With the upcoming “two sessions” of the National People’s Congress in 2022, a number of deputies to the National People’s Congress from the pharmaceutical industry have prepared a number of suggestions aimed at offering suggestions and suggestions for some pain points in the development of the pharmaceutical industry.
In recent years, with the reform of medical review and approval system, the innovation enthusiasm of China Meheco Group Co.Ltd(600056) industry has been ignited, and pharmaceutical enterprises have successively invested in the research and development of innovative drugs. However, many enterprises are clustered in the research and development of anti-tumor drugs, and few people pay attention to some drugs urgently needed in clinic, one of which is orphan drugs. Internationally, drugs used to treat rare diseases are called “orphan drugs”.
Ding liming, deputy to the National People’s Congress and chairman of Betta Pharmaceuticals Co.Ltd(300558) ( Betta Pharmaceuticals Co.Ltd(300558) . SZ), told China business news that he would submit a proposal on Further Encouraging and supporting the research and development of orphan drugs.
Ding lieming said that at present, the shortage of orphan drugs has become a major global public health problem, mainly due to two major obstacles in the research and development of orphan drugs: first, the cost of drug research and development is high, while the number of patients with a single rare disease is small, the income after listing is not enough to recover the research and development cost, and the willingness of enterprises to research and develop is not strong; Second, due to the small number of patients, it is difficult to recruit clinical subjects. Therefore, it is difficult for enterprises to rely on the policy driven mechanism to further increase the R & D cost and reduce the expected rate of success.
Therefore, Ding lieming put forward several suggestions. First, strengthen the overall planning of the diagnosis and treatment of rare diseases at the national level, expand and dynamically adjust the catalogue of rare diseases based on the epidemiological data of the rare disease registration system, and establish the qualification identification procedure of orphan drugs.
Second, it is suggested to increase the incentive and support for the research and development of orphan drugs. Refer to the practice of the United States, and reward the pharmaceutical enterprises that have obtained the marketing license of orphan drugs for children with unrestricted use of priority evaluation vouchers. The priority evaluation vouchers are anonymous and tradable, and can be used for the evaluation of various disease treatment drugs, which will greatly stimulate the enthusiasm of pharmaceutical enterprises; In the application of national scientific research projects, it is suggested to give policy preference to orphan drug R & D projects, increase the support of scientific research funds for orphan drug R & D projects, and give enterprise tax relief at 50% of the R & D expenses of orphan drugs; Third, it is suggested to grant orphan drugs market monopoly protection, and give orphan drugs approved for listing a certain period of market monopoly, during which the listing of the same variety with the same indications is not approved.
Li Yan, deputy to the National People’s Congress and President of Qilu Pharmaceutical Group, said that China’s drug regulatory system has continuously deepened the reform of drug regulatory system and gradually established a scientific regulatory system in line with international standards. The number of new drugs applying for clinical trials has increased significantly every year, the number of innovative drugs on the market has reached a record high, and the ability of enterprises to carry out international cooperation has been continuously enhanced. However, it is undeniable that, China Meheco Group Co.Ltd(600056) the concentration of manufacturing industry is still low, the task of upgrading product structure is urgent, the innovation ability, especially the original innovation ability, is insufficient, and there are few high-quality innovation achievements. It is still in the stage of following and catching up with the United States and other advanced countries.
Therefore, she suggested that we should further optimize the integration mechanism of industry, University and research, accelerate the transformation of basic research achievements and help original innovation.
In terms of original innovation, colleges and universities are the key participants. However, there is a reality that the success rate of cooperation between colleges and universities’ original innovation projects and enterprises is low in China. Therefore, Li Yan suggested to strengthen the cooperation concept and mechanism of CO creation and sharing, incorporate the transformation of achievements into the conditions for the new round of Professional Title Recognition and evaluation of colleges and universities, appropriately delegate the right to use, dispose of and benefit from scientific and technological achievements of colleges and universities and scientific research institutes to the head of the research team, and the head of the research team has the right to speak and participate in the opinions on the transformation and cooperation of scientific and technological achievements, Break the current situation that the decision-making power of project cooperation is only in the transformation of achievements in Colleges and universities.
At the end of last year, the guidance on medical insurance supporting the inheritance, innovation and development of traditional Chinese medicine jointly issued by the State Medical Security Bureau and the State Administration of traditional Chinese medicine is boosting the development of the whole traditional Chinese medicine industry.
Geng Funeng, deputy to the National People’s Congress and chairman of good doctor Pharmaceutical Group, said that the development of traditional Chinese medicine, especially the traditional Chinese medicine industry, still faces great pressure and challenges. According to statistics, the main business income of the traditional Chinese medicine industry has continued to decline since 2017, with a decline of more than 30%. In the pharmaceutical industry, the overall proportion of traditional Chinese medicine industry has also decreased from 29% to 22%, which is directly due to the adjustment of national medical insurance payment policy and strict control.
\u3000\u3000 “From the overall and long-term perspective, it is imperative to implement centralized procurement of traditional Chinese medicine and DRG and dip payment. The national medical insurance bureau and local medical insurance competent departments have made adjustments and support to traditional Chinese medicine as much as possible. However, under the payment conditions of DRG and dip, if the key bottleneck of giving full play to the clinical advantages of traditional Chinese patent medicine in the treatment of diseases can not be solved, traditional Chinese patent medicine continues to be squeezed out of the clinical use of general hospitals Risk, the role of Chinese patent medicine in the clinical treatment of advantageous diseases will not be brought into play. ” Geng Funeng suggested that while strengthening the construction of advantageous specialties of traditional Chinese medicine, we should strengthen the research on the treatment of advantageous diseases with proprietary Chinese medicine. At the same time, the research on health economics of traditional Chinese medicine is complementary and reference with the current research on pharmacoeconomics.
