Support for the creation of a regional analytical
Testing and Development laboratory in Ghana
A major problem in Ghana is the inadequate supply of affordable and safe medicines to combat life-threatening diseases. The reasons for this are the high price of medicines imported from international producers and the limited availability of local products having adequate quality. Technologies unavailable to local manufacturers combined with a lack of controls lead to substandard drugs and encourage counterfeiting. An effective method for improving the quality of available pharmaceuticals is the implementation of quality control of the products by certified laboratories. In view of the urgent need for action, the Ghanaian Ministry of Health has decided to set up a new Bioequivalence and Biopharmaceutical Testing and Research Centre.
An effective tool for improving the quality of medications available on the market is the introduction of a strict inspection process before approval by the regional authority. Also necessary is a continuous quality control of the products by authorized laboratories. Often, however, employees lack the necessary expertise and scientific qualifications. For critical medicines bioequivalence studies may be required. By means of these studies, it can be determined whether the generic products achieve the same level of active ingredient as the original products, and are thus bioequivalent. In order to approve a generic medication, the appropriate authorities require proof of bioequivalence with the original product. Ghana has taken a proactive stance on this project and the preparatory process is being supported by in-depth analysis, stakeholder dialogue and consultation. Potential alternatives to the Bioequivalence Centre were also presented by the study.
The aim of this measure was to define factors essential to the establishment of a centre for pharmaceutical quality control and to develop the first steps toward implementation. The use of expertise available in North Rhine-Westphalia has helped to give the start-up phase of the laboratory centre key recommendations for action. Thus, the planning process was accelerated and given a solid foundation for the institutional and economic sustainability of the laboratory.
The measure included the following activities and methodological components:
- Deepening of the present pre-feasibility study:
As part of a pilot study, the product range and the economic and technical feasibility of the laboratory setup was clarified.
- Creation of a laboratory concept and specifications for bid proposals:
The concept study established the basis for the planning and included a cost estimate, taking all the required laboratory services into consideration. In planning the facilities, the necessary equipment and personnel were considered as well.
- Dialogue meeting in Ghana with local stakeholders:
The main Ghanaian stakeholders were involved in the process right from the beginning. After the submission of the studies, a stakeholder workshop was held to present and discuss the laboratory concept study.
- Briefing of the steering committee of the Ghanaian government:
Over a period of three months, the Ghanaian partners—and especially the steering committee—deliberated with the German Society for International Cooperation (GIZ) GmbH. The findings of the laboratory concept study originated in dialogue with Ghanaian stakeholders (ministries, local governments, academic institutions, private pharmaceutical companies, etc.), and were documented with appropriate recommendations for action. A laboratory concept was thus presented to the Steering Committee and adapted to the circumstances of Ghana.
Partners and Stakeholders
- action medeor e. V.
- Ghanaian Ministry of Health