The Commission's view on paediatric extensions

Recently, the Commission sent the official records of the 3rd meeting of national SPC experts held on 26 September at the EMEA to national patent offices. This meeting was mainly devoted to the implementation of paediatric extensions. The records are particularly interesting to those who are involved with the administrative implementation of Regulation 1901/2006. Some national patent offices, such as the German PTO, have yet started a consultation procedure to discuss with representatives of industrial pharmaceutical associations administrative issues, such as the format of proofs.

As regards the contents of the records it is somewhat disappointing that, by and large, the Commission takes a rather formalistic approach, even when the wording of the provisions seems to be quite clear. This is especially true with respect to Article 36.3 of Regulation 1901/2006 and Article 8.1.d.ii of Regulation 1768/92. When the wording is somewhat ambiguous, as in Article 36.1 of Regulation 1901/2006 and Article 8.1.d.i of Regulation 1768/92, the result is the same. The Commission seems to apply the maxim "in dubio contra paediatric extension".

Consequently, this basic incentive will be devaluated. Of course, such tendencies of strict interpretation undermine the very aims of the Regulation 1901/2006. It remains to be seen if the national patent offices are able and willing to practise the relevant provisions in a more flexible way, e.g., by using the instrument of Article 10.3 of Regulation 1768/92.

Mark your diaries

The colourful and rather exotic Italian English-language weblog Catch Us If You Can !!! carries a short post by Mauro Turrini, "Pharmaceuticals for paediatric use". This item summarises the effect of Regulation 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and reminds readers that there is a significant SPC-related calendar date next month:

"The Paediatric Regulation introduces the requirement to include information about paediatric studies in the Marketing Authorisation (MA) application. This requirement, already mandatory for new medicinal products as from 26 July 2008, will start soon to be compulsory also for previously authorised medicinal products covered by a supplementary protection certificate (SPC) or a patent, which qualifies for the granting of the SPC (as from 26 January 2009)".

Significant date ahead for EU Paediatric Regulation

The Medicines for Children Research Network has produced a handy summary of developments regarding the the EU Paediatric Regulation. In short, while over 100 million people in the EU -- around 22% of its population -- are under 19 years old, more than half the medicines they take have not been tested or authorised specifically for their use. The dangers are obvious and need not be spelled out here. In 2006 the EU Paediatric Regulation was adopted. This provided for the establishment of the Paediatric Committee (PDCO), allowing drug manufacturers to apply for Paediatric Investigation Plans (PIPs) or requests for waivers.

This is very topical since tomorrow, 26 July 2008, is the date from which there is imposed an obligation to submit results of studies according to an agreed PIP with applications for (new) marketing authorisations (see Article 7) or a decision granting a waiver or deferral.

The new requirements apply to most products, but not to generics, hybrid applications, biosimilars and well-established medicinal products, or to homeopathic and traditional herbal medicinal products. Different rules govern patented and off-patented medicines, as well as both rewards and incentives for compliance.

For products still under patent, a PIP must be submitted and agreed with the PDCO. If the agreed programme is conducted and the obligations are fulfilled there is the possibility of gaining a 6 months extension of the Supplementary Patent Certificate.