医疗创新改革有望 各国卫生部长需把握良机
Day 1,644, 06:37
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Published in China 
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by Yuan Shikai
65th World Health Assembly to debate binding convention on research and development
第六十五届世界卫生大会将讨论具约束力的研究与开发公约
The world’s health ministers, gathering in Geneva for the World Health Assembly this week, will decide whether or not to start the process for a binding agreement that would jumpstart research and development (R&D) for medical needs that are currently unmet. The international humanitarian medical organisation Médecins Sans Frontières (MSF) urged health ministers to seize the unique opportunity and give the green light to a proposal that has been years in the making. By passing a resolution at the WHA, governments can this week take the first step to making an R&D convention a reality.
各国卫生部长将于本周在瑞士日内瓦出席世界卫生大会（World Health Assembly），决定是否展开程序制定一项具约束力的协议，以促进并未足以应付当前医疗需要的研究与开发工作。国际医疗人道救援组织无国界医生促请各国的卫生官员把握这次难得的机会，通过这份筹备多年的建议书。各国政府可以在本周踏出令研究与开发公约成真的第一步，在世界卫生大会上通过有关决议。
“Medical innovation is not delivering for the needs of people in developing countries. Governments have the power, the responsibility and, from today, the opportunity to change this,” said Michelle CHILDS, Director of Policy/Advocacy at MSF’s Access Campaign. “A clear and compelling case has been made for an R&D convention. World Health Organization (WHO) Member States must get on with starting the process, and not look for excuses to delay.”
无国界医生“病者有其药”项目政策／倡议总监蔡尔兹（Michelle CHILDS）表示：“当前的医疗创新并没有满足发展中国家人民的需要。各国政府有能力和义务，并从今天起有机会作出改变。制定研究与开发公约的理据清晰和迫切。世界卫生组织成员国须继续开展有关程序，不要藉词拖延。”
Today’s system for medical R&D is flawed, in that it is predominantly driven by commercial rewards rather than health priorities. This means that research is steered towards areas that are the most profitable, leaving fundamental medical needs – particularly those that disproportionately affect developing countries like tropical diseases or tuberculosis - unaddressed.
目前的医疗研究与开发系统有缺陷，主要靠商业回报来推动，而非公共卫生的优次考虑。这意味着研究与开发被引导倾向盈利最丰厚的地方，而基本的医疗需要却被置之不理，特别是一些不合比例地影响发展中国家的疾病，如热带病或结核病等。
MSF field teams see the consequences of this every day, and struggle to deliver quality care when appropriate medical tools do not exist. When drugs, diagnostics and vaccines do exist, they are often unsuitable for use in countries where MSF works, as they have been designed for resource-rich countries. Unmet needs include: more effective treatments for drug-resistant tuberculosis; paediatric versions of HIV drugs; a test to determine whether a patient with Chagas disease has been cured; new antibiotics to treat life-threatening infections in the face of increasing resistance; and vaccines that do not need to be refrigerated or can be given without an injection.
无国界医生的前线队伍，每天都看到这缺陷所带来的种种后果，并在缺乏合适医疗工具的情况下，为提供具质素的医疗护理而挣扎。有时即使有药物、诊断试剂和疫苗，但往往不适用于无国界医生工作的国家，因为它们是为富裕国家而研发。未被满足的医疗需要包括：较有效治疗耐药性结核病的疗法、为儿童而设的艾滋病药物、检测美洲锥虫病患者是否痊愈的试剂、应对各种愈来愈耐药的致命感染的新抗生素，以及毋须冷藏或非注射型的疫苗。
“Our field teams know where the medical needs are, but that knowledge isn’t enough to address the gaps,” said Dr. Tido VON SCHOEN-ANGERER, Executive Director of MSF’s Access Campaign. “We need to connect the research priorities with the money, to drive the money spent on medical research to where the needs are and to ensure that the fruits of innovation are affordable and accessible. This is where the R&D convention can bring about transformation.”
无国界医生“病者有其药” 项目总干事冯提多医生（Tido VON SCHOEN-ANGERER）说：“我们的前线队伍知道医疗需要在那里，但这不足以填补当中的鸿沟。我们需要把研究的优次与资金挂钩，以推动将用于医疗研究的资金投放到有医疗需要的地方，并确保创新的成果是有需要的人可以负担和容易获得的。这正是研究与开发公约可带来的转变。”
In April, a report was released by the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), a WHO-convened group of experts mandated to look at medical innovation. They concluded that a binding convention “is needed to secure appropriate funding and coordination to promote R&D needed to address the diseases that disproportionately affect developing countries and which constitute a common global responsibility.”
