Biotech Review of the Year: latest developments

Authors: Claire Smith and Ben Steele

Since publishing the 12th edition of our Biotech Review, a significant milestone has been reached for both the AI and biotech industries, when earlier this year the first AI-powered companion diagnostic device received regulatory recognition. 

In April, Roche announced that the US FDA had granted Breakthrough Device Designation for its VENTANA® Device. The device is powered by the TROP 2 algorithm, which incorporates a proprietary AI-driven computational pathology platform developed by AstraZeneca. The CDx (companion diagnostic device) is indicated as an aid in identifying patients most likely to benefit from treatment with DATROWAY®, a new therapy being jointly developed by AstraZeneca and Daiichi Sankyo.

AstraZeneca and Roche are working together to co-develop the CDx, marking the expansion of their existing collaboration into the realm of AI. Collaborations between biopharmaceutical companies and diagnostics companies are becoming more prevalent, and with the increasing impact AI is having on both industries, this trend shows no sign of slowing down. To learn more about these kinds of collaborations and the role of AI in biotechnology, read our articles on Key issues in companion diagnostics partnering deals and How AI affects biotech companies, published in our 12th Biotech Review of the Year.

Original article: “Key issues in companion diagnostics partnering deals” co-authored by Claire Smith, Adam Coughlin and Pippa Davis. Published on 03 February 2025.

Author: Manon Rattle

On 2 June 2025, Skills England published its “Sector skills needs assessments” for Life Sciences. The report notes an increasing demand for interdisciplinary skills, particularly the combination of scientific skills with digital and technological ability considered to be vital for areas such as personalised medicine and digital health. It also identifies small and medium enterprises (SMEs) may struggle to invest in training, with these businesses considered to be critical to innovation in areas such as personalised medicine. Modular training is also recommended as a means to addressing immediate skills gaps, for example, as opposed to more traditional multi-year courses. Expanding ‘non-traditional’ routes into the workforce was also highlighted as a way to “build the future workforce”, for example expanding apprenticeship programmes. However, given the understandably high value placed on academic qualifications in order to commence employment in the sector, there remain barriers to entering the pharmaceutical industry via other non-traditional paths.

Four days later, on 6 June 2025, the Business and Trade Committee published its Industrial Strategy Report which welcomes the Government’s proposals to introduce a new 10-year strategy to facilitate economic growth in the UK. The life sciences sector has been selected as one of eight “growth-driving” sectors, demonstrating the Government’s commitment to invest in this industry. Each sector has been selected as an area of focus due to a recognition that these areas are “where the UK has a comparative advantage or the ability to build one”. Life sciences therefore maintains its status as an integral area for success and economic growth, however skills shortages continue to be cited as an example of challenges facing the UK economy.

Just two days later, on 8 June 2025, a Government press release announced a £86 billion funding commitment towards science and technology, to boost the UK’s status in R&D and innovation. A portion of this funding is expected to go towards the pharmaceutical industry, for example funding new drug treatments, with a hope that the investment will drive new jobs and economic growth.

Closing the skills gap will inevitably take time and the investment of resources. Identifying and understanding the problem is the first step to addressing the talent challenges faced by the life sciences sector. More commentary around the growing importance of skills and targeting the gap can only be a good thing, resulting in increased funding from the Government and a renewed vigour of collaboration across the industry. 

Original article: “Talent trends and solutions for the life sciences sector” authored by Manon Rattle. Published on 03 February 2025.

Authors: Sophie Lawrance, Francion Brooks and Katharine Head

In our article “Lies, damn lies and denigration: misleading statements as a competition law infringement”, we examined the growing wave of competition law enforcement in Europe focused on disparaging conduct. Since then, the European Commission (EC) has published its 560-page decision in one of the most prominent cases to date: the Copaxone investigation. The UK CMA has also concluded its first investigation into disparagement with commitments and a very substantial payment (£23M) to the NHS. The Copaxone case is under appeal but nonetheless provides fresh insight into the EC's approach in denigration cases:

All eyes on pharma

Although competition law infringements based on disparagement are not, in principle, limited to any particular sector, the EC has focused on the pharmaceutical industry. The EC is particularly concerned with any communications directed at prescribing physicians, pharmacists and other healthcare professionals, viewing this group as particularly vulnerable to disparaging practices due to their generally risk-averse approach. There is typically a degree of inertia when it comes to switching patients between products, which means that even minor doubts can be sufficient to deter substitution.

Contradicting health authority findings is likely to be misleading

Communications that contradict the findings of health authorities are likely to be considered misleading. For example, communications which directly or indirectly raise doubts about a product’s safety, efficacy or therapeutic equivalence are likely to be problematic once these issues have been settled through the grant of a marketing authorisation.

The EC has acknowledged that there may be a “broader margin” to raise questions where there is no "more definite scientific position". For example, in the Copaxone decision, the EC accepted that raising concerns about automatic substitution (i.e. substitution not decided by a prescribing healthcare professional) may be justified given that there was some scientific uncertainty on that issue. However, any such communication must objectively reflect the range of evidence and should not form the basis of any broader disparagement of the competing product. If the scientific thinking evolves, the onus is on the party that raised the concerns to provide an update.

Pharmacovigilance concerns are unlikely to justify anti-competitive conduct

The EC is unlikely to accept an objective justification based on claims that a dominant company’s conduct was intended to warn the public, healthcare professionals or payers, such as pricing and reimbursement authorities, about the risks associated with a competing product. The EC has emphasised that pharmacovigilance obligations rest solely with the marketing authorisation holder of a medicinal product. It is not for a dominant undertaking to take steps to eliminate products which it regards as dangerous or inferior. Genuine safety concerns should instead be raised with the competent authorities following proper pharmacovigilance procedures in a proportionate manner.

