European Union Regulations Prevent "Lifesaving" Drugs From Getting To Children

Regulation in the European Union allows pharmaceutical companies producing cancer drugs the ability to opt out of pediatric trials when testing new drug products. This has resulted in cancer patients in Europe being denied access to drugs that could possibly save their lives.

Many in the healthcare industry have called the ability for drug companies to opt out of pediatric trials a “loophole” that needs to be closed with new EU legislation. Louis Chesler, a pediatric oncologist at Britain’s Institute for Cancer Research (ICR), believes that many cancer drugs could save young patients’ lives if they were available to them. “Many cancer drugs developed for adults could be effective in children if we were able to test them in clinical trials. Kids get hand-me-downs in many areas of life. But cancer drugs should not be an area where kids get hand-me-downs.”

The current loophole scenario allows pharmaceutical companies to avoid lengthy and expensive testing processes for patients who are under the age of 18. It also creates a situation where cancer drugs are available to adults long before children are able to use the same drugs. Many industry experts believe the current regulation is outdated, based on previous scientific thinking that cancer was a disease unique to each particular organ.

The ICR has worked with the European Consortium for Innovative Therapies for Children with Cancer in order to study adult cancer drugs’ potential application with children. They found that 26 of 28 different cancer drugs already approved for use with adult patients would be relevant for children with cancer.

Source:

http://www.reuters.com/article/2014/02/10/us-cancer-drugs-children-idUSBREA191ZM20140210