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欧盟希望修改儿童药物审批条件

来源:生物谷 2014-02-13 08:40

2014年2月13日讯 /生物谷BIOON/ --英国癌症研究中心(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研究。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研究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研究资料的药物,保险公司可能会以此为理由拒绝买单。(生物谷Bioon.com)

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 seek waivers to avoid doing the trials.

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

The ICR wants these "class waivers" to be scrapped.

The European Commission is considering whether to change its guidelines.

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

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

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

Under current legislation, drug companies are 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 only in adults but also in children, whenever the mechanism of action of the drug suggests they could be effective. That requires a change to EU rules, since the current system is failing to provide children with access to new treatments that could add years to their lives.

"Modern cancer treatments are often targeted at genetic features of the tumour that may be common to a number of tumour types, and to adults' and children's cancers. That means a drug developed for a cancer in adults could also be effective against a cancer affecting a completely different part of the body in children. The way EU rules are 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. But without enough trial evidence to support its use, healthcare providers may not want to pay for it.

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

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

 

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