Annexes

Purpose and scope

The “Fiscal Contribution” section included in the “Financial Performance” chapter provides information on the taxes paid by the Grifols Group globally in 2023 in a clear and concise manner. Disclosures includes data from the following territories: Spain, the United States, Ireland, Germany and United Kingdom, as the most relevant in terms of their business volume and presence within the Grifols Group.

The measurement used data obtained from information systems following the PwC Total Tax Contribution (TTC) methodology. In addition to the amounts indicated, other tax payments may have been omitted because they are not individually identified in the information systems and/or are not significant in terms of materiality.

TTC methodology

The Total Tax Contribution methodology measures the total impact of a company’s tax payments. This assessment is made from the perspective of total tax contributions paid directly to the different public administrations as a result of the Grifols Group’s economic activity.

In general, the TTC methodology allocates both input and output taxes to each tax year on a cash basis.

The following points should be kept in mind regarding this methodology:

1. It distinguishes between taxes that are a cost to Grifols and taxes collected.

Taxes borne are taxes paid by Grifols to the governments of countries in which it operates. These taxes represent an effective cost for Grifols, such as taxes on profits and certain environmental taxes.

The taxes collected are those that have been received as a result of Grifols’ economic activity, without representing a cost to the Group other than that of its management. These include withholdings from workers due to income tax, VAT, and other taxes on products and services. Nonetheless, these amounts are paid into public coffers as a result of Grifols’ economic activity and therefore should be included in the analysis since they represent tax revenue stemming from Grifols’ operations.

2. TTC framework classifies taxes under 5 categories for clarification purposes:

(i) Profit taxes: taxes borne on profits earned by companies such as corporate income tax, business tax and taxes levied as withholding taxes on payments to third parties.

(ii) Property taxes: taxes on the ownership, sale, transfer or occupancy of property.

(iii) People (or Employment Taxes): employment-related taxes both borne and collected, including employee income tax withholdings and social security payments payable by both Grifols and the employee.

(iv) Taxes on Products and Services: indirect taxes on the production and consumption of goods and services, including VAT and customs duties.

(v) Planet (Environmental Taxes): taxes on the supply, use or consumption of products and services deemed to affect the environment.

3. It includes all tax payments made to public administrations

Readers should take into account that figures detailed in this report include tax payments made to public administrations for items whose characteristics make them tax-related, although they have not been classified as such for cyclical or historical reasons. Readers should also take into consideration that figures in this report exclude other amounts that, based on the methodology and reports issued by the OECD and other international administrations, are not considered a tax contribution.¹

4. Profit before taxes assumptions made during the preparation of this report

The amount of profit before tax excludes intercompany dividends to avoid duplicating the same income of various entities in the case of its distribution as dividends to other Grifols entities. This calculation enables reflecting the objective amount of profit before taxes at country levels and calculating the objective ETRs, as dividends are usually subject to beneficial tax treatment compared to the other types of income (i.e. “participation exemption” regime).

5. There are certain particularities with regard to value added tax (VAT) and equivalent taxes

Value added tax (and equivalent taxes) is characterized as a tax on products and services collected, the amount of which reflects the result of net payments made by Grifols to the tax authorities in its jurisdictions of operation in the corresponding period.

In calculating VAT, the country-specific figure indicated for this concept includes the positive amount paid to the corresponding tax authorities, resulting from subtracting the VAT accrued from the amount of VAT deducted.

No figure shall be shown for this item in cases in which the net amount resulting from subtracting VAT accrued from VAT deducted for an entire year and country is negative due to a refund.

On the other hand, VAT amounts that are not refundable because the value chain cannot be continued by means of the reverse charge instrument shall be considered as input tax on products and services, since they represent a cost for the company.

1. Main sources of Total Tax Contribution Methodology:

• https://www.oecd.org/tax/tax-policy/oecd-classification-taxes-interpretative-guide.pdf
• http://www.ifs.org.uk/mirrleesReview/design

The Social Return on Investment (SROI) method aims to gain a deeper understanding of an organization’s social, environmental and economic impact. The SROI method represents a valuable cost-benefit analysis, offering the leadership team and investors a solid decision-making tool to assess and optimize the firm’s social and environmental impacts.

The SROI uses individual assessments to measure the change in stakeholders’ lives because of Grifols’ activities. The evaluations are quantified and recorded on an impact map, and monetary value is then assigned to the resulting social, environmental and economic impacts.

