Organization for Global Health

From Lab to Village
An Interview with Dr. Abdallah Daar and Dr. Peter Singer, Co-Directors of the McLaughlin-Rotman Centre for Global Health’s Program on Life Sciences, Ethics and Policy
Excerpts from Juxtaposition 2008 Issue

In recent years, there has been a burgeoning interest in harnessing biotechnological innovations for the improvement of health in developing countries. Innovations surrounding vaccine development and other technological interventions have increased dramatically to meet pressing needs for disease amelioration such as malaria and AIDS. However, while scientific knowledge is of crucial importance, commercialization of such innovations is an essential next step.
Fundamental to the progression of this field has been the development of the McLaughlin-Rotman Centre for Global Health (MRC) based at the University Health Network and University of Toronto. MRC is a affiliated research organization with the clear mandate to translate biomedical breakthroughs into cost-effective technologies that will improve global health. Additionally, it seeks to further engage Southern collaborators in establishing sustainable initiatives that will support local innovation in developing countries. To enhance our understanding of current research, Co-Directors of the MRC’s Program on Life Sciences, Ethics and Policy, Dr. Abdallah Daar and Dr. Peter Singer, sat down with Juxtaposition to discuss current trends in global health, with a focus on how to take science “from the lab to the village”.

“What are the key challenges in global health that you feel the MRC is addressing?”

Dr. Daar: “There are a number of ways to talk about challenges. I will start with our work with the Bill and Melinda Gates Foundation’s “Grand Challenges in Global Health Initiative” which outlines 14 challenges such as developing vaccines that don’t require refrigeration, creating vaccines that can be given at birth, and discovering drugs and delivery systems that minimize the likelihood of drug-resistant microorganisms. Our long term goals are to ensure that these technologies are developed rapidly, and delivered to where they are needed safely and affordably. In the end, we want to achieve our ultimate aims which are to save lives and improve health in the developing world. We are also interested in the use of science and technology for development generally.”

Dr. Singer: “Additionally, the MRC has two components - a discovery and development side as well a delivery and commercialization side. On the discovery and development side, we have Dr. Kevin Kain and Dr. Conrad Liles who are doing some exciting work on malaria. On the delivery and commercialization side, we do four things. Firstly, we help launch grand challenges that Dr. Daar has described. Secondly, we provide ethical, social, cultural and commercial consults to grand challenges programs. Thirdly, we work on emerging economies in commercialization. For example, we had a conference last May with biotechnology companies from India and China with a global health focus to foster partnership. We also published a series of articles of Indian and Chinese biotechnology companies. And fourthly, we have the MaRS Africa program for which we work with the African governments to help accelerate their commercialization and it has been featured in an article published by the MIT Innovations Journal.”

“Since your 2001 article titled Harnessing Genomics and Biotechnology to Improve Global Health Equity, what sustainable examples of genome-related biotechnology have been successful in addressing real problems within developing countries?“

Dr. Daar: “It is more important to identify the overarching trends than to focus on individual examples. Enormous changes have taken place in the last 7 years in the consciousness of the world with regards to science and technology after that paper was published. For example, almost all countries in Africa have committed to spending 1% of their GDP on science and technology, which didn’t exist 7 years ago. Secondly, because of its enormous resources, there has been a particular focus in Africa, on harnessing the life sciences in the areas of health, agriculture, mining, environment, etc. I am part of the African Union High Level Panel commissioned by the African Union that put out a recent report entitled “Freedom to Innovate” that examines this potential. It has recommendations that have informed a 20-year African strategic plan for harnessing life sciences. Big groups such as the G8, TICAD, etc for example, have focused on Africa over the past three years and are thinking of putting in more resources into science and technology. All of the aforementioned are new developments.

