In recent years, the healthcare industry has witnessed a significant transformation in the way medicines are classified and accessed. This shift, particularly in the reclassification or switching of medicines from Prescription Only Medicine (POM) to Pharmacy (P) and, in some cases, to General Sales List (GSL) categories, has become a cornerstone of the government’s Pharmacy First approach and wider push to help ease pressure on GP services and overall strain on the NHS.

With many more switches anticipated in the coming years, I thought it might be useful to explore the driving forces behind medicine reclassification, its impact on healthcare systems and patients, and how Impact Health leverages its broad expertise to navigate these changes for healthcare companies.

The underlying principle of medicine classification is straightforward yet vital: to maximise timely access to effective medicines while minimising the risk of harm due to inappropriate use. The move towards reclassification, especially in countries like the UK, which leads this practice globally, signifies a paradigm shift towards empowering patients and making healthcare more accessible and efficient.

• Untapped Potential in Pharmaceutical Portfolios: There exists a significant opportunity for pharmaceutical companies to revitalise interest in older medicine portfolios, extending their life cycle and reaching more patients.
• Data Exclusivity: A successful first-in-class switch application can secure an additional year’s data exclusivity, offering a competitive advantage.
• Cost Savings for National Health Authorities: Reclassification can lead to substantial cost savings, with some EU Member States being more receptive to switches than others. The UK stands out for its proactive stance, making it an attractive location for initiating switch applications.
• Patient Empowerment: Allowing patients to self-medicate for certain conditions saves considerable time and resources, avoiding the need to obtain prescriptions for treatable conditions.

Whilst the principle behind reclassification is straightforward, the procedures and requirements to initially make the change and then make the strategy a success requires close collaboration with industry experts and stakeholder groups including patients, GPs, pharmacists, and pharmacy staff.

• Developing pricing & promotional strategies to maximise sales revenue
• Category and portfolio optimisation, exploring anticipated uptake/demand and impact on existing products
• Ideation and testing potential brand names and packaging options
• Understanding knowledge gaps and challenges to anticipate awareness needs and potential training requirements
• Understanding and addressing pharmacy barriers
• Designing education materials and category displays to optimise footfall and engagement
• Shopper experience research to help design launch preparations, campaigns (in-store and digital) and store layout and category fixtures

Areas in which we have significant experience include:

• Dermatology
• Sexual health (erectile dysfunction & contraception)
• Allergy – eye drops and tablets for hay fever and seasonal allergic rhinitis (SAR)
• Cold and flu – cough lozenge and throat sprays

Our strategic approach not only aids pharmaceutical companies in extending their product lifecycle but also in enhancing patient care by making medications more accessible.

The significance of OTC medicines in the UK underscores the importance of reclassification. According to a survey by PAGB, the consumer healthcare association, nearly a fifth of the UK workforce relies on OTC medicines to self-care or manage chronic conditions, which translates to around 7 million people. This reliance on OTCs enables employees and their dependents to miss fewer days of work, effectively contributing to the economy by reducing potential losses in wages estimated at £364 million annually.

Moreover, the average UK citizen suffers 4.2 self-treatable illnesses per year, with a substantial majority utilising OTC medicines for treatment. This not only demonstrates the essential role of OTC medicines in the healthcare system but also highlights the potential savings for both consumers and healthcare providers through reclassification.

The move towards medicine reclassification represents a shift towards a more patient-centred, efficient healthcare system. At Impact Health, we have extensive experience in this area, working with both large and small pharmaceutical companies and offering comprehensive support in navigating the complexities of medicine reclassification and influencing entrenched behaviours to make the switch a success!

Our expertise spans:

• launch strategy including brand planning, forecasting and P&L support
• regulatory processes and medical affairs support
• market research – ensuring a comprehensive strategy reflects consumer needs and requirements
• promotion and marketing strategy (digital and in-store)

Our combined offering makes us an ideal partner for companies looking to maximise their portfolio’s potential while contributing positively to public health outcomes.

In an era where timely access to effective medication is more critical than ever, Impact Health stands ready to guide your company through the evolving landscape of medicine re-classification, unlocking new opportunities for growth and patient care.

For more information on this or any of our case studies in this area please don’t hesitate to direct message me, or email at jamie.margerison@impacthealthmr.com