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Saatja: <[email protected]> Saadetud: 07.11.2022 11:05 Adressaat: <[email protected]>; <[email protected]> Koopia: <[email protected]> Teema: Reminder: SUPPLY PROJECT - WP4 Survey Manused: image001.jpg; SUPPLY European project_SURVEY for CAs for blood and blood components_2022.docx; ABSTRACT_SUPPLY European project.pdf Dear Competent Authorities for blood and blood components, With reference to the message here below, we kindly remind you that the deadline to fill in the survey is November 30. For further information, please contact directly SUPPLY Project coordinators at [email protected]; [email protected] Thank you and best regards, The SoHO team. European Commission DG SANTE (Health and Food Safety) Unit D2 – Medical Products: quality, safety, innovation Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm From: SANTE SOHO Sent: Monday, October 17, 2022 8:25 AM To: SANTE SOHO <[email protected]>; '[email protected]' <[email protected]>; '[email protected]' <[email protected]> Cc: SANTE DL SOHO <[email protected]> Subject: SUPPLY PROJECT - WP4 Survey Dear Competent Authorities for blood and blood components, This is a message sent on behalf of the SUPPLY project coordinator to fill in the Survey on “Plasma collection and plasma-derived medicinal products (PDMPs) production from national plasma in EU”. See below and attached for more details. The deadline is on 30 November. For further information, please contact directly SUPPLY Project coordinators at [email protected]; [email protected] Best regards, The SoHO team. European Commission DG SANTE (Health and Food Safety) Unit D2 – Medical Products: quality, safety, innovation Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm ------------------------------------------------------------------------------------------------------------------------------------------ ---------------------------------------------------------------------------------------------------------- Dear Competent Authorities for blood and blood components, As anticipated in occasion of the kick-off meeting of the SUPPLY project - Strengthening voluntary non- remunerated plasma collection capacity in Europe – held in September in hybrid format, this initiative, which is co-funded by the European Commission and led by the European Blood Alliance, will formulate a set of recommendations and guidelines addressed to EU Member States to help them grow plasma collection and to achieve a resilient supply in the EU. In order to achieve the aforementioned goals, the Survey on “Plasma collection and plasma-derived medicinal products (PDMPs) production from national plasma in EU” is now available for compilation. The main objectives of the Survey are: - to investigate the presence and the effectiveness of different national legislation/policies aimed at promoting strategic independence in the public sector for PDMPs coming from national plasma; - to define the framework capable to mitigate the effects of the decrease in plasma availability (and consequently in PDMPs) following the Covid-19 pandemic and, in general, in any crisis of plasma supply from outside Europe. The Survey will be available starting from October 17 to November 30 at the following link: https://ec.europa.eu/eusurvey/runner/b638424e-d015-db05-4378-e21148888a16 You can access the EU Survey Platform at any time during the whole duration of the Survey. This broad Survey includes questions related to different topics on plasma and PDMPs. Thus, some questions may fall outside Your major area of responsibility and knowledge. If this is the case, we kindly invite You to retrieve the information within or outside Your organisation. In order to facilitate the collection of information, a MS word-version of the questionnaire is enclosed. For info and support, please contact: [email protected]; [email protected] Many thanks for Your kind attention. Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or [name of the granting authority]. Neither the European Union nor the granting authority can be held responsible for them. ABSTRACT OF THE PROJECT The Covid-19 crisis has shown how vulnerable the world is in supply of life-saving medicines. Plasma-derived medicines, particularly immunoglobulins, today face shortages in Europe. Simultaneously, there is an imbalance in the global collection of plasma needed for the products, with a high dependence of plasma coming from the U.S. The SUPPLY project therefore aims to increase and strengthen the resilience of plasma collection in the EU to enable a stable and adequate supply of medicines in Europe. A substantial part of plasma collection in the EU is conducted by the non-profit blood establishments (BEs) from voluntary non-remunerated donors, but not at the level needed. This project will focus on how BEs can improve and build up voluntary non-remunerated plasma collection programs and make