Guest Column | December 17, 2021

How The EU's Biopharma Industry Can Deliver More With IDMP Data Standards

By Frits Stulp, Iperion, a Deloitte business

ISO standards quality control assurance GettyImages-1265200449

Although the link may not seem immediately apparent, the ISO identification of medicinal products (IDMP) data standards currently being implemented across the EU offer an important facilitator for change in the way patients, and stakeholders across the healthcare ecosystem, will engage with and choose treatments in future — as long as the industry encompasses the potential as part of their internal IT and process adjustments.

Healthcare Stakeholders Seek To Make Informed Choices

Change is already afoot in the way patients view and decide on their own treatments. Consider the young adult today who wakes up with a sore throat or fever, and a mobile device in hand. Particularly after the extended waiting times during the pandemic, their first port of call is more likely to be Google or Amazon than a health line or doctor’s office. Unless something needs to be professionally prescribed, this individual’s choice of medicine will be dictated by search listings, customer reviews, and price. A drone might drop it to their door the same day, so they never need to get out of bed.

While this example is more applicable to over-the-counter drugs, the internet is connecting all kinds of healthcare stakeholders to the information they need now. Anecdotally, a specialist cancer nurse once told me that she, too, has been known to Google the specific oncology-related advice about possible drug interactions when dispensing medicine to patients, if that information isn’t otherwise readily at hand. Such scenarios are likely to become increasingly common, too, as society demands free choice — for patients to have informed influence over their own care.

This, then, is a call to action to the pharma industry to provide that information in a readily usable format and to regulatory agencies to become the go-to place for approved information.

It is in such situations that data standards like ISO IDMP for medicinal products, being implemented currently in the EU but with growing support internationally, offer to make such choices more viable — supported by accessible and reliable information, in an agreed global format, which can be understood by clinicians, pharmacists, and the general public (as well as regulators, payers, insurers, and so on).

Standardized Data Key To Maintaining Profile & Remaining Relevant

In due course, consideration of all stakeholders will be essential for life sciences companies, and their IDMP plans and decisions today will be instrumental in dictating how well they can adapt to the new world of more transparent healthcare that is centered around the patient.

The not-for-profit organization CTADHL has made it a mission to promote a new era of health literacy through global collaboration and partnerships. Among its activities, it is working toward harmonization and adoption of ISO IDMP around the world — between EMA/EU requirements and those of the U.S. FDA, for instance, and by the World Health Organization (WHO). We are also seeing a lot more clinical discussion now about the need for cross-border prescribing, aided by an interoperable data set that describes medicines in a uniform way from country to country, so that prescriptions from other territories can be understood and exact equivalents identified.

As biopharma innovation becomes more mainstream, and as more personalized treatments feature more commonly, more tailored information on drug suitability and contraindications will become important.

In the crowded market for medicinal products, the need for custom, personalized products is growing. The absence of new big blockbuster drugs is helping to drive this development, inviting the industry to better understand their patients. Unless each variant of a product has its own data stamp, clinicians won’t be able to safely prescribe it. At the same time, patients will increasingly expect to understand for themselves the characteristics of products, the available alternatives and how these compare, and how a given product addresses or targets their situation. Standardized data will be essential in enabling all of this.

So where are pharma companies today in regard to this new global data-enabled healthcare ecosystem, which places the patient at the center?

Putting Patient Centricity Into Practice

Although some pharma companies are making the right noises about patient-centricity today and working hard to provide better resources for their customers, in many cases the gap between the information provided by pharma brands and that which patients actually need and receive remains considerable.

Too often, patient information leaflets and equivalent digital resources are treated as marketing material or as a compliance-oriented activity, rather than as something that empowers patients to make informed choices. Currently, it tends to be the market regulators — as labelling/leaflet gatekeepers and public guardians – rather than the pharma companies themselves that are advocating for patient-centricity in published patient information.

To change the emphasis, software needs to embrace and promote use of data standards, enabling better insights, actionable reporting on adverse drug events, product shortages, and more. These rich and actionable data, and reliable data analytics, are crucial to enable improved, safer medicines.

Keeping a broad perspective when rolling out IDMP projects is an important first step in staying open to optimal external information provision and international data exchange across national, regional, and global healthcare ecosystems. Other opportunities include greater integration with patient forums, where allowed, so that pharma companies can meet current and future customers where they are and provide relevant and helpful information to them at the point of need.

Understanding what patients – and other stakeholders across the healthcare environment – need is critical. The European Medicines Agency, which has an active interest in patient advocacy, aims to help here by facilitating conversations between healthcare providers, pharma companies, and patients toward better outcomes for all.

Will It Take Biotechs To Show Big Pharma What’s Possible?

For pharma companies, proactive interventions in the form of better external information that is fit for purpose will help build stronger and more trusted relationships by demonstrating that their priority and focus are the health and well-being of patients.

But it may well be biotechs/biopharma start-ups that show the way, thanks to their relative freedom, unencumbered by legacy products, data, and regulatory records. These companies won’t be as dependent on expensive, specialist tools: Rather, they will be able to take advantage of a fresh approach to object-based information, external collaboration, and harmonized data exchange, underpinned by IDMP.

Given that these data standards are something all companies must embrace, it follows that these more dynamic companies could take data-based process innovation to the next level – showing the more established players what’s possible.

About the Author:

Frits Stulp is managing director of Iperion - a Deloitte business, where he leads a team of regulatory/IDMP experts active in various projects to deliver value to both pharmaceutical companies as well as regulators. In addition to having more than two decades’ industry and consultancy experience, he is regarded internationally as a subject matter expert on IDMP and he proactively shares his rich knowledge and experience wherever he can. Iperion, now part of Deloitte, is a globally operating life sciences consultancy firm paving the way to digital healthcare by supporting standardization and ensuring the right technology, systems, and processes are in place to enable insightful business decision-making and innovation. Stulp can be reached at