saving medicines for poor people in low-income countries.

College students are well positioned to make a difference on this issue because many patented drugs are based on research conducted at Western universities. While universities have traditionally licensed their drug patents to the highest bidder, student activists are convincing a growing number of universities to change their approach to patent licensing. In this new model, universities require their pharmaceutical partners to ensure that patented drugs are available at reasonable prices in developing countries, even if that lowers the amount they are willing to pay for the license.

Bryan Collinsworth is the executive director of UAEM. We spoke by phone on Monday.

Timothy B. Lee: What are the student activists who attended last weekend's conference trying to accomplish?

Bryan Collinsworth: The key issue for us is basically making sure that patients worldwide, particularly in low-income countries with neglected health needs, are able to get access to medicines. We want to make sure that the technologies are there at all. And we want to ensure they can get them at an affordable price, and that governments and NGOs can do that affordably.

We have this big international medical research and development enterprise. We hear about foundations like the Gates Foundation, and pharmaceutical companies and funders like the National Institutes of Health. You don't hear as much the role of universities in [developing medicines]. They do a huge amount of basic research that gets developed for lifesaving medicines for HIV/AIDS, or cancer, or many other maladies. Since we're a student organization, we're really focused on universities because we're students, many are law students [and] are particularly concerned about how their campuses are doing work in this area.

Unfortunately, there is not as much going on at universities as we'd like to see. In many many cases we see this pattern of universities prioritizing lucrative research and revenues from licensing deals over research that's accessible to global health needs that's then being made accessible to people in poor places through their licensing approach.

How did the organization get started?

It started at Yale in 2001 with one group of students on that campus. Yale had developed d4T, one of the first AIDS drugs. Folks working on the ground in places like sub-Saharan Africa were seeing these immensely expensive prices. Pharmaceutical companies said, "We aren't going to lower these prices. We're going to protect our patents."

Students at Yale said, "Wait a minute, the university originally developed this. Isn't the dynamic a little different with a university? Look at our mission statement, look at the public funding we get. Shouldn't we reach out to Bristol Myers Squib [the company selling the drug]? We're the ones who licensed it."

The students started causing a ruckus about that. They worked with the developer who [created d4T], William Prusoff. He said, "The goal of my research was to save lives, not to bring licensing revenue into Yale University."

Eventually Yale did renegotiate with Bristol Myers Squib. There was a massive 90 percent price drop for HIV/AIDS treatment. You've seen this huge expansion [of AIDS drug availability] over the past decade for people largely due to these big price reductions. Programs like PEPFAR [George W. Bush's program to treat AIDS in Africa] started buying generics. That doubled the number of people they could treat overnight.

Our group expanded out of that initially. The students sat down after that and said, "We don't want to have to have this same fight every time a new drug or medicine is not accessible." [It was a coalition of] law students and medical students. They sat down together and wrote a proposal: here's how a university could do globally accessible licensing or socially responsible licensing.

Instead of it being all about what royalties you're going to get from [drug companies] if [universities] license their promising medical research, it's a conversation about how can we have provisions for low-income markets, where you allow them to produce it for sale at a much lower cost for those areas. How will you find some kind of other carve-out or a tiered pricing system. Or even just not have a patent outside of the high-income world.

If the goal is to have have the drug widely available, wouldn't the best approach be to not sign an exclusive license at all and let multiple companies produce the drug?

That's a really interesting question. In many cases, universities do non-exclusive licenses, though it's for things they don't see as lucrative. In the long run, we do need to think about a system where the revenue consideration is not the main consideration of how these things are licensed, particularly if they're funded with government resources.

In most cases, it's not like these licensing deals bring in a steady stream of moderate licensing [revenue.] Many licensing offices actually spend more to stay open than they bring in. Those that are lucrative have one or a handful of blockbuster medications. Princeton has one blockbuster cancer drug that generated huge licensing deals. That has put them in the nasty business of suing people who are trying to build competing products to keep revenues high.

How did you become interested in this issue?

My background is mostly in policy and advocacy. I did some work in D.C. back in the day for Rep. Betty McCullum (D-Minn.). She did some work when PEPFAR was being reauthorized to add Mali, Lesotho and Swaziland, three countries that were overlooked. That extended HIV treatment to another million people. That got me really interested in the opportunities for really high-level advocacy at the structural level here in the U.S. to impact global health abroad.

