[pic] | KOMISIJA EVROPSKIH SKUPNOSTI |

Bruselj, 6.4.2005

KOM(2005) 115 končno

2005/0042 (COD)

SPOROČILO KOMISIJE EVROPSKEMU PARLAMENTU, SVETU, EVROPSKEMU EKONOMSKO-SOCIALNEMU ODBORU IN ODBORU REGIJ

Bolj zdravi, varnejši, zadovoljnejši državljani: Strategija na področju zdravja in varstva potrošnikov

Predlog

SKLEP EVROPSKEGA PARLAMENTA IN SVETA

o vzpostavitvi programa ukrepov Skupnosti na področju zdravja in varstva potrošnikov 2007-2013 {SEC(2005)425}

(predložila Komisija)

1. UVOD

1.1. Kaj si želijo naši državljani?

Državljani EU želijo živeti bolj zdravo in varneje, kjerkoli in kdorkoli so, in imeti več zaupanja v proizvode in storitve, ki jih uporabljajo. Prav tako želijo sodelovati pri odločitvah, ki vplivajo na njihovo zdravje in potrošniške interese. EU, nacionalni in regionalni organi, podjetja in civilna družba, vsi morajo delovati posamezno, da bi odgovorili na te skrbi, vendar obstajajo skupni izzivi na področju zdravja in varstva potrošnikov, ki se lahko rešijo le z ukrepi na ravni EU.

To sporočilo opisuje, kako namerava EU izboljšati zaupanje na področju zdravja in varstva potrošnikov z uporabo določb Pogodbe[1]. Tako bo pripomoglo približati Evropo njenim državljanom in k izboljševanju njene konkurenčnosti. Boljše zdravje prispeva k evropski produktivnosti, stopnji delovne aktivnosti in trajnostni rasti. Slabo zdravje zvišuje stroške in je breme za gospodarstvo. Nasprotno pa bo doseganje notranjega trga blaga in storitev, ki ustreza potrebam in zahtevam potrošnikov, izboljšalo konkurenčnost.

1.2. Zakaj skupni pristop?

To sporočilo in priloženi predlog programa združujeta politiko in programe javnega zdravja in varstva potrošnikov v enoten okvir, da bi politika EU delovala bolje za državljane. Mnogi cilji na področju zdravja in varstva potrošnikov v členih 152 in 153 Pogodbe so skupni: krepitev varovanja zdravja, informiranja in izobraževanja, varnost in vključevanje zadev na področju zdravja in varstva potrošnikov v vse politike. Politike na področju zdravja in varstva potrošnikov za doseganje svojih ciljev prav tako uporabljajo mnoge podobne vrste ukrepov : npr. obveščanje državljanov, posvetovanje z interesnimi skupinami, ukrepi za enake možnosti, ocene tveganja. Spajanje teh dveh področij bo tako vodilo k večji skladnosti politike, ekonomiji obsega in večji preglednosti.

Nenazadnje bo skupni program zagotovil prihranke in sinergije v smislu enotnih upravnih in proračunskih postopkov, skupnih orodij in skupne izvajalske agencije.

Z izkoriščanjem sinergij bo program ohranjal in razvijal temeljne posebnosti ukrepov na področju zdravja in varstva potrošnikov, da bi se lahko odzvali na težave interesnih skupin.

2. Bolj zdravi, varnejši in zadovoljnejši državljani Evrope

Cilj politike EU na področju zdravja in varstva potrošnikov je izboljšanje kakovosti življenja državljanov EU v smislu njihovih zdravstvenih in potrošniških interesov. Na področju zdravja se bo napredek ocenjeval s strukturnim kazalcem let zdravega življenja (Healthy Life Years–HLY) pričakovano število let, ki jih človek preživi pri dobrem zdravju) in s kazalci zdravja ES. Na področju politike varstva potrošnikov je v pripravi vrsta kazalcev.

