Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products.

[1]  M. Juan,et al.  The hospital exemption pathway for the approval of advanced therapy medicinal products: an underused opportunity? The case of the CAR-T ARI-0001 , 2022, Bone Marrow Transplantation.

[2]  Elisabete Gonçalves.  Value-based pricing for advanced therapy medicinal products: emerging affordability solutions , 2021, International Journal of Technology Assessment in Health Care.

[3]  M. Juan,et al.  Is Hospital Exemption an alternative or a bridge to EMA for developing Academic CAR-T in Europe? Our experience with ARI0001. , 2021, Human gene therapy.

[4]  P. Canonico,et al.  Price and reimbursement of advanced therapeutic medicinal products in Europe: are assessment and appraisal diverging from expert recommendations? , 2021, Journal of pharmaceutical policy and practice.

[5]  H. Gardarsdottir,et al.  Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries. , 2020, Regenerative medicine.

[6]  A. Eggimann,et al.  An assessment of the hospital exemption landscape across European Member States: regulatory frameworks, use and impact. , 2020, Cytotherapy.

[7]  H. Gardarsdottir,et al.  Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries. , 2020, Cytotherapy.

[8]  P. Knoepfler.  Rapid change of a cohort of 570 unproven stem cell clinics in the USA over 3 years. , 2019, Regenerative medicine.

[9]  J. Kimmelman,et al.  Ethical development of stem-cell-based interventions , 2019, Nature Medicine.

[10]  P. Kefalas,et al.  Concise Review: The High Cost of High Tech Medicine: Planning Ahead for Market Access , 2017, Stem cells translational medicine.

[11]  J. Rasko,et al.  Global Distribution of Businesses Marketing Stem Cell-Based Interventions. , 2016, Cell stem cell.

[12]  S. Hill,et al.  Prices, Costs, and Affordability of New Medicines for Hepatitis C in 30 Countries: An Economic Analysis , 2016, PLoS medicine.

[13]  Aaron D. Levine,et al.  Positioning a Scientific Community on Unproven Cellular Therapies: The 2015 International Society for Cellular Therapy Perspective. , 2015, Cytotherapy.

[14]  A. Izeta,et al.  The puzzling situation of hospital exemption for advanced therapy medicinal products in Europe and stakeholders' concerns. , 2014, Cytotherapy.

[15]  I. Huys,et al.  Business oriented EU human cell and tissue product legislation will adversely impact Member States’ health care systems , 2013, Cell and Tissue Banking.

[16]  Richard R. Cline,et al.  Vaccine supply, demand, and policy: A primer , 2009, Journal of the American Pharmacists Association.