今年四月，世界卫生组织的研究与开发方面筹资和协调问题的磋商性专家工作小组（由世界卫生组织召开的专家工作小组专责处理医疗创新事宜，Consultative Expert Working Group on Research and Development: Financing and Coordinationm CEWG）发表了一项报告。工作小组总结需要一项具约束力的公约︰“以确保有合适的拨款和统筹，来推广应对不合比例地影响发展中国家疾病的研发工作，以及建构共同的全球责任。”
A convention would bring significant advantages. It would create an evidence-based process to define priorities. Signatory countries would then be bound to invest towards addressing those priorities. Importantly, any research funded thanks to the convention would deliver accessible and affordable products; for example, by ensuring price and supply commitments, adopting flexible licensing policies for developers, and supporting open innovation that would make knowledge available to others.
该公约将可带来重大的好处，建立一套以证据为基础的过程，从而厘定研究与开发考虑的优次。各个签署国将受制约，投入资源应对这些考虑。重要的是，任何受惠于该公约的资助研究，产品将是容易获得和可负担的，例如，透过确保价格及供应的承诺、采取弹性的许可政策授权发展商生产产品、以及支持开放式创新以让知识能广为众人使用。
Over the past ten years, product development partnerships have been created to fill some of the innovation gaps and new funding from philanthropic foundations and governments has been forthcoming. But these efforts are piecemeal and vulnerable.
在过去十年，产品发展合作伙伴的出现，填补了一些创新鸿沟，慈善基金和各国政府的新资金亦陆续有来。但这些努力都很零碎和脆弱。
“We need a more sustainable system, particularly now that donor funds are increasingly scarce,” said Childs. “The convention would encourage a fair contribution from all, but also shape how the money is spent. It should ensure that the money goes further and achieves more by supporting alternative models to stimulate R&D that cost less and deliver medical tools that are accessible and affordable to those that need them”.
蔡尔兹说：“我们需要一个更可持续的系统，尤其是现在捐助机构的资助愈来愈少。公约将鼓励各方作出公平的贡献，也为资金的运用订定方向。公约应透过支持非主流的模式，以刺激研究与开发成本较低，并能够让有需要的人容易获得和可负担的医疗工具，以确保资金的用途更广和达至更多。”
The WHO Framework Convention on Tobacco Control provides a precedent of an internationally binding agreement negotiated and adhered to under the auspices of WHO.
世界卫生组织烟草控制框架公约（WHO Framework Convention on Tobacco Control），已提供了在世界卫生组织的主持下作出洽商和遵守实行的具国际约束力协议的先例。
第六十五届世界卫生大会将讨论具约束力的研究与开发公约
The world’s health ministers, gathering in Geneva for the World Health Assembly this week, will decide whether or not to start the process for a binding agreement that would jumpstart research and development (R&D) for medical needs that are currently unmet. The international humanitarian medical organisation Médecins Sans Frontières (MSF) urged health ministers to seize the unique opportunity and give the green light to a proposal that has been years in the making. By passing a resolution at the WHA, governments can this week take the first step to making an R&D convention a reality.
各国卫生部长将于本周在瑞士日内瓦出席世界卫生大会（World Health Assembly），决定是否展开程序制定一项具约束力的协议，以促进并未足以应付当前医疗需要的研究与开发工作。国际医疗人道救援组织无国界医生促请各国的卫生官员把握这次难得的机会，通过这份筹备多年的建议书。各国政府可以在本周踏出令研究与开发公约成真的第一步，在世界卫生大会上通过有关决议。
“Medical innovation is not delivering for the needs of people in developing countries. Governments have the power, the responsibility and, from today, the opportunity to change this,” said Michelle CHILDS, Director of Policy/Advocacy at MSF’s Access Campaign. “A clear and compelling case has been made for an R&D convention. World Health Organization (WHO) Member States must get on with starting the process, and not look for excuses to delay.”
无国界医生“病者有其药”项目政策／倡议总监蔡尔兹（Michelle CHILDS）表示：“当前的医疗创新并没有满足发展中国家人民的需要。各国政府有能力和义务，并从今天起有机会作出改变。制定研究与开发公约的理据清晰和迫切。世界卫生组织成员国须继续开展有关程序，不要藉词拖延。”
Today’s system for medical R&D is flawed, in that it is predominantly driven by commercial rewards rather than health priorities. This means that research is steered towards areas that are the most profitable, leaving fundamental medical needs – particularly those that disproportionately affect developing countries like tropical diseases or tuberculosis - unaddressed.