2023 global SROI analysis

The study was conducted by Hugo Narrillos Roux, holder of a doctorate with honors in economics from the Complutense University of Madrid, a specialist in social value and the author of “Social Economy: Valuation and Measurement of Social Investment (SROI method) and his doctoral thesis, "The Social Return on Investment: A Good Method to Measure the Social Value Created by Companies".

Mr. Narrillos Roux is recognized as an accredited SROI professional by Social Value International, a network of professionals dedicated to generating knowledge on change and social value. He serves as a faculty member at several universities and a social-impact consultant at leading global organizations..

Main references:

Alpha 1: Augmentation Therapy for α1 Antitrypsin Deficiency: A Meta-Analysis. Chapman, K.R., Stockley, R.A., Dawkins, C., Wilkes, M. M., Navickis, R. J. COPD: Journal of Chronic Obstructive Pulmonary Disease, 6:177–184 (2009)

Factor VIII: Pasi, J., Hermans. C., Hakimi,Z., Nazir, J., Aballéa, S., Ezzalfani, M., and Fatoye, F. (2022): Improvement in pain-related quality of life in patients with hemophilia A treated with rFVIIIFc individualized prophylaxis: post hoc analysis from the A-LONG study. Therapeutic Advances in Hematology. 2022, Vol. 13: 1–9

PID: The impact of plasma-derived therapies in Europe. The health and economic case for ensuring sustainable supply. Copenhagen Economics. June 2021. Available at: https://www.copenhageneconomics.com/publications/publication/the-impact-of-plasma-derived-therapies-in-europe (website visited on January 2024).

CIDP: Hartung, H., Mallick, R., Bril, V., Lewis, R. A., Sobue, G., … Lawo, J. (2019). Patient-reported outcomes with subcutaneous immunoglobulin in chronic inflammatory demyelinating polyneuropathy: the PATH Study. European Journal of Neurology.

SID: Benbrahim, O., Viallard, J.-F., Choquet, S., Royer, B., Bauduer, F., Decaux, O., … Lévy, V. (2018). The use of octagam and gammanorm in immunodeficiency associated with hematological malignancies: a prospective study from 21 French hematology departments. Hematology, 24(1), 173–182.

ITP: Efficacy and mechanism of intravenous immunoglobulin treatment for immune thrombocytopenia in adults. Ruqayyah J. Almizraq1, Donald R. Branch. Annals of Blood. Vol 6 (March 2021).

GBS: Immunoglobulin Use for the Management of Painful Peripheral Neuropathy: A Systematic Review and Meta-Analysis. Z. Panagiotis, Liampas, A., Pozotou, T., Parperis, K., Artemiadis, A., Hadjigeorgiou, G. (2022). Pain And Therapy (2022). 11:1219–1227

MG: Porras L.D., Homedes C., Alberti M.A., Santamaria V.V., Casasnovas C. (2022).Quality of Life in Myasthenia Gravis and Correlation of MG-QOL15 with Other Functional Scales. Journal of Clinical Medicine. 2022; 11(8).

HC: Runken, M. C., Caraceni, P., Fernandez, J., Zipprich, A., Carlton, R., & Bunke, M. (2019). The cost-effectiveness of albumin in the treatment of decompensated cirrhosis in Germany, Italy, and Spain. Health Economics Review, 9(1).

The following groups have been excluded from the calculation:

• SELT
• Executive Chairperson
• Partial retirees
• Expatriates or displaced employees
• Employees of foundations
• Undeclared and non-binary employees
• The company Plasmavita Healthcare is not yet fully integrated into the systems and policies of Grifols at 100%.

In total, 19,660 employees have been included in the wage gap calculation, distributed by country as follows:

• EE.UU.: 13,852
• España:4,103
• Alemania:1,334
• Irlanda: 371

According to the Global Reporting Initiative standards, the unadjusted gender pay gap is the difference between the average salary of men and the average salary of women, calculated based on the average salary of men. For the purposes of this report, average salary is understood as the mean of the gross annual fixed salary at 100% employment.

Unlike the unadjusted gender pay gap, adjusted wage gaps allow isolating the effect of wages from existing differences between men and women, considering both their socio-economic characteristics (age, seniority, level of education, etc.) and the positions they hold (working hours, type of occupation, etc.). In this way, adjusted wage gaps serve as a more reliable indicator to measure whether men and women receive "equal pay for equal work"

The existence of an unadjusted gender pay gap does not directly imply gender-based discrimination, as various factors affecting the compensation for a specific position must be considered, such as required experience, tenure in the role, responsibility, supervisory roles, shift work, and hardship, among others.

