Tougher EU Obligations in Sight for Pediatric Medicines Trials

The European Parliament gave drug firms an unwelcome Christmas present at its December session when it voted through a resolution criticizing their performance on pediatric medicines development.
 
It calls for punishment to be imposed on drug companies that dodge out of investigating possible pediatric applications of a new medicine.
 
For the last 10 years, EU rules have obliged developers of most new medicines to conduct a study of possible use in children. The downside, say drug firms, is that it costs a lot and can slow research down. But the upside for them is that success can be rewarded with extended patent coverage. So far the result has not been a roaring success, most MEPs believe, so they have urged a change in the rules, to boost the incentives – perhaps with tax breaks – and to toughen up the disincentives.
 
French center-right MEP Francoise Grossetête, usually a strong supporter of the drug industry, played a prominent role in this debate and sided with the lobbies of the cancer charities and pediatricians. The rules are "not being respected," she said, accusing the industry of "not doing so great in terms of completing pediatric research plans".
 
Noting that industry "doesn't want more obligations" and being "cautious and timid" in this debate, she pointed out that in the end the outcome is "a fair balance".
 
A cursory glance at the way this resolution emerged demonstrates just what she means. The internal parliament discussions that led up to this debate reveal yet more of the hostility to the drug industry that this column has frequently commented on in the past. Grossetête's claim to have found a balance are based on the deals she and her colleagues did with other political groups in the parliament to keep the final resolution free of some of the shriller criticisms of drug industry practice on pricing and patents.
 
The run-up to the debate featured criticisms from French ecologist MEP Michèle Ravasi of failures to ensure that incentives were matched by obligations.
 
UK socialist Glenis Willmott blamed "major delays in starting pediatric clinical trials for oncology drugs" on developers who "wait for the drug to show promise in adult cancer patients first." She said there is "nothing to stop an investigator terminating a promising pediatric trial early if a drug fails to deliver positive results in the target adult population."
 
Attacks on industry did not come only from the left. French far-right MEPs Joëlle Mélin, Sylvie Goddyn and Jean-François Jalkh alleged that the EU scheme had "contributed only a fraction to improving the overall situation" and hadn't tackled "the serious shortcomings seen repeatedly in the ways of carrying out research and clinical trials."
 
And far-right Italian MEP Eleonora Evi demanded measures to prevent drug firms "misusing or abusing" the system in search of additional patent protection and pushing drugs that "are not likely to be effective, that are unsafe or not useful for children or adults."
 
Industry has been tight-lipped so far on the outcome of the debate. But the result has been welcomed by many cancer charities in Europe. The European Society for Pediatric Oncology – representing parents, researchers and health professionals – said it was delighted. "The problem is that there is still not enough research, not enough drugs and not enough options," it said in a statement that called for efforts to develop more drugs "and save our children".
 
The European Commission is due to review the rules next year and come up with improvements to boost its performance. It will find it difficult to avoid making some concessions to the critics who have found their voice in the parliament.