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中国修法为进口仿制药“开绿灯”
China Eases Rules on Cheap Drug Imports to Fight Chronic Diseases

来源:纽约时报    2019-08-28 10:11



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        BEIJING — China said it would reduce the penalties for the sale and import of unapproved drugs, effectively giving poor and critically ill patients the green light to access cheaper generic pharmaceuticals from other countries.        北京——中国表示,将减轻对销售和进口未经批准药品的处罚,此举实际上为贫困和危重病人从其他国家获得更便宜的仿制药开了绿灯。
        The move, announced on Monday, could help fill a gaping hole in the country’s overburdened health care system. For years, Chinese patients and their relatives risked the threat of heavy criminal penalties in their hunt for affordable drugs in a country increasingly suffering from chronic diseases like cancer. In the most desperate of cases, relatives of these patients have resorted to making their own cancer drugs at home using raw pharmaceutical ingredients that they have found online.        周一宣布的这一措施,可能有助于填补中国负担过重的医疗体系的一个缺口。多年来,在这个癌症等慢性病越来越严重的国家,病人及其亲属冒着受严厉刑事处罚的危险寻找价格合理的药物。在最绝望的情况下,有些患者亲属不得不用网上找到的原料药成分在家里自制抗癌药。
        The effectiveness of the new move could depend on the details. The Chinese government said the changes to the current law would take effect on Dec. 1 but did not specify how penalties would be reduced.        新措施的有效性可能将取决于细节。中国政府说,新修订的药品管理法将于12月1日生效,但没有具体说明将如何减轻处罚。
        Chinese law currently holds that drugs not approved by the National Medical Products Administration are “fake,” and companies and individuals caught selling such drugs could be fined up to five times their value as well as criminally charged.        中国目前的药品管理法规定,未经国家药品监督管理局批准的药品都是“假药”,被发现销售假药的公司和个人可能被处以最高五倍于其价值的罚款,并受到刑事指控。
        Selling these drugs may result in a jail sentence of up to three years, even if there are no serious consequences, according to the state-backed China Daily newspaper. Harsher penalties may apply in more serious cases, it said.        据官方的《中国日报》报道,即使没有造成严重后果,出售这些药品也可能导致最高三年的监禁。报道说,对更严重的案例,可能采取更严厉的处罚。
        [How sick people in China break the law to get life-saving drugsbreak the law to get life-saving drugs, as Beijing struggles to provide a safety netstruggles to provide a safety net for more than one billion people.]        [中国病人如何违法获取救命药,同时,政府努力为十多亿人口提供保障措施。]
        Chinese state media said the changes could allow more people to obtain generic drugs from countries such as India without waiting for the approval of official regulators. In China, such drugs are currently purchased through “daigous,” or black market purchasing agents.        中国官方媒体说,这些变化可能会让更多的人从印度等国获得仿制药,而无需等待官方监管机构的批准。在中国,这类药品目前通过“代购”(也就是黑市采购代理)购买。
        “This new move is significant because it redefines ‘fake or counterfeit drugs’ by focusing on their safety and efficacy, not on whether they obtain government approval,” said Yanzhong Huang, a senior fellow for global health on the Council on Foreign Relations, in an email.        “这个新措施意义重大,因为它通过把重点放在药品的安全性和有效性,而不是是否获得了政府批准上来重新定义‘假药’,”美国外交关系委员会(Council on Foreign Relations)全球健康高级研究员黃延中在电子邮件中说。
        “Under the new definition, a cheaper generic drug made in India can be imported and sold in China,” Dr. Huang wrote. “Given that these drugs are usually much cheaper than the prohibitively priced Western patented drugs, a significantly larger percentage of Chinese people can now afford those lifesaving drugs.”        “根据新的定义,更便宜的印度仿制药可以进口到中国、在中国销售,”黄延中写道。“考虑到这些仿制药通常比让人承受不起的西方专利药便宜得多,这意味着相当大比例的中国人现在买得起这些救命药了。”
        According to Dr. Huang, the Indian version of the anti-lung cancer drug Iressa cost $10 a day in 2016, compared to $100 a day for the patented drug in China. He said that generic drugs cost, on average, 97 percent less than patented drugs sold in China.        据黄延中的说法,在2016年,使用印度版抗肺癌药易瑞沙(Iressa)每天所需的费用是10美元,而在中国使用易瑞沙专利药物每天需要100美元。他说,仿制药的费用,平均来说,比在中国销售的专利药的费用低97%。
