原文链接：http://the-scientist.com/2011/01/01/the-profits-of-nonprofit/

重庆医科大学检验系吴珊初译+四川大学生物治疗国家重点实验室陈铁林校正。水平有限请大家指正。

The Profits of Nonprofit

非营利产生的利润

The surprising results when drug development and altruism collide

药物的发售与服务社会相碰撞的意外结果

By Megan Scudellari | January 1, 2011

来自于Megan Scudellari | 2011年1月1日

Victoria Hale, founder of the Institute of One World Health, the first nonprofit pharmaceutical company in the US

POPTECH

Victoris Hale是是美国第一家非营利性制药公司——OneWorld健康研究所的创始人。

In the beginning, they called her a fool. When pharmaceutical chemist Victoria Hale told friends and colleagues that she wanted to start a nonprofit pharma company, they laughed at her, said it was career suicide, that it couldn’t be done. “About 90 percent said that in strong or gentle words,” recalls Hale, who had previously worked at the US Food and Drug Administration and Genentech. “But I knew I wanted to try.”

刚开始，大家都叫她傻瓜。当药物化学家Victoria Hale把她想开一家非营利性的药品公司这个想法告诉周围的朋友和同事们时，大家都笑话她，他们告诉她那在事业上无异于自杀，是不可能实现的。以前供职于美国食品和药品管理局和基因技术公司的Hale回忆说：“大约90%的人都直接或委婉地说了这样的话，但是我知道我想试试。

And so she did. In 1998, Hale wrote a business plan, gathered seed money, and submitted an application for nonprofit status to the IRS. It was denied. Pharmaceuticals are a profitable industry, the IRS replied, so what’s the need for a nonprofit? Frustrated, Hale defended her philosophy for what felt like the hundredth time: Big Pharma makes drugs for Westerners. She, on the other hand, wanted to make drugs for all of humanity—drugs that don’t necessarily pull a profit.

她确实这样做了。1998年，黑尔拟写了一份商业计划书，筹集了种子资金，并向美国国内税务署（IRS）提出了非营利性企业资格证的申请。然而她遭到了拒绝。IRS回复她说：“制药行业原本就是个有经济效益的行业，那么一个非营利性的制药公司有什么存在的必要性呢？”沮丧后，Hale感觉像第一百次那样捍卫了她的信念：大型制药公司为西方人制药，而她则想为全人类制药—没必要一定盈利的药物。

In 2001, the argument finally worked, and the Institute for OneWorld Health became the first nonprofit pharmaceutical company in the United States. Since its inception, iOWH has received more than $200 million from the Bill & Melinda Gates Foundation as well as funds from other philanthropic donors. The socially conscious company has even tugged at the heartstrings of several for-profit pharmaceutical companies, who have agreed to make and distribute drugs developed by iOWH on a no profit, no loss basis. With that backing, the company has already brought to market a drug to treat visceral leishmaniasis—the world’s second-largest parasitic killer after malaria—and developed a pipeline of others designed for scourges of the developing world: malaria, diarrheal diseases, and parasitic worm infections.

2001年，黑尔的坚持终于有了结果，iOWH成为了美国第一家非营利性的药品生产公司。自成立以来，iOWH已经收到了来自Bill & Melinda Gates基金会和其他慈善机构总共超过200万美元的捐款。这家有社会意识的公司甚至拽动了几家营利性制药公司的心弦，他们同意在不盈利也不损失的基础上生产并发行iOWH研发的药物。有了这样的支持，iOWH推出了一种可以治疗内脏利什曼病——仅次于疟疾的世界第二大寄生虫传染病，并且为发展中国家的其他疾病防治开辟了全新的道路，这些疾病包括疟疾、腹泻、寄生虫感染。

iOWH is unusual, but it is not alone. With philanthropists funneling billions of dollars into biomedical research and traditional drug discovery efforts producing fewer and fewer therapies, the line between for-profit and nonprofit life science companies is beginning to blur as both sides of the divide look for new options. More and more for-profit enterprises are experimenting with nonprofit models, while nonprofit organizations look to incorporate for-profit business practices to stay afloat.

iOWH特立独行却并不孤独。随着慈善家将数十亿美元投入到生物医学研究领域和传统药品的开发工作产生的效益越来越少，营利性和非营利性的生命科学领域的公司之间的界限开始模糊因为两边都在寻求新的方向。越来越多的营利性企业正在尝试非营利性的经营模式，同时非营利性组织希望能结合营利性的商业模式得以维持。

“At one time, people in the nonprofit world had a disdain for business, and business people thought nonprofits were without discipline,” says Jack Faris, CEO of the Pacific Northwest Diabetes Research Institute, a nonprofit research center in Seattle, Washington. “People have matured a substantial amount beyond that…There’s much more appreciation of the role that each plays and a readiness to work together.”

