Since 2018, the national unified negative list system of market access has been formally implemented, or it has far-reaching impact on the pharmaceutical industry

Source: Caizhi, No.1 drugstore, 2015-10-20 since CFDA issued the measures for the supervision and administration of Internet food and drug distribution (Draft for comments) on May 28, 2014, the discussion about the policy liberalization of online sale of prescription drugs has been drawing people's attention Once the policy is liberalized, in what form, will the online sale of prescription drugs issue a "positive list" or“ In particular, on October 19, 2015, the State Council issued opinions on the implementation of the market access negative list system The opinion requires that a negative list system should be established and implemented in all fields and links involving market access And will formally implement the national unified negative list system of market access in 2018 According to the opinion, although the list mode of Internet drug sales has not been finalized, the policy direction has become increasingly clear The State Council's website released the opinions of the State Council on the implementation of the system of negative list of market access on September 19, which described the positioning, requirements and schedule of the system The opinion points out that all kinds of market entities can enter industries, fields and businesses other than the negative list of market access equally according to law The opinions set a timetable for the implementation of the system From December 1, 2015 to December 31, 2017, the system of negative list of market access was tried out in some regions to accumulate experience and gradually improve, explore the formation of a unified negative list of market access and corresponding institutional mechanisms, and formally implement the unified system of negative list of market access from 2018 The main points are summarized as follows: 1 The negative list system of positioning market access refers to a series of institutional arrangements in which the State Council clearly lists the industries, fields and businesses that are prohibited and restricted from investment and operation within the territory of the people's Republic of China, and the governments at all levels take corresponding management measures according to law Industries, fields and businesses other than the negative list of market access can be equally entered by all kinds of market entities according to law 2 In general, all departments in all regions should seriously implement the negative list system of market access For the voluntary investment and operation behaviors of various market entities, the negative list system shall be established and implemented in all fields and links related to market access; when the conditions are mature, the current market access items under catalog management shall be incorporated into the negative list of market access 3 The negative list of category market access includes the categories of forbidden access and restricted access, which is applicable to the initial investment, expansion investment, merger and acquisition investment and other market entry behaviors of various market entities based on their own willingness For the prohibited access items, the market subject is not allowed to enter, the administrative organ is not allowed to approve and approve, and the relevant procedures are not allowed to go through; for the restricted access items, or the market subject applies, and the administrative organ makes the decision on whether to enter according to the laws and regulations, or the market subject enters according to the access conditions and access methods stipulated by the government; For industries, fields and businesses other than the negative list of market access, all kinds of market entities can enter equally according to law 4 Applicable conditions According to the laws, administrative regulations and relevant regulations decided by the State Council, the following management measures can be taken for the investment and operation behaviors and other market entry behaviors of various market subjects involving the following fields, such as prohibiting or restricting the qualification of market subjects, equity ratio, business scope, business type, business model, spatial layout, land and space development and protection: involving people's life and property Industries, fields and businesses related to national security, such as security, political security, homeland security, military security, economic security, financial security, cultural security, social security, scientific and technological security, information security, ecological security, resource security, nuclear security and new field security; Industries, fields and businesses related to national major productivity layout, strategic resource development and major public interests; industries, fields and businesses related to the investment and operation of market entities that can be set up with administrative permission according to law; other situations stipulated by laws, administrative regulations and decisions of the State Council 5 The State Council shall formulate and issue the list of negative market access procedures; if local governments need to make adjustments, the provincial people's governments shall submit it to the State Council for approval When formulating the negative list of market access, the relevant departments shall improve the decision-making mechanism combining public participation, expert argumentation and government decision, fully listen to the opinions of all departments in various regions, organize experts to demonstrate the necessity and feasibility, and solicit opinions from the public Where national security is involved, it shall be reported in advance to the Central National Security Committee for examination 6 The implementation steps follow the principle of first trying and pushing forward step by step, from December 1, 2015 to December 31, 2017, trial market access negative list system in some regions, accumulate experience and gradually improve, explore and form a unified national market access negative list and corresponding institutional mechanisms, from 2018 Since, China has formally implemented a unified negative list system for market access Reporter: Pan Lingfei's relevant links: opinions of the State Council on the implementation of the negative list system of market access