Thus, there has been a huge shift in the way developing countries think about science and technology and its potential applications. Around 2003, we published a series of papers that looked at Cuba, Brazil, Mexico, South Africa, Egypt, China, India and for comparison, South Korea and how those countries are harnessing biotechnology for health. Mexico has established institute called The National Institute of Genomic Medicine, which is probably one of the most advanced in the world in linking public health and genomics. Other countries such as Brazil and China are also doing a lot of work in this area. In fact, China has always been at the forefront of genomics: it was the only developing country in the Human Genome Project featured in the publication reporting the sequencing of the human genome.”

Dr. Singer: “The ones that are closer to success are for example the malaria vaccine which is going into phase III trial which is exciting. Some of the needle-free vaccine technologies are getting closer as well. There are other examples of technologies that are close which weren’t the case 7 years ago when our paper was published. There have also been disappointments – the Merck HIV vaccine trial as well as the two microbicide trials published to date have been a huge disappointment which is to say that when you are in the high risk area of technology, you have to toughen yourself up for some disappointments and build on your successes.”

“What key innovations hold promise within the developing world? Are they sustainable?”
Dr. Singer: “You can generally think of global health innovation in three phases. In the first phase, which is between pre-history and 1996, there was almost no innovation in global health; there was the yellow fever vaccine, malaria blood smear, and Koch discovered tuberculosis bacillus. That is the age of empty pipeline. Around 1996, the first cases of product development and public-private partnerships arose such as the International AIDS Vaccine Initiative. This is really about the public and private sectors getting together to make the pipeline move forward. There are now 60 products or so in the pipeline entering field trials; a lot of these have been funded by foundations such as the Gates and Rockefeller. This was a great phase but has been more focused on Northern innovations for Southern problems. The phase we are in right now is the phase of global innovation. You’ve got stories like Shantha Biotechnics that brought the price of the hepatitis B vaccines down. That is what is going to make it sustainable in the long-term; people closer to the problems innovating on the problems and participating in the global value chain of innovation.“

Dr. Daar: “The Indian company that Dr. Singer talked about, Shantha Biotechnics, was able to also dramatically decrease the cost of hepatitis B vaccine from $13-14 to about 39 cents a shot. This means that millions of people now can get access to it. Another example is the insulin which is controlled by 3 companies, but now locals can make insulin by recombinant technology that drastically dropped the price as well. India took the insulin cost from more than 400 rupees per vial of 100 IU down to less than 100 over a period of a year or two. All these are important and they are sentinels of what’s coming down the road. The key to sustainability is affordability and autonomy in development and production.”

“What are the political trends in funding pertaining to the global health field? While the governments especially the US are investing more and more in research and health care, how does this impact your vision and mission within the realm of business entrepreneurship?”

Dr. Singer: “There is definitely a lot more funding now - $70 billion endowment at the Gates foundation spending $3 billion per year. There is a huge set of investments by the US under PEPFAR and so on, but still mostly on the delivery side. Even in the last federal budget this year, $50 million goes towards the Development Innovation Fund which is about science and the developing world. You see a big increase in funding for global health and funds that can be generated for global health; most of it is for access to products and delivery, but you also see an increase in the amount of funding that goes into innovation - a few billion into the advance market commitments for the pneumococcal vaccines, for example. In addition, the Grand Challenges project is a $500 million program. A lot more funding is available now - most in delivery so far but some are moving upstream into development and discovery. It’s actually a much more optimistic situation now in terms of funding compared to 7 years ago when we wrote that article.”
“Are there ethical criteria for private sector relationships within developing countries? If so, what are they and are they realistic?“

Dr. Singer: “When we say the private sector, we start by thinking about the small to medium enterprise sector in the developing world themselves. Take a concrete example of A to Z Textile Mills in Tanzania which is the largest manufacturer of the long-lasting insecticide treated malaria bednets in Africa. It’s a private company that makes 10 million nets a year and it employs 5500 people. If there was not only one, but 100 businesses like A to Z in various sub-sectors in Africa manufacturing products operating on a sustainable basis tackling health, we would be better off. We feel strongly that the private sector has a strong role to play, primarily those that are small to medium enterprises. You cannot deliver on scale products and services to four billion people in the developing world without the strong participation of the private sector.

