Welcome to the Summer edition of Inside Life Sciences.
This edition picks out some notable developments in the constant battle relating to innovator drugs and generics/biosimilars. Those interested are commended to read David Rose's and Nina O'Sullivan's report on the recent decision in Pfizer v Roche, where Pfizer sought an Arrow declaration to support its launch of a biosimilar to compete with Roche's AVASTIN product. The case is interesting: notwithstanding the Court inferring that Roche's conduct of de-designating the UK from its relevant patents was to shield its patent portfolio from an adverse decision by the English Court, the declaration was refused because there was no connection with the UK at the relevant time.
On a positive note for generic/biosimilar companies, the launch of the new SPC waiver, effective as of 1 July for SPCs applied for on or after that date, means that products can be manufactured in the EU for export to countries where no protection exists or manufactured for stockpiling before a day one launch in the EU, where this would otherwise be an infringement.
However, it is the ongoing medical cannabis debate which continues to attract significant attention. On 3 July, the House of Commons Health and Social Care Committee published its report: Drug Policy: medicinal cannabis.
The report is succinct, but the Committee evidently canvassed the views of a large number of interested parties (with some 57 written submissions). It is highly critical of the fact that, since November 2018, very few prescriptions have been issued for medical cannabis, and the list of recommendations (page 26) are thoughtful. These include investigating proposals for observational studies and having the National Institute of Health Research make resources available for clinical trials.
However, one is left with the impression that the Committee has failed to grasp the reality of the situation. What many people call medical cannabis - cannabidiol or CBD, with or without an element of THC – is routinely and widely on sale on the high street and on the internet. The legality of these products is questionable, as is their quality and provenance. It is all very well for the Committee to call for further double blind, randomized clinical trials on medical cannabis products, but this begs a number of questions: which products, which formulations, which dosage regimes? But, above all, how long will this take and how will it be funded? The NIHR is a public body and simply does not have the necessary funds, and the relative lack of patent protection for such products means that there is little incentive for the private sector to fund such trials.
In the meantime, a lack of medical cannabis products which are at least regulated as to the content, formulation and quality of manufacture means that the many people seeking the relief they believe that medical cannabis can offer will continue to use products without any such provenance.
The Report is a useful contribution to the debate on medical cannabis, but is a long way from being the solution.
I hope you enjoy reading this edition. Please get in touch if you have any queries on any of the issues discussed.