On December 22, 2021, on the first anniversary of the establishment of the Peking University Institute for Global Health and Development (PKU-iGHD), the “2021 Peking University Global Health and Development Forum: Human Health and Medical Innovation in the Era of Low Carbon Economy”was successfully held. Dr. XU Ming, Advisor to the Global Fund to Fight AIDS, Tuberculosis and Malaria, delivered a keynote speech at the session of Medical Innovation for Sustainable Development.

Today I would share some of my observations regarding how Chinese companies may do in this particular area. I'm very much honored to compare notes and exchange views with senior professors, scholars from across the health community today.

As you know that sustainable Development Goals(SDG) is very clear. International development tries to aim at improving the life of individuals, particularly in the low and middle income countries. With areas such as health, it is desirable for the people there to be equipped, to live more equitable lives and enjoy easier access to those basic commodities, especially essential drugs and medical services. So this is actually the goal stipulated by SDG.

When talking about the commodity supply for international development programs, I have to say that, to fight the major infectious disease like AIDS, TB, malaria, and COVID-19, actually has become a top priority for many countries, particularly those in lower and middle income countries. let's take malaria as an example. Just because of COVID-19 pandemic, the test last year actually increased because there was less care for the vulnerable population, especially in Africa. If you look at the deaths, more than 70% of this deaths happened last year among children under five years old. So this is actually a very challenging situation we are facing today. When we talk about the special market for the public procurement, especially the market for development assistance.

I just try to give you a clear picture by diseases and also by donors. This is a very special market. I just want to walk you through very briefly. As I just mentioned earlier that, the market of the development assistance is focused primarily on the major infectious diseases, as well as reproductive products. Malaria, TB, HIV, maternal/newborn, those are the major areas the development assistant market are looking at.

There are some major donors to the development assistant programs like UNICEF, the Global Fund, WHO and other UN agencies. Each foundation, of course, is clearly a bigger contributor to those international development programs as well. Before COVID-19 pandemic, the size of the development systems for health was just about 35 billion to $40 billion a year，with an average annual growth rate of roughly 1%.

But just because of the COVID-19 pandemic, the market expanded dramatically, particularly in the past two years. Here's the snapshot of those health focus area. Prevention, diagnosis, treatment, vaccine, nutrition, family planning, actually are the program areas for this particular market. Before the COVID-19 pandemic, over $10 billion in Development Assistance for Health（DAH） is of interest for manufacturers across the world.  Now, actually the picture has totally changed, much bigger than that before the pandemic.

Very quickly, and I'll just talk about the Access to COVID-19 Tool Accelerator (ACT-A) Initiative. ACT-A was launched in April 2020 by WHO and other UN agencies. There are three pillars of ACT-A, vaccine partnership, therapeutic partnership, and diagnostic partnership.

For the vaccine partnership, Gavi, UNICEF and WHO actually are the co-conveners. For therapeutic partnership, UNIPAID, Global Fund actually are responsible for developing the new treatments as well as the deployment of new therapeutics, especially in the lower and middle income countries. For the diagnostic partnership, Global Fund actually is playing a crucial role, especially in the deployment of those badly needed RVDs for those risky countries. FIND and WHO are providing support to this particular pillar.

World Bank and Global Fund are also responsible for the health system connector. Because there’s a cross cutting issue those organizations have to address. So there's what is called health system connector under this particular umbrella. They are in the priorities, so I think we're conscious of time, we do not want to elaborate on this. Let's take vaccine for example. For vaccine, WHO made it very clear that to ensure equitable access, and a fair allocation is the priority. To ensure deliberate scale, and also accelerate the further development, the safe applications in the program optimized vaccine to address new risks.

Well, when we talk about the commodity supply for the companies, you have to get your products registered. For ACT-A, there is a special procedure, EUL (Emergency Use Listing) on the part of WHO approval procedure.

The EUL procedure involves care for a rigorous assessment of all quality, safety and advocacy data to enable early targeted use of yet to be licensed to vaccines, treatments or diagnostics, in order to respond to what is called public health emergency of international concern. So there are three phases for EUL, preparedness phase, emergency phase and post-listing phase.

So what is the nature, the essence of EUL, and how is the EUL procedure different from pre-qualification? Because as you know, prequalification is the precondition for a certain product to be purchased by those UN and international agencies. The procedure of EUL is intended to provide a time limited listing for unlicensed products in an emergency context. When limited data are available and products are not yet to be approved for prequalification. As part of the EUL, the expectation is that the manufacturer will complete the development of the product and submit for licensure and WHO prequalification. Here's a short description of those categories of medicines for WHO prequalification. You know that the primary categories of medicines are those products related to HIV/AIDS, malaria, TB, and also to reproductive health, influenza, and acute diarrhea, neglected tropical diseases, et cetera.

In addition to that, those APIs for making formulations of these products are also required to apply for WHO prequalification.

This slide shows the prequalified china made products. So far, there have been 33 Chinese manufacturers, which have already got the prequalification from WHO, with 55 active pharmaceutical ingredients. In terms of vaccines, there are four Chinese manufacturers with seven vaccines prequalified, including JE vaccine, influenza vaccine, polio vaccine, HPV vaccine.

HPV vaccine was just approved several months ago by WHO. There are also some IVDs and the vector control products like the bad nets. For the EUL approval, there are 10 China made PCR tests and 2 vaccines endorsed by WHO under this particular procedure. Global Fund and UNICEF actually are the major purchases of those WHO prequalified products, including those products approved under EUL procedure.

Let's take the Global Fund for example. Before the COVID-19 pandemic, Global Fund purchased roughly $1.7 billion worth of products every year. China, actually, is a very important supplier of those essential drugs to the Global Fund. The Chinese companies ranked 5th among all the suppliers of those essential drugs.

Lastly, I just want to bring your attention to some initiatives and arrangements launched or promoted by the UN agencies to facilitate access to those essential medicines in middle income countries. Maybe you have known that the other day Pfizer has just signed licensing agreement with MPP. What is MPP? MPP is what is called Medicine Patent Pool.

This is a special arrangement backed by UNAID in Geneva. The MPP aims to enable affordable production of essential drugs still under patent protection by obtaining volunteering licenses from the patent holders, and making these licenses available to generic companies in lower and middle income countries. These companies can only sell these products in the developing countries.

You are not allowed to sell without permission in your own country. So this is actually a very special feature of this arrangement. So far MPP has signed agreements with 10 patent holders for 13 HIV antiretroviral, 1 HIV technology platform, 3 hepatitis C direct acting antivirals, and 1 TB therapeutic.

Another arrangement launched by Gavi is called IPTK Bank( Intellectual Property Technology, and Knowhow Bank). This is a special initiative launched by Gavi to enable early market entry of multiple developing country vaccine manufacturers to facilitate rapid enrollment and sustainable pricing of new vaccines in developing countries.

Another initiative very interesting to the Chinese companies called the Product Development Partnership, such as Medicines for Malaria Venture, MMV. This is a public private partnership to encourage pharmaceutical companies to develop innovative drugs to treat malaria. Some other arrangements, I think also might be interest to you, is called, differential or tiered pricing, for example.

In order to attract more companies to produce the generic drugs, tiered pricing has been used a lot, especially in the low and middle countries to improve the excess of those essential drugs, particularly in an emergency context. So I think this is high time, and first to think about how to work together, to galvanize more Chinese companies into providing quality assured and affordable commodities. Especially for those development assistant programs internationally.