“曾经的一段时期内，非营利阵营的人们不屑于商业谋利，商界人士也认为非营利组织是无纪律的，”西北太平洋地区糖尿病研究所是位于华盛顿州西雅图市的非营利性研究中心，其CEO Jack Faris,说，“但是现在人们在这个问题上已经成熟了很多…现在更多的是对彼此工作的认可赞赏和合作意向。

The profits of partnering

    合作产生的利润

Visceral leishmaniasis is a severe disease, transmitted by the bite of an infected sand fly that is almost always fatal without treatment. India accounts for half of all cases recorded worldwide each year, and there, current treatments for the disease cost up to $300. Because such a price would bankrupt the majority of Indians, forcing many to turn to money lenders and put their children in debt, iOWH’s first project was to develop an affordable treatment for the disease, says CEO Richard Chin. But to do that required some drastic changes to the traditional drug development paradigm. “To have affordable drugs, we have to have affordable drug development,” says Chin.

     内脏利什曼病是一种严重的传染病，它通过受感染的白蛉叮咬传播，若不加以治疗就几乎是致命的。印度的病例占了全世界每年所有病例的一半，而且在那里，完全治愈这种病需要高达300美元的花费。由于如此高的价格会使大多数的印度家庭破产，从而导致许多印度人不得不向放债人借贷而把他们孩子作为抵押，所以iOWH的第一个任务就是研发一个让他们负担得起的疾病疗法，”CEO Richard Chin说，但是那样做需要传统药物的开发模式有巨大的改变。Richard Chin说“为了得到低价的药品，我们必须有公司可负担得起的药品研发流程。”

In 2002, the company identified a promising off-patent antibiotic once cast aside by a large pharmaceutical company for its lack of profitability. Since the drug had been previously approved and marketed in the late 1950s as a broad-spectrum antibiotic, iOWH was able to skip directly to a phase III clinical trial to test the drug as a treatment for visceral leishmaniasis. The trial commenced in 2003, and just three years later—record time in the drug development world—paromomycin was approved for sale in India.

    2002年，iOWH鉴定了一种很有前途的专利已过期的抗生素，这种抗生素曾经被一家大型制药公司投产，因经济收益不佳被停止生产。因为这种药品在20世纪50年代末已经作为一种广谱抗生素被批准和销售，One World健康公司能够直接进入第三阶段的临床试验来测试这种药物对心脏利什曼病的疗效。临床试验 开始于2003年，短短三年之后巴龙霉素就在印度被批准出售了—打破了药物研发领域的时间纪录。

iOWH, however, did not have funds for manufacturing facilities to make and distribute the product. So to get the drug to those who needed it, iOWH partnered with a for-profit company in India, Gland Pharmaceuticals, which has agreed to take on those roles for no profit, no loss. With Gland’s help, paromomycin is now available in India and costs $10-15 for the whole 21-injection course of therapy. “It’s a family-run company, and they really care a lot about diseases of the poor,” says Chin. “They’ve been fantastic.”

    然而，iOWH没有资金购买设备来生产和推广这种药品。所以为了能让药物达到需要人的手中，iOWH与印度一家营利性企业Gland制药公司合作，它已经同意在不盈利也不亏损的基础上生产并发布这种药品。在Gland公司的帮助下，paromomycin在印度广为使用并且在21个注射治疗过程中仅花费10到15美元。“它是一个家族企业，他们真的很关心穷人的疾病问题，”查理德金说，“他们真的太棒了。”

BDA Foundation ecopreneurs work in tandem with Pharm Africa to grow and market medicinal plant products.

