The state encourages innovation, why should it vigorously develop generic drugs?

Why do doctors and ordinary people have little confidence in domestic generic drugs? Shi Luwen, a professor at the School of Pharmacy of Peking University, was commissioned by relevant departments in 2014 to do some projects. Research shows that China's generic drug companies have been excessively competitive for a long time and repeated production at a low level, resulting in uneven drug quality and affecting public confidence.

Therefore, this "opinion" proposes to establish an inter-departmental information sharing mechanism, formulate and regularly publish the list of drugs to encourage imitation, formulate the list of drugs to encourage imitation, take the demand as the orientation, strengthen the technical research of generic drugs, and include some key common technology research in the relevant national science and technology plans; We will strengthen technological research on generic drugs, and guide enterprises to develop, register and produce high-quality generic drugs that are in short supply.

Fu Hongpeng said: "Mainly to encourage five categories of drugs, one is clinically necessary, effective but in short supply of varieties, the other is children's drugs, infectious disease drugs, and public health emergencies, and the last is the patent is about to expire within a year, there is still no enterprise to apply for imitation of this drug, the focus is to guide the development of such drugs."

To make people have confidence in generic drugs, the key is to improve the quality and efficacy of generic drugs. The development history of China's pharmaceutical industry is relatively short, and the regulatory approval of drugs has a gradual process. Foreign generic drugs are approved according to the same standards as the quality and efficacy of the original drug, and China only began to implement this work in 2015. This time, in the "Opinions" again emphasized that it is necessary to accelerate the evaluation of the quality and efficacy of generic drugs.

How do we understand this consistency? Domestic gefitinib is the first batch of products that passed the consistency evaluation announced by the country in December 2017, and it has three similarities compared with the original drug.

Zheng Xiaoqing, assistant director of the pharmaceutical preparation Institute of a pharmaceutical enterprise group, said: "The first consistency is that the prescription process is completely consistent with the original product, so as to ensure the consistency of clinical efficacy; The second consistency is the consistency of product quality test results; The third is the consistency of the clinical effect and the original product. This has also been well demonstrated in our three clinical trials."

It seems that it is not easy to make high-quality generic drugs. Innovation and imitation, it seems to be a contradiction, but in fact, high-quality generic drugs are definitely not a simple copy, it needs to thoroughly study the original drug, the same need for research and development and innovation. The research and development of domestic gefitinib lasted for 6 years and invested more than 100 million yuan.

Bao Haizhong, vice president of a pharmaceutical enterprise group, said: "To make a good generic drug, the first is research and development, in the research and development stage, the establishment of the production prescription process and the setting of quality standards have determined the innate quality of drugs; How to build a quality assurance system consistent with the international developed countries is also very key to the consistency of drug production quality, so only from the research and development, production, transportation and storage of all aspects of quality control, drug life cycle management, in order to ensure the quality of drugs in the final use process."

Therefore, in this "Opinion", from pharmaceutical excipients to packaging materials, process level, and then to the review and approval of drugs, quality supervision, a series of planning for the whole industry chain of generic drugs.

There are still many links between making high-quality generic drugs and actually using them by patients. Although some of our generic drugs are consistent with the original drugs in terms of quality and efficacy, their promotion in the market is not ideal. Statistics show that the original research drug gefitinib has entered more than 1,200 hospitals in China, while domestic gefitinib only entered more than 200 hospitals in China.

Xu Yuanling, vice president of a pharmaceutical enterprise group, said: "Even after entering the hospital, there are some restrictions on the use of, for example, some provinces and cities clearly stipulate that in the country's 36 negotiated varieties, the original drug does not account for the proportion of drugs, and generic drugs occupy the proportion of drugs, if it is the proportion of drugs, it limits the hospital's prescription."

Shi Luwen, director of the Department of Pharmaceutical Management and Clinical Pharmacy at Peking University's School of Pharmacy, said: "To really make this product play its role, the following policies need to be supporting, from bidding, procurement and the entire medical insurance reimbursement, to entering the hospital, we need to build corresponding supporting mechanisms."