Against the backdrop of COVID-19 disruption, there has been good progress made with European IDMP data standards. Remco Munnik of Iperion Life Sciences Consultancy looks back at the main IDMP developments in 2020 – and looks ahead to a future better supported by data standardisation.
The COVID-19 pandemic has highlighted the potential for global data standards, including those defined via ISO IDMP (Identification of Medicinal Products), which Europe is now so close to implementing via the EMA SPOR program. 2020 has been a time of great emphasis on healthcare. Speed to market yet also thoroughness in safety and quality assessments, have become paramount and visible to a much greater degree in society.
Covid has helped to crystallise the potential of data standards, such as IDMP, in real-world use cases. Although IDMP is about identifying medicines and their constituent substances and manufacturing specifics – and does not cover the clinical efficacy of a product – the ISO IDMP data model allows for medicinal products, their packaging, any different versions, ingredients, specific batches, and who have manufactured them, to be differentiated as part of any vaccine-based track-and-trace effort.
Over the past 12 months, the European Medicines Agency (EMA) has committed to ensuring that any investments in the product data standards are reusable across a wide range of use cases – addressing critical everyday business processes. This is significant. If set up properly, standards-based master data about products could be used for all kinds of uses cases between industry and regulators – from clinical trial approvals and shortages management, to product serialisation and tracking.
Another crucial development 2020 has been the replacement of the Common European Single Submission Portal (CESSP) initiative with an EMA-sponsored project. All of these advances are building momentum behind IDMP, its rollout and its potential impact. This, combined with a growing awareness across all stakeholders of the value of high-quality reusable data in streamlining routine processes, is creating a new sense of purpose and urgency around the ISO standards – in Europe at least. (WHO is looking into Substance IDs and Pharmaceutical Product Identification (PhPIDs) as part of a global solution.)
A further development which is helping to make a seemingly complex landscape easier to navigate and link to longer-term real-world benefits is a growing alignment between two important systems – the EU SRS (scientific database for substances) and EMA’s SPOR Substance Management Services (SMS) system, which distributes relevance substance information.
Master data transforming processes
As we head into 2021, we’re in a better position than ever to ensure that IDMP-based master data forms the basis of transformation of critical business processes, raising the standards above the purpose of compliance for its own sake.
In the year ahead, the SPOR Task Force co-chairs have compromised on a two-step approach which works around any current limitations. The first step has been to define electronic data submission for the centralised regulatory process only, via EMA’s Gateway and/or API. In phase two, as the CESSP gives way to the new technical platform, MAHs will be able to submit data once to stakeholders at both EMA and NCAs. This step requires that the application forms are capable of supplying IDMP-ready messages using the provided technology.
This two-step process allows a ‘Europe of multiple speeds’ – the possibility that individual NCAs might each pick a different point at which to move to phase 2. To contain that risk, the various stakeholders are working to secure a commitment to a capped transition period, so that the two systems don’t run in parallel indefinitely.
European SPOR implementation guidance is approaching the completion of version two – following a huge effort by industry, technology vendors and consultants, which has been largely a labor of love. This guidance is expected to be published by Q1 2021. The clock will then start ticking towards SPOR data-based submissions: these will be possible within 12 months, and become mandatory a year after that. That might sound a way off, but that compliant data-based submissions to be obligatory by Q1 2023 will be sobering for those companies that have relied on a hard compliance date remaining on a distant horizon.
Putting patients first
Where companies persist in seeing SPOR and IDMP as a burden to be endured, the next years will be painful and increasingly demanding. Now is the time to put a stake in the ground and decide whether EMA’s mandate is the only driving force for change, or whether this is a defining moment to change the way they do things – to make life easier in the long run.
There is increasing emphasis on giving patients all of the information they need to make their own healthcare decision. Data standardisation will help align and clarify drug information across the world at a time of global crisis.
About the author
Remco Munnik is Associate Director at Iperion, a globally-operating life sciences consultancy firm which is paving the way to digital healthcare, by supporting standardisation and ensuring the right technology, systems and processes are in place to enable insightful business decision-making and innovation.