BDA基金会工作人员与Phram Africa一起合作种植并市场推广药用植物产品。

iOWH has also partnered with other for-profit companies, such as Sanofi-Aventis, to produce an affordable antimalaria drug. Artemisinin-based therapies are currently the most effective treatments for malaria in areas where other treatments have succumbed to drug resistance. The supply of artemisinin, however, is contingent on the labor- and time-intensive process of harvesting and processing wormwood in Asia and Africa. iOWH’s semisynthetic version of the antimalaria drug has entered the commercial scale-up process and is on schedule to be manufactured by Sanofi-Aventis for no profit, no loss, by 2012.

     iOWH也跟一些其他的营利性企业合作，比如Sanofi-Aventis公司，来生产低价的抗疟疾药物。在某些地区，由于其他疗法不能克服耐药性，，所以以青蒿素为基础的疗法成为了那里最有效的疗法。但是，由于在亚洲和非洲青蒿的采集和加工是劳动力和时间密集型，青蒿素来源不稳定。iOWH的抗疟疾药的的半合成方式已经进入商业扩大规模阶段，并且计划到2012年由Sanofi-Aventis公司在无盈利和无亏损情况下生产。

“This type of partnership is very new,” says Henri Farret, past director of the artemisinin project at Sanofi-Aventis. “This is the first time we’ve worked in such a way with a nonprofit pharmaceutical company, but we do it to cure big diseases in developing countries.”

     “这种合作模式很新颖，”曾任Sanofi-Aventis公司青蒿素项目总监的Henri Farret说，“虽然这是我们第一次同非营利性制药公司做这样的工作，但是我们是为了遏制发展中国家的恶性疾病。”

Other nonprofits have also taken to collaborating with for-profit companies, often very closely, to achieve their goals. The Montreal-based Biotechnology for Sustainable Development in Africa Foundation, for example, works in tandem with its for-profit sister company PharmAfrican to build an industry for medicinal-plant products in Africa. The nonprofit foundation teaches medicinal-plant farmers in Africa to build and launch businesses, while the for-profit arm develops and commercializes products from the region.

    其他非营利组织也采取了跟营利性公司合作的方式实现他们的目标，且这种合作往往是非常密切的。比如总部设在Montreal的可持续发展生物技术非洲基金会，同它的营利性姐妹公司Pharm African公司在非洲建立了一个药用植物产品产业。非营利性基金会教非洲地区种植药用植物的农民建立和开始贸易，而营利性公司则从这个地区开发并商业化这些产品。

The Pacific Northwest Diabetes Research Institute in Seattle, Washington, one of many nonprofit research centers in the Northwest, uses a slightly different strategy, hosting innovative for-profit companies in their own headquarters, and providing workspace, access to equipment, and encouraging interaction between scientists at the for-profit companies and the nonprofit researchers.

    位于华盛顿州西雅图的西北太平洋地区糖尿病研究所——西北地区众多非营利性研究中心之一，运用了一种稍有不同的策略，他们在自己的总部创办了新型的营利性公司，提供工作场所，相关设备的使用机会，并鼓励营利性公司的科研人员和非营利性组织的科学家之间的沟通互动。

“These days, we’re interested in building on our internal assets in a whole array of partnerships,” says Faris, CEO of the institute. “We’re looking for ways to collaborate with for-profit and nonprofit enterprises to do more creative and powerful things.”

    “这些天，我们对在大量伙伴关系中建立自己内部财产很感兴趣，”研究所的首席执行官Faris说，“我们正在寻找合作方式来联系营利性和非营利性企业做更多创新和强大的东西。”

Going pharma free

    让制药更自由

Though the idea of a nonprofit pharmaceutical company is still new, nonprofit foundations and institutes have long been a staple in biomedical research funding in the United States. But they too are breaching the barriers between profit and nonprofit, adopting best practices from the for-profit business world.

     虽然经营一个非营利性制药公司这个想法是先进的，长期以来非营利性基金会和研究机构都是美国生物医学研究经费的主要部分。但是他们也正在打破营利性和非营利性之间的隔阂，从营利性的商业领域里吸收最佳的做法。

The Acumen Fund, a nonprofit venture fund that seeks solutions for global poverty, invests philanthropic funds in for-profit businesses that have a social impact in the developing world, such as Botanical Extracts EPZ Limited, a private Kenyan company that works with local farmers to produce artemisinin. Any returns on investments are funneled into new investments, maintaining the company’s nonprofit mission to alleviate global poverty. “We want to recycle the money, because we think it’s a more efficient use of philanthropic capital,” says Yasmina Zaidman, director of communications for the Acumen Fund.

