Health as a Human Right: Rights, Roles, and Responsibilities

December 02, 2008

Introduction

DEVIN STEWART: I'm Devin Stewart, from the Carnegie Council. Thank you very much for coming. This is a great audience, a great panel, a real treat.

We have people on this panel coming from Texas, Boston, Australia, and the New York area as well. I think we benefited a lot from luck and timing, just to have a great panel with diverse views and perspectives and sectors. We are going to learn a lot today about "Health as a Human Right: Rights, Roles, and Responsibilities."

There are many reasons to think about how timely this issue is. The Obama administration is thinking about how to take care of the many millions of uninsured Americans. How do you keep the pharmaceutical and medical industries profitable and yet still increase access to medicines and health services?

There are many ethical questions to think about here. This series, Workshops for Ethics in Business, grapples with them every few months and will continue to do so as long as possible.

I would like to thank our sponsors, Booz & Company, their magazine strategy+business, as well as SAP, Merck & Company, and NYU's Center for Global Affairs. They have all helped to make this possible today.

We have a great panel. I'm going to put it right to the speakers as soon as possible, because we have a lot to get through, a lot of touchy issues. I'm going to act as a control rod, I hope. But this is a very civilized audience, so I know it's going to be fun.

We are going to start with our own Christian Barry. He was the editor of the Carnegie Council's excellent journal, Ethics & International Affairs. He is now a Senior Research Fellow for the Center for Applied Philosophy and Public Ethics at the Australian National University. He also teaches philosophy in the School of Humanities there.

Christian Barry is going to talk about what is a human right. He's going to look at that core question. We are looking at, is health a human right? A lot of international treaties and declarations have claimed such. Christian is going to get to the very core, the rock-bottom, of the issue: What is a human right? He is going to also talk about his own project with Thomas Pogge and other philosophers looking at health and ethics issues, including his own project called the Health Impact Fund.

Christian, take it away, please. Thank you very much.

Remarks

CHRISTIAN BARRY:Thanks, Devin.

The problem with being identified as a philosopher is that you always get asked to get to the rock-bottom of something. I really wanted to pitch a proposal, but I'll try to get to the rock-bottom briefly and then talk a little bit about how some of the more practically oriented work fits with some of these concerns.

To ask whether or not health is a human right is, in some sense, a very ambiguous question. It's not a very clear question. There are all sorts of ways of formulating the idea of a right to health, some of which would seem to be rather implausible. The idea that I have a right to be kept alive to a certain age indefinitely or to a certain age no matter what the cost is for others seems to be implausible as a right, certainly as a human right.

But usually when we think about human rights, we are thinking about somewhat more minimal standards, broad standards that apply that are held by all individuals that give them claims both on the conduct of a range of agents and also on the design of social institutions.

So I think that probably the best way to formulate the idea of a right to health, to make it a plausible moral human right, which may require different types of legal protections, is to formulate it in such a way that it seems to issue plausible demands on a broad range of agents.

The other thing that is unclear is that even if we understand the idea of a human right to health in a narrow way—say, all human beings have some sort of claim to minimally adequate health protection or something of that sort—it's still ambiguous in terms of what those claims give them claims to. In international treaties and others, there are often distinctions between different types of duties of different agents. I think it's very good that in the title of today's discussion, roles and responsibilities are there. The mere fact that human rights are universal in the sense that everyone has them—it doesn't follow that everybody must do exactly the same thing for the protection or the fulfillment of human rights.

So another thing, in trying to defend and clarify what a human right to health is, is clarifying what the nature of the duties with respect to this health right is.

As it has been formulated in different international treaties, different types of obligations are sometimes formulated:

One is the idea of a right to respect health, the idea that you would not actively deprive people of a certain type of minimal health protection or certain components of healthy living.

A second is the idea of "protect," that you would protect this right from other third parties that might violate it or other things that might undermine it.

A third, "fulfill," ensure that the object of the human right, the enjoyment of some sort of minimal adequate health protection, is actually enjoyed by all people.

I think those are rather uncontroversial as species of obligations. But what is controversial is just who has which types of obligations. It's typically thought that governments have all three obligations with respect to people who live within their countries. Each American citizen has a claim, in this understanding, on their government that they do what they can to ensure minimally adequate health protection for all of them; that this right be fulfilled, and not merely respected and protected.

But it's much more controversial, the idea that, say, the U.S. government or the European Union or other types of institutional actors or pharmaceutical companies have additional duties to fulfill these rights of people beyond their borders or people with whom they bear no relation.

Now, I don't necessarily agree with this, but some of the work that I have been doing has been trying to formulate a standard of a human right to health and trying to develop a proposal that is consistent with it that takes a rather minimalist understanding of the responsibilities of different agents with respect to this right.

In particular, we try to defend the proposal as stemming from a claim that all people have that the rules governing intellectual property, the rules governing trade and so on, be formulated so that adequate health protection is not undermined. This is a claim that all agents, whether pharmaceuticals or other governments, respect, not just directly in terms of not depriving, actively, people of this claim to minimally adequate health protection, but that they formulate rules that maximally satisfy this right for all people.

No doubt there will be some controversies associated with this, but that's the moral understanding of what these human rights to health are that we have been operating with.

The proposal—and this gets to the more practical aspect of the work that I have been working on with colleagues in an organization called Incentives for Global Health—is to try to find a way to get beyond what Devin mentioned, what is often thought of as a fundamental dilemma in achieving the right to health, and that is that between innovation and access.

One of the things that seems to limit access to medicines, one significant thing, is price. Price on medicines, patented and unpatented medicines, often has very much to do with intellectual property protection. So a lot of the debate about the right to health has been, in a sense, trying to attack the intellectual property system, as realized in the TRIPS agreement and other bilateral and national agreements, as somehow violating or depriving people of their right to health.

It's certainly true that intellectual property protection can restrict access. This is presumably not a good thing. But, of course, the other side of the argument is that anything you would do to weaken this protection would eliminate the types of incentives that companies have to innovate in the first place.

This is put very colorfully by commentators, which is to say, it looks like it's a good thing in the short term, if we were to simply override patent protection, if we were to make drugs widely available. But then why on earth would anybody bother investing in the extremely painstaking and expensive process of trying to bring drugs to market if he couldn't recoup on his investment?

So unlike other critics of the status quo, the group I have been working with has not been challenging either the TRIPS agreement or any of the existing agreements that protect intellectual property between countries, but rather has been trying to offer an alternative, a complement to the existing system of patent protection that would create greater access to medicines for those who most need them—overwhelmingly, poor people in developing countries—and yet at the same time protect innovation.

The thought we have—and we have been elaborating it in a proposal; I have some booklets with me, and it's also available online—is to create what is called the Health Impact Fund. The thought here is that you would try to further the fulfillment of the right to health by creating a fund that would reward companies on the basis of the health impact of their innovations. So each company facing the choice of how to develop a medicine would have a choice of either opting into the existing patent-protection system or a Health Impact Fund patent.

The idea there would be that they would have a choice of whether they would think that they would better recoup on their investment by recouping on the high prices that they hope to enjoy if they successfully bring their medicine to market after it has been patented, or whether they would recoup their investment better if they took out a patent in which they would allow anyone to produce it at cost, but they would be rewarded in terms of the health impact that their innovation actually had.

It's quite clear that the types of diseases that would attract innovators in different ways would be quite different. Probably hair-loss drugs would not be the sort of thing that people would try to seek under the Health Impact Fund, at least if health impact is measured in things like quality-adjusted life-years and so on—the normal measures that health economists focus on. Other things, including so-called type III diseases which affect the poor in developing countries, would be obvious candidates. They would be the sort of low-hanging fruit that innovators would want to go to.

Right now innovators don't have very much incentive. They may have some goodwill. They may also be given some type of incentive through piecemeal initiatives that different organizations, like the Gates Foundation, have been providing for the development of these diseases. But they don't have anything like the same incentives that they have to develop hair-loss medicine. They are oriented—and it's not because they are ill-willed—they are oriented by the current system of incentives to develop medicines that disproportionately serve the advanced needs of aging populations in wealthy countries.

Of course, those needs are important, and we are not challenging the importance of those things or the rights of pharmaceutical companies to go into them. It's simply that we don't think there should be a tradeoff between that and fulfilling the minimally adequate health-protection needs of the poor people in developing countries, and not only there.

