Tuberculosis and malaria are two of the world’s most pervasive yet neglected diseases. Together, both affect one-third of the world’s population: three out of seven people globally are infected or at risk for malaria or TB, and one in seven are actually infected.
Although deaths caused by malaria and TB worldwide have considerably decreased, and each nearly halved in the past two decades according to the World Health Organization, mortality cases remain concentrated in mostly low-income countries, and funding for research and development to treat and cure the diseases is slow and unsteady. TB especially continues to present new challenges, as multi-drug resistant TB is now on the rise.
Pharmaceutical companies alone cannot invest the hundreds of millions of dollars in research and development for malaria, TB and other neglected diseases, since they cannot expect to see a quick return on the investment, says B.T. Slingsby, the executive director of the Global Health Innovation and Technology Fund.
The public or civil sector could fund the research, but they too cannot do it without support, lacking the “know-how of the private sector,” Slingsby explained during an exclusive interview with Devex.
The Tokyo-based GHIT Fund — a consortium of the government of Japan, five Japanese pharmaceutical companies and the Bill & Melinda Gates Foundation — is now exploring new territory in the field of public-private partnerships.
Below are more highlights from our conversation with Slingsby about what needs to be done on R&D to continue fighting malaria and TB, and why this PPP fund — the first of its kind — could help put these overlooked diseases back on the map:
How do you plan to bring in a range of pharmaceutical companies to invest in malaria and tuberculosis, with the knowledge that it might not have a monetary return?
Well, if you look at the growth strategies over many of these pharmaceutical companies over the next 10 years, a common focus is on the developing world. Many of these companies have been prominent in the United States, Europe and Japan, but not so much in the developing world. So, if you compare the Japanese pharmaceutical partners to Pfizer or to Merck, they are not as well known in the developing world and don’t have as robust operations there. In order to create networks and to become responsible as a corporation and to contribute to societies in the developing world, you have to be engaged in global health R&D.
Are you only looking to markets in emerging countries that show economic growth, or would you be willing to invest in a place where you see less progress and more political or social turmoil?
If you look at the burden of these diseases, it actually increases with conflict. What we invest in is the development of a new product. That product, once developed, needs to be accessible to the endemic populations that have that disease. Our funding strategy is not influenced by whether that disease is in a potentially profitable or emerging country or not. How we create our funding strategy is by considering: In order to eliminate and treat these diseases, what are the necessary tools that aren't out there yet? That’s the first filter. The second filter is looking at the global pipeline for these diseases. What are the holes in the pipeline, where can we actually provide added value in terms of new products?
What is your funding strategy to help make all of the treatment and drugs accessible?
We would like all of our products to be priced at a no-gains, no-loss policy. That means sustainability is the key. You can't just donate a product because that creates a risk that the company goes into the red or would not be able to donate anymore. So the most sustainable solution to actually providing these products to price it basically at a cost where you are not creating a profit, but you are not losing money. It’s sustainable. And with sustainability you are increasing the volume, and with that you are decreasing the cost. The price goes down and down with an increase of volume. That’s the general principle going forward with these products.
What is it about this model that makes it different from other public-private partnerships?
It is a true PPP, from which you have not only a one time commitment, but all of our private partners and public partners are on our council. However, our private sector partners are not involved with the management or selection of grants — they are removed from the selection or decision making, but they are on our council, meaning that they are committed to our fund. They are not just donating. This has never been done before — to have such a commitment from the get-go, in terms of working together and making this actually successful.
If someone wanted to replicate this model, what advice would you give? Do you always need the same ingredients, like participation of a government?
You always need the support of the government. It goes back to the funding. The private sector cannot do this alone. It would be inexplicable to shareholders to solely invest in the development of these products when you cannot attain return on investment, so in order to be responsible to one’s shareholders, the government has to step in and participate in the funding.
What challenges have you had to overcome and do you now foresee moving forward?
One challenge at the get-go was looking at the potential conflicts of interests of private sector. How we addressed that was through a structure of governance that ensured that potential conflicts of interests were addressed, and those on our board, and on our management team and selection committee had no affiliation with any of those companies. So you are looking at the selection, the review, the monitoring and the reporting of all grants to see that there is no relationship with any of those partners. We have created a very thick line between the funding and the actual distribution of grants. That was a challenge, but we overcame that with a robust government structure. Challenges going forward are likely to be that we want to expand this fund. A key to getting a product out there is creating a robust pipeline, and in order to create such a pipeline you need more partnerships and thus more funding. All in all, to increase the likelihood of multiple products, you have to increase the size of the fund. A challenge here is not a problem but an opportunity and a goal to expand the fund in terms of its size.
Malaria and TB have both been on the radar for the United Nations and organizations like the GAVI Alliance and the Global Fund for years now. What has made it so difficult to really combat them effectively?
If you look at the drugs, the therapies that are being used to treat these diseases, many are decades old. They have resistance. If you look at TB therapy, about 10 percent of patients out there show resistance. You are also looking at a regiment of therapy that is difficult. It is not just a five-day course. It’s a multi-week course, and this is not only with TB but also with other disease therapies as well.
There’s always the difficult question of delivery, the question of access. The product may not always be there. Then there is adoption. So, the patient or the population may not want to use it. It is either a lack of education, or it tastes bad, or it makes you sick. In some cases it is difficult to afford it even if it is there and you want to take it. So these are the three points: adoption, availability, affordability — which ultimately lead to access.
What we’re trying to do is improve the current therapies out there or to create new therapies or vaccines, and by doing that actually makes it easier to access those therapies and thus it would be easier to eliminate those diseases. If you look at cancer, there are multiple drugs that are produced every year. If you look at diabetes, there are multiple drugs, cholesterol, again, even male baldness. But if you look at these diseases, many of them have not had new drugs or therapies for decades.
Is it just a lack of funding?
Yes, it is. And a lack of these partnerships. The U.N. can't do it alone, governments can’t do it alone, and the reason why the private sector can’t do it alone is that the return on that investment is difficult. A company is not going to do it by itself because it is not a sustainable investment for that company.
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