Page contents Page contents Availability of medical equipment Disponibbiltà tat-tagħmir mediku Mis-26 ta’ Mejju 2021, daħlu fis-seħħ ir-regoli l-ġodda dwar l-apparati mediċi (MDR), u b’hekk ġie stabbilit qafas regolatorju modern u aktar robust biex jiġu protetti s-saħħa pubblika u s-sikurezza tal-pazjenti. Ir-regoli l-ġodda bdew japplikaw wara posponiment ta’ sena minħabba l-isfidi bla preċedent tal-pandemija tal-coronavirus, u jindirizzaw il-ħtieġa għal disponibbiltà akbar ta’ apparati mediċi ta’ importanza vitali fl-UE kollha. Disponibbiltà tal-mediċini Il-Kummissjoni appellat biex il-pajjiżi tal-UE jiżguraw li matul il-pandemija tal-coronavirus l-Ewropej ikollhom aċċess għall-mediċini neċessarji u bi prezz tajjeb, filwaqt li tiġi ppreservata l-integrità tas-Suq Uniku. Dawn il-linji gwida jiżguraw il-provvista raġonevoli, it-trasport, l-allokazzjoni u l-użu ta’ mediċini vitali u jipprevjenu kwalunkwe skarsezza. Identifikazzjoni tad-domanda u t-tlaqqigħ tal-provvisti ta’ tagħmir mediku Il-Kummissjoni waqqfet “punt ċentrali ta’ koordinament għat-tagħmir mediku (COVID-19)” biex tidentifika l-provvisti disponibbli u tiffaċilita t-tlaqqigħ mad-domanda fil-pajjiżi tal-UE. Dan serva bħala pjattaforma għad-djalogu u l-kondiviżjoni ta’ informazzjoni mar-rappreżentanti tal-Istati Membri dwar id-domanda u l-provvista ta’ tagħmir mediku fil-livell tal-UE u dwar mezzi biex jingħelbu n-nuqqasijiet u tinbena l-kapaċità. Akkwist pubbliku ta’ tagħmir mediku u ta’ protezzjoni Il-Ftehim ta’ Akkwist Konġunt volontarju għal kontromiżuri mediċi jippermetti x-xiri konġunt ta’ provvisti u tagħmir mediċi vitali. L-Akkwisti Konġunti jgħinu lill-Istati Membri jiġġieldu kontra l-pandemija tal-COVID-19 f’konformità mal-politiki tal-UE dwar l-ittestjar u t-tilqim. Sa mill-bidu tal-2020, sa 36 pajjiż ipparteċipaw fi tnax-il proċedura ta’ akkwist konġunt, li rriżultaw f’aktar minn 200 kuntratt li ppermettew lill-pajjiżi jordnaw provvisti mediċi essenzjali u terapiji innovattivi għal kważi €13-il biljun. Meta twettaq akkwisti konġunti, il-Kummissjoni Ewropea għandha rwol ta’ koordinazzjoni, filwaqt li l-pajjiżi tal-UE jixtru l-oġġetti. OĠĠETTI DISPONIBBILTÀ VOLUM LIMITU MASSIMU TAL-BAĠIT Ingwanti u coveralls Avviż dwar għoti ta’ kuntratt 2020 April 2020-2021 (ingwanti) Mejju 2020-2021 (coveralls) Diversi miljuni €97 miljun Protezzjoni għall-għajnejn u protezzjoni respiratorja Avviż dwar għoti ta’ kuntratt 2020 Avviż dwar għoti ta’ kuntratt 2021 April 2020-2021 20 miljun goggle 12-il miljun tarka tal-wiċċ 37 miljun maskra tat-tip FFP2 26 miljun maskra tat-tip FFP3 301 miljun maskra kirurġika €1.4 biljun Ventilaturi Avviż dwar għoti ta’ kuntratt 2020 April 2020-2021 110,000 unità €1.4 biljun Tagħmir tal-laboratorju Avviż dwar għoti ta’ kuntratt 2020 Mejju 2020-2021 30 lott differenti €192 miljun Mediċini użati fl-unitajiet tal-kura intensiva Ottubru 2020 - Settembru 2022* 103 miljun kunjett ta’ 19-il mediċina (analġeżiċi, antibijotiċi, rilassaturi tal-muskoli, anestetiċi, risuxxitazzjoni, oħrajn) NB. Inkluż id-deksametażon taħt il-lott 1 (L-Aġenzija Ewropea għall-Mediċini tapprova l-użu tad-deksametażon f’pazjenti bil-COVID-19 fuq l-ossiġenu jew il-ventilazzjoni mekkanika) €543 miljun Remdesivir (Veklury) Avviż dwar għoti ta’ kuntratt 2020 Ottubru 2020 - April 2022* Aktar minn 500,000 kors ta’ trattament (Aġenzija Ewropea għall-Mediċini - kundizzjonijiet tal-użu) €3.4 biljun Tagħmir mediku għat-tilqim Avviż dwar għoti ta’ kuntratt 2021 Diċembru 2020 - Marzu 2022* 1.2 biljun siringa 588 miljun labra 760 miljun par ingwanti 307 miljun fardal 1.18 