So the thought is that creating a complement to the system—how would it be funded? You need to fund it. Part of the thought of the proposal is that it would be funded primarily by governments, paying in proportion to their wealth into the system.

Why would they do this? In some sense, you could say it would benefit them as well. First of all, the wealthy countries, which would disproportionately bear the burden of the cost, are also where many of the pharmaceutical companies are concentrated. So they would, in a sense, be benefiting some of their important stakeholders and some of the more important firms that they have.

It offers, I think, a great opportunity for governments to show that they are doing something about global problems, in a way that seems to be cost-effective.

Another benefit of this system—this was something we were discussing over lunch. One of the big problems now is not just that there aren't medicines, but actually delivering medicines—having a health infrastructure, having systems whereby drugs can actually be brought to the customer and used properly.

But one of the features of the current system is that companies right now don't have any incentives to do that. Once at the point of sale, their incentives to do anything with respect to the medicine runs out, whereas if they are rewarded on the basis of the health impact of the drug, then they have incentives to make it as likely as possible that the drugs will actually be delivered and used properly.

One of the big problems, actually, in serving the needs of poor people in developing countries has to do with very rudimentary problems of not following full courses of treatment, which creates all sorts of problems that not only affect them, but eventually affect other populations with the development of drug-resistant disease strains and so on.

Another thing, of course, that could appeal to the wealthy taxpayers who might be funding this is that they, too, benefit. It has become harder and harder to contain problems related to health. The phenomenon of drug-resistant strains of things which we thought we had gotten beyond is becoming more and more prevalent. It seems to have a lot to do with the fact that the health-protection needs of the poor are not being met.

So it's partly a moral argument—that there are these human rights—and it's also partly a prudential argument—that we collectively can do something without butting heads, necessarily, with the existing intellectual property–protection system that might do a whole lot of good with respect to realizing this right.

Thank you.

DEVIN STEWART: Thank you very much, Christian. Almost on time.

We're going to turn it over to Lisa Oldring, who will give another sort of international-system view of this problem. Again, we are starting from the foundation and working our way up to the future, at the very end here.

Lisa Oldring brings the unique perspective of having worked with Paul Hunt. I don't know if you want to talk about that. It's a very unique perspective, working in a UN system. Lisa is also Special Adviser to Mary Robinson, who is chair of the GAVI Fund.

Lisa, without further ado, please take it away. Thank you very much.

LISA OLDRING: Thank you, Devin. Thanks very much.

I think the topic of this panel is really timely because next week we are celebrating the 60th anniversary of the Universal Declaration of Human Rights. A group called the Elders, which includes people like Mary Robinson and Nelson Mandela and Jimmy Carter, have been leading a yearlong campaign in celebration of the 60th anniversary. I think this panel is exactly the kind of discussion that they would hope that the 60th anniversary of the declaration would inspire.

I also think it's interesting, the topic of the panel today. From the perspective of somebody who works in international law, health has been recognized as a human right for many decades now, from the constitution of the World Health Organization, which in 1946 provided for the enjoyment of the highest attainable standard of health as one fundamental right of every human being, to the Covenant on Economic, Social, and Cultural Rights, which is one of the documents that makes up the International Bill of Rights, which also recognizes the right to health. This is a treaty that has been ratified by the vast majority of states in the world. I think it's now at 159 states. There are many other human rights treaties that recognize the right to health.

It's a right also that is dependent upon and indivisible from virtually every other human right, when we start thinking about rights to access to information, education, even freedom from torture, and so on.

So why are we asking this question today? I think Christian went straight to the heart of this question. I think for many years, even the international human rights community has neglected health as a human right. It was seen politically by many as sort of a lofty aspiration rather than a source of any legal entitlement, or at least somehow a less pressing objective than other human rights.

Here in the United States, there has been pretty consistent opposition to the very concept of health as a human right. Globally, progress was starting to be made in the 1990s and in 2000–2001, when the human rights community really started to focus on health as a human right and better understanding what this right means. It's very well to have it on paper, but there was a greater effort to try to focus exactly, as Christian was saying, on understanding the content and the contours of the right.

There was also the establishment of a mandate of a special rapporteur on the right to health, as Devin mentioned, for the first time. Whereas 20 years earlier there were these mandates created by the United Nations to monitor a number of other human rights, for health it was that many years later before it was recognized as a right which should be monitored around the world.

So this special-rapporteur mandate was established to try to assist governments in better fulfilling this right to health. This was an individual, Paul Hunt, who was appointed to do country missions, again to try to support states, and others as well. He met a lot with private-sector actors—for example, with the civil society community—in the course of his work.

I think it's interesting that here in the United States there has been this sort of consistent opposition to the concept of health as a human right. The United States hasn't ratified this treaty that I just mentioned, the Covenant on Economic, Social, and Cultural Rights, and opposed the creation of the mandate of the special rapporteur. It was one of the very few states that did so.

But I think it's interesting in the current climate, because there are indications that that is starting to change. I just want to refer back to the comments that were made during the second presidential-campaign debate, when the candidates were asked whether health care is a right, a privilege, or a responsibility.

I found the answer that then-Senator Obama gave to be very interesting. He said, "I think it should be a right for every American. In a country as wealthy as ours, for us to have people who are going bankrupt because they can't pay their medical bills, for my mother to die of cancer at the age of 53 and have to spend the last months of her life in a hospital room arguing with insurance companies because they were saying that this may be a preexisting condition and they don't have to pay for her treatment—there's something fundamentally wrong with that."

I think his answer hints at a shift, but it also reflects feelings shared by many people, both in this country and in other parts of the world, in the face of health inequities.

Again, I think today there is a growing appreciation of the linkages between health and human rights, and the recognition of the importance of the right to health itself. I think part of that, again, is a bit of a shift in the international human rights community. While a lot of the focus was on bringing legal cases to the right to health, there is now more of an understanding of the importance of health as a human right in health policy and efforts to integrate human rights into health policy.

I just want to give one example that I think really illustrates these linkages, which is maternal mortality. (And I'm not saying that just because half of our panel is pregnant right now.)

For me, these statistics are really very shocking. Reproductive health problems are the leading cause of death for women of reproductive age in developing countries. Over half a million women die from pregnancy-related causes each year. Globally, over 300 million women live with illnesses due to pregnancy or childbirth.

But 99 percent of these deaths occur in developing countries. Even within developed countries, I think the inequities are really massive. In the United States, for example, the rate of maternal mortality is 1 in 2,500, which is extremely high, one of the highest among industrialized nations. But the rate among African-American women is almost four times that of non-Hispanic white women.

Again, it's socioeconomic inequities, not a lack of medical solutions, that determine these health outcomes for women. For example, factors that increase the risk of maternal death relate to delays in seeking care. In some countries, that has to do with cultural issues around where women have to get permission from male members of the family to travel, for example, where there are delays in reaching emergency care due to lack of transportation, and delays in receiving care from providers where there just aren't enough staff or the facilities or care is just unaffordable.

Again, these rates could be drastically reduced by building well-resourced, accessible, and community-based health systems which respond to the health needs of women.

Just thinking about what the obstacles to the realization of the right to health are, I think there are examples in the case of maternal mortality, and I'll just focus on one, which is this inequitable access due to weak health systems, including the lack of skilled health professionals.

This is a key challenge. There is a great deal of attention being focused now at international and national levels on this issue. There is much more support going into building strong health systems. I think part of this is in recognition of the fact that the vertical health interventions have only had limited success, including some of the disease-specific initiatives.

There is a recognition that without the health systems in place to deliver these interventions, any of these initiatives are going to be sort of limited in their success. But from a human rights perspective, the results of these efforts to strengthen health systems depend on how the human and financial resources are distributed, whether they are community-driven, and whether the health systems are designed and implemented to meet the needs of the most marginal parts of the population, and with their participation.

I just want to focus on the health-system-strengthening support provided by the GAVI Alliance, to give one example. I think there are a lot of organizations, as I said, that are now focusing on this issue. GAVI has worked since 2000, since its establishment, to radically improve access to vaccines. They have had really great success in doing that. In its early years, GAVI support led to drastic improvement in health outcomes in the lives of children in most eligible countries.

