natgillin/translations-raw huggingface dataset:
Bilag 53 Beredskabs-og indsatsplanlægning i internationalt perspektiv Det internationale sundhedsregulativ fra 2005 (IHR 2005) 1. 
Annexes 53 Preparedness and response planning in the international context International Health Regulations 2005 (IHR 2005) 1.
WHO’s internationale sundhedsregulativ fra 1969 er blevet gennemrevideret og erstattet af IHR 2005, som trådte i kraft i 2007. 
The 1969 WHO International Health Regulations were fully revised and replaced by the IHR (2005), which entered into force in 2007.
IHR’s mål er at forebygge, beskytte imod, bekæmpe og sørge for folkesundhedsmæssig reaktion på international sygdomsspredning på en måde, som står i rimeligt forhold til og er begrænset til kun at omfatte folkesundhedsmæssige risici, og som undgår unødvendige indgreb i international trafik og handel1. 
The IHR objective is ‘to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade’1.
IHR 2005 fastsætter, at deltagerstaterne skal anmelde enhver hændelse, der kan udgøre en folkesundhedsmæssig krisesituation af international betydning, til WHO, uanset kilden til hændelsen, og udvikle, styrke og fastholde deres kernekapacitet til overvågning og indsats på folkesundhedsområdet ved anvendelse af de eksisterende nationale ressourcer, f.eks. de nationale beredskabsplaner for pandemisk influenza. 
The IHR 2005 requires State Parties to report to WHO any event that may constitute a public health emergency of international concern, independently of its origin, and to develop, strengthen and maintain core public health capacities for surveillance and response by using existing national resources, such as the national plans for influenza pandemic preparedness.
IHR er også udformet med henblik på at reducere risikoen for sygdomsspredning i internationale lufthavne, havne og ved landegrænser og fastsætter, at både deltagerstaterne og WHO skal etablere knudepunkter til udveksling af hastemeddelelser. 
The IHR are also designed to reduce the risk of disease spread at international airports, ports and ground crossings and require the establishment of national and WHO IHR focal points for urgent communication.
IHR 2005 indeholder ingen håndhævelsesmekanisme, der kan anvendes over for stater, der ikke overholder regulativets bestemmelser. 
The IHR (2005) do not include any enforcement mechanism for States which fail to comply with its provisions.
WHO overvåger gennemførelsen af IHR samt udsender og ajourfører relevante retningslinjer. 
WHO monitors the implementation of the IHR, and issues and updates relevant guidelines.
WHO’s ekspertpaneler og evalueringsudvalg undersøger også IHR’s effektivitet i krisesituationer, som det f.eks. skete efter ebolaudbruddet (der gives flere detaljer i beretningens tekstboks 3). 
Its expert panels and review committees also review IHR effectiveness in emergency situations, as was done, for example, after the Ebola outbreak (see Box 3 in the report for more information on this).
Folkesundhedsmæssige krisesituationer af international betydning (PHEIC) 3. 
Public Health Emergencies of International Concern (PHEIC) 3.
IHR definerer en folkesundhedsmæssig krisesituation af international betydning som en ekstraordinær folkesundhedsmæssig hændelse, der udgør en folkesundhedsmæssig risiko for andre stater gennem international sygdomsspredning og potentielt kræver en koordineret international indsats. 
Under the IHR, a public health emergency of international concern refers to an extraordinary public health event which constitutes a public health risk to other States through the international spread of disease and potentially requires a coordinated international response.
Det er WHO’s generaldirektør, der efter henstilling fra kriseudvalget erklærer en hændelse for en folkesundhedsmæssig krisesituation af international betydning. 
The PHEIC is declared by the director-general of WHO based on a recommendation from the Emergency Committee. If a PHEIC is declared, WHO is required to deliver a ‘real time’ response to the emergency.
WHO’s generaldirektør udformer og anbefaler med bistand fra kriseudvalget de kritiske sundhedsmæssige foranstaltninger, der skal træffes af deltagerstaterne. 
The Director-General of WHO, assisted by the Emergency Committee, will develop and recommend the critical health measures for implementation by State Parties.
IHR og EU 4. 
The IHR and the EU 4.
Alle EU’s medlemsstater er medlem af WHO og rapporterer til WHO om deres gennemførelse af IHR, f.eks. i spørgeskemaer og selvevalueringer. 
All EU Member States are State Parties to WHO and report to WHO, for example through questionnaires and self-assessments, on their IHR implementation.
EU som sådan er ikke medlem af WHO og er derfor ikke part i IHR. 
