Ding lieming of Beida Pharmaceutical Co., Ltd.: it is suggested to compensate for the patent period of patent innovative drugs first listed in China

On March 3, the first financial reporter learned that Ding liming, deputy to the National People's Congress and chairman of Beida Pharmaceutical (300558 SZ), brought 8 suggestions to the two sessions, of which 3 focused on support for domestic innovative drugs Under the guidance and support of national policies, great progress has been made in the research and development of innovative drugs in China, and a number of innovative drugs independently researched and developed, such as exetane, sidabanide, apatinib, and cindilimab, have been successively published Among them, etinib hydrochloride of Beida pharmaceutical is the first small molecule targeted anticancer drug independently developed by Chinese local enterprises However, after the domestic innovative drugs come into the market, they are faced with many market access problems To some extent, the R & D returns of domestic innovative pharmaceutical enterprises are not as good as those of developed countries Therefore, Ding Liming proposed to implement patent period compensation for the first time in China Ding liming, chairman of Beida Pharmaceutical Co., Ltd., pointed out that China's R & D of innovative drugs needs more patent period compensation system on October 8, 2017 Along with the launch of the deepening reform of the review and approval system for pharmaceutical medical devices, China clearly proposed to carry out the pilot of the patent period compensation system for drugs, which opened the door for the implementation of the patent period compensation system in China Then, on December 23, 2018, the amendment (Draft) to the patent law of the people's Republic of China (hereinafter referred to as "the draft") was submitted to the seventh session of the Standing Committee of the 13th National People's Congress for deliberation It is proposed in the draft that, in order to compensate for the time occupied by the examination and approval of the listing of innovative drugs, the State Council may decide to extend the period of patent right for innovative drugs that are simultaneously applied for listing in China and abroad, which shall not exceed five years, and the total effective patent right period after the listing of innovative drugs shall not exceed fourteen years Ding Liming said that the implementation of patent compensation system for drugs stems from the particularity of drugs themselves, that is, the transformation of drug patent technology into products must be subject to the approval of legal clinical trials and regulatory authorities, and its patent period is partially occupied because of the legal provisions Throughout the world, all the pharmaceutical innovation powers take the patent compensation system as a magic weapon to encourage pharmaceutical innovation Compared with foreign enterprises, the research and development of innovative drugs in China need more patent compensation system In Ding's view, the reason is that, on the one hand, due to the particularity of the bidding, purchase and use policies of drugs in China, it will take a longer time for innovative drugs in China to obtain higher profits For example, the average remaining patent period after compensation is 13.2 years after the U.S patent drugs are listed, while the average remaining patent period after approval of domestic class 1 new drugs is only 8 years On the other hand, our country is lack of experience and ability in innovative drug research, clinical trials, application and approval, which takes longer time to develop According to Ding liming, according to the principle of "who occupies who compensates", the compensation period for patent period should be determined based on the time taken for conducting clinical trials or administrative examination and approval in China in accordance with Chinese laws, with strict geographical restrictions Both Chinese and foreign applicants, as long as they carry out clinical trials in China and apply for listing approval in accordance with the law, can be compensated for the patent period Ding Liming believes that the current draft proposes to compensate for the patent period of "innovative drugs applying for listing simultaneously in China and abroad" Because the application for listing is not always approved and the time for listing approval is also different due to the difference of declaration quality, the administrative compensation is in an uncertain state; moreover, there is no legal basis for taking domestic and foreign synchronous application for listing as the premise of application for compensation, in reality, "synchronous" declaration is not equal to "simultaneous" approval "Such regulations make the patent compensation period actually incalculable, which also means that new drugs that only conduct clinical trials and apply for listing in China will not be able to apply for patent compensation, which will damage the interests of domestic enterprises and institutions that focus on research and development of drugs more suitable for the treatment of patients with diseases in China, and will not be conducive to the improvement of innovation ability and international competitiveness of Chinese pharmaceutical enterprises." Ding Liming thought that Tao Therefore, Ding lieming proposed to make clear in the patent law that the compensation period for the patent innovative drugs listed for the first time in China should be no longer than 5 years; the State Council is authorized to formulate the measures for the administration of the compensation for the patent period of drugs, and the scope of compensation, application conditions, calculation methods of the period, application procedures and materials, and the scope of patent protection within the compensation period should be specified It is suggested that priority should be given to domestic innovative drugs with volume procurement starting this month, and the centralized procurement of drugs in 11 national pilot cities will be launched continuously Prior to that, on December 6, 2018, the centralized procurement in 11 cities had been negotiated Finally, 25 of the 31 pilot generic drugs are to be selected through centralized procurement Compared with the lowest purchase price of the same kind of drugs in the pilot cities in 2017, the average price of the proposed medium-sized drugs will be reduced by 52%, and the maximum price will be reduced by 96% The effect of price reduction is obvious The purpose of the state's centralized procurement is to enable the people to use higher quality drugs at a relatively low price Ding Liming said that while the level of independent drug innovation in China is improving, it is also faced with many problems, especially after the product is put on the market, due to the difficulty of market access, it is difficult to apply it on a large scale nationwide Therefore, he suggested that in the national drug centralized procurement, we should strengthen the support for independent innovative drugs, establish a linkage mechanism between the national drug centralized procurement and the national medical insurance negotiation, and give priority to the inclusion of domestic innovative drugs in the procurement, especially the domestic innovative drugs that have passed the national drug price negotiation and entered the national medical insurance catalogue, and purchase at the medical insurance negotiation price, and fully High or high proportion of reimbursement, promote domestic innovative drugs to benefit Chinese patients as soon as possible Ding Liming also said that the "4 + 7" centralized procurement pilot adopted the exclusive bid winning method In the investigation, it was also learned that the bid winning of a single variety has reduced the market expectation of many enterprises that are carrying out or are about to carry out the conformity evaluation of generic drugs, which has a certain impact on their enthusiasm to promote the conformity evaluation Therefore, it is suggested to further optimize the national centralized procurement system, determine the reasonable bid price through competitive bidding, and adopt the mode of multi variety bid winning In addition to the support for domestic innovative drugs after being put on the market, Ding also proposed to strengthen and optimize the approval process of human genetic resources on the R & D side As a pre approval item of clinical research, administrative approval of human genetic resources is of great significance for accelerating the research and development of innovative drugs According to Ding liming, the current approval scope of genetic resources is set according to the requirements of the company's shareholder composition, which causes local pharmaceutical enterprises with foreign capital background in the shareholder composition, as well as Chinese pharmaceutical enterprises listed in Hong Kong, when submitting for approval of clinical trials, regardless of whether the project has participated in international cooperation or whether there is export of genetic resources, it must be put forward to the genetic office Apply Ding Liming said that this regulation has a great impact on the progress of clinical trials carried out by local pharmaceutical enterprises, which is not conducive to the construction of new drug research and development and local pharmaceutical innovation ecosystem of Chinese enterprises Therefore, he also suggested that the export of genetic resources should be taken as the prerequisite for approval.