But by the end of 2005, they realized that there were still large numbers of children that weren't being reached, and they undertook a study to find out where the barriers were. It was clear that weak and failing health systems were a serious barrier to increasing sustained immunization coverage. Some of the barriers included unpredictable funding for salaries, transportation, and so on.

So GAVI opened a funding window in 2006 to provide support for health-system strengthening. The uptake for this support has really exceeded expectations. Of the 72 countries that are eligible for the support, 51 countries have applied for this sort of support to strengthen their health systems.

I'll just give one example of one of these proposals. They are still only at the proposal stage. They haven't actually started to implement. But I think there are some interesting examples at the proposal stage. In Nepal, for example, the immunization coverages are actually very high. They are above 90 percent in 50 of the country's 75 districts. But Nepal's proposal aims to extend this high immunization rate to all districts, particularly by targeting the hardest-to-reach and most marginal populations. It also aims to improve health outcomes for women and children. They propose to do this by addressing the system barriers that are currently faced by immunization services, which also constrain the delivery of essential health care and other maternal and child health services.

I just wanted to give this example because I think this is an initiative that has the potential to strengthen health systems and enable them to be more responsive to the needs of the marginal populations. I think it's one example of exactly what the right to health means in practice.

Thank you.

DEVIN STEWART: Thank you very much, Lisa.

I'm going to turn it over to Maggie Kohn. Maggie is Director of Global Corporate Responsibility at Merck & Company. She has been there since 1996. Maggie is going to talk about the roles and responsibilities of businesses in health and how businesses can help people obtain the right to health.

Thank you very much for coming, Maggie.

MAGGIE KOHN: Thanks, Devin. Thanks for having me.

As a pharmaceutical industry, to answer the question you really posed to us—is health a human right?—I would say without question the perspective of Merck is that it is a human right. I think this is a very different answer than you would have gotten from any pharmaceutical company, probably, five years ago, for a lot of the reasons that Lisa has been citing. Our perspective is that it really shouldn't be just an aspiration. It really is a right that needs to be respected, protected, and fulfilled, and there are different players and partners who have a legitimate role to play. We do believe that the pharmaceutical industry does have a role and a responsibility.

What becomes very interesting, and why I think this panel will be interesting today, is that it's a very gray area. It's not clear—and that's why we have initiatives such as the Paul Hunt initiative, some of the work that Oxfam is doing, certainly the Access to Medicine Index that came out earlier this year, where different organizations are trying to define it a little bit more clearly. But it is very controversial and very complex. It's what makes it so interesting.

I think when you have this discussion—my background is not in law, so I'll speak from what I know, which is being at a pharmaceutical company—I think there are two starting points that need to be acknowledged.

One is that a pharmaceutical company like Merck is a business; we are a for-profit business. That's a fact that we shouldn't be shy about. We have a business model that requires us to make a profit so that we can reinvest that money into ongoing R&D, as Christian talked about, and also a responsibility to our shareholders to return to them their investment. Without their ongoing investment, obviously, we would be out of business.

Even our harshest critics would agree, I would hope, that the demise of the pharmaceutical industry wouldn't be in anyone's best interests, certainly not patients'. For that reason, giving away product or even giving away product at below cost is not a sustainable solution to the right to health, nor is it in the best interests of patients in the long term.

So that would be one starting point.

I think the other starting point that I would assume that most everybody on the panel would agree with is that while the pharmaceutical industry certainly has a role to play in the right to health, we are just one player. When you think of the spectrum of right to health and you start at one end, where you have lifestyle and health education, going on to preventive measures, going on to diagnosis, treatment, rehabilitation, and support, you really at that point have a view of all the different players that need to be involved.

Unfortunately, I think that in a lot of these discussions and debates, we tend to have a siloed view, and whether it's the pharmaceutical industry or developing-world countries or the donor community, the sole focus will be on one of those organizational structures. Unfortunately, what has happened is that we get kind of mired in this debate and we lose sight of what really is necessary to move toward the realization of the human right.

It reminded me—recently I was at an event where we heard from Stephen Lewis, who is the former special adviser to the UN secretary-general for AIDS in Africa from, I think, 2001 to 2006, who is just an amazing person. He was recounting that he was in a rural village in Africa—I can't recall the country—and he was meeting with a small group of HIV-positive women.

He said to them, "What is the one thing that you need that would help you in this situation?"

He fully expected the response to be, "We need access to antiretroviral medicines," because, of course, in the United States and Europe this is keeping people alive.

Their response, he said, really was an eye-opener. They said, "What we need is access to clean water and food." Drugs weren't even on their radar screen.

I think that just really shows the systematic challenges that we face when we start talking about how we achieve this right to health. It's really looking at the collapsing health-care system in a number of developing countries. It's looking at the lack of trained health-care professionals. Certainly, the availability of pharmaceutical products is on that list as well, but it shouldn't be the only one.

What I will spend the rest of my time on—because I have been asked to speak about my own experiences—is talking about what I do think is the responsibility of a pharmaceutical company, but within that context.

If you think about the right to health, there are four cornerstones: availability to health, quality, accessibility, and affordability. I'll talk about each of those briefly and what I think could be a responsibility and role of a pharmaceutical company.

The first two, availability and quality, from our perspective, are the "must" rights. These are our obligations as a pharmaceutical company. Availability, obviously, comes down to our core business of making available medicines and vaccines to treat unmet medical needs. If we just stick for a moment with HIV as an example, that's a field that we at Merck have been invested in for over 20 years, since the virus was identified in the early 1980s. Over that 20-year time span, the result of that investment has been four products that are on the market.

We continue to invest. We, unfortunately, completed our vaccine research last year, when a vaccine we were working on was found to be ineffective. That was a huge blow to the hundreds of employees who had been working on it, and also the international community. But we are still looking at medicines, which is incredibly important, given resistance and so forth in HIV.

The other aspect of research which is important, especially in a human rights discussion, is medicines for disadvantaged groups. In that area, we are very committed to working in pediatric settings and making sure that there are indications and formulations for children, which is huge, given that there are 2.5 million HIV-positive children under the age of 15.

We are also working with groups such as the International Partnership for Microbicides to look at preventive measures, which would be a huge boost for women, particularly in sub-Saharan Africa, who need such measures as that.

In terms of quality, this comes down to quality of product, quality of delivery. We are talking here about things, obviously, such as safety of product, monitoring side effects, providing information to the health community and consumers, also safeguarding the safety of patients who are involved in clinical trials.

Again, availability and quality, I think, are the absolute "must" obligations that no one would question, that any pharmaceutical company operating today must abide by in order to respect human rights.

It's a little bit more unclear when it comes to accessibility and affordability. Again, I'll just put forth some of the steps that I believe pharmaceutical companies should take. I can only speak for my own company.

In terms of accessibility, I think you are seeing a trend for companies to make sure that their products are registered worldwide, not only in markets such as the United States and Europe, where we have a market, but increasingly in least developed countries.

Patenting, which is a big issue that we will talk about, I'm sure—we have a policy of not patenting our products in least developed countries, which I think is important.

Finally, affordability comes down to the issue of price. We could go on and on about the issue of price. There was an interesting article in, I think, The Lancet yesterday talking about prices of pharmaceuticals being a big barrier to health. It was actually the markups that take place in-country by wholesalers, where the markup could be up to 400 percent.

But from our perspective, we have had a policy since 2001 around our HIV products in least developed countries and those countries hardest hit by the epidemic to provide our products at no-profit pricing, and, in middle-income countries, to make our products available at significantly reduced pricing. We are able to still make a profit in those middle-income and high-income countries, but we are able to do that and in return make them available at no profit in the absolute poorest countries of the world.

Clearly, the pharmaceutical industry does have a responsibility, but I'll just return to the main point I made: So do other players. Certainly developed countries have a responsibility to continue to invest in basic research and research organizations, like the National Institutes of Health.

I think, importantly, developing countries have a crucial responsibility to invest in health. I think you will find today that very few sub-Saharan African countries are actually investing the 15 percent that was suggested back in, I think, 2000. I think it's also a responsibility for those middle-income countries to recognize that they can and should pay more for some of these innovations that are on the market today.

I'll end just by putting forth a recommendation, an idea that we have been tossing around within our country, which is trying to move the debate forward.

