Pressure for cheap drugs
For the billions of potential victims of Aids and malaria in the developing world, a reliable vaccine would be the holy grail. But for the pharmaceutical or biotech company that discovers it, it could be a poisoned chalice.
Owen Barder, who leads a public health programme at the US Center for Global Development, a think-tank, says: “One representative from the pharmaceutical industry told us that in some ways, actually discovering a vaccine for Aids was their biggest nightmare.”
Malaria kills at least 1m people a year and HIV-Aids more than 3m, both mainly in sub-Saharan Africa. But the ambivalence of the big pharmaceutical companies, Mr Barder says, is evidence not of their immorality but of the perverse incentives they face in developing drugs and vaccines mainly of use in poor countries.
The Group of Eight rich countries are hoping to change those incentives. Plans for advance purchase schemes for malaria and Aids vaccines, under which donor countries would provide funds for drug development, could overcome what some see as a glaring failure of the market. The existing system of drug patents is designed to enable companies to recover development costs through the granting of a temporary monopoly. But the incentive for pharmaceutical companies to pour billions into researching and developing drugs is diminished by the ability of poor nations to override patents in case of medical emergency, a power granted to them by international rules on intellectual property rights, and their simple lack of funds. Given researchers have been looking unsuccessfully for an Aids vaccine for more than 20 years, any company that develops one would come under heavy pressure to produce it at a loss for developing countries.
Roger Bate, resident fellow at the conservative American Enterprise Institute in Washington, says research into Aids drugs and vaccines dropped by about a third between 1997 and 2003 after companies were pressed into selling antiretroviral (ARV) Aids drugs cheaply.
“When you have middle-income countries like Brazil sabre-rattling about wanting ARVs at cost price, companies can recoup their research outlays only from markets in the US, Europe, Japan and a couple of other countries,” says Mr Bate. For tropical diseases such as malaria, the market in rich countries, apart from soldiers stationed abroad and frequent travellers, is likely to be insufficient to make the research pay off.
“When you don't have a market you are not going to have much investment in these developing world diseases,” says Bill Gates, the Microsoft co-founder whose family foundation has ploughed billions of dollars into buying vaccines. An advance purchase fund could offer an incentive to invest. The critical element of such a scheme, however, would most likely be a binding legal commitment from donor countries to pay out in the future for a successful vaccine.
If designed intelligently, perhaps with a fee for each inoculation, such a fund could replicate the operation of the market by allowing the latest vaccines to supersede earlier ones rather than awarding the whole prize to the first one developed.
Mr Barder believes a fund of about $3bn for each disease should be enough to encourage development.
Another option might be to allow pharmaceutical companies to extend patents on existing drugs in return for distributing new vaccines cheap or for free.
Even the most fervent advocates of advance purchase schemes recognise their limitations. “Push” mechanisms the direct funding of research through agencies such as the US National Institutes [sic] of Health will still be required to do the basic science. “Pull” mechanisms, such as advance purchase schemes, would be needed later in the process.
Some sceptics question whether such incentives are needed at all. Chris Hentschel, CEO of the Medicines for Malaria Venture, a non-profit, public-private sector alliance, says there is already incentive for companies to develop vaccines, including the billions of dollars available from the Geneva-based global fund for Aids, tuberculosis and malaria. Michael Sinclair, vice-president at the Kaiser Family Foundation, a health policy organisation, says the problem with advance purchase schemes “is that they mortgage resources into the future that are needed now”. But crucially, the industry is showing interest. Jeffrey Kemprecos, director of public affairs for Europe and Africa for Merck, which already has a large Aids vaccine research programme, says: “Signals are very important to the private sector. We all need to take a look at how to turbo-charge the research already being done on tropical disease.”
