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European Pharmaceutical Contractor

No Kidding

In his social history book, The Disappearance of Childhood, Neil Postman said: “Children are the living messages to a time we will not see.” I was put in mind of this quotation after reading two items in the news recently: a ban on smoking in cars carrying children in England, due to be introduced in the next year or so; and the Institute of Cancer Research’s (ICR’s) call for a revision of the European Clinical Trials Directive in relation to paediatric trials.

The first development will create a number of dilemmas if the ban is brought into force, as seems likely: how will it be enforced and will it apply retrospectively? Smoking is supposed to leave residues in a car for up to twoand- a-half hours, so will children only be allowed to enter the vehicle after this time? And what age will ‘child’ be defined as?

In its regulations on paediatric medicines, the European Medicines Agency (EMA) defines a child as being under 18 years of age. If this definition were to be applied to the car smoking ban in England, it would leave an anomalous situation whereby a driver aged 17 will be banned from smoking, whereas on reaching 18 he or she could do so.

The EMA’s paediatric regulations have three main objectives: promoting No Kidding high-quality research on children; providing more information on the use of paediatric medicines; and allowing the authorisation of medicines for diseases that affect children with age-appropriate pharmaceutical forms and composition.

These regulations have been in force since August 2007 and the agency regards its implementation as a great success. On the other hand, the ICR is urging the EU to scrap the current system whereby a pharma company can obtain waivers and exemptions from a requirement to perform paediatric clinical trials on all drugs if the company – and, critically, the regulatory authorities – deem testing in children to be inappropriate. The ICR believes that children with cancer are being denied new, potentially life-saving drugs, because the EU rules are allowing companies to trial some drugs only in adults by means of these waivers.

At one time, it was believed that, pharmacologically, children were merely small adults, and the dosing of drugs was decided on the basis of their size. We now know, however, that a child’s immune system and metabolism changes dramatically from neonate to adolescent. The ICR has noted that, in some cases, cancers in adults forced by mutations in anaplastic lymphoma kinase or epidermal growth factor receptor genes have been exempted from testing in children, despite some evidence that these mutations can play a role in childhood cancers.

The European regulations grant incentives for companies to develop medicines in children. One of these incentives is an extension of patent protection by a further six months, even when the study’s results proved negative. For orphan medicines, the incentive is an additional two years in market exclusivity, while scientific advice and assistance in developing protocols at the EMA are free of charge for questions relating to development of medicines for children.

As several articles in this and our sister journal, International Clinical Trials, have shown, the setting up of paediatric clinical studies is not straightforward, and can be both timeconsuming and extremely expensive. Pharma companies must therefore balance the cost of the trial and the potential delay to registration and marketing of the drug caused by the paediatric study, against the economic and social benefit of carrying out the research. On this basis, they may apply for waivers.

The EMA is fully committed to assisting the development of medicines for children. It would appear from reading the press release of the ICR that the Institute is more concerned about implementation than regulation. When the updated Clinical Trials Directive comes into force, hopefully mid-2014, I would expect the EMA to look at this issue in detail again. Perhaps, eventually, regulators and legislators will truly look at children as messengers for the future.

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