You’ve been frame worked

Key changes to the European Market Access Landscape have emerged this year

Over the course of the past decade, there’s been a vast increase in the recognition of the Market Access function among pharma companies. It is now viewed as an independent function within the industry, which serves as a critical link between other parts of the business, ensuring patients are receiving products as quickly as possible. Despite the increased recognition internally, however, market access remains one of our industry’s greatest challenges.

In Europe, one such challenge is the impact of Brexit on the regulatory environment. The UK’s departure from the EU has triggered a period of change and uncertainty, all of which has been exacerbated by COVID-19’s impact on the economy and healthcare systems. For the Market Access function, this means that we now have an additional regulatory process to take into account when planning our European access strategy.

The UK’s decision to leave the EU has undoubtedly raised concerns over patients’ access to healthcare, as the Medicines and Healthcare products Regulatory Agency (MHRA) licence is no longer recognised in the EU, making UK medicines’ validity for EU sales more uncertain. New rules and changes, however, bring new opportunities to streamline regulation and reform legislation.

In 2021, the UK government elected to join two international alliances to expedite the approval of new drugs – Project Orbis and the Access Consortium – and the first authorisations and approvals granted through these schemes have already seen medicines delivered to patients in the UK.

Project Orbis is coordinated by the US Food and Drug Administration (FDA), involving the MHRA and other regulatory authorities of well-regulated markets. The initiative was formed with the aim of conducting marketing authorisations of promising drugs with shared resources and expertise. The Access Consortium is a similarly structured but more diminutive regulatory grouping, currently comprised of Australia, Canada, Singapore, Switzerland and the UK.

Of course, changes in the UK are recent and long-term impact is yet to be determined, while the so called ‘reliance’ route still allows the UK to closely align with its neighbours. But there’s promise that these new and reformed policies and processes will deliver faster access to patients. Being from the UK myself and working at a European level, I am excited by the different range of options we can now explore to bring innovation forward.

I am sure that the European Medicines Agency will be keeping a close eye on how things unfold in the UK in order to leverage any insights and potentially adopt models that work well to accelerate patient access across the entirety of Europe.

It remains critical that we monitor the ever-changing access environment and ensure that we focus on learning about the changes in stakeholders’ needs so we can anticipate challenges and translate those learnings into flexible access strategies that start at the beginning of a molecule’s life cycle.

This will ultimately enable us to be better partners to our stakeholders and bring treatments to patients faster.

Nicholas Jones is Head of Oncology Europe – Value, Access & Pricing at Daiichi Sankyo.
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