Frits Stulp of Iperion Life Sciences Consultancy assesses the impact of the Covid-19 crisis on European progress towards Identification of Medicinal Products (IDMP) data standardisation. At a time of global focus on getting drug and vaccines to market quickly and safely, 2021 looks set to be the year when the potential of IDMP is realised.
Standards
Covid-19 has dominated the headlines in life sciences in 2020. But it would be wrong to conclude that everything else has been shelved while focus and resources have been diverted to responding to the pandemic. In fact, Covid-19 has shone a light onto the broader 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 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 and holders (MAAs and MAHs), and of regulators, in a crisis. Speed to market (bringing relevant medicinal products, for example new vaccines, to market swiftly), yet also thoroughness in safety and quality assessments, have become paramount and visible to a much greater degree in society. Countries, governments, health care providers, entire societies are crying out for approved medicinal products, but no one can afford for standards and requirements to be compromised in the rush to deliver what’s needed. No one wants a vaccine with side-effects worse than the symptoms of Covid. So stakeholders across industry and the regulatory community have had to perform a careful balancing act.
Supporting pharmacovigilance
If IDMP data-based regulatory submissions had been standard issue by now, the pharmacovigilance element of bringing new vaccines to market safely would be much easier to manage. 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 have helped with the identification of new clinical trials, too, to track the composition and indications of newly-developed products.
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.
Covid 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’.
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 European Medicines Agency (EMA) completed its reorganisation and ‘futureproofing’ exercise. Along with the National Competent Authority (NCAs) and industry co-chairs of ISO IDMP SPOR Task Force (which is focused on finalising the introduction of Substance, Product, Organisation and Referentials data) Task Force, the EMA is 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.
Harnessing the potential of IDMP
So what can we expect in 2021, and what should life sciences companies be doing now 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 EMA and 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 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 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.
Mandatory compliant data-based submissions
In the meantime, the life sciences industry must accept and acknowledge that time is ticking on and that waiting for all of the stars to align perfectly before they take action is not an option. SPOR data-based submissions 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.
It is a good time to start identifying 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 has been a considerable challenge, which more efficient and consistent information exchange would have helped alleviate.
And in 2021, the ability to trace where vaccines and Covid-linked treatments have ended up will be critical. Patients are at the heart of all these developments. To give patients all the information they need about their medicines and vaccines, how and where these products were made and what goes into them, there is a need for data that all parties can align with and refer to.