Multinational corporations also have a role to play in fostering that sector. Having said that, one needs to look at how companies behave. The starting point has to be meeting the health needs. The issues of corporate responsibility are also very important. We have a book of case studies of bioscience companies that addresses ethics and some of the key things are reporting and maybe even auditing, both financially and socially. This is a very effective mechanism for large companies in seeing that the mission and vision around the ethics plays into their human resource policy for example. Without the strong participation of the private sector especially the small to medium enterprises in the developing world, it would be impossible to solve this conundrum of global health inequities.”

“How do you perceive ownership and patent laws within the context of private sector relationships?“

Dr. Daar: “This is inherently a hugely complex subject. Intellectual property (IP) regimes are not fixed in stone. To give you an example, we travel a lot and we come across this problem frequently:. a scientist has discovered something but he or she does not want to tell his or her lab colleagues because there is no patent existing in that country to protect its invention. As a result, that invention gets bottled up and fails to get disseminated; even he or she doesn’t benefit from it because there’s no patent. If you ask me who really needs the patent system to serve real needs, it’s more the developing than the developed world – the latter is already reaping the profits. In the early days, the US ignored European IP rights and broke the rules in order to build up its innovation system. You can’t get away with that today but you can legislate what suits you best, and you can work within the global system and you can be smart to get what you want out of it.

Countries have the opportunity and power to do what they want with IP. You can use IP to do three things at different levels of development. Firstly, you can use IP simply to create access to health goods. Secondly, you can use IP regimes to build scientific capacity, which is an intermediate step. Thirdly, when you do have the infrastructure, you can use IP regimes to serve the purpose of capturing the value of your research and development so you can get profit out of it. Developing countries need to be smart about what they want with IP, and they need to understand the flexibility built into it so they can legislate the way they want with it with certain minimum constraints when they sign on to the World Trade Organization.”

Dr. Singer: “In addition, India and China for instance have agreed and are implementing TRIPS (Trade-Related aspects of Intellectual Property Rights) heavily starting in 2006 which in the long term is good for global health because countries are taking local innovations seriously. The African countries have until 2016 because they are less developed; what they should be doing now is building their capacity so that when TRIPS comes in 2016 or possibly later in Africa, they are ready to take full advantage of it.”

“How are countries managing to engage and recruit domestic firms to the challenge of global health inequity?”

Dr. Singer: “There is a lot that Indian and Chinese companies are already contributing to global health. You’ve got the example of Shantha Biotechnics innovating in hepatitis B vaccines and making it more affordable. You’ve also got Shanghai United Cell Biotech that is one of the only two manufacturers in the world that makes oral cholera vaccines. As they develop early on, they almost only focus on their local markets. The challenge over time as local companies face the multination corporations is - how do you make sure they stay focused on global health instead of coming up with another blockbuster drug for hypertension that they want to sell in the US?
In terms of Africa, you’ve got only a few examples like A to Z which is the best one; there are only three or four others of real small to medium enterprises outside of South Africa that are innovating on global health problems. In a country like Tanzania, you’ve got good research and commercialization, but they are like parallel tracks on the railroad and they don’t meet. We were in a meeting in Dar es-Salaam, Tanzania and we met this person who stood up and started talking about his malaria research on insecticides and bednets for the past 25 years and his products are papers in other academic journals. At the same time, the people from A to Z stood up and talked about their bednets, which they obtained the license to produce from a large Japanese company called Sumitomo that provides the technology to improve the longevity of the bednets or otherwise, the insecticide is removed in the wash.