目前的医疗研究与开发系统有缺陷，主要靠商业回报来推动，而非公共卫生的优次考虑。这意味着研究与开发被引导倾向盈利最丰厚的地方，而基本的医疗需要却被置之不理，特别是一些不合比例地影响发展中国家的疾病，如热带病或结核病等。
MSF field teams see the consequences of this every day, and struggle to deliver quality care when appropriate medical tools do not exist. When drugs, diagnostics and vaccines do exist, they are often unsuitable for use in countries where MSF works, as they have been designed for resource-rich countries. Unmet needs include: more effective treatments for drug-resistant tuberculosis; paediatric versions of HIV drugs; a test to determine whether a patient with Chagas disease has been cured; new antibiotics to treat life-threatening infections in the face of increasing resistance; and vaccines that do not need to be refrigerated or can be given without an injection.
无国界医生的前线队伍，每天都看到这缺陷所带来的种种后果，并在缺乏合适医疗工具的情况下，为提供具质素的医疗护理而挣扎。有时即使有药物、诊断试剂和疫苗，但往往不适用于无国界医生工作的国家，因为它们是为富裕国家而研发。未被满足的医疗需要包括：较有效治疗耐药性结核病的疗法、为儿童而设的艾滋病药物、检测美洲锥虫病患者是否痊愈的试剂、应对各种愈来愈耐药的致命感染的新抗生素，以及毋须冷藏或非注射型的疫苗。
“Our field teams know where the medical needs are, but that knowledge isn’t enough to address the gaps,” said Dr. Tido VON SCHOEN-ANGERER, Executive Director of MSF’s Access Campaign. “We need to connect the research priorities with the money, to drive the money spent on medical research to where the needs are and to ensure that the fruits of innovation are affordable and accessible. This is where the R&D convention can bring about transformation.”
无国界医生“病者有其药” 项目总干事冯提多医生（Tido VON SCHOEN-ANGERER）说：“我们的前线队伍知道医疗需要在那里，但这不足以填补当中的鸿沟。我们需要把研究的优次与资金挂钩，以推动将用于医疗研究的资金投放到有医疗需要的地方，并确保创新的成果是有需要的人可以负担和容易获得的。这正是研究与开发公约可带来的转变。”
In April, a report was released by the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), a WHO-convened group of experts mandated to look at medical innovation. They concluded that a binding convention “is needed to secure appropriate funding and coordination to promote R&D needed to address the diseases that disproportionately affect developing countries and which constitute a common global responsibility.”
今年四月，世界卫生组织的研究与开发方面筹资和协调问题的磋商性专家工作小组（由世界卫生组织召开的专家工作小组专责处理医疗创新事宜，Consultative Expert Working Group on Research and Development: Financing and Coordinationm CEWG）发表了一项报告。工作小组总结需要一项具约束力的公约︰“以确保有合适的拨款和统筹，来推广应对不合比例地影响发展中国家疾病的研发工作，以及建构共同的全球责任。”
A convention would bring significant advantages. It would create an evidence-based process to define priorities. Signatory countries would then be bound to invest towards addressing those priorities. Importantly, any research funded thanks to the convention would deliver accessible and affordable products; for example, by ensuring price and supply commitments, adopting flexible licensing policies for developers, and supporting open innovation that would make knowledge available to others.
该公约将可带来重大的好处，建立一套以证据为基础的过程，从而厘定研究与开发考虑的优次。各个签署国将受制约，投入资源应对这些考虑。重要的是，任何受惠于该公约的资助研究，产品将是容易获得和可负担的，例如，透过确保价格及供应的承诺、采取弹性的许可政策授权发展商生产产品、以及支持开放式创新以让知识能广为众人使用。
Over the past ten years, product development partnerships have been created to fill some of the innovation gaps and new funding from philanthropic foundations and governments has been forthcoming. But these efforts are piecemeal and vulnerable.
在过去十年，产品发展合作伙伴的出现，填补了一些创新鸿沟，慈善基金和各国政府的新资金亦陆续有来。但这些努力都很零碎和脆弱。
“We need a more sustainable system, particularly now that donor funds are increasingly scarce,” said Childs. “The convention would encourage a fair contribution from all, but also shape how the money is spent. It should ensure that the money goes further and achieves more by supporting alternative models to stimulate R&D that cost less and deliver medical tools that are accessible and affordable to those that need them”.
蔡尔兹说：“我们需要一个更可持续的系统，尤其是现在捐助机构的资助愈来愈少。公约将鼓励各方作出公平的贡献，也为资金的运用订定方向。公约应透过支持非主流的模式，以刺激研究与开发成本较低，并能够让有需要的人容易获得和可负担的医疗工具，以确保资金的用途更广和达至更多。”
The WHO Framework Convention on Tobacco Control provides a precedent of an internationally binding agreement negotiated and adhered to under the auspices of WHO.
世界卫生组织烟草控制框架公约（WHO Framework Convention on Tobacco Control），已提供了在世界卫生组织的主持下作出洽商和遵守实行的具国际约束力协议的先例。
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