miljun kontenitur għat-trasport tal-vaċċini 3.38 miljun kontenitur tal-iskart 98 miljun diżinfettant 5.5 miljun anestetiku għall-konsum €2.27 biljun Testijiet tal-antiġeni rapidi Avviż dwar għoti ta’ kuntratt 2021 Frar 2021 - 2022 557 miljun test 1,733 apparat tal-qari €2.67 biljun Antikorpi monoklonali April 2021 - tmiem l-2021*** 220,000 trattament ta’ VIR-7831 (sotrovimab) 220,000 trattament tat-taħlita ta’ bamlanivimab u etesevimab 55,000 trattament ta’ Regn-COV2 (taħlita ta’ casirivimab u imdevimab) €937 miljun * Skont id-data tal-iffirmar tal-kuntratt. ** Tiġdid ta’ żewġ kuntratti. *** B'estensjoni possibbli tal-kuntratt. Gwida dwar l-użu tal-qafas tal-akkwist pubbliku Riżerva u distribuzzjoni tal-provvisti u tat-tagħmir Ir-riżerva tar-RescEU hija riżerva Ewropea komuni ta’ apparat mediku bħal: ventilaturi tagħmir protettiv personali maskri li jistgħu jerġgħu jintużaw vaċċini u aġenti terapewtiċi provvisti għal-laboratorji Il-Kummissjoni tiffinanzja 100% tal-ispejjeż tal-kumulazzjoni tar-riżerva u se timmaniġġja d-distribuzzjoni tat-tagħmir biex tiżgura li dan imur fejn l-aktar hemm bżonnu. Żieda tal-kapaċitajiet Ewropej ta’ produzzjoni Standards armonizzati riveduti se jippermettu lill-manifatturi jagħmlu apparat ta’ kwalità għolja biex jipproteġu lill-pazjenti, lill-professjonisti tal-kura tas-saħħa u liċ-ċittadini b’mod ġenerali. L-istandards riveduti jirrelataw ma’ provvisti kritiċi bħal maskri mediċi ħwejjeġ protettivi lożor kirurġiċi aġent ta’ diżinfettant u sterilizzazzjoni protezzjoni tal-għajnejn personali ingwanti mediċi apparati respiratorji protettivi Il-Kummissjoni għamlet gwida disponibbli fi 3 oqsma biex tgħin lill-manifatturi biex iżidu l-produzzjoni ta’ tagħmir u materjal mediku essenzjali, l-aktar il-produzzjoni ta’ tagħmir protettiv personali bħall-maskri prodotti għat-tindif tal-idejn u sanitizzaturi tal-idejn li jitħallew fuq il-ġilda stampar 3D Gwida dwar l-apparati mediċi Tneħħija temporanja tad-dazji doganali u tal-VAT fuq l-importazzjonijiet Il-Kummissjoni approvat it-talbiet mill-pajjiżi tal-UE kollha u mir-Renju Unit biex jitneħħew b’mod temporanju d-dazji doganali u l-VAT fuq l-importazzjoni tal-apparati mediċi u tat-tagħmir protettiv minn pajjiżi terzi. Ir-rinunzja temporanja reġgħet ġiet estiża sal-31 ta’ Diċembru 2021. Il-Kummissjoni ppubblikat ukoll gwida speċjalizzata biex tiffaċilita x-xogħol tal-awtoritajiet doganali tal-Istati Membri u ta’ partijiet ikkonċernati rilevanti oħra, meta jittrattaw il-proċeduri doganali, pereżempju, il-minimizzazzjoni tal-formalitajiet tal-importazzjoni tal-organi umani u tal-mudullun li jkunu destinati għat-trapjanti fl-UE jew ta’ diversi faċilitajiet ta’ pagament tad-dejn doganali jew tal-provi tal-oriġini preferenzjali tal-oġġetti. Il-Kummissjoni pproponiet ukoll li l-isptarijiet u l-prattikanti mediċi m’għandhomx iħallsu l-VAT fuq il-vaċċini u fuq il-kits tal-ittestjar. Wara l-approvazzjoni mill-Istati Membri, dawn il-miżuri temporanji ta’ ħelsien mill-VAT se japplikaw sal-31 ta’ Diċembru 2022. Il-Kummissjoni tipproponi wkoll eżenzjoni mill-VAT tal-oġġetti u s-servizzi vitali distribwiti mill-UE fi żminijiet ta’ kriżi. L-inizjattiva se timmassimizza l-effiċjenza tal-fondi tal-UE użati fl-interess pubbliku meta tirreaġixxi għall-kriżijiet. Il-Fond Ewropew ta’ Solidarjetà se jindirizza l-pandemija tal-coronavirus Fil-11 ta’ Marzu 2021, il-Kummissjoni Ewropea ressqet pakkett ta’ kważi €530 miljun f’appoġġ finanzjarju addizzjonali taħt il-Fond ta’ Solidarjetà tal-UE. Dan se jikkontribwixxi għall-isforzi mwettqa minn 17-il Stat Membru u 3 pajjiżi