2.1. Skupni cilji politik zdravja in varstva potrošnikov

Politiki zdravja in varstva potrošnikov ES imajo tri glavne skupne cilje:

1. varstvo državljanov pred nevarnostmi in tveganji, ki so izven nadzora posameznika in ki jih ena sama država članica ne more uspešno rešiti (npr. nevarnosti za zdravje, nevarni proizvodi, nepošteno poslovno ravnanje);

2. povečanje sposobnosti državljanov za sprejemanje boljših odločitev o lastnih interesih na področju zdravja in varstva potrošnikov;

3. vključevanje ciljev politik zdravja in varstva potrošnikov v vse politike Skupnosti, da se postavi vprašanja zdravja in varstva potrošnikov v središče oblikovanja politike.

2.2. Skupni ukrepi

Obstaja več področij sinergije med politikama zdravja in varstva potrošnikov EU in s tem veliko prostora za dopolnilne ukrepe, kot so:

( izboljšanje komunikacije z državljani v smislu zagotavljanja informacij, ki jih potrebujejo v zvezi s svojimi interesi na področju zdravja in varstva potrošnikov in odzivanjem na njihove težave z boljšim oblikovanjem politike, npr. organiziranjem spletnih portalov, kampanj za ozaveščanje, anket, konferenc in informacijskih točk;

( povečanje sodelovanja potrošnikov in zdravstvenih organizacij pri oblikovanju politik EU, npr. s promocijo njihovega povezovanja, posvetovanja s širšo javnostjo in boljšo zastopanostjo v posvetovalnih organih. Zdravstvene organizacije in organizacije za varstvo potrošnikov potrebujejo aktivne, strokovne in jasne glasove. Še vedno obstaja pomanjkanje verodostojnega potrošniškega gibanja v EU in potreba po okrepitvi zdravstvenih mrež;

( razvoj pristopa Komisije za vključevanje vprašanj zdravja in varstva potrošnikov v druge politike in posredovanje najboljših praks drugim državam članicam. Na področju zdravja bosta razvita sistem ocenjevanja vpliva na zdravje (Health Impact Assessment) in sinergije, ustvarjene s politikami, kot so varnost hrane, socialna politika, okolje, carine, raziskave in regionalna politika. Na področju varstva potrošnikov so najpomembnejše politike, ki uravnavajo trge ali pravice državljanov (npr. avtorske pravice, dostop do pravnega varstva), konkurenčnost, službe splošnega interesa, standardizacija in informacijska družba.

( povečanje znanstvenega svetovanja in strokovnega ocenjevanja tveganj, npr. s pospeševanjem zgodnjega odkrivanja tveganj; analize njihovih možnih vplivov; izmenjave informacij o nevarnostih in izpostavljenosti; pospeševanje usklajenih pristopov k ocenjevanju tveganj in podpiranje usposabljanja ocenjevalcev;

( pospeševanje varnosti proizvodov in snovi človeškega izvora (kri, tkiva in celice), npr. z izmenjavo najboljših praks, dviganjem ozaveščenosti, navodil za izvajanje, usposabljanje in povezovanje, nadzor in razvoj standardov;

( pospeševanje mednarodnega sodelovanja z mednarodnimi organizacijami in tretjimi državami na področju zdravja in varstva potrošnikov. EU mora igrati pomembnejšo vlogo na področju mednarodnega zdravja, npr. s krepitvijo sodelovanja z WHO in OECD in s podpiranjem tretjih držav pri velikih zdravstvenih tveganjih, posebej držav kandidatk in sosednjih držav ter Zahodnega Balkana. Na področju potrošniških zadev je potrebno mednarodno regulativno sodelovanje, npr. glede varnosti proizvodov in obravnavanja prekupčevalcev.

Predlagani proračun za program je 1203 milijone EUR, kar predstavlja znatno povišanje glede na trenutne izdatke. Izvajalska agencija , ustanovljena s Programom javnega zdravja[2], bo razširjena v podporo novemu programu (glej Prilogo 1).

3. Bolj zdravi evropski državljani

3.1. Kje smo?

Zdravje je osnovna človekova pravica. Izboljšanje zdravja Evropejcev je osnovni cilj vseh zdravstvenih dejavnosti, ki izhajajo iz Pogodbe.

