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.
最近发生的两件事突显了药品监管方面的多个难题。1月中旬，法国雷恩市(Rennes)一场止痛药临床试验不幸出错，致一名男子死亡。去年12月，纽约前对冲基金经理马丁史克雷利(Martin Shkreli)因涉嫌证券欺诈被捕，不过他否认自己有违法行为。此前史克雷利执掌的公司将救命药达拉匹林(Daraprim)的售价从13.5美元一片抬高到750美元一片，令他荣获“全美最可恨的人”封号。
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.
达拉匹林问世于上世纪50年代，专利早已过期。但达拉匹林市场很小，史克雷利的公司又收购了唯一的美国生产商。其他公司要想出售该产品，必须先获得美国食品和药物管理局(FDA)的批准，这一过程需要投入大量时间和金钱。而且这样做企业还会面临一个风险，其产品一旦上市，市面上现有品牌或许会降价，展开掠夺性竞争，这一可能性会阻止潜在进入者。
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.
达拉匹林定价事件是不完善的可竞争经济的经典案例，体现在市场结果不止受到竞争者数量的影响，也受潜在竞争的影响。
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.
准入规定有可能会滋生漫天要价的行为，但雷恩的悲剧提醒了人们，药品需先经过批准再上市发售的逻辑强而有力。20世纪60年代，FDA没有批准沙利度胺(thalidomide)在美国发售，这种药物导致英国和德国数千名婴儿患先天性身体缺陷，这件事证明了谨慎细致的监管审查的价值。
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.
药品上市前需经历标准的（且成本昂贵的）三阶段临床试验过程，雷恩事故发生在第一阶段。很显然，该药过早被投入临床试验，而且此事将带来加强监管的压力。但在行业内外，已经有人理直气壮地批评这些审批程序过于官僚。
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.
对于监管者来说，听凭病人因可能救命的药物推迟发售而死亡，比听凭病人因使用提前发售的危险药物而死亡，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.
正是这些严格且昂贵的临床试验为史克雷利这类人创造了市场机会，并帮助药品行业取得令人羡慕的资本回报率——虽然该行业对此仍抱怨不已。
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.
因此很容易得出这样的结论，既然国家控制了药品上市和市场准入，就必须对药物定价也进行控制。不过对于一种药品来说，怎样才算合理定价呢？药物价格当然应包括对一种有效药物价值的承认，但让某种救命药的受益者按照该药物对他们的价值支付药价，这种提议也不合理。有一部分人相信定价问题可以通过呼吁制药行业表现出理智和公德心来加以解决，达拉匹林价格上涨对这种观念造成了致命打击。
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.
这个问题没有正确答案。虽然很大一部分药品研发支出直接或间接来自国家资助，但在前苏联，国家对制药行业的控制基本没产生创新。
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.
也许我们应该更多地对符合公共利益的发现进行奖励。另外，在全球使用组合手段——监督行业总收入，垄断性采购谈判，一旦发生滥用市场支配地位的情况时削弱这种支配地位——似乎是正确、务实的路线。
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.
药品行业必须认识到，自己负责的对象不止是股东，更是全社会。史克雷利就不明白这一点。雷恩事故是对这些责任的一次提醒。
