Progress on human medicinal product standards in 2020

Photo of author, Frits Stulp to accompany his article on progress on human medicinal product standards in 2020

Frits Stulp, Managing Director of Iperion Life Sciences Consultancy, looks at how veterinary regulations disrupt progress on human medicinal product standards in 2020, and in the meantime, who’s speaking up for patients?

After positive progress towards EU Identification of Medicinal Products (IDMP) data standards implementation in 2019, certainly from a substances perspective, there is now a need for greater focus on delivering patient benefits and greater cross-industry cooperation. This will ensure that momentum is maintained in 2020, which will be a pivotal year for international medicinal data standards.

“2020 needs to be a year of closer collaboration and more decisive action”

One of the important IDMP-related developments in 2019 has been the demonstration of the impact shared definitions of substances can have internationally, via a proof-of-concept project led by the Dutch regulator (Medicines Evaluation Board) on behalf of the European regulatory network. This considered the benefits of data continuity in a substances context, from a scientific point of view. Specifically it explored how agreed descriptions/coding for complex molecules would help in cross-border medicines management – for instance in scenarios where a patient loses their medication on holiday, or needs a new prescription, and a healthcare provider needs to check the active ingredients, and identify any contraindications or allergy implications.

The proof-of-concept study is currently demonstrating that describing molecules in a consistent, agreed way, with common mapping, would provide significant support for data and process interoperability. Instead of individual professionals having to sift through dossiers to confirm the constituent ingredients of equivalent products, they could simply exchange the agreed identifier – much as people use their social security number to identify themselves as individuals to different government organisations. Here, the primary benefit is reduced risk of wrong medicines being issued (though the efficiency gains for all stakeholders, and the accelerated speed of decision-making, are clear sub-benefits).

This is just one of up to 20 use cases making up the business case for IDMP – that is, for having a common method of identifying medicines.

Maintaining momentum

IDMP developments in relation to substances are not yet being matched by developments around product-level descriptions. And there have been some concerns that momentum might once again be lost here in relation to human medicines, as measures to address veterinary medicine data come into central focus: January 2022 has now been designated as a hard deadline for compliance with standardised identifiers.

Yet there is no reason why the two streams of work should not happen in parallel. Indeed, they could both feed off and help drive the other, as there will be considerable commonality between most of the process requirements – and one of the big points of IDMP is to foster greater efficiency/replication of proven success. Parallel planning will allow the respective work parties to learn from each other and accelerate overall progress.

The target go-live date for human medicines/IDMP compliance is 2023, and it is in everyone’s interests that we keep to this deadline. So if we can harmonise the process, rather than create two sets of definitions, vocabularies and so on, so much the better for everyone concerned. With a concerted effort, I believe we can all hit our deadlines, and in 2020 it would be immensely encouraging to see all industry stakeholders – regulator, industry and technology vendors – come together to drive progress against SPOR data standards, whichever angle they are coming from.

Accessible patient information

Something else we very much need to see in 2020, in the context of human medicines, is greater and more prominent representation of the patient voice in discussions and developments. It is ironic that, despite the public being the ultimate intended beneficiaries of IDMP medicinal data standards, this important stakeholder group currently has no seat at the table.

We all accept that very few patients read the lengthy advice leaflets included with drugs. To address this, in future patients will be given access to more audience-friendly ‘instructions for use’ (IFU) content, with alternative formats including audio instructions, video explanations and pictograms, delivered via websites or mobile platforms. But this won’t happen until the various IDMP stakeholders collectively prioritise these developments, and set deadlines for first iterations.

A common set of definitions is critical to all of this, allowing both the pharmaceutical industry and the regulator to have an agreed understanding of the product, in whatever communication may follow.

Working together

2020 needs to be a year of closer collaboration and more decisive action. Stakeholders from across the life sciences industry should look at the encouraging progress and development of use cases for substance data, and accept veterinary medicine data developments as additional blocks they can build on for human medicines data developments under IDMP, rather than a new cause for delay.

Driving the patient agenda, meanwhile, requires more concerted multi-stakeholder effort towards common definitions and process flow, so that a standardised European approach to electronic patient information can take shape – and a deadline for adherence can be set. People pay their taxes for this kind of thing: it’s time the industry delivered.

Top 5 takeaways

  1. January 2022 is the hard deadline for compliance with standardised identifiers.
  2. The target go-live date for human medicines/ IDMP compliance is 2023.
  3. Parallel planning between human and veterinary work parties will accelerate overall progress.
  4. The patient voice needs a seat at the table.
  5. A common set of definitions is critical.

Frits Stulp is Managing Director of Iperion Life Sciences Consultancy. Go to www.iperion.nl