There is very little in invested life science venture capital in Africa outside of sub-Saharan Africa. There is tremendous wastage of the ideas - a young African scientist has to yet to attain the capacity to take an idea for a product, finance and develop and finally deliver it to the community. You can do it here but not there. Talent and bright ideas are world-wide. Why do you think large multinational corporations are scouring China and India for talents and not in Africa? It’s just being wasted or lost through brain drain. This needs to be addressed.”

“Speaking of which, what are your perspectives on the brain drain since there is a massive health care disparity between developed and developing world?”

Dr. Daar: “This is a very important question that illustrates the spectrum of issues that need to be addressed. Doctors and nurses trained in the developing world are leaving their own countries. In some countries, Ghana for example, half of the doctors are leaving to work in the West or in other countries in Africa. It’s a huge problem in those countries. The real question is whether this can be stopped and the answer till now is that it you cannot. People will find a way to leave. What do you do?

We did a study of diaspora populations working in three biotech clusters in Toronto, Montreal, and Vancouver that was subsequently published in Science. We were interested in how you can convert from brain drain to brain gain. What can those diaspora scientists and entrepreneurs contribute without going back to their countries of origin? They have managerial capacity, knowledge, networks, ability to invest, to go back and teach and take on graduate students here, etc without going back permanently to their countries if they don’t wish to. One thing we know for sure is that all the people we talked to in that study were very keen to help their countries back home but didn’t have the means to do so. There is no government policy in Canada or in other receiving countries to make it possible to help them help their original countries. We came up with a few policy recommendations in our article. At the moment we’ve just reached stage one, which is to recognize that there is a problem and there are potential creative solutions. There are also, of course, circumstances whereby people will return.”

Dr. Singer: “A good example of people returning to their home countries is the “sea turtles” in China (The term “sea turtle” in Chinese is a pun that refers to people who have returned to their home country). We have featured on our China paper in Nature Biotechnology Ge Li, a “sea turtle” who founded WuXi Pharma Tech in China which mainly does outsourcing of research and development. This shows that it is possible for people to return to their home countries.”

“Is it possible to establish real 50/50 partnerships with developing countries (i.e. North- South collaborations)? With so many of these countries still heavily indebted and reliant on donor funds, how are these “equal” collaborations facilitated? “

Dr. Singer: “That’s ideal, isn’t it? In theory it’s possible. Certainly in terms of the moral commitment, it’s mandatory. In terms of the actual science, it’s a matter of mutual respect among people and that’s what you strive for. There are inequities in scientific knowledge. This is part of the way to build capacity to make it more sustainable. The equal partnership is a great ideal and that’s what everyone should strive for. You build it in the programmatic initiatives, but you don’t want to use it as ideological hammer to hit people over the head with because then you won’t get the discoveries you need. What is at stake here is how you move from the lab to the village. The process of moving from lab to village has gone unconscionably slowly. The hepatitis B virus was discovered in the 70’s, the first vaccine was discovered in the 80’s but it wasn’t until the 90’s when Shantha made it affordable and even now, hepatitis B is a huge problem and there are lots of primary liver cancer. Why does it take so long from discovery to delivery? What kind of world is it when you can live to 80 but if you are born in the rural setting in some parts of Africa you get to live to half of that age? This is the mother of all ethical challenges and this is a very strong motivating force. The other point is that I’ve been so impressed with the motivation and engagement of young people who are really going to move this along. I’m hugely optimistic because you see all this attention and funding on global health especially on Africa and new products in the pipeline, it’s really a golden era for global health.

The issue is to translate that money, enthusiasm and attention into the discovery and development that are needed. We need to rethink foreign aid. There’s a strong role for humanitarian assistance but there’s also a strong role for making sure what you are doing has some chance of leading to a situation where the country you are helping won’t need your help in 20 years. Fifty years ago, the GDPs of Ghana and Korea were the same. Today, Ghana and Korea are totally different countries. This has to do with focusing on the use of science and technology knowledge in terms of creating products initially for local problems, then regional and global markets. You can not develop economically without that focus on domestic innovation.”

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