2014年10月21日发布

英国癌症中心(ICR)最近表示目前的医药研发审批流程存在着很大弊端,而这一弊端可能影响到儿童药物安全。根据官方提供的数据,2007年以来,欧盟批准了28种癌症新药,而其中26种被批准用于儿童,这里面又有14种被批准免于进行儿童癌症临床。ICR认为这一现存政策不利于儿童药物安全,并建议欧盟议会重新考虑制定新的规则。


   虽然目前欧盟规定进行儿童临床的药物可以享受更长时间的专利保护期,ICR认为欧盟在这方面仍然有改进的空间。ICR有关负责人表示每年英国有1600名儿童确诊为癌症,而医生如果使用一些没有儿童资料的药物,保险公司可能会以此为理由拒绝买单。


详细英文报道:


  The UK's Institute of Cancer Research (ICR)says the current system acts as a disincentive to drug companies who can seekwaivers to avoid doing the trials.


  Of 28 new cancer drugs approved in the EUfor adults since 2007, 26 could potentially work in children, but 14 have beenexempted from child testing.


  The ICR wants these "classwaivers" to be scrapped.


  The European Commission is consideringwhether to change its guidelines.


  The ICR says the EC should no longer grantpharmaceutical companies exemptions on the basis that the adult cancer that thedrugs treat does not occur in children.


  Although waivers are appropriate when anadult cancer drug will not work in childhood cancers, says the ICR, they areoften granted even when a drug has a broader action and could potentially treatchildhood tumours.


  For example, drugs have been approved fortreating adult cancers linked to certain gene mutations, but the manufacturershave been granted waivers from testing the drugs in children who have cancerslinked to the same gene errors.


  Under current legislation, drug companiesare offered longer market exclusivity if they test their products in children.But the ICR says too few take up this incentive.


  ICR chief executive Prof Alan Ashworth said:"It's essential that ground-breaking cancer treatments are tested not onlyin adults but also in children, whenever the mechanism of action of the drugsuggests they could be effective. That requires a change to EU rules, since thecurrent system is failing to provide children with access to new treatmentsthat could add years to their lives.


  "Modern cancer treatments are oftentargeted at genetic features of the tumour that may be common to a number oftumour types, and to adults' and children's cancers. That means a drugdeveloped for a cancer in adults could also be effective against a canceraffecting a completely different part of the body in children. The way EU rulesare implemented fails to take this into account."


  Once a treatment is licensed for adult use,a doctor can chose to prescribe it "off-label" to a child. Butwithout enough trial evidence to support its use, healthcare providers may notwant to pay for it.


  Around 1,600 children are diagnosed withcancer every year in the UK.


  A spokesperson for the National Institute forHealth and Care Excellence, which sets guidelines for the use of NHS treatmentsin England and Wales, says all children and young people with cancer should beoffered the opportunity to enter any clinical research trial for which they areeligible, and adequate resources should be provided to support such trials.

欧盟希望修改儿童药物审批条件

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