Therefore, the adjusted wage gap has been estimated using a multiple linear regression model that quantifies, through a single equation, the relationship between predictor or independent variables (X_i1,X_i2…X_iM) and the dependent or response variable (W_i). This is done to better understand or explain the mechanisms of this relationship

In this equation, W_i represents the gross annual fixed salary at 100% employment for employee i transformed to its logarithm, while Gender is a dichotomous variable equal to 1 if male and 0 if female

The econometric calculation of the adjusted wage gap has taken into account the following variables: Age, seniority, area, business division, professional category, performance rating, level of education, type of contract, Geodif, Plasma or non-plasma.

The results are presented for each country separately to avoid applying a currency exchange rate that may distort the outcome.

Due to confidentiality and personal data protection reasons, wage gap data is not shown for professional categories where there are fewer than 4 individuals of each gender.

In some cases with small groups, the adjusted wage gap data is not shown as it is not possible to obtain statistically significant results through the econometric model. For these cases, only the unadjusted wage gap data is presented.

• AECOC: Spanish Association of Manufacturers and Distributors.
• AENE: Spanish Association of Manufacturers and Distributors of Enteral Nutrition Products.
• AmCham: American Chamber of Commerce in Spain, China and Thailand.
• ASEBIO: Spanish Association of Bio Companies.
• BIOcom Life Sciences Organization of California: California association of bioscience companies and research institutes.
• Biotechnology Innovation Organization (BIO): the world’s premier biotech trade association whose membership includes industry firms, academic institutions and U.S. state-level centers and organizations.
• CAEME: Argentine Association for Pharmaceutical and Biotech Products.
• CBDL: Brazilian Chamber of In Vitro Diagnostics Companies .
• EMIG: Ethical Medicines Industry Group .
• EUCOPE: trade association representing small- to medium-sized pharmaceutical and med-tech firms in Europe .
• EURORDIS: non-governmental patient-driven alliance representing 949 rare disease patient organizations in 73 countries.
• Farmafluid: Spanish Association of Fluid Therapy and Parenteral Nutrition Pharmaceutical Laboratories .
• Farmindustria: Italian Association of Pharmaceutical Companies .
• Global Business Alliance: an association of globally focused U.S. firms that promotes foreign investment in the country.
• JACRI: Japanese Association of Clinical Reagents Industry .
• LEEM: French industry association representing drug companies operating in France.
• MedTech Europe: Trade association representing the medical technology industries, manufacturers of in vitro diagnostics and medical devices operating in Europe and diverse national associations.
• National Health Council (EE.UU.): platform for diverse organizations to forge consensus and drive patient-centered health policy.
• North Carolina BIO: trade association for North Carolina’s life science industry whose membership includes companies and research institutions working in the pharmaceutical, medical device, diagnostic, clinical research and agricultural biotechnology sectors.
• Pathology Technology Australia: Australian association of manufacturers and distributors of in vitro diagnostic reagents and systems.
• PPTA: Plasma Protein Therapeutics Association.
• SIGRE: not-for-profit organization established to ensure proper environmental management of medicines and their packaging in the home.
• SINDUSFARMA: Brazilian Association of Pharmaceutical Companies.
• United States-Spain Council: An organization of U.S. and Spanish leaders who work to cultivate stronger ties between both countries.

Grifols advances social progress by collaborating with an array of public- and private-sector organizations. The following table outlines its most significant financial contributions by industry:

(1) IFPMA - Homepage: (https://www.ifpma.org/
(2) Medtech Europe – Homepage (https://www.medtecheurope.org/) 
(3) ICBA – Homepage (https://internationalbiotech.org/about/)

European Union Taxonomy

One of the cornerstones of the European Union’s Sustainable Finance Action Plan (SFAP) consisted of approving the EU Regulation 2020/8521 (known as the Taxonomy Regulation) in 2020. European Taxonomy comprises a classification system devised by the European Union to evaluate whether an economic activity can be considered environmentally sustainable, thereby guiding the degree of environmental sustainability of an investment. Fundamentally, European Taxonomy aims to establish a common and transparent framework for companies and investors to assess and report the environmental impact of their business activities. Its overarching goal is to channel investments towards sustainable activities and support the shift towards a more sustainable, greener economy.

The Taxonomy addresses different economic activities and industries providing uniform criteria to evaluate their contribution toward six defined environmental objectives:

• Climate change mitigation.
• Climate change adaptation.
• Sustainable use and protection of water and marine resources.
• Transition to a circular economy.
• Pollution prevention and control.
• Protection and restoration of biodiversity and ecosystems.

