240 Chapter 7 in this matter, with a comprehensive system which includes clinical guidelines, a demand management plan, and a national Ig database, of which a detailed report on Ig usage is produced yearly. Even so, the UK undertook initiatives to curb its usage during the pandemic, which included measures to hinder stockpiling and share extra supply within its hospital systems. Such judicious use and constant monitoring resulted in one of the lowest levels of usage in the European area at 90g/1000 inhabitants in 2021. Further, since there are some similarities and many differences between countries’ Ig management plans, prioritization plans (if either plan even exists), and even communication methods for shortages, there is a need for harmonization of such plans or methods.39Additionally, there is need for data on Ig usage at patient level to measure and monitor trends and clinical efficacy of Ig treatment. (SUPPLY recommendations have listed specific ways in which this data can be collected at the regional/national and continental levels.40) As described in Chapter 4, specialties such as neurology, immunology, and hematology are the top three consumers of Ig, hence, continual monitoring of them is necessary. The latter two will reflect the impact of secondary immune deficiencies (SIDs), which is projected to have a large effect on future demand. Last but not least is the regulatory factor. The European Medicines Agency (EMA) is the regulatory body of all medicines, including Ig. Two EMA documents on the scientific guidelines for Ig usage and the listing of indications in the core SmPC impact usage. As described in Chapter 3, any inclusion of indications into the core SmPC gives it legitimacy but more indications can only be added by following appropriate procedures and submitting evidence, which then circles back to the first need. On April 24th, 2024, the substances of human origin (SoHO) Regulation was passed in the European Parliament. This regulation covers the entire supply chain from donors to patients and takes significant steps to enhance the safety and quality of SoHOs and safeguarding the well-being of donors and patients. Addressing the controversy of remuneration of plasma donors, this regulation upholds the principle of voluntary non-remunerated donations and forbids financial gain, aims to increase the resilience and continuity of SoHO supply, and sets up a robust quality and safety standards system.41 A section of this regulation also mandates that Member States have emergency plans for SoHO products, which links to the aforementioned need for an emergency prioritization plan. Additionally, the Parliament also adopted the European Health Data Space (EHDS), which will establish a data-sharing framework, digital infrastructure, and governance framework for the use of health data for research, innovation, and public health purposes42 which links to the previous point on data collection at patient level.
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