ta’ adeżjoni (l-Awstrija, il-Belġju, iċ-Ċekja, l-Estonja, Franza, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, il-Kroazja, il-Latvja, il-Litwanja, il-Lussemburgu, il-Portugall, ir-Rumanija, Spanja, l-Ungerija u l-Albanija, il-Montenegro u s-Serbja) biex tiġi ssalvagwardjata s-saħħa pubblika fil-ġlieda kontra l-coronavirus. Il-finanzjament se jappoġġja parti min-nefqa pubblika tagħhom fuq tagħmir protettiv mediku u personali, appoġġ ta’ emerġenza għall-popolazzjoni, u miżuri għall-prevenzjoni, il-monitoraġġ u l-kontroll tat-tixrid tal-marda. Ladarba tiġi approvata mill-Parlament Ewropew u mill-Kunsill, l-għajnuna finanzjarja mbagħad se tiġi żborżata lill-pajjiżi applikanti. Availability of medicines The Commission has called on EU countries to ensure that Europeans have access to necessary and affordable medicines during the coronavirus outbreak while preserving the integrity of the Single Market. These guidelines ensure the rational supply, transport, allocation and use of vital medicines and prevent any shortages. Identifying demands and matching supplies of medical equipment The Commission set up a ‘clearing house for medical equipment (COVID-19)’ to identify available supplies and facilitate the matching with demand in EU countries. It served as a platform for dialogue and sharing of information with Member States’ representatives on the demand and supply of medical equipment at EU level and on means to overcome shortages and build capacity. Public procurement of medical and protective equipment The voluntary Joint Procurement Agreement for medical countermeasures enables the joint purchase of vital medical supplies and equipment. Joint Procurements help Member States to fight the COVID-19 pandemic in line with the EU policies on testing and vaccination. Since early 2020, up to 36 countries, participated in twelve joint procurement procedures, which resulted in over 200 contracts allowing countries to order essential medical supplies and innovative therapeutics for nearly €13 billion. When conducting joint procurements, the European Commission has a coordinating role, while the EU countries purchase the items. ITEMS AVAILABILITY VOLUME BUDGET CEILING Gloves and coveralls Contract award notice 2020 April 2020-2021 (gloves) May 2020-2021 (coveralls) Several million €97 million Eye and respiratory protection Contract award notice 2020 Contract award notice 2021 April 2020-2021 20 million goggles 12 million face shields 37 million FFP2 masks 26 million FFP3 masks 301 million surgical masks €1.4 billion Ventilators Contract award notice 2020 April 2020-2021 110,000 units €1.4 billion Laboratory equipment Contract award notice 2020 May 2020-2021 30 different lots €192 million Medicines used in intensive care units October 2020 - September 2022* 103 million vials of 19 medicines (analgesics, antibiotics muscle relaxers, anaesthetics, resuscitation, other) NB. Includes dexamethasone under lot 1 (European Medicines Agency endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation) €543 million Remdesivir (Veklury) Contract award notice 2020 October 2020 - April 2022** Over 500,000 treatment courses (European Medicines Agency - conditions of use) €3.4 billion Medical equipment for vaccination Contract award notice 2021 December 2020 - March 2022* 1.2 billion syringes 588 million needles 760 million pairs of gloves 307 million aprons 1.18 million vaccine carriers 3.38 million waste containers 98 million disinfectants 5.5 million anaesthetic consumables €2.27 billion Rapid antigen tests Contract award notice 