In our Autumn 2004 edition of Patent issues, we commented on the EC proposals for new regulations on children’s medicines, aimed to stimulate innovation in the paediatric pharmaceutical industry. At the time, around 50% of medicines being used to treat children in Europe had not been fully tested or authorised for such use, and the regulation was intended to increase the research and development of medicines specifically for children.
As a result of subsequent consultation, Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use was published in the Official Journal on 27 December 2006 and entered into force on 26 January 2007. The regulation offers a number of incentives to qualifying parties, such as;
· six-months extension to the supplementary protection certificate(SPC - in effect, a six-month patent extension);
· for orphan medicines, an additional two-years of market exclusivity added to the existing ten-years awarded under the EU orphan regulation;
· a new type of marketing authorisation, the Paediatric Use Marketing Authorisation (PUMA), which allows ten-years of data protection for innovation (new studies) on off-patent products.
In order to be awarded these incentives, the party must supply, at the time of application for marketing authorisation, sufficient data on the use of the medicine in children resulting from an agreed paediatric investigation plan.
A system of deferrals is in place, so that the timing of this requirement can be changed to ensure that the medicines are tested in children only when it is safe to do so. The system of deferrals will also prevent the requirements delaying the authorisation of medicines for adults.
The EC regulation also put into place a system of waivers from the requirement for medicines that are unlikely to benefit children. The waivers will be applicable in specific circumstances, for example where the disease is particularly serious or there is a sever lack of alternative treatments for the condition.
Patent proprietors must file the application for the six-month extension before a deadline of two years prior to the expiry of the SPC. A five year transitional period was put into place whereby the deadline to file for an SPC extension is reduced to six months prior to the expiry of the SPC. This will allow a small number of additional products that have met all the requirements but who were no previously aware of the new Regulation to apply for an SPC extension. Patent proprietors should be aware that due to the length of time it takes to conduct studies in children and meet the regulatory requirements, the effective transitional period equates to about one year.