14 ministries joint release: limit antibiotics abuse comprehensive upgrade-antibiotics, medicine-IT information
On August 25, the State Health Commission, United 14 sectors of China's national development and Reform Commission published the national action plan to curb drug resistance (2016-2020). Document states that "because of new drug research and development capacity, pharmacy prescription sales of antibiotics, medical and farming areas are not rational application of antimicrobial drugs, the pharmaceutical industry and waste standards, public awareness of rational drug use in such a variety of factors, antibiotic resistance has become an acute problem." Target file specified "by 2020, the retail pharmacy prescription sales ratio of antibiotics to reach full coverage. National level II hospital established medical institutions management mechanism of clinical use of antimicrobial agents drug-resistant bacteria growth is effectively controlled. "
National Health Commission medical administration Guo Yanhong, Deputy Director of the HA said: "will launch the ' negative list ' management, prohibitions or restrictions on the use of antimicrobials in clear conditions. Continue to do testing, access to drug-resistant bacteria prevalence and trends, strengthen supervision and publicity efforts, to work or there is a serious problem of regional briefings or interviews. "The logic behind this file can be read as" limited resistance to comprehensive upgrade. "
In fact as early as in 2005, China has established respectively for anti-infective medicines and bacterial drug resistance monitoring system, and bacterial drug-resistance surveillance system has from the original 109 hospitals increased to 1400 hospitals now. For anti-infective drug restrictions, health and family planning in China in August 2011, the Commission issued a three-year limit the use of anti-infective drugs action plan. Provisions of this policy, level-III hospitals of antibiotics used shall not exceed 50, level-II hospital should not exceed 35. In 2012, the resistance limit order to go further. Antibiotics have been rated does not limit use, restrictions on the use and special use three categories. 2015 China health family planning Commission once again issued a document to strengthen anti-limit order execution.
1, a large number of antibiotics business exit
Increasingly stringent regulation and a decrease in use of antibiotics is fundamentally endanger the lifeline of antibiotic production enterprises. And the situation with the "action plan" released, short-term antibiotics likely to change life and death still on the line more minimal.
Thomson Reuters reported that China Shandong Lukang pharmaceutical giants of antibiotic production, Harbin pharmaceutical group, North China Pharmaceutical Corporation and Shanghai pharmaceutical sales are to varying degrees of decline in recent years. Lukang pharmaceutical in June 2016, published a response to Shanghai's securities market regulators for its five consecutive years of profit loss inquiry said in a statement, policies restricting the use of antibiotics, health control fees, market growth slowed and allowed the purchase of a smaller proportion of antimicrobials in hospitals, have contributed to the company profits for the causes.
Lu Kang said in a statement: "in the planning of Twelve-Five, as a series of policy adjustments, Chinese antibiotics market suffered such unprecedented challenges, reduction in clinical usage, and market growth plunged, the main production enterprise sales-Cliff drop. ”
Faced with declining profit margins, enterprises can only alter the development of antibiotics policy. Lukang has been shifted to lipid-lowering and diabetes drug development. It is clear that Lukang can no longer be its antibiotic products as profit growth.
So King bio-technology company said: "I understand those enterprises who are sweeping out antibiotics market. Because new anti-infective drug development time and financial needs huge investment and antibiotic itself is not a therapeutic drug for a long time, so the pricing is not too high, making profit difficult, so a company's return on investment considerations had to change strategy. ”
But he also said the antibiotics market competition, and now, still a lot of space. For anti-infective drug development for the main business too view biotech company, the 1.1 listing approval of a new antibiotic Taigexyn in June 2016 to the CFDA, this product has been approved in Taiwan.
2, limits and encouraged between embarrassing
After the success of the phase I clinical trials ultimately approved the possibility of listing is much larger than the other indications, but on the whole, an antibiotic approved indications more than other less likely. Meanwhile, antibiotic research and development spending was huge, but faces obstacles in clinical use. This makes antibiotics enterprises was embarrassed, and therefore, lack of motivation.
In January 2016, from 18 countries, with more than 80 biotechnology and traditional pharmaceutical companies, and 9 industry organizations jointly signed a statement. The statement called on the Government to abolish current restrictions of the antibiotic r negative. They point out that antibiotics pricing should ensure a reasonable profit margin. Government restrictions and reduce the use of antibiotics, on the other hand looking for companies to increase investment for antibiotic research and development, that the traditional model of making profits tied to sales are no longer applicable in the antibiotics business, Government and business should explore new measures of compensation. New incentives can try new model similar to insurance, that is, when pharmaceutical companies prior to listing a new antibiotic, before they can obtain a risk against the Fund.
