Geng Hongwu: Analysis of Drug Collection Trend and Enterprise Response

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With the promotion of the policy of quality and efficacy consistency evaluation of generic drugs and the normalization of centralized procurement of drugs organized by the state, the "big year" of drug collection in China is approaching, and pharmaceutical production and operation enterprises are facing greater policy challenges. Similarly, the future policy requirements and environment in the field of medical devices will be very similar to those of drugs.

This conclusion is based on the overall development process of China's drug centralized bidding procurement in the past 20 years, each stage of policy and the latest policy research.

In the past 20 years, China's centralized drug procurement has gone through five stages. They are: from 2000 to 2004, the policy was established and improved (the first national regulation); From 2005 to 2008, policy reform and exploration (provincial regulation); From 2009 to 2014, policy adjustment (the second national regulation); From 2015 to 2018, policy adjustment (the third national regulation); From 2019 to now, policy adjustment (the fourth national regulation). We are currently in the fifth phase.

From 2016 to 2019, many new medical reform policy documents have been issued, and enterprises should pay attention to five policies in the near future.

The first is the "Notice of the State Council Leading Group for Deepening the Reform of the Medical and Health System on Further Promoting the Experience of Deepening the Reform of the Medical and Health System in Fujian Province and Sanming City" issued on November 15, 2019. The policy defines the timetable for volume and budget procurement in the pilot provinces in 2020 and encourages other provinces and cities to adopt the above-mentioned methods, as well as the time requirements for centralized bidding and procurement of high-value medical consumables.

Second, on November 29, 2019, the State Council's Leading Group on Deepening the Reform of the Medical and Health System issued a number of policies and measures to further deepen the reform of the medical and health system with the centralized procurement and use of drugs as a breakthrough. The policy clarifies the specific operating methods, operating methods and related requirements for centralized bidding and procurement in 2020.

Third, the Opinions on Deepening the Reform of the Medical Security System issued by the Central Committee of the Communist Party of China and the State Council on March 5, 2020. This document is the highest-level document on the reform of the medical insurance system since 1998. It points out the overall reform goals and reform methods in the next three to five years, and even 2030 from a macro perspective, including innovative medical insurance reform measures and reform paths.

Fourth, on February 5, 2020, the National Health Insurance Administration issued the "2020 Medical Security Work Points". The document clarifies the tasks of the National Health Insurance Bureau in 2020, involving the pilot of centralized bidding and procurement in various places, the requirements of high-value medical consumables, and the pilot of cross-regional alliance procurement.

Fifth, on July 31, 2019, the General Office of the State Council issued the Reform Plan for the Governance of High-Value Medical Consumables. This document is of great significance to the development of medical device industry. Through this document, we can see that policies such as centralized bidding and procurement, medical insurance catalog access negotiation system have landed in the medical industry. This document is not only applicable to high-value medical consumables, but also partially applicable to general medical consumables.

Under the influence of national volume procurement in the past two years, in the field of pharmaceuticals, Fujian, Hebei and other places have also carried out a variety of pilot centralized procurement of drugs, including Fujian Province volume procurement, Beijing-Tianjin-Hebei integration cross-regional alliance procurement, Qinghai Province classification belt procurement and other practical experience are worthy of attention.

After the outbreak, the density of equipment bidding and procurement will increase. In 2019, with the issuance of the Reform Plan for the Governance of High-value Medical Consumables, the centralized bidding and procurement model in Ningbo City, Zhejiang Province became a national model, followed by different models of band procurement in Anhui, Jiangsu, Shandong, Shaanxi and other provinces, with Liaoning Province taking the lead in band procurement of ordinary medical consumables. This year, the centralized bidding and procurement of medical consumables will be more complex than the centralized procurement of drugs, which requires enterprises to actively respond.

Judging by the above trends, the future centralized procurement will be more test of the enterprise's market access management ability, that is, the management system construction ability, the cognitive deconstruction ability of the policy, the operation management ability of the project, the policy communication ability and compliance binding force in the operation management. It is suggested that enterprises should improve their overall ability, prepare for various changes, make changes in marketing transformation, product upgrading, channel reconstruction, access promotion and compliance guarantee, establish knowledge framework and cognitive framework, and then form capability framework and action framework, so as to improve the adaptability of enterprises to the future and better win the future.