雙語閱讀-經濟學人20180830期-中國醫藥改革

Swallowing bitter pills

吞咽更苦的藥品

China is sprucing up its pharma sector

中國醫藥改革

The changes are helping multinational drugmakers. In time they may boost the domestic industry.

這項改革正在幫助多國的製藥廠——促進國內產業。

China is home to 1.4bn people. The population is ageing, and thus more vulnerable to ailments. Sustainable economic growth is making the country richer, and more able to afford remedies. To foreign pharmaceutical firms, this looks like a winning combination. They are less keen on protracted review times, onerous rules and the reams of paperwork required to sell drugs in China. It can take a decade after approval in America for foreign drugs to reach Chinese patients.

中國有14億人口，人口逐漸老齡化，因此也將面臨越來越多的疾病。持續的經濟增長使得中國越來越富有，也比以前能負擔更多的醫療支出。對於國外的製藥公司來說這似乎是一件好事。國外製葯公司在中國出售藥品不再需要他們不太喜歡冗長漫長的審查時間、複雜的規定和在中國銷售藥品所需的大量文字材料——同樣的藥品在美國通過審批後可能需要長達十年時間才能到達中國病人的手中。

The Chinese authorities at last appear to have acknowledged the problem-and are administering a cure in doses that have surpassed even optimists』 expectations. A reinvigorated regulator is waving through drugs from abroad, and clamping down on unscrupulous domestic companies. The government is spending more on drugs, including foreign ones, as it expands public health care. It is letting market forces weed out frail local firms. In other words, China is becoming a more normal market. Global drugmakers are rubbing their hands. By some estimates China became the second-largest global consumer of medicines in 2017. The market is worth $122.6bn, according to IQVIA ,a research firm.

最近，中國官方似乎承認了這個問題，並正在批准一大批方案，這些方案甚至超過了樂觀者們的期待。一項重新提出的規定將向進口葯敞開懷抱並取締那些不合格的國內製葯公司。隨著公眾醫療覆蓋範圍的不斷擴大，政府在醫藥上的支出越來越多，也包括在進口葯上的支出。市場規則逐漸淘汰一些弱小的國內製葯公司。也就是說，中國正在成為一個越來越規範的市場。全球的製藥廠都摩拳擦掌。一些估算表明，2017年，中國已經成為全球第二大藥物消費國。根據市場調查公司IQVIA的調研，中國的藥物市場價值1226億美元。

The normalization owes a lot to the overhaul of the China Drug Administration (CDA). Under Bi Jingquan, who took over the regulator in 2015, the CDA introduced fast-track review for drugs for unmet medical needs, ditched the requirement to perform clinical trials with Chinese patients in state-run Chinese labs and relaxed rules that obliged many firms to invest in local factories. The CDA has also joined a global body which harmonises the way drugs are assessed. It is adopting international standards for the collection of clinical data. In three years Mr Bi accomplished what would normally take three decades, gushes Lu Xianping, the co-founder of Chipscreen Biosciences, a Chinese biotechnology firm.

藥物市場的規範化在很大程度上歸功於中國藥品管理局的大改革。畢井泉從2015年開始接管葯監局，在他的管理下，CDA引進了急需藥物的快速審查機制，摒棄了原有的新藥物需在國家實驗室對中國病人開展臨床試驗的要求，還放鬆了關於公司投資本地工廠的規定。CDA還加入了一個改善藥物評估方式的全球機構，正在採用國際化標準來收集臨床數據。Chipscreen生物科技公司是中國一家生物技術公司，其聯合創始人盧先平說，畢先生在三年內做成了通常需要三十年完成的事。

For foreign drugs firms this means quicker and cheaper drug approval. The approval in March last year of AstraZeneca』s lung-cancer drug, Tagrisso (osimertinib), came seven months after regulators in developed markets gave theirs-「a very different timeline」 compared with the past, confirms Sean Bohen, head of global medicines development at the British firm. On August 20th Roche, a Swiss company, secures Chinese consent for its own lung-cancer drug, Alecensa (alectinib), less than nine months after it launched in the West.

對於國外藥品公司來說，這意味著藥品審批流程更快、花費更少。去年三月，AstraZeneca公司的肺癌葯Tagrisso (osimertinib)的審批通過僅比發達國家晚7個月。Sean Bohen是這家英國公司的全球藥品研發老總，他強調說相比以前這是一個非常不同的時間表。8月20日，瑞士羅氏公司與中國共同保證肺癌葯Alecensa (alectinib)在中國的上市不晚於西方9個月。

As well as these regulatory changes, China』s national insurance scheme has expanded to cover most citizens. Although patients remains on the hook for part of the cost of the priciest treatments, the government is coughing up for more high-end drugs. In May the government extended patent protection for pharmaceuticals by five years, to as much as 25 years. It also removed import tariffs on cancer drugs and cut it on other medicines, despite trade tensions with America.

除了這些規定的變化，中國的國家保險制度也不斷擴展到大部分公民。儘管許多病人依然無法負擔部分價格昂貴的治療方案，政府還是在不斷實施更加先進的藥物。5月，政府將藥品專利保護延長了5年至長達25年。同時，儘管目前與美國存在貿易摩擦，政府還是對抗癌藥實施了進口零關稅，同時降低了其他藥物的進口關稅，。

The Chinese authorities do demand steep discounts on the prices of expensive treatments. Across 36 premium drugs that were included on the national reimbursement list last year, producers had to swallow price cuts of 44% on average, relative to the previous year』s average prices, calculates IQVIA. But firms are making up for lower margins with mammoth volumes. Deutsche Bank reckons that in the first quarter of 2018, the top 20 global pharma firms saw Chinese sales grow by 18% compared with last year. This was chiefly thanks to newly approved drugs.

