Loophole in EU Regulation Means Under-18s With Cancer Will Be Denied Life-Saving Drugs

life-saving drugs

The EU really seems to have outdone itself in terms of misplaced and dangerous legislative action. In one of its more controversial decisions, the EU has decided to prevent under-18s diagnosed with cancer from receiving potentially life-saving medication. 

This immoral position is based on the fact that EU rules currently allow the trial of some drugs on adults, but not on children. This Tuesday, the UK’s Institute for Cancer Research (ICR), the country’s leading centre for research on paediatric cancer, expressed their opposition to these unjustified EU exemptions.

Now these are drugs in questions have already been shown to benefit adults, so this loophole in EU law comes at a devastating cost to children with cancer, who without this treatment will continue to suffer and lose out on what could be a long, healthy and fulfilling life. 

Many medical experts reject this loophole. They argue that it rests on the false assumption that adult cancer targeted doses do not apply to children. Professor Alan Ashworth, Chief Executive of The Institute of Cancer Research, London, 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.

According to the ICR, 26 out of the 28 drugs approved for use in adults in Europe have potential benefits for children, yet 14 have been denied to them since 2007. These exemptions are in the interests of the pharmaceutical companies, since testing these drugs on under-18s would be extremely expensive. So here we have a case of Big Pharma lobbying the EU for its own financial interests, at the expense of the incredible benefits and life-saving opportunities that these miracle drugs will provide for many children. And these are all drugs which, as far as the evidence suggests, would be equally effective for children as they are for adults.

This loophole in EU law appears to have no scientific basis to it. As Professor Ashworth goes on to explain:

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.

This comes from evidence that cancers are not a disease specific to an organ, but are driven by genetic changes, the outcome of which can vary depending on age. For example, a mutation of the gene ALK in adults can result in lung cancer for adults, whilst in children, it can result in cancer of the nerve cells. Therefore, a drug effective for treating lung cancer in adults could be effective for treating cancer of the nerve cells in children.

The ICR is co-operating with the European Consortium for Innovative Therapies for Children with Cancer (ITCC), based in France, who likewise wish to see an end to this unscientific and unkind legislation. The ICR and ITCC are demanding that the European Union Regulation on Paediatric Medicine be revised. This is regulation that was initiated in 2007 and was intended to improve children’s access to new treatments. But as we have seen, this regulation has failed to meet this urgent demand and has instead betrayed its intentions.

This shocking revelation is one more reason why the EU may be ill-equipped to advise on medical problems which Member States are able to deal with based on their own scientific investigations. Remaining in the EU also means that the British public is unable to vote against legislation like this, preventing us from achieving full democratic rule.

Leave a Reply