2021 February 2021 - 2022 557 million tests 1,733 reading devices €2.67 billion Monoclonal antibodies April 2021 - end 2021*** 220,000 treatments of VIR-7831 (sotrovimab) 220,000 treatments of bamlanivimab and etesevimab combination 55,000 treatments of Regn-COV2 (combination of casirivimab and imdevimab) €937 million * Depending on the contract signature date. ** Two contract renewals. *** With a possible contract extension. Guidance on using the public procurement framework Stockpiling and distributing supplies and equipment The rescEU stockpile is a common European reserve of medical equipment such as: ventilators personal protective equipment reusable masks vaccines and therapeutics laboratory supplies The Commission finances 100% of the costs of the stockpiling and will manage the distribution of the equipment to ensure it goes where it is needed most. Increasing European production capacities Revised harmonised standards will allow manufacturers to make high quality devices to protect patients, healthcare professionals and citizens in general. The revised standards relate to critical supplies such as medical facemasks protective clothing surgical drapes disinfectant and sterilization agent personal eye protection medical gloves respiratory protective devices The Commission has made guidance available in 3 areas to assist manufacturers in increasing the output of essential medical equipment and material, namely the production of personal protective equipment such as masks leave-on hand cleaners and hand disinfectants 3D printing Guidance on medical devices Temporarily lifting customs duties and VAT on imports The Commission approved requests from all EU countries and the UK to temporarily waive customs duties and VAT on the import of medical devices, and protective equipment, from third countries. The temporary waiver has been extended again until 31 December 2021. The Commission also published specialised guidance to ease the work of Member State customs authorities, and other relevant stakeholders, when dealing with customs procedures, e.g. minimising formalities on the import of human organs and bone marrow destined for transplant in the EU or various payment facilities for handling customs debt or proving preferential origin of goods. The Commission also proposed that hospitals and medical practitioners should not have to pay VAT on vaccines and testing kits. Following the green light by Member States, these temporary VAT relief measures will apply until 31 December 2022. The Commission also proposes to exempt vital goods and services distributed by the EU from VAT in times of crisis. The initiative will maximise the efficiency of EU funds used in the public interest when responding to crises. European Solidarity Fund to address the coronavirus pandemic On 11 March 2021, the European Commission put forward a package of almost €530 million in additional financial support under the EU Solidarity Fund. It will contribute to the efforts deployed by 17 Member States and 3 accession countries (Austria, Belgium, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Portugal, Romania, Spain and Albania, Montenegro and Serbia) to safeguard public health in fighting the coronavirus. The funding will support part of their public expenditure on medical and personal protective equipment, emergency support to the population, and measures to prevent, monitor and control of the spread of the disease. Once approved by the European Parliament and the Council, the financial aid will then be disbursed to the applicant countries.
