Source: Gmw.cn
According to reports, recently, "mercaptopurine tablet", an indispensable medicine for treating children’s acute lymphocyte leukemia, experienced a serious short supply across China, and in some places, the short supply even lasted continuously for 5 months. Not long ago, this medicine only sold for 40 yuan/bottle, but now, fueled by speculation, its price has risen to 148 yuan/bottle. But even with that price, it is still very difficult to get that medicine, which has caused wide public concern. On November 21, according to news from state media, the supply of mercaptopurine has been gradually restored. The production and inspection of the first batch of 2,950,000 tablets of mercaptopurine has been completed by Zhejiang Zhebei Pharmaceuticals, and is ready for delivery. These mercaptopurine tablets can meet one year's clinical demand for the medicine in China, and they will be put online for direct purchase, and timely delivered, so as to ensure that child patients' demand is met.
The causes that resulted in the short supply of some medicines on the market in China
Since the beginning of this year, due to various reasons including price, short supply of supply of raw materials occurred in many industries, including the medicine industry, which resulted in a big increase of price, and a relatively complicated situation. Moreover, regarding the affected products, there are such problems as asymmetry in supply and demand information, low clinical use volume, low profit, and insufficient production and supply. Taking production of mercaptopurine in China as an example, mercaptopurine is a cheap medicine, with a total clinical use volume of 3 million tablets every year and a total price of about 3 million yuan. Since the clinical use volume is small and the profit is low, the medicine’s production and supply is not sufficient, and generally, manufacturers do not have the motivation to produce this medicine. Currently, there still exists some short supply of medicines that urgently requires solving. Among them, 27 medicines have been in short supply for a long time. Taking as an example dapsone, a medicine which is used to treat leprosy, domestic manufacturing companies of its raw medicine material and its preparations stopped their production many years ago. Presently, we mainly use foreign manufactured dapsone that comes from charity donations, for clinical use, and restoration of production will be very difficult, and will take a long time.
Besides the price factor, many factors in other aspects, such as environmental protection requirements, cutting of production capacity, and structural adjustment, also play a role. As far as we know, currently, there are three manufacturers who have obtained approval numbers for production of the raw medicine material for mercaptopurine, but only one of them is actually making production. There are six preparation manufacturers that have obtained approval numbers for production of the medicine’s preparation, but only two of them are actually making production. In the second half of 2016, one of the two manufacturers stopped its production of the preparation, due to difficulty in purchasing raw medicine material, as a result of rapid price rise of the raw medicine material; in the first half of 2017, another manufacturer stopped its production due to GMP certification problems, which directly resulted in a relatively serious short supply of mercaptopurine in the market.
National level monitoring and early warning plays a positive role
Over recent years, more than 130 types of medicines in short supply have been included in the scope of China's key monitoring, and the medicine monitoring and early warning system has been continuously expanding its scope of monitoring. Currently, on the basis of the over 500 monitoring posts in medical institutions, the monitoring system's coverage is being extended to important links in production and circulation, so as to promote achievement of full coverage for medicines in short supply, by properly laying out monitoring posts. Meanwhile, we should promote implementation of the reporting system in the two aspects, namely, monitoring information zero reporting system, and production cease filing system for medicines and their raw medicine materials. We should establish a long term mechanism, and improve and perfect the monitoring and early warning system for medicines in short supply, and prevent the situation of severe delays in treatment of patients. In the above case, the reason that the supply of mercaptopurine tablets can be quickly restored after the short supply occurred is the gradual establishment and perfection of the monitoring network for medicines in short supply. Experts from the industry point out that, without early warning and monitoring, based on the general rules of medicines' production and circulation, restoring of the supply of mercaptopurine tablets will take a period of about six months. Meanwhile, this is closely related with China's work of ensuring the supply & guarantee of medicines in short supply as an important livelihood project.
