An introduction to the paediatric extensions

  

What’s it all about?

“Paediatric extensions” encourage the development and availability of medicines for children by extending the term of protection of a patent or a supplementary protection certificate by six months.

 

Worldwide, there are not enough safe, high-quality medicinal products that have been especially developed or adapted for children.“Paediatric extensions” remedy this problem. Those contributing to the research and development of new medicines for children are granted, on application, a six-month extension of patent protection or a supplementary protection certificate.

 

This amendment to patent law is part of the ordinary revision of the Therapeutic Products Act. The revised Patents Act and its implementing provisions will come into force together with the revision of the Therapeutic Products Act on 1 January 2019.

 

The paediatric extensions are possible:

  • by extending an already granted supplementary protection certificate (SPC) by six months; or
  • Through the new paediatric supplementary protection certificate, which is linked directly to the term of the patent and is also valid for six months.


Whoever applies for a paediatric extension must conduct clinical studies on children that comply with the paediatric investigation plan for the authorisation of a medicine. In addition, the study results must be publicly available in the information on the medicinal product. The application for authorisation in Switzerland must be submitted no later than six months after the application for authorisation in the European Economic Area.

  

What has happened so far?

  • In January 2007, the European Regulation on Medicinal Products for Paediatric Use came into force. Its objective is to authorise and put on the market more medicinal products for paediatric use. In Switzerland too, children should be better provided for with medicinal products which are tailored for them. For this purpose, a partial revision of the Patents Act should be carried out within the scope of the revision of the Therapeutic Products Act. This provides for the introduction of a paediatric extension of a SPC.
  • In May 2014, the new paediatric SPC is introduced within the scope of the parliamentary discussions on the ordinary revision of the TPA.
  • On 18 March 2016, Parliament adopts the ordinary revision of the Therapeutic Products Act including the partial revision of the Patents Act  (under “Amendment of other legislative instruments”).
  • The IPI subsequently drafts the implementing provisions for the paediatric extension.
  • On 22 June 2017, the partial revision of the Patents Ordinance is put to consultation. The consultation period ends on 20 October 2017 (results of the consultation procedure in German).
  • The Federal Council decides in its meeting on 21 September 2018 that the partial revision of the PatA and its implementing provisions together with the revision of the Therapeutic Products Act will come into force on 1 January 2019.
  
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