in the reputable British Medical Journal on how a Malta-based consultancy firm kENUP Foundation is undermining efforts to bring vaccine manufacturing to Africa.
What immediately jumped out at me was that the authors lack a basic understanding of how medicines are regulated and how the existing norms and standards that guide medicines regulation work the world over. The central thesis of kENUP’s white book is the “transfer of mobile factories with embedded product-specific production processes”, with “the associated regulatory approvals from the EU to Africa”.
In essence, what kENUP is suggesting is to create a mobile copy of a European medicines factory that makes a vaccine that is approved for use in Europe, bring it to African soil, start producing the vaccine locally, and distribute it under the oversight of the European Medicines Agency, with no further scrutiny or regulatory approvals required by regulators in the respective African countries.
kENUP’s recommendations present a real risk of serious harm to the African people who would take those medications. They also weaken the local manufacturing industry by advocating against BioNTech fully conceding oversight over its African manufacturing operations to the respective African regulators or to the African Medicines Agency.JOIN THE DISCUSSION: Send us an email with your comments to letters@businesslive.co.za. Letters of more than 300 words will be edited for length.