Državljani EU živijo dlje in so boljšega zdravja kot kdajkoli prej. Kljub temu se Evropa sooča z resnimi zdravstvenimi izzivi, ki zahtevajo odziv na ravni EU.

Odprto posvetovanje o zdravju je pokazalo na potrebo po pospešitvi ukrepov EU[3], npr. vključevanje zdravja v splošno politiko, obvladovanje dejavnikov zdravja, preprečevanje bolezni, naložbe v zdravstveno raziskovanje, izboljšanje obveščanja, reševanje neenakosti, izboljševanje mednarodnega sodelovanja, vključevanje interesnih skupin v oblikovanje politike in potreba po večjih sredstvih. Ocena zdravstvenih programov 1996 - 2002[4] vsebuje priporočilo za osredotočanje na preprečevanje, širjenje informacij ter izmenjavo znanja.

Prvič, znotraj držav članic in med njimi obstajajo za velike neenakosti glede pričakovane življenjske dobe, zdravstvenega stanja in dostopa do zdravstvene oskrbe. To vodi do neenakosti pri rasti in konkurenčnosti. Zdravje prispeva k produktivnosti, stopnji delovne aktivnosti in gospodarski rasti. Ukrepi s stroškovno učinkovitostjo in naložbe v preprečevanje so zato potrebne za izboljšanje zdravja in gospodarstva. To so zaključki Lizbonskega procesa, kjer je bilo prav tako poudarjeno, da bo „velik izziv znižati znatne razlike med državami članicami, kar zadeva pričakovano dolžino življenja, razširjenost hudih bolezni in zdravstveno zmožnost. Modernizacija zdravstvenega sektorja (…) lahko občutno pripomore k ohranitvi delovne moči“ [5] . EU lahko pripomore k premoščanju zdravstvene vrzeli in k definiranju zdravja kot faktorja konkurenčnosti, npr. s širjenjem ozaveščenosti, zbiranjem in širjenjem dokaznega materiala in dobrimi praksami.

Poročilo za spomladansko zasedanje Sveta poudarja, da je dvigovanje let zdravega življenja (Healthy Life Years–HLY) osrednjega pomena za privabljanje večjega števila ljudi k zaposlovanju[6]. Zviševanje let zdravega življenja s preprečevanjem bolezni in spodbujanjem aktivnega staranja je pomembno za trajnost javnih financ, ki so preobremenjene zaradi vedno večjih stroškov zdravstvenega in socialnega varstva, saj se obremenitev veča s staranjem prebivalstva in zmanjševanjem deleža delovno sposobnega prebivalstva.

Soočanje z izzivi, ki so posledica neenakosti na področju zdravstva in staranja, zahteva vrsto medsektorskih ukrepov. Tudi povečanje zadevnih otroških bolezni, npr. debelosti, zahteva posebno osredotočanje na spodbujanje zdravja otrok.

Neenakosti na področju zdravstva , staranje in zdravje otrok so tako glavne teme vseh zdravstvenih ukrepov trenutnega programa.

Drugič, nauki, pridobljeni ob globalnih zdravstvenih nevarnostih, kot je ptičja gripa, kažejo na potrebo po večji zmogljivosti EU za varovanje svojih državljanov pred nevarnostmi, ki zahtevajo usklajen odziv, vključno z biološkim terorizmom. V skladu s Strateškimi cilji za leta 2005 - 2009[7] ki poudarjajo pomembnost boja proti nevarnostim za zdravje državljanov in varnosti na ravni EU, Komisija predlaga, da se v program vključi nov element za odzive na nevarnosti.

Tretjič, države članice se soočajo s skupnimi izzivi, ki zahtevajo spodbujanje zdravja in preprečevanje bolezni . Vedno večje breme bolezni, ki se jim je mogoče izogniti in so povezane z načinom življenja in odvisnostmi (npr. tobak, alkohol, uporaba drog, prehrana), bolezni kot so HIV in duševne bolezni, zahteva ukrepe na ravni EU. Da bi se lažje spoprijeli s temi izzivi, je treba utrditi področje dejavnikov zdravja in jih dopolniti z novim področjem preprečevanja bolezni. Četrtič, EU lahko pomaga pri odzivu zdravstvenih sistemov na izzive, s katerimi se soočajo. Lizbonski proces je pokazal, da lahko pomoč EU zdravstvenim sistemom ustvari pomembno dodano vrednost. Zato je bilo predlagano novo področje sodelovanja zdravstvenih sistemov.