If we were to come together with other organizations—donor organizations, governments, NGOs, other pharma companies, generic companies, and other private companies—to think about coming up with a list of principles, similar to what Paul Hunt tried to do with the pharmaceutical industry, a list of principles necessary to obtain the right to health that could be applied across the board, and then, working with a third-party organization, like, perhaps, the Global Reporting Initiative, to come up with indicators for each of the organizations and then measure governments, donor organizations, NGOs, pharma companies on those indicators to see how well they are living up to their responsibilities each year—I think this really could do more than a lot of the polemics that, unfortunately, we get into sometimes on this issue.

DEVIN STEWART: Thank you very much, Maggie. Excellent. You even brought in a proposal and brought up the issue of patents, which is a great segue to Meg Boulware, who is on my left.

Meg is an intellectual property attorney, with an emphasis on chemistry and biotechnology, at Baker & McKenzie. Meg will talk about the establishment of a rule of law in order to facilitate health rights and also the issue of intellectual property and distribution—maybe the thorniest of the whole panel, but we'll see.

Meg, thank you very much for coming.

MEG BOULWARE: Thank you, Devin.

First of all, I want to tell everyone how pleased I am to be in New York City today at the Carnegie Council, participating in a wonderful panel discussion.

When I was contacted to participate in the panel, the agenda was framed as "Roles and Responsibilities." I looked at it first as an attorney—roles and responsibilities with health care. Also attorneys like to look at whether rights exist or don't exist. My very first knee-jerk reaction was, "Of course there is a right to basic health care. How could you say there wouldn't be?" particularly with the fortunate rule of law we have in this country that I hope supports it in the future even more—and then looking at the intellectual property issues that often get discussed in some minutiae, so that you really don't look at the big picture.

So I'm going to talk about rule of law and then kind of hopscotch through a few IP issues that come up quite a bit in the pharmaceutical industry.

First of all, I was also asked, what does your organization do to support these types of initiatives worldwide? My firm is quite large. It's a global firm. I went to do a little bit of research and found out what others were doing in this area. One of the things, when I was discussing this with colleagues, my colleagues—the non-IP lawyers, if you will—viewed this from a very broad, expansive viewpoint.

One of the items that came up is that we support training prosecutors and courts in prosecuting war crimes. In Sierra Leone and Cambodia, specifically, basic rights were denied from women and children, and basic health care and food. This was part of, basically, genocide. You really have to look at providing health care at a very high level and look at the underdeveloped countries to determine if they are going to have even a legal framework where you can deliver health care.

We first started with the rule of law. Also, if you don't have a proper, sustainable political framework, you can have all the innovations in the world, and the delivery of those medicines and the delivery of services simply is not going to be feasible. One of the initiatives with mine and a number of other law firms is assisting the United Nations, Save the Children, and a number of other organizations in just having a framework where you can deliver health care.

It was very interesting. When Maggie was discussing what people need—clean water, food—if you don't have that, you are not going to have any type of basis for sustainable health care.

So I think that is a role and responsibility of the United States and other developing-world legal systems, to be able to set up a basic framework from that.

I'm going to connect that with one area that is often very controversial, but keys into the nutrition aspect, and that is genetically modified organisms. I'm not going to discuss the patentability of them right now, but we can, of course, do that later if we want to. There is quite a bit of discussion and debate about genetically modified organisms—on one end of the spectrum, whether they should exist or whether you should even have science in this area.

One of the things I would like to say is that, regardless of what your intellectual property system is or how you are going to protect innovation, science is not going to stop. Science doesn't stop. It's going to continue. That's one of the aspects of the human condition, our curiosity.

I want to discuss one area where genetically modified organisms have been very, very helpful in health, and health in underdeveloped countries. One of the organizations that we work with is the PIPRA, the Public Intellectual Property Resource for Agriculture. PIPRA is an organization that has a number of sponsors, including universities and private entities.

PIPRA developed a patent review for golden rice, which is rice that is rich in vitamin A, and found out that throughout the developing world there were some countries who were getting patents. There were about 70 different patents that were out there on golden rice. PIPRA took the initiative to go through the licensing and the legal clearances to obtain the rights to golden rice so it could be distributed in developing countries. This is a good thing. It's simply a seed that you can teach people to plant.

Actually, there are 500,000 cases of blindness a year that simply a diet of golden rice will basically cure. There are also over 2 million premature deaths due to malnutrition that are in part related to a deficiency in vitamin A.

In this case, the legal community and the intellectual property lawyers, on a very basic right—that is, to simple nutrition—got together and had a very successful initiative. PIPRA also is looking into other genetically modified food crops that are for drought-resistant crops and other issues with nutrition, going forward and cobbling together any of the legal rights and making these foodstuffs available.

One other thing I wanted to mention also—another necessity for many diabetics, obviously—is insulin. Prior to genetically modified organisms, insulin was basically isolated from animal urine. Now we have a real wonderful source of insulin due to the scientific advancements in microbiology. There are a number of other advancements that we just take for granted and don't think about.

The international system is 100 years old. The intellectual property system that we have in this country is as old as 1790. The Patent Act was passed in 1790.

I want to thank Christian for giving a very good summary of the tensions in the intellectual property system. I think the pharma industry is criticized for trying to build a wall around their intellectual property. There is the need to have the investment for these new drugs, obviously, as Maggie said. Also we need to recognize that the patents on drugs can be extended past 20 years, but it's generally 20 to 25 years, which, depending on your point of view, is not that long a period of time. Many of the blockbuster drugs are coming off patent in the next two to three years—many, many blockbuster drugs—and will be available generically.

Also in the United States, we have a system to challenge patents that is quite robust. It's called the Hatch-Waxman Act. As soon as Merck or any other company has a patent on a drug, it goes into a list called the Orange Book. Once a patent for a drug goes in the Orange Book, virtually any generic drug manufacturer can challenge that patent. If it's not patentable, then it goes generic, and there you go. It's free to use. We have a lot of generics that have entered the market through that vehicle.

I will stop with that example, to show that there is balance in the system here, and turn it over to Devin.

DEVIN STEWART: Thank you very much, Meg. A lot of issues.

I was pleased that, when I asked this panel pretty much the same question, all six of them, we discovered before the lunch that everyone was going to give very much a different answer, hitting on very different issues. They have come from various sectors as well.

Next up is Rohit Malpani, who is Senior Campaigns Adviser at Oxfam America. He is specializing in various issues, including health. He will talk about access to medicines and community empowerment, as well as a couple of other issues.

Please take it away, Rohit. Thank you.

ROHIT MALPANI: Thanks a lot for having me here.

I feel like you guys have heard quite a bit already on access to medicines. The right to health is very broad. For Oxfam, we do feel that the right to health is absolutely a fundamental right. This really has developed from our on-the-ground work. Oxfam works in over 100 countries to reduce poverty and promote social justice. So I think, from our day-to-day work, we see that the right to health is absolutely essential to achieving all other fundamental human rights. I think that is sort of the same evolution that we have seen at the international level.

I think what is complicated for Oxfam isn't so much whether there is a right to health, but it's how to work on that. It's how to know exactly what the right to health is to poor people in developing countries, how to hold people accountable to the right to health, and it's how to even identify the right people to hold accountable and what the right balance is. I think we have heard different versions of that during this panel.

There has been an interesting evolution, I think, at Oxfam from just looking at countries and looking at international financial institutions to seeing the private sector as a part of this overall solution. We really do take two approaches, both in engaging the private sector in a very positive way in delivering services and empowering poor people in developing countries to lift themselves out of poverty and to realize their rights, and also holding various industries accountable in promoting human rights. I think there is always a very difficult balance between the two of them.

I think we are seeing a lot of work being done by advocacy organizations and also being done at the international level. I think the work that is being done by John Ruggie, who is the Special Representative on Business and Human Rights, on the responsibility to protect human rights and respect human rights is very instructive.

I think the work done by Paul Hunt around the pharmaceutical industry was great, because it really moved beyond the rhetoric of talking about the right to health and tried to create very specific guidelines and definitions. I think there can be a lot of back-and-forth as to what that exactly means, but it's important to understand that there are very specific actions that need to be taken.

