The Belgian commitment to pharmaceutical quality: a model policy to improve quality assurance of medicines available through humanitarian and development programs

Abstract

Today, a combination of globalization of pharmaceutical production, lack of regulatory harmonization, and weakness of Medicines Regulatory Authorities, creates the “perfect conditions” for poor-quality medicine to circulate in the global market and to penetrate the less-regulated countries. Medicines regulation is the responsibility of the national regulatory authorities in the recipient country, but in the poorer countries, in practice, the responsibility of supply of quality-assured medicines is often taken by Non-Governmental Organizations and other implementers. But with some notable exceptions, many donors lack a pharmaceutical procurement policy with adequate quality requirements; and many implementers lack the skills and expertise needed to orient themselves in the complex web of global pharmaceutical supply. Thus, patients served by humanitarian or development programs may remain exposed to the risk of poor-quality medicines.

When public money is used to purchase medicines for medical programs to be carried out overseas, adequate policies should be in place to assure that the same quality requirements are set that would be required for medicines marketed in the “donor” country.

We will describe here a policy recently adopted in Belgium, i.e. the “Commitment to Quality Assurance for Pharmaceutical Products”, signed in October 2017 by the Vice Prime Minister and Minister for Development Cooperation and 19 Belgian implementing agencies. By signing the new policy, the counterparts committed to ensure quality of medicines in the programs funded by Belgium’s Official Development Assistance, and to build quality-assurance capacity in the recipient countries. Implementers are requested to integrate in their financing applications a section for pharmaceutical quality assurance, with a justified budget. They are also invited to consider how costs could be rationalized and mutualized by aligning the strengths of the various implementers. This model policy has the potential to be considered for adoption by other donors, to help to reduce the current multiple standards in pharmaceutical quality, and to contribute to protect vulnerable communities from the plague of poor-quality medicines.

Keywords:

• Quality of medicines
• Quality assurance
• Belgium
• Low-income countries
• Capacity-building
• Pharmaceutical policy
• Supply

Additional file

Acknowledgements

We thank the 19 Belgian organizations that signed the “Commitment”. We thank the Social Development Unit of the Belgian Directorate-General for Development Cooperation and Humanitarian Aid, and the members of the Medicines Working Group of Be-cause Health, who contributed to the reflection that led to the “Commitment”.

Funding

There was no external funding for writing this commentary. CD is a full-time public civil servant of the Belgian DGD. RR and TR are employed by the Institute of Tropical Medicine, Antwerp, through the DGD Framework Agreement 4, 2017–2021.

Availability of data and materials

The text of the Belgian “Commitment”, provided as Additional file 1, is available at https://diplomatie.belgium.be/sites/default/files/downloads/commitment_to_quality_assurance_for_pharmaceutical_products.pdf

Authors’ contributions

RR wrote the draft version of this manuscript. CD and TM gave significant inputs to it. All authors read and approved the final manuscript.

Ethics approval and consent to participate

No ethical approvals were required for writing this Commentary.

Consent for publication

Not applicable.

Competing interests

CD is a public health officer at the Belgian Directorate-General for Development Cooperation and Humanitarian Aid, and she was the lead author of the “Commitment” that is presented in this paper. RR contributed as policy advisor to the contents of the “Commitment”. TR is the coordinator of the Be-cause Health Platform mentioned in this paper.

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