them more efficient. Emphasis will be paid to maintaining donor safety in a way that benefits donor health and plasma quality intended for production of medicinal products. The project will evaluate current legal frameworks and policies in the EU on plasma collection and tender models to facilitate this process. Since plasma demand comes from the use of immunoglobulins, it is vital that its use is appropriate, and prioritisation is properly guided. The SUPPLY project, led by the European Blood Alliance, will be carried out by a large European consortium with broad and complementary expertise relating to all aspects in blood and plasma collection, processing, and medicinal use. The main project outcome is a set of recommendations and guidance for BEs, competent authorities, medical societies, and other professional stakeholders to support them in being able to increase plasma collection in the EU by the public health sector and achieve optimal availability of plasma medicines for patients both in a general situation as well as in times of crises. This project will therefore contribute to the EU becoming more strategically independent in its need for plasma medicines. TITLE: Survey on plasma collection and PDMPs production from national plasma in EU TARGET GROUPS: Competent authorities YEAR : 2019 and 2020 Data BRIEF BACKGROUND The SUPPLY project - Strengthening voluntary non-remunerated plasma collection capacity in Europe – is a co-funded initiative coordinated by the European Blood Alliance and involving 19 partners (14 EU MS , including UK) that aims : To formulate recommendations for the development of a proposal of common EU policies (or also legal frameworks) aimed to support national and EU efforts to achieve a higher degree of strategic independence from non-EU sources in the collection of plasma and its fractionation in PDMPs; To provide evidence-based recommendations and implementation tools towards best practices regarding (unpaid) plasma donor recruitment and retention; To develop a set of recommendations that will support increased and improved plasma collection programmes by BEs throughout Europe and will ultimately strengthen the resilience of plasma collection during crisis; To develop recommendations towards evidence-based pl asma donor protection practices; To deliver a set of recommendations on the appropriate use of PDMPs at baseline and on its prioritisation in times of crises . In particular, the W ork-package 4, which is led by the Italian National Blood Centre in collaboration with the partners of the C onsortium, aims to investigate the presence and the effectiveness of different national legislation/policies aimed at promoting strategic independence in the public sector for PDMPs coming from national plasma. Thanks to the data collected, WP4 will emphasize the framework capable to mitigate the effects of the decrease in plasma availability (and consequently of PDMPs on the market) reported by pharmaceutical companies following the Covid-19 pandemic and, in general, in any crisis of plasma supply from outside Europe. SPECIFIC OBJECTIVES OF THE SURVEY The present survey aims to collect i nformation on the current European nationa l policies/legal frameworks with particular regard to: strategic independence in collection of plasma for fractionation ; management of PD MPs coming from national plasma; national demand for PDMPs, inclu ding pharmaceutical expenditure; national nee ds of plasma for fractionation; different tendering models for the choice of the fractionator; state-of-the art of plasma economics which can be useful and educational for BEs in their interaction with the fractionators. DATA SENSITIVENESS It is assume d that most of the data and information is within the public domain; however, confidentiality of data and information will be granted if respondents consider them as sensitive. Results on sensitive data will be presented as aggregate or anonymized data and without any link to the respondent. PRIVACY DISCLAIMER FOR PARTICIPATION IN THE SUPPLY PROJECT SURVEY (Updated pursuant to EU Regulation 2016/679 and the Privacy Code, implemented by Legislative Decree 101/2018) The CENTRO NAZIONALE SANGUE (CNS, Italian National Blood Centre), with registered office in via Giano della Bella 27 - 00162 Rome (RM), as Data Controller informs, pursuant to Articles 13 and 14 of the EU Regulation 2016/679 (hereinafter "GDPR"), that the data will be used for the following purposes and that they will be processed as follows: 1. Purpose and Legal Basis of Data Processing The processing of the collected personal data is for the specific purpose to possibly contact those who filled in the survey in order to ask for any further information or clarification). The Legal Basis for the processing of personal data is found in Article 6(1)(a) of the GDPR, as "the data subject has given consent to the processing of his or her personal data for one or more specific purposes (…); 2. Recipients to which the personal data are disclosed Data will be disclosed to the other partners of the Consortium. 