First, new drugs should always offer added value – better efficacy, lower toxicity, or greater ease of treatment. Unfortunately, this is not required by current legislation in Europe, where only quality, efficacy, and safety must be demonstrated, without any need for comparative studies.
我们能做些什么呢？首先，新药应该总是提供附加值—更佳的疗效、更低的毒性或更便利的治疗。不幸的是，目前欧洲的立法却没有这样的要求：药物只需证明其质量、药效和安全性，而在比较研究方面却没有任何规定。因此，新药比目前市场上同类药品的实际效果更差的风险也是存在的。