The dominant firm's reputation may be relevant  

The EC considers that a disparagement campaign is more likely to produce exclusionary effects when carried out by a dominant firm with a strong reputation and well-established relationships with key stakeholders. The EC considers that when the disparaging undertaking is a large, incumbent player, it is more likely to benefit from a high level of trust among healthcare professionals which will generally strengthen the impact of its messages.  

Internal documents can be highly influential in investigations

The EC tends to place significant weight on internal documents in investigations. For example, documents may be used to support multiple elements of the abuse finding, including intent and (importantly) the absence of legitimate explanation. Firms should therefore consider maintaining contemporaneous records that document legitimate explanations for behaviour that could later be subject to scrutiny.

High penalties and onerous commitments

The penalty for communications falling the wrong side of the line can be very high – the fine in Copaxone stands at €462.2M (across two infringements). Even when a company settles with the Commission before a formal decision, acceptable commitments are also likely to place a significant financial and practical burden on a defendant undertaking. Commitments given to end another recent EC investigation bind the company to undertake a “comprehensive, multi-channel, clarification communication campaign” and subject it to a 10-year monitoring period, during which time it will have to face the threat of fines in the event of non-compliance.

Food for thought?

Businesses considering lobbying in relation to a competing product will need to give detailed and careful consideration to their factual circumstances in the context of of their antitrust risk appetite, whilst keeping a close watch as this area of law develops in light of the pending Copaxone appeal in Europe.  

In the UK, the CMA has taken account of various national regulations and guidelines that govern the advertising of medicines to inform its assessment of when a communication in a pharmaceutical context is misleading.  

Bristows' expert teams in both Competition and Life Sciences Regulatory matters work closely together and have market-leading expertise on these issues. We can help companies to navigate issues, whether in terms of minimising risks to their own business, or where facing disparaging conduct by a competitor. 

Original article: “Lies, damn lies and denigration: misleading statements as a competition law infringement” co-authored by Sophie Lawrance and Sean-Paul Brankin. Published on 03 February 2025.

Author: Xisca Borrás

In our article “The pressing need to have a coherent and solid legal framework to support innovation in the life sciences sector”, we examined key legislation that affects the biotech and pharma industries and the way in which their design and implementation is negatively impacting innovation and the sector as a whole in the European Union (EU). Since then, the European Commission (EC) published its Call for evidence for an impact assessment for the future European Biotech Act. Even though the period to submit feedback has now ended, this document provides some insights into what the future legislation – which is currently planned to be adopted in Q3 of 2026 – will regulate. 

Consistent with the thesis of our article, the EC recognises that the EU is not currently reaping the full potential of biotech and that European companies are not competitive enough as they face barriers and complexity when translating innovation into products. It this context, the European Biotech Act should make it easier to bring biotech from the lab to the factory and then onto the market.

The challenges faced by biotech companies that the EC has identified in need of addressing are:

1. A complex regulatory framework that is perceived as slow and burdensome. The situation is aggravated by the divergent implementation of the relevant EU regulatory framework among Member States. 
    
2. Market fragmentation, risk capital constraints, and scattered innovation support. The EC recognises that EU companies lack sufficient access to risk-tolerant capital and the lack of coordinated investment (private and public) to support the translation of innovation into products and the scaling-up of production.¹
    
3. National interests often lead to support for local champions, resulting in a fragmented landscape. 
    
4. A mismatch between the labour supply and the biotech and biomanufacturing skills required. This, combined with the fast-developing nature of this field, calls for greater efforts to attract suitable candidates to the biotech workforce and for upskilling and frequent reskilling to improve retention of staff.
    
5. Despite AI and big data offering huge potential for all sectors underpinned by biotechnology, their potential is not yet fully exploited.
    
6. Even if the EU is a global leader in biomanufacturing, particularly when it comes to biological medicines, global competition is intensifying and supply chains remain subject to disruption.

The EC is well aware that, without intervention at EU level, the competitiveness gap between the EU and other countries/regions will probably widen and so the region is likely to fall behind and dependencies on third countries will increase.

In view of this, the EC has identified the following needs: 

1. The promotion of an ecosystem for the entrepreneurial economy, including the creation of a supportive environment to raise private finance for EU companies at a competitive scale. 
    
2. Biotech clusters need to be significant and meaningful on a continental scale to compete globally. 
    
3. The development and deployment AI solutions for biotech will benefit from supporting the storage, access and sharing of data across the EU and facilitating access to sufficient supercomputing capacity. 
    
4. Increasing efforts to attract, reskill and upskill workers in the biotech sectors.
    
5. Lean and streamlined regulatory and risk assessment frameworks to support the functioning of the internal market. As some of the legislation applicable to the biotech industry is already harmonised at EU level, any further streamlining should be undertaken at EU level.

The need for a sector-focused approach to supporting the biotech industry in the EU is obvious to anyone familiar with the sector and who reads the EC’s call for evidence for an impact assessment. The European Biotech Act should therefore be welcomed news. A public consultation will be launched in Q3 2025, and targeted consultation activities, tailored to specific stakeholder groups, will also take place. 

[1] _{^{According to the EC, and despite increases over the last decade, the share of global venture capital funds raised in the EU is only 5%, compared with 52% in the United States and 40% in China.}}

Original article: “The pressing need to have a coherent and solid legal framework to support innovation in the life sciences sector” authored by Xisca Borrás. Published on 3 February 2025.