3. Categories of the personal data For the purposes referred to in paragraph n.1, the treatment will be subject to the following categories of personal data: - Personal data (name and last name); - Contacts (e-mail address, phone number) ; 4. Processing Methods The processing of personal data is carried out as indicated in art. 4, par. 1, no. 2 GDPR and more precisely: collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction; The data processing will take place only with methods, tools and computer/digital procedures strictly necessary to achieve the purposes described in paragraph n. 1 of this privacy disclaimer. 5. Data Storage Personal data will be stored for five years. Subsequently, the data will be deleted. 6. Rights of the data subject The subject data has the rights referred to in art. 15 GDPR et seq., more precisely the right to access, the right to rectify, the right to erasure, the right to restrict data processing, the right to data portability, the right to object, as well as the right to lodge a complaint with the Supervisory Authority (art. 77 GDPR and 141 Privacy Code, as amended by Legislative Decree 101/2018). The data subject has the right to withdraw his/her consent, previously given, at any time, pursuant to art. 17, par.1, lett . b) GDPR. However, such withdrawal shall not affect the lawfulness of the processing carried out on the basis of the consent previously given, and it shall have the sole effect of ceasing to process the personal data of the data person for the future. 7. Exercise of rights At any time, the data subject may exercise his/her rights by sending a communication to the CENTRO NAZIONALE SANGUE at the e-mail and PEC addresses indicated in point 8 of this privacy disclaimer, or by sending a request by registered letter to the institutional address of via Giano della Bella n. 27 - 00162 Roma (RM). 8. Contact details Data Controller - CENTRO NAZIONALE SANGUE - E-mail: [email protected] PEC: [email protected] DPO (RPD) – SCUDO PRIVACY S.r.l , E-mail: [email protected] PEC: [email protected] LIST OF ACRONYMS: 3F-PPCs : 3 Factors - Prothrombin Complex Concentrates 4F-PPCs : 4 Factors - Prothrombin Complex Concentrates BE: Blood Establishment CA: Competent Authority EU: European Union FVIII: Coagulation Factor VIII concentrates FVIII/ vWF : Coagulation Factor VIII and von Willebrand Factor, in combination , concentrates FIX: Coagulation Factor IX concentrates gr: grams kg: kilograms Ig : Immunoglobulin IgG: Immunoglobulin G IU International Unit IVIg : IntraVenous Immunog lobulin l : litres mg: milligrams MAH : Marketing Authorisation Holder MS: Member State PDMPs: Plasma-Derived Medicinal Products PfF : Plasma for F ractionation PMF: Plasma M aster File QMS: Q uality M anagement System SCIg : SubCutaneous Immunog lobulin UK: United Kingdom W B: Whole Blood W P: Work-package Explanatory notes Cost neutral : the total costs ( expenses ) for the apheresis program me are equal or lower than the selling price of plasma ; Excess of PDMPs : the availability of PDMPs (supply) made from national plasma is higher than the national demand; Fractionator : a pharmaceutical company in charge of the fractionation of plasma (processing ) ; Legislative framework : one or more legal binding act s issued ; Market mean price per unit : the ratio of the total cost (excluding VAT and possible national fees) incurred in purchasing a product preferably by the end user in the market to the corresponding quantity of product purchased ; National plasma : In this survey, we primarily refer to the plasma collected by the public sector like blood establishments, hospitals and not-for-profit organisations . If in the Country the collection is performed also by the industry and/or private companies, there will be a possibility to mention this separately. National programme /policy : a non-binding indication/ recommendation; Plasma for Fractionation : whether it is recovered from whole blood donation or collected by plasmapheresis ; Self-sufficiency : the national needs of patients for safe blood and blood products, as assessed within the framework of the national health system, are met in a timely manner, that patients have equitable access to transfusion services and blood products derived from voluntary non-remunerated blood donors ; Shortage : a situation in which the supply of a medicinal product that is authorized and placed on the market in a MS does not meet demand for that medicinal product at a national level, whatever the cause ; Strategic independence : in the context of the present survey strategic independence and self-sufficiency are used with the same meaning. COUNTRY NAME OF THE ORGANISATION TYPE OF ORGANISATION Blood Establishment Health Authority (please, specify…) Competent authority