Lexchin J
Int J Health Serv. 1994;24(2):253-64. doi: 10.2190/NYKA-UH7E-WBQ4-RD1J.
Over the past decade the Canadian drug approval system has come under intensive scrutiny, with the greatest amount of attention being given to the length of time required to approve new drugs. This issue has obviously also been of considerable interest to the pharmaceutical industry, and the question arises as to whether or not the concerns of the industry may be driving the proposed reforms to speed up the approval process. Both industry and government maintain that quicker approval of new drugs will ensure that Canadians have more rapid access to new medications without sacrificing safety. There are problems with these claims. The number of therapeutically important new drugs introduced annually is less than five and these are already "fast tracked," so the need to speed up approval for all products is dubious. There is also evidence that safety may be compromised with faster approvals. Industry does not need quicker approval times for its financial viability, but getting new, more expensive drugs onto the market more rapidly will increase sales and profit levels. Alternative approaches to dealing with problems such as drug approval times will only be possible when the policy-making process becomes more transparent and open.
在过去十年里，加拿大的药品审批系统受到了严格审查，其中新药审批所需时间受到了最多关注。显然，这个问题也引起了制药行业的极大兴趣，于是就出现了一个问题：行业的担忧是否在推动拟议中的加快审批流程的改革。行业和政府都坚称，更快地审批新药将确保加拿大人能在不牺牲安全性的情况下更快地获得新药物。这些说法存在问题。每年推出的具有治疗重要性的新药数量不到五种，而且这些药物已经在“快速通道”上，因此加快所有产品审批的必要性值得怀疑。也有证据表明，更快的审批可能会损害安全性。行业的财务可行性并不需要更快的审批时间，但更快地将新的、更昂贵的药物推向市场将增加销售额和利润水平。只有当决策过程变得更加透明和开放时，才有可能采取其他方法来解决药品审批时间等问题。