The EU itself is not a WHO member, and therefore is not a party to the IHR.
EU’s potentielle rolle som regional økonomisk integrationsorganisation anerkendes imidlertid i IHR, og det fastsættes, uden at det berører deres forpligtelser i henhold til sundhedsregulativet, at deltagerstater, som er medlemmer af en regional økonomisk integrationsorganisation, i deres indbyrdes relationer skal anvende de fælles regler, der gælder i den regionale økonomiske integrationsorganisation. 
However, the IHR recognises the potential role of the EU as a ‘regional economic integration organization’ and states that, ‘without prejudice to their obligations under these Regulations, States Parties that are members of a regional economic integration organization shall apply in their mutual relations the common rules in force in that regional economic integration organization’.
Kommissionen og ECDC koordinerer deres aktiviteter med WHO på politisk2 og teknisk plan, bl.a. ved at udveksle oplysninger om risikokommunikation og give læseadgang til bestemte varslingssystemer (såsom WHO’s »Event Information System« og EU’s EWRS). 
The Commission and ECDC coordinate their activities with WHO at policy2 and technical level, including information sharing for risk communication and read access to certain alert systems (such as the WHO Event Information System and the EU’s EWRS).
1082/2013/EU indførte som en nyskabelse, at Kommissionen kan udsende en erklæring om en folkesundhedsmæssig krisesituation, men denne erklæring adskiller sig væsentligt fra WHO-generaldirektørens erklæring om en folkesundhedsmæssig krisesituation af international betydning (jf. tekstboks A). 
Decision No 1082/2013/EU also introduced the innovation of a public health emergency declaration by the Commission, but it is significantly different from a PHEIC declaration by the Director-General of WHO (see Box A).
1 »International Health Regulations (2005)«, anden udgave, Verdenssundhedsorganisationen 2008. 
1 International Health Regulations (2005), Second Edition, World Health Organisation 2008.
2 Jf. f.eks. den fælles erklæring fra 2010 (Moskvaerklæringen) om samarbejde mellem WHO og Kommissionen samt relevante opdateringer på GD for Sundhed og Fødevaresikkerheds offentlige websted. 
2 See for example the 2010 Joint Declaration (‘Moscow Declaration’) outlining cooperation between WHO and the Commission, as well as relevant updates on DG Health and Food Safety’s public website.
Der er også indgået en administrativ aftale mellem ECDC og WHO. Bilag I 
An administrative agreements is also in place between ECDC and WHO.2ww Annex I
Bilag 54 Tekstboks A - Erklæring om en folkesundhedsmæssig krisesituation i EU Som beskrevet ovenfor definerer det internationale sundhedsdirektiv en folkesundhedsmæssig krisesituation af international betydning som en ekstraordinær folkesundhedsmæssig hændelse, der efter direktivets forskrifter vurderes at udgøre en folkesundhedsmæssig risiko for andre stater gennem international sygdomsspredning og potentielt kræver en koordineret international indsats. 
Annexes 54 Box A — Public health emergency declaration in the EU As explained above, the term Public Health Emergency of International Concern is defined in the International Health Regulations as ‘an extraordinary event which is determined, as provided in these Regulations: to constitute a public health risk to other States through the international spread of disease; and to potentially require a coordinated international response’.
Det er WHO’s generaldirektør, der har ansvaret for at fastslå, om en hændelse hører til i denne kategori, og der skal først afholdes møde i IHR-kriseudvalget, som er et ekspertudvalg. 
The responsibility of determining whether an event is within this category lies with the WHO Director-General and requires the convening of a committee of experts — the IHR Emergency Committee.
En af nyskabelserne i afgørelse nr. 1082/2013/EU er, at Kommissionen nu også kan udsende en erklæring om en folkesundhedsmæssig krisesituation i EU. 
One of the innovations of Decision No 1082/2013/EU is that the Commission can now also declare a situation of public health emergency for the EU.
