Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
The Future of Plasma-Derived Medicinal Products in the European Union under the European Commission’s Proposed Regulation on Substances of Human Origin: An Analysis of the Amendments and Their Impact ***
Bich Nguyet Seipel (Abschlußjahr: 2024)
Summary
Language: English
On 14th July 2022 the European Commission published its proposal for a Regulation on the safety and quality of substances of human origin (SoHO) intended for human application (hereinafter the “SoHO Regulation”) which will repeal the outdated Blood, Tissues and Cells Directives. It will be directly applicable in the European Union (EU) and hence achieve uniform implementation of the legislation. Among others, it aims to improve the quality and safety standards for both, donors and patients and the patient access to SoHO therapies by the harmonization of standards across the Member States within an innovation-friendly environment.
One of the main concerns relate to the vulnerability of plasma supply for the manufacture of plasma-derived medicinal products (PDMPs) deepened by the COVID-19 pandemic and is evaluated under the provisions of the SoHO Regulation in this thesis. The EU’s dependency on third countries – specifically plasma from the USA – and the continuous growing demand for PDMPs represent a serious risk to patients in need. The prevention of shortages on PDMPs requires EU-wide measures that strengthen the resilience of the plasma collection in the EU. The SoHO Regulation provides basic tools for the goal of self-sufficiency by promoting plasma donation on the principle of voluntary and unpaid donation while protecting donors. However, detailed definitions and instructions need to be further examined. This includes together with the principle of voluntary and unpaid donation and the development of plasma collection system for self-sufficiency, inter alia, the strategic political positioning of plasma and the scientific differentiation of plasma for fractionation from other blood components, the clinical use based on most recent scientific data as well as measures for the protection of donors. As the SoHO Regulation maintains the Member States’ competence for healthcare organizations, the probability that several Member States adopt more stringent measures on a national level remains. This will have a negative impact on the cross-border exchange due to increasing mistrust among the Member States.
Nevertheless, the SoHO Regulation is a first and encouraging step towards an effective plasma collection and continuous supply of safe PDMPs for reduction of the dependence on the US plasma and must center the interests of patients as well as donors’ health based on scientific experience. Overall, this thesis provides an overview of the potential benefits and challenges for relevant PDMP stakeholders (policymakers, industry and patients) under the SoHO Regulation.
Pages: 62