Representative Ren Wuxian: improve relevant policies and promote the transformation from a big pharmaceutical country to a powerful one

"The 12th Five Year Plan for national drug safety has made it an important task to comprehensively improve the quality of generic drugs." Ren Wuxian, deputy to the National People's Congress and chairman of Yabao pharmaceutical, pointed out that the consistency evaluation of generic drugs has been officially included in the national plan This not only improves the quality of generic drugs from the technical level, but also lays the foundation for promoting the fair competition of pharmaceutical enterprises Through drug consistency evaluation, generic drugs should enjoy the same treatment as the original drugs if there is no difference between generic drugs and reference drugs in quality and efficacy However, due to the protection of China's preferential policies, foreign pharmaceutical enterprises enjoy "super national treatment" for a long time and earn a lot of excess profits The original preferential policies for drug research are set up by the state to ensure the quality of drugs and encourage pharmaceutical enterprises to develop innovative drugs The policy stipulates that the drugs originally developed by the enterprise, whether or not the patent expires, will not be subject to the national restrictions on reducing the price of essential drugs, and will be priced separately, directly listed in the catalogue of essential drugs and enjoy full reimbursement conditions "This policy has been implemented for more than 20 years since 1993 The fact is not the original intention of policy-making, and there are many drawbacks," Ren said In order to revitalize the national pharmaceutical industry, enhance the innovation strength of domestic pharmaceutical enterprises, and promote the transformation of China from a big pharmaceutical country to a powerful pharmaceutical country, Ren Wuxian proposed the following suggestions: 1 Strict drug consistency evaluation standards For the consistency between generic drugs and original drugs, not only the standards are consistent, but also the bioequivalence, safety equivalence and clinical equivalence are achieved As the main body of consistency evaluation, before preparing to register generic drugs, pharmaceutical manufacturers should conduct in-depth research on the participating drugs to ensure the consistency of biology, safety and efficacy with the original research drugs, and apply to the relevant national departments for registration For those failing to meet the conformity evaluation standard, the State Administration and other relevant departments firmly refuse to register 2 Cancel the independent pricing policy of the original research drug and unify the pricing with the generic drug After the expiration of the original research patent, it is no longer protected by law Through the consistency evaluation, the quality and price of generic drugs are the same Administrative protection will inevitably lead to unfair pricing, which should be cancelled and unified by the state 3 Cancel the "separate quality level" policy of original research drugs, and let generic drugs compete with original research drugs in the market access link After the generic drugs passed the consistency evaluation, the concept of quality stratification no longer exists, and should participate in the market competition under the same conditions Let the domestic pharmaceutical enterprises be profitable and let the people enjoy the fair drug price Related links: Interview: Ren Wuxian talks about reforming the medical management system and promoting the healthy development of the industry