The establishment of a national-level monitoring and early warning system for medicines in short supply, plays a positive role in restoring supply of medicines in short supply in China. Still taking production of mercaptopurine tablets as an example, mercaptopurine tablets are mainly used for treatment of such cancers as leukaemia and chorion epithelioma, especially for later period maintenance treatment of children's acute lymphocyte leukaemia. After the national monitoring and early warning system for medicines in short supply received the information, the National Health and Family Planning Commission and China Food and Drug Administration soon conducted group consultation and coordination with relevant enterprises, and helped expedite the examination and approval procedure of GMP certification, which promoted rapid restoration of production and supply of mercaptopurine. The National Health and Family Planning Commission issued a circular, requiring all local governments to properly coordinate and organize the purchasing and distribution of mercaptopurine, and realize direct online purchasing so as to reduce intermediate links.
Speed up establishing an institutional system for supply & management of medicines in short supply
The guarantee of normal supply & guarantee of medicines in short supply concerns the life of the public, and it is a major livelihood project. To fundamentally solve the problem of supply & guarantee of medicines in short supply in China, it is far from enough to establish a national-level monitoring and early warning system for medicines in short supply, and there exist asymmetry of information in the monitoring and early warning system for medicines in short supply. This is because supply & guarantee for medicines in short supply involves many different links and many entities, including R&D registration, production and circulation, and purchasing and use, and it concerns various aspects, including. patients, medical institutions, production and circulation enterprises and industry associations. In a word, it involves many participating entities, attracts high public concern, and poses high difficulty for solving. Besides establishing a multi-source short supply information acquisition and supply business collaboration platform, to fundamentally solve the problem of supply & guarantee of medicines in short supply in China, the key is to speed up establishing an institutional system for supply & management of medicines in short supply, and to change the situation of extensive management and inadequate supervision by relevant government entities institutionally.
At the end of June 2017, the National Health and Family Planning Commission, National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Commerce, the Ministry of Human Resources and Social Security, the State-owned Assets Supervision and Administration Commission, the State Administration for Industry and Commerce and China Food and Drug Administration, jointly printed and distributed the Implementation Opinions on Improving the Supply and Guarantee Mechanism for Medicines in Short Supply. This is the first state-level guidance document about improving the supply & guarantee mechanism for medicines in short supply, symbolizing the overall launch and implementation of an institutional system addressing and management of medicines in short supply at the state level. Presently, the urgent tasks are: Firstly, for some small-variety medicines in short supply, we should actively promote the building of centralized production bases. Now, relevant entities are speeding up study and preparation of relevant documents. The documents are expected to be promulgated soon, so as to support and guide enterprises to orderly produce clinically indispensable, but small use volume, medicines that are in short supply. Secondly, we should ensure stable supply of upstream raw medicine materials. Many enterprises complain that the management over supply of raw medicine materials must be tightened urgently. The follow-up monitoring of the supply source of raw medicine materials, enterprises’ inventories and transaction activities in the market must be strengthened, emerging issues that signal unfavorable trends shall be judged and assessed comprehensively in order to make timely intervention and addressing, so as to ensure stable supply of raw medicine materials in the upstream.Thirdly, a national and provincial dual-level management system for the list of medicines in short supply must be established, and the management measures for the list of medicines in short supply must be developed and promulgated and the list of medicines in short supply must be developed and promulgated according to the procedures stipulated in the measures, so as to guide local government to establish provincial level management system for the list of medicines in short supply, standardize and clearly define such work processes as selection and argumentation of medicines in short supply, comprehensive assessment, addressing & resolving, and adjustment and improvement. Fourthly, the role of state-owned enterprises in the supply & guarantee of medicines in short supply must be fully developed, the efforts in fighting against behaviors that violate laws or regulations must be increased, so as to maintain good market order, guide orderly participation of all relevant parties, and strive to establish a supply & guarantee system for medicines in short supply with Chinese characteristics.
(The author is a part-time researcher of Shanghai Academy, and a specially invited researcher at the Center for China And Globalization).
