China has an ambition to strengthen its innovative pharmaceutical industry and improve access to innovative treatments for its population. It has already taken steps towards achieving this such as implementing reforms to accelerate regulatory approvals for innovative medicines.
While these reforms are necessary measures, protecting and incentivising innovation, including the data generated through clinical trials, is key to supporting both the industry growth and access to new medicines to the benefit of patients. If innovation is not protected, companies will lack sufficient incentives to invest in bringing innovative medicines to patients. This limits the growth potential of the industry and may leave patients without much-needed treatments.
Today in China, innovative medicines face competition from generics and biosimilars swiftly after their approval, on average after 4 years. This does not allow companies sufficient time to recoup their investments, thus reducing incentives to invest in bringing innovative medicines to the market.
In this context, implementing Regulatory Data Protection (RDP), protecting the data generated through clinical trials and submitted for regulatory approval, will be key for the development of a successful innovative pharmaceutical industry and to support access to medicines in China.
We estimate that introducing RDP would increase the availability of innovative medicines in China by up to 66% as China would become a more attractive place for companies to launch their innovative medicines. As a result, China could also experience an increase in the number of clinical trials by up to 90%.
To build on the benefits of RDP, additional measures should be considered to support patient access to innovative medicines and the industry’s growth. In particular, a predictable and science based regulatory system, a value-based pricing and reimbursement system, and a strong system of protection of innovation are necessary.
A successful pharmaceutical industry would make a significant contribution to the Chinese economy, both in terms of GDP and jobs supported. The industry’s contribution to GDP could grow from 100 bn USD to 124 bn USD. This growth will support a whole ecosystem of suppliers and partners adding another 167 bn USD to the Chinese economy effectively driving a total of 563 bn USD of GDP. This can sustain almost 25.8 million local jobs.
Drawing from our previous research, in this report, we describe the benefits of implementing RDP in China for society, industry and the Chinese economy.
The study is commissioned by PhRMA.
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