        The lack of access to drugs has taken on more urgency as the Chinese government grapples with the mounting health problems of its 1.4 billion people. Heart disease, strokes, diabetes and chronic lung disease account for 80 percent of deaths in China, according to a World Bank report in 2011.        随着中国政府努力解决14亿人口日益严重的健康问题,用药难的问题也变得更加紧迫。根据世界银行2011年的一份报告,心脏病、中风、糖尿病和慢性肺病占中国死亡率的80%。
        Cancer diagnoses in China are soaring, and survival rates are low. About 4.3 million cancer cases were diagnosed in 2015, or almost 12,000 cases a day. That is nearly double the rate five years before, according to official figures.        中国的癌症诊断率正在快速上升,而生存率却很低。根据官方数据,2015年,中国确诊癌症约430万例,几乎每天1.2万例,与五年前相比差不多翻番。
        In China, the public has long expressed frustration with their lack of access to effective drugs to treat those kinds of diseases. A 2018 film, “Dying to Survive,” was based on the real-life story of a Chinese leukemia patient who smuggled generic drugs from India to save himself and others. A box office hit, it was almost universally lauded for shedding light on the difficulties of getting cancer drugs in China. The movie’s popularity prompted Premier Li Keqiang to call for speeding up price cuts for the medication.        长期以来,中国公众一直对无法获得治疗这些疾病的有效药表示失望。2018年上映的电影《我不是药神》就是根据一个中国白血病患者的真实故事改编的,他为了挽救自己和他人的生命,从印度走私仿制药。这部电影十分卖座,获得了几乎所有人的称赞,它让人们了解了在中国获得抗癌药品的困难。这部电影的受欢迎程度促使李克强总理呼吁加快抗癌药的降价。
        Even the rich in China contend that red tape and stringent regulatory rules prevent them from getting access to new drugs that are approved in the United States, and many say they are forced to fly overseas for treatment.        就连中国的富人也认为,官僚作风和严格的监管规定阻碍了他们获得已在美国获得批准的新药,许多人说,他们被迫飞往海外接受治疗。
        Yuan Jie, a senior official with the Standing Committee of the National People’s Congress, a top group of Chinese lawmakers, said the decision to redefine the scope of counterfeit drugs was “a response to the concerns of the people,” according to an official transcript.        据官方发布的文字实录,中国最高立法机构全国人民代表大会常务委员会的高级官员袁杰说,重新界定假药范围的决定是“回应了老百姓的关切”。
        In a statement, the National Medical Products Administration said the government would reduce punishment for the distribution of such drugs. If no harm is caused or no treatment is delayed, the parties can be exempt from punishment. And if the circumstances are deemed to be “relatively minor,” the parties involved will face “lighter penalties” if they are importing a “small amount” of drugs.        国家药品监督管理局在一份声明中表示,政府将减少对销售未批进口药的惩罚。不造成伤害或不延误治疗的,可以免责免罚。如果被认为“情节较轻”,而是只是“进口少量”未经批准的药品,涉事者将面临“较轻的处罚”。
        Drug approvals, while accelerating, remain dauntingly backlogged in China. Until October 2017, pharmaceuticals approved in the United States and Europe had to go through an extensive vetting process in China.        尽管中国的药品审批速度已经在加快,但积压的工作仍让人望而却步。2017年10月以前,在美国和欧洲获得批准的药品必须在中国经过涉及范围广泛的审查程序。
        Chen Xi, an assistant professor of health policy and economics at the Yale School of Public Health, said in an email that while China has more than tripled the number of people evaluating new drug applications, “it is still far from meeting the rising and diversifying demand.”        耶鲁大学公共卫生学院(Yale School of Public Health)健康政策与经济学助理教授陈希在电子邮件中说,尽管中国评估新药申请的工作人员数量是原来的三倍多,“但仍远远不能满足日益增长且多样化的需求。”
        Experts said they remain concerned about the enforcement of the law and that the vague terms such as “light penalties” and the lack of a definition of “small amount of unapproved drugs” give the government a lot of leeway to interpret them strictly.        专家说,他们仍然对法律的执行感到担忧,“较轻的处罚”等含糊术语,以及对“少量未经批准的药品”缺乏定义,给政府更严格地解释法律提供了很大的空间。
        Dr. Chen said a more significant step would be to continue improving the efficiency of drug approvals in China and reducing drug prices to meet the demand.        陈希说,更重要的一步是,继续提高中国药品审批的效率,降低药品价格以满足需求。
                
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