Welcome to the Spring 2019 edition of Inside Life Sciences.
The period covered by this edition saw a number of significant developments in the life sciences field and the EU report on competition enforcement in the pharma sector is very interesting, and not least because of the statement that "the adoption of settlement agreements in the field of patents is not necessarily contrary to competition law".
Also of interest is the EU agreement on SPC reform and whether the UK is moving towards a "Formstein" defence in patent infringement as a counter balance to the doctrine of equivalents introduced by Actavis v Lilly; and, of course, the more or less constant stream of Brexit related issues affecting the life sciences industry.
At the time of writing the UK Parliament had voted down the possibility of a 'No Deal' Brexit. Of course, until anything concrete is agreed, that remains the default position but it seems that one thing that almost all sides agree on is that a No Deal Brexit is the least desirable outcome.
Some news on the ever moving landscape in relation to medical cannabis and the sale of one of the principal constituents, cannabidiol, or CBD. The European Commission's recent classification of CBD as a novel food under the Novel Food Regulation (EU 2015/2283), with the result that CBD foods or food supplements require a rigorous safety assessment before they can be placed on the market, is not remarkable in itself. What is noteworthy, however, is that in a letter from the UK Food Standards Agency on 13 February, to the All Party Parliamentary Group on Medical Cannabis under Prescription, the FSA indicated that it was "engaging" with various interested parties "to achieve compliance in the market place in a proportionate manner".
This is reminiscent of the situation following the MHRA's statement on CBD issued on 13 October 2016 that products containing CBD used for medical purposes are medicines. The MHRA wrote to stockists and manufacturers to notify them of this… with the result that retail CBD oils and products are not only still on sale but now more widely available than ever, none of which comply with the Human Medicines Regulations.
It remains to be seen what the FSA will do but what is interesting is the implicit acknowledgement that the simple response of immediately banning all sales of CBD oil and related products in shops in the UK (which include Boots and Holland & Barrett) is unlikely to work and may ultimately drive the market to unregulated internet sales, which is hardly in the interest of the public.
It is believed that the sales of CBD oil and related products increased significantly during the course of 2018, undoubtedly related to the claimed therapeutic or health benefits. It is time for the relevant authorities – the Home Office, the MHRA and the FSA – to develop a coherent approach to the regulation of these products in the interests of the public.
I hope you enjoy reading this edition. Please get in touch if you have any queries on any of the issues discussed.