Interview With Howard Zucker, Senior WHO Official On IP

[Please note: This interview has been republished to clarify the transcription.]

Howard Alan Zucker, assistant director general of health technology and pharmaceuticals at the World Health Organization, is among other things in charge of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (referred to as “IGWG”), which was set up by the World Health Assembly in May 2006, and which had its first meeting on 4-8 December. The group was asked to come up with a global strategy and plan of action by May 2008 for how research and development into neglected diseases may be improved. Intellectual Property Watch‘s Tove Iren S. Gerhardsen sat down with Dr. Zucker in mid-December to discuss the mandate of WHO to deal with issues such as IP and trade, the area of counterfeit medicines that he also oversees, what role IP should play in such a plan, his first year at the WHO and why he chose to come to Geneva.

INTELLECTUAL PROPERTY WATCH [IPW]: At the IGWG, the United States raised the issue of whether WHO should deal with IP and trade at all. Do you think this whole exercise of the IGWG has become one about what belongs where?

HOWARD ZUCKER [ZUCKER]: There are certain subjects that fall within the jurisdiction of WTO [World Trade Organization] and others within that of WIPO [World Intellectual Property Organization], and yet others within that of WHO. For the areas that overlap we need to foster all partnerships. One of the topics which falls in this grey zone is patent issues and pharmaceuticals. WHO has been at the table when these issues are discussed at other international organizations. WHO provides a level of expertise in public health which is instrumental to discussions at WTO and WIPO. We are involved in these areas as evidenced by documents on the Web from these other international organizations.

IPW: I guess there were certain countries that did not want IP to be part of this IGWG plan? Would it be possible to have a plan which at least does not change the IP regime?

ZUCKER: The new [WHO] Director General [Margaret Chan] said [in her November speech], that we need to recognise intellectual property rights as well as identify ways to find medicines for neglected diseases. I believe that we can’t just eliminate existing systems. We must work within structures that are in place and develop avenues which address the issues of public health. The challenge is getting R&D and innovation into the developing world with a particular focus on neglected diseases. This can be a win-win if we just think creatively.

IPW: I guess there are two questions: Whether IP should be part of the global strategy and plan of action, and number two, whether it needs to be a new IP system, because that’s a different question.

ZUCKER: Intellectual property is part of the global strategy. It is noted as one of the eight subsections of the IGWG topics. It was raised by the member states and we at WHO have responded accordingly. As for building a new system, I would have to say that IP involves a great deal more than just our issues in public health. As such, I think that our goals should be to advance public health innovation in the context of IP. The member states have asked WHO to look at these issues and that is part of the reason it falls within the eight subgroups. You might wish to speak with WIPO and get their perspectives as well.

IPW: The counter argument, from the people who want the extreme overhaul, is that there is a system, they would agree with you, but because it is not working for these [neglected] diseases, it needs to be changed.

ZUCKER: So then the real issue is how do we find innovative ways to advance R&D for neglected diseases. And this is exactly what the IGWG in follow-up to the CIPIH [WHO Commission on Intellectual Property Rights, Innovation and Public Health] report is focused on. Disrupting systems simply for the sake of changing something needs to be evaluated carefully. It doesn’t necessarily work. It has been just shy of a year since my arrival at WHO and we have made great progress in many areas. For example in the area of fighting counterfeit medicines, I have been asked: ‘Why not have an international convention resulting in a treaty?’ My reply is that we will spend millions of dollars, three years in the planning and in the end will have delayed the actual job of reducing, and hopefully eliminating, this problem. So instead we developed IMPACT [International Medical Products Anti-Counterfeiting Taskforce] with its five subgroups and we are already moving towards solutions in the areas of legislative, technology, regulation, and other areas. With the same resources and time we are making great progress in this area. I am frequently told of problems and as much as I recognize that there are challenges, I always want to hear what people believe is the solution, a practical solution which can be implemented on a reasonable timetable.

IPW: You have now been here [WHO] for a year. How do you like the work you are doing on the working group versus the counterfeiting effort? Some people said at the meeting that counterfeiting does not fit at all in the plan of action [IGWG].

ZUCKER: Well firstly, as for the counterfeit issue, they are incorrect. The counterfeit issue fits into the IGWG as much as anything else. How can one argue for increased access to medicines, and not recognize that these medicines must be safe. Issues of counterfeit medicines is part of the CIPIH report. And the issue falls within my cluster at WHO.

