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| Sichuan Province Encourages Generic Drug Research and Development to Accelerate the Development of a Payment Standard for Medical Insurance |
Recently, the People’s Government of Sichuan Province issued the Implementation Opinions on Reforming and Perfecting the Supply and Guarantee Policy of Generic Drugs, which vigorously promoted the research and development of generic drugs in Sichuan Province, improved the quality and efficacy of generic drugs, and better met the needs of clinical drugs and public health. It will speed up the formulation of payment standards of medical insurance drugs, and the generic drugs and original research drugs that are consistent with the original drug in terms of quality and efficacy will be paid by the same standard.
The Opinions proposed to establish an inter-departmental information sharing mechanism for drug development, production and use, encourage the imitation of drugs that are clinically needed with effective efficacy and in short supply, and preferentially imitate the drugs needed for the prevention and treatment of major infectious diseases and the treatment of rare diseases, and drugs required for health events, for the use of children, and that have not been filed for registration one year before the patent expires. It also encouraged the product research and development of key common technologies and that of chemical and biopharmaceuticals in the generic drug catalogue to be included in relevant scientific and technological planning and research and development plans, which would support the industry-university-research units of Sichuan Province to apply for relevant national science and technology plans.
It urged them to accelerate the evaluation of the quality and efficacy consistency of generic drugs, make public the generic evaluation resources of generic drugs, and support and promote the participation of qualified medical institutions, institutions of higher learning, scientific research institutions and social inspection and testing institutions to participate in the consistency evaluation. It called for vigorous endeavors to promote technological innovation and transformation, promote the application of new technologies, and give priority support to projects that meet the scope of support for key technology industrialization, new product industrialization, and new editions of pharmaceutical production quality management practices (GMP). It advised them to strengthen supervision and inspection, do a good job in risk prevention and control of highly risky enterprises and varieties, increase the intensity of sampling inspection of generic drugs, investigate and deal with them in accordance with the law and crack down on illegal activities such as data fraud, cut corners, doping and falsehood, and make public the inspection and punishment results.
The Opinionsrequired that the procurement catalogue be compiled according to the generic name of the drug to provide the generic drugsthat are consistent with the quality and efficacy of the original drug with equal opportunities in competition. It laid out rules to further refine and improve the classified procurement policy to support generic drugs that have passed the quality and efficacy consistency assessment.
The formulation of drug payment standard for medical insurance is to be accelerated, and the standards for the payment of generic drugs and original research drugs that are consistent with the quality and efficacy of the original drug are to be uniformed. The drugs in the basic medical insurance drug list shall not be restricted according to the name of the product or the manufacturer. The medical insurance information system shall be updated in time to ensure that the generic drugs approved for listing are equally included in medical insurance payment.
We will comprehensively implement tax incentives such as the development of the western region, high-tech enterprises, deductions for research and development expenses, and accelerated depreciation, so as to promote the expansion of technological innovation capabilities and promote transformation and upgrading of generic drug companies. For generic enterprises that meet the preferential policies for the development of the western region or high-tech enterprises, the enterprise income tax shall be levied at a reduced rate of 15%. We will improve the mechanism for the formation of drug prices mainly from the market, and do a good job in connecting with reform policies such as drug procurement and medical insurance payment. We will adhere to classified procurement of drugs, highlight the clinical value of drugs, take into consideration the cost of drugs, and formulate a purchase price that fluctuates in a sound and reasonable way.
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