Licensing Executives Society Britain & Ireland 2025 Annual Conference: Licensing as a solution in an age of uncertainty

Earlier this month, Ellen Lambrix and Luca Cericola from Bristows’ Commercial & IP Transactions team attended the Licensing Executives Society Britain & Ireland (“LES B&I”) 2025 Annual Conference, with Ellen also speaking on one of the expert panels. The conference brought together legal practitioners, policy experts and industry leaders for a day of robust discussion and practical insights into the ever-evolving licensing landscape in the midst of impending regulatory reform and rapidly advancing technologies.

The conference featured five sessions, each with a moderated panel of subject-matter experts, covering EU pharmaceutical strategy, licensing amidst global uncertainty, artificial intelligence (“AI”) and machine learning (“ML”) in contracts and MedTech and wellness technology commercialisation.

The EU pharmaceutical strategy and its impact on licensing

The conference opened with a keynote on the EU pharmaceutical package (the “Pharma Package”) – the first significant revision of European pharmaceutical laws in over two decades. The Pharma Package is intended to modernise the EU pharmaceutical rules to better serve patients, ensure security of supply and support innovation across the EU. The keynote outlined the need for reform of the current regulatory framework to facilitate innovation and investment in the life sciences sector, noting that (according to the European Federation of Pharmaceutical Industries and Associations’ Patients W.A.I.T Indicator and Pharmaceutical Industry in Figures report) only 46% of innovative medicines centrally approved between 2020-2023 were found to be available to European patients in 2024, and that in 2023 China had overtaken Europe as the leading originator of new active pharmaceutical substances globally for the first time. On 4 June 2025, the Council of the European Union adopted its position on the Pharma Package, which now moves on to the next stage of trilogue negotiations. The European Commission separately launched a new strategy on 2 July 2025 to make Europe the most attractive place in the world for life sciences by 2030. Given that the trilogues are anticipated to last until at least the end of 2025, the final question posed by the keynote was whether the measures proposed by the Pharma Package are suitable and adequate to meet its objectives. 

This set the tone for the first panel session, which explored the EU pharmaceutical strategy’s implications for licensing and how the changes proposed in the Pharma Package – particularly to regulatory data protection (“RDP”) and orphan drug market exclusivity – could reshape deal-making. In particular, the panel noted the importance of robust and predictable RDP periods and that the proposed "modulation" system of incentives under the Pharma Package introduces: (i) unwelcome unpredictability for innovators and generic/biosimilar companies alike with regard to their strategy for launching medicines; and (ii) additional intricacies in licensing negotiations for early-stage biotech companies that may not be as cognisant of RDP considerations given where such companies are in their lifecycle. The panellists also suggested that due care and attention must be given to ensuring that any regulatory incentive ambiguity is accounted for when drafting financial milestone provisions in licence agreements in order to avoid future litigation as to whether or not specific milestones have been achieved.

Despite the challenges caused by this additional complexity, the panellists unanimously agreed that such complexity also presents companies in the UK and EU in this space with a unique opportunity to stand out as attractive collaboration partners by demonstrating creative, considered and consistent ways to navigate the regulatory ambiguity in their licence agreements.

Licensing in an age of global uncertainty

The second session addressed the macroeconomic and geopolitical forces reshaping licensing dynamics across Europe, the UK and the US.

Building on the keynote presentation, the panel discussed how the uncertainty caused by US policy fluctuations (including restrictions on international student enrolment and funding cuts for the National Institutes for Health under President Trump’s Big Beautiful Bill) has led to the growing prominence of China as an attractive market for R&D and commercialisation in the life sciences sector. However, the panel also suggested that any consequential influx of US students (or international students who may have previously wished to attend a US university) could be considered a real benefit to the UK and EU academic ecosystem.

