Pharmaceutical companies are being encouraged to develop medicines specifically for children, under European Union legislation approved this week.
The new rules, which are expected to come into force early next year, will reward firms that produce new paediatric drugs by giving them a six month extension to their patents. Manufacturers of orphan medicines for children will enjoy an extra two years of market exclusivity on top of the 10 years already in operation for adult drugs.
Françoise Grossetête, the French Conservative MEP who steered the legislation through the European Parliament, said that it would stimulate laboratories developing adult drugs to try and find a child friendly form.
“Until now, there has been no encouragement for research into paediatric medicines in Europe. This has put European children at a disadvantage. For several years, pharmaceutical research of this type has been supported in the United States, Japan, and Canada,” she said.
Currently, more than half of the medicines used to treat children have not been tested and authorised for this use, and they tend to be diluted to take account of the young person’s age and weight. However, some adult drugs, especially for AIDS, cancer, and psychiatric illnesses, can have negative side effects when administered to growing bodies.
In future, companies will have to submit a paediatric investigation plan containing data on the use of the drug in children when applying for marketing authorisation. This should ensure sufficient information on dosage levels, helping to reduce the risk of side effects and of ineffective treatment due to a reduced dose.
But approval for a new adult drug will not be delayed if it is ready before a child-friendly version. Nor will companies have to develop a model of every drug for children, and waivers exist for medicines unlikely to benefit children.
The legislation will apply both to medicines that are currently being developed but are not yet authorised and to medicines that are authorised and either covered by patents or are not subject to intellectual property rights.
A new paediatric committee will be established in the London based European Medicines Agency. Its members will have no “financial or other interests in the pharmaceutical industry” and will have to act independently and in the public interest. After two to three years, the scientific committee, whose opinions will be made public, will draw up an inventory of therapeutic benefits to help determine research priorities.
In the coming year, the European Commission will select a logo, which will be placed on medication boxes that benefit from paediatric guidance.
The commission estimates that with the extended patent companies could make an extra €9m (£6m; $12m) in sales to offset the €4m usually spent on a clinical trial.
The European Federation of Pharmaceutical Industries and Associations, which represents leading drug companies, has welcomed the new regulations.