In terms of talking about Oxfam's work, we really do work on the right to health from a broad range and in a lot of different ways:

  • Funding the Global Fund fully. We have been doing this for years and years, trying to get full funding.
  • Supporting the use of female condoms to empower poor women to prevent the transmission of HIV and AIDS.
  • Developing health-care systems and preventing stock-outs in health-care systems.
  • Retraining and training health-care workers in developing countries.

These are all important ways. The way I want to talk about is, relating to a lot of the other discussions, around access to medicines. Why is this important to Oxfam?

Two billion people still lack regular access to affordable medicines today. There certainly are a lot of reasons as to why this occurs. In our perspective, one of the important reasons is due to cost. The important statistic to think about is that in developing countries today, on average, 60 percent of health-care budgets are spent on medicines. This creates very difficult choices for health-care systems between medicines, building a health-care system, training health-care workers, engaging in prevention. Often many medicines that are needed in health-care systems cannot be provided, and they fall upon people to pay for out of pocket.

In a lot of our work and a lot of research that is done by the World Health Organization and other organizations, it is shown that one of the highest costs for poor people in developing countries is the out-of-pocket cost for medicines, as well as food.

So it's very important to focus upon what the real consequences are in developing countries and why this is an important issue for advocacy groups.

In terms of talking about why we are concerned about access to medicines in relation to the pharmaceutical industry, the starting point and the ending point is that it's important for developing countries to have access to affordable generic medicines. Prior to the introduction of the World Trade Organization, and even afterwards, this really has been the key basis for developing countries to provide health care.

It's certainly admirable that companies like Merck and, I think, a lot of other companies are not patenting medicines in least-developed countries. But that's actually part of the World Trade Organization rules. Actually, they don't have to until 2016.

The real concern isn't so much in least-developed countries that are recipients of medicines—because the reality is that they can't produce medicines—but it's in the producing countries that export them to developing countries.  In particular when we think about this, we think about India, which produces 70 percent of the world's generic medicines and 80 percent of the world's antiretroviral medicines.

The concern has been, for civil society groups, how to ensure that generic medicines that have been provided for years from India and from other centers of generic production can continue to keep health-care costs down and to allow health-care systems to expand and to ensure that we achieve the right to health.

How has the campaign worked at Oxfam? I often say within the organization that I have the most boring campaign to work on. It's extremely technical. It involves a lot of law and intellectual property. But all we are really talking about at Oxfam is enforcing the existing trade rules. The reality is that the existing WTO agreement actually creates different rights and responsibilities, as we are talking about, and creates a system of a rule of law.

What developing countries have to do is provide 20 years of patent protection for medicines, but they are also provided a variety of safeguards and flexibilities to reduce the cost of medicines when public health is under threat. This was reaffirmed on numerous occasions, and especially in 2001.

But, unfortunately, what we have seen is that, from 2000 onwards, the pharmaceutical industry has gone to great lengths to prevent developing countries from using these safeguards, which exist under trade rules to protect the right to health.

So for an organization like Oxfam, how do we support developing countries in using this policy space and ensuring they can protect the right to health? Here's a good example.

In the Philippines over the last two years, we have had a very active campaign supporting local civil society groups and patient groups to promote the right to health. The Philippines has the second-highest medicine costs in Asia, only behind Japan. Even though we might think of it as a middle-income country, there are massive numbers of poor people. Over 60 percent of the population lives under the poverty line. So there are very difficult choices that the government has to make to provide affordable health care.

The government took two actions a few years ago to try to reduce health-care costs:

  • To use some of these safeguards and flexibilities to reduce the cost of a key cardiovascular disease medicine, with cardiovascular disease being the number-one cause of morbidity and mortality in the country. This was at the encouragement of civil society groups.
  • To also change their law to reduce the cost of all medicines across the board.

 

But what we saw instead, and while this went forward, were very aggressive actions by the pharmaceutical industry—by one pharmaceutical company, Pfizer, to file a lawsuitagainst the government and against government officials in their personal capacity to prevent them from reducing the cost of this cardiovascular disease medicine, even though their actions were fully legal—and, second, really, really tough lobbying of the government, of legislators, to prevent these laws from being passed, even though the European Union itself actually has these same laws on its books.

So what is the role of an Oxfam? Yes, we can tell companies that they are wrong. Yes, we can tell the government they should make changes. But what is very important for us is to empower local groups.

We spent a lot of time educating local patient groups and local civil society groups and land-rights groups about why this was important and what these rules were about and why it needed to be passed in the Philippines and why it was important for the government to stand up. We encouraged local patient groups to enter into the lawsuit between Pfizer and the Philippines government on the grounds of the right to health. We really tried to develop a political angle around this, to say that the right to health does create accountability in the country for the government to ignore the pressure and lobbying by the pharmaceutical industry, to promote the right to health.

What we saw was an amazing groundswell of support across a large variety of civil society groups, supporting the right to health within the country. This really came from their interests and their needs, from 60-year-old patients with heart disease speaking on their own right and on their own behalf. That's what really matters, not only in the limited sense of trying to build this right to health, but to go beyond that and talk about more funding for the health-care system and to train health-care workers and to provide support and prevention and education.

There has been a lot of success. The government has passed this law in order to reduce the cost of medicines. They stood up to this lawsuit from Pfizer. We are seeing, really, a groundswell of support in building the right to health.

My purpose here isn't to be negative and to talk about only all the bad things that pharmaceutical companies have done. I really think there has been a great evolution by pharmaceutical companies over the last few years to look more seriously at this and to realize that poor people are not just recipients of charity, but are also people who have rights and that they are rights holders. The evolution that needs to occur—and I think it's important that Maggie said this—is recognizing that there does have to be a broader framework and that the rights and needs of developing countries and of poor people have to be recognized.

If we think about why this problem exists in the first place, when the WTO agreement was signed, it was done by trade negotiators. In fact, a lot of pharmaceutical companies in 1995 were very proud of the fact that they were able to ram through this trade agreement, called TRIPS.

If we think about it, if developing countries had had the right people at the table who spoke to the right to health, who spoke to the need for having this critical balance, I'm not sure that we would have had this outcome. So then, with the other concerns with intellectual property and with the lack of research and development for neglected diseases, we would have recognized the need to have a broad-based solution that really recognizes various needs, and especially the right to health.

I think it's important to recognize that when we are talking about the right to health, it's not only about the specific needs of and empowering developing countries, but it's also making sure that the right to health is recognized in all different capacities and spheres, whether we are negotiating trade agreements, whether we are talking about the right to food, whether we are talking about commercial provisions. It's that necessity to mainstream it that is really going to make sure we have the right to health that is recognized in every sphere of activity.

Just to conclude, I think that the right to health means means a lot of different things. It does mean working on the right to food and the right to water. But it's not enough to just talk about the elements of poverty. It's important to talk about the systemic causes of poverty. Trade agreements and trade rules and intellectual property are one example of them, as well as, perhaps, subsidies that prevent cotton farmers from having higher income to pay for basic necessities.

So it's important for us to, yes, talk about the basic needs that are needed on the ground and to deliver those services, but we can't do that to the exclusion of talking about the broader needs and responsibilities, including the roles and responsibilities of the pharmaceutical industry, within that framework.

I think it's important to work at all levels, to focus on governments and corporations and to hold them accountable. But it's equally important to mobilize local organizations and local communities, because that's really where we have to be grounded in talking about the right to health, so that we don't imagine what we think is important for other people, but that we actually are following what is being told to us by community-level organizations. It's doing that that converts them from being just recipients of charity and being perceived as being recipients of charity to being rights holders and being individuals who speak on their own behalf.

I guess that would be, broadly, what I would like to say.

DEVIN STEWART: Rohit, thank you so much. I just want to tell you that this panel right here has been more than a year in the making. It's really thanks to Laura and Merck and Christian and all the people here, who have been patient throughout more than a year of planning, that we are all able to be at this place right now.

Thank you very much to the panel.

ROHIT MALPANI: And I do just want to say one more thing, sorry.

One example of the work that is being done by community groups in developing countries: In India right now, there are local civil society groups that are facing off to prevent the patenting of medicines that are needed not only in India, but in poor countries around the world. They are really relying on the technical expertise of very new lawyers, very ad-hoc lawyers. This is occurring on a case-by-case basis.

