Financial and operational impact of the PIC/S regulation

The ABPH has developed a model to objectively assess the new production costs and propose financing and operating scenarios that meet the authorities’ needs.
Olivier Camaly

Strategic challenge

Represented by the Department of Public Health, Belgium would like to apply the PIC/S regulations established at a European level for the manufacturing of preparations in hospital pharmacies.

Hospitals’ compliance with these regulations will significantly impact the operation, organization, and infrastructure of hospital pharmacies, especially production activities related to preparations.

The ABPH, Belgian Association of Hospital Pharmacists, has asked Möbius to develop a model to objectively assess the new production costs and propose financing and operating scenarios that meet the industry’s and authorities’ needs for all of Belgium.


The study was divided into two parts to achieve these objectives:

Developing a cost model for a clean room for multiple operating scenarios

The first part was aimed at developing a cost model based on the Time/Process-Driven Based Costing method. In this model, several scenarios were integrated to assess the impact that the various quality standards (zones B, C or D for preparations) have on the costs and organization of a clean room.

This model was developed based on the data collected from five hospitals that partnered with each other in the study: Cliniques Universitaires Saint-Luc, AZ Groeninge, Grand Hôpital de Charleroi, AZ Sint-Blasius, and Clinique Saint-Joseph de Vivalia.

Depending on the amount of preparations, this model allows for assessing the investment and operating costs of a clean room.

Applying the model to all Belgian hospitals and feedback of operating & financing scenarios

During this phase, a national survey enabled actual data from each hospital to be collected. By combining this data and the cost model for a clean room, different funding and operating scenarios were analyzed for all of Belgium.

Within these operating scenarios, the merging of clean rooms by hospital groups was assessed and made available in several options.

These analyzes produced quantitative results (investment and operating costs) and qualitative results (risks, dependencies) on a national level.


This study has helped provide the following information:

  • Different costs related to clean rooms in connection with PIC/S regulations: The study provided perspective on organization, investments, and operating costs related to PIC/S regulations for clean rooms. This insight enables us to understand the different impacts for hospitals.
  • Funding & operating scenarios and recommendations: Application of the cost model to all Belgian hospitals, under different scenarios, has helped provide a thorough analysis of the impact of PIC/S regulations and various means to reduce their financial impact on the industry and authorities (selected quality, production planning, groups of clean rooms).
  • This result was presented to and used by the Ministerial Office of Public Health to support the implementation of the PIC/S regulations and how they will be implemented and funded.
  • This study has also been used by several organisations, including Zorgnet Vlaanderen, to formulate an opinion on the PIC/S regulations and their implementation throughout Belgium.

The cost model Möbius developed will allow the SPF and the FAMHP to legislate and that will guide the hospitals towards the mutualisation.

Dominique Wouters, President
Belgian Association of Hospital Pharmacists (ABPH/BVZA)

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