Meanwhile, anti-infective drug patents should be expanded. Global antibiotic sales by about $ 40 billion a year, but only $ 4.7 billion for a patented product. In 2014, anti-infective drugs less than 50 product lines, while the big cancer drugs more than 800.
Established for anti-infective drug development of new incentive mechanism has become a consensus in the world.
To address the growing problem of bacterial resistance and issues related to enterprise development, lack of motivation of, United States Congress passed the Bill of antibiotics to stimulate action (GAIN), the Act in order to obtain FDA anti-infectives special certification (QIDP) product provides an additional five years of market exclusivity. QIPD certification can get FDA priority review and expedited review of the right channel.
Up to now, a total of 63 different compounds in got 107 FDA QIDP certification. The past two years, FDA GAIN a Bill already approved under the 5 antibiotics. 2008-2012 years five years awarded only 2 listed antibiotics.
3, flood of antibiotics
United States of antibiotics abuse is very serious. According to the United States by March 2016, published by the Centers for disease control and the Pew Charitable Foundation study shows that United States unnecessary antibiotic prescriptions up to $ 47 million a year, which involved United States one-third of doctor's offices, emergency rooms and hospital clinics. The study also found that the United States 13% outpatients, about 154 million people per year are required to prescribe antibiotics. And many of those people just to cure colds, bronchitis and other viral infections.
Problems of bacterial resistance is a huge challenge for the countries of the world, especially in Asia.
In March 2014, the India Ministry of health will strengthen the regulation of pharmacy sales of antibiotics, clear 24 kinds of antibiotics on the outer packaging must have the "prescription drug" logo. Thailand measures as early as 2007, antibiotic prescriptions in the lower and appeal to the hospital if there are alternative must not use antibiotics. Viet Nam and Korea restricted antibiotic use, minimize the risk of bacterial resistance is more radical.
Misuse of antibiotics in the retail end against bacterial resistance in South America has become the biggest challenge. In Brazil, and Chile, and Costa Rica and Mexico, pharmacies have been banned the sale of OTC antibiotic drugs.