So I do think this discussion of rule of law and empowerment is incredibly important, not only here in the United States or in the European Union, but in developing countries: investing resources to ensure that community groups and local individuals and patients who feel that their needs are at threat are able to stand up for their rights and are able to have this back-and-forth.

I call attention to a decision at the European Commission just two days ago that has launched a large investigation into anticompetitive practices within the pharmaceutical industry that might have cost the European Union €3 billion over the last seven years.

So when we think about this, if the European Union cares about this and they care about the cost of medicines, then I certainly think a country like Thailand or the Philippines or Namibia or South Africa is going to have equal or greater concerns. We have to think about enforcing these legal rights not only in developed countries, but also in developing countries, because the right to health depends on that so much.

DEVIN STEWART: Laura Herman, from FSG Social Impact Advisors, has ten years of strategy consulting experience in international health. She is based in Boston, another one of the panelists who came from far away today to join this panel. Laura Herman is going to talk about investment opportunities, investment solutions, and private-sector solutions, looking at what can be done—so looking more at the future.

Thank you very much, Laura.

LAURA HERMAN: Sure. The future in eight minutes or less.

There have been a lot of suggestions about what might be done in the future. We have talked about alternative patent systems, empowering local advocacy groups, maybe establishing new sets of principles and guidelines in terms of work in global health. A lot of this has revolved around the private-sector actors that are involved in new technologies.

I would like to suggest another area of investigation for the future, which is private-sector actors involved in health-care delivery.

If you will indulge me, you can imagine moving from the Upper East Side of Manhattan, for a moment, to West Bengal. Put yourself in the shoes of a mother of a child with severe diarrheal disease, and you are contemplating where you might take the child for care. The probability is very high that you will take her to your private-sector provider. What does that mean, private-sector provider in this case? It could be a local traditional healer, obviously unlicensed. It could be an unlicensed practitioner who actually is served by pharmaceutical companies and carries commercial medicines. It could be a regular licensed physician. It could be a missionary-run clinic. It could be a primary-care clinic or a tertiary-care facility.

So there is a range of private-sector providers that are delivering care in the developing world. Indeed, in India, about 76 percent of all health-care spending is out of pocket. The government is not covering that.

This highlights the importance of the role of the private sector in delivering care. It's a major factor in most of the developing world, for a number of reasons. On the one hand, it may be closer to the patient and saves them the opportunity cost, obviously, of traveling to what might be a very distant government facility. It may be staffed by a member of the community, a trusted adviser in terms of delivering care in a culturally appropriate way. We hear the stories of women who are used to delivering their children one way and are quite intimidated by being in a rather sterile, white-tile hospital environment. That may be very inconsistent with their cultural experience.

In some cases, there is a range of training that may be available, a range of oversight that may be provided by the government. The private-sector providers certainly vary widely in their quality and availability of care. But they are, nevertheless, an important force to reckon with. I think there are a number of ways we can consider strengthening this actor within the health-care system.

One would be to invest in those service providers. What might this look like? You could imagine folks that run clinics that could be franchised and taken a bit more to scale. Private-sector investment, whether it's in the form of loans or risk capital, might help expand those services. That reach may be broadened beyond urban centers or peri-urban centers, reaching the rural populations who now have very few alternatives.

This creates a profit incentive that may help ensure that health-care providers remain in their countries of origin, where you actually see a career and the ability to sustain a living in serving your local population. It also brings new resources to the issue of health-care delivery that doesn't burden governments further. Risk capital is certainly something that we see plenty of in terms of growing industries in the developed world that has thus far not been applied extensively in the health-care arena in the developing world.

So a couple of ideas there in terms of supporting the private-sector health-care delivery alternatives and helping them improve both in quality and efficiency.

That's not to say that there isn't a role for government. I think it's dicey to be an advocate for the private sector these days in a lot of circles. I think alongside that, there is, in the spirit of roles and responsibilities, a quite distinct role for government in terms of licensing and providing training and oversight and regulatory services to ensure the quality of the care provided by the private sector.

This is an idea that has gained traction among a number of donor organizations. The Gates Foundation has started looking at this with the International Finance Corporation and is starting to fund small investment groups that may go on the ground in Africa or India and look at very specific investment opportunities, providing due diligence in terms of the viability of the business model and many of the other criteria you would expect to see in terms of an investment structure.

Related to this, also in the private sphere—or it could be public—is the role of health insurance. Again, I think this is something we have talked about at length in the developed world vis-à-vis our health-care systems. But it is talked about less in developing countries. Insurance schemes can bring a level of transparency to pricing and help control costs, whether that's in the spirit of the markup on drugs that are covered by different insurance schemes, whether that's in terms of the cost of care provided. It creates an alternative system for monitoring quality and ensuring a certain standard of care that is then covered by a certain scheme. So it also can help proliferate the services to peri-urban and rural areas where you can provide an incentive to do that.

There are some health-financing schemes that have been under way. We have seen in Colombia and China, for example, that they do actually improve the utilization of health services. When you know you have coverage, you are more likely to take that child sooner to get care. So you see increased utilization in health services and then an improvement in the overall health outcomes. By not delaying care or by not stopping at what is an unlicensed or unregulated provider, you are more likely to get the appropriate care sooner.

I think this also relates to the broader debates around poverty, as Rohit was saying, in terms of helping prevent families from being driven into poverty as a result of health expenditures. It's a major driver of the sorts of catastrophic events that put a family deeper into poverty. This, then, is a protection mechanism in terms of what might be future health issues that the family needs to fund.

Again, many challenges exist with this. I think with all insurance, the first one that probably comes to mind is the issue of risk pooling and how you do that effectively over a large number of people. The risk of malaria is going to be pretty consistent for a large region, for example, at the same time of year. So how do you diversify risk? This is starting to be taken on by different groups.

I think the question of quality of care still remains to be answered, the extent to which, then, those insurance schemes are regulated in terms of the type of care that they are paying for. The government obviously has a role there. Many of these schemes are beginning to be initiated also by governments, thinking about mutuelles [community prepayment health insurance schemes] and some of those examples.

So those are a couple of ideas that are relevant to the private sector, beyond the role of the technology providers and the health research companies, that focus more on delivery and get us closer to the patients and some of the issues that the patients are confronting head-on as they make very micro-level day-to-day decisions about how to provide health care for their families.

Which isn't to say that we don't also need to continue to innovate along the lines of other health-care issues, but that's one area that we are seeing as a new area for investigation and experimentation, both in the donor community and the government community, and then within the private medical community, where you can imagine these things are quite controversial, in terms of, most especially, involving unlicensed practitioners and how to engage the unlicensed providers.

Within FSG, we have worked with a number of clients to look at this issue, whether it's the Gates Foundation and looking at health-financing schemes. The original idea about a health-care-delivery fund emerged from work with one of our clients about six years ago. We were able to talk with the IFC [International Finance Corporation] about moving that forward. It has been very rewarding to get into these issues and actually find some of the actors who can start to experiment with these new models.

I encourage all of you to think broadly about what the role might be in the private sector in ensuring the right to health care.

DEVIN STEWART: Thank you very much, Laura.

I keep looking out at the audience and I see all this expertise, so I want to get you involved with this conversation very quickly. But I will just give the panel an opportunity to respond internally.

Is there any question or comment on each other's presentation?

MAGGIE KOHN: I'll just respond to some of the comments that Rohit made. I think we have had this discussion a lot.

Price is certainly something that is on the table, and patents will continue to be a very controversial issue. What strikes me as curious, though, is, when you look at the essential drug list, 99 percent of the drugs that are on the WHO's essential drug list are not patented. Yet those aren't getting to the people who need them in the countries.

In my mind—again, I'm not an IP lawyer, by any stretch—that seems to show that the patents aren't the be-all/end-all barrier, if even those drugs that have been off patent for years are simply not getting to people.

There was an interesting article, I think it was yesterday, in The Wall Street Journal by an African—I can't recall if he is a minister of health or a former health aide. He was coming to the defense of the pharmaceutical industry, which you don't see often, particularly in The Wall Street Journal, so it caught me by surprise.

He was saying in his country the products aren't getting to people, but the reasons he cited were basic things. There are not roads to get to the rural villages. There aren't warehouses that are safeguarded. Medicines in the warehouses are stolen. You have corrupt government officials who often require bribes if you want the medicines in your villages.

