On September 29, the Access to New Drug Policy Sharing Forum (herein after referred to as “the Forum”) of 2020 China BioMed Innovation and Investment Conference (2020 CBIIC) was successfully held. The Forum was moderated by Feng Lan, Secretary-General of China Pharmaceutical Innovation and Research Development Association (PhIRDA), and experts, scholars and entrepreneurs from fields of healthcare, pharmaceutical policy making, pharmaceutical management and clinical pharmacy attended the forum. Participants had a fruitful discussion on drug approval, dynamic adjustment mechanism of National Drug Reimbursement List (NDRL) and hospital access of innovative drugs. Keynote speeches and panels around innovative drugs’ access strategy gave thoughts to the pharmaceutical innovators and investors on better understanding the pharmaceutical innovation policy and future direction for investment and R&D.

Moderator: Ms. Feng Lan, Secretary-General of PhIRDA

Mr. Yang Sheng, Deputy Director-General of Department of Drug Registration of NMPA made a speech on the Achievement of China’s Drug Evaluation System Reform in the Past Five Years and Future Trend. He pointed out that the reform of drug review and approval system in the past five years has achieved a good start, which lied on the better security of drug accessibility, prioritized approval of innovative drugs and improved drug affordability. From the achievement we can see that 267 categories of drugs passed bioequivalence evaluation, MAH’s pilot project optimized the supply-side structural reform, registration and review system in line with international standards and facilitate the transition of ICH guidelines, review capability significantly improved and gradually established clinical-oriented review system and legalized the reform measures. 
Deputy Director-General Yang Sheng pointed out that future priorities will be advanced as follow: First, to adhere to the principles of science, transparency and efficiency, and continuously improve the review and approval system. Continue to reform and improve clinical trial management, build a review team based on separate indications, optimize and accelerate market approval procedures, improve review mechanisms to strengthen service awareness, fully promote the consistency evaluation of generic drugs and improve process-oriented scientific management. Second, to reform and improve the vaccine management system. Promote the improvement of vaccine standards, encourage innovative vaccine R&D and strengthen vaccine quality and safety life cycle management. Third, to promote the inheritance and innovative development of Traditional Chinese Medicine. NMPA will issue 9 guidelines including Technical Guidelines for the R&D of Quality Standards for New Traditional Chinese Medicines, 3 of those guidelines will solicit public opinion. Fourth, to improve the construction of the system of laws and regulations, accelerate the formulation of supporting documents that have been issued, and further consolidate the effectiveness of the reforms. Other aspects include drug development and registration management.
Deputy Director-General Yang Sheng stated that the next step of NMPA will be deepening the medical reform, facilitating the high-quality development of pharmaceutical industry, strengthening the capability development, accelerating the market review and approval, gradually facilitating the implementation of bioequivalence evaluation and innovation of Traditional Chinese Medicines and solving the historical problems carried over from the past.

Mr. Yang Sheng, Deputy Director-General of Department of Drug Registration of NMPA

He Ruyi, CMO of RemeGen, CMO of SDIC, Former Chief Scientist of Center for Drug Evaluation of CFDA, moderated the panel on Scientific Supervision Promote China's Pharmaceutical Innovation. Deputy Director-General Yang Sheng, Prof. Song Ruilin, Executive President of PhIRDA, Ms. Shao Rong, Vice Executive Director of the Research Center of National Drug Policy & Ecosystem of China Pharmaceutical University and Mr. Feng Yi, Vice President for R&D and Chief Strategy Officer of Sichuan Kelun Pharmaceutical participated in the panel and had a fruitful discussion on facilitating the China’s pharmaceutical innovation. The panelists, representing the researcher, regulator, facilitator and participants in scientific regulation process, shared distinctive views from the perspectives of policy makers, scholars and entrepreneurs etc.

The participants believed that in the past years, major breakthroughs have been made in the legislation of drug regulatory policies and regulations, as well as the construction of the regulatory system. Risks in the innovation process need to be undertaken and solved by multiple parties. The reform on innovative drugs is clinically centered. The dialogue between supervision and innovators itself is a learning process. Risks must be identified and controlled together. It is hoped that such a system will develop in a sustainable manner. It is necessary for the regulatory agencies and enterprises to jointly build a new system, and fully consider the fairness, enforceability, verifiability and sustainability of the policies formulation and introduction processes. For drug regulatory authority, it is fundamental to do the work well in drug quality supervision. Service innovation is also of great significance to the development of the industry, those works help to provide more opportunities for better innovative products in China and will eventually benefit the public.