     Acumen基金会，一个旨在消除全球贫困问题的非营利性风险投资基金会，它在发展中国家中有社会影响的营利性企业中投入慈善基金，比如EPZ有限公司，肯尼亚一家与当地农民合作生产青蒿素的私人企业。每次投资的回报都会作为基金注入到新的投资中，来维持公司消除全球贫困的非营利性的使命。Acumen Fund公关主任Yasmina Zaidman说： “我们想让钱循环起来，因为我们认为这是让慈善资金更有效利用的一个途径。”

Similarly, Scott Johnson, a businessman with no medical background, uses the business savvy he accrued from decades of working as a serial entrepreneur to run a nonprofit foundation as a business. “It struck me that by applying some business principles, you could speed up all elements of the drug discovery process,” he says.

    同样的，Scott Johnson是一位没有医学背景的商人，他运用自己做跨行企业家几十年的工作经验练就的商业头脑，作为业务来运营非营利性基金会。“这让我吃惊，运用一些商业经营方式，你可以加快药物发现过程中的所有要素。”他说。

“The definitions of for-profit and nonprofit are less useful than they were. It’s a brave new world of creative structures and financing mechanisms.”

—Yasmina Zaidman, Acumen Fund

    “定义非营利性和营利性没太大意义，这是一个勇敢的创造性结构和融资机制的新世界。”——Yasmina Zaidman，Acumen Fund

In 2003, Johnson, who has had multiple sclerosis for 34 years, founded the Myelin Repair Foundation in Saratoga, California. He put together a “dream team” of PIs studying myelination and set up a board of industry professionals to help them identify and prioritize targets that come out of the lab. The company was formed as a nonprofit partly to attract the PIs, who didn’t want to be associated with a for-profit company, but also for research freedom. In contrast to for-profit biotechs, which are typically “encouraged” by funders to tackle just one or two promising targets, Johnson says, “we, as a nonprofit, can move dozens of targets forward with a variety of corporate partners,” offering the best chance at a real therapy rather than a real profit.

    2003年，曾患有多发性硬化症34年的Johnson，在加利福尼亚州萨拉托加成立了髓鞘修复基金会。他组成了一个髓鞘研究的主要研究员”梦之队”并促成一个产业专家委员会来帮助他们鉴定并优化出自实验室的药物靶点。这个公司定位为非营利性的组织来吸引那些不愿意参与营利性公司却还是希望能自由的进行研究的主要研究员。与那些典型的因为投资者的“鼓励”而去实现一两个有价值的药物靶点的营利性生物技术公司相比，Johnson说,“我们，作为一个非营利性机构，可以跟众多的合作者向很多药物靶点迈进，”在真实治疗而不是真实利润方面提供最好的机会。

“It’s a wonderful entity,” says Brian Popko, a neurologist at the University of Chicago and a PI with the foundation who has been developing a new animal model for demyelination. “The infrastructure is there to move discoveries that occur in our basic science labs forward to therapeutic uses.”

   “它是一个美妙的实体，” ——芝加哥大学的一位神经学主要研究者Brian Popko也是用这个基金研发出脱髓鞘病变新动物模型的，他说：“这里的基础设施将我们技术科学实验室的发现转化应用到治疗使用中。”

The model has already proven its worth: in the last five years, the company has produced 19 new myelin-repair drug targets, 18 patentable inventions, and more than 50 papers; and over 60 research organizations have expressed interest in the model, according to Johnson. The advantages of the structure are real, says Popko. “I think it will catch on.”

    这个模型已经证明了自身的价值：在过去的五年里，该公司已经生产出了19个新型髓鞘修复药物靶点，18项专利发明，和50多篇的论文：并且超过60家的研究机构都表达了对这种这个疾病动物模型的兴趣，据约翰说。这个基金会的框架优点是真实存在的，帕克说，“我认为它会发展起来。”

But embracing for-profit’s best practices may pose a serious threat to the mission of nonprofits, warns Bill Landsberg, an attorney for AspenPointe, a large conglomeration of nonprofit mental health companies in Colorado Springs, Colorado. In 2004, Landsberg warned that his own organization’s mission was at stake when he witnessed a shift toward business priorities, including an influx of MBAs with no clinical background into the organization’s top ranks and a shift in focus from the companies’ patients to financial issues.