Artikel 12 fastsætter, at Kommissionen kan anerkende en folkesundhedsmæssig krisesituation i forbindelse med: a) humaninfluenzaepidemier, der betragtes som havende pandemisk potentiale, hvor generaldirektøren for WHO er blevet underrettet og endnu ikke har truffet beslutning om at erklære en situation for en pandemisk influenzasituation i henhold til WHO’s gældende regler, eller b) andre end de i litra a) omhandlede tilfælde, hvor generaldirektøren for WHO er blevet underrettet og endnu ikke har truffet beslutning om at erklære den givne situation for en folkesundhedsmæssig krisesituation af international betydning i henhold til det internationale sundhedsregulativ (2005) og hvor: i) den pågældende alvorlige grænseoverskridende sundhedstrussel bringer folkesundheden i Unionen i fare ii) ikke alle medicinske behov er dækkede i forhold til truslen, hvilket betyder, at der ikke findes en tilfredsstillende diagnose-, forebyggelses-eller behandlingsmetode, der er godkendt i Unionen, eller, hvis en sådan metode allerede findes, godkendelsen af et lægemiddel ikke desto mindre ville have store fordele for behandlingen af de berørte patienter.« Artikel 13 tilføjer, at anerkendelse af en krisesituation i henhold til artikel 12, som eneste retsvirkning har, at artikel 2, nr. 2), i forordning (EF) nr. 
In accordance with Article 12, the Commission may recognise a situation of public health emergency in relation to: (a) epidemics of human influenza considered to have pandemic potential, where the Director-General of WHO has been informed and has not yet adopted a decision declaring a situation of pandemic influenza in accordance with the applicable rules of WHO; or (b) cases other than that referred to in point (a) where the Director-General of WHO has been informed and has not yet adopted a decision declaring a public health emergency of international concern in accordance with the IHR, and where: (i) the serious cross-border threat to health in question endangers public health at the Union level; (ii) medical needs are unmet in relation to that threat, which means that no satisfactory method of diagnosis, prevention or treatment is authorised in the Union or, despite the existence of such a method, the authorisation of a medicinal product would nonetheless be of major therapeutic advantage to those affected’.
507/20063 kan finde anvendelse, eller når anerkendelsen specifikt vedrører humaninfluenzaepidemier, der betragtes som havende pandemisk potentiale, at artikel 21 i forordning (EF) nr. 1234/20084 kan finde anvendelse. Det betyder, at kriseerklæringen i henhold til artikel 12 i afgørelse nr. 
Article 13 then adds that this recognition of an emergency situation pursuant to Article 12 shall have the sole legal effect of enabling point 2 of Article 2 of Regulation (EC) No 507/20063 to apply or, where the recognition specifically concerns epidemics of human influenza considered as having a pandemic potential, of enabling Article 21 of Regulation (EC) No 1234/20084 to apply.
1082/2013/EU kun skal anvendes med henblik på hastegodkendelse af medicinske modforanstaltninger i forbindelse med pandemier og operationalisering af lægemiddellovgivningen. 
This means that the purpose of emergency declaration under Article 12 of Decision No 1082/2013/EU is restricted only to a fast track authorisation for pandemic medical countermeasures and operationalising pharmaceutical legislation.
Denne erklæring er langt mere begrænset end en erklæring fra WHO’s generaldirektør om en folkesundhedsmæssig krisesituation af international betydning, selv om der kan forekomme situationer, hvor en alvorlig grænseoverskridende sundhedstrussel, uanset oprindelse, specifikt vedrører EU og ikke nødvendigvis det øvrige verdenssamfund, som WHO har ansvaret for. 
Its application is much more limited compared to a declaration of a Public Health Emergency of International Concern by WHO, even though situations could occur where a serious cross-border threat to health, from any potential origin, specifically affects the EU and not necessarily the wider global community for which WHO is responsible.
Det betyder også, at der i EU ikke er forskellige beredskabsniveauer (f.eks. fastsat i Udvalget for Sundhedssikkerheds forretningsorden), som udløser indsatsaktiviteter og -kapacitet i henhold til afgørelsen eller udløser en mekanisme, der kan levere spidsbelastningskapacitet eller finansiering. 
It also means that there is no EU scale of alert levels (e.g. linked to the rules of procedure of the Health Security Committee) triggering response activities and capacities within the remit of the decision or to ensure the triggering of a mechanism for surge capacity or funding.
3 Kommissionens forordning (EF) nr. 507/2006 af 29. marts 2006 om tilladelse til markedsføring af humanmedicinske lægemidler omfattet af Europa-Parlamentets og Rådets forordning (EF) nr. 
3 Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 92, 30.3.2006, p.
1234/2008 af 24. november 2008 om behandling af ændringer af betingelserne i markedsføringstilladelser for humanmedicinske lægemidler og veterinærlægemidler (EUT L 334 af 12.12.2008, s. 
6). 4 Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ L 334, 12.12.2008, p.
Bilag 55 Internationale initiativer vedrørende beredskabsplanlægning og gennemsigtighed 5. 
Annexes 55 International initiatives on preparedness planning and transparency 5.