These environmental objectives defined by the European Union are detailed in the Delegated Regulation (EU) 2021/213982 published on June 4, 2021. This regulation includes a comprehensive list of economic activities deemed environmentally sustainable. For each activity, the regulation provides a description and specifies the technical criteria required to determine whether it contributes significantly to any of the six environmental objectives. Additionally, it outlines the criteria to ensure that the activity is carried out in such a way that it does not harm any other environmental objectives. Furthermore, in order to align with the European Taxonomy and be considered as sustainable, organizations must adhere to minimum social safeguards.

The European Taxonomy has established three key indicators based on specific financial ratios derived from data on CapEx investments, OpEx operating expenses and turnover linked to the activity carried out by the company.³

In this context, Grifols performed a comprehensive analysis of its economic activities along these three dimensions and their intersection with its six environmental objectives in order to determine which actions make a substantial contribution. The results were as follows:

This analysis was conducted in two phases: The first identified whether any of the economic activities associated with the three KPIs correspond to any of the activities outlined in the Taxonomy (eligibility assessment). The second assessed the extent to which these activities align with environmentally sustainable criteria (alignment).

First phase: Eligibility Analysis

This first phase involved assessing Grifols’ economic indicators (CapEx, OpEx and turnover) to identify whether the company’s activities correspond to the economic activities described in the Taxonomy Regulation on environmental objectives.

Unlike the previous two years, when the Taxonomy analysis was conducted solely in relation to the first two environmental objectives in which Grifols only reported activities linked to its investments or expenses incurred, this year marks a significant change. Grifols’ primary activity, and part of the company’s income, are included in the list of activities recognized by the Taxonomy. Specifically, this is “1.2. Manufacture of pharmaceuticals,” which falls under the environmental objective "Pollution Prevention and Control."

1. Regulation (EU) 2020/852 of the European Parliament and of the Council
2. Commission Delegated Regulation (EU) 2021/2139 of 4 June 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council and establishing the technical selection criteria to determine the conditions under which an economic activity is deemed to make a substantial contribution to climate change mitigation or adaptation, and to determine whether that economic activity causes significant harm to any of the other environmental objectives (europa.eu
3. The Taxonomy Regulation sets out specific criteria for using figures related to CapEx, and turnover, which diverge from traditional accounting concepts. Therefore, there may be discrepancies between the figures used to calculate the Taxonomy and those presented in other sections of Grifols’ report.

Additionally, some of the company’s other economic activities have been identified, which while not directly related to its main activity, are related to the investments or expenses incurred, and considered eligible under the Taxonomy.

List of Grifols’ eligible activities for 2023

Second phase: Alignment Analysis

In line with the requirements set out in the Taxonomy Regulation for the 2023 fiscal year, Grifols’ analysis specifically focused on those activities that contribute to the first two environmental objectives: Climate Change Mitigation and Climate Change Adaptation. This assessment was carried out based on the three essential conditions that an economic activity must satisfy to be classified as environmentally sustainable:

• Offer substantial contribution to at least one of the 6 objectives defined by the Taxonomy.(EU Regulation 2020/852 Arts. 10 to 16)
• Do no significant harm to the other defined objectives.(EU Regulation 2020/852 Art. 17))
• Comply with minimum social safeguards (EU Regulation 2020/852 Art. 18)

The results of the alignment analysis determine that Grifols contributes via investments to the objective of Climate Change mitigation. The following activities are considered to be classifiable as environmentally sustainable:

• 7.4 Installation, maintenance and repair of electric vehicle charging stations in buildings (and parking spaces adjacent to buildings).

In the alignment analysis of Grifols’ economic activities for the 2023 fiscal year, the aforementioned activities are deemed environmentally sustainable based on their substantial contribution to the “climate change mitigation” objective. These activities meet the technical criteria for substantial contribution and adhere to the principle of Do Not Significant Harm (DNSH) to other environmental objectives defined in the European Taxonomy. Additionally, they comply with the minimum social safeguards. The ways in which these activities meet each of the three conditions are detailed below:

Technical criteria for substantial contribution to climate change mitigation

Grifols is considered to contribute to the Climate Change Mitigation objective in the following economic activities, 7.4 Installation, maintenance and repair of charging stations for electric vehicles in buildings, since these activities meet the technical criteria of substantial contribution to the environmental objectives. 

Do No Significant Harm (DNSH

Parallel to this, in the "Environment" section of this document, it was determined that Grifols’ economic activities adhere to the “Do No Significant Harm” technical criteria. Specifically, for these activities, the only criterion to be analyzed comes under the “Climate Change Adaptation” objective, as the regulation itself states that no significant harm must be caused to any of the other four objectives.

