William Steiger, Lead Of US Delegation To World Health Assembly

The 59th World Health Assembly, taking place from 22-27 May followed by a meeting of the World Health Organization Executive Board, is addressing three resolutions related to intellectual property rights. These include a proposal to establish a working group to develop a plan of action for research into diseases disproportionately affecting poor countries, and a proposal to link issues of trade and health. William (Bill) Steiger, the lead of the US delegation to the assembly, met with Intellectual Property Watch reporter William New at the assembly on 25 May 2006. He discussed the US desire to help address problems of diseases in developing countries, the US view on the proposed resolutions, the similarity of the government’s position to that of the pharmaceutical industry, the WHO’s role in patent matters, and described a decision-making process that excludes non-governmental organisations.

Intellectual Property Watch (IPW): What are the US goals on intellectual property-related issues at the World Health Assembly this week and how is it going?

William Steiger (STEIGER): The primary goal of the US is as it always is, is to make sure what we do at the health assembly is sound public policy and that it takes into account that innovation is essential to producing medicines and vaccines and medical devices, that the relationship between public health, innovation and intellectual property is complex, there are a lot of interacting factors, and that it is necessary that we have partnerships that involve the private sector. So our goal would be a balanced set of resolutions or one resolution if they end up being combined that recognises those.

We also support the goals of many of the cosponsors of the resolutions on the table of widening access to life-saving treatments, and of providing incentives for greater research and development into diseases that disproportionately affect poor countries and that have not been the focus of a lot of intensive research over the last few decades.

So far it’s going okay, but we’ve barely started. The actual textual negotiations have not yet begun. We’re really far behind in the schedule of the work of the week because of the unfortunate and untimely death of [WHO Director-General] Dr. Lee. So here we are on Thursday, and we’ve not actually started to go through the resolutions in any depth.

IPW: What’s the significance of that delay for the prospect of the resolutions?

STEIGER: The work will go on. Dr. Lee would have wanted an assembly that concluded successfully and on time. I don’t think there will be a postponement in consideration of any of the agenda items.

IPW: Some would characterise the US position as opposed to the resolutions. Is there more to the message than that?

STEIGER: There’s a lot more than that. We almost never oppose a resolution outright. We will wish to see modifications to language in a resolution, but we have no objection to having this assembly produce a resolution or a couple of resolutions that speak to the follow-up to the Commission on Intellectual Property Rights, Innovation and Public Health on the one hand, or a resolution that focuses on new ways to promote, for example, public-private partnerships to produce more research into so-called neglected diseases. We have no objection to those goals at all, nor as a whole to the text.

“Our principal objection to one of the resolutions floated by Brazil and Kenya was the idea of starting negotiations on a binding international legal instrument on research and development in the biomedical field.”What we do, though, is we will stick up policy positions where we say that some of the ideas floated in the text, as in any text here, aren’t along our lines of thinking. Our principal objection to one of the resolutions floated by Brazil and Kenya was the idea of starting negotiations on a binding international legal instrument on research and development in the biomedical field. For a number of reasons, we don’t think that’s a particularly good idea, perhaps the principal one being the length and expense of a treaty process that we don’t think actually will produce tangible benefits in any immediate period of time. Whereas focusing on what we all could do together with the WHO, with industry, with academia, with developing countries, to increase access and increase R&D through partnerships, for example, will produce results much quicker.

So there’s a lot of discussion now about trying to launch, instead of a treaty, a plan of action or a strategy that would take a number of the recommendations of the commission report to see if we can implement some of them right away, and also, I would imagine, convene some kind of intergovernmental working group of interested countries that could think through and talk through, over the very short term – I mean over the next six months or so – a strategy for moving more quickly toward producing research into these so-called neglected diseases, or some of the diseases that disproportionately affect developing countries.

IPW: So the US is not opposed to setting a working group of some sort to discuss these issues, but would you like it to have a limited focus on neglected diseases and not range into other areas related to intellectual property?

“We think that many of the cures for these so-called neglected diseases are going to come from researchers in the developing world.”STEIGER: At the moment, inside the discussion of the member states here, it’s not clear where everybody stands on that issue. The short answer is, we don’t know yet what even the terms of reference might look like for such a group. We’ve had a series of more philosophical discussions with the sponsors, and with other interested parties over the past couple of days. I’ve sat with the Brazilian delegation at great length, we’ve sat with the Kenyans, the Swiss, the Canadians, the Australians, and a number of others. South Africa’s been involved in a number of these behind the scenes conversations. We’re still trying to define what everybody means by some of these terms.