Other (please, specify…) THE ORGANISATION IS COMPETENT FOR CONTACT DETAILS Name Last name Email Phone number SURVEY OVERVIEW Section A. Main information on the national collection of plasma Section B. Information on plasma fractionated into PDMPs Section C. Information on legislative framework/ programme /policy on collection and prioritising use C1. Collection of plasma for fractionation C2. Appropriate and rational use of PDMPs C3. Prioritising the use of PDMPs C4. Excesses and shortages of PDMPs Section D. Quality of plasma for fractionation D1. Plasma donor recruitment and retention D2. Plasma donation Section E. Financial aspects E1. Collection E2. Manufacturing E3. Distribution of PDMPs E4. Funding SURVEY 734999 50552 Main information on the national collection of plasma Who can collect plasma in your Country ? ( multiple choice) Public sector blood establishments / hospitals not - for - profit organi sa tio n s others Please, specify: Free text Free text Private sector for-profit fractionator plasma collection company others Please, specify: Free text Free text Does your Country collect plasma intended for: Clinical transfusion (including pathogen -reduced plasma) Fractionation Please, quantify the volumes collected by public/private sector (specify if kg/l): Clinical transfusion (including pathogen -reduced plasma) Fractionation I f your Country collects PfF , specify the following: from WB separation (recovered plasma) by plasma apheresis (source plasma) by multicomponent apheresis (source plasma) If your Country collects PfF by public/private sector , p lease , quantify the volumes per donation (specify if g r / mL ; kg/l ) : from WB separation by plasma apheresis by multicomponent apheresis If you r Country do es not collect PfF , please specify the reason s (more than one answer allowed ) : Legal constraints Financial constraints Reasons related to the QMS Plasma does not fulfil PMF requirements (fractionator contract) Low total volumes not retained by any fractionator No interest from the companies /fractionator Logistics /infrastructure Lack of materials Lack of know - how Significant use of whole blood in clinics Other _______ _________ __ P lease, quantify the volumes of PfF ( public/private ) discarded for any reason (specify if kg/l): F rom WB separation B y multicomponent apheresis Information on plasma fractionated into PDMPs The national plasma is fractionated into PDMPs within : sale to one compan y on exclusive basis ; sale to different compan ies ; toll-manufacturing agreements ; sale to the companies and toll-manufacturing , please describe Free text Free text o the r, p lease, describe Free text Free text Are PD MP s from national plasma , or from equivalent volumes of PfF as supplied from this to fractiona tor s , r eturned to the Country /BEs? Please, describe the model of distribution of PDMPs , including the specific legislative framework . Free text Free text Please also indicate i f PDMPs are not returned and if they are mainly or partly purchased on the free market for medicines. Free text Free text If the PDMPs return back to the Country / BE , please specify the following: PDMPs ( multiple choice ) ☐ Albumin ☐ IVIg ☐ SCIg ☐ FVIII ☐ F VIII/ vWF ☐ FIX ☐ 3F-PPCs ☐ 4F-PPCs ☐ Fibrinogen ☐ A lpha-1-antitrypsin ☐ A ntithrombin ☐ C1-esterase inhibitor ☐ Specific immunoglobulins (e.g. , Hepatitis B , Anti-D (Rh) , etc.) : _______________ ___ __ _______________ ___ __ _______________ ___ __ _______________ ___ __ _______________ ___ __ ☐ Other . Please, s pecify : _______________ ___ __ _______________ ___ __ _______________ ___ __ quantity for each of PDMPs (multiple choice) ☐ Albumin ____________ gr ☐ IVIg ____________ gr ☐ SCIg ____________ gr ☐ FVIII ____________ IUs ☐ FVIII/vWF ____________ IUs ☐ FIX ____________ IUs ☐ 3F-PPCs ____________ IUs ☐ 4F-PPCs ____________ IUs ☐ Fibrinogen ____________ gr ☐ Alpha-1-antitrypsin ________ _ mg ☐ Antithrombin ____________ IUs ☐ C1-esterase inhibitor _______ _ IUs ☐ Specific immunoglobulins (e.g. , Hepatitis B , Anti-D (Rh) , etc.) : _______________ ___ __ _______________ ___ __ _______________ ___ __ _______________ ___ __ _______________ ___ __ ☐ Other . Please, s pecify : _______________ ___ __ _______________ ___ __ _______________ ___ __ If t he yield of specific protein s in the PDMP s from the plasma (particularly of IG) is described or accounted for in toll manufacturing agreements , please describe here: Free text Free text If the PDMPs return back to the Country / BE within toll manufacturing , please describe the following aspects of the agreement/contract: Specific legislative framework __________________ Part/s and counterpart/s __________________ Selection criteria to identify the company/ ies (e.g. , tender) __________________ Duration __________________ Other __________________ Free text Free text If plasma is sold without PDMPs return ing to the Country /BE of origin , please describe the following aspects of the agreement/contract: Specific legislative framework __________________ Part/s and counterpart/s __________________ Selection criteria to identify the company/ ies (e.g. , tender) __________________ Duration __________________ Other __________________ If PDMPs are returned under a different framework to the Country /BE of origin, please describe the following aspects of the agreement/contract: Specific legislative framework __________________ Part/s and counterpart/s __________________ Selection criteria to identify the company/ ies (e.g. , tender) __________________ Duration __________________ Other __________________ If information is not available, please, specify why (e.g., disclosure constraints) Free text Free text Information on legislative framework/ programme /policy on collection and prioritising use C1. Collection of plasma for fractionation D oes your Country have a specific legislative framework on the collection of plasma intended for fractionation into PDMPs ? Y/N If Yes , specify type of legislative act (e.g. law, decree) and who is in charge to issue it __________ (consider to upload the document) If Yes , who are the actors involved in the definition? Ministry of Health CA for blood and blood components Drugs Agency Scientific society/ ies BEs Voluntary Blood Donors Association/s Patient Association/s Other relevant H ealth Authorities . Please, specify : __________________ P harmaceutical companies Other/s . Please, specify __________________ D oes your Country have a national programme /policy on the collection of plasma intended for fractionation into PDMPs ? Y/N If Y es , please, specify the type of act and who is in charge to issue it __________ If Yes , who are the actors involved in its definition? Ministry of Health CA for blood and blood components Drugs Agency Scientific society/ ies BEs Voluntary Blood Donors Association/s Patient Association/s Other relevant Health Authorities. Please, specify: __________________ Pharmaceutical companies Other/s. Please, specify __________________ C2. Appropriate and rational use of PDMPs Does your Country have a specific legislative framework on the appropriate and rational use of PDMPs? Y/N If Yes , specify type of legislative act (e.g. , law, decree) and who is in charge to issue it __________ If Yes , who are the actors involved in its definition? Ministry of Health CA for blood and blood components Drugs Agency Scientific society/ ies BEs Voluntary Blood Donors Association/s Patient Association/s Other relevant Health Authorities. Please, specify: __________________ Pharmaceutical companies Other/s. Please, specify __________________ Does your Country have a specific programme /policy ( e.g., guid ance documents, recommendations ) on the appropriate and rational clinical use of PDMPs? Y/N If Yes , specify the type of specific programme /policy and who is in charge to issue it __________ If Yes , who are the actors involved in its definition? Ministry of Health CA for blood and blood components Drugs Agency Scientific society/ ies BEs Voluntary Blood Donors Association/s Patient Association/s Other relevant Health Authorities. Please, specify: __________________ Pharmaceutical companies Other/s. Please, specify __________________ C3. Prioritising the use of PDMPs Does your Country have a specific legislative framework on prioritising PDMPs use ? Y/N If Yes , please specify the type of specific legislative framework and who is in charge to issue it __________ Are there any guideline /indication on prioritising PDMPs use ? Y/N If Yes , please specify the type of guidelines /indications and who is in charge to issue it _______ C4. Excesses and shortages of PDMPs Does your Country have a specific legislative framework /policy on exceeding PDMPs ? Y/N If yes, specify the type of specific legislative framework/policy on exceeding PDMPs and who is in charge to issue it __________ Does your Country have a specific legislative framework/policy on PDMPs shortage (e.g ., mandatory storage and/or contingency rules ) ? Y/N If yes, specify the type of legislative framework/policy on PDMPs shortage and who is in charge to issue it __________ Quality of plasma for fractionation D1. Plasma donor recruitment and retention If your organisation is not directly involved, could you please specify who is in charge of donor recruitment and retention strategies? [organisation / department - optional: e mail address] Are there donor recruitment and retention strategies that were used in your organisation during the past 5 years? If possible, please specify name and/or describe them to the best of your knowledge : If you have any other remark or further helpful information and comments, please feel free to add any of that in the following text box : D2. Plasma donation Which department in your organisation is involved in donor health protection strategies (e.g. , medical