Munroe J Brian
Millennium Pharmaceuticals, Government Relations and Public Policy.
Per Med. 2004 Dec;1(1):9-13. doi: 10.1517/17410541.1.1.9.
The widespread adoption of personalized medicine will require the harmonization of many components: advances in technology; changes in healthcare infrastructure and medical practice convention; improvements in the efficiency and quality of healthcare delivery; diagnostic and therapeutics business models for genetically defined markets; attempts by government and private payers to justify a new genre of tests and drugs; a different approach to regulatory oversight; and, of course, the ethical and legal issues that go along with the extensive use of genetic information in medical records. Personalized medicine is, in fact, a systems-level challenge, in which no single component or stakeholder can hope to push through a coherent and encompassing policy for adoption on its own. The need for a nationwide, multi-industry policy consensus for the next generation of medicine has led to the creation of the Personalized Medicine Coalition - an independent, non-profit organization of over 20 leading pharmaceutical, diagnostic, biotechnology and information technology companies, as well as major academic institutions and governmental agencies. The Coalition provides a structure for achieving consensus positions on crucial public policy issues and serves as a forum for debate and education in personalized medicine.
技术进步;医疗保健基础设施和医疗实践惯例的变革;医疗服务提供效率和质量的提升;针对基因定义市场的诊断与治疗商业模式;政府和私人支付方为新型检测和药物提供合理性依据的努力;监管监督方式的转变;当然,还有医疗记录中大量使用基因信息所引发的伦理和法律问题。事实上,个性化医疗是一项系统层面的挑战,没有任何一个单一要素或利益相关方能够独自推行一项连贯且全面的政策以供采用。对下一代医学达成全国性、多行业政策共识的需求催生了个性化医疗联盟——一个由20多家领先的制药、诊断、生物技术和信息技术公司以及主要学术机构和政府机构组成的独立非营利组织。该联盟为在关键公共政策问题上达成共识立场提供了架构,并充当个性化医疗领域的辩论和教育论坛。