EU May Encourage Drug Testing in Children
By Emily Hayes
Originally published by Reuters Health, March 28, 2002
LONDON (Reuters Health) — US-style measures to encourage companies to test drugs on children, including 6-month extra marketing exclusivity, are expected to be adopted soon, according to European Commission officials and industry experts.
Traditionally, most medication has not been tested in children, leaving doctors to guess as to appropriate dose or potential side effects in youngsters. In the US, each medicine studied in children can gain a drug company an extra 6 months without generic competition, time that can mean hundreds of millions of dollars in profit.
A European Commission (EC) consultation document on paediatric medicine, "Better Medicines for Children," was released in February by Europe's enterprise commissioner Erkki Liikanen. It draws heavily on experience in the US, where similar legislation 5 years ago boosted the number of paediatric clinical trials.
A key element of the European plan is to offer manufacturers an extended period of exclusivity in exchange for developing a paediatric indication for a patented drug. While no time period has yet been specified, an extension of at least 6 months is expected.
"Six months could be seen as the bottom line, it would be difficult to provide less," Philippe Brunet, head of the EC's pharmaceuticals unit, told Reuters Health in a telephone interview.
Some sectors of the pharmaceutical industry are hoping for a longer period of exclusivity for all paediatric applications. The European Federation of Pharmaceutical Industries and Associations (EFPIA), is expected to push for a period of one year.
However, Brunet said generics manufacturers would oppose this. Six months represented a compromise and had worked well in the US, he added. There was general agreement on pushing the legislation forward, and disagreements over the length of the exclusivity period were unlikely to hold the process up, he said.
Dr. Ingrid Klingmann, head of the European wing of the pharmaceutical industry's Drug Information Association said such a change would be welcome. "There is a very good chance we will have 6-month exclusivity and this will be a very strong driver for the (clinical paediatric trial) process in Europe," she said.
The document would also impose a new requirement that all new drugs with possible paediatric applications be tested in children before marketing. The paediatric applications for new drugs would carry the same extended period of exclusivity as in the case of drugs already patented, according to Brunet.
But there are still some unanswered questions. A proposed new marketing authorisation mechanism and market exclusivity status for children's versions of generic drugs might prove difficult to enforce, according to Brian York, a senior Novartis executive who chairs the intellectual property policy committee at the EFPIA.
"If the child's version is totally different, that might be okay (to grant market exclusivity), but it if you just break half of an adult tablet, it becomes more difficult."
A proposal that would require new drugs with paediatric applications to first be tested in children has also come under scrutiny.
"If that was mandatory, it could delay the approval of drugs, and that might not be in the overall interest (of the public)," York said.
However, Brunet said this is unlikely to prove to be a problem, because additional time will be granted for submitting documentation for the paediatric application, beyond the date of the submission of the adult version.
The Commission is aiming to make a final decision on all of these issues raised in the consultation process by June, and to submit its proposed legislation to the European Parliament by September or October.
"The EU is very interested in making this a reality as quickly as possible," Klingmann said.