The panel also discussed further uncertainties that have arisen as a consequence of positions taken by the US administration. Aside from the disquietude in the life sciences sector around the potential impact of tariffs on pharmaceuticals, it was also noted that, on 12 May 2025, Trump issued an executive order (Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients) that seeks to align the price for a drug in the US with the lowest price of the drug in other developed countries, and threatens various regulatory actions against pharmaceutical manufacturers that fail to make “significant progress” towards most favoured nation pricing for US patients. While most favoured nation pricing in the US has been discussed at a high level for some time, how this would be executed remains to be seen and is yet another example of policy change which may influence where life sciences companies choose to build their business and launch their products. 

The panellists explored the implications of this uncertainty on life sciences transactions noting that, despite a shift towards more risk-averse deal structures, licensing continues to be a key vehicle for commercialisation opportunities. The pharmaceutical industry is approaching another patent cliff (with 190 drugs losing patent exclusivity and, in the US, $236 billion projected to be at risk between now and 2030 according to Deloitte’s Navigating the Pharmaceutical Odyssey 2024 report) that will incentivise pharmaceutical companies to continue filling their pipelines with innovation that has originated from elsewhere through in-licences from academic and industry partners alike.

Adapting contracts for AI and ML: Navigating risk, regulation and intellectual property

This session examined how the nature of AI and ML systems, and the data used to train such systems, can give rise to myriad questions around IP ownership, protection of IP rights, regulatory restrictions and commercial models for the data and systems generated using them. 

The panellists stressed that challenges in the drafting and negotiation of contracts that have AI and/or ML at the core of the deal often stem from the ever-increasing hybridisation of technology, contending that, by bringing together stakeholders with different areas of expertise (for example, chemists and software engineers in a life sciences licensing deal relating to an AI drug discovery platform) it is possible that there may be a technical/subject matter language barrier that may stall negotiations. The panellists noted that those involved in negotiating licensing deals that include AI and/or ML elements must, from the very outset, drill into what each party actually wants to own (for example, rights in the algorithm itself, the data set used to train the algorithm, or the results generated).

Furthermore, the panellists drew particular attention to the value that can be attributed to carefully curated data sets, the know-how of key individuals who are able to make use of such datasets and how thorough management of such datasets is fundamental to preserving its value and maximising commercialisation opportunities.

Medtech and wellness: Technology commercialisation and IP licensing 

The final panel examined the regulatory and commercial challenges facing the MedTech and wellness sector.

The panellists discussed that, with the democratisation of healthcare leading to increasing numbers of healthcare professionals coming up with innovative ideas and solutions, a key challenge is ensuring that such individuals are aware of, and properly advised on, the complex requirements of UK and EU medical device regulations.

The panellists agreed that the UK and the EU continue to be global hubs for MedTech innovation; however, there are several challenges that mean companies developing innovative MedTech and wellness solutions may look elsewhere to commercialise their products. It was suggested that the fragmentation of the NHS as a buyer of MedTech means that more mature companies in this sector are increasingly viewing the NHS a less attractive prospective buyer. Furthermore, the panellists concurred that the significant complexity of the relevant regulation is a continued barrier for innovators to convert ideas into commercially successful businesses.

 In the context of “FemTech” (a rapidly growing sector focused on technology-based solutions for women’s health issues), we recently reported on the: (i) legal and regulatory nuances of determining when FemTech apps and software qualify as medical devices and the difficulty in navigating the misalignment of medical device frameworks in the UK and EU in this article; and (ii) main early-stage funding options available to UK-based FemTech companies and key associated legal considerations in this article (both published as part of the Bristows’ Women’s Health Initiative).

Final thoughts

A clear takeaway from the day emerged: while regulation, market forces and emerging technologies are transforming the licensing landscape, they also open up new possibilities for forward-thinking stakeholders and practitioners.

The importance of adaptable and strategically sound licensing models has never been greater. Whether navigating the uncertainties of pharmaceutical reform, the promise of AI, commercialising academic research or the regulatory hurdles of MedTech, proactive legal and strategic guidance is essential.