Hong Kong provides some of the best and most efficient healthcare in Asia, with Hong Kongers living to over 85 on average (compared to 83 in Singapore and 78 in mainland China), and the World Health Organisation ranks the city among the top 20 healthcare systems globally. However, unlike many comparator territories, Hong Kong has managed to achieve this without its own independent regulatory body for medicines; instead running a ‘secondary review’ system whereby two approvals from regulators in other geographies count towards a local approval.
The current system has not had a negative impact on the functioning of healthcare in the city, but stakeholders in government, industry, and academia are increasingly making the case for the establishment of an independent local regulatory body. In line with Hong Kong’s ambitions to become a life science innovation hub, there are hopes that a ‘Hong Kong FDA’ with oversight for the introduction and vetoing of the latest advancements in medical technology would attract more pharmaceutical firms to carry out research in the city. Research projects, including clinical trials, tends to occur close to where a regulator (such as the US FDA or EMA in Europe) is based, notes Lo Chung-mau, Hong Kong’s secretary of health.
A Hong Kong regulator could also help strengthen China’s Greater Bay Area (GBA) initiative which encourages increased integration of the two ‘Special Administrative Regions’ of Hong Kong and Macau with Guangdong Province in the south of mainland China. Hong Kong-registered products are not generally cleared for use on the mainland as it stands, but the establishment of a city regulator could help shift the dial and allow more cutting-edge innovations to make it into the GBA. Already, 23 Hong Kong-registered drugs and 13 medical devices have been permitted for use in 19 mainland institutions as part of a pilot scheme launched in 2021.
Establishing a primary review system may not have been a primary focus of previous Hong Kong governments, but the perspective is now shifting
Henry Yau, HKU-CTC
Lo feels that the current system is “relatively passive” and does not provide enough incentives to attract pharma companies to carry out R&D developments in Hong Kong. “If [a pharmaceutical product] is approved as long as it has obtained registrations from the United States or Europe, it doesn’t have to carry out R&D in the city,” he states, noting the close links between research and approvals.
Those involved in Hong Kong’s burgeoning clinical research sector also see the benefit of a Hong Kong regulator. As Henry Yau, managing director of the Hong Kong University (HKU) Clinical Trials Centre in Hong Kong and CEO of the Centre’s mainland China arm, outlines, “Establishing a primary review system may not have been a primary focus of previous Hong Kong governments, but the perspective is now shifting.”
He continues, “In order to position Hong Kong as a technological hub, especially in the field of biomedical development, we must strengthen our regulatory system. Having the competence to review and approve drug marketing applications is vital to attracting more research and investment in the long run. It will enhance our appeal to global companies and researchers looking for a reliable and efficient regulatory environment, and Hong Kong will be able to boost its capabilities further and contribute significantly to the growth of the biomedical research landscape in the region.”
Representatives from multinational pharma, such as Lawrence Wong of Swiss reproductive health firm Ferring, are also aligned on this project. Wong asserts that the development of a unique system for drug registration in Hong Kong is “a strategic imperative.” He adds that “this will, in turn, foster a more comprehensive ecosystem, and attract more clinical research to take place here.”
Professor Lo Yuk Lam, the man commonly regarded to be ‘the father of Hong Kong biotechnology’, feels that a local regulator will be crucial to building more biotech start-up success stories in the territory, in line with the latest governmental strategies. “There seems to be a lack of willingness to understand the legal and compliance parts of biotechnology,” bemoans Professor Lo.
We need a strong independent regulator with a one-country, two-way system framework that takes China into consideration
LO Yuk Lam, HK Bio-Med Innotech Association
“If you look at similar smaller markets like Singapore, they have a system in which new drug discovery R&D being performed there has a pathway to achieving independent regulatory approval. Biotechnology companies will not conduct R&D here if it is not internationally recognised, so we must reach the relevant international levels so we can compete with other markets in attracting investment within biotechnology start-ups and global R&D for large companies.”
Professor Lo points out that a regulatory body which meets international standards and draws on Hong Kong’s close ties to mainland China could prove massively beneficial for the city’s biotech scene. “The authorities want a regulatory body equivalent to the US, Japan, and Europe, so why not include approval for China also and act as the gateway jurisdiction?” he asks. “We are meeting the international standard in clinical trials, so why can we not do it for investigational new drug applications (INDs) in biotechnology? If you want to put in place the next steps of the chain like manufacturing, you first must build a strong foundation. We need a strong independent regulator with a one-country, two-way system framework that takes China into consideration.”
There seems to be broad consensus on the benefits of creating a Hong Kong regulator and some clear steps forward have been proposed, including joining the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), a global organisation that brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug developments and registration. However, creating an FDA of Hong Kong’s own will not happen overnight and, as Derek Chang of Novartis warns, “it could be some time before this becomes a reality.” Secretary of Health Lo, agrees, adding that “joining the ICH is not the only key to attracting more R&D activities to Hong Kong … We will press ahead in the right direction.”
