Paediatric Medicines
This article was originally published in SRA
Executive Summary
EU draft regulation enters final stages
EU draft regulation enters final stages
A European Parliament committee has approved the draft European Union regulation on paediatric medicines, which will now go to the full parliament for a vote and then to the Council of Ministers for final adoption. If all goes smoothly, the regulation could be in force before the end of 2006.
The committee on the environment, public health and food safety approved the report on the draft regulation on 04 May 20061. The report included a number of amendments to the draft approved by the council in March, but these are not expected to hold up the regulation's progress as all those involved want to get the regulation adopted as soon as possible.
The rapporteur, Françoise Grossetête, is expected to hold informal talks with the Austrian presidency of the council in order to reach agreement on the final version of the text before the parliament holds its second-reading plenary vote on 4 July 2006. The idea is that the parliament would then wave the legislation through, and the council would adopt it without further debate at one of its future meetings, possibly after the summer.
The regulation will encourage the development of paediatric versions of medicines by granting a six-month extension to supplementary protection certificates (SPCs) on products for which trials are conducted in children in accordance with a paediatric investigation plan (PIP). The PIP will be agreed by the company and a new paediatric committee at the European Medicines Agency (EMEA). The regulation also provides for free-standing paediatric marketing authorisations for off-patent drugs.
Among the amendments approved by the environment committee was one relating to the SPC extension. In its first-reading vote last September, the parliament had introduced an amendment to the effect that applications for an SPC extension had to be lodged no later than six months before the SPC expired, the idea being to allow more products to gain an extension. The European Commission's original version had proposed a period of two years - this position was supported by the council and by generics firms, which said that they needed the two years' notice to allow them to plan development strategies for their generic versions.
The council threw out the parliament's amendment, but the rapporteur reinserted it. However, she made one concession to those in favour of two years - the six-month period would apply only for the five years after the regulation had entered into force.
The committee also passed an amendment that would strengthen the independence of the EMEA's future paediatric committee by ensuring that its members had no financial or other interests in the pharmaceutical industry that might affect their impartiality. Committee members would have to declare any interests in a register at the EMEA.
References
1. http://www.europarl.europa.eu/meetdocs/2004_2009/documents/am/604/604731/ 604731en.pdf