Change creates opportunity, they say. Here’s one change that might benefit – if handled right – the medicine originator, the service provider, and foremost the patient by just moving the responsibilities of an entire medicinal product line into different hands.

Part I – The Opportunity

What opportunity am I talking about, as outsourcing itself is neither new nor terribly exciting? I’m sure you have noticed a fair number of outsourcings of specific tasks such as eCTD submissions or QPPV activities by pharma. This might be for example to cover high peak demands, getting access to specialists or for exploring alternative markets. But what about outsourcing end of life or less profitable products or entire product lines? A single medicine or an entire product line will naturally reach a point in its life cycle, after all, when the original investment has been recouped, the vast proportion of profit extracted as a result, and market maturity has long been reached. Further business opportunities are limited and attention is drawn to products that make more (financial) sense. And should resources be scarce, this will certainly end the life of the product concerned. Never mind that Unexpected Adverse Drug Reactions for example have to be taken care of.

Should a decline in profit be the end of a medicinal product?

Reaching this stage in the medicinal product life cycle, a fair number of companies would rather retire or withdraw the product than continue offering a medicine low on profit and high on overheads. After all, this is a business and profits have to be made. There comes a tipping point when covering compliance with latest regulations, ‘housekeeping’ in terms of drug safety and other overheads to keep the product on the market, starts to eat away the last bits of revenue sought.

But just withdrawing the product might not be such a smart move, as there is still a definite value for all parties concerned, especially the patient. Wouldn’t it be kind of foolish to deny yourself and your patients such a benefit? Why not outsource the product?

And for others, why not take this opportunity off the originator’s hands? Doesn’t supporting mature products to extract all the remaining potential make better sense for all parties concerned? Wouldn’t it be more economical to support new and/or developing markets or find economies of scale that maybe weren’t possible before? The opportunities seem endless and rather appealing.

And that is where ‘Medicinal Information Management’ comes in. What do I mean by that? Medicinal Information Management is much more than Regulatory Information Management or RIM, as we are looking at the entire life cycle of the drug, with possible new undiscovered markets, maybe alternative product strength or form of administration, not only regulatory requirements and/or changes. This also extends into new areas of product marketing, whether in new regions or new target markets.

So how would ‘Medicinal Information Management’ work? Third parties would engage in dialogues with pharma companies, looking to take their mature less profitable products off their hands, paying a royalty and looking to extract all the remaining potential of the material. That third party can look, for example, to put this into new or developing markets or find economies of scale that maybe someone else wouldn’t. This is good economics; there is no need to let something ‘die’ that still has potential to give back to investors and patients at the same time.

Part II will look at how to overcome the challenge of doing all of the above effectively on limited budget.

Please feel free to contact us with any questions or if you require further information.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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