Exploiting the EMA medicines database to full effect
Remco Munnik is an associate director at Iperion, a globally operating life sciences consultancy firm paving the way to digital healthcare, and as such is strongly committed to contributing to the actual implementation of the ISO IDMP standards.
substantial amount of thought, time and investment has gone into the preparations for the EU’s implementation of the ISO identification of medicinal products (IDMP) standards over recent years. It is a great shame, then, that markets are not further along in harnessing these developments for real world gain. So, as this year continues to unfold, focus and ambition must not be lowered by late completion of the European Medicines Agency (EMA) IDMP initial implementation guidelines, nor the new veterinary regulation that is increasingly vying for attention.
The goal of IDMP — shared by EMA, national competent authorities (NCAs), the life sciences industry and its suppliers — is to arrive at a comprehensive central database of medicinal products that can be readily searched, understood and relied upon from country to country, irrespective of borders and language barriers.
Substance, product, organization and referential (SPOR) data management services are the key to enabling this. Agreed-upon terminology, product definitions and data formats will enable meaningful data sharing across departmental, organizational and geographical borders in a variety of use cases. This should be supported by a target operating model that will assess data during the regulatory process and thereby ensure data quality and consistency, and that will optimize the exchange of application data between regulators and applicants.
With implementation so close, the really interesting and exciting work should begin: the manifestation of real industry and public benefits from having a definitive central source of consistent, high quality, up-to-date and standardized medicinal product data. It is time that pilot projects proliferated, reminding everyone why IDMP was conceived in the first place.
But there is still work to be done, and every stakeholder group has a part to play in ensuring this momentum is maintained and that tangible progress is made this year.
Make data the focus, not documents
So where are the gaps? Although the explicit aim of IDMP is to capture complete, high-quality data sets about each medicinal product as regulatory documents are submitted, any sort of clearly articulated plans for how that data will be validated and used are currently lacking. This means that documents will continue to be the primary vehicle for regulatory approvals — not master product data, which has the potential to be reused in any number of different and innovative ways. After all of the work that has already gone into IDMP preparations, it is in no one’s interests for all of this painstakingly collated data to simply sit in an EU database, rather than serving its real purpose.
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 the eXtended EudraVigilance Medicinal Product Dictionary today). This would go against everything IDMP stands for, not to mention that it would be a poor use of resources, in this digital age where it is so easy for all parties to collaborate. This could be done by 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 data(base) 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 realization. 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.
Against this backdrop, it is encouraging that Joris Kampmeijer, CIO of Dutch regulatory agency MEB and NCA co-chair of the EU’s IDMP SPOR Task Force, has pledged to work with his fellow co-chairs (EMA and Industry) to lead the way. Plans over the next year include a rollout 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 workstreams 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. A recent EMA alert related 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. For example, 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. This is 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 serialization 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 realize these process innovations.
Everyone has a part to play in delivering the big vision
Over the coming months, there needs to be a more concerted effort to promote IDMP’s broader potential. In the absence of clear ownership for extended innovation, it is going to require that all parties from across the EU regulatory community, in partnership with life sciences organizations and IT/service providers, play their part in advancing ideas. In practice, this means setting aside time, budget and skilled personnel to determine and explore what’s possible — ideally this means getting involved with or driving new POC projects.
The existence of live, exchangeable data has the potential to unlock new opportunities for transformation both internally within individual organizations, and externally in the market. It 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 leaflets conflicts with just about every other consumer experience people have. Data-driven submissions, prompt interagency data exchange and greater use of electronic formats for patient information could change all of that.
Momentum and vision around IDMP must be maintained in 2020 if standardized medicinal product data is to be of tangible real-world benefit — not least because of the huge commitment already made by stakeholders internationally.
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 may have, or gain access to the latest applicable medicinal product information online, in their native language, if they fall 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. For instance, the EU Telematics management board is currently made up primarily of EMA and NCAs; life sciences organizations and their technology/service providers are invited to these meetings just once a year and are not integrally involved in codeveloping a strategy, or in setting priorities for how IDMP data might be processed, exchanged and used to drive transformation. That’s despite those stakeholders’ commitment to improvements to regulatory processes and patient experiences.
In the meantime, Heads of Medicines Agencies 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. Without such assertive action, PDF files will continue to be the default means by which drugs are reviewed and approved, when the real opportunity here is to do more with the data being registered.
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 and a strong target operating model — to be able to capitalize on the potential.
Above all, whatever the conflicting priorities facing EMA as 2020 progresses, it is critical that IDMP momentum is not lost now. This must be the immediate focus.