While I don't discount that we need to continue to examine and have a robust dialogue on IP and on pricing, I just think it's a more complex issue, and there are many, many factors.

ROHIT MALPANI: I couldn't agree more. Again, from Oxfam's perspective, we really do try to work on this from a very broad-based perspective, whether it's investment in health care; holding donor countries accountable for the promises they made in 2005 around providing an additional $50 billion per year by 2010; working in developing countries to reduce corruption, especially through funding advocacy groups; ensuring that there are no stock-outs. It really is a broad range.

I think it's important, though, on the essential-medicines list to realize that the WHO actually doesn't put medicines on the essential-medicines list if they are too expensive. So it's one of those catch-22 situations.

If it was affordable or if there could be a generic, then they would put it on there. A lot of advocacy groups have spent a lot of time, actually, trying to push the WHO to expand the essential-medicines list.

You would be surprised to know that it took an act of God to even get the essential-medicines department to put HIV medicines on there at first, because they were concerned about the pricing and the burdens on health-care systems in developing countries. In fact, we have been pushing to have a secondary list of patented medicines that might be more expensive.

CHRISTIAN BARRY: Coming in on this issue, a couple of things. One is, of course, with respect to infrastructure and delivery problems, why are there these problems? Who are they being delivered to? They are being delivered to people who have very little influence, typically, over the political situation in their countries. They have very little power to hold accountable those who are delivering the drugs.

One of the advantages of actually instituting a scheme whereby those who are producing and selling medicines recoup on their reward only if it actually reaches and has a health impact is that it introduces another actor with an incentive to make sure that these infrastructural issues get sorted. Now, that is not a guarantee, but it actually does create something significant.

A second thing. With respect to nonpatents and the compulsory-licensing issue, the more widespread compulsory licenses in some of these medicines come to be used—Rohit is completely right. One of the things that is most striking when you look at the TRIPS flexibilities is to look at how little they have actually been used by countries that legally would seem to have a good case to use them.

Clearly, this has to do with a number of different factors, not simply pressure from pharmaceutical companies. The more widespread these things are, the less these types of firms will actually have the incentives to innovate in areas which are of interest to countries in these innovations, because the less likely they are going to be able to sell these at a high price, the less likely it is that they are going to be able to recoup on their investment.

Another thing, of course, is that even if you had greater flexibility and all these drugs were not on patent, it still doesn't deal with the problem that many of the things that affect poor communities are diseases for which medicines do not now exist.

One of the reasons they don't exist is because there is no incentive for companies to actually innovate in these areas, aside from these small incentives they can be given by funds.

So even dealing with the current system and utilizing the flexibilities that exist, even a fully reformed pharmaceutical industry that was friendly to these objectives wouldn't solve a significant number of the problems that affect the issue of realizing the right to health in developing countries.

DEVIN STEWART: Any other comment on that issue?

LAURA HERMAN: To Christian's point, one observation in doing some research on this in India was the extent to which the pharmaceutical producers in India had recognized the market opportunity with very small rural medical providers.

These guys walked with their bags through the fields to get their products out to the folks who were providing care at the furthest reaches. We were shocked to find—unfortunately, it was third-line antibiotics, so it was not really what we would like to see at the village level. But it was illustrative of the point that when the incentive is there, the infrastructure barriers can be overcome. In this case, it was a local manufacturer.

MEG BOULWARE: My last point that I didn't get to make was about the compulsory licensing under TRIPS. I recall back in 1986 that flaming liberal Carla Hills saying that perhaps AIDS medicines should be compulsory-licensed outside the United States. I believe recently Thailand had Cipro under compulsory license. This alternative is being viewed as one way to overcome patent barriers.

My question is—and my panel members would have the answer to it; it's not my area—I wonder, if the medicines that are on the essential list were getting out to the people who need them, how much higher the level of health would be. I do think that, to some degree, patents are mischaracterized as the major way medicine is not being distributed. As a patent lawyer, I don't see it quite that way.

That's my question.

DEVIN STEWART: We should get the audience involved here. Lots of questions.

Questions and Answers

QUESTION: Maggie, you mentioned a speech by Stephen Lewis, which I also heard. He was talking about the Millennium Goalsand he was going through the list and saying how, tragically, they had not been met. He got to equality for women and he said, "You know, if this were met, a lot of these would just automatically be met."

I'm wondering, listening to you, if the health rights were met, would that then create an environment where hunger could be solved? Is it a lever to address hunger, torture, and all the other issues? Or does health have to be, for some reason, subsumed to others that might be considered more important? What is the relationship in the rights world?

CHRISTIAN BARRY: I can't speak from the human rights international legal perspective, but in thinking about human rights, how we define the object of the human right is by some conception of what are fundamental human interests that stand in need of urgent protection. It's likely that those interests will be plural in nature. Some of them may refer to certain types of capabilities, functioning, that we have as biological beings. Some also have to do with more specific features of human beings, such as our need to have certain types of opportunities for creative expression and other types of basic things.

So I would be tempted to think that all human rights are, in some sense, oriented towards protecting these fundamental interests. None are necessarily subsumable or necessary or sufficient to bring about others, and all should be conceived as directed towards this package.

Now, of course, it's all in the details about how exactly you understand what these fundamental interests are, how they are weighed against one another. They will be plural, I think. Unless you are utilitarian and think that the fundamental interest is just being happy, you are probably going to have a broad range of types of capabilities and functioning that you want to protect.

I tend to think of international human rights as legal rights. You might be able to protect these interests without them, but they have proved very useful as a means of protecting these interests and holding agents accountable for making sure that they are satisfied.

LISA OLDRING: I think it's a really interesting question. I just want to reflect on the fact that historically human rights, in their original conception, were agreed as interdependent, indivisible, and interlinked. Really, it was for political reasons that you ended up with the split between what are now seen as civil and political rights and economic, social, and cultural rights. I think we are sort of coming back to the point where we really appreciate the indivisibility of these rights and the fact that you can't look at the right to health in isolation from other rights.

They are truly interdependent—and also looking at the components of the right to health itself. It's not just a right to access health care; it's also the right to underlying determinants of health and the sort of social and economic inequalities that drive health, like food, water, education, and so on. I think gender inequities—again, the example that I was talking about earlier with maternal mortality—really drive this home.

So for me they are very much linked.

QUESTION: One of the challenges that we see in global health, particularly in developing countries, is the shortage of health workers. One of the factors in that is immigration. I'm wondering if any of you have any comments on how we can find that balance or deal with this issue—as Mary Robinson has put it, this tension between the right to health, as well as the right these individual health-care workers have.

ROHIT MALPANI: I guess part of our perspective—not necessarily to answer your question, as any good panelist would do—it is again about the chronic underinvestment in public health care in developing countries—the payments or the salaries that go to doctors and nurses, the absolute scarcity of doctors and nurses (most are working very long hours, under very difficult conditions, with very little success), and to some extent, the doublespeak from developed countries of not putting the donor funds into what is needed to build public health-care systems in developing countries, at the same time that there is obviously a lack of investment in their own medical school systems and building their own employee workforces.

So I think it is really holding governments to account. I misspeak by only saying it's a question of donor funding, but it is developing countries. It's inexcusable for India to only spend two to three percent of its GDP on health care or for most African countries, which for years have committed to the Abuja Declaration for 15 percent of spending on health, to really be far, far short of that.

This is to say that that is a false choice to make. It's really just about governments following through what they have said they are going to do in terms of building public health-care systems, providing the right salaries, adequate salaries, and making sure that the tools that health-care workers need to save lives are there.

LAURA HERMAN: I think related to that—and I mentioned this in terms of developing the private-sector health-care facilities—is to create a professional track and a career for folks in the private sector, potentially, which doesn't mean only serving those who are wealthy or who have the ability to pay, at the top end of the spectrum. There are ways to structure that so that they can be serving a much broader population.

I think there has been a preoccupation, really, with the role of the public sector and improving the public sector's health. Whether it's right or not, if they don't have the money, they don't have the money. At the end of the day, we want to find a way to improve the quality of the care. If there is a way to incentivize those health-care providers to work in their local context, where there is mentorship and community and safe working conditions, that all goes a long way towards keeping them more local and improving the numbers in terms of the accessibility of human resources for health.

