Medical Research in UK Law

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.

The “third party certainty” point is further undermined by the fact that there is no requirement that third parties shall be entitled to see sufficient of the details of the application to form a view as to whether it will succeed. Or any of the details of an application for an MA or a variation of an MA. Nor is there any requirement that a national authority must come up with a decision by a particular time after the application.

The crucial issue before us concerns Article 10(3), and the meaning of “irregularity”. There are a number of reasons for giving the word a wide meaning. There is no contextual indication of any different meaning, and no basis in the wording or Article 10 or, as Lord Justice Jacob has shown, in the Recitals to the Regulation to limit its meaning. More particularly, nothing in the Recitals or the substantive provisions of the Regulation suggests the distinction contended for by Miss May.

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.

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.

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.