Minimum Social Safeguards

Finally, these activities are considered to be in alignment with environmentally sustainable criteria, since the sections on “Promoting Integrity” and “Human Rights” in this document determine that Grifols complies with the “Minimum Social Safeguards” set out in Article 18 of the Taxonomy Regulation.

Calculation of Economic Indicators

To illustrate Grifols’ contribution to sustainability, the following shows the percentages representing the proportion of the company’s total turnover, CapEx and OpEx which are attributable to eligible and/or aligned activities. This offers a transparent view of how much of the company’s financial activities contribute to sustainability.

Turnover percentage calculation

The value of the turnover percentage, as set out in Article 8(2)(a) of EU Regulation 2020/852, was calculated by taking the portion of the net turnover attributable to products or services, including intangible assets. This portion is associated with economic activities that comply with the taxonomy and represent the numerator in the calculation, divided by the net turnover (denominator) as defined in Article 2(5) of Directive 2013/34/ EU.

Turnover includes revenue recognized in accordance with International Accounting Standard (IAS) 1, paragraph 82, letter a), adopted by Commission Regulation (EC) No. 1126/2008. In the specific case of Grifols, the numerator in the turnover KPI is calculated as the total turnover (recorded under Group 70 of the General Chart of Accounts) selected based on accounts considered eligible from a taxonomic standpoint. With regard to the numerator of the turnover KPI, Grifols identified "Activity 1.2: Manufacture of pharmaceuticals" as eligible. This corresponds to environmental objective “Pollution Prevention and Control.” Consequently, revenues from the Biopharma functional area have been included in the numerator calculation.

The denominator corresponds to Grifols’ total turnover.

CapEx percentage calculation

The CapEx ratio, as stipulated in Article 8(2)(b) of Regulation (EU) 2020/852, was calculated as the numerator divided by the denominator, the denominator being the additions to tangible and intangible assets during the reporting period before depreciation, amortization and possible revaluations, including those resulting from revaluations and impairments during the relevant period, excluding changes in fair value. The denominator also includes additions to tangible and intangible assets resulting from business combinations.

Specifically, the denominator is Grifols’ total CapEx, which includes investments in intangible assets, investments in property, plant and equipment, investments in assets for rights of use and assets transferred without consideration. The numerator consists solely of the aggregation of the CapEx of the activities considered eligible from a taxonomic standpoint.

OpEx percentage calculation

The OpEx ratio, according to Article 8(2)(b) of Regulation (EU) 2020/852, was calculated by dividing the numerator by the denominator. The OpEx denominator includes non-capitalized direct costs related to research and development, building renovation measures, short-term leases, maintenance and repairs, as well as other direct costs related to the day-to-day maintenance of property, plant and equipment by the company or a third-party subcontractor to ensure the continued efficient operation of these assets. Leasing costs for non-financial companies that apply national GAAP and do not capitalize right-of-use assets are also included in the OpEx.

In this case, the OpEx indicator calculation covers:

• Direct non-capitalized costs associated with research and development
• Short-term leases
• Maintenance and repair costs

However, other expenses related to the day-to-day maintenance of property, plant and equipment, such as cleaning services or repairs to computer systems, have not been included in the numerator calculation, in compliance with Article 8 of the regulations and the accounting methodology adopted by Grifols to present these expenses. Furthermore, as a precautionary measure, those situations in which an expense account was not sufficiently detailed to be able to determine whether it was a maintenance expense directly linked to any of the taxonomic activities analyzed, or other types of maintenance such as those mentioned above, have not been considered as eligible.

Accordingly, the denominator of the indicator includes the total expenditure of these three Grifols items, while the numerator is composed of the same items, but only for the activities that have been recognized as eligible in accordance with the established criteria.

Results

The following tables set out the data corresponding to turnover, CapEx and OpEx for Grifols’ economic activities that comply with the European Taxonomy.

Grifols Results

Turnover

*1 All activities added in 2023 were not checked for taxonomy conformity
*2 Economic activity is to be reported for the first time for FY 2023 or did not exist in the previous year, so no previous year’s figures are reported here.
*3 Not applicable, as alignment is to be reviewed for the first time for the 2024 financial year for the other 4 environmental targets.

CapEx

*1 All activities added in 2023 were not checked for taxonomy conformity
*2 Economic activity is to be reported for the first time for FY 2023 or did not exist in the previous year, so no previous year’s figures are reported here.
*3 Not applicable, as alignment is to be reviewed for the first time for the 2024 financial year for the other 4 environmental targets.