LISA OLDRING: Just very briefly, I think it's really one of the biggest issues that is challenging the right to health in developing countries today. It's understandable. There is a global shortage of health workers, including in industrialized countries as well. But the net loss for developing countries is where it's really hitting home.

There is now an initiative to try to develop some sort of a framework of ethically based rules through the WHO code of practice. It's something that the Health Workforce Migration Initiative is currently trying to develop. Maybe it's something that you are already aware of.

CHRISTIAN BARRY: This does seem to be an issue also of, obviously, the immigration policies of developed countries, because even with greater investment in these things, it's going to be very difficult to limit the incentives for skilled professionals to move, when they can, and get much higher salaries and better working conditions.

I'm always of two minds about this. I'm generally in favor of much more liberal immigration policies. But given that we have the system that we have, I sometimes feel that a much less liberal one would actually be less harmful to some developing countries because of these issues. But it seems to me that insofar as we want to have strict controls over borders and authorize countries to make their policies the way they want, certainly this is an area where the claim that countries at least respect the right to health would seem to trigger certain types of obligations to not offer such strong incentives for health professionals to move from countries which are—at least without compensation, not to the worker, but to the country, for what's going on.

QUESTION: I was not surprised to hear that everybody on the panel was in favor of human health as a human right. But I wondered why everybody was in favor. I have a pretty good idea, I think, why. It is because nobody is willing to say what they mean by that, which, as a businessman and a person that has a foundation, I find difficult.

My question is, why don't you define what you mean? It's tough. I really understand why you don't want to. As soon as you say what you mean, you are going to be shot at like you can't believe. I know that. But you need to have that. Can you imagine where the First Amendment to the Constitution would be if nobody had been quite specific in discussing this and shooting at it, and doing a lot of work on it?

One last comment. I said I have a foundation. Not a few people have come in with medical things. A lot of people say, "Human rights, health—we have to do something about it." Do you really expect somebody to give you money if you don't say what you want to do with it, what you intend to do, making medicine a human right?

CHRISTIAN BARRY: I tried to say what I think it means.

QUESTIONER: [Not at microphone]

CHRISTIAN BARRY: Right. Obviously, we would have to talk about what seem to be standard threats. We start out with some idea of what normal human functioning is like, certain types of biological functions that ordinary human beings have—something like the idea of a lifespan, although it's obviously blurry at the edges. We look at what seem to be consensus issues which we could recognize as serious setbacks to these basic interests. We talk about what the claims are in terms of protecting them.

Clearly, you can write philosophical tomes trying to define exactly what you mean by it. But for the purpose of defending something like a proposal, it seems that we can work with some rough and ready idea of what seems to be clearly undermining these interests that people have in health. If their child mortality and infant mortality is very high, if maternal mortality at birth is extremely high, if the life expectancy in some countries is extremely low, if people are prone to certain types of opportunistic infections—these seem to be issues where some minimally adequate health protection is not being offered to them, and so we want to look at perturbations of international rules or policies which would make it such that their interests are better served.

I think that would be my sort of Deweyan pragmatic response to your very difficult questions. But if you want to know what to do with your foundation money, I can tell you.

QUESTION: My question is for Maggie Kohn. It has to do with strategic corporate communications.

I would like to know how the recognition of health as a human right has changed the strategic communications of Merck, and particularly its branding. I'm thinking of an analogy from a completely different sector, petroleum, where BP has redefined itself as "Beyond Petroleum."

MAGGIE KOHN: It's interesting. We don't do a lot of corporate branding. We don't have a corporate branding campaign. The pharmaceutical industry, I think, is very different from so many industries, because we interact mostly with physicians, and there are a lot of regulations on advertising.

But I think that as we have started to think more about our business with a rights-based approach, we have seen changes in how we think about business and opportunities. It somewhat touches on your comment about why a pharmaceutical would even enter this debate and discussion. We do this not only because we think it's the right thing to do, the morally right thing to do, but at the end of the day, it comes down to a business decision.

We know that to continue to be successful and sustainable, we need to look at other markets, increasingly emerging markets and countries like that. We need to change the way we do business. We need to, I think, learn from other industries that have done this and think about how we can change our product, how we can change our selling methods, our marketing methods, to get to that bottom of the pyramid—not only the two percent in a country like Brazil or Thailand or the Philippines, but the masses of people.

From a branding perspective, I don't know if I can answer that, because we don't do a lot of branding. Certainly, in the last five to seven years, how we are starting to make business decisions, thinking through a different lens than we would have, it has certainly had an effect.

QUESTION: One of the things we have been chatting about over here in the corner—and it's kind of inevitable. The panel was wonderful, but the analysis has been very post-symptomatic. That is to say, it's all about ensuring people's right to pills and bypass surgery and things that occur after symptoms have been determined. I'm addicted to the show House, and I understand that if that cranky man spent all of his time trying to get people to eat their broccoli and inoculating them against typhus, it wouldn't be a very interesting show. I get that.

But from the standpoint of what it is that we have to do as a community, going back to the woman with the water and the food, it's not sentimental for her to say, "Well, I've got these basic needs that need to be met first." As one of the panelists mentioned, there are clear relationships between having clean water, having decent nutrition, and not needing your pills so much.

So I think there does need to be some kind of follow-up discussion—I'm not sure how this would work in terms of the Council—to talk a little bit about the pre-symptomatic aspects of this issue and how we can put more people in positions to not need the things that we are fighting for them, quite rightly, to have.

DEVIN STEWART: That's very interesting. A couple of weeks ago in Brussels, one of my copanelists in the European Parliament said he believes that the medical industry will move from prevention to wellness. It's kind of similar to what you are saying.

Do any of the panelists want to address that or have any final comments? Rohit?

ROHIT MALPANI: I couldn't agree more. Again, I think this panel focused very specifically on one or two issues. But I think anyone who works in this field recognizes that it really is a broad range of interventions. The same techniques or the same tools we use to hold companies accountable around access to medicines are the same that we have to use around improving the right to food or the right to water or ensuring that the basic conditions are there or that health-care systems function.

I think that goes back to the broader question of how rights work together. I think, when you build up capacity or momentum around accountability in one issue, it naturally lends itself to building broader accountability on others.

I think you could bring in another range of experts that just focus on the right to water and probably have a very fruitful discussion on that. It's just part of, I think, working in this field. People really do get siloed in a bit on the specific issue they are working on, even though the approach and analysis often tend to be the same.

MAGGIE KOHN: I think it has been a good discussion today. I think, though, as we get ready to prepare for the anniversary—it's on the 10th, right?—of the UN Universal Declaration of Human Rights, there couldn't be a better way to celebrate that anniversary than around the right to health, again, moving past these types of discussions that often are talking in circles on different issues and being very pragmatic and practical about what we can do together so that on the next anniversary of the Human Rights Declaration we have actually made progress. That's what I don't think we have seen enough of, actual progress, over the last decade.

I think it would behoove the people that we are ultimately talking about here, the disadvantaged populations, if we thought in more pragmatic and practical ways about how we could sit together, roll up our sleeves, and really think about what the barriers are and what we can do.

CHRISTIAN BARRY: Actually, this kind of goes back to the last questioner's point. I think he's completely right. This dovetails with what Maggie just said. Of course, when we are doing diagnostics and saying what the biggest sources of problems are, we will end up focusing on some of these more general issues. We probably won't focus on patents. We will talk about certain basic infrastructure issues. Obviously, the issues are interrelated. When we think what, if achieved, would do the most good, it will often be these things.

But I think we need to put on a slightly different hat when we are thinking about where we are going to put our energies, and agitating energies, which is that we want something that can do some good and actually have some chance of exciting people's passions and getting done. Sad as it is, infrastructure improvement has not been something that has gotten people agitated and excited, including pharmaceutical companies.

So one of the reasons why I think some of us are focusing on some of these access issues is trying to create a system whereby pharmaceuticals and other companies would have stronger incentives to do things that actually have some chance of doing some good for populations.

DEVIN STEWART: Thank you to the panelists. I want to remind you that we will have our next panel in January—a big kickoff. We are going to do something pretty big: "Ethical Decisions for the World for 2009." Stay tuned for that. That's going to be quite a show.

Thank you all for coming.

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