Future ready labeling: How to thrive and survive

Labeling continues to grow in importance in terms of delivering value for patients, prescribers, and industry. Regulators are increasingly emphasising the need to deliver accurate, relevant, and informative product information, not just to themselves, but also to prescribers and patients in order to better inform prescribing and treatment decisions, minimise medication errors, and speed up the identification and reporting of undesirable risks and adverse events. This remains the case today, with demands on labeling continuing to expand exponentially with the COVID-19 pandemic only adding another level of complexity. As the public’s interest in drugs, treatments, and medications increases, now more than ever, labeling is playing a critical role in public health and must be well managed and future-ready.

We are seeing labeling teams responding and positioning themselves to lead into the future, to not just survive, but to thrive in an environment where they are constantly required to do more with less. In this paper we will explore five trends that are critical to the future success of labeling.

A shift to value

The trend is for labeling to increasingly engage earlier in the development lifecycle, with 35 per cent of our member companies now starting activities at Phase I. This is very much a conscious shift to demonstrate delivery of strategic value and, to be successful, there is a requirement to move away from the typical decentralised ownership of activities within the business and move to strong strategic leadership, cross-functional partnering, and senior leadership buy-in. This must all be underpinned by the development of new, strengthened skills and capabilities within the labeling team. Value measures to drive labeling performance tracking continue to mature but have some way to go before they are established and harmonised within the overall process.

Increased workload amid global regulatory complexity

There is certainly no respite from regulatory complexity. Workload pressures continue at both local and global levels, with changes in Health Authority (HA) requirements and expectations a key challenge for industry. We are seeing continued demands on the workload for core labeling.

While the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and France’s L’Agence nationale de sécurité du medicament et des produits de santé (ANSM) remain two of the most active Health Authorities, they are now seeing increasing inspections from the regulators of Eastern European and the Middle East (95 per cent of members have experienced at least one inspection in the last three years).

The drive for efficiency

We frequently see labeling teams on something of a quest for efficiency amid rising workloads. The industry continues to look to outsource, optimise the end-to-end process, and automate, all as levers to help drive efficiency while Full Time Equivalents (FTEs) remain static. In industry, labeling outsourcing has certainly grown in popularity, although some resistance remains. In our experience, we see as many as 88 per cent of companies outsourcing at least 25 per cent of their product portfolio owing to lack of capacity. With the increased maturity and domain experience of vendors, coupled with customised flexible resourcing models (single, multi and hybrid) availability, this can be an effective solution.

We see that digital transformation continues to shape healthcare activities. With the cross-functional nature of end-to-end labeling, digital transformation has the potential to drive better integration and, in turn, efficiencies. Automation, Cloud, Artificial Intelligence (AI), and Analytics will all help, and we expect to see the number of companies adopting more disruptive technologies rise in the coming years.

Building a global workforce

The labeling organisation is evolving with a growing need to strengthen both collaboration and oversight. In a bid to achieve this, we are starting to see the formation of a new global workforce, an evolved labeling global-local organisation. We see in the archetype labeling organisation, that there are common characteristics, many of which are adapted to meet specific scope needs and organisational scale. Typically, a Global Head of Labeling will report into either global Regulatory Affairs or Regulatory Operations and, while strategy and content operations and compliance are common sub-functions (~85 per cent of companies), new sub-functions are emerging including digital, innovation, and dedicated labeling IT, as well as global footprint broadening in order to meet specific labeling opportunities. This new g-local organisation and interface is business-critical, and to establish high-functioning teams, companies have been successful through developing leading-edge best practices.

Future focus: Digital Patient and Talent

The major future opportunity for labeling evolution is through digital. We know that the labeling technology infrastructure is typically highly fragmented and multi-solutioned, but it is maturing with a future focus centred on digital, the patient, and talent management (over 70 percent of our member companies are investing or looking at RWE, Digital, eLabeling, and Machine Learning). Digital is emerging strongly as an efficiency enabler and, when implemented correctly, can ensure companies remain patient centric by enhancing patient communications and interactions.

In the context of balancing workload pressure and process optimisation, technology is a key opportunity with some dominant tools emerging, but the fragmentation in the technology landscape requires ongoing or planned integration projects. These are often focused on delivering seamless end-to-end labeling management, with a future focus on integrated Regulatory Information Management (RIM), Structured Content Authoring, and analytics. Vendor readiness, validation, and internal mindset are considered key hurdles to achieving a structured data-driven technology end-to-end landscape.

Labeling is looking to demonstrate value via impact on patient, in line with emerging areas of patient centricity labeling and digital health.

The future of labeling

We have established the importance of labeling and acknowledge that it is an important mechanism for communicating safety and benefit-risk information to patients and healthcare professionals. Labeling errors can pose a significant risk to patient safety, resulting in instances of regulatory non-compliance. This in turn leads to high costs to the company, including those related to product recall and potential fines, ultimately, damaging the brand reputation. In addition, end-to-end labeling is a critical process to launch a product on time, as it encompasses multiple stakeholder groups, from pharmacovigilance and regulatory to artwork and manufacturing, and spans from signal to patient across markets and geographies.

So, with these pressures, and the five trends that we have explored in mind, just what does the future of labeling look like?

As previously mentioned, we are seeing labeling teams responding. As labeling evolves into a strategic business asset, teams are better positioning themselves to lead into the future. Yes, there is a requirement to do more with less, but with the balance of a skilled team, formalised processes across functions, and a mix of digital tools NextGen labeling has the potential to thrive.