Der er flere andre internationale initiativer, der har fokus på styrket beredskabsplanlægning og øget gennemsigtighed. 
There are also several other international initiatives addressing the need to enhance preparedness planning and increase transparency.
Det gælder især Global Health Security Agendas5 peerevalueringsinitiativ6, støtten fra G7 og Global Health Security Initiative7 til disse aktiviteter8 samt ECDC’s landebesøg, der gennemføres på frivillig basis og også omhandler beredskab9. 
These initiatives mainly include the Global Health Security Agenda5 initiative to perform ‘peer reviews’6 and the G7 and Global Health Security Initiative7 support to these activities8, as well as ECDC country visits that occur on a voluntary basis and where preparedness is also addressed9.
Rapporten fra konferencen10 »Lessons learned for public health from Ebola outbreak in West Africa - how to improve preparedness and response in the EU for future outbreaks«, som indgik i Rådets konklusioner fra december 2015, giver som anbefaling, at en peerevalueringsmekanis-me kan hjælpe medlemsstaterne med at forbedre deres nationale beredskabsplaner under hensyntagen til tidligere og nuværende initiativer vedrørende uafhængige landeevalueringer på globalt og regionalt niveau. 
The report on the conference10 ‘Lessons learned for public health from the Ebola outbreak in west Africa — how to improve preparedness and response in the EU for future outbreaks’, which fed into the Council conclusions of December 2015, included the following recommendation: ‘A peer-review mechanism could help Member States to improve their national preparedness plans taking into account past and current initiatives on independent country evaluations on global and regional level.’
5 Global Health Security Agenda (GHSA) blev oprettet i februar 2014 og er et voksende partnerskab bestående af næsten 50 nationer, internationale organisationer og ikkestatslige aktører. GHSA’s formål er at hjælpe lande med at opbygge kapacitet, så de kan bidrage til at skabe en sikker verden uden trusler fra infektionssygdomme, og at fremhæve global sundhedssikkerhed som en national og global prioritet. 
5 ‘The Global Health Security Agenda (GHSA) was launched in February 2014 and is a growing partnership of nearly 50 nations, international organisations, and non-governmental stakeholders to help build countries’ capacity to help create a world safe and secure from infectious disease threats and elevate global health security as a national and global priority.
GHSA anvender en multilateral og multisektoriel tilgang for at styrke både den globale kapacitet og de enkelte landes kapacitet til at forebygge, opdage og reagere på trusler fra infektionssygdomme hos mennesker og dyr, uanset om de er naturligt forekommende eller spredes hændeligt eller forsætligt (https://ghsagenda. org). 
GHSA pursues a multilateral and multi-sectoral approach to strengthen both the global capacity and nations’ capacity to prevent, detect, and respond to human and animal infectious diseases threats whether naturally occurring or accidentally or deliberately spread.’ (https://ghsagenda.org).
6 Defineres af GHSA som en selvevaluering og en ekstern evaluering foretaget af et hold af eksperter fra andre GHSA-lande. 
6 ‘A self-assessment and an external assessment conducted by a team of experts from other GHSA countries.
Ifølge GHSA sikrer denne model en objektiv tilgang og fremmer grænseoverskridende læring. 
This peer-to-peer model ensures an objective approach and facilitates cross-border learning.
Eksterne GHSA-evalueringer skal foretages mindst to gange i hvert land, først for at fastlægge en basismåling og derefter for at måle fremskridt. 
GHSA external assessments should be conducted at least twice for each country, once to establish a baseline measurement and, subsequently, to identify progress made.’
To EU-lande har allerede deltaget og er blevet omtalt i en rapport: Portugal og Det Forenede Kongerige. 
EU Member States that have already participated and for which a report has been published are Portugal and the United Kingdom.
7 Global Health Security Initiative (GHSI) er et uformelt, internationalt partnerskab bestående af ligesindede lande. GHSI’s formål er på globalt plan at styrke sundhedsberedskabet og -indsatsen over for biologiske og kemiske trusler, radionuklear terrorisme og pandemisk influenza. 
7 ‘The Global Health Security Initiative (GHSI) is an informal, international partnership among like-minded countries to strengthen health preparedness and response globally to threats of biological, chemical, radio-nuclear terrorism (CBRN) and pandemic influenza.
Initiativet blev iværksat i november 2001 af Canada, Den Europæiske Union, Frankrig, Tyskland, Italien, Japan, Mexico, Det Forenede Kongerige og USA. 