    但是这种包容营利性的最佳做法可能会对非营利性的原始使命带来严重威胁，位于科罗拉多州斯普林斯的非营利性心理健康研究的大型集团AspenPointe公司的律师Bill Landsberg,警告说。2004年，Landsberg警告到，当他目睹一场向优先商业的转变，包括大量没有临床医学背景的MBA进入组织的高层和公司的焦点从病患变成了财务问题，他感到自己的组织的原始使命受到了威胁。

In response, the CEO of AspenPointe, formerly called Pikes Peak Mental Health, made an effort to keep the mission in the forefront of all dealings, says Landsberg. Today, mental health clients routinely visit board meetings to share their recovery stories, and posters of clients dot the boardroom. “They’re right there, staring us in the face,” says Landsberg. The CEO “never lets it get out of our minds,” he adds.

    为了避免上述问题， AspenPointe公司——原名为Pikes Peak Mental Health公司的CEO尽最大努力让原始使命作为一切经营的前提，Landsberg说。现在，公司的客户定期参加董事会议来分享他们的康复故事，并且用客户的海报来装饰会议室。“他们就在那里，盯着我们的脸，”兰茨贝格说。CEO一定不会让我们忘记使命，他补充到。

Victoria Hale has also made a move toward borrowing business strategies, this time not only to enable nonprofits to develop drugs, but to make and market them without Big Pharma’s help. In 2008, she left iOWH to found a “second-generation” nonprofit pharmaceutical company called Medicines360. With a focus on women and children’s health, Medicines360 aims to become self-sustaining over time, using revenue from sales of its products at a premium price in the West to subsidize the same products for those who can’t afford them in developing countries. The company is currently developing an intrauterine device (IUD) for contraception.

     Victoria Hale也朝着借鉴商业策略迈进了，这次不仅要让非营利性组织研发药物，还要让它摆脱大型制药公司的帮助独立生产和销售药品。2008年，她离开OneWorld健康公司创立了“第二代”非营利性制药公司——Medicines360公司。以妇女和儿童的健康为关注点，Medicines360公司旨在渐渐成为自给自足的公司，用在西方国家以较高价格销售产品的收入来补充为发展中国家无法担负药品价格的人同样的产品。这家公司目前在研发用于避孕的宫内节育器。

“We’re learning that the definitions of for-profit and nonprofit are less useful than they were,” says Acumen Fund’s Zaidman. “It’s a brave new world of creative structures and financing mechanisms.”

    “我们正在学习，定义营利性和非营利性不是很重要，” Acumen Fund的Zaidman说，“这是一个勇敢的创造性结构和融资机制的新世界。”

HYBRID HAVEN?

二者兼容的天堂

“Technology is way advanced, and it’s the business models that are lagging way behind, limiting what social entrepreneurs are able to accomplish,” says Victoria Hale, founder of two nonprofit pharmaceutical companies. Yet today, a few emerging hybrid business models may allow companies to combine their altruistic and business interests in a single company. In 2006, the United Kingdom passed legislation creating community interest companies (CICs), allowing proprietors to run a for-profit business for the benefit of the community. The model has readily caught on—close to 4,400 CICs have been registered across the UK.

   “技术是先进的,且是商业模式却是落后的后面，它限制了社会企业家能够完成的，”创立两家非营利性制药公司的Victoria Hale说。然而今天，一些新兴的混合商业模式也许可以让公司将无私造福他人的愿望和商业利益联系在一个公司内。2006年，英国通过了建立社会利益公司（CICs）立法，允许股东运行一个造福社会的营利性商业活动。这种模式已经被接受了——有接近4400个这种公司在英国注册。

In the United States, L3Cs, low-profit, limited-liability companies, now bridge that gap. Eight states have passed legislation that permits the creation of L3Cs—defined as socially beneficial for-profit ventures. Many companies have adopted the status, including alternative-energy companies, newspapers, and food companies, but no pharmaceutical or biotech company has yet attempted the model, according to L3C experts. That’s not to say they won’t, however.

—M.S.

   在美国，L3Cs，低利润，有限责任公司，衔接了这个缺口。八个州已经通过法案，承认L3Cs的存在——被定义为服务社会的营利性企业。据L3C 的专家说，许多公司都接受了这样的法律定位，包括能源替代公司，报刊，食品公司，但是制药或者生物技术公司还没有尝试这种模式。但是，那并不是说他们不会那样做。

—M.S.