On May 16 the second edition of our new global series, Life Sciences and Health Care Horizons, took place in London featuring two panel discussions that focused on the challenges and opportunities in two of the sector’s emerging markets: (1) Artificial Intelligence; and (2) Cannabusiness. We are excited to share the following highlights from London, and we look forward to future discussions as we forecast and help clients prepare for what’s to come.
The rise of the machines – AI and digital health
Artificial Intelligence (AI) covers a number of subfields such as robotics, machine learning, natural language and speech processing and deep learning and at our London Life Sciences and Health Care Horizons event, the panel discussions looked at the potential benefits of using AI in the drug design process including improving success rates for the development of new drugs and reducing the length of time, and money, spent on the initial design phase. The panel also discussed some of the legal and ethical questions that might arise with the use of AI.
Imogen Ireland, Senior Associate in the firm’s Intellectual Property practice, discussed how AI is being used to discover lead compounds for therapeutic use. . Imogen noted that a key factor in the use of AI is that it can gather and review data in enormous quantities very quickly – AI can "review and process, in a matter of hours, data that could take teams of scientists years." Imogen noted, however, that the use of AI in drug discovery is likely to raise some interesting legal and regulatory considerations. In patent law, for instance, a key issue is whether or not it is possible to patent AI output and, if it is, who owns the output? Related to this is the issue of disclosure – in other words, explained Imogen, how do you demonstrate to others that your AI-developed drug works? What sort of data do you have to do this? If you are relying on algorithms, who do these algorithms belong to, and are they confidential? Such issues could be relevant when filing a patent for the AI-developed drug, or working with regulators at the clinical trial stage.
Dr. Sandeep Shah, CEO of Tarilian Laser Technologies, provided a practical example of how companies are making use of AI and innovative technology to improve health. Dr. Shah described how his company is taking advantage of AI technologies such as deep learning and neural networks to find more effective ways of handling the diagnosis and treatment of hypertension. Dr. Shah noted that about 40% of the adult population is potentially affected by hypertension and current methods of measuring and monitoring the condition were generally short term and inconvenient for the patient. Dr. Shah discussed the development of new ways of monitoring utilising innovative medtech sensing and data insight to provide precision therapeutics which could be a game changer in terms of providing cheaper, more efficient monitoring of the condition long term.
Dr. Alan Payne, Honorary Professor at UCL and CIO of Cloudsolve, discussed data protection issues arising from the collection of personal data through health monitoring apps and devices. Dr. Payne discussed the importance of consent and of using clear language in describing how the data will be used. Dr. Payne also commented on the need to segment data, stripping away the individual identifying personal data from the core health data, which would allow companies to analyse the health data without infringing on the patient's ownership of their personal data.
How AI might shape the world of medicine and pharmaceuticals in the future was also a key point of discussion for the panel. Imogen Ireland suggested that AI could lead to an increased rate of drug discoveries and approvals which would be of benefit to patients – providing them with more options. Dr. Shah discussed how AI could assist with providing continuous monitoring of health conditions which could lead to the development of individualised doses and "the ability to dynamise change in the way we manage our medicines".
The panel finished up by reflecting on whether AI will ever be given personhood. Dr. Payne said this was "probably inevitable" as at some point it would be necessary to apply some sort of legal status and have some legal framework to deal with AI. Dr. Payne considered that a historic lack of trust in AI meant there was a need for legislation if AI was to be fully accepted.
A business up in smoke - Cannabusiness
Cannabis has a long history, its use being documented in China as far back as 2,400 years ago. Traditionally it was used as a food source, for its fibres and also for its psychoactive properties, however more recently there has been much discussion about its medicinal properties. This increased interest has triggered a wave of scientific research into the active compounds, including recent research suggesting that endocannabinoids can be produced during running, the so called 'runners high', as well as much debate about effective regulation. This session explored some of these ideas in more depth.
Dr. Marion Palmer, Senior Scientist at Hogan Lovells, kicked off the session with a look at the science behind cannabis and its medicinal properties. Cannabis contains a vast array of different chemicals, including flavonoids, steroids and phytocannabinoids, the concentrations of which vary according to species and growing conditions, and which can also be altered post-harvest by storage and treatments. The main endocannabinoids in the human body are AEA and 2-AG and they act by altering neurotransmission at the cannabinoid receptors; these receptors play important roles in a wide range of bodily functions such as pain, inflammation and epilepsy. THC is the psychoactive component, with a synthetic version being available commercially for use in cancer and anorexia treatment whereas CBD is non-psychoactive and is important in epilepsy treatment. Marion concluded by setting out that there is currently a lack of standardised protocols and methodologies for testing to assess the quality and constitution of cannabis products.
Jane Summerfield, Counsel in the firm’s Global Regulatory practice, set out the UK regulatory framework for cannabis products covering every stage of the supply chain, from growing and R&D, through to the processing and sale of products. Three main areas of regulation are especially relevant; controlled drug regulation, product regulation and consumer regulation.
The Misuse of Drugs Act 1971 sets out the penalties for misuse of controlled drugs with cannabis listed as a Class B drug. The Misuse of Drugs Regulations 2001 set out conditions for lawful production, supply and possession of controlled drugs with cannabis listed in Schedule 1, meaning that possession and supply are prohibited unless the Home Office has issued a license. Cannabis-based medicines have recently been moved to Schedule 2 meaning that they can be prescribed subject to special conditions, however to date only a limited number of packs have reached UK market. Pure CBD products are outside the scope of the controlled drugs regime, but the onus is on the producer to show that no THC or other controlled substances are present.
In terms of product regulation, Jane explained that products containing CBD and which are used for a medical purpose are regulated as medicines, while many non-medical CBD products are regulated as foods or food supplements. Other CBD products can fall within cosmetics legislation or other categories such as veterinary medicines, depending on their composition and use.
Jane concluded by explaining the whole raft of consumer regulation that could be relevant when selling cannabis-based products to consumers, including on consumer rights, e-commerce/ distance selling and advertising .
Dan Brook, Partner in the firm’s Intellectual Property practice, explained that there are exceptions to patentability, including on the grounds of immorality and for plant varieties, however over 1000 patents are currently granted for cannabis products. The immorality test was set during the 1993 Roundup case- the question to be asked is, 'is it abhorrent to EU society?' Dan also explained that the plant variety question had proved to be somewhat a political hot potato and concluded by explaining that whilst there appear to be mechanisms to prevent something like cannabis being patented, there really are no any special rules being implemented at present.
The panel concluded that Cannabis is likely to be a huge growth market with many companies already investing huge amounts. Understanding the regulatory environment is essential to success in this market.