R&D AND INNOVATION
Pursuing innovation-driven development is a core strategy in China's 13th Five-year Plan, and the bio-pharma industry is one of the pillars of China's innovation-driven strategy. Bio-pharma innovation not only provides a long-term growth engine for the economy but also is a fundamental requirement for improving people's well-being. The reform of drug review and approval system in China conducted in the past several years brings a serious of policy measures, including optimizing review system, improving review capability and efficiency, enhancing global harmonization, etc. to promote and encourage bio-pharma innovation, so as to improve marketed drug quality.
We are aiming to be a valued partner to the Chinese government, with cooperation with member companies to support on regulatory departments, to promote industry-academia communication and collaboration, to encourage collaboration of various parties in early R&D for a promoted clinical study capability establishment. We are willing to support China to establish an international, scientific, transparent and predictable regulatory framework system, unleash China's innovation potential and accelerate the launch of innovative drugs in China, improving the accessibility of innovative drugs and benefit patients around the word in a global innovation system.
DRUG QUALITY AND SAFETY
In order to thoroughly implement the purpose of “guaranteeing the quality of drugs, safeguarding the safety and legal rights of the public, and protecting and promoting public health” in the Drug Administration Law, RDPAC is willing to work with member companies which are drug quality management benchmarks in the industry, to share the advanced experiences of drug manufacture management, full life cycle quality management system, actively provide suggestions on related regulations and policies, support post-marketing drug surveillance regulation under MAH, and committed to provide patients high quality, safe and effective drugs.
PATIENT ACCESS
As the bridge between government and industry, by promoting the communication and cooperation between enterprises and government as well as carrying out academic research based on international advanced experience and local practice, we have provided suggestions for health reform priorities such as drug value assessment, drug procurement and supply, and payment reform. We will work together with member companies and all walks of life to support the government build a high-quality, multi-level and sustainable universal health care system, so that everyone in China can "use and afford" good innovative drugs in their earliest needs.
A sound and sustainable pricing and reimbursement (P&R) policy framework that facilitates access to innovative medicines will improve people's well-being, foster a drug innovation ecosystem, and achieve the ultimate goal of Healthy China 2030, according to the Report.
RDPAC, jointly with industry partners to design a comprehensive pricing and reimbursement policy framework for innovative medicines. These policies would promote a healthier China by achieving the following objectives:
• Improve patient access to innovative and quality medicines and reduce financial burden on patients;
• Optimize allocation and use of medical resources by focusing on patient needs and rewarding value; and
• Develop a sustainable ecosystem for continuous pharmaceutical innovation and enhanced national competitiveness.
Download Report Improving Patient Access to InnovaIPR PROTECTION
Improving innovative drug intellectual property rights protection not only provides China's innovative pharmaceutical industry development, it also secures the patients’ access to innovative drugs. As innovative drug R&D is characterized by significant investment, high risk, and long cycle length, protection of intellectual property rights is the foundation of the innovation industry and plays a key role in ensuring the sustainable development of the pharmaceuticals industry. It is suggested to enhance four key areas (patent application, data protection, patent linkage system, and patent term extension system) to fully leverage intellectual property rights protection as a stimulant for drug innovation.
ETHICAL BUSINESS PRACTICES
Since 2013, RDPAC has been committed to promote the Pharmaceutical Enterprises Ethical Business Practice jointly with industry associations. As of 2015, 17 industry associations signed Petition for the Implementation of Pharmaceutical Enterprise Ethical Business Practice, which requires pharmaceutical practitioners to adhere to six principles, including healthcare and patient focus, integrity, independence, legitimate intent, transparency and accountability, also the other items. The principles also advocate for government to shore up their approach to system reform, law-based administration, praising virtue and punishing vice, as well as to purify the market for the better development of a normative market, and work together toward a robust healthcare industry environment.
In 2018, 25 local associations and foundations in pharmaceutical and medical device sectors, and healthcare professionals’ associations signed the Chinese Consensus Framework for the Ethical Collaboration in the Pharmaceutical and Medical Device Sectors jointly. It was the first time that the participating organizations had been extended to hospitals’ industry organizations with the coverage of pharmaceutical industry associations from various provinces and municipalities. It also indicated a formal and wide association among pharmaceutical and medical device companies, and healthcare professionals under the Framework, to regulate and embrace high standards of ethical practices, strengthen interactions among pharmaceutical and medical device enterprises of production and sales and their industry associations, healthcare professionals, and government agencies in order to advance public healthcare.
In 2018, 25 local associations and foundations in pharmaceutical and medical device sectors, and healthcare professionals’ associations signed the Chinese Consensus Framework for the Ethical Collaboration in the Pharmaceutical and Medical Device Sectors jointly. It was the first time that the participating organizations had been extended to hospitals’ industry organizations with the coverage of pharmaceutical industry associations from various provinces and municipalities. It also indicated a formal and wide association among pharmaceutical and medical device companies, and healthcare professionals under the Framework, to regulate and embrace high standards of ethical practices, strengthen interactions among pharmaceutical and medical device enterprises of production and sales and their industry associations, healthcare professionals, and government agencies in order to advance public healthcare.