中國當局確實需要對昂貴的治療方案給予大幅降價。IQVIA對去年國家補貼清單上的36種基本藥物價格進行了計算，相比去年，製藥廠平均需要降價44%。但是製藥公司能夠通過巨大的市場規模彌補利潤率的降低。德意志銀行估計，2018年第一季度，全球前20大製藥公司在中國的市場規模較去年增長了18%，這主要是由於新藥物的審批通過。

Big Pharma thus has reason to cheer the shake-up; local drugmakers less so. Chinese producers of low-quality copycat drugs have been slow to meet the CDA』s tougher new manufacturing standards and the requirement to prove their pills are biologically equivalent to the original drugs. Unblocking of the backlog of 22,000 applications for approval for sale (by foreign and domestic firms) will stiffen competition, which weaker firms may struggle to withstand. A programmme to verify clinical-trial data appears to have curbed flaky applications. Mr Lu thinks that in the next five to ten years, half of China』s 4,000 pharma companies could die as a result of the changes.

大型製藥公司因此有理由為這種形勢轉變歡呼，而本地製藥廠則相反。中國國內生產低版本仿製葯的公司越來越難以達到葯監局較以往更為嚴格的新生產標準，也難以提供對於其生產的藥物在生物學方面與原藥物具有相同效果的證明。而若此前積壓的國內外製藥廠22000項藥物銷售申請通過將使得競爭更為殘酷，因此較為弱小的公司可能會提出抗議。驗證臨床試驗數據的程序可能會阻礙那些簡單的申請。盧先生認為接下來的5到10年間，中國4000家製藥廠可能會有一半因為這些變化而倒閉。

That appears to be the point. Hong Chow, general manager of Roche in China, reports that she has heard a government official say:」 Better short-lived pain than a long one.」 The tough love is meant to let laggards wither and innovators flourish. It is having an effect: perhaps 50 local generics firms are transforming into research-driven ones and more biotechnology companies are being founded, often by Chinese returning from stints at foreign companies. A decision by the Hong Kong stock exchange earlier this year to allow firms to list before they turn a profit will encourage Chinese biotech startup to seek capital at home rather than abroad.

這似乎就是問題的關鍵。羅氏製藥中國總經理Hong Chow說她聽到以為政府官員說「長痛不如短痛」。嚴格的愛就意味著讓落後者淘汰讓創新者繁榮。這種效果已經開始出現：大概有50家本地仿製葯公司開始轉型為研發驅動型企業，新成立的生物科技公司也越來越多——這些公司通常都是由在國外公司工作多年的人士回國建立的。香港股票交易所在今年早期出台一項決定允許公司在盈利前就納入交易列表，這將鼓勵中國的生物技術創新公司在國內尋求融資而不需要去國外融資。

In the longer term that should spell stiffer competition for foreign drugmakers. Mr Bohen says that it is only a matter of time before a Chinese discovery in basic science leads to a new drug sold by a Chinese firm. Mark McDade of Qiming Venture Partners, a big health-care investors in China, points to top–notch Chinese research in cancer therapies known as CAR-T. The number of molecules approved for clinical trials in China has ballooned.

從長期來說，國外製藥廠將面臨更嚴峻的競爭。Bohen先生說，由中國公司銷售中國的基礎科學研發出來的新藥物只是一個時間問題。Qiming風險合夥公司是中國一家大型健康投資公司，Mark McDade指出中國自主研發的尖端癌症治療方案CAR-T就是其一。在中國，被批准進行臨床試驗的分子數急劇增長。

The speed of change is not guaranteed. Developing new drugs is an uncertain, lengthy process. Mr Bi, the regulator who championed drug quality, was ironically one of those forced to resign in August after hundreds of thousands of children were discovered to have been given ineffective vaccines. Reforms to the CDA still have a long way to go. The agency has only just begun harmonizing its rules with those of foreign counterparts. The goal of having 289 generics pass bioequivalence tests by the end of the year is optimistic.

改革的速度卻是無法保證的。開發新藥物是一個不確定且漫長的過程。畢先生作為大力倡導藥物質量的管理者，在8月由於成千上萬兒童被注射無效疫苗事件的曝光而成為了被強制免職的官員之一。葯監局的改革之路依然漫長。機構僅僅開始了對於國外藥廠的規則調整。而今年年內289項仿製葯通過生物等效性檢驗的目標顯得過於樂觀。

Franck Le Deu, a senior partner with Mckinsey, a consultant, foresees a period of uncertainty following Mr Bi』s sudden departure. The direction of reform is unlikely to change but its pace or focus might, he notes. That in turn will determine how long the boom times last for foreign pharma firms in China.

Franck Le Deu是麥肯錫的高級合伙人及顧問，據他預測，畢先生的突然離開將會給葯監局帶來一段時間的不確定性。改革的方向可能不會改變，但改革的速度和焦點可能會發生變化。這也決定了國外製藥廠在中國還有多長的繁榮期。