prop · H10396 · 2014-03-11 00:00:00 — a)Om den behöriga myndigheten eller delegerade inrättningen i mottagarmedlemsstaten underrättas om en allvarlig avvi kande händelse eller allvarlig biverkning och misstänker att den hänger samman med ett organ som mottagits från en annan medlemsstat, ska den underrätta den be höriga myndigheten eller delegerade inrättningen i ur sprungsmedlemsstaten, och en första rapport innehållande den information som fastställs i bilaga I ska översändas till denna behöriga myndighet eller delegerade inrättning utan onödigt dröjsmål, om sådan information finns tillgänglig. b)Den behöriga myndigheten eller delegerade inrättningen i ursprungsmedlemsstaten ska underrätta de behö riga myndigheterna eller delegerade inrättningarna i varje berörd bestämmelsemedlemsstat och till var och en av dem översända en första rapport innehållande den infor mation som fastställs i bilaga I, i samtliga fall när den under rättats om en allvarlig avvikande händelse eller allvarlig bi verkning som den misstänker hänger samman med en do nator vars organ också skickats till andra medlemsstater. c)När ytterligare information blir tillgänglig efter den första rapporten ska den vidarebefordras utan onödigt dröjsmål. d)Den behöriga myndigheten eller delegerade inrättningen i ursprungsmedlemsstaten ska, i regel efter översändandet av den första rapporten enligt led a eller b, till de behöriga myndigheterna eller delegerade inrättningarna i samtliga bestämmelsemedlemsstater översända en gemensam slutlig rapport innehållande den information som anges i bilaga II. De behöriga myndigheterna eller delegerade inrätt ningarna i bestämmelsemedlemsstaterna ska förse den behöriga myndigheten eller delegerade inrättningen i ursprungsmedlemsstaten med relevant information. Slutrap porten ska utarbetas när relevant information har samlats in från alla medlemsstater. 1.Medlemsstaterna ska meddela kommissionen kontaktupp gifterna till den behöriga myndighet eller de delegerade inrätt ningar till vilka den relevanta informationen ska vidarebefordras med tanke på tillämpningen av artikel 5 å ena sidan och ar tiklarna 6 och 7 å andra sidan. Kontaktuppgifterna ska innehålla åtminstone följande information: organisationens namn, telefon nummer, e-postadress, faxnummer och postadress. 2.Om en medlemsstat har flera behöriga myndigheter eller delegerade inrättningar ska den se till att den information som en av dem har fått enligt artiklarna 5, 6 eller 7 vidarebefordras till den lämpliga behöriga myndigheten eller delegerade inrätt ningen på nationell nivå, i enlighet med behörighetsfördel ningen i den medlemsstaten. 3.Kommissionen ska förse medlemsstaterna med en förteck ning över alla behöriga myndigheter och delegerade inrättningar som utses av medlemsstaterna i enlighet med punkt 1. Med lemsstaterna ska hålla informationen i den förteckningen aktu ell. Kommissionen får ge en tredje part i uppdrag att upprätta och föra denna förteckning. Medlemsstaterna ska sätta i kraft de lagar och andra författningar som är nödvändiga för att följa detta direktiv. När en medlemsstat antar dessa bestämmelser ska de innehålla en hänvisning till detta direktiv eller åtföljas av en sådan hänvis ning när de offentliggörs. Varje medlemsstat ska själv utfärda närmare föreskrifter om hur hänvisningen ska göras. Medlemsstaterna ska till kommissionen översända texten till de centrala bestämmelser i nationell lagstiftning som de antar inom det område som omfattas av detta direktiv. L 275/30 Europeiska unionens officiella tidning Detta direktiv träder i kraft den tjugonde dagen efter det att det har offentliggjorts i Europeiska unionens officiella tidning. Europeiska unionens officiella tidning L 275/31 Första rapport om misstänkta allvarliga avvikande händelser eller allvarliga biverkningar 2.Identifieringsnummer för rapporten: Land (ISO-kod)/nationellt nummer 3.Kontaktuppgifter till rapporterande instans (behörig myndighet eller delegerad inrättning i den rapporterande med lemsstaten): Telefon, e-post och eventuellt faxnummer 4.Rapporterande centrum/organisation 5.Kontaktuppgifter till samordnare/kontaktperson (transplantationscentrum/centrum för tillvaratagande i den rappor terande medlemsstaten): Telefon, e-post och eventuellt faxnummer 6.Datum och tidpunkt för rapportering (ÅÅÅÅ/MM/DD/TT/mm) 8.Nationellt identifieringsnummer för donatorn, som det anmälts enligt artikel 6 9.Samtliga bestämmelsemedlemsstater (om dessa är kända) 10.Nationellt/nationella identifieringsnummer för mottagare, som det/de anmälts enligt artikel 6 11.Datum och tidpunkt när den allvarliga avvikande händelsen eller allvarliga biverkningen började (ÅÅÅÅ/MM/DD/ TT/mm) 12.Datum och