QUALITY BEFORE TRANSACTION
The opportunity
A client was evaluating an opportunity to supply an essential hospital medicine to a Caribbean healthcare institution. On the surface, the proposition appeared compelling: an available manufacturer, attractive pricing, a defined institutional need and a potential commercial opportunity estimated at US$1 million. Before proceeding, the client asked HENYIDA to independently assess the proposed product and manufacturer. What initially appeared to be a straightforward procurement opportunity became a question of whether there was sufficient evidence to stand behind the quality, safety and reliability of the medicine being supplied.
What we found
During our engagement, the manufacturer was unable to clearly distinguish between a Certificate of Analysis (CoA), a product dossier and the Common Technical Document (CTD). When supporting documentation was requested, the manufacturer could not provide the relevant Module 2 quality summaries or Module 3 quality documentation needed to adequately evaluate the product's manufacture, controls and quality. Ultimately, the documentation available to us appeared to consist principally of a Certificate of Analysis. That was not sufficient. A CoA can report results for a particular batch, but it does not replace the broader evidence needed to understand how a medicine is manufactured and controlled, whether appropriate specifications and validated methods are in place, and whether quality can be consistently assured from batch to batch. A site visit revealed personnel within fill-finish areas without PPE and gowning practices that wew considered inappropriate for the activities being performed. These observations raised further questions about manufacturing controls and the conditions under which the finished product was being produced.
Our recommendation
Based on the available evidence and controls available being insufficient for us to responsible conclude that medicines were not defective, we determined that the commercial case alone could not compensate for the quality uncertainty. Therefore, we recommended that the client not proceed with the proposed manufacturer, despite the potential value of the transaction. We also considered the client's longer-term position. Introducing a medicine into a hospital does not end when the product is delivered. A quality failure could affect patients, the healthcare institution and the reputation of the organization that brought the product to market. Rather than simply advising the client to abandon the opportunity, HENYIDA helped identify an alternative manufacturer capable of supporting a more appropriate quality-assurance pathway.
The outcome
We helped our client recognize that a good price, an available product and a willing manufacturer do not, by themselves, make a medicine a responsible procurement. The client avoided proceeding with a supply source that HENYIDA could not adequately qualify, protecting both the integrity of the procurement decision and the client's reputation while preserving the underlying commercial opportunity through an alternative sourcing strategy. For HENYIDA, the decision reflected a simple principle: If we cannot stand behind the quality, we will not recommend the transaction.
Product, client, manufacturer, healthcare institution and market details have been withheld to protect commercial confidentiality.