OpEx

*1 All activities added in 2023 were not checked for taxonomy conformity.
*2 Economic activity is to be reported for the first time for FY 2023 or did not exist in the previous year, so no previous year’s figures are reported here.
*3 Not applicable, as alignment is to be reviewed for the first time for the 2024 financial year for the other 4 environmental targets.

Scope of the European Taxonomy Analysis

In line with the rest of the Annual Integrated and Sustainability Report, the data tables for Grifols Consolidated and the Biotest Group is presented separately to facilitate data comparison. The taxonomy study for Grifols Consolidated is presented in the previous sections. The eligibility and alignment analysis is published by Biotest Group annually along with management approaches and main application policies at www.biotest.com. The main results are presented in section "Biotest Results" in this Appendix.

Biotest results

Turnover

*1 All activities added in 2023 were not checked for taxonomy conformity
*2 Economic activity is to be reported for the first time for FY 2023 or did not exist in the previous year, so no previous year’s figures are reported here
*3 Not applicable, as alignment is to be reviewed for the first time for the 2024 financial year for the other 4 environmental targets

CapEx

*1 All activities added in 2023 were not checked for taxonomy conformity
*2 Economic activity is to be reported for the first time for FY 2023 or did not exist in the previous year, so no previous year’s figures are reported here.
*3 Not applicable, as alignment is to be reviewed for the first time for the 2024 financial year for the other 4 environmental targets.

OpEx

*1 All activities added in 2023 were not checked for taxonomy conformity
*2 Economic activity is to be reported for the first time for FY 2023 or did not exist in the previous year, so no previous year’s figures are reported here
*3 Not applicable, as alignment is to be reviewed for the first time for the 2024 financial year for the other 4 environmental targets.

The selected GRI Disclosures below refer to those published in 2016, except those that have undergone and in which case the year of publication is indicated.

This index collects the main SDGs and principles of the United Nations Global Compact to which Grifols contributes with its activity. The main areas of Grifols’ contributions include references to indicate where additional information can be found in the 2023 Integrated Annual Report.

