全美最可恨的人 The painkiller tragedy that underlines the need for rules
Two recent events have served to highlight the range of difficult questions raised by pharmaceuticals regulation. Last week, a man died in the French city of Rennes after a clinical trial of a painkiller went tragically wrong. In New York last month, Martin Shkreli, a former hedge fund manager, was arrested on securities fraud charges; Shkreli, who denies wrongdoing, won the sobriquet of “most hated man in America” after the company he controlled raised the price of the life-saving drug, Daraprim, from $13.50 a tablet to $750.
最近發生的兩件事突顯了藥品監管方面的多個難題。1月中旬，法國雷恩市(Rennes)一場止痛藥臨牀試驗不幸出錯，致一名男子死亡。去年12月，紐約前對衝基金經理馬丁史克雷利(Martin Shkreli)因涉嫌證券欺詐被捕，不過他否認自己有違法行爲。此前史克雷利執掌的公司將救命藥達拉匹林(Daraprim)的售價從13.5美元一片擡高到750美元一片，令他榮獲“全美最可恨的人”封號。
Daraprim was developed in the 1950s and the patents expired a long time ago. The market, though, is small and Shkreli’s company had acquired the only US producer. Any other company that decided to sell the product would need to gain approval from the Food and Drug Administration, which would cost time and money. Anyone taking that path would face the risk that, when their product appeared, the incumbent might reduce their price in predatory competition, and this knowledge may deter prospective entrants.
達拉匹林問世於上世紀50年代，專利早已過期。但達拉匹林市場很小，史克雷利的公司又收購了唯一的美國生產商。其他公司要想出售該產品，必須先獲得美國食品和藥物管理局(FDA)的批准，這一過程需要投入大量時間和金錢。而且這樣做企業還會面臨一個風險，其產品一旦上市，市面上現有品牌或許會降價，展開掠奪性競爭，這一可能性會阻止潛在進入者。
The pricing of Daraprim is a textbook example of the problematic economics of contestability — the way in which market outcomes are influenced not just by the number of competitors but by the potential for competition.
達拉匹林定價事件是不完善的可競爭經濟的經典案例，體現在市場結果不止受到競爭者數量的影響，也受潛在競爭的影響。
Regulation that limits entry creates the possibility of price-gouging, but the death in Rennes is a reminder that the logic of requiring approval before drugs are put on sale is compelling. The value of careful regulatory scrutiny was demonstrated in the 1960s, when the FDA blocked US approval for thalidomide , the drug that led to the birth of thousands of babies with physical impairments in Britain and Germany.
准入規定有可能會滋生漫天要價的行爲，但雷恩的悲劇提醒了人們，藥品需先經過批准再上市發售的邏輯強而有力。20世紀60年代，FDA沒有批准沙利度胺(thalidomide)在美國發售，這種藥物導致英國和德國數千名嬰兒患先天性身體缺陷，這件事證明了謹慎細緻的監管審查的價值。
The Rennes incident occurred during the first phase of a clinical trial in the standard (and costly) three-stage process for bringing a product to market. Plainly, this drug was put into testing prematurely and there will be pressure to further strengthen regulation. However, in the industry and outside, some already justly criticise these approval processes for being too bureaucratic.
藥品上市前需經歷標準的（且成本昂貴的）三階段臨牀試驗過程，雷恩事故發生在第一階段。很顯然，該藥過早被投入臨牀試驗，而且此事將帶來加強監管的壓力。但在行業內外，已經有人理直氣壯地批評這些審批程序過於官僚。
It is politically safer for a regulator to allow patients to die because a potentially life-saving drug has been held back than to allow patients to die because a dangerous drug has been released early.
對於監管者來說，聽憑病人因可能救命的藥物推遲發售而死亡，比聽憑病人因使用提前發售的危險藥物而死亡，政治上要更安全。
Such rigorous and costly testing creates market opportunities for people such as Shkreli and, industry complaints notwithstanding, enables the pharmaceuticals sector to report enviable returns on capital.
正是這些嚴格且昂貴的臨牀試驗爲史克雷利這類人創造了市場機會，並幫助藥品行業取得令人羨慕的資本回報率——雖然該行業對此仍抱怨不已。
It is tempting to conclude that, where the state regulates products and market entry, it must also regulate prices. What, though, is a fair price for a drug? Prices should surely include acknowledgment of the value of an effective drug but it would be unconscionable to propose that beneficiaries of a life-saving product pay what it is worth to them. The Daraprim price rise dealt a fatal blow to any belief that the question could be resolved by appeal to the good sense and public spirit of the pharma industry.
因此很容易得出這樣的結論，既然國家控制了藥品上市和市場準入，就必須對藥物定價也進行控制。不過對於一種藥品來說，怎樣纔算合理定價呢？藥物價格當然應包括對一種有效藥物價值的承認，但讓某種救命藥的受益者按照該藥物對他們的價值支付藥價，這種提議也不合理。有一部分人相信定價問題可以通過呼籲製藥行業表現出理智和公德心來加以解決，達拉匹林價格上漲對這種觀念造成了致命打擊。
This is a problem with no right answer. Although much pharmaceuticals spending is directly or indirectly funded by government, state control of the industry in the Soviet Union produced very little innovation.
這個問題沒有正確答案。雖然很大一部分藥品研發支出直接或間接來自國家資助，但在前蘇聯，國家對製藥行業的控制基本沒產生創新。
Perhaps we should make more use than we do (or once did) of prizes for discoveries of public benefit. Otherwise, a mix of devices used around the world — supervision of aggregate industry revenues, monopolistic purchasing negotiations and readiness to undermine dominant positions when they are abused — seems the proper, pragmatic course.
也許我們應該更多地對符合公共利益的發現進行獎勵。另外，在全球使用組合手段——監督行業總收入，壟斷性採購談判，一旦發生濫用市場支配地位的情況時削弱這種支配地位——似乎是正確、務實的路線。
The industry has to understand, as Shkreli did not, that its responsibilities are to a wider community than its own shareholders. The Rennes incident is a reminder of those responsibilities.
藥品行業必須認識到，自己負責的對象不止是股東，更是全社會。史克雷利就不明白這一點。雷恩事故是對這些責任的一次提醒。