People sometimes come in with a conception that it's only about going to that village in Uganda or Nicaragua [where people need medical care]. But UAEM is also looking at the structural level to make sure the people delivering treatment at the clinic have the medicine they need at an affordable price. We have this conversation about how patent monopolies can drive up the price and restrict access.

The standard economic argument is that we need patents to incentivize the creation of new drugs. Are there cases where that model doesn't work?

There's very little money in areas where companies don't think they can recoup their investment for high-price patented product. There's a concept of neglected diseases. There's a specific list of those diseases.

This is what we're really focused on right now -- this conversation about could you come up with an alternative innovation system that would drive resources to those neglected areas. Obviously this couldn't be a system that was reliant on intellectual property. But it would probably require much more public investment. But you could also see how eliminating some of those intellectual property barriers would make the research more efficient.

The Drugs for Neglected Diseases Initiative spun out of Doctors Without Borders and some other groups. It develops treatments for things like Chagas disease. We never hear about them but they are huge issues in the developing world. DNDI has focused on a very open research model to develop new treatments for these diseases and then get them produced at cost in the most affordable way possible. They've had about six new treatment in six years in a total expenditure of $100 to 150 million. Compare that to the standard pharmaceutical talking point that it takes a billion dollars to develop a new drug. That price doesn't take into account some of the know-how they've brought in with universities and drug companies.

When they collaborate, they say, here are the open IP terms under which we're going to develop this. We're going to share information, ensure that the research is moving along as quickly as possible. If you have a big library of patented compounds that you haven't developed into products, we want to see if that's usable for neglected diseases.

Now there's a bigger conversation going on around this at the level of the World Health Organization where they're looking at projects like the DNDI and testing out demonstration projects around the world, models for non-IP-driven ways to do research in these neglected areas.

How large has this student movement for access to medicine become?

This is the third conference I've run for us and it's the biggest while I was there. It may have been our largest ever. Nearly 100 institutions were represented. Typically there are student chapters on campuses. A good chunk of those were from the U.S. That's where it started off with that Yale story in 2001. There are probably 50 or so chapters around the U.S. There were 40 students from five or six universities in Canada.

Over the past three years, we've been growing rapidly in Europe where we're now in seven or eight European countries. [We're seeing increasing activity in] what you call the BRICs [Brazil, Russia, India, China], rapidly emerging economies. They still see this huge need for access to health care and medicine, but these universities are beginning to develop their research capacity. On the one hand you have representatives of the U.S. pharmaceutical industry or big university licensing organizations offering expertise on how to set up their licensing system. But that's emulating the problematic U.S. model. So having student voices there talking about alternatives is really key.

In places like the U.S., students are going in and negotiating with administrators: "Will you adopt a policy that says you're going to responsibly license globally-relevant health technologies to make sure there are provisions for affordability?" The other side of that is having the same conversation about, Yyou're a publicly funded non-profit research institution, can you devote more of your research to these neglected diseases that aren't getting for-profit investment." Universities shouldn't have that same concern over patent incentives.

A few years back, there was a group of universities that got together and issued a joint policies and principles statement that they would take steps to make licensing affordable. Harvard, Yale, the University of Pennsylvania, [Brown, Boston University], and Oregon Health & Science University [were the initial founders]. Many more universities have signed onto that agreement or adopted similar principles. Harvard, one of the original universities, has been putting this into practice. They meet with licensing officials to talk about how these provision are being used in agreements.

Harvard went through their licensing agreements and now 75 percent of their licensing agreements included these global access provisions: a requirement that the company allow generic versions to be sold in developing countries. One of the other interesting provisions, Harvard has a requirement that if a company they license in is considering suing for patent infringement, they should have a discussion of whether it's legitimate or would just restrict access, restrict lower-cost versions of these medicines form reaching people.

The reason [universities] join with Myriad [a genetic testing company] in these follow-up lawsuits [using patents to shut down competing] breast cancer tests is they're contractually obligated to be a party to those infringement lawsuits. We're working with universities to think really carefully about how they're licensing and help them avoid these kinds of really nasty cases where they're joining in these infringement suits.

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