Starting this year, imported stents—subject to a 50% tariff reduction—are likely to see tangible price cuts. However, it will be the centralized tendering process that truly brings down the prices of stents, which have long remained prohibitively high.

　　After 30 rounds of price cuts for pharmaceuticals, high‑priced medical devices—long considered beyond the reach of such measures—are finally coming under scrutiny as part of broader price‑control efforts. The first to be targeted will be high‑value medical consumables, including stents. According to recent reports from the Ministry of Health, the ministry, along with five other departments, has jointly issued the “Work Guidelines for Centralized Procurement of High‑Value Medical Consumables (Trial)” (hereinafter referred to as the “Guidelines”).

　　Eight years of pilot programs have forged a powerful bidding tool.

　　The draft “Regulations on Centralized Procurement of High-Value Medical Consumables” only opened for public comment in September last year. However, according to the Ministry of Health, as early as August 2004, it had already launched a pilot program in eight provinces and municipalities, including Beijing, to conduct centralized procurement of three categories of high-value medical consumables: cardiac intervention devices, artificial joints, and cardiac pacemakers, at tertiary-level medical institutions.

　　Due to the significant cost‑reduction effects, building on the pilot program conducted in eight provinces and municipalities during 2008–2009, the Center for International Cooperation and Exchange of the Ministry of Health was also entrusted with organizing two rounds of centralized procurement for selected high‑value medical consumables nationwide. In addition, a supplementary procurement of new products was carried out in 2010.

　　Prior to the issuance of the “Regulations,” numerous provinces, autonomous regions, and municipalities—including Sichuan, Ningxia, Jiangsu, Hubei, and Zhejiang—had, in light of their local circumstances, launched province‑level centralized procurement initiatives for certain high‑value medical consumables.

　　In accordance with the requirements of the Ministry of Health and five other departments, high-value medical consumables—including vascular intervention devices, non-vascular intervention devices, orthopedic implants, neurosurgical instruments, electrophysiological equipment, pacemakers, extracorporeal circulation and blood purification devices, and ophthalmic materials—will all be subject to centralized tendering and procurement. At the same time, all public, non-profit medical institutions at or above the county level are required to participate fully in this centralized procurement process.

　　It aims to reduce unreasonable costs in the distribution chain.

　　“Prior to 2004, the procurement of high-value medical consumables across various regions suffered from low market concentration, high purchase prices, substantial price disparities among regions, heavy burdens on enterprises, frequent occurrences of improper practices in the buying and selling process, and irregular conduct by intermediary agencies.” This is an officially acknowledged fact.

　　However, even after 2004, allegations of bribery involving multinational medical device companies in China have continued to surface from time to time.

　　Cai Tianzhi of the China Chamber of Commerce for Import & Export of Medicines & Health Products told reporters frankly that, for imported medical devices to see genuine price reductions, marketing expenses must be cut. In his view, overt or covert markups at intermediate stages have become a major factor driving up the prices of certain high-value medical equipment.

　　As evidenced by the “Regulations,” the centralized procurement of high-value medical consumables will draw on the model used for drug centralized procurement, implementing three forms of unification: unified organization, a unified platform, and unified oversight. At the same time, the leadership, management, operational, and supervisory bodies established for drug centralized procurement will also be retained.

　　Tao Duchen, president of the Shenzhen Medical Device Industry Association, told a Nanfang Daily reporter that the implementation of centralized procurement for high-value consumables represents a significant step forward. In his view, the issue of excessively high and widely varying markups in the distribution of high-value medical devices has reached a critical juncture requiring urgent regulation. Tao Duchen noted that, following the release of the “Regulations,” many medical device companies will need to transform their traditional “one-to-one” sales model—where firms sell directly to hospitals.

　　However, some medical device companies operating in China remain cautious about the impact of the new regulations. One multinational firm even stated bluntly, “Whether local tendering and procurement processes are truly transparent remains to be seen, and how each province will conduct its bidding is still an open question.”

　　According to industry insiders, in 2006, relevant authorities also attempted to curb the prices of high-value medical devices by capping markup rates and maximum markups on certain high‑value medical consumables, and publicly released a draft document titled “Opinions on Strengthening Price Monitoring and Management of Implantable Medical Devices.” However, that policy was never implemented. In addition, the National Development and Reform Commission once sought to introduce the “Provisional Measures for Managing Markup Rates in the Distribution of Implantable Medical Devices and for Monitoring Purchase and Sales Prices” (hereinafter referred to as the “Measures”). To date, however, these Measures have not been made public or put into effect.

　　Chen Qiulin, an assistant researcher at the Institute of Population and Labor Economics of the Chinese Academy of Social Sciences, publicly wrote: “The fundamental purpose of centralized procurement for high-value medical consumables is to reduce their costs, thereby lowering overall pharmaceutical expenditures. However, if the ‘using drug profits to subsidize medical services’ mechanism remains unbroken, this goal will continue to be difficult to achieve.”

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　　For a long time, the industry has maintained that the prices of coronary stents are excessively high and that their profits exceed those from drug trafficking.

　　According to statistics, in 2011, China performed 330,000 percutaneous coronary interventions, with an average of 1.7 stent systems used per PCI procedure, resulting in a total annual consumption of 560,000 stent systems.

　　Previously, Hu Dayi, Chairman of the Cardiovascular Disease Branch of the Chinese Medical Association, released a set of data: the Journal of the American Medical Association (JAMA) published an analysis of more than 500,000 coronary artery interventions (stenting) performed in the United States between 2009 and 2010. The findings showed that 71.1% of cases were acute coronary syndromes, while 28.9% were stable coronary artery disease. Among patients with acute coronary disease, 99% received guideline‑consistent, appropriately indicated stenting; by contrast, only 50.4% of those with stable coronary artery disease underwent stenting in accordance with appropriate indications. In other words, among U.S. patients with stable coronary artery disease, half of stent placements were not justified.

　　Meanwhile, in China, the overuse of interventional therapies has become a widely acknowledged consensus within the domestic medical community. Wang Longde, a member of the Standing Committee of the National People’s Congress, deputy director of the Brain Protection Committee of the Ministry of Health, and an academician of the Chinese Academy of Engineering, presented the following data: in 2011, among cases screened at national reference hospitals with stenosis rates exceeding 70%, the ratio of coronary artery bypass grafting to percutaneous coronary intervention was 1:4, whereas in the United States this ratio stood at 9:1. The underlying reasons are self‑evident.