Glossary and abbreviations

• Alpha-1 antitrypsin deficiency (AATD): inherited disease characterized by low levels or no alpha-1 antitrypsin (AAT) in the bloodstream. In its normal function, this protein is generated in the liver, released in the bloodstream and diffused to other organs such as the lungs.
• Albumin: the most abundant protein found in plasma (approximately 60% of human plasma). Produced in the liver, it is important in regulating blood volume by maintaining the oncotic pressure of the blood compartment.
• Alzheimer’s disease: the most common form of dementia, AD is an incurable, degenerative and terminal disease first described in 1906 by German psychiatrist and neuropathologist Alois Alzheimer.
• Anti-thymocyte globulin: blood serum with antibodies that bind with human T-cells, administered to patients before a stem cell transplant to destroy.
• ASFA: American Society for Apheresis, an organization of physicians, scientists and allied health professionals dedicated to promoting apheresis medicine for patients, donors and professionals through education, evidence-based practice, research and advocacy.
• Autoimmune disease: condition in which the immune system mistakenly attacks healthy cells.
• Babesiosis/Babesia virus: disease caused by microscopic parasites that infect red blood cells.
• Beta-amyloid: protein strongly implicated in Alzheimer’s diseases as the main component of certain deposits found in the brains of AD patients.
• Bullous pemphigoid: autoimmune disease that appears when the immune system attacks the skin and causes blisters, more common among the elderly.
• CIDP (chronic inflammatory demyelinating polyneuropathy): neurological disorder which causes gradual weakness, numbness, pain in the arms and legs, and difficulty in walking.
• Cirrhosis: medical condition resulting from advanced liver disease, characterized by generation of liver tissue by fibrosis (scar tissue) and regenerative nodules (lumps that occur due to attempted repair of damaged tissue).
• Cognitive impairment: alterations in thinking, learning, memory, judgment and decision making.
• COVID-19: infectious disease caused by a new coronavirus strain, with ”CO” short for corona, “VI” for virus and ”D” for disease.
• ELISA: enzyme-linked immunosorbent assay.
• EMA: European Medicines Agency.
• Factor VIII or FVIII: an essential blood clotting factor also known as anti-hemophilic factor (AHF). In humans, factor VIII is encoded by the F8 gene. Defects in this gene lead to hemophilia A, a sex-linked disease occurring predominantly in males. FVIII concentrated from donated blood plasma or recombinant FVIII (rFVIII) can be administered to hemophiliacs to restore hemostasis.
• Factor IX: an important blood clotting factor also known as Christmas factor or plasma thromboplastin component (PTC). It is one of the serine proteases of the coagulation system belonging to the peptidase family S1. In humans, a deficiency of this protein causes hemophilia B, a sex-linked disease that occurs predominantly in males.
• FDA: Food and Drug Administration, a U.S. health authority.
• Fibrin sealant: surgical adhesive material derived from plasma.
• Fibrinogen: coagulation factor found in human plasma crucial for blood clot formation.
• Fractionation: process of separating plasma into its component parts including albumin, immunoglobulin, alpha-1 antitrypsin and coagulation factors.
• GMP good manufacturing practice.
• GPO group purchasing organization.
• HAE (hereditary angioedema): Rare but serious genetic disorder characterized by recurrent episodes of severe swelling (angioedema), particularly of the face and airways, and abdominal cramping, caused by low levels or improper function of the C1- esterase inhibitor protein.
• HBV: hepatitis B virus.
• HCV: hepatitis C virus.
• Hematocrit: the percentage of red blood cells in the blood.
• Hematology: the study of blood, blood-forming organs and blood diseases.
• Hemoderivative: proteins obtained from the fractionation of human blood plasma (see plasma-derived proteins).
• Hemophilia: genetic deficiency characterized by the lack of one of the clotting factors, with two main variants:
  • Hemophilia A: genetic deficiency of coagulation Factor VIII, which causes increased bleeding (more prevalent among males).
  • Hemophilia B: genetic deficiency of coagulation Factor IX.
• Hemotherapy: treatment of a disease using blood, blood components and its derivatives
• HIV: human immunodeficiency virus.
• Hyperimmune globulins: type of immunoglobulins prepared in a manner similar to human normal immunoglobulin, except that the donor plasma has high titers of antibodies against an organism or antigen.
• IA: immunoassays, systems available in several formats to detect antibodies, recombinant proteins or a combination thereof.
• Intravenous: administration of drugs or fluids directly into a vein.
• Immunohematology: : branch of hematology related to the study of recombinant proteins and antibodies and their effects on blood and relationships between blood disorders and the immune system. Also referred to as transfusion medicine – blood bank, its main activities include blood typing, compatibility tests and crossmatching and antibody identification.
• Immunology: branch of biomedical science that covers the study of all aspects of the immune system in organisms, encompassing the physiological functioning of the immune system in states of both health and disease; malfunctions (autoimmune diseases, hypersensitivities, immune deficiency, transplant rejection) and the physical, chemical and physiological characteristics of the components of the immune system in vitro, in situ and in vivo.
• Immunoglobulin (IgG): plasma-derived proteins also known as antibodies that control the body’s immune response. They have multiple indications, with main uses including the treatment of: (i) immune deficiencies, (ii) inflammatory and autoimmune diseases and (iii) acute infections. IVIG is an immunoglobulin administered intravenously that contains IgG (immunoglobulin (antibody) G).
• ITP (chronic immune thrombocytopenia): autoimmune disorder in which patients produce antiplatelet autoantibodies and specialized white blood cells that destroy their blood platelets. This results in a low blood platelet count (thrombocytopenia) that may produce bruising or excessive bleeding
• IVD: in vitro diagnostic.
