The Japan Pharmaceutical Manufacturers Association (JPMA) is collaborating with the government to help domestic pharmaceutical companies expand into Asian emerging markets.
IHS Life Sciences perspective | |
Significance | The Japan Pharmaceutical Manufacturers Association (JPMA) is collaborating with the government to help domestic pharmaceutical companies expand into Asian emerging markets. |
Implications | Key focus areas include mainland China, regulatory harmonisation within Asia, and HTA in developed markets. |
Outlook | This type of private-public partnership as reflected by the JPMA's collaboration with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is expected to increase, given the greater role played by cost-effectiveness considerations in increasingly complicated drug review processes and companies' soaring R&D costs. |
The Japan Pharmaceutical Manufacturers Association (JPMA) is collaborating with the government to help domestic pharmaceutical companies expand into Asian emerging markets, according to Pharma Japan. Haruhiko Hirate, the chairman of the JPMA's International Affairs Committee, said the strategy involves the following steps:
- Working out strategies to facilitate pharmaceutical firms' overseas operations and prioritise action plans.
- Sharing these strategies with Japanese regulators and liaising with overseas governments and trade groups to improve the business environment in local markets.
Focus on China market, concerns persist
According to an internal survey, the mainland Chinese market remains a key focus for JPMA member companies, nearly all of which export there or have locally based operations. The JPMA's role in this regard includes collecting information on local business conditions and policy initiatives in China, sending public-private delegations to mainland China, promoting dialogue between the Japanese and Chinese governments, and formulating policy proposals to the Chinese government. This role is targeted in particular at medium-sized drug makers, which lack access generally to overseas information.
A major concern among the JPMA's members is the need for faster regulatory review for drugs in China. According to Hirate, the China Food and Drug Administration (CFDA)'s recent moves to reform its drug review process – including sharply increasing review fees, boosting CFDA staff – reflect the Pharmaceuticals and Medical Devices Agency (PMDA)'s earlier moves to shorten its own review time. Prior to its reform, the PMDA had fewer than 200 reviewers, a figure that was raised to nearly 800, alongside higher drug review fees.
Push for regulatory harmonisation within Asia
The JPMA is also campaigning for increased regulatory harmonisation within Asia, with the ultimate goal of having PMDA-approved drugs eligible to obtain automatic marketing approval in other Asian countries. An example of this is Malaysia's recognition of the Japanese pharmacopoeia earlier this year.
Focus on HTA in developed markets
Another key focus of the JPMA is health technology assessment (HTA) in developed markets and facilitating Japanese drug makers in dealing with cost-effectiveness-related information. However, at home, the JPMA has opposed the introduction of HTA, arguing that the current NHI drug pricing rules already include the assessments of drug value.
Outlook and implications
The campaigning activities of the JPMA, whose members include international and domestic pharma heavyweights such as AstraZeneca (UK), Takeda (Japan), and Eli Lilly (US), reflects the ongoing shifts in the Japanese and Asian drug regulatory environment. In particular, the promotion of pharmaceutical innovation in Japan has become an increasingly prominent national policy over the last decade, resulting in the country becoming the first to reimburse PD-1 inhibitor Opdivo (nivolumab) in September 2014, and a burgeoning regenerative medicine sector (see Japan: 2 September 2014: Japan approves 22 APIs as it becomes first country to reimburse Opdivo).
Furthermore, the type of private-public partnership reflected by the JPMA's collaboration with the PMDA is expected to increase in future, as cost-effectiveness considerations play a greater role in increasingly complicated regulatory reviews, in addition to companies' soaring R&D costs. The JPMA's efforts also come as Japan's share of the global drug market declines, from 20% around 20 years earlier to around 8% currently, according to the source.
The JPMA outreach efforts to other drug regulatory authorities in Asia's emerging markets is likely to help smooth market access for its Japanese companies, particularly if the overseas markets adopt policies modelled on those in Japan, for which domestic companies would already hold the relevant data for marketing approval applications. In turn, emerging markets in Asia, such as Vietnam and Indonesia, are also expected to benefit from information sharing with the JPMA as their drug approval systems continue to evolve.