A huge amount of investment has gone into preparations for the EU’s implementation of the ISO IDMP (identification of medicinal products) standards over recent years. It is disappointing, then, that we are not further along in harnessing these developments for real-world gain. So in 2020 focus and ambition must not be compromised by the continued struggle for completion of the European Medicines Agency’s IDMP initial implementation guidelines, nor the new Veterinary Regulation, which increasingly is vying for attention.
The goal of IDMP is to create a central database of medicinal products that can be readily searched, understood and relied upon internationally. SPOR (Substance, Product, Organisation and Referential) data management services are the key to enabling this. Agreed terminology, product definitions and data formats will enable meaningful data-sharing across departmental, organisational and geographical borders, in a variety of use cases – supported by a Target Operating Model which will assess data during the regulatory process to ensure data quality and consistency, and optimise the exchange of application data between regulators and applicants.
It is now – with implementation so close – that the really interesting and exciting work should begin: the manifestation of real industry and public benefits from having a definitive central source of standardised medicinal product data. It is time that pilot projects proliferated, to remind everyone why IDMP was conceived in the first place.
But there is still work to be done, and every stakeholder group has its part to play in ensuring momentum is maintained and tangible progress made in 2020.
Making data, not documents, the focus
Although the explicit aim of IDMP is to capture complete, high-quality product data sets as regulatory documents are submitted, clearly articulated plans for how that data will be validated and used are currently lacking. After all of the work that has already gone into IDMP preparations, it is in no one’s interest that this rich data simply sits in an EU database, unexploited.
Improved collaboration should be a priority across the board, and IDMP promises to make this possible in abundance: speeding up regulatory processes; providing greater product status transparency; and significantly enhancing patient safety and people’s overall experience of medicines. It follows that mechanisms need to be in place to promote this. Certainly it makes no strategic or economic sense for the different stakeholders across Europe to maintain distinct data sets, and versions of the product truth (as happens with xEVMPD today). This would go against everything IDMP stands for, not to mention result in poor use of resources, when in the digital age it would be so easy for all parties to collaborate using the same data – via a secure cloud, for instance.
One factor hampering data-driven process innovation is that, between the pharmaceutical companies, the NCAs, EMA and the wider industry, there isn’t one single party with overall accountability for the IDMP database and how its contents will be used. Yet, all stakeholders have a role to play in moving things forward. Just as the SPOR Task Force leadership is made up of three co-chairs (EMA, NCA and industry), so each stakeholder group must assume responsibility for their own contribution to the bigger picture for IDMP realisation. That includes contributing to plans for how IDMP data could transform experiences in the real world – for regulatory and industry stakeholders, and for customers: patients and their prescribers/product dispensers.
It is encouraging then, against this backdrop, that Joris Kampmeijer, chief information officer of Dutch regulatory agency MEB and NCA co-chair of the EU’s IDMP SPOR Task Force, has pledged to work with co-chairs EMA and Industry to lead the way. Plans over the next year include the roll-out of new test cases, which will help to demonstrate the wider potential of IDMP data in transforming everyday life sciences activity.
For instance, one will be a proof-of-concept (PoC) for administrative data exchange in scenarios where there is a company name change. It will show how, via a single portal accessible by all stakeholders, a data-driven change to details could alleviate duplication of effort as the updates are reflected promptly across all affected records.
Other work-streams will look at how unique signature fields to identify substances internationally could transform the ability to pinpoint and take action if new safety findings are reported. Poignantly, a recent EMA alert linked to sartans (also known as angiotensin-II-receptor antagonists), indicating a potential link with cancer, highlights just how useful (or even essential) such a facility would be: ie if any affected product could be swiftly identified across EU markets. If EU and US medicinal data projects could be aligned on substance identification, this capability would be even more valuable – something else that will be explored in a PoC.
A further project will look at the potential impact of linking the EMA’s IDMP database with the existing drug serialisation database which is designed to ensure that medicines cannot be falsified. Integration between the two resources could make it easier to spot relative product shortages versus availability between different EU markets.
The importance of projects like these cannot be underestimated, as they focus attention on what’s possible as well as on what needs to be done to realise this kind of process innovation.
Everyone has a part to play
As 2020 unfolds, there needs to be a more concerted effort to promote and realise IDMP’s broader potential. In the absence of clear ownership for extended innovation, all parties from across the EU regulatory community – in partnership with life sciences organisations and IT/service providers – must play their part in advancing ideas. This means setting aside time, budget and skilled personnel to determine and explore what’s possible; ideally getting involved with or driving new PoC projects.
The existence of live, exchangeable data could lead to improved information availability across internal operations as well as reduced timelines and better reporting. Beyond company boundaries, it could result in better and more promptly available product information for patients. In the digital age, having to wait a year for the latest safety information to be reflected in product instructions-for-use (IFU) leaflets jars with just about every other consumer experience people have. Data-driven submissions, prompt inter-agency data exchange, and greater use of electronic formats for patient information, could change all of that.
Easy and reliable data exchange between diverse end points, meanwhile, could pave the way for patients to be able to access up-to-date information on any clinical studies related to a condition they have. Or gain access to the latest applicable medicinal product information online, in their native language, if taken ill abroad.
To secure more of a say in how IDMP developments unfold, it would help if the full set of stakeholders had greater representation on influential committees – such as the EU Telematics management board, which today is made up primarily of EMA and NCAs. In the meantime, Heads of Medicines Agencies (HMA) and EMA need to look at setting some firm deadlines, by which drug approval based on the submission, assessment and approval of data becomes the standard process.
Legislation alone is not a sufficient driver for real progress, however, and while the EMA 2025 regulatory strategy is comprehensive in its vision, a lot of the activities proposed need SPOR data management services – with good data quality/a strong target operating model – to be able to capitalise on the potential. So, this needs to be the immediate focus. Above all, whatever the conflicting priorities facing EMA over the coming months, it is critical that IDMP momentum is not lost now.
Remco Munnik is associate director at life sciences consultancy firm Iperion