tidpunkt när den allvarliga avvikande händelsen eller allvarliga biverkningen konstaterades (ÅÅÅÅ/MM/ DD/TT/mm) 13.Beskrivning av allvarlig avvikande händelse eller allvarlig biverkning 14.Omedelbara åtgärder som vidtagits/föreslagits L 275/32 Europeiska unionens officiella tidning Slutrapport om allvarliga avvikande händelser eller allvarliga biverkningar 2.Identifieringsnummer för rapporten: Land (ISO-kod)/nationellt nummer 3.Kontaktuppgifter till den rapporterande instansen: Telefon, e-post och eventuellt faxnummer 4.Datum och tidpunkt för rapportering (ÅÅÅÅ/MM/DD/TT/mm) 5.Identitetsnummer för de(n) första rapporten/rapporterna (bilaga I) 8.Resultat och slutsats av utredningen 9.Förebyggande och korrigerande åtgärder som vidtagits 10.Slutsats/uppföljning, om så krävs L 275/27 COMMISSION IMPLEMENTING DIRECTIVE 2012/25/EU of 9 October 2012 laying down information procedures for the exchange, between Member States, of human organs intended for transplantation (Text with EEA relevance) Having regard to the Treaty on the Functioning of Union, Having regard to Directive 2010/53/EU of Parliament and of the Council, of 7 2010, on standards of quality and safety of human organs intended for transplan tation (1), and in particular to Article 29 thereof, (1)In order to ensure a high level of public health the exchange of human organs between Member States requires a detailed set of uniform procedural rules for the transmission of information on organs and donor characterisation, for the traceability of organs and for the reporting of serious adverse events and reactions. (2)A variety of stakeholders in the Member States may be involved, as or as addressees, in the transmission of information for the exchange of human organs, such as competent authorities, delegated bodies including European organ exchange organisations, procurement organisations and transplantation centres. Where such bodies send or receive information for the exchange of human organs, they should act in accordance with the common procedures laid down in this Directive. These procedures should not preclude additional verbal contacts, in particular in case of urgencies. (3)In the implementation of this Directive, Member States are to ensure that the processing of donors and recipients personal data complies with Directive 95/46/EC of Parliament and of 1995 on the protection of indi viduals with regard to the processing of personal data and on the free movement of such data (2). In order to enhance awareness of the persons processing information (1) OJ L 207, , p. 14, corrected by OJ L 243, , p. (2) OJ L 281, 23.11.1995, p. transmitted pursuant to this Directive, it is appropriate to include a reminder in the written communications pursuant to this Directive. (4)In order to allow for rapid responses in case of alerts, and in order to facilitate the implementation of the obligation, provided for in Article 10(3)(b) of Directive 2010/53/EU, to keep data needed to ensure full tracea bility for a minimum of 30 years after donation, and without prejudice to the obligations of other bodies in that respect, it is appropriate that competent authorities or delegated bodies handle and record that information. Procurement organisations and transplantation centres should therefore ensure that their respective competent authorities or delegated bodies receive a copy of the information on organ and donor characterisation exchanged pursuant to this Directive, where applicable. (5)Given the current variety of practices between Member States, it is not appropriate at this stage to provide for a standard form for the transmission of information on organ and donor characterisation in this Directive. However, in order to facilitate mutual understanding of the information transmitted, such a standard form should be developed in the future, in cooperation with the Member States. (6)A serious adverse event or reaction may be detected in a of origin or destination and may be of concern for the quality and safety of the donated organs and as a consequence for the health of recipients, and in case of living donation also for the health of the donor. When organs are exchanged between Member States, such concerns may occur in different Member States. Moreover, organs from one donor might be trans planted into recipients in different Member States so that, if a serious adverse event or reaction is first detected in one of destination, the competent auth orities or delegated bodies in the of origin and in the other Member States of destination have to be informed. It is essential to ensure that all competent authorities or delegated bodies of all the Member States concerned