RSNN Expert Meeting: Collecting informed insights on pharmaceutical compounding

21 May 2019
Utrecht, the Netherlands
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Read the meeting report here (Dutch only). An English version of the report will follow soon.

A discussion is taking place in the Netherlands on the role of pharmaceutical compounding. Traditionally, pharmaceutical compounding was important for providing patients with personalized medicines.

With rising industrial production of registered drugs, the role of pharmaceutical compounding decreased, yet in recent years we have seen a resurgence of this practice. Other aspects are also being discussed, such as the role of large producers; the value of pharmaceutical compounding for drug rediscovery; pharmaceutical compounding in times of drug shortages; and the importance of pharmaceutical compounding as an alternative to expensive registered drugs.

All of these developments evoke different reactions, some supportive and some disapproving. We see wonder, excitement, but also confusion reflecting the substantial gaps in knowledge that currently exist. There is a pressing need for additional insights.

The mission of Regulatory Science Network Netherlands (RSNN) is as follows:

"To combine expertise, to share and disseminate knowledge and to give guidance to scientific research from different stakeholders to advance an efficient and effective regulatory system that supports medicines development, marketing authorization, access, and appropriate use of medicines.”

Within the framework of this mission, RSNN wishes to contribute to discussions and knowledge development around pharmaceutical compounding in its broadest sense – collecting informed insights on pharmaceutical compounding. For example, the following are pertinent questions:

  • Is pharmaceutical compounding a provocation or a structural solution?
  • What are the implications for the position of registered drugs?
  • How does compounding affect innovation and access to new medicines?

This is far from an exhaustive list, and the RSNN Expert Meeting held on the 21st of May will be questioning several experts on how they view this matter, asking what relevant insights science can give us and establishing which questions remain to be answered to advance understanding. The meeting’s goal is to minimize the opinion-to-data ratio and pay sufficient attention to underlying questions. This reflects RSNN’s central role of disseminating knowledge and giving direction to regulatory science research.

The results of this knowledge request will be summarized in an article for a relevant journal. An attempt will be made to publish relatively quickly in order to provide an optimum contribution to the ongoing discussion.

Date: 21 May 2019

Location:  Utrecht, the Netherlands

Attendance:  By invitation only