IPW: So the US doesn’t have a specific vision of where it would like the outcome to be. Is a way of characterising your position to ensure that the ‘wrong’ thing doesn’t happen?

STEIGER: I think that sells us a bit short. If I were to outline some principles for you about what we view as critical to this discussion, however it goes, would be some of the following:

One, we want to stress in this process the importance of funding basic research. Not every country, in our view, does enough in funding biomedical research. We want to recognise in this process that taking the results of basic research and turning them into safe and effective new drugs or devices for patients is a high-cost endeavour. We, as we’ve done domestically, would like to participate in efforts to help reduce those costs by improving regulatory measures. Some of the things we’re doing at the FDA [US Food and Drug Administration] and some of the translational research efforts that are going on at the NIH [National Institutes of Health]. [Health and Human Services] Secretary [Michael] Leavitt is very convinced there are ways we can bring down the cost of drug development by just being more efficient in some of the regulatory procedures and in moving efficiently in some of the research enterprise.

In that, though, we want a process that will recognise, as I think everyone does here, that intellectual property is a fundamental element of innovation, and we need to provide incentives for the private sector to take the risks necessary to develop new drugs, whether for neglected diseases or not. And that the ability to sell an innovation, a profitable marketplace for an innovation is also necessary in this process. So we would want to see also a recognition of market competition once products are introduced and approved by regulatory authorities. In some countries the price-setting systems are, we think, distorting. Generally speaking, they keep the cost for generic drugs artificially high, reduce the incentives for innovation, and have an adverse effect on patients because they don’t get new drugs as fast, they also don’t get generic drugs at the prices that even we pay in the United States.

“We’re really coming into this saying, ‘We recognise the importance of looking at the system in a way that is going to spur public-private partnerships, investment, the free market, and also provide greater access in a balanced way’.”We also want the process to recognise that innovation is often incremental. It doesn’t always come in a big blockbuster. And that this is, when we talk about what the role of the developing countries in the process is, it’s a two-way street. Governments in developing countries have to take some responsibility for ensuring they’ve got necessary regulatory mechanisms in place, that their public health and medical authorities can adapt themselves to the results of new research, that procurement bodies are flexible enough to shift purchasing patterns, and there’s a growing capacity and expertise for doing clinical research in developing countries. We want to cultivate that in a way that’s safe and a way that’s ethical because we think that many of the cures for these so-called neglected diseases are going to come from researchers in the developing world, maybe not going to come out of Harvard or Johns Hopkins. Probably more likely they’re going to come out of some of these, like the Butantan Institute in Sao Paolo, or a research institute in South Africa, or the wonderful research institutes in India. One of the things we’ve done at HHS through the NIH and CDC [Centers for Disease Control] is help to build the capacity of those very institutions.

But to create more opportunities for discovery, you need intellectual property systems that work in those countries. You also need transparent regulatory regimes, the rule of law consistently applied, the enforcement of contracts, and as I said, reimbursement mechanisms that properly reward innovation in those countries as well. So we’re really coming into this saying, ‘We recognise the importance of looking at the system in a way that is going to spur public-private partnerships, investment, the free market, and also provide greater access in a balanced way. And that we want to form an alliance with developing countries that will take another look, as a first step and an urgent step, at these neglected diseases to find out if there are ways to do things better.

IPW: The message that you are giving sounds a lot like the message some of the industry groups would give. Couldn’t I ask, isn’t the US just giving the industry view?

