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跨国药企从中国医药改革新规中看到利好
Drugmakers hope new rules will slow China sales slide

2017-5-17 14:37| 发布者: 悠儿| 查看: 177| 评论: 0

摘要: The world’s largest pharmaceutical companies, which are struggling with pricing pressures in China, are hoping that wider access to drugs and a faster approval process will boost sales.China is the w ...
The world’s largest pharmaceutical companies, which are struggling with pricing pressures in China, are hoping that wider access to drugs and a faster approval process will boost sales.

China is the world’s second-largest pharmaceutical market with sales worth $116.7bn in 2016, according to QuintilesIMS. But the spread of public health insurance has handed provincial governments greater power over prices.

A range of companies have reported slowing or even falling sales in China, with Merck saying its sales there fell 3 per cent in the first quarter.

GlaxoSmithKline blamed a 5 per cent drop in first-quarter sales of its “established” products partly on competitive pressure on its hepatitis drug Zeffix in China. That came after a 12 per cent decline in its China sales last year that the company blamed on “healthcare reforms including price reductions”.

AstraZeneca said its China sales increased 7 per cent in the first quarter to $782m after sales growth of 10 per cent in 2016 and 15 per cent in 2015.

Sanofi said its sales in China grew 9 per cent in 2016, about half the rate of the previous year.

At the heart of the multinationals’ struggle is the breakdown of a status quo established in the early 2000s that allowed overseas companies to sell at a premium branded drugs that had lost patent protection — in many cases three to five times the price of comparable generic medicines.

But that market began to shrink after 2011 alongside the rollout of public health insurance, which covers up to 80 per cent of the cost of selected drugs. The system includes a tendering process in which companies and provincial governments negotiate prices. Since then, prices have fallen as each province uses the lowest price established elsewhere as the starting point in negotiations.

“In the past different companies have enjoyed special status. If you have off-patent drugs you can have room to manoeuvre in pricing. But that’s gone,” says Xu Ming, vice-president of China’s chamber of commerce for import and export medicines. Foreign companies should “forget about the special status they have enjoyed”, he adds.

In the past year Beijing has rolled out policies banning state hospitals, responsible for more than 80 per cent of pharmaceutical sales, from padding the price of the drugs they distribute.

Underfunded hospitals make up that lost revenue by seeking to buy drugs for less than the prices set by provinces, making the policy “an incentive to negotiate the price to go downward”, says Gordon Liu, a healthcare economics expert at Peking University.

The reform does have a bright spot for the drug companies — the state co-payment cuts costs for patients, making drugs covered by the programme affordable to a wider group.

In February, China added 130 new compounds to the roughly 1,200 eligible for reimbursement. The update was heralded by multinationals as a way to boost the reach of their products in China. Sellers of branded drugs tend to receive reimbursement priority over Chinese generics, which have faced questions about quality.

But joining the list comes with price pressure. GSK slashed the price of its hepatitis drug Viread in China by two-thirds last year, and AstraZeneca halved the price of cancer drug Iressa.

Sales by most multinationals outpaced the overall market last year in China, which saw just 1 per cent value growth. That is partly because their portfolios are more adapted to a new wave of chronic conditions hitting China as it ages and becomes richer. Sanofi says its oncology division was the star performer in the country last year.

Drug companies are also pinning their hopes on draft regulations that could dramatically speed up the approval process for medicines, which can take up to five years longer than in Europe and the US. The regulations propose abolishing a requirement that overseas trials be at an advanced stage before the approval process in China starts.

The proposed rules will mean drugs can be launched in China “almost at the same time” as in advanced economies, says Olivier Charmeil, Sanofi’s head of emerging markets. “As the middle class get richer?.?.?.?they want to ensure access to the most innovative drugs.”

But here too, companies will face pricing pressure: China’s State Council has said new drugs will be approved only on condition “the price is not higher than the country of origin or comparable prices in countries near to China”.

China’s health ministry says 45 mostly on-patent drugs are targeted for price-reducing negotiations this year.

