Bill Gates and Melinda Gates

Former Microsoft CEO Bill Gates and his wife Melinda are arguably two of the most visible philanthropists in the world, operating under the mantra that “we are impatient optimists working to reduce inequity.”

In June, the Bill & Melinda Gates Foundation set their sites on reducing inequities in China’s drug evaluation and approval system. In an unprecedented move, Foundation Co-Chair Bill Gates and China Food and Drug Administration (CFDA) Minister Bi Jingquan signed a Memorandum of Understanding on Strategic Cooperation between the People’s Republic of China CFDA and the Gates Foundation.

The two sides pledged to cooperate on efforts to improve China’s drug supervision capability and drug technical standards, and establish mechanisms for introducing international high-end talent of drug supervision and fostering internationalized supervision talents. Efforts will include creating a drug supervision think tank to support reform of China’s drug evaluation and approval systems.

So why do Bill Gates and the Gates Foundation want to join the CFDA’s efforts to improve regulatory processes and ultimately pharmaceutical manufacturing in China?

Comments made by Christopher Elias, president of the Gates Foundation’s Global Development Program, reveal the answer. On the Foundation’s website, he states, “Fragmented, slow, and understaffed regulatory systems introduce years of delay in terms of getting products approved … When manufacturers face unpredictability, they integrate that unpredictability into the price of their products. Market shaping can reduce that uncertainty, and therefore reduce the costs of products, and greatly increase their (drugs) accessibility.”

China is in the throes of overhauling its healthcare system. While they have succeeded in lifting 600 million citizens out of poverty, their current healthcare system – including the pharmaceutical industry – is broken. In most developed countries, pharmaceuticals account for less than 10% of total healthcare cost (the US is 16-18%). In China, drugs account for 40% of the country’s healthcare spend. Lowering drug costs is a top priority as is increasing access among China’s 1.4 billion citizens to the latest innovative pharmaceuticals.

The CFDA plans to double the number of its reviewer staff, which will expand China’s new Fast Track Drug Approval pathway for innovative drugs. The Gates Foundation’s support will aid the CFDA in reforming their historically slow record for CTA/IND (clinical trial application/investigational new drug) trial approvals and drug marketing authorization reviews and approvals by helping them achieve optimized and global regulatory review standards. We expect that the CFDA will look to the US FDA and EU EMA for experienced talent, which will be challenging given government salary differentials between the West and China. Support from the Gates Foundation may help at this transitional phase.

Long term, the CFDA plans to “grow their own talent” internally by taking advantage of global, regional and Overviewdomestic educations and training opportunities. As more develop and seek regulatory oversight of increasingly innovative drugs, often, injectable, hands on understanding of their manufacture will be important for CFDA reviewers. Locally in China, the Trans-Pacific Aseptic Institute of Training (TPA-IT)™ , a sterile university established by PaizaBio in Hangzhou, representing an $8 million investment, is Asia’s most comprehensive technical

TPA-IT: Trans-Pacific Aseptic Institute of Training
TPA-IT: Trans-Pacific Aseptic Institute of Training

training program dedicated to aseptic manufacturing. Employing a combination of lecture and hands-on learning, TPA-IT teaches the theory and principles of aseptic processing, sterile manufacturing, quality management, regulatory compliance, and more. TPA-IT™ welcomes executives and frontline workers from drug companies as well as regulatory bodies like the CFDA.

As the Gates Foundation seeks ways to “up the game” of the CFDA, we encourage them to include in-country resources like the Trans-Pacific Aseptic Institute of Training that possess the intellectual and physical resources and ease of access to accelerate the expertise and capabilities of the CFDA.