Petič, zdravstvena politika mora temeljiti na trdnih podatkih. Obstoječe področje informiranja bo razširjeno, z večjim poudarkom na analizi in obveščanju državljanov.

Šestič, zdravstvene politike bodo oblikovane ob tesnejšem sodelovanju z državljani in interesnimi skupinami, npr. z zagotavljanjem podpore za razvoj organizacij za zastopanje bolnikovih interesov ali organizacij, ki pripomorejo k pospeševanju zdravstvenega načrta.

Program tako krepi tri področja Programa javnega zdravja (obveščanje, nevarnosti in dejavnike) ter ustvarja tri nova: odziv na nevarnosti, preprečevanje bolezni in sodelovanje med zdravstvenimi sistemi.

3.2. Kateri je naslednji korak?

EU si bo prizadevala izboljšati zdravje državljanov v njihovem celotnem življenjskem obdobju, krepiti zdravje kot človekovo pravico in spodbuditi naložbe v zdravje z izpolnjevanjem naslednjih ciljev.

Prvič, varovati državljane pred zdravstvenimi nevarnostmi.

Drugič, pospeševati politike, ki prispevajo k bolj zdravemu načinu življenja.

Tretjič, prispevati k znižanju pojavnosti hudih bolezni v EU.

Četrtič, prispevati k razvoju bolj učinkovitih zdravstvenih sistemov.

Petič, podpirati zgornje cilje z zagotavljanjem zdravstvenih podatkov in analiz.

Predvidena so naslednja področja ukrepov. Priloga II k priloženemu predlogu sklepa določa izčrpni seznam ukrepov, načrtovanih za vsako področje.

3.2.1. Krepitev spremljanja in obvladovanja zdravstvenih nevarnosti

Varovanje državljanov EU pred zdravstvenimi nevarnostmi je obveznost, ki izhaja iz Pogodbe. Ustanovitev Evropskega centra za preprečevanje in obvladovanje bolezni (European centre for Disease Prevention and control–ECDC)[8] je ključni korak. Center bo izvajal analize in svetovanja glede nevarnosti prenosljivih bolezni in krepil zmogljivosti. Ukrepi iz Programa in dejavnosti ECDC se bodo dopolnjevali in tako pospeševali prizadevanja držav članic. Center bo prav tako podpiral delo mednarodnih organizacij na področju obvladovanja prenosljivih bolezni.

Program bo zajemal spremljanje in obvladovanje nevarnosti, ki ne spadajo v obseg dela ECDC, v povezavi s „področjem obveščanja“, posebej o fizikalnih in kemičnih sredstvih; pretvoril raziskave v praktične metodologije; in izvajal odločbo, ki vzpostavlja mrežo EU za spremljanje[9], direktive o krvi, tkivih in celicah, ter politike cepljenja. Za razvoj diagnostičnih zmogljivosti EU za patogene je potrebna struktura evropskih referenčnih laboratorijev za redke povzročitelje bolezni ali povzročitelje bolezni z visokim tveganjem. Določena bodo merila za ocenjevanje delovanja teh laboratorijev. Nazadnje, cilj ukrepov je, da države članice izboljšajo izvajanje mednarodnih zdravstvenih predpisov s strani.

3.2.2. Odzivanje na zdravstvene nevarnosti (novo področje)

Za učinkovito varstvo svojih državljanov potrebuje EU tehnične in operativne zmogljivosti za pripravljenost in odzivanje na zdravstvene nevarnosti. Zmogljivosti so potrebne za odzivanje na zdravstvene nevarnosti, ki se pojavijo zaradi nekega dogodka (znotraj ali zunaj EU), da bi kar najbolj zmanjšali vpliv na EU.

