Six ministries issue the \"Guidelines for the Development Plan of the Pharmaceutical Industry\"

The development goals emphasize the focus on benefiting people’s livelihoods, and their \"high strategic perspective\" is the overall assessment of the \"Planning Guidelines\" by Li Song, a researcher at the Academy of Medical Sciences and an academician of the Chinese Academy of Engineering. He believes that the Planning Guidelines focus not only on the development of the pharmaceutical industry over the next 5 years, but their core objective is to benefit people’s well-being, that is, to prioritize meeting the health needs of the general public. “Once people have resolved their basic needs for food and shelter, the next issue they need to address is health, which inevitably places demands on the development of the pharmaceutical industry. ”Li Song pointed out that currently, many important patented drugs in China’s market are held by foreign companies, and high-end medical equipment relies heavily on imports, which is one of the main reasons for high healthcare costs. The pharmaceutical industry needs to vigorously develop new drugs and medical devices to meet the needs of disease prevention and control, improve product quality, reduce costs, and ensure access to medications. “The \"Planning Guidelines\" are written in a highly practical manner, relying heavily on data to support their arguments; the analysis addresses the key pain points in the industry, and the goals set are clear and achievable. ”Shao Rong, a professor at China Pharmaceutical University and deputy director of the **Center for Drug Policy and Pharmaceutical Industry Economics, said that while summarizing the achievements of China’s pharmaceutical industry during the 12th Five-Year Plan period, the Plan Guidelines also identified seven major problems, including weak original innovation capabilities, an urgent need to improve product quality, and low international competitiveness. “These seven issues are highly relevant to industry practices. ” Shao Rong emphasized. According to the Planning Guidelines, the overall goal for China’s pharmaceutical industry during the 13th Five-Year Plan period is to achieve steady growth in scale and efficiency by 2020, a significant enhancement in innovation capabilities, a comprehensive improvement in product quality, a more robust supply chain system, an accelerated pace of internationalization, and a substantial rise in the overall quality of the pharmaceutical industry. Among them, the industry’s growth target is an average annual increase in main business revenue of over 10%, with its share in the industrial economy increasing significantly. Officials from the Ministry of Industry and Information Technology stated that the overall goals reflect efforts to benefit people’s livelihoods, stabilize economic growth, and adjust the economic structure. The industry growth target takes into account the current development status of the pharmaceutical industry, the challenges it faces, and the measures that need to be taken. It is also aligned with the relevant indicators set out in the State Council’s \"Guiding Opinions on Promoting the Healthy Development of the Pharmaceutical Industry.\" The growth rate target of 10% is lower than that during the 12th Five-Year Plan period, but it still represents a medium-to-high growth rate ； The share of the added value of the pharmaceutical industry in total industrial output is set to reach a new level, building on the 3.0% figure. The reporter also noted that, under the \"product quality\" goal, the \"Planning Guidelines\" specify that it is necessary to essentially complete the evaluation of the quality and efficacy consistency of generic drugs in the form of oral solid preparations. ”Shao Rong said that in Japan, the process of improving drug quality through evaluations similar to those for consistency took 10 years; China, on the other hand, has to complete the consistency evaluations for 289 essential drugs within just a few years, which represents considerable pressure.