• IV solutions/intravenous solution: medicine or homogeneous mixture of a substance in liquid, enabling its infusion into the circulatory system through a needle.
• Lipemic plasma: plasma with a cloudy and/or milky appearance caused by excess lipids (hyperlipidemia) due mainly to cholesterol and/or triglycerides in the blood.
• MRB: Marketing Research Bureau.
• Molecular diagnostic: discipline that studies genomic (DNA) and proteomic (proteins) expression patterns using information to distinguish between normal, precancerous and cancerous tissues at the molecular level.
• Monoclonal antibody (mAb): antibody produced by a single clone of cells typically used in immunotherapy (i.e. treatments of autoimmune or inflammatory disorders and cancer); diagnostic testing; cell identification; and tracking. Monoclonal antibodies are a cornerstone of immunology and becoming increasingly prevalent as therapeutic agents.
• Myasthenia gravis (MG): chronic autoimmune, neuromuscular disease that causes weakness in the skeletal muscles which worsens after periods of activity and improves after periods of rest. These muscles are responsible for functions involving breathing and moving parts of the body.
• NAT: nucleic acid amplification testing.
• Neurology: science that deals with the anatomy, functions and organic disorders of nerves and the nervous system.
• North America: United States and Canada.
• Ophthalmology: branch of medicine and surgery that deals with the diagnosis and treatment of eye diseases.
• Pandemic: worldwide spread of a new disease.
• Parkinson’s disease: complex neurodegenerative disorder characterized by different combinations of motor and non-motor symptoms for each patient.
• PCR: polymerase chain reaction, a method widely used to rapidly make millions to billions of copies of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail.
• pdFVIII: plasma-derived Factor VIII.
• Pharmacovigilance: practice of monitoring the effects of medical drugs after they have been licensed for use, especially to identify and evaluate previously unreported adverse reactions.
• Plasma: yellow-hued liquid part of the blood comprised by numerous proteins in solution.
• Plasma-derived proteins: purified plasma proteins with therapeutic properties obtained through the fractionation of human plasma. Albumin, immunoglobulins, factor VIII and alpha-1 antitrypsin are the main plasma proteins.
• Plasma proteomic:high-throughput analysis of plasma biomarkers using very powerful and sensitive specialty instruments.
• Plasmapheresis: technique by which plasma is separated from other blood components such as red blood cells, platelets and other cells. These unused blood components are suspended in saline solution and immediately reinjected back into the donor. Since donors only provide plasma as opposed to whole blood, the recovery process is faster and better tolerated, enabling greater frequency of donations. Developed by José Antonio Grifols Lucas in 1951, plasmapheresis is the only procedure capable of obtaining sufficient quantities of plasma to cover the manufacturing needs for plasma protein therapies.
• Pneumology: specialty focused on the diagnosis and treatment of respiratory diseases and conditions, from asthma to tuberculosis.
• PPTA: Plasma Protein Therapeutics Association.
• Primary arthroplasty: surgery performed to replace damaged joints with artificial joints or prostheses, used in cases of hip fractures, osteoarthritis and other rheumatic diseases.
• Primary immunodeficiency: inherited condition affecting one or more areas of the immune system characterized by an impaired immune response, weakening the immune system and increasing the likelihood of infections and other health problems.
• Prolastin^®/ Prolastin^®-C: concentrated form of alpha-1 antitrypsin (AAT) derived from human plasma and approved only for chronic replacement therapy in people with genetic AAT deficiency. Administered as prescribed, Prolastin raises the levels of AAT in the blood and lungs, which may help reduce the damage to the lungs caused by destructive enzymes.
• Proteome: complete set of proteins expressed by an organism that determine an organism’s nature, bodily functioning and behavior.
• Recombinant: protein prepared by recombinant technology, coded by the manipulated gene, with procedures used to combine segments in a cell-free system (an environment outside a cell organism). Known as highly potent medicines, they avoid off-target side effects and take a shorter time to develop than small molecules.
• Recovered plasma: plasma derived from whole blood collected in blood donations
• rFVIII: recombinant Factor VIII, the antihemophilic factor A obtained using recombinant DNA technology. Using this technology, pure factor is synthesized in the laboratory instead of being extracted from blood plasma.
• Rh (Rhesus) blood group system : the most important blood group system after ABO, the Rh blood group system consists of 50 defined blood-group recombinant proteins, among which the five recombinant proteins D,C, c, E and e are the most important. The commonly used terms Rh factor, Rh positive and Rh negative refer to the D antigen only.
• ROW: rest of the world.
• SARS-CoV-2:: severe acute respiratory syndrome coronavirus 2, the coronavirus strain that causes coronavirus disease 2019 (COVID-19).
• Secondary immunodeficiency: compromised immune system due to an environmental factor such as HIV, chemotherapy, severe burns or malnutrition.
• SCIG: subcutaneous immunoglobulin.
• Single-cell transcriptomics: technique to characterize cell identity.
• SubQ: sub-cutaneous.
• Thrombin: enzyme that presides over the conversion of fibrinogen to fibrin, which promotes blood clotting.
• Transfusion medicine: branch of medicine that encompasses immunohematology, blood and plasma screening, and blood typing, among others.
• West Nile virus (WNV): mosquito-transmitted virus. Humans are mainly infected through mosquito bites, but infection may also occur through organ transplantation and blood.
• Von Willebrand disease (vWD): the most common hereditary coagulation abnormality described in humans, although it can also be acquired as a result of other medical conditions. It arises from a qualitative or quantitative deficiency of von Willebrand factor (vWF), a multimeric protein required for platelet adhesion.
• Zika virus: infectious disease spread by the bite of an infected Aedes species mosquito

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