Leveraging Lessons Learned
Building an innovation ecosystem for a healthier, more secure future
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Since the onset of the Covid-19 pandemic, the biopharmaceutical industry has come together in unprecedented ways to attack the virus, and we have achieved incredible progress in just two years. Working across the global healthcare ecosystem, biopharmaceutical companies, academia, and the public sector have harnessed decades of investment, research, and past discovery to deliver safe and effective vaccines and treatments to patients. As a result, the industry was able to develop vaccines in just 12 to 18 months, and almost 11 billion doses have been administered worldwide.
To put this success in perspective, it typically takes eight to 10 years to develop a vaccine, and the overall success rate is only 5 to 10 percent.
But our work is far from over. Today, there are more than 1,700 clinical trials underway globally for treatments and vaccines to combat the virus. Across the industry, companies are continuing clinical research to assess whether modifications or boosters are warranted, and to identify further treatments. We also continue to scale up production facilities and manufacturing capacity, while working collaboratively on manufacturing to increase the supply of vaccines and treatments.
Enhance the Innovation Ecosystem
As the pandemic continues, we must build on lessons learned and prepare for challenges ahead. This begins with strengthening the innovation ecosystem that led to the discovery and development of Covid-19 vaccines and treatments, and ensuring that the healthcare system is more resilient in the future.
Given the Japanese government’s desire to be better prepared for future healthcare challenges, enhance domestic biopharmaceutical research and development (R&D), and promote economic growth, now is the time for Japan to take concrete steps to enhance its innovation ecosystem. This will help the government achieve its important domestic goals, including safeguarding patients’ early access to innovative medicines and treatments as well as ensuring that Japan remains a world leader in advancing public health.
Regulatory and reimbursement policies that incentivize innovation are needed to develop an innovation ecosystem that expands R&D and drives economic growth in Japan. However, in recent years, the policy environment in Japan has become increasingly difficult for the biopharmaceutical industry.
Since 2015, more than 50 new drug pricing rules have been introduced, and we are starting to see the results of these policies that disincentivize investment and undermine early access to innovative medicines. For example:
- Between 2015 and 2020, biopharmaceutical industry R&D investment grew 33 percent on average globally, while in Japan it declined 9 percent
- The number of medicines in clinical trials in Japan grew 8 percent annually between 2009 and 2016. However, following the implementation of harmful policy changes, growth in clinical trial activity has fallen to 3 percent annually
- In 2016, 51 percent of global new medicines from the prior five years were available in Japan, but by 2020 had declined to 43 percent
Strengthen US–Japan Collaboration
It is clear that the Covid-19 pandemic has provoked some important reflection in Japan on the policy environment for innovative medicines, and there is growing recognition of the need for Japan to improve its innovation ecosystem.
The government must ensure greater transparency in both its healthcare policy decision-making and its application of new policies. More focused bilateral engagement could help achieve progress in these areas. A US–Japan healthcare dialogue under mechanisms such as the Competitiveness and Resilience Partnership or Economic Policy Consultative Committee could help ensure that both countries remain global leaders in driving innovation in the life sciences and promoting global health security.
Having joined the Pharmaceutical Research and Manufacturers of America in January as the new Japan representative, I am honored to speak on behalf of the biopharmaceutical industry at this critical time. I look forward to working with the ACCJ and policymakers in Japan and the United States to advance strong economic and health ties between our countries, and to ensuring that Japanese patients continue to have early access to lifesaving and life-enhancing medicines.