“We continue to advocate when we talk to the activists that there is a conversation we can have broadly about what incentives work and that we think there are some models in the United States and probably some other places that have produced results where apparently a market might not have existed before.”STEIGER: No. I think industry needs to do more too. There’s no question about that. This is probably a chair that has four legs. You have developed country governments, developing country governments, industry and academia. Everyone has to be partner here. We’d like to see industry to continue and expand some of the things that they’ve done with exploring their own compound libraries for example to screen those compounds and molecules against a wider range of diseases perhaps than they had considered at first. We’d like to see the industry, as they have done against potential agents of bioterrorism in the years since 9/11 [11 September 2001 terrorist attacks]. We’d like industry to continue to explore voluntary licensing arrangements with producers in the developing world that meet appropriate standards. We think that the program that the [Bush] administration set up under [former HHS] Secretary Tommy Thompson and Ambassador [Randall]Tobias [who oversees White House international effort again HIV/AIDS] whereby we welcome generic producers of antiretroviral medicines to come into the FDA and gain a tentative approval for their products so we can procure them under the president’s emergency plan for AIDS relief and eventually of course those products will be eligible for marketing in the United States, has been a great incentive to raise standards among generic producers around the world, and actually is a real market incentive for them to gain stringent regulatory approval which maybe they didn’t have in the past. We’ve had Indian companies, a South African company, an American company come in. There are 15 compounds now, 15 drugs approved and we’re purchasing all of them. Cipla finally came in, a few months ago, and we approved the first Cipla product last week. So we’re looking at industry as a partner here as well and we hope that everyone else in the debate is too. All of us have a collective and shared responsibility to work flexibly together if possible.

IPW: Is there any flexibility on the US part with the regards to the possibility that the patent system or R&D system may need change, or do we start from the assumption that it’s working well?

STEIGER: First of all, the patent system and intellectual property per se are not the responsibility of the World Health Organization. There is an international organisation set up that has intellectual property in its name and as its central mandate. We always want to be careful here at WHO about making sure we are drawing the lines appropriately between the mandates and the footprints of the UN agencies. So every system whatever it is around the world can always stand some kind of improvement. But I’m not an intellectual property lawyer, I’m not a patent lawyer, we have taken steps I can say in the United States in a variety of innovative ways when faced with orphan drugs to consider new ways of looking at incentives for producers. And I think our people would argue, patients would argue, physicians would argue that those incentives have worked. So we continue to advocate when we talk to the activists that there is a conversation we can have broadly about what incentives work and that we think there are some models in the United States and probably some other places that have produced results where apparently a market might not have existed before.

IPW: You are signalling flexibility in finding alternative ways for incentives for a problem that you do agree exists.

“WHO and the World Health Assembly have an unfortunate tendency to view the private sector as somehow the enemy.”STEIGER: I don’t think there’s any question that there’s clearly a series of diseases for which we have inadequate treatments or no treatments. And we want to be part of that conversation about how we solve the problem. With the amount of funding we devote to this at the NIH and the work we’re doing at the CDC, we think we are part of that conversation. We’d like other governments to step up their own involvement in this kind of research. But WHO and the World Health Assembly have an unfortunate tendency to view the private sector as somehow the enemy, and we want recognition in whatever resolution comes out of here, whatever conversation comes out of the report of the commission, that the private sector is a bona fide partner, that academia is a bona fide partner, and they need to be equal partners of this conversation as well, because we don’t believe that the public sector, whatever public sector we’re talking about, can produce results by itself that will solve this problem.

IPW: So the WHO has a role in this process. I’ve heard some say that everybody’s talking about these issues except the WHO. You don’t disagree, and it’s a just a matter of what their involvement is?

STEIGER: If I can break that into a couple of parts. One is that we want WHO to stay within its mandate and its expertise. There are not patent lawyers on staff here at the WHO. There are not trade lawyers on staff here at WHO. There are organisations, WIPO and the WTO, that have that expertise, and we want the three of them to work together on this issue, very important. WHO has a role in pointing out public health problems around the world and helping member states to prioritise investments, to make recommendations on how to intervene appropriately to try and solve those health problems. In a conversation that involves the right UN agencies together, yes, we think WHO can be part of a balanced and full conversation on trade and health and intellectual property and health. But it cannot act in a vacuum, and it cannot act by itself.

IPW: What is the status of the trade and health resolution? The US was opposed to it a year ago.

STEIGER: That is non-controversial. There was a process of negotiation at the Executive Board, we came to a good understanding with the cosponsors, and this is a document as it is drafted, that we’re prepared to support. We’re hoping that one will come up soon, because we’re behind and we’d like to get that one off the table.

IPW: Thank you.

William Steiger was appointed in 2001 as the director of the Office of Global Health Affairs and special assistant to the secretary for international affairs at the U.S. Department of Health and Human Services.