As one of the hot topics focused by the industry, Regulations of Implementing the Mechanism of Solving the Pharmaceutical Patent Disputes at Early Stage (Trial Version, Draft for Comment) was discussed a lot. The mechanism is still under construction, for instance, there are 3 categories in the NRDL core patent registration process, namely TCM, chemical drugs and biologics. While pilot should be conducted in chemical drug sector about whether the NMPA should make approval after receiving judges from the court. The panelists agreed that the mechanism should be designed and conducted smoothly in chemical drug sector, then we can start to consider the further plans. 

Panel: Scientific Supervision Promote China’s Pharmaceutical Innovation

Mr. Fan Changsheng, Secretary General of Beijing Medical and Health Economic Research Association made a keynote speech entitled “Research on the Evaluation of Medical Insurance Negotiation Access under the Background of Pharmaceutical Innovation”. He stated that at present, breakthrough technologies are leading the research and development direction of innovative drugs, which have multiple values to patients, health systems and society. Specifically, innovative drugs create great clinical value and bring clinical benefits to patients, also it significantly reduce redundant medical expenditures and indirect expenditures related to diseases, and relieve the financial burden on patients and the society. The biopharmaceutical industry has also created employment opportunities and socioeconomic value.

As for exploring and optimizing the formation mechanism of value evaluation and payment standards in China's medical insurance negotiations, he stated that we need to establish and optimize the mechanism of dynamic adjustment of NRDL, explore a more transparent and scientific negotiation and evaluation method for medical insurance access process, specify the value frame and evaluation standards of purchase decision of medical insurance to develop the HTA that suits China’s medial security system and healthcare system and technical standards that fits PE evaluation and put forward improvement project based on the existing payment standard in the current national medical insurance negotiations.

Based on the principle of “evidence-based decision, value oriented, respect innovation”, can we better establish the value-oriented payment evaluation standards. First, the medical insurance negotiation should be value oriented and innovation should be respected, the negotiation results should reflect multidimensional value of drugs, which can be evaluated from dimensions of clinical, patients, innovation and society. Second, comprehensively consider the various price affecting factors when evaluating the negotiated price to avoid selecting products only for its lowest price. Providing a higher payment standard to innovative products, relative to the older products. Third, for exclusive products, price maintenance during contract renewal negotiations should be allowed to maintain a stable payment standard for products.

Mr. Fan Changsheng, Secretary General of Beijing Medical and Health Economic Research Association

Mr, Mao Zongfu, Director of Global Health Research Center of Wuhan University, moderated the panel on Discussion on Optimizing Dynamic Access of Medical Insurance for Innovative Drugs. Mr. Hu Shanlian, Professor of Health Economics of School of Public Health of Fudan University, Ms. Zhao Kun, Director of Division of Health Policy Evaluation and Technology Assessment of the National Health Development Research Center, Mr. Liu Junshuai, Committee Member of National Expert Consultation Committee of Diagnosis and Treatment of Rare Disease, Mr. Xia Sujian, Director of the Medical Statistics Teaching and Researching Section of Jinan University of Basic Medicine and Mr. Zhao Zhigang, Director of Department of Pharmacy of Beijing Tiantan Hospital participated in the panel. The panelists discussed two optimized updates of the NRDL in the past two years. They believed that a transparent, scientific and faire standards for evaluation standard should be well established with the joint effort of the experts in all aspects, as well as on policy level.

As for the dynamic adjustment of NRDL, experts believed that the approach of dynamic adjustment is correct, it is available for all the innovative enterprises in the industry. Continuous innovation brings challenges to the products in NRDL, which will also facilitate the development of companies. However, there may also be fake innovations that is wasting resources of regulatory agencies such as review and approval, medical security and other government departments. Therefore, it is essential to balance whether the innovation should be evaluated. As for the terms of payment, it is worth to considering how to embody the incentive mechanism of payment.