IPW: I guess people mix it up, generic versus counterfeit medicines.

ZUCKER: I think that may be the case. Just as with brand name medicines, there are many generic medicines available that are absolutely safe. They are not counterfeit. Counterfeit medicines involve everything from incorrect formulations, inaccurate labeling, absence of active ingredients, among many other things. [Counterfeit medicines] is a major problem in the developing world and it is growing. The key issue is to get to the root of the problem and find a solution. I am always looking for a solution. That is what the entire team in my cluster is focused on – finding solutions. Millions of people in the world are not getting safe medicines and we need to solve that. One of the problems is access, another one involves health systems, and a third is counterfeit medicines. Our cluster doesn’t work on health systems but as for access and the issue of counterfeits, we do. And we need to work towards a solution.

IPW: But the main thing is innovation, right? And counterfeiting is out there after you have the medicines and they are trying to make fake copies of it [while for neglected diseases there are actually no medicines available yet]?

ZUCKER: That is why one of the key points of the IGWG involves this issue of neglected diseases. It’s just one part of this whole [CIPIH] report. We must go after this part of the bigger problem – innovation and R&D. I was actually surprised that an issue was made at the IGWG about whether counterfeits is a WHO or WTO issue. [at the IGWG meeting; read about Brazil’s intervention] (see ip-watch.org, 7 December). It’s definitely a health issue and is part of our cluster’s responsibility. Let me actually clarify one point, WTO and WHO work closely on issues. Counterfeit medicines is definitely a public health crisis in some parts of the world.

IPW: Percentage wise, how much are you working on counterfeiting and how much on the working group?

ZUCKER: It really is hard to break down one’s time, I always say I work 90 percent on issue number one, 90 percent on issue number two and 90 percent on issue number three. My days are extremely busy. Serving as the director general’s representative on intellectual property, innovation and public health is just one responsibility. The cluster still is responsible for technology, prequalification programme, anticounterfeit efforts, traditional medicines, blood safety, access to medicines. I need to oversee all of these and it does involve lots of juggling. However, I have found that I’ve been juggling things my whole life.

IPW: How have these jobs been compared with what you had expected? Also, I understand that you were rising within the Bush administration, so why did you decide to come to Geneva?

ZUCKER: I expected the challenges that I found when I arrived. And yet there were unexpected ones as well. Working to get dozens of nations to agree is a task. I expected that there would be incredible talent, technical talent, within the organisation, which there absolutely is. That is what WHO usually attracts, experts in all fields of public health. I expected to find all the challenges of a large organisation, whether it’s public or private. I haven’t been in the private sector so I may be jumping to a conclusion here but let me say that in the public service and academic worlds, ones that I can speak to, the challenges at WHO are comparable. My approach to most things involves finding practical solutions to problems, turning theories that people have into real practise. And that’s my whole perspective on all issues. Show me how it helps someone. I moved from clinical medicine to policy but I have not changed the overall premise to fix problems that exist. In New York I was taking care of patients who were literally on death’s door. These children in intensive care units were incredibly ill. My objective for the end of the day was to have a major improvement in their health status. I had deliverables with extremely short time frames. The long-term deliverables were actually measurable in two or three days. The objective was to get these children home out of the intensive care unit and home. I have always looked at problems in the following way: “Where do we want to be, how can we get there and what is a really practical solution to this problem, how do we make people better.’ So I have just taken that approach, from those days of clinical practice to a national level in the US, to an international level now. This is the same thing: how do we get to a solution, solve the problem. Maybe this approach is just part of one’s own genetic code.

IPW: So do you like this [IGWG] group, then?

ZUCKER: Yes, but let’s solve the problem. So I push everyone to work together to find solutions and they know that.

IPW: And why did you decide to come here?

ZUCKER: J. W. Lee [former WHO Director General Lee Jong-wook] asked me to consider joining his team. He said that the position involved issues of medicine, policy, law, and public health. He asked if I would come take a look. I looked at what the Health Technology and Pharmaceuticals cluster does and thought this would be interesting and it would be possible to make some changes to help the world. So I said: “let’s do it, go for it.”

IPW: Thank you.

Tove Iren S. Gerhardsen may be reached at tgerhardsen@ip-watch.ch.