What hurdles need to be overcome for domestic pharmaceutical innovation
Economic Daily · China Economic Net reporter Wu Jiajia
Statistics show that my country's pharmaceutical market will reach 1.75 trillion yuan in 2020.
As the pharmaceutical market continues to grow, pharmaceutical innovations continue to emerge, and private capital has accelerated into the field of pharmaceutical innovation.
However, it is worth noting that problems such as repeated research and development of homogeneity and insufficient integration of limited resources frequently occur, resulting in ineffective development and waste of investment.
Therefore, my country’s pharmaceutical innovation sector urgently needs to accelerate reforms. While improving the innovation environment, it is necessary to further strengthen the protection of intellectual property rights and stimulate the innovation vitality of enterprises.
In recent years, benefiting from the support of various national policies and measures, China's pharmaceutical industry, especially the biomedical industry, has a good momentum of innovation, and private capital has accelerated into the field of pharmaceutical innovation.
Data shows that from 2014 to 2018, my country's pharmaceutical market has grown at an annualized growth rate of 8.1%, from 1.1 trillion yuan to 1.5 trillion yuan, and will reach 1.75 trillion yuan in 2020.
Compared with Europe and Japan, my country's pharmaceutical innovation still lags behind and faces many difficulties.
How can patients have innovative drugs available?
How to create a good innovation environment?
How to strengthen technical protection?
In response to these focal topics of public opinion, the Economic Daily reporter interviewed relevant experts and scholars.
Continue to support innovation
To allow the people to use innovative drugs, it is necessary to strengthen local innovation and to attract foreign innovative drugs to be launched in China.
Shao Rong, executive deputy director of the National Center for Drug Policy and Pharmaceutical Industry Economic Research of China Pharmaceutical University, said at the symposium on "Improving the Access to Innovative Drugs and Building a Healthy China" hosted by the People’s Political Consultative Conference Daily Innovating and attracting the first release of innovative drugs in China are inseparable from the coordination and incentives of policies such as review and approval, pricing, payment, and procurement.
Wu Ming, assistant director of Peking University Medical Department, said that the current policy environment is conducive to medical innovation.
On the one hand, the purchase price of pharmaceutical consumables has been significantly reduced, and the space for medical insurance funds has been released to a certain extent. A certain proportion can be used to include those innovative drugs with very high clinical value and high demand; on the other hand, generic drugs have entered a small profit. In the era of high sales, if companies pursue higher profits, they must carry out pharmaceutical innovation.
At the same time, Wu Ming also stated that it is necessary to further improve the innovation environment, guide and encourage relevant enterprises to carry out pharmaceutical innovation activities, and enable enterprises to maintain their innovation momentum.
For example, in medical insurance negotiations, it is necessary to consider giving innovative drugs enough room for return.
Hou Yanning, the former dean of Bethune International Peace Hospital, suggested that a mechanism for evaluating the value of domestically-made innovative drugs should be established, and innovative drugs should be refined and classified.
In terms of medical insurance access for innovative drugs, a refined management model has been introduced to evaluate in terms of minimum cost, cost-effectiveness, cost-effectiveness, and degree of utility.
At the same time, it is necessary to implement a more scientific and refined classification of new drug creation, pricing evaluation, and selection of types of drugs included in medical insurance.
Li Zhen, a professor at the School of Public Administration of Renmin University of China, suggested that the top-level design of my country's total health expenditure should be further strengthened, the stock of medical insurance funds should be revitalized, and the utilization rate of medical insurance funds should be improved.
At the same time, accelerate the development of mutual insurance, expand the increment of medical insurance, and effectively support medical innovation.
Not engage in vicious competition
"At present, most of the innovative drugs entering clinical research in my country are follow-up innovative drugs with known targets and lead compounds abroad, and the repeated research and development of homogeneity has led to the phenomenon of'multiple, small, scattered'." Deputy Hospital of Henan Cancer Hospital Changhua Yawei said that to solve related problems, it is necessary to further improve financial subsidies and support policies, accelerate the pace of clinical application of new drugs, and continue to encourage priority review and approval of drug innovation.
