Japan’s healthcare economy has evolved immensely since WWII. In 1961, it established universal health insurance, it made huge advancements in the control and eradication of infectious diseases and, notably, it achieved the world’s highest life expectancy.

Most recently, Japanese firms have led research on plasma-based treatments for COVID-19. In the bridging studies I have led in the last two decades, there have been significant reductions in the time it has taken for a drug to reach market.
However, for all its successes, Japan faces the complications of an ageing population and low fertility rates, as well as the economic factors that affect health, such as increasing unemployment. Japan’s health system is seeing a corresponding rise in the conditions common to an ageing population, such as cardiac disease, autoimmune diseases, diabetes, osteoporosis and osteoarthritis.

Not only does this provide a set of challenges for the Japanese government and health system, but for pharmaceutical companies trying to develop new and increasingly personalised treatments.

Historically, Japan has struggled to recruit patients and conduct trials within its domestic population. This has partly been driven by the perceived lack of availability of potential volunteers, and the cost associated with this research.

As a solution to this, in 1998 Japan’s Pharmaceutical and Medical Devices Agency (PMDA) adopted the International Conference on Harmonisation (ICH) ‘Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data’.

These guidelines exist because, historically, some regions have had limited willingness to rely on foreign clinical data. Japan, with its own set of health challenges and demographics, may have been one such region.

Adopting these guidelines recognised procedures under which trial data gathered in one region could be used to fulfil regulatory requirements in another.

This change in approach started the drive towards studies involving Japanese subjects conducted outside Japan. Coupled with the acceptance by the PMDA in 2007 of clinical data from non-Japanese patients, medicines can now be brought to the Japanese market in both a cost and time-efficient manner.
Despite these developments, the PMDA still has strict criteria regarding clinical data generated from trials conducted outside Japan. A strong track record of adherence to these regulations and the ability to reliably source suitable participants are key considerations when Japanese pharmaceutical companies identify research partners.

I know from first-hand experience – having completed over 60 successful protocols involving Japanese subjects – how clinical research excellence in the UK provides significant benefit to Japan’s population and the economy. What is non-negotiable, however, when working on these trials is access to a considerable Japanese patient population.

Perhaps unsurprisingly, London is the most popular European city for Japanese residents to live in overseas and therefore gives a clear competitive advantage in this regard. In October 2019, 34,000 Japanese people were recorded living in the capital. This provides a considerable pool of patients for CROs operating in and around the city, especially as it constitutes more than half of the total Japanese population in the UK (approximately 65,000).

While not everyone in the UK of Japanese descent is eligible or wants to participate in research, the country has a very high share of its Japanese population participating in trials compared to trials in Japan and in the United States. Leading CROs have established dedicated Japanese patient recruitment and clinical teams in the capital to deliver these trials. With this in mind, the UK’s importance in the development of new chemical entities for release into the Japanese market should not be understated.

Similarly, bridging studies play a huge role in speeding up the approval times in Japan and other key markets. The ability of CROs to create and implement integrated protocols for these studies means that all the required data is captured to fulfil the requirements of the FDA, PMDA, MHRA and EMA. By continuing to deliver these protocols and maintaining close relationships with the MHRA, as a regulator facilitating this innovation through the MHRA Innovation Office, the UK research industry has an operational advantage with regards to Japanese pharmaceutical clients.

UK CROs have a unique set of resources and expertise that support pharmaceutical companies in meeting the needs of the Japanese population. These include access to an eligible Japanese patient population, an understanding of the regulatory requirements of the PMDA, the most advanced and efficient protocols, and global scientific networks that enable access to leading expertise. While they want studies that are tailored to a Japanese population, they also want trials to be delivered efficiently and clearly, by organisations with transparent relationships with their regulators. The MHRA meets the standards of the EMA, PDMA and FDA, but it also encourages innovation through its openness, advice and support services for partners. This role has increased since Brexit and can be critical in delivering the fastest and most effective trials.

With this all said, the UK should work to ensure that its collaboration with Japan on scientific research and innovation continues in the years ahead, by finding new ways to stay connected with our colleagues in Japan through the latest communications technologies, and by promoting the UK’s life sciences environment during a period when face-to-face contact is limited.

Moreover, we should look internally to continue finding ways to deliver the most streamlined and efficient trials for Japanese clients. The Association for the British Pharmaceutical Industry (ABPI) has made recommendations to the UK Government, including increased investment for the NIHR, HRA and MHRA, better utilising the NHS’s vast healthcare data and patient connections, and ensuring that the UK attracts and develops the skills needed to compete globally. Lastly, to international audiences, we need to continue to highlight the leading work of the MHRA to adapt its regulation to encourage innovation post-Brexit.

Jorg Taubel is CEO of Richmond Pharmacology