The European Medicines Agency’s (EMA) headquarters in Amsterdam
The global response to COVID-19 has shone a light on the broader potential for global data standards, including those defined via the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) that Europe is now so close to implementing via the European Medicines Agency’s (EMA) substance, product, organisation and referential (SPOR) programme.
Amid the disruption caused to just about everything over the last year, this has also been a time of great emphasis on healthcare and the role of the pharma organisations, marketing authorisation applicants (MAAs) and marketing authorisation holders (MAHs), and of regulators, in a crisis.
Bringing medicinal products such as new vaccines to market swiftly and safely has become paramount and visible to a much greater degree in society.
Although IDMP is about identifying medicines and their constituent substances and manufacturing specifics – and does not cover
the clinical efficacy of a product – the ability to instantly determine where products were made, the batch they came from, the exact ingredients and more would play a crucial role in monitoring, managing any side effects, and in supporting regulatory preventions and interventions.
IDMP could also have helped with the identification of new clinical trials, to track the composition and indications of newly developed products.
Crystallising the potential of IDMP
Currently we find ourselves in uncharted territory, in that soon we are likely to have multiple new vaccines being distributed across the globe, to be given to billions of people – the largest human population ever to be targeted at once.
And, although the profiles of those vaccines look good, inevitably there will be side effects which regulators and the life sciences industry will need to react to responsibly.
While IDMP doesn’t offer a definitive solution, the ISO IDMP data model does allow 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.
This information could also form the basis of any electronic vaccination-based passports that may become desired for use as part of travel restrictions and border controls.
Hindsight is a wonderful thing, and we are not there yet, but COVID-19 has helped to crystallise the potential of data standards, such as IDMP, in real-world use cases, at a time when many life sciences companies continue to view the requirements as ‘just another compliance burden’, or ‘something to be left to one side until IDMP data-based marketing authorisation submissions are mandatory’ (which is expected to be the case across the EU by 2023).
IDMP in 2020
So where are we now? There has been plenty going on in the background to progress IDMP in 2020, certainly in Europe. Over the last 12 months, the EMA completed its reorganisation and ‘future- proofing’ exercise.
The EMA 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. Up to now, EMA’s chief goals for IDMP have been to streamline the regulatory assessment and authorisation of medicinal products and to support pharmacovigilance activities.
Yet, 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 towards this end in 2020 has been the replacement of the Common European Single Submission Portal (CESSP) initiative with an EMA-sponsored project.
The network is still looking for a technical solution to comply with ISO IDMP and exchange of Fast Healthcare Interoperability Resources (FHIR) messages between industry and the regulator. EU-wide agreement on data exchange between regulators and industry would be ideal, to ensure optimisation of processes and use cases.
All of these advances are building towards a stronger backbone and greater momentum behind IDMP, its roll-out 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. (The World Health Organization (WHO) is looking into Substance IDs and Pharmaceutical Product Identification (PhPIDs) as part of a global solution.)
IDMP in 2021
Looking ahead, what should life sciences companies be doing in 2021 so that they keep pace with requirements – and put themselves in the best position to harness IDMP’s fullest potential?
Knowing that the model for submitting regulatory data within the regulatory processes – the so-called Target Operating Model (TOM) – will change, and that technology environments at the EMA and National Competent Authorities (NCAs) will have to support this, the SPOR Task Force co- chairs have been working to set an optimum level of ambitions to allow positive forward movement.
They 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 application programming interface (API).
With fewer players involved initially, the initiative will be easier to control and will provide the means to test for any bugs or issues before extending SPOR-based data submissions to a more distributed regulatory scenario involving NCAs.
In phase two, as the Common European Single Submission Portal (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.
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 labour 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 like it is a fair way off, but the fact that compliant data-based submissions will be obligatory by Q1 2023 will be sobering for those companies that have relied on a hard compliance date remaining on the distant horizon.
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.
For many organisations, IDMP will have been seen up to now as just another secondary data set that has to be generated – much as IDMP’s predecessor, the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) was treated by many companies.
The alternative, which is much more desirable and prudent, is to treat the new, richer data sets as a backbone to their operations and an asset in support of primary business processes – the basis of all future regulatory information-based activity, with application that ultimately extends beyond Europe.
Identifying pain points
Another way to bed in new thinking is to look for the pain points in routine, everyday activity – those times when regulatory, quality/PV/safety or clinical teams have to trawl through piles of documents to get to the information they need.
Managing recalls is often a particularly painful reminder of the need for greater information visibility and product traceability. In 2020, managing supply shortages had been a considerable challenge, which could have been alleviated by more efficient and consistent information exchange.
And in 2021, the ability to trace where vaccines and COVID-19- linked treatments have ended up will be critical. As red tape has been relaxed to get products out, any gaps in administration will need to be backfilled, to allow PV teams, regulators and R&D teams to fulfil their obligations.
The achievements of 2020 have put us in a good position to ensure that IDMP-based master data forms the basis of transformation of critical business processes, moving the standards beyond the purpose of compliance for its own sake towards patient-focused outcomes.
In 2021, whatever path the COVID-19 crisis takes, the focus must be on empowering patients with the information they need about the medicines they take, how and where these products were made and what goes into them.