The Rising Cost of Clinical Errors

Clinical errors are not just unfortunate events for the individuals affected, they have far-reaching consequences for the UK healthcare system and the wider pharmaceutical industry. As medical innovation accelerates and clinical trials expand across borders, the ripple effects of medical negligence are increasingly evident. For pharmaceutical companies, clinical research organisations (CROs), and NHS partners, effective risk management is no longer optional, it is essential.

Understanding the rise in medical negligence claims

A medical negligence claim in the UK typically arises when a patient is harmed due to a breach in the duty of care by a medical professional or organisation. While such claims have historically focused on hospitals and clinicians, there is now growing awareness that other stakeholders, such as drug manufacturers, trial sponsors, and even regulatory bodies, may also be involved where systemic failures occur.

Several factors are contributing to the upward trend in these claims:

• Greater public awareness of patient rights and legal routes for redress
• More complex drug regimens and multi-disciplinary treatments
• The digitalisation of health records and increased data accessibility
• Stricter oversight from regulatory bodies such as the MHRA

With the cost of claims rising, not just in financial terms but also in reputational damage, organisations across life sciences are re-evaluating how they engage with clinical risk and governance.

The expanding duty of care in the UK pharmaceutical sector

While doctors remain the primary focus in most clinical negligence cases, pharmaceutical companies are increasingly being held accountable, particularly where harm can be traced back to product information, trial protocols, or inadequate post-marketing surveillance.

In the UK, legal tests such as Bolam and Montgomery are used to assess whether a medical professional, or by extension, an organisation, has fulfilled their duty to adequately inform and protect the patient. For example, a poorly written patient information leaflet that fails to mention common side effects could be viewed as a breach of that duty, opening the door to potential litigation.

Drug manufacturers and research organisations now face greater expectations to ensure that both healthcare professionals and patients are clearly and correctly informed about risks associated with a product.

Clinical trials: Legal risks in an evolving landscape

Clinical trials are subject to increasingly complex regulations and scrutiny. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees clinical trial approvals and safety, while ethics committees ensure that participants’ rights and welfare are protected. Any failure to adhere to these protocols, such as insufficient informed consent or delayed adverse event reporting, can lead to legal consequences.

Moreover, new technologies like gene therapies and digital diagnostics, though promising, also introduce fresh legal grey areas. Ensuring participants understand these novel risks is essential for trial sponsors operating in the UK. Litigation arising from experimental treatments could put both CROs and sponsors at risk if governance frameworks are lacking.

To reduce exposure, UK-based trials are increasingly implementing:

• Comprehensive and participant-friendly informed consent procedures
• Real-time pharmacovigilance systems
• Internal audits of trial conduct and documentation
• Early legal consultation during protocol development

Post-pandemic lessons: Speed vs. safety

The COVID-19 pandemic accelerated drug development timelines in the UK, leading to emergency authorisations and fast-tracked trials. While this allowed life-saving interventions to reach patients faster, it also exposed vulnerabilities in safety oversight and long-term data collection.

Since then, the MHRA has revised its guidance to reinforce the need for post-marketing monitoring and clear communication of risks, even after a treatment has been approved. The pharmaceutical industry must now balance agility with diligence, ensuring that future innovation does not come at the cost of patient safety.

Embedding risk awareness into company culture

Preventing medical negligence requires more than policies, it demands a culture of accountability. UK pharma companies and CROs are increasingly investing in staff training, cross-departmental collaboration, and ethical oversight to reduce the risk of harm reaching the patient.

Proactive governance includes:

• Encouraging staff to raise safety concerns without fear of reprisal
• Engaging legal and compliance teams at every stage of development
• Establishing clear lines of responsibility between R&D, marketing, and pharmacovigilance

These steps not only protect patients but also reduce the likelihood of protracted litigation and regulatory scrutiny.

Conclusion: A proactive approach is essential

In today’s complex healthcare landscape, medical negligence claims are no longer confined to operating theatres and GP surgeries. As the pharmaceutical industry becomes increasingly integrated with clinical care, companies must understand and embrace their role in protecting patients.

From the early stages of clinical research through to post-market safety surveillance, risk must be managed as a shared responsibility. Organisations that build comprehensive, transparent systems, and embed a genuine culture of safety, will be far better equipped to withstand legal challenges and maintain public trust.

In the end, the best defence against a medical negligence claim is a relentless commitment to doing things right, first time and every time.