30亿美金悬赏艾滋病疫苗
对于发展中国家几十亿艾滋病和疟疾的潜在患者，一种可靠的疫苗将成为圣物。可对于开发疫苗的制药公司或生物技术公司，却可能是毒物。
美国智囊机构――全球发展中心（Center for Global Development）公共卫生项目负责人欧文?巴达尔（Owen Barder）说：“一位制药业的代表告诉我们，从某些角度看，研制艾滋病疫苗实际上是他们最可怕的恶梦。”
每年疟疾造成至少100万人死亡，艾滋病及其病毒致死人数为300多万，主要分布在撒哈拉沙漠以南的非洲地区。但巴达尔先生说，制药巨头举棋不定，并非说明它们缺乏道义，而且说明在开发主要用于贫穷国家的药物和疫苗方面，它们缺少适当的动力。
由富裕国家组成的八国集团（Group of Eight）目前希望改变激励措施。根据有关疟疾和艾滋病疫苗的提前预定计划，捐助国将为药物开发提供资金，这可以克服某些人眼中的严重市场失灵。现行的药物专利体系旨在使公司能够通过获准占据短暂的垄断地位，来收回开发成本。由于国际知识产权法规允许贫穷国家在急需药物的情况下侵犯专利权，再加上自身缺乏资金，制药公司投入巨资研发新药的动力日渐减少。考虑到研发人员历经20余年都未能找到艾滋病疫苗，任何一家开发这种疫苗的公司都将面临亏本为发展中国家生产的沉重压力。
罗杰?贝特（Roger Bate）是位于华盛顿的保守的美国企业研究所（American Enterprise Institute）研究员。他说，制药公司受到低价出售抗逆转录（ARV）艾滋病药物的压力后，从1997到2003年，艾滋病药物和疫苗的研究减少了大约三分之一。
贝特先生说：“当你面对巴西等中等收入国家叫嚣着要以成本价格得到抗逆转录药物时，制药公司只能从美国、欧洲、日本以及其他几个国家的市场上收回研发费用。”对于疟疾等热带病的治疗药物，富裕国家市场很可能不足以收回研发成本，因为只有派驻海外的士兵和经常旅行者才需要。
微软公司（Microsoft）合伙创办人比尔?盖茨（Bill Gates）说：“当你缺乏市场时，你就不会向这些发展中国家的疾病投入大笔资金。”盖茨家族基金已投入几十亿美元用于购买疫苗。提前预定基金可以带来投资的动力。不过，此类计划的关键因素最可能在于，捐助国作出具有约束力的法律承诺，今后疫苗一旦研制成功，就必须支付费用。
如果精心策划，或许通过每次均收取接种费，此类基金可以效仿市场运作，允许最新疫苗取代旧疫苗，而不是让第一个开发者独享硕果。
巴达尔先生相信，每种疾病建立一个大约为30亿美元的基金，应该足以鼓励相关治疗药物的开发。
另一个选择可以是允许制药公司延长现存药物的专利期，作为低价或免费分发新疫苗的回报。
即使提前预定计划最热情的倡导者也承认其局限性。为促进基础科学研究，仍需要“推动”机制，即通过美国国家卫生研究所（National Institutes of Health）等机构直接提供研究经费。这一进程的晚些时候则需要“拉动”机制，如提前预定计划。
一些持怀疑态度者提出，究竟是否需要此类激励措施。非赢利性公私合营机构――疟疾药品事业会（Medicines for Malaria Venture）首席执行官克里斯?汉兹契尔（Chris Hentschel）说，对于公司开发疫苗已有激励措施，包括日内瓦全球艾滋病、结核病和疟疾基金提供的几十亿美元。卫生政策组织――凯萨尔家族基金会（Kaiser Family Foundation）副会长迈克尔?辛克莱（Michael Sinclair）说，提前预定计划的问题在于，“他们把现在需要的资源抵押给了未来。”
但关键的是，制药业正表现出兴趣。默克公司（Merck）已设立大规模的艾滋病疫苗研发项目。其欧非公共事务主管杰弗里?坎姆普里克斯（Jeffrey Kemprecos）说：“信号对私营部门非常重要。我们都需考虑如何促进业已展开的热带病药物研究。”
