China's generic drugs to replace the import of the original research action to speed up |

Medical Network, April 10: In the midst of a hot trade war between China and the United States, China's generic drugs have begun to accelerate the substitution of imported original research.

On April 3, the General Office of the State Council formally issued the “Opinions on Reforming and Perfecting the Supply and Use Policy of Generic Drugs” (hereinafter referred to as "Opinions"). drug In this way, we have clarified the follow-up preferential policies for landing, and provide high-quality generic drugs in many aspects such as procurement, medical insurance, taxation, and publicity.

'This is a good policy. Whether it is a generic drug or an innovative drug, it can enter the Medicare reimbursement directory and eventually enter hospital It is the core. To really achieve import substitution, it is to reimburse only the generic drugs that pass the consistency assessment on medical insurance reimbursement. medicine Chairman Zheng Weiyi said in an interview with the First Financial Department: 'Since your generic medicine is already the same as the original research medicine, only from the medical insurance reimbursement system provides that China's generic medicine can really do a good job and import substitution can become a reality. , This policy for generic drugs enterprise Eat a reassuring pill. '

The development of generic drugs is the basis for the establishment of a pharmaceutical industry system in China. The low prices of generic drugs are beneficial to control the cost of treatment and increase the level of drug protection for patients. They are highly valued in all countries. In developed countries, generic drugs are important for controlling drug costs. The method is to maintain the strategic considerations of sustainable development of the medical and health industry while encouraging innovation.

'Therefore, China needs more generic drugs. It must accelerate the formulation of generic drug supply guarantee and use policies, accelerate the transition from generic pharmaceutical giants to generic pharmaceutical giants, establish public confidence in generic drugs, and effectively improve access to medication in China. Slowing down the rapid growth of medical costs and achieving universal health .' Shi Wenwen, professor at Peking University School of Pharmacy said.

'The consistency evaluation of generic drugs has started, but it must be given an identity, need to support and implement the document, otherwise the confidence of generic pharmaceutical companies is not enough, in the medical insurance, the use of links need to be protected.' Zheng Weiyi said.

China's generic drugs have low-level redundant construction, and the problem of high-end supply is insufficient. The phenomenon that there are still no imitations of drugs with high clinical needs after expiration of patents has occurred frequently. How to effectively guide high-quality and orderly imitation and optimize the pharmaceutical industry structure has become a major issue. The important focus of the Opinion.

The Opinions require further release of generic drug conformity assessment resources, development of a catalogue of drugs that encourage imitations, demand-oriented encouragement of imitation of clinically necessary, definitive curative effect, supply of short-supplied drugs, and promotion of imitation of major infectious disease prevention and treatment of rare diseases. Drugs, drugs required for handling public health emergencies, drugs used by children, and drugs that have not been filed for registration in the year prior to expiration of the patent.

In the use of links, it is based on an alternative to the original research. The Opinions require that drug procurement be based on the generic name of drugs, and that generic drugs and equal research should compete on an equal footing. Clinical use of generic drugs should be strengthened in order to monitor efficacy and the original research drug. The incentive role of medical insurance. Accelerate the formulation of medical insurance drug payment standards, and the generic drug with the quality and efficacy of the original research drug. Original research drug pays according to the same standard.

'Building a clinical demand-driven generic pharmaceutical R&D mechanism to make full use of the market's regulatory role and to give play to the enthusiasm of companies, medical institutions and other parties involved in independent research is an important guarantee for rapidly upgrading the quality level of generic drugs in China.'

Xiao Hanshan, a research fellow at Minsheng Securities Pharmaceuticals, told First Finance that: “The Weijian Department formulates policies and incentives that encourage the use of generic drugs. Except for special circumstances, no prescriptions may appear on the prescriptions. When providing drugs to AIDS and tuberculosis patients as required, , The priority is to purchase generic drugs; generic drugs with the same quality and efficacy as the original drug, the original drug should be paid according to the same standard, and the eligible drugs should be included in the basic medical insurance catalog in a timely manner. No restrictions can be imposed on the name of the product or the manufacturer. , The substitution of generic drugs for imported drugs will continue to accelerate.

"After the introduction of this policy, we have greatly encouraged the consistency evaluation of generic medicines so that the interests of generic pharmaceutical companies can be guaranteed and enterprises can be rewarded to further solve the problem of innovation. Scientific research will also be strengthened." Zheng Weiyi said.

Xiao Hanshan believes that companies with leading progress in consistency assessment will have a card position advantage and have the opportunity to use their products to take the lead in listing the exclusive opportunity to enjoy the policy dividend. With the progress of consistency assessment, the quality of generic drugs will increase, and pharmaceutical companies will fall behind. After being eliminated, the concentration of the industry has increased, and the pattern of the strong and permanent ones has appeared.

'High demand, scarcity of therapeutic drugs will be taken seriously, and will also become the main direction for future generic pharmaceutical companies.' Xiaohan Shan said, 'The data provided by the Weijian Committee showed that there were 631 patents expired in 2012~2016 globally.' The original research drug, due to the asymmetry of supply and demand information, most of them have no companies in China to apply for imitation registration. Of course, China's generic pharmaceutical companies are catching up, many high-quality companies have begun applications for high-quality generic drugs. '