Europe adopts new pediatric drug rule

Plan will spur studies on child-specific meds

By Peter Woodford

The EU plan closely resembles the United States' Best Pharmaceutical for Children Act passed in 2002, right down to the six month patent extension. The US was the first to seriously look for a solution to the scarcity of child-specific drug research. Back in 1998, the FDA and Congress enacted the first 'pediatric rule' which was subsequently thrown out by the courts. Unlike the newer 'carrot' incentive schemes, the older plan took more of a 'stick' approach, attempting to force drug patent applicants to conduct pediatric studies unless they could come up with a valid reason not to — for instance, if the drug was for a disease that doesn't affect kids. The courts ruled the FDA didn't have the authority to impose such conditions.

WHAT ABOUT HERE?
The Canadian Paediatric Society (CPS) wants our country to adopt a plan that would encourage pediatric drug testing too. A position paper in 2003 aired their support for such a plan, but so far Health Canada hasn't budged. Dr Robin Walker, past president of the CPS, is ill at ease with the status quo in Canada. "Most of the drugs we pediatricians use are off-label — they've never been tested on children," he says, speaking from the CPS annual meeting in St John's, NL. "This really does add an element of risk and we don't think this is fair for our kids."

Dr Walker feels there are a number of reasons Canada has been slow to adopt a plan. First off, it's a limited market. "Kids are a minority and, with the exception of neonates, as a population they tend to be rather healthy," he says. "And also, until recently children haven't been a high priority in the minds of those who set policy. To be fair," he adds, "this is changing, Paul Martin's government created the Office of Paediatric Initiatives while it was still in office."

Ethics concerns also serve to slow down pediatric research. "I think children not being able to consent to testing themselves is obviously a problem. We effectively rely on surrogate consent-givers like parents," says Dr Lionel Dibden, a pediatrician at the Stollery Children's Hospital in Edmonton. "This is a constant dilemma for us and this is why research involving children has to be closely monitored for ethics." For him, collaboration is the best way to avert ethics problems. "I think the drug companies need to adequately involve the pediatric healthcare community in their studies," he says. "It's not a simple problem."

Some physicians worry a pediatric drug testing plan would create more red tape, but Dr Dibden isn't convinced. "There's the argument that it takes drugs longer to get to market if they're pediatric tested, and I have some sympathies for that argument. But on the other hand, when we ask 'What's in the best interest of children?' I would think the safety that comes from drugs being specifically tested on them would be in kids' best interest."

GIVE AND TAKE
Dr Walker would be happy for Canada to offer patent extensions if it would lead to more pediatric drug testing here. "What's interesting about the EU plan is the element of quid pro quo," he says. "We at the CPS are not necessarily against such arrangements. We understand that there is cost involved in running trials and we recognize that in some cases the expense of studying a drug's effect on children could be more than the profit. We're not necessarily against a pragmatic approach — as long as it's in the best interest of children's health needs."

Dr Dibden does have some reservations about the patent extension, but he says if push came to shove he'd support it to get a deal done. "It's ultimately meeting the needs of children to have adequate testing on medicines," he says.

WISHING WELL
Upon hearing the news of the EU adopting a 'pediatric rule' Dr Walker got an uneasy feeling about where we're at as a nation. "One would like to hope that Canada wouldn't be the last country in the world to do something that's good for kids," he says. "In fact I'd like to think that we'd be the next to move to adopt [a rule similar to the EU's] because it seems we're falling behind." He adds that when he spoke to his many American colleagues attending the CPS meeting, they were by and large very pleased with how the US plan is working out.

Dr Dibden, too, is hopeful Canada will do something to encourage more pediatric drug testing. "Prescribing off label gives pediatricians — and gives me in particular — a great deal of discomfort."