At the same time, it is necessary to establish a diversified R&D capital investment mechanism and further improve the financial service model.
In addition, we must continue to strengthen the training of local talent teams, and support the cooperation between enterprises, medical institutions, and universities to cultivate internationally competitive brands.
Song Ruilin, a special expert from the CPPCC National People’s Political Consultative Conference and Executive Chairman of the China Pharmaceutical Innovation Promotion Association, emphasized that pharmaceutical innovation needs to accelerate the integration of “production, education and research”, with enterprises as the main body and clinical as the value orientation, and establishing a multi-party co-payment mechanism; in commercial insurance There must be a breakthrough, based on the division of rights and responsibilities of social security, through commercial insurance, corporate profits and medical insurance payments, to promote the innovative development of medicine in many ways.
"Relying on government investment for innovation is not feasible. How to get social capital into the field of pharmaceutical innovation is an urgent problem to be solved."
Currently, anticancer drugs have become an important area of innovation.
Zhi Xiuyi, deputy director of the Central Medical and Health Work Committee of the Peasants and Workers Party and director of the Lung Cancer Diagnosis and Treatment Center of Capital Medical University, said that my country currently lacks a top-level design for drug innovation in the oncology field. Whether it is foreign companies entering the Chinese market or increasing their investment, there is no general Planning.
Zhi Xiuyi suggested that the top-level design of new drug research and development should be strengthened, and the whole process management should be implemented from the access of innovative drugs, pre-market policy support, and post-market market management, and strengthen resource integration to promote the sound development of the industry.
Gu Jianwen, director of the Special Medical Center of the Strategic Support Force, said that currently my country’s drug innovation is facing three major problems. First, there are few original innovations and insufficient integration of limited resources; the second is the lack of clinical research institutions and the level of unevenness; the third is the influx of hot money into new drugs Research and development, but in the absence of scientific evaluation, repeated investment is frequent.
"We must further strengthen resource integration and overall planning, improve the accuracy of investment in innovative drugs, and focus on the input-output ratio. At the same time, we must improve the supporting policies for medical innovation as soon as possible to encourage clinicians to join the medical innovation team." Gu Jianwen said.
Strengthen technical protection
“At present, the domestic policy environment is changing rapidly, which has brought great uncertainty to the market. It is difficult for companies to adjust the layout of R&D pipelines quickly, resulting in ineffective development and waste of investment.” Shanghai Junshi Biomedical Technology Co., Ltd. Manager Li Ning said that based on clinical drug demand and drug market structure, a mechanism should be established to closely match drug review and approval with drug demand.
On the one hand, while further accelerating the access of clinically urgently needed innovative drugs, products with high market saturation should be appropriately controlled to avoid capital waste and overcapacity; on the other hand, after the review and listing, value evaluation should be the basis. Expedite the entry of medical insurance reimbursement to benefit patients.
In addition, in the review of the medical insurance catalogue, the product payment standards should be set reasonably, and the protection of the sustainability of innovation and the price impact of domestic independent innovation in the competition of foreign pharmaceutical markets should be fully considered.
Luo Yongzhang, director of the National Engineering Laboratory of Anti-tumor Protein Drugs, proposed that legislation should be passed to further improve drug registration and management laws and regulations involving the protection of key core technologies, and increase penalties for leaks of key core technologies. The legal form clearly reveals that key core technologies are subject to heavy criminal responsibility.
In addition, Yue Bingfei, a researcher at the China Food and Drug Control Research Institute, believes that the construction of digital system engineering should be strengthened, and the production, registration, inspection and other related digital paths of the innovative pharmaceutical industry should be formulated; digital standards for the pharmaceutical innovation industry should be established, and related issues such as intellectual property protection should be paid attention to; Blockchain technology implements the traceability and supervision of the entire industry chain; breaks the situation of information islands, shares relevant clinical data of the pharmaceutical innovation industry, and enhances the innovation capability of the pharmaceutical industry.