跨國藥企從中國醫(yī)藥改革新規(guī)中看到利好

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.

在中國市場上正承受定價壓力的世界各大制藥公司希望，中國擴大藥品準入并加快審批流程將有助于它們提高銷售額。

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.

QuintilesIMS的數(shù)據(jù)顯示，中國已是全球第二大醫(yī)藥市場，2016年銷售額達1167億美元。但是，公共醫(yī)療保險的普及使省級政府在藥品定價上獲得了更大權(quán)力。

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.

多家公司報告在華銷售額增長放緩甚至下降，比如默克(Merck)今年第一季度在華銷售額下降了3%。

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”.

葛蘭素史克(GSK)認為，今年第一季度其“成熟”產(chǎn)品在華銷售額下降5%，部分原因在于其肝炎藥拉米夫定(Zeffix)在中國面臨競爭壓力。去年其在華銷售額就已下降了12%，該公司認為原因在于“包括降價在內(nèi)的醫(yī)療改革”。

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.

阿斯利康(AstraZeneca)表示，今年第一季度其在華銷售額增加7%至7.82億美元，相比之下，2016年和2015年的銷售額增幅分別為10%和15%。

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

賽諾菲(Sanofi)表示，2016年其在華銷售額增長9%，約為上一年增速的一半。

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.

跨國藥企在中國市場遇到困難，核心原因是本世紀頭十年初建立起來的那種模式已經(jīng)瓦解。在那種模式下，中國允許外資藥企以較高價格銷售已過專利保護期的品牌藥品，這類藥品的價格常常是可比普藥的3至5倍。

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.

但是，2011年以后，伴隨著公共醫(yī)療保險的全面覆蓋，這塊市場開始萎縮(納入公共醫(yī)保的藥品最高可報銷80%費用)。公共醫(yī)保體系中包含招標流程，在這個環(huán)節(jié)藥企和省級政府以談判方式確定藥價。自那時以來，由于每個省都把其他省份商定的最低價作為談判起點，藥價有所下降。

“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.

“過去，個別企業(yè)享有特殊地位。如果你有過了專利期的藥，你在定價上會有回旋空間。但那種時候過去了，”中國醫(yī)藥保健品進出口商會(CCCMHPIE)副會長許銘說。外國公司應當“忘掉它們曾經(jīng)享有的特殊地位”，他接著說。

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.

中國80%以上的藥品銷售額來自公立醫(yī)院，過去一年里北京方面頒布了新政策，禁止公立醫(yī)院將它們所分銷藥品的價格定得過高。

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.

經(jīng)費不足的醫(yī)院想方設法以比各省定價更低的價格采購藥品，從而彌補收入減少。北京大學(PKU)衛(wèi)生經(jīng)濟領域的專家劉國恩表示，這導致上述政策成為促使有關(guān)方面在談判中盡量壓低藥價的激勵因素。

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.

醫(yī)療改革對藥企而言的確存在一個亮點：政府分擔醫(yī)藥費降低了患者負擔，讓更多人用得起被納入醫(yī)保報銷范圍的藥品。

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.

今年2月，中國決定在原有的約1200種可報銷西藥的基礎上新增130種可報銷西藥。跨國公司盛贊這一調(diào)整將能增加它們藥品在中國的使用。與質(zhì)量受懷疑的國產(chǎn)非專利藥相比，品牌藥品的賣家往往能獲得報銷方面的優(yōu)先權(quán)。

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.

不過，納入藥品目錄也伴隨著定價壓力，葛蘭素史克去年將其肝炎藥韋瑞德(Viread)在中國的價格降了三分之二，阿斯利康則把抗癌藥易瑞沙(Iressa)的價格降了一半。

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.

去年，多數(shù)跨國公司在華銷售額的增幅都超過中國總體藥品市場的增幅，后者只有1%。這在一定程度上是因為，隨著社會老齡化和變得更加富裕，中國爆發(fā)了新一波慢性病，跨國公司的產(chǎn)品組品更適應這種變化。賽諾菲就表示，其腫瘤學部門是去年的在華業(yè)績明星。

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.

藥企還把希望寄托于能大幅加快藥品審批流程的監(jiān)管規(guī)定草案。在中國，藥品審批流程可能會比歐美多耗5年之久。擬議新規(guī)提出取消藥品境外臨床試驗進入后期階段才能啟動在華審批流程的要求。

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.”

賽諾菲新興市場部門主管奧利維耶•沙爾梅(Olivier Charmeil)表示，這一擬議中的規(guī)定將意味著，藥品在中國能夠與在發(fā)達經(jīng)濟體“幾乎同時”推出。“隨著中產(chǎn)階級越來越富有……他們希望確保能用上最具創(chuàng)新性的藥品。”

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”.

不過，在這方面藥企同樣將面臨定價壓力。中國國務院已表示，新藥通過審批的一個前提是承諾在中國銷售的“價格不高于原產(chǎn)國或我國周邊可比市場價格”。

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

中國衛(wèi)計委表示，今年將就45種主要處于專利期的藥品展開降價談判。