This initiative was launched in November 2001 by Canada, the European Union, France, Germany, Italy, Japan, Mexico, the United Kingdom and the United States.
Verdenssundhedsorganisationen fungerer som ekspertrådgiver for GHSI (http://www.ghsi.ca/english/index.asp). 
The World Health Organisation serves as an expert advisor to the GHSI’ (http://www.ghsi.ca/english/index.asp).
8 Efter et møde den 8.-9. oktober 2015 i Berlin erklærede G7-sundhedsministrene, at G7’s ledere med henblik på at forhindre fremtidige sygdomsudbrud i at udvikle sig til omfattende folkesundhedsmæssige krisesituationer havde vedtaget, at de ville tilbyde at støtte gennemførelsen af IHR i mindst 60 lande, herunder landene i Vestafrika, over de næste fem år, bl.a. gennem Global Health Security Agenda (GHSA) og de fælles GHSA-mål samt andre multilaterale initiativer. 
8 ‘In order to prevent future outbreaks from becoming large-scale public health emergencies, the G7 leaders have agreed to offer to assist at least 60 countries, including the countries of west Africa, over the next 5 years to implement the IHR, including through the Global Health Security Agenda (GHSA) and its common targets and other multilateral initiatives’, Declaration of the G7 Health Ministers, 8 and 9 October 2015, Berlin.
9 ECDC Technical Report, »Ebola emergency preparedness in EU Member States: conclusions from peer-review visits to Belgium, Portugal and Romania«, juni 2015. 
9 ECDC Technical Report, ‘Ebola emergency preparedness in EU Member States: conclusions from peer-review visits to Belgium, Portugal and Romania’, June 2015.
10 Højniveaukonference arrangeret af GD for Sundhed og Fødevaresikkerhed den 12.-14. oktober 2015 i Mondorf-les-Bains, Luxembourg. 
10 High level conference organised by DG Health and Food Safety on 12 to 14 October 2015 in Mondorf-les-Bains, Luxembourg.
Bilag 56 De vigtigste roller og ansvarsområder i EU-rammen for beskyttelse af borgerne mod alvorlige grænseoverskridende sundhedstrusler Medlemsstaternes folkesundhedsmyndigheder 1. 
Annexes 56 Description of main roles and responsibilities in the EU framework for protecting citizens against serious cross-border threats to health Member State public health authorities 1.
Medlemsstaternes folkesundhedsmyndigheder er ansvarlige for folkesundhedspolitikken på nationalt plan og for håndteringen af trusler mod folkesundheden. 
Member State public health authorities are responsible for public health policy at national level, and for dealing with public health threats.
Fra medlemsstat til medlemsstat kan der afhængigt af de administrative strukturer, nationale risici og særlige forhold være forskel på, hvordan ansvaret for visse aspekter af beredskabs-og indsatsplanlægningen samt tidlig varsling og reaktion er fordelt mellem forskellige offentlige myndigheder. 
Differences in responsibilities for certain aspects of preparedness and response planning and early warning and response might exist between Member States, involving different public authorities, depending on their government organisation, national risks or specific situations.
Nogle medlemsstater kan have decentraliseret en del eller de fleste af deres ansvarsopgaver på folkesundhedsområdet, herunder ansvaret for beredskabs-og indsatsplanlægning. 
Some Member States may have decentralised parts or most of the public health responsibilities, including those for preparedness and response planning.
EU’s medlemsstater er også medlemmer af WHO’s europæiske region1 og forpligtede til at gennemføre det internationale sundhedsdirektiv, jf. bilag I. 2. 
EU Member States are also members of the WHO Europe Region1 and have an obligation to implement the International Health Regulations as explained in Annex I. 2.
Siden vedtagelsen af afgørelse nr. 1082/2013/EU har medlemsstaterne også været forpligtede til at give Kommissionen oplysninger om deres beredskabs-og indsatsplanlægning. 
Since the adoption of Decision No 1082/2013/EU, Member States also have an obligation to provide certain information on their preparedness and response planning to the Commission.
1082/2013/EU fastsætter, at medlemsstaterne og Kommissionen skal konsultere hinanden i Udvalget for Sundhedssikkerhed for at udvikle, styrke og fastholde deres kapacitet til monitorering, tidlig varsling og vurdering af samt indsats over for alvorlige grænseoverskridende sundhedstrusler. 
Decision No 1082/2013/EU requires Member States and the Commission to consult each other in the Health Security Committee to develop, strengthen and maintain their capacities for the monitoring, early warning and assessment of, and response to, serious cross-border threats to health.