Regulatory Negotiations

​A small US based company with a virtual European presence had acquired a specialist pharmaceutical product. The product had an approved centralised MA, but for a variety of reasons had not been launched in the EU. There was concern that the Sunset Clause would be enacted and EMA would revoke the MA.

Reviewing the regulatory history, the management of the MA and the physical product, we determined that there was an opportunity to utilise this history to justify an extension of the Sunset Clause. This would provide sufficient time to put arrangements in place to make the product available during the extended period. This justification was constructed through review of the regulatory dossier, EMA's SOPs and the legal framework. This was put to EMA, who upon reviewing the proposal, amended their position and agreed to an extension of the Sunset period, thus allowing the product to remain viable for its planned introduction and creating substantial value for the MAH.

 

In a separate case, the MA Holder and the Paediatric Development Committee (PDCO) of EMA had agreed a Paediatric Investigation Plan (PIP) for an adult medicine at the time of initial approval. When the MA Holder was developing the clinical plan it became clear that one of the two indications in the PIP was not a feasible target to investigate due to changes in medical practice. Nevertheless it was a Key Binding Element in the PIP. We developed a proposal to remove the non feasible indication from the PIP based on diagnostic criteria, its incidence and prevalence, together with a comprehensive literature review and summary of how medical practice had evolved to render the indication largely irrelevant. This was presented as a PIP Request for Modification. Despite our compelling evidence PDCO requested an Oral Explanation to explain and justify these changes.

We further developed the proposal and a rationale for presentation to PDCO, who robustly tested of the strength of our data and proposals at the meeting. Through these wide ranging discussions and negotiation with PDCO, we achieved a removal of the non feasible indication and a confirmation of the validity of the remaining elements of the PIP for the client. This allowed the progression of the PIP in the remaining underserved indication and increased the feasibility of achieving the PIP Compliance Check timelines and the exclusivity incentive. The client estimated that this change alone generated over $440m in value for the product.

Please contact us for a discussion of how we can undertake Regulatory Negotiations to maximise the patient potential and value of your projects