are informed without undue delay. In order to reach this objective, Member States should ensure that all relevant information is disseminated among all Member States concerned through a set of written reports. Initial reports should be updated if additional relevant information becomes available. L 275/28 (7)The transmission of information is very often a matter of urgency. It is essential that the of information are able to identify and inform rapidly the relevant addressees. The competent authorities or delegated bodies of a should, where appropriate in accordance with the repartition of competence in the concerned, transfer the information received pursuant to this Directive to the appropriate recipient. A list of national contact points, including their contact details, should be made available at Union level and be constantly kept up to date. (8)The measures provided for in this Directive are in accordance with the opinion of transplantation, established under Article 30 of Directive 2010/53/EU, HAS ADOPTED THIS DIRECTIVE: This Directive shall apply to the cross-border exchange of human organs intended for transplantation within Union. In line with Article 29 of Directive 2010/53/EU, this Directive sets out: (a)procedures for the transmission of information on organ and donor characterisation; (b)procedures for the transmission of the necessary information to ensure the traceability of organs; (c)procedures for ensuring the reporting of serious adverse events and reactions. For the purpose of this Directive, the following definitions shall apply: (a)of origin means the where the organ is procured with the purpose of transplantation; (b)of destination means the to which the organ is sent for the purpose of transplantation; (c)National donor/recipient identification number means the identification code attributed to a donor or a recipient in accordance with the identification system established at national level pursuant to Article 10(2) of Directive 2010/53/EU; (d)Specification of the organ means (1) the anatomical description of an organ including: its type (e.g. heart, liver); (2) where applicable, its position (left or right) in and (3) whether it is a whole organ or a part of an organ, mentioning the lobe or segment of the organ; (e)a delegated body means a body to which tasks have been delegated in accordance with Article 17(1) of Directive 2010/53/EU or a European organ exchange organisation to which tasks have been delegated in accordance with Article 21 of Directive 2010/53/EU. Member States shall ensure that the information trans mitted pursuant to this Directive between competent authorities or delegated bodies, procurement organisations and/or trans plantation centres: (a)is transmitted in writing either electronically or by fax; (b)is written in a language mutually understood by the and the addressee or, in absence thereof, in a mutually agreed language, or, in absence thereof, in English; (c)is transmitted without undue delay; (d)is recorded and can be made available upon request; (e)indicates the date and time of the transmission; (f)includes the contact details of the person responsible for the transmission; (g)contains the following reminder: Contains personal data. To be protected against unautho rised disclosure or access.. 2.In case of urgencies, the information can be exchanged in a verbal form, in particular for exchanges pursuant to Articles 5 and 7. These verbal contacts must be followed by a trans mission in writing in accordance with those Articles. 3.The Member States of destination or origin shall ensure that the receipt of the information transmitted in accordance with this Directive is confirmed to the , in accordance with the requirements set out in paragraph 1. 4.Member States shall ensure that designated personnel in competent authorities or delegated bodies: (a)are available 24 hours a day and 7 days a week, for urgent situations; (b)are able to receive and transmit information pursuant to this Directive without undue delay. Information on organ and donor characterisation Member States shall ensure that, where organs are envisaged for exchange between Member States, prior to exchanging the organ, the competent authority or delegated body of the of origin transmits the information collected to characterise the procured organs and the donor, as specified in Article 7 and in the to Directive 2010/53/EU, to the competent authorities or delegated bodies of the potential Member States of destination. L 275/29 Member States shall ensure that, where some of the information to be transmitted in accordance with paragraph 1 is not available at the time of the initial transmission