Delo na tem področju programa bo pospešilo učinkovitost nacionalnih struktur in virov s pomočjo ukrepov za izboljšanje obvladovanja tveganja in načrtov za primere izrednega zdravstvenega stanja; olajšalo obveščanje in nadaljnje sporazumevanje in usklajevanje ukrepov v primerih izrednih zdravstvenih razmer; izboljšalo pripravljenost in sposobnost posredovanja v primeru izrednih zdravstvenih razmer z osredotočanjem na konkretne mehanizme in zagotavljanje zdravstvenih sredstev; spodbujalo povezovanje v mreže in izmenjave strokovnih znanj in najboljših praks.

Tako bodo države članice lažje razvile lastno infrastrukturo, zmogljivosti in sistem usklajevanja, ki so potrebni za odzivanje na nevarnost, npr. vzpostavljanje mrež, usposabljanje strokovnjakov in razvijanje predvidevanja možnih dogodkov. Razen tega, naravne nesreče ali nesreče, ki jih povzroči človek, z zdravstvenimi posledicami zahtevajo npr. napotitev zdravstvenih strokovnjakov in odpošiljanje medicinske opreme. To vključuje načrtovanje in usklajevalne mehanizme za mobilizacijo, razmestitev in uporabo zdravstvenih virov v primeru izrednih zdravstvenih razmer ali kriz.

3.2.3. Spodbujanje zdravja z obravnavanjem dejavnikov zdravja

Spodbujanje dobrega zdravja zahteva tako spopadanje z dejavniki načina življenja in odvisnosti, ki škodljivo vplivajo na zdravje (npr. kajenje, alkohol, nezdrava prehrana), kot tudi s širšimi socialno-ekonomskimi in okoljskimi dejavniki zdravja. Celoten pristop k doseganju tega cilja sestavlja vrsta strategij Skupnosti za reševanje najpomembnejših dejavnikov, kot so prehrana in debelost, prekomerno uživanje alkohola, kajenje tobaka in uživanje drog[10], kot tudi HIV/AIDS[11] in reproduktivno zdravje. Socialno-ekonomski dejavniki, kot so revščina in delovni pogoji, bodo obravnavani z ukrepi za širjenje najboljših praks in za obravnavanje vprašanj neenakosti na področju zdravstva in drugih politik. Okoljski ukrepi bodo temeljili na Akcijskem načrtu za okolje in zdravje 2004 - 2010 in se bodo osredotočali na kakovost zraka v zaprtih prostorih, tobačni dim v okolju in zdravstvene posledice, ki so povezane z okoljem.

Ker veliko težav izvira iz otroštva, bo uporabljen pristop življenjskega cikla, da bi se osredotočili na zdravje mladih ljudi. Nadalje bodo predlagani ukrepi za omejitev vplivov staranja na zdravje in zdravstveno varstvo.

Komisija bo razvila tematske platforme, ki bodo združevale države članice in interesne skupine in različne ukrepe v zvezi s posameznimi dejavniki.

3.2.4. Preprečevanje bolezni in poškodb (novo področje)

Nekatere bolezni, vključno z duševnimi boleznimi, rakom in boleznimi srca in ožilja, predstavljajo velik del bremena bolezni na ravni EU. Ukrepe v zvezi z dejavniki morajo dopolnjevati ukrepi za obravnavanje takih bolezni, če to prinaša dodano vrednost ali če so zaradi učinkovitosti potrebni čezmejni ukrepi, kot npr. pri redkih boleznih. Ukrepi vključujejo podporo za sekundarno preprečevanje, npr. pregledi in zgodnje odkrivanje z izmenjavo dobrih praks, platformami, študijami in povezovanjem v mreže. Predvidene so sinergije s 7. okvirnim programom za raziskave.

Da bi pripomogli k zmanjšanju nesreč in poškodb, bodo predlagani preprečevalni ukrepi, kampanje in strategija, ki se bodo osredotočali na posamezne skupine in situacije tveganja.