Panel: Discussion on Optimizing Dynamic Access of Medical Insurance for Innovative Drugs

Mr. Chen Hao, Director of Drug Policy and Management Research Center of Tongji Medical College of Huazhong University of Science and Technology, made a keynote speech on the Access Dilemma of Innovative Drugs in Hospital and Protection of Patients' Rights and Interests. The access of innovative drugs in hospital depends on three factors: drugs, healthcare and medical insurance. Those factors should be taken deep consideration as a whole rather than separating drugs based on lifecycle.

At present, the difficulties faced by the hospital access of innovative drugs include restrictions on product categories, price, medical insurance coverage and accessibility. In addition, lack of non-medical insurance affordability, professional service, education and other systematic function insufficiency also exert an influence. How will those problems be solved? Director Chen Hao pointed out that we should keep advancing the policies that facilitating the accessibility of innovative drugs both by basic and commercial medical insurance, optimizing the comprehensive environment of hospital access of innovative drugs, improving hospitals’ scientific cognition to innovative drugs and service ability, innovating the terms of payment, establishing the innovative drugs cost-sharing system with multiple payment methods, optimizing the access process, stimulating and restriction of innovative drugs in hospital and facilitating rational drugs use.

He added that we understand difficulties of finishing the last step of the whole process, however, we need to finish that patiently. Access of innovative drugs in hospital should by co-established and co-administered based on the management of full lifecycle. The final goal is to establish the ecosystem for the common interest for the all-round facilitation.

Mr. Chen Hao, Director of Drug Policy and Management Research Center of Tongji Medical College, Huazhong University of Science and Technology

Mr. Hu Xin, Director of Department of Pharmacy of Beijing Hospital, moderated the panel on Difficulties and Challenges in Procurement and Clinical Use of Innovative Drugs in Medical Institutions. Mr. Leng Jiahua, Director of Department of Medical Insurance of Peking University Cancer Hospital and Institute, Ms. Wang Xiaoling, Director of Department of Pharmacy of Beijing Children's Hospital, Capital Medical University, Ms. Feng Wanyu, Chief of Pharmacy of Peking University People’s Hospital, Mr. Zhu Jiangguo, Director of Pharmaceutical Department of The First Affiliated Hospital of Soochow University and Ms. Lynn Fan, Senior Director of Public Affairs Department of Jiangsu Hengrui Medicine participated in the panel. According to Jiangsu Hengrui’s data, by August, 2020, after Apatinib entering the NRDL, its drug access rate of national top 500 hospitals reached 53% and the temporary purchasing rate is 70%. As an oncology drug, Apatinib is more commonly used in Grade A Class 3 hospitals and comprehensive hospitals. In 2019, Pyrotinib entered into the medical insurance negotiation and marketed after finishing the phase II clinical trial. Before entering the NRDL, its hospital access rate only reached 12%, after entering, the access rate in top 500 hospitals reached 29.3%. For innovative drugs, entering the NRDL means better access in the hospitals.

The panelists agreed to conduct full consideration on the NRDL access of innovative drugs. The first need to be considered is the situation of innovative drugs, which should be cleared to be only a part of the medical security. The public health could be well protected only after the development of the whole public health industry. The second is the data. Real-world data should be used to influence the policy of medical insurance payment. The last is to improve the culture and level of hospital management to let the patients feel the sense of gain and warm. Medical institutions should consider patients’ actual demands and solve their problems in getting the medical services and drugs. China’s innovative drugs must speed up in data access to bring more benefit to the public.

Panel: Difficulties and Challenges in Procurement and Clinical Use of Innovative Drugs in Medical Institutions

Under the great support of all parties, CBIIC is gradually becoming an international, authoritative, diversified communication platform to interpret policies on drug and financing and investment circle, present pharmaceutical innovative achievements at home and abroad, lead new investment trends. Through CBIIC, can social capital playing a leading role in the development of pharmaceutical innovation, create a more scientific and attractive investment environment and contribute to China's economic and social development to meet the clinical needs and advance the pursuit of Healthy China.

Access to New Drug Policy Sharing Forum

Access to New Drug Policy Sharing Forum