Goodman C S, Gelijns A C
Lewin Group, Fairfax, Virginia, USA.
Baxter Health Policy Rev. 1996;2:267-315.
A distinguishing feature of American health care is its emphasis on advanced technology. Yet today's changing health care environment is overhauling the engine of technological innovation. The rate and direction of technological innovation are affected by a complex of supply- and demandside factors, including biomedical research, education, patent law, regulation, health care payment, tort law, and more. Some distinguishing features of technological innovation in health care are now at increased risk. Regulatory requirements and rising payment hurdles are especially challenging to small technology companies. Closer management of health care delivery and payment, particularly the standardization that may derive from practice guidelines and clamping down on payment for investigational technologies, curtails opportunities for innovation. Levels and distribution of biomedical research funding in government and industry are changing. Financial constraints are limiting the traditional roles of academic health centers in fostering innovation. Despite notable steps in recent years to lower regulatory barriers and speed approvals, especially for products for life-threatening conditions, the Food and Drug Administration is under great pressure from Congress, industry, and patients to do more. Technology gatekeeping is shifting from hundreds of thousands of physicians acting on behalf of their patients to fewer, yet more powerful, managed care organizations and health care networks. Beyond its direct effects on adoption, payment, and use of technologies, the extraordinary buying leverage of these large providers is cutting technology profit margins and heightening competition among technology companies. It is contributing to unprecedented restructuring of the pharmaceutical and medical device industries, leading to unprecedented alliances with generic product companies, health care providers, utilization review companies, and other agents. These industry changes are already having considerable effects on investment patterns and the development, adoption, and use of new technologies. Until recently, new technologies that offered the prospect for health benefit, however, marginal or unproven, were paid for with little or no regard to cost. Technical wizardry alone no longer carries the day in health care. Today's health care market increasingly demands what other markets do--measurable improvements in benefits at acceptable costs--and innovators have begun to respond accordingly. Even so, certain key venues for health care innovation are at risk.
美国医疗保健的一个显著特点是其对先进技术的重视。然而，当今不断变化的医疗保健环境正在彻底改变技术创新的引擎。技术创新的速度和方向受到一系列供需双方因素的影响，包括生物医学研究、教育、专利法、监管、医疗保健支付、侵权法等等。医疗保健领域技术创新的一些显著特点现在面临着更高的风险。监管要求和不断增加的支付障碍对小型技术公司尤其具有挑战性。对医疗保健服务和支付的更严格管理，特别是可能源于实践指南的标准化以及对研究性技术支付的限制，减少了创新机会。政府和行业中生物医学研究资金的水平和分配正在发生变化。财政限制正在限制学术医疗中心在促进创新方面的传统作用。尽管近年来在降低监管壁垒和加快审批方面迈出了显著步伐，特别是对于治疗危及生命疾病的产品，但美国食品药品监督管理局仍面临来自国会、行业和患者的巨大压力，要求其采取更多行动。技术把关正从代表患者行事的数十万医生转向数量更少但更有影响力的管理式医疗组织和医疗保健网络。除了对技术的采用、支付和使用产生直接影响外，这些大型供应商巨大的购买影响力正在削减技术利润率，并加剧技术公司之间的竞争。这导致了制药和医疗器械行业前所未有的重组，促成了与仿制药公司、医疗保健供应商、利用审查公司及其他机构前所未有的联盟。这些行业变化已经对投资模式以及新技术的开发、采用和使用产生了相当大的影响。然而，直到最近，那些有望带来健康益处的新技术，无论其益处多么微小或未经证实，在支付时几乎都不考虑成本。仅凭技术诀窍在医疗保健领域已不再占上风。如今的医疗保健市场越来越像其他市场一样，要求以可接受的成本实现效益的可衡量提升，创新者也已开始相应地做出回应。即便如此，医疗保健创新的某些关键领域仍面临风险。
