TIPLO Dinner Meeting , June 11th 2008, Gray's Inn
Pharmaceutical Regulation and the Protection Of Innovation
Against the backdrop of the Hall, Gray’s Inn, the recent evening meeting provoked an animated debate following the excellent address by Ian Dodd-Smith of Arnold & Porter. The event was chaired by Lord Justice Jacob, who concluded that Mr Dodd-Smith had delivered an “astonishing and excellent piece” by his speech which highlighted the need for the European Commission “begin to understand the economics of this [ pharmaceutical] industry”. Lord Justice Jacob and the assembled members of TIPLO and guests were so impressed with Mr Dodd-Smith’s comments that there have been calls for his speech to be published verbatim. We will provide details if and when this happens.
He managed to convert what can be an essentially dry and rather complex topic into a stimulating and though provoking series of well analysed and brilliantly researched commentaries. The audience were taken through the recent history of the development, challenges and changes to the regulations and prompted to consider the interaction of political, commercial and moral issues which surround this area. The exceptions for so called “orphan drugs” and paediatric care pharmaceuticals demonstrate the ability of the EU to follow the lead often provided by the USA, and suggestions from Mr Dodd-Smith and the audience indicated that the time may be nigh when we see extended patent life protection for certain pharmaceuticals in an effort to protect and engender innovation. As our speaker put it, “ both IP and competition law should foster innovation but protect consumers”. However, the practicalities are much more complex than the theories. This are of law has seen a plethora of references to the ECJ, but with such references have come delay, increased costs and further “fuzziness” as Lord Justice Jacob put it ; lack of legal certainty as to interpretation and effect of the regulatory provisions. It was suggested that the pharmas face a “minefield” of “ever changing guidelines and judicial guidance”.
We were reminded that this are of law is bigger than Europe and the global implications are felt across the worldwide industry. However, England is leading the field insofar as the English High Court have made many of the recent ECJ references, although our speaker concluded by asking the question, “ Is the European Court really fit for its current purpose ?” He is also concerned that the recent policy changes have not favoured innovators, and that generally there is room for amendment of the regulations and regulatory framework to provide a more proportionate protection to the huge investments required.
Report prepared by: Denise McFarland, Barrister, Three New Square Intellectual Property Chambers, www.3newsquare.co.uk
TIPLO Committee & Founder Member.
