MAST Grants Conditional Operating License to Ísteka for Mare Blood Collection

The Icelandic Food and Veterinary Agency (MAST) has issued a conditional operating license to Ísteka ehf., a pharmaceutical company, for the collection of blood from pregnant mares. This decision, which permits blood collection from up to 4,900 mares over the next two years, is a significant development in the production of Pregnant Mare Serum Gonadotropin (PMSG), also known as eCG. The license is specifically for the production of eCG when alternative medicinal products are not scientifically sufficient, and it comes with stringent conditions aimed at ensuring animal welfare and preventing anemia among the mares. MAST's decision reflects a careful balancing act between the need for this specific pharmaceutical ingredient and the ethical considerations surrounding animal use.

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The license is only issued for the production of PMSG (eCG) for use where the efficacy of other drugs is not scientifically sufficient. Additional conditions are also included to prevent anemia in individual mares. The agency reserves the right to review the license if further information emerges during the license period, including in the ongoing risk assessment by the European Food Safety Authority (EFSA) on blood mare welfare.

Ísteka had initially applied for a license to collect blood from up to 10,000 mares. However, MAST, after a comprehensive review of the application and supplementary information, determined that the requested number was not fully justified. Factors such as the availability of alternative treatments and the lack of clear information on the need for increased domestic production of eCG led MAST to limit the scope of the license. This measured approach underscores MAST's commitment to responsible regulation and animal welfare. The agency will maintain a close watch on Ísteka's operations, implementing detailed monitoring of blood collection practices and the health of the mares. The company is obligated to provide mares with rest periods if any signs of anemia appear, further emphasizing the welfare-centric conditions of the license.

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The active ingredient eCG is derived from the blood of mares and is used for drug production. When deciding on the issuance of the operating license, it was considered, among other things, that there are no adequate substitute drugs for certain uses of the drug.

From the perspective of Morgunblaðið, this story highlights Iceland's unique position in specialized industries like biopharmaceuticals, where animal resources play a crucial role. While international coverage might focus on the scientific or economic aspects, we emphasize the regulatory framework and the commitment to animal welfare that are paramount in Iceland. The fact that MAST has imposed strict conditions and reserves the right to review the license demonstrates the agency's diligence and Iceland's dedication to upholding high standards in animal husbandry and pharmaceutical production. This story is not just about a company receiving a license; it's about how Iceland manages its resources responsibly, ensuring that economic activities align with ethical principles. The detailed oversight by MAST is a testament to Iceland's robust regulatory environment, which aims to protect both animal welfare and the integrity of the products derived from these practices. This careful approach is something we believe is essential and worthy of detailed reporting for our readers.

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The operating license is limited to blood collection from 4,900 mares.