3.2.5. Doseganje sinergij med nacionalnimi zdravstvenimi sistemi (novo področje)

Zdravstvene storitve spadajo v glavnem na področje odgovornosti držav članic, vendar lahko sodelovanje na ravni EU pacientom in zdravstvenim sistemom pomaga pri soočanju s skupnimi izzivi, npr. zdravstvena predplačila, staranje, mobilnost pacientov in zaposlenih. Komisija omogoča sodelovanje v okviru srečanj Skupine na visoki ravni o zdravstvenih storitvah in zdravstvenem varstvu in odprte metode usklajevanja[12]. Učinkovito sodelovanje zahteva vire, npr. za vzpostavitev in upravljanje mrež in izvajanje analiz.

Podpora Skupnosti naj bi vključevala omogočanje čezmejnega zagotavljanja zdravstvenega varstva, izmenjavo podatkov, spodbujanje varnosti pacientov, podporo za vzpostavitev sistema EU za referenčne centre in zagotavljanje podatkov o zdravstvenih storitvah. Prišlo bo do dopolnjevanj s 7. okvirnim programom za raziskave in z akcijskim načrtom za e-Zdravstvo.

3.2.6. Pridobivanje in širjenje večje količine in bolj kakovostnih zdravstvenih informacij državljanom, zdravstvenim strokovnjakom in oblikovalcem politik

Za zbiranje, analizo in širjenje primerljivih in zanesljivih zdravstvenih informacij državljanom in oblikovalcem politik je potrebna baza znanja na ravni celotne EU. Zbiranje in širjenje bolj kakovostnih zdravstvenih informacij pomeni razširjanje obstoječega dela, da bi razvili sistem EU za spremljanje zdravja, ki se vključuje v vse zdravstvene dejavnosti, ob možni uporabi Statističnega programa Skupnosti.

Izvajanje tega cilja pomeni razvoj obstoječih kazalcev in novih orodij za zbiranje podatkov, evropske zdravstvene ankete, več obveščanja državljanov s pomočjo zdravstvenih portalov EU, kampanj, ki so usmerjene na mlade ljudi, povezovanje v mreže in obveščanje o redkih boleznih. Ta cilj vključuje tudi pospeševanje zdravstvenih analiz in podporo orodjem e-Zdravstva.

4. PRIBLIžEVANJE EVROPSKEMU TRGU ZA EVROPSKE POTROšNIKE

4.1. Kje smo?

Doseženo je bilo boljše razumevanje zaupanja potrošnikov kot osnovne tržne zahteve, vendar to vprašanje ni bilo zadostno obravnavano in vključeno v vsa področja politik Skupnosti.

Države članice dajejo zdaj več prednosti varstvu potrošnikov. Podjetja prepoznavajo vrednost evropskih predpisov na področju varstva potrošnikov za boljši razvoj notranjega trga, pospeševanja zaupanja potrošnikov in izključevanja prekupčevalcev. Pomembnost močnega, zanesljivega potrošnika je nesporna.

Kot kažejo ocene vplivov, potrebujemo več napredka na področjih, ki so določeni kot prednostni za potrošniško politiko. Naši trenutni cilji: Še zmeraj so pomembni visoka skupna raven varstva potrošnikov, natančno izvajanje predpisov in močnejši glas potrošnikov pri oblikovanju politik, kot tudi cilj vključevanja interesov potrošnikov v druge politike. Kljub nedavnemu napredku pa ostaja pridobivanje podatkov za razumevanje težav in potreb potrošnikov še zmeraj izziv.

Tržno vključevanje vodi k ekonomskim koristim za potrošnika (večja izbira blaga in storitev, konkurenčnost, ki temelji na kakovosti, nižje cene, višji življenjski standard). Politike notranjega trga morajo zagotavljati, da se te koristi uresničujejo, vključno s kakovostjo blaga in storitev in njihovo dostopnostjo ter vključenostjo potrošnikov. Notranji trg brez zaupanja potrošnikov ne more pravilno delovati.Za rast in konkurenčnost je nujno primerno varstvo potrošnikov.

