As ISO Identification of Medicinal Products (IDMP) compliance plans are refreshed in the light of new movement towards implementing the product data standards across the European Union, life sciences companies find themselves at an important crossroads. In recent years, a series of delays to IDMP’s rollout have elicited an increasingly lackluster response to the considerable new product data requirements. Although firms’ have always known that IDMP as a set of standards would be realized eventually, their stop-start manifestation has steadily sapped any initial momentum. So it could be hard for firms to get going again with renewed commitment, even with the clock ticking towards the European Medicines Agency (EMA) go-live date in 2021.
Yet there is another far more important factor at play here, and that is the public’s growing appetite for access to medicinal product data—and not just the wider healthcare market, but consumers themselves. In the detail of specific regulatory mandates, it is easy to lose sight of why new measures are being introduced, but bringing the industry back to the original drivers for IDMP and other information-based regulations can help to reframe compliance initiatives with a more positive and strategically significant emphasis. After all, life sciences firms have hard-won reputations to protect, and being responsible for good patient outcomes, and upholding patients’ best interests, are high on their list of corporate pledges.
This being the case, it is worth keeping patients, clinicians, pharmacists and the wider public front of mind when evaluating priorities and best next steps towards IDMP and other emerging international quality and safety standards.
Transcending Format Specifics: Preparing to Meet Consumer Expectations
Looking specifically at IDMP, which is now moving closer to becoming a reality, life sciences firms should now be looking to embrace evolving regulatory standards, to define a practical target operating model for managing their product data. The aim being to ensure that what is submitted to regulators is an accurate reflection of the current truth.
While much of the advice around ISO IDMP preparations concerns how different categories of data must be categorized and formatted (the nitty-gritty of how to keep within the specific database parameters) the bigger picture surrounds how firms can get that data into the hands of those who need it, and quickly. This doesn’t just include the EMA and other international regulatory bodies, which before long will insist on accurate and complete data filings alongside traditional dossiers. It also includes the patients of medical products, and those prescribing or selling them.
Companies can become so caught up in their regulatory obligations that they lose sight of why compliance exists and is so important. Once product records are brought under control, and consolidated in a robust, credible and definitive living record (a single, up-to-date version of the product truth), there are plenty of other keen consumers of that information besides the industry watchdogs.
Immediacy of Access to Product Advice
In the digital age, it should not be taking months or years for the latest safety advice to filter through to patients (i.e., simply because patient information leaflets haven’t been updated).
In the future, we can expect to see QR codes (matrix barcodes, which when scanned open a relevant web page) being used as standard on medical products, as a means to providing links to the latest, revised instructions for use online. That is, access to complete, up-to-the-minute advice will be much more immediate and convenient than it is today.
All of which comes back to the need for companies to have an accurate master data source, along with visibility of where this data is re-used and a way of managing interoperability between the central master and wherever information has been reproduced. Even keeping submitted regulatory dossiers and electronic data equivalents in sync will require appropriate controls, because information may continue to be updated after original documentation has been put together.
It is undoubtedly unfortunate that the timelines around IDMP have been subject to delays over recent years, slowing down preparation of a definitive data truth about products that clinicians, pharmacies, patients and other stakeholders could benefit from today. But this should not be allowed to stymie all progress.
It is one thing to put off IDMP compliance plans because the specific details of required formats are not fully known. But it is another to stall activity just because one thinks there is a bit more time. On the contrary, there is much to be gained from pressing ahead—not least favorable public perception of a life sciences brand that commits itself to greater product transparency.
For just a few hundred euros, any company today can buy the ISO IDMP specifications from their local standards organization and begin working toward a target operating model for wider data exchange. So why delay?
It’s worth remembering that 60 countries participated actively in proposing and setting these new ISO standards, and 160 countries have pledged to recognize and enforce them. That’s a strong endorsement to justify preparing and managing electronic product data in support of wider public access. Committing to this is an important step toward the democratization of healthcare and medicine data, something respected industry players have talked about a lot this year.
If society’s growing expectations are not enough of a driver for change (and they should be), consider this: A technological giant like Amazon may yet disrupt the life sciences industry, using as its leverage its superior grasp on information management to create new value around medicinal products for consumers. It is not beyond the bounds of credibility to imagine that if Amazon wanted to buy the intellectual property for a drug compound, along with the other operational elements to running a pharmaceutical business, it could establish a healthcare organization with relative ease.
In the life sciences industry, product information is vastly underestimated as a business asset, and certainly no company wants to expose itself to huge risk by failing to gain control of this while they have the chance.