Innovation becomes the main driver for transformation and upgrading. “In general, the pharmaceutical industry needs to accomplish two key tasks during the 13th Five-Year Plan period: innovation and internationalization.” Its core is to drive the transformation and upgrading of the pharmaceutical industry, as well as to improve its quality and efficiency. ”Yu Mingde said. “\"Innovation\" is undoubtedly a term that appears frequently in the \"Planning Guidelines.\" The Planning Guidelines not only place \"enhancing industrial innovation capacity\" at the top of the 8 key tasks, but also specify regarding technological innovation that by 2020, the R&D investment intensity of enterprises above a certain size across the industry should reach over 2%; the quality of innovations should improve significantly, new drug registrations should account for a larger proportion of total drug registrations, a number of high-quality innovative achievements should be put into commercial use, and progress should be made in the international registration of new drugs. Among the six major **projects, the project aimed at enhancing innovation capacity is also ranked first. Yu Mingde emphasized that innovation is the essential path for China to move from a major pharmaceutical country to a strong one and to achieve industrial transformation and upgrading. It is also the only means to break the monopoly of foreign patented drugs over China’s high-end pharmaceutical market and to enable domestic drugs to fully replace original branded drugs. “The focus of \"internationalization\" actually lies in innovation as well. “Internationalization means utilizing global resources to develop the country’s pharmaceutical industry. ”Yu Mingde said. The top priority is to make use of multi-level and diversified international market resources in order to help some of China’s advanced enterprises establish connections with well-regulated markets in Europe and the United States ； Or by entering mid-to-low-end international markets such as Africa, Southeast Asia, South America, etc., to strengthen international technical cooperation and promote international capacity cooperation. Among the six key areas for development listed in the Planning Guidelines – biopharmaceuticals, new chemical drugs, high-quality traditional Chinese medicines, high-performance medical devices, new excipients and packaging materials, and pharmaceutical equipment – Yu Mingde is most optimistic about biopharmaceuticals. He believes that during the 13th Five-Year Plan period, a competitive landscape will emerge in the field of biopharmaceuticals in China. “In the field of biotechnology, the gap between our country and international advanced levels is relatively small, and it is entirely possible to catch up and surpass them through efforts in a short period of time. Additionally, more than 2,000 Chinese researchers have returned to their home country as part of international biotechnology R&D teams. China is about to embrace a great opportunity for the development of biotechnology. ”Yu Mingde predicted.

There is an expectation that combined policy efforts will ensure the implementation of these guidelines. As is well known, the pharmaceutical industry is highly influenced by policies, and due to its long supply chain and involvement of numerous departments, ensuring the implementation of all the tasks and measures outlined in the Plan Guidelines is a very practical challenge. “We look forward to the formation of a coordinated policy effort among various ministries. ”Shao Rong said. Officials from the Ministry of Industry and Information Technology emphasized that, unlike previous plans such as the \"12th Five-Year Plan for the Pharmaceutical Industry\" which were formulated by a single department within the ministry, this \"Plan Guide\" was developed jointly by six ministries ； The six ministries will also establish an inter-ministerial coordination mechanism to jointly advance the implementation of the plan, ensuring that all tasks and measures are carried out effectively. The Planning Guidelines also state that during the 13th Five-Year Plan period, efforts will be made to enhance coordination between industrial policies and policies related to quality and safety supervision, price regulation, centralized procurement, clinical use, medical insurance reimbursement, finance and banking, as well as foreign trade. Li Song is full of expectations for increased financial, fiscal, and monetary support. He pointed out that policies such as additional deductions for R&D expenses, tax incentives for high-tech enterprises, and accelerated depreciation of fixed assets already existed before, but were not implemented in many places. “The health industry accounts for 17% of the U.S. GDP, while in China it makes up less than 4% at present. This shows that there is a significant gap between China’s health industry and that of the United States, but it also presents great opportunities. If supportive policies such as tax reductions can be effectively implemented, they will help promote the development of China’s health industry into a pillar industry of the national economy. ”Shao Rong is more concerned about prices, procurement, and the improvement of medical insurance policies. She said that the Planning Guidelines emphasize the need to establish a market-driven mechanism for setting drug prices, and to strengthen the coordination between price policies and policies related to health insurance, procurement, and drug use. This approach aims to curb excessively high drug prices while preventing excessively low prices from affecting supply security and product quality. Improve the policies for categorized procurement of drugs, and establish scientific evaluation criteria for tender-based procurement. Scientifically and reasonably establish payment standards for basic medical insurance drugs. Based on the affordability of medical insurance funds, eligible innovative drugs are included in the medical insurance catalog in accordance with relevant regulations. She said outright that, as a **, it is necessary to focus on the public interest. However, while focusing on the public interest, industrial interests must not be ignored. Only when the industry develops healthily can the public interest be better protected and made sustainable.