Emilien G
Laboratory of Pharmacology, Université Catholique de Louvain, Cliniques Universitaires Saint Luc, Brussels, Belgium.
Int J Health Plann Manage. 1997 Apr-Jun;12(2):81-101. doi: 10.1002/(SICI)1099-1751(199704)12:2<81::AID-HPM460>3.0.CO;2-3.
The cost of the development of a new pharmaceutical product from its conception and synthesis through to the regulatory approval process has more than quadrupled in the last 20 years. Both clinical and total development times have increased substantially. To amortize the costs incurred, the pharmaceutical industry has taken an international dimension. The incentives for pharmaceutical firms to discover and develop new drugs depend on the length of the development and regulatory review process plus the potential market size. Recent regulatory, economic and political changes may have significant implications for the future of new drug developments in Europe. The European Union industrial policy felt that there is a need for convergence in the area of pricing. It is recommended that the policy should aim to contain growth in pharmaceutical expenses by means specific to reimbursement rather than direct price controls. By encouraging doctors to prescribe and customers to use generics, competition is enhanced to bring down drug prices. More emphasis is being laid by government in educating customers to cost-awareness and cost-benefit ratios with regard to pharmaceuticals. Concerning clinical trials, European harmonization has been achieved by significant developments: the rights and integrity of the trial subjects are protected; the credibility of the data is established; and the ethical, scientific and technical quality of the trials has improved. Future European health care forecasts a whole change in the pharmaceutical business. Important issues in cost and outcome measurement should be carefully planned and considered in drug development. Due to important mergers and acquisitions, the pharmaceutical sector will consist mainly of important multinational corporations. In this way, valuable new products may be brought to the market.
从新药概念的提出、合成到监管审批过程，开发一种新药品的成本在过去20年里增长了四倍多。临床开发时间和总体开发时间都大幅增加。为了摊销所产生的成本，制药行业已走向国际化。制药公司研发新药的动力取决于开发和监管审查过程的时长以及潜在市场规模。近期的监管、经济和政治变革可能对欧洲新药开发的未来产生重大影响。欧盟产业政策认为在定价领域需要趋同。建议该政策应旨在通过报销方面的具体手段而非直接的价格控制来抑制药品费用的增长。通过鼓励医生开通用名药以及消费者使用通用名药，增强竞争以降低药品价格。政府更加重视教育消费者在药品方面的成本意识和成本效益比。在临床试验方面，通过重大进展已实现欧洲协调统一：试验受试者的权利和权益得到保护；数据的可信度得以确立；试验的伦理、科学和技术质量有所提高。未来欧洲医疗保健预示着制药行业将发生全面变革。在药物开发中，应仔细规划和考虑成本及结果衡量方面的重要问题。由于重大的并购，制药行业将主要由重要的跨国公司组成。这样一来，有价值的新产品可能会推向市场。
