Medical Research in UK Law

But, like all guidance on construction, Lord Wilberforce's remarks are more appropriate to some cases than others. This is not a case in which one starts with the presumption that Parliament's intention was directed to the state of affairs existing at the time of the Act. It obviously intended to regulate research and treatment which were not possible at the time.

The Paediatric Regulation was to encourage specific research – and dissemination of knowledge about its results —into already known medicines as to their applicability for children. Prior to the Regulation there was no specific incentive for such research. The Paediatric Regulation provides an incentive – an extra six months of protection —for having conducted such research.

In my judgment, therefore, this is not a case where the Claimant can show that a novel duty of care would be but an incremental development from some well established duty. It would, on the contrary, be a radical departure to impose liability in circumstances such as these.

Lo 1, and the other Patents, are subject to a Pooled Patents Agreement dated 2 December 2014 between Illumina and Sequenom ("the PPA"), which concerns intellectual property relating to NIPD. Illumina alleged that an exclusive licence under the Lo 1 Patent was granted by Sequenom to Illumina under Section 2.3 of the PPA.

Common law liability would be measured against those standards, with the relevant professional practice and guidance very much to the fore. Indeed it seems to me evident, given the difficulty of such decisions, that the Courts would allow considerable latitude to clinicians faced with such a dilemma.

Good policy-making, administration and decision taking involve studying problems from all angles. It is a practical process and must never be allowed, and still less induced, to become a theoretical or legalistic exercise. For my part I can find nothing whatsoever to criticise in the approach of a decision maker which involves him in saying to himself, "I do not know whether, as a matter of law, factor A is or is not a relevant consideration.