Substantial effort and investment have gone into preparations for new regulatory requirements around medicinal and medical products, including ISO IDMP (identification of medicinal products) standards and the EU’s Medical Device Regulation (MDR) and the New Veterinary Regulation (NVR). It is a shame, then, that we are not further along in harnessing these developments for real-world gain. So, in 2020, focus and ambition should turn back to where it is needed: On the higher purpose of such initiatives, and the innovation and improved patient experience they are designed to elicit—rather than on the intricate logistical details and deadlines that are still being ironed out by regional regulators.
Ultimately, however the final data definitions come together, all life sciences organizations—whether human/veterinary pharmaceutical companies, and/or medical device manufacturers—need to in effect move to a data-driven way of working, and provide data in a structured format to regulators, distancing themselves from the current reliance on static documents to provide required information. For the companies, this change will have an impact on the technology that is currently used (such as internal databases), and on process and on the broader organization. And it is this, and the associated opportunities for transformation to patient experiences and outcomes, that demand more concerted attention now.
In the case of IDMP, whose goal is to create a central database of medicinal products that can be readily searched, understood and relied upon internationally, SPOR (Substance, Product, Organization and Referential) data management services are the key to making this a reality. Agreed terminology, product definitions and data formats will enable meaningful data-sharing across departmental, organizational and geographical borders, in a variety of use cases—supported by a target operating model that will assess data during the regulatory process to ensure data quality and consistency, and optimize the exchange of application data between regulators and applicants.
With implementation so close, it is now that the really interesting and exciting work should begin: The manifestation of real industry and public benefits from having a definitive central source of standardized medicinal product data. It is time that pilot projects proliferated, to remind everyone why IDMP was conceived in the first place. Yet there is still work to be done, and every stakeholder group has its part to play in ensuring momentum is maintained.
The medical device industry, similarly, has an obligation to the public to think outside of the box about how new rigor around product traceability and monitoring could transform patient experiences and outcomes.
Data Should Drive Everything Now
Improved collaboration should be a priority across the board, and tighter data-based regulations promise to make this possible in abundance: Speeding up regulatory processes, providing greater product status transparency, and significantly enhancing patient safety. It follows that mechanisms need to be in place to promote this. Certainly it makes no strategic or economic sense for the different stakeholders to maintain distinct data sets, and versions of the product truth. This would go against everything the new rules stand 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 life sciences companies, the regulatory authorities and the wider industry, there isn’t one single party with overall accountability for how new centralized database contents will be used. Yet, all stakeholders have a role to play in moving things forward.
In the medicinal products world, it is encouraging, against this backdrop, 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 co-chairs EMA and industry to lead the way and drive new test cases, to help to demonstrate the wider transformational potential of standardized product data.
One will look at the scope for simplified administrative data exchange in scenarios where there is a company name change. It will show how, via a single central portal, 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 the improved ability to pinpoint and take action if new safety findings are reported. In the pharma sector, 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 (i.e., if any affected product could be swiftly identified across EU markets). If EU and U.S. 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 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.
Traceability of products is also the major thrust of the new MDR rules affecting medical device manufacturers. A live, official central database or registry will support very practical needs—for example, urgent safety recalls or notifications in the event of a fault or safety issue with a particular device.
A Call to Action: For All Stakeholders
As 2020 unfolds, there needs to be a more concerted effort to promote and realize the broader potential of new regulatory initiatives around standardized, centralized life sciences product data. In the absence of clear ownership for extended innovation, all parties from across the EU regulatory community—in partnership with life sciences organizations 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, and ideally getting involved with or driving new PoC projects.
To secure more of a say in how developments unfold, it would help if the full set of stakeholders had greater representation on influential committees, such as the EU Telematics management board. In the meantime, authorities would do well to lay down some firm deadlines, by which product approval based on the submission, assessment and approval of data must become the default process.
Legislation alone is not a sufficient driver for real progress, however, and ultimately it is going to be strong data management services—with good data quality/a strong target operating model—that will drive tangible progress with new process innovation. This, then, needs to be the immediate focus, whatever any fluctuating deadlines and final details around the regulations themselves.