department or similar)? If possible, please specify the email address Which plasma apheresis donation frequency (donations per week/month) is allowed in your Country ? Which multicomponent apheresis donation frequency (donations per week/month) is allowed in your Country ? How many days have to be between two plasma donations in your Country ? How many plasma donations per year are allowed in your Country ? Financial aspects E1. Collection Is your apheresis plasma collection cost neutral? Y/N If not, what is the % of the costs above neutral? ☐ 0 – 25% ☐ 25 – 50% ☐ &gt;50% E2. Manufacturing If national plasma fractionated into PDMPs is sold to the companies, please specify the following : specify the fee/price per kg/l: ________________ If available, specify From apheresis: ________________ From WB: ________________ If information is not available, please, specify why (e.g., disclosure constraints) ________ If national plasma fractionated into PDMPs is delivered through a toll-manufacturing contract, please specify the following: specify the fee/price per kg/l: ________________ If available, specify From apheresis: ________________ From WB: ________________ If information is not available, please, specify why (e.g., disclosure constraints) ________ E3. Distribution of PDMPs In your Country , do you have access to market prices of PDMPs? Yes No 34.1 If no, please indicate where such information can be obtained. Free text Free text 34.2 If such prices are not publicly available (due to commercial tender agreement or similar arrangements), please also mention this. Free text Free text If the market prices (final price by end user, preferably excluding VAT and local fees) are publicly known, what is the market mean price observed in the past years ? (These prices can be public tender prices, either national or local for hospitals or purchase areas, or other known final prices. We are interested in a general price level in the Country , not all prices for every purchase area, hospital or pharmacy) . 1927860 5715 For example: IVIg: EUR 33.65 (2019) or EUR 40.00 (2019 - 2021) 0 For example: IVIg: EUR 33.65 (2019) or EUR 40.00 (2019 - 2021) per gram of IVIg? per gram of SCIg? per gram of Albumin? per IU of FVIII ? per IU of FVIII/ vWF ? per IU of FIX ? per IU of 3F-PPCs ? per IU of 4F-PPCs ? per gram of Fibrinogen ? per mg of Alpha-1-antitrypsin ? per IU of Antithrombin ? per IU of C1-esterase inhibitor ? per gram/IU of Specific immunoglobulins _______ ? per gram/IU of Sp ecific immunoglobulins _______ ? per gram/IU of Specific immunoglobulins _______ ? Please provide more information about the prices and the source for the information. Free text Free text Is there a national maximum sale price (price cap) for some products, like e.g. , immuno glo bulins? Y/N If yes , please provide information on where such information can be obtained publicly. (For example, many C ountries reimburse products only if approved in the national reimbursement system and at the maximum price for reimbursement. Sometimes this sets the market price as asked for in 3 5 , but market prices may also be lower than the maximum sales price) Free text Free text In the last years 2019-2022, has there been an increase in the price for immuno glo bulins in your Country ? Y/N C an you describe the changes in Immunoglobulin prices observed during these years? ( You can answer refer ring to prices given in 35 an d 37 , or only elaborate on this freely on the basis of what you know ) . For example, if known: IMMUNOGLOBULINS FOR INTRAVENOUS USE: MEAN MARKET PRICE: EUR 33.65 (2019); EUR 33.55 (2020); EUR 33.55 (2021); EUR 33.55 (2022) AND/ OR NATIONAL MAXIMUM SALE PRICE (PRICE CAP) : EUR 44.00 (2019-2021); EUR 55.00 (2022) OR We observed an increase in prices in the purchase of Ig on the market from 45 EUR/gr to 60 EUR/gr For example, if known: IMMUNOGLOBULINS FOR INTRAVENOUS USE: MEAN MARKET PRICE: EUR 33.65 (2019); EUR 33.55 (2020); EUR 33.55 (2021); EUR 33.55 (2022) AND/ OR NATIONAL MAXIMUM SALE PRICE (PRICE CAP) : EUR 44.00 (2019-2021); EUR 55.00 (2022) OR We observed an increase in prices in the purchase of Ig on the market from 45 EUR/gr to 60 EUR/gr How often are prices usu ally adjusted for a particular PDMP ? At least once per year Once every 2 years Once every 3 years Other: …………………. Does this have a positive effect on the availability of PDMPs ? Yes No Please, comment : …………… ….. E 4 . Funding Does your Government fund initiatives about plasma ? If yes, please specify : Collection Please, describe __________________ Manufacturing Please, describe __________________ Distribution Please, describe __________________ Other __________________ Did you receive any EU grants or other EU financing options to support your plasma collection programme ? Yes No Please, specify …………… ….. 734999 50552 Many thanks for taking your time to fill in this survey! If necessary, we may contact you for clarifications.