4.2. Kateri je naslednji korak?

Potrošniška politika mora slediti razvoju. Izzivi, s katerimi se sooča potrošniška politika…

Kot so:

( staranje prebivalstva kot tudi potreba po vključevanju (posebej v kontekstu informacijske družbe) glede na posebne potrebe. To vključuje težave glede varnosti blaga in storitev, nezaščitenost pred goljufijami in prekupčevalci, enostaven dostop do osnovnega blaga in storitev;

( izzivi, s katerimi se soočajo vsi potrošniki zaradi bolj kompleksnih in zapletenih modernih trgov, ki omogočajo večjo izbiro, ampak prinašajo tudi večja tveganja, vključno s kriminalom;

( omogočanje čezmejnega nakupovanja z odstranitvijo ostalih ovir, ki ovirajo dokončno oblikovanje notranjega trga za maloprodajo;

( izziv glede izboljšanja uporabe in izvajanja predpisov, zlasti čez mejo.

…zahtevajo dodatni trud in nove zamisli, ki bodo obravnavani z ukrepi na naslednjih dveh prednostnih področjih:

( zagotavljanje visoke skupne ravni varstva vseh potrošnikov EU, kjerkoli v EU živijo, potujejo ali kupujejo, pred nevarnostmi in tveganji za njihovo varnost in ekonomske interese;

( povečanje zmogljivosti potrošnikov za spodbujanje svojih lastnih interesov, npr. pomoč potrošnikom za samopomoč.

Evropski institut za potrošnike, ustanovljen v okviru enotne izvajalske agencije programa, bo temelj za izvajanje teh ukrepov (glej Prilogo 1).

Predvidena so štiri področja ukrepov:

4.2.1. Boljše razumevanje potrošnikov in trgov

To vključuje:

( razvoj in posodabljanje baze znanstvenega znanja in orodij za ocenjevanje izpostavljenosti potrošnikov kemikalijam, vključno z upoštevanjem splošne varnosti proizvodov in prispevanje k uporabi sistema REACH;

( razvoj primerljivih kazalcev in mejnih vrednosti potrošniške politike: merjenje uspešnosti trga z rezultati za potrošnika, npr. cene, raven čezmejnih nakupov vrste podjetje - potrošniku, čezmejno trženje, goljufanje potrošnikov, nesreče in poškodbe, pritožbe potrošnikov – s posebnim poudarkom na storitvah splošnega interesa;

( poglabljanje znanja o zahtevah potrošnikov, njihovem obnašanju in medsebojnem delovanju s podjetji in o vplivih predpisov na trg, npr. z obdelavo podatkov, ki je na voljo potrošnikom in oceno zadovoljstva potrošnikov z uporabo Statističnega programa Skupnosti.

Nekatere od teh nalog lahko sovpadajo s 7. okvirnim programom za raziskave.

4.2.2. Boljši predpisi na področju varstva potrošnikov

To vključuje:

( zaključek pregleda direktiv o potrošniškem pravu, razvoj skupnega referenčnega okvira za evropsko pogodbeno pravo;

( analizo varnostnih vidikov vedno večjega čezmejnega trga storitev, celostno analizo direktive o splošni varnosti proizvodov in bolj sistematično uporabo standardov;

( boljše razumevanje nacionalnih potrošniških politik: ugotavljanje in spodbujanje najboljših praks, postavljanje mejnih vrednosti in priporočil, usposabljanje oblikovalcev politik in izvajalcev;

( raziskave o vključevanju interesov potrošnikov pri standardizaciji, ugotavljanje potreb po izboljšavah;

( zagotavljanje sodelovanja potrošnikov pri oblikovanju politike EU, podpiranje učinkovitih potrošniških organizacij na ravni EU in njihovega sodelovanja v posvetovalnih organih, skupinskih forumih in strokovnih odborih.

4.2.3. Boljše izvajanje, spremljanje in pravna sredstva

To vključuje:

( krepitev čezmejnega izvajanja zadevnih predpisov in usklajevanje dela vseh akterjev, posebej carinskih organov, tudi na področju splošne varnosti proizvodov, sistema RAPEX (sistem Skupnosti za hitro izmenjavo informacij) in ob upoštevanju mednarodnih dimenzij;

( izboljšanje prenosa in izvajanja direktiv EU z osredotočanjem virov na spