Pharmaceutical Research and Manufacturers of America (PhRMA)

China’s leadership has shown commitment to strengthening biopharmaceutical innovation and ensuring Chinese patients have greater access to innovative medicines. These objectives are an integral part of China’s 14th Five-year Plan and Long-Range Objectives for 2035, Healthy China 2030 Blueprint and a wide range of related legislative and regulatory reforms. These policies emphasize innovation as a central tenet and aim to ensure that China is an important part of the global biopharmaceutical industry.

China has made important strides reforming its regulatory system and has nearly eliminated the medicine registration application backlog, allowing for greater patient access to medicines. China has also made great progress strengthening its health care system and providing Basic Medical Insurance (BMI) to its vast population, thereby increasing the availability of innovative medicines. China has also improved intellectual property (IP) protections for medicines and to develop a system that more closely aligns with international norms. While these policy reforms represent progress, continued improvements are needed if China is to realize the vision of Healthy China 2030. For example, only 23 percent of new medicines launched globally in the past decade are available to patients in China, and among these roughly a third are not included in the National Reimbursement Drug List (NRDL).

The global innovative biopharmaceutical industry seeks to build upon the progress that has been achieved to date in creating a growing and vibrant biopharmaceutical sector in China. Further advancing biopharmaceutical sector development and patient access in China will depend on an ecosystem that promotes innovation. A successful biopharmaceutical innovation ecosystem is comprised of three core components that are closely related and equally necessary for growth and sustainability:

1) The Regulatory System: The regulatory system should establish and consistently apply clear, science-based, and neutral rules to assess the safety, efficacy and quality of products, from preclinical and clinical development to post-market surveillance and risk management. Such features will enable the regulatory system to produce consistent and predictable approval decisions within reasonable timeframes, and allow for simultaneous global development. China can further streamline its regulatory approval processes by continuing to adopt harmonized guidelines and removing China-specific requirements when possible.

2) The Intellectual Property System: A robust IP system drives biopharmaceutical innovation by providing the necessary incentives to invest substantial capital and other resources needed to research, develop and launch innovative medicines. To bring valuable new medicines to patients, biopharmaceutical innovators must be able to effectively secure and enforce patents, receive regulatory data protection (“RDP”) for clinical information demonstrating the safety and efficacy of a medicine for marketing approval, and protect trade secrets and confidential commercial information. We recommend that China continue to vigorously advance IP reforms so that innovators will have the predictability and certainty that they need to collaborate with partners, compete successfully and accelerate the launch of new medicines.

3) The Pricing and Reimbursement System: The pricing and reimbursement system should reflect the holistic value that innovative medicines provide to patients and society and enable companies to continue to invest in the next generation of treatments and cures. China can enhance access to innovative medicines by adopting a more timely, transparent, predictable and evidence-based NRDL adjustment mechanism that meaningfully engages stakeholders. We also support China’s efforts to strengthen supplemental commercial health insurance (CHI) as part of a multi-layer medical security system that improves access and reduces out-of-pocket costs for Chinese patients.

PhRMA and its members are committed to partnering with the Chinese government and other stakeholders to strengthen the biopharmaceutical innovation ecosystem in China and improve patient access to new medicines.

Download the full report：Delivering for Chinese Patients: Strengthening Patient Access to Biopharmaceutical Innovation