在中国市场上正承受定价压力的世界各大制药公司希望,中国扩大药品准入并加快审批流程将有助于它们提高销售额。

QuintilesIMS的数据显示,中国已是全球第二大医药市场,2016年销售额达1167亿美元。但是,公共医疗保险的普及使省级政府在药品定价上获得了更大权力。

多家公司报告在华销售额增长放缓甚至下降,比如默克(Merck)今年第一季度在华销售额下降了3%。

葛兰素史克(GSK)认为,今年第一季度其“成熟”产品在华销售额下降5%,部分原因在于其肝炎药拉米夫定(Zeffix)在中国面临竞争压力。去年其在华销售额就已下降了12%,该公司认为原因在于“包括降价在内的医疗改革”。

阿斯利康(AstraZeneca)表示,今年第一季度其在华销售额增加7%至7.82亿美元,相比之下,2016年和2015年的销售额增幅分别为10%和15%。

赛诺菲(Sanofi)表示,2016年其在华销售额增长9%,约为上一年增速的一半。

跨国药企在中国市场遇到困难,核心原因是本世纪头十年初建立起来的那种模式已经瓦解。在那种模式下,中国允许外资药企以较高价格销售已过专利保护期的品牌药品,这类药品的价格常常是可比普药的3至5倍。

但是,2011年以后,伴随着公共医疗保险的全面覆盖,这块市场开始萎缩(纳入公共医保的药品最高可报销80%费用)。公共医保体系中包含招标流程,在这个环节药企和省级政府以谈判方式确定药价。自那时以来,由于每个省都把其他省份商定的最低价作为谈判起点,药价有所下降。

“过去,个别企业享有特殊地位。如果你有过了专利期的药,你在定价上会有回旋空间。但那种时候过去了,”中国医药保健品进出口商会(CCCMHPIE)副会长许铭说。外国公司应当“忘掉它们曾经享有的特殊地位”,他接着说。

中国80%以上的药品销售额来自公立医院,过去一年里北京方面颁布了新政策,禁止公立医院将它们所分销药品的价格定得过高。

经费不足的医院想方设法以比各省定价更低的价格采购药品,从而弥补收入减少。北京大学(PKU)卫生经济领域的专家刘国恩表示,这导致上述政策成为促使有关方面在谈判中尽量压低药价的激励因素。



医疗改革对药企而言的确存在一个亮点:政府分担医药费降低了患者负担,让更多人用得起被纳入医保报销范围的药品。

今年2月,中国决定在原有的约1200种可报销西药的基础上新增130种可报销西药。跨国公司盛赞这一调整将能增加它们药品在中国的使用。与质量受怀疑的国产非专利药相比,品牌药品的卖家往往能获得报销方面的优先权。

不过,纳入药品目录也伴随着定价压力,葛兰素史克去年将其肝炎药韦瑞德(Viread)在中国的价格降了三分之二,阿斯利康则把抗癌药易瑞沙(Iressa)的价格降了一半。

去年,多数跨国公司在华销售额的增幅都超过中国总体药品市场的增幅,后者只有1%。这在一定程度上是因为,随着社会老龄化和变得更加富裕,中国爆发了新一波慢性病,跨国公司的产品组品更适应这种变化。赛诺菲就表示,其肿瘤学部门是去年的在华业绩明星。

药企还把希望寄托于能大幅加快药品审批流程的监管规定草案。在中国,药品审批流程可能会比欧美多耗5年之久。拟议新规提出取消药品境外临床试验进入后期阶段才能启动在华审批流程的要求。

赛诺菲新兴市场部门主管奥利维耶?沙尔梅(Olivier Charmeil)表示,这一拟议中的规定将意味着,药品在中国能够与在发达经济体“几乎同时”推出。“随着中产阶级越来越富有……他们希望确保能用上最具创新性的药品。”

不过,在这方面药企同样将面临定价压力。中国国务院已表示,新药通过审批的一个前提是承诺在中国销售的“价格不高于原产国或我国周边可比市场价格”。

中国卫计委表示,今年将就45种主要处于专利期的药品展开降价谈判。

译者/何黎


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