and becomes available later, it is transmitted in due time to allow for decisions: (a)by the competent authority or delegated body of the of origin to the competent authority or delegated body of the of destination; or (b)directly by the procurement organisation to the transplan tation centre. Member States shall take appropriate measures to ensure that procurement organisations and transplantation centres transmit to their respective competent authorities or delegated bodies a copy of the information pursuant to this Article. Information to ensure the traceability of organs Member States shall ensure that the competent authority or delegated body of the of origin inform the competent authority or delegated body of the of destination of: (a)the specification of the organ; (b)the national donor identification number; (c)the date of procurement; (d)name and contact details of the procurement centre. Member States shall ensure that the competent authority or delegated body of the of destination inform the competent authority or delegated body of the of origin of: (a)the national recipient identification number or, if the organ was not transplanted, of its final use; (b)the date of transplantation, if applicable; (c)name and contact details of the transplantation centre. Reporting of serious adverse events and reactions Member States shall ensure that the following procedure is implemented by their competent authorities or delegated bodies: (a)Whenever the competent authority or delegated body of the of destination is notified of a serious adverse event or reaction that it suspects to relate to an organ that was received from another , it shall immediately inform the competent authority or delegated body of the of origin and transmit without undue delay to that competent authority or delegated body an initial report containing the information set out in , in so far as this information is available. (b)The competent authority or delegated body of the of origin shall immediately inform the competent authorities or delegated bodies of each concerned of destination and transmit them each an initial report containing the information set out in , whenever it is notified of a serious adverse event or reaction that it suspects to be related to a donor whose organs were also sent to other Member States. (c)When additional information becomes available following the initial report, it shall be transmitted without undue delay. (d)The competent authority or delegated body of the of origin shall, as a rule within three months of the initial report transmitted pursuant to point (a) or (b), transmit to the competent authorities or delegated bodies of all Member States of destination, a common final report containing the information set out in . The competent authorities or delegated bodies of the Member States of destination shall provide relevant information in a timely to the competent authority or delegated body of the of origin. The final report shall be drawn up after collecting relevant information from all Member States involved. Interconnection between Member States 1.Member States shall communicate to the Commission the contact details of the competent authority or delegated bodies to which the relevant information shall be transmitted for the purpose of, on the one hand, Article 5, and, on the other hand, Articles 6 and 7. These contact details include at least the following data: the organisations name, telephone number, e- mail address, fax number and postal address. 2.Where a has several competent authorities or delegated bodies, it shall ensure that the information received by one of them pursuant to Article 5, 6 or 7 is forwarded to the appropriate competent authority or delegated body at national level, in accordance with the repartition of competences in that . 3.The Commission shall make available to the Member States a list of all competent authorities and delegated bodies designated by Member States in accordance with paragraph 1. The Member States shall keep the information in that list up to date. The Commission may entrust the and main tenance of this list to a third party. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by at the latest. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. L 275/30 This Directive shall enter into force on the twentieth day following that of its publication in the . Done at , 9 October 2012. L 275/31 Initial Report for suspected serious adverse events or reactions 2.Report identification number: country (ISO)/national number 3.Contact details of the reporter (competent authority or delegated body in the reporting Member State): telephone, e-mail and, when available, fax 4.Reporting centre/organisation 5.Contact details of coordinator/contact person (transplant/procurement centre in the reporting Member State): telephone, e-mail and, when available, fax 6.Reporting date and time (yyyy/mm/dd/hh/mm) 7.Member State of origin 8.National donor identification number, as communicated under Article 6 9.All Member States of destination (if known) 10.National recipient identification number(s), as communicated under Article 6 11.Onset date and time of serious adverse event or reaction (yyyy/mm/dd/hh/mm) 12.Detection date and time of serious adverse event or reaction (yyyy/mm/dd/hh/mm) 13.Description of serious adverse event or reaction 14.Immediate measures taken/proposed L 275/32 Final Report of serious adverse events or reactions 2.Report identification number: country (ISO)/national number 3.Contact details of the reporter: telephone, e-mail and, when available, fax 4.Reporting date and time (yyyy/mm/dd/hh/mm) 5.Identification number(s) of initial report(s) () 8.Outcome of the investigation and final conclusion 9.Preventive and corrective actions taken 10.Conclusion/Follow-up, if required L 207/14 Europeiska unionens officiella tidning OCH RÅDETS DIREKTIV 2010/45/EU av om kvalitets- och säkerhetsnormer för mänskliga organ avsedda för transplantation OCH EUROPEISKA UNIONENS RÅD HAR ANTAGIT DETTA DIREKTIV med beaktande av fördraget om Europeiska unionens funktions sätt, särskilt artikel 168.4, med beaktande av Europeiska kommissionens förslag, med beaktande av Europeiska ekonomiska och sociala kommit téns yttrande (1), efter att ha hört , med beaktande av europeiska datatillsynsmannens yttrande (2), i enlighet med det ordinarie lagstiftningsförfarandet (3), och av följande skäl: (1)har organtransplantation blivit vanligt överallt i världen, vilket inneburit enorma fördelar för hundratusentals patienter. Användningen av mänsk liga organ (nedan kallade organ) för transplantation har ökat stadigt . Organtrans plantation är nu den mest kostnadseffektiva behandlings formen för njursvikt, och den enda tillgängliga behand lingsformen för organsvikt i sådana organ som lever, lungor och hjärta. (2)Användningen av organ vid transplantation medför dock risker. Omfattande terapeutisk användning av organ för transplantation förutsätter att organens kvalitet och sä kerhet är sådan att den minimerar riskerna för överföring av sjukdomar. Välorganiserade nationella och internatio nella system för transplantation och användning av bästa (1) EUT C 306, 16.12.2009, s. 64. (2) EUT C 192, , s. 6. (3) ståndpunkt av (ännu ej of fentliggjord i EUT) och rådets beslut av . tillgängliga expertis, teknik och innovativ medicinsk be handling kan avsevärt minska de risker som transplante rade organ medför för mottagarna. (3)Tillgången på organ för terapeutiska ändamål är des sutom beroende av unionsmedborgarnas vilja att donera organ. För att skydda folkhälsan och förhindra att sjuk domar överförs via dessa organ bör försiktighetsåtgärder vidtas vid tillvaratagande, transport och användning av organ. (4)sker utbyten av organ mellan medlemsstaterna. Organutbyte är ett viktigt sätt att öka antalet tillgängliga organ och göra det enklare att hitta organ som bättre passar ihop mellan donatorn och mottagaren, vilket i sin tur höjer kvaliteten på transplantationen. Detta är särskilt viktigt för bästa möjliga behandling av patienter med särskilda behov, såsom patienter som snabbt behöver vård, hypersensibiliserade patienter eller underåriga pa tienter. Tillgängliga organ bör kunna föras över gränserna utan onödiga problem och dröjsmål. (5)Transplantationen genomförs dock av sjukhus eller sjuk vårdspersonal som omfattas av olika rättssystem, och det finns stora skillnader i kraven på kvalitet och säkerhet mellan medlemsstaterna. (6)Det behövs därför gemensamma kvalitets- och säkerhets normer på unionsnivå för tillvaratagande, transport och användning av organ. Sådana normer skulle underlätta organutbyte till förmån för tusentals europeiska patienter i behov av denna typ av behandling . Unionslagstiftningen bör säkerställa att organ uppfyller vedertagna kvalitets- och säkerhetsnormer. Sådana normer skulle bi dra till att ge allmänheten förtroende för att organ som tillvaratas i en annan medlemsstat uppfyller samma grundläggande krav på kvalitet och säkerhet som organ från det egna landet. (7)En av de oacceptabla företeelser som förekommer i sam band med donation och transplantation av organ är han deln med organ, vilken ibland är kopplad till människo handel som syftar till att komma åt organ, vilket är ett allvarligt brott mot grundläggande rättigheter, särskilt mot människans värdighet och fysiska integritet.