European agreement to improve children’s medicines
pharmafile | June 2, 2006 | News story | Sales and Marketing |
It will soon be easier for pharma companies to develop medicines specifically for children, after the European Parliament approved a range of new measures to improve the process.
At present, doctors have a limited choice of medicines for sick children, and, in fact, more than 50% of drugs being given to children are not tested or authorised for paediatric use – but this is about to change.
The new regulations come into force on 1 January, 2007, and should bring an end to the current situation where most children take small doses of medicines developed for adults, which may not correspond to their metabolism and can even be harmful.
Maria Rauch-Kallat, Minister for Health in Austria, the current holder of the European Council presidency, said: "This compromise paves the way for the greatest possible safety in the treatment of children with pharmaceuticals in the future."
From next year, drug companies that develop effective and safe tests for paediatric medicine will receive a six-month patent extension. Orphan drugs will receive an additional two-year market exclusivity.
Other measures in the new law include:
* The establishment of an expert EMEA Paediatric Committee to determine paediatric research priorities and whose members must have no financial or other interests in the pharmaceutical industry which could affect their impartiality.
* A new Paediatric Use Marketing Authorisation, which will allow 10 years of data protection for new studies on off-patent products.
* A special logo for the packaging of medicines that have gone through the new process.
The regulations cover medications currently in development and not yet authorised; authorised medications covered by patents, as well as authorised products that are off-patent.
There will be additional protection for infants, with companies who want to market their products for this age group having to meet strict, new standards.
When applying for marketing authorisation, drug companies will have to present a 'paediatric investigation plan' – an R&D programme aimed at guaranteeing the necessary paediatric data.
The European Parliament says this will overcome the major obstacle of lack of information regarding the dosage levels of children's drugs. This problem can lead to inappropriate dosing, which may increase the risk of side-effects and even cause death, or it can result in ineffective treatment due doctors exercising caution and prescribing a dose that is too low.
Vice president and rapporteur of the European Parliament Francoise Grossetete said: "Europe's citizens do not want big words, they want action. This regulation for children's medicines is a concrete answer to their expectations."
