The MHRA has published a body of guidance on the medicines-related changes being brought about by the Windsor Framework. Those in the supply chain will need to get used to a new way of doing things in the UK. The latest guidance (Advertising and Promotion following agreement of the Windsor Framework) is about territorial advertising of products from 1 January 2025 onwards.
In 2025, manufacturing is going local. The UK government has laid Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024 in Parliament. The new regulations set up a system of hub-and-spoke authorisation that is intended to give prompt and more convenient access for patients and is particularly relevant for advanced therapies and personalised medicines.
There will always be a few nuanced legal arguments left to be made in the world of parallel trade and we expect next year to be no different. A recent interesting case involves an electronic goods company and a distributor arguing about who has to prove whether goods had been marketed with consent or not (if they had then the relevant trade mark rights would have been exhausted making parallel trade activity lawful, at least with respect to trade mark use).
The burden of proof is relevant to the scope of disclosure in litigation of this nature. The judge considered that it was not reasonable or proportionate to require the claimant to disclose its suppliers and related details, as the defendant had requested. This early decision in the case serves as a reminder for trade mark proprietors and parallel traders to consider evidence of consent for placing products on the market in the EEA/UK, anticipating these kinds of difficult disputes.
We have all heard the anguished commentary about the decline of clinical trials in the UK. The Office for Life Sciences has published its report on competitiveness indicators which presents a mixed picture on patient recruitment and the speed of regulatory review in recent years. The UK government has announced a big pot of cash, most of which will be spent on reviving the UK commercial clinical trial scene. We therefore hope to see more activity in this area in the new year.
The UK legislation governing the regulation of medical devices is in a state of reform. It feels like I have been saying that for a while. The UK government has announced the next step on that journey, a consultation on pre-market requirements. The topics are broad and the deadline is on 5 January 2025, after which we can expect a further legislative proposal to be laid in Parliament next year.
Nothing stands still. Yes, that includes regulators. In 2025, watch out for regulators getting with the times and using artificial intelligence and real-world data, including social media data.
Though regulators are recognising the opportunities to improve patient outcomes using AI, we can expect a cautious approach. The European Medicines Agency (EMA) recently issued a report which concluded that the use of AI and machine learning technologies "[shows] great promise for enhancing all phases of the medicinal product lifecycle" but highlighted the risks to patient safety and the integrity of clinical study findings that would need to be mitigated. In the UK, the MHRA has recognised the value of AI powered medical devices and has recently announced that it is piloting five AI technologies to better understand how it can regulate these types of devices.
Different regions have individually considered the value of leveraging real world data and real world evidence to develop and evaluate medicines. For example, Heads of Medicines Agencies (HMA) and the EMA have considered how social media data may be harnessed to feed into EU regulatory decisions. Recognising the challenges presented by regulatory gaps, the ICH has outlined a strategy for a harmonised approach to real world data usage with common definitions and best practice. It will be interesting to see what progress can be made on this in the new year.
In its recent article on data anonymisation, the European Federation of Pharmaceutical Industries and Associations (EFPIA) highlighted the important role of public trust and confidence in developing data handling practices and for scientists looking to balance privacy and using data to further innovation.
The Health Foundation, an independent charitable organisation, recently published its findings following a survey of the public's attitude to the use of health data to develop AI in the NHS. As reported by the Foundation in its press release, the majority of the public is in support of sharing some personal health data for this purpose and there is trust in the NHS's holding of personal data. The Foundation does however indicate that the survey shows that attitudes towards the use of data vary among different socioeconomic groups and that there is hesitance around the adoption of technologies (such as "care chatbots") that may reduce patient interactions with healthcare staff.
In its budget, the UK government recently showed support for further digital adoption in the NHS, allocating over £2 billion for technology and digital improvements. It will be interesting to see what steps are taken in 2025 to increase engagement with different socioeconomic groups so that health data can be harnessed to develop AI systems and tackle health inequalities, and to also increase public confidence in the use of technologies to improve patient experience.
There may be some positive planning changes in the pipeline. The UK government's consultation on revising the National Planning Policy Framework (which closed in September) promised changes to the planning system which would support access to and scaling up of laboratory space.
The creation and maintenance of sustainable buildings (particularly laboratory space) will also remain a key issue for the sector, particularly as the NHS continues on its journey towards net zero healthcare. Sustainability in real estate will feature at our PING conference next year, the theme of which will be Sustainability - what must pharma do now? If you are interested in attending the conference, please get in touch.
As you can see, there is plenty in store for the sector in 2025. We will of course report on updates as they come, so please check our website for insights. Festive best wishes to you and your teams, and looking forward with anticipation to an exciting year of life sciences developments.