14部委联合出手：限制抗生素滥用计划全方位升级 - 抗生素,医药 - IT资讯
8月25日，国家卫生计生委、中国国家发展改革委员会联合14个部门发布《遏制细菌耐药国家行动计划（2016-2020年）》。文件指出“由于新型抗菌药物研发能力不足、药店无处方销售抗菌药物、医疗和养殖领域不合理应用抗菌药物、制药企业废弃物排放不达标、群众合理用药意识不高等多种因素，细菌耐药问题日益突出”。在行动目标中，文件明确规定“到2020年，零售药店凭处方销售抗菌药物的比例基本达到全覆盖。全国二级以上医院基本建立抗菌药物临床应用管理机制医疗机构主要耐药菌增长率得到有效控制”。
国家卫生计生委医政医管局副局长郭燕红表示：“将推行‘负面清单’管理，明确抗菌药物禁止使用或限制使用的条件。继续做好检测，掌握中国耐药菌流行和变化趋势，加大监督和公示力度，对工作不力或存在严重问题的地区进行通报或约谈。”这一文件背后的逻辑可以解读为“限抗全方位升级”。
其实早在2005年，中国就建立了分别对于抗感染类药物和细菌耐药性的监控体系，而细菌耐药性监控体系已经由最初的109个医院增长到现在的1400个医院。而针对抗感染类药物的限制，中国卫生计划生育委员会在2011年8月发布了一项为期三年的限制抗感染类药物的使用行动计划。这一政策规定，三级医院使用的抗生素不得超过50种，二级医院不得超过35种。2012年，限抗令再进一步。抗生素被分级为不限制使用、限制使用和特殊使用三大类。2015年中国卫生计划生育委员会再次发文强化限抗令的执行。
1、大批抗生素企业退场
日益严格的监管和抗生素使用量的下降正在从根本上危及抗生素生产企业的生命线。而且这一情况随着“行动计划”的发布，短期内抗生素企业改变生死仍然命悬一线的可能性更加微乎其微。
汤森路透报告显示，中国抗生素生产的巨头企业山东鲁抗医药、哈药集团、华北制药和上海医药在近几年的销售均不同程度出现下滑。鲁抗医药在2016年6月发布的一份回应上海证监会市场监管部门对其连续五年利润亏损问询的声明中表示，限制抗生素使用的政策、医保控费、市场增速放缓以及医院允许采购的抗感染药物比例越来越低，都是造成公司利润连续低迷的原因。
鲁抗在声明中说：“在十二五规划中，由于多项政策调整，中国的抗生素类市场遭受了前所未有的挑战，临床使用量减少，市场增速大幅跳水，主要生产企业的销售也断崖式下降。”
面对不断下降的利润空间，抗生素企业只能改变发展策略。鲁抗已经在向降血脂和糖尿病药物研发转移。很显然，鲁抗不能再以其抗生素产品作为利润增长点。
太景生物科技公司企业人士说：“我理解那些正在大举退出抗生素市场的企业们。因为新型抗感染类药物的研发在时间和资金上都需要巨额投入，而抗生素类药物本身又不是长期治疗性药物，所以在定价上也不能太高，这就让盈利变得困难，所以很过公司处于投资回报率的考量不得不改变发展策略。”
但他同时表示，就抗生素药物现在的市场竞争而言，发展空间仍然很多。以抗感染类药物研发为主营业务的太景生物科技公司，其1.1类新型抗生素Taigexyn在2016年6月拿到CFDA的上市批准，该产品已在台湾地区获批。
2、限制与鼓励之间的尴尬
虽然在一期临床试验取得成功后最终获批上市的可能性则比其他适应证要大很多，但从整体来看，一个抗生素的获批可能性要比其他适应证更低。同时，抗生素研发投入巨大，在临床使用上却又面临着重重限制。这让抗生素企业的现状很尴尬，也因此动力不足。
2016年1月，来自18个国家、超过80家生物科技公司和传统制药企业，以及9个行业组织共同签署了一项声明。这一声明呼吁政府取消目前对于抗生素研发投入不利的限制措施。他们指出，抗生素定价应该保证合理的利润空间。政府一方面限制和减少抗生素使用，另一方面又希望企业加大对于抗生素研发的投入，这让盈利与销量挂钩的传统模式不再适用于抗生素企业，因此政府和企业应该探索出新的补偿措施。新的激励措施可以尝试类似于购买保险的新模式，即当制药企业上市一个新抗生素之前，它们可以先获得一笔风险抵御基金。
同时，抗感染类药物的专利权应该扩大。全球抗生素市场销售额每年约为400亿美元，但其中只有47亿美元为专利产品。2014年，抗感染类药物产品线不到50个，而大热的肿瘤药物则超过800个。
建立对于抗感染类药物研发新的激励机制已经在全球成为共识。
为解决细菌耐药性问题日益严重而相关企业研发动力不足的问题，美国国会通过了抗生素激励行动法案（GAIN），该法案为获得FDA抗感染药物特别认证（QIDP）的产品提供额外的五年市场独占期。QIPD认证可以获得FDA优先审评权和快速审评通道。
截至目前，共有63个不同分子化合物拿到了107个FDA QIDP认证。过去两年，FDA在GAIN法案下已经批准上市了5个抗生素。而在2008~2012年五年间，获批上市的抗生素只有2个。
3、泛滥的抗生素
美国的抗生素滥用问题也十分严重。据美国疾控中心与皮尤慈善基金会在2016年3月共同发布的研究显示，美国每年非必要抗生素处方量高达4700万美元，这涉及美国三分之一的医生办公室、急救室和医院诊所。该研究还发现，美国13%的门诊患者，约每年1.54亿人口都要求处方抗生素。而其中很多人只是为了治疗感冒、支气管炎以及其他病毒性感染。
细菌耐药性问题对于全球各国来说都是一个巨大挑战，而在亚洲尤其如此。
在2014年3月，印度卫生部就强化了对于药店抗生素销售的监管，明确24种抗生素在外包装上必须有“处方药”标识。而泰国早在2007年就采取措施，降低医院抗生素处方，并且呼吁医院如果有替代性方案则一定不使用抗生素。而越南和韩国在限制抗生素使用，最小化细菌耐药性风险方面更加激进。
抗生素在零售终端的滥用在南美已经成为抗击细菌耐药性最大的挑战。在巴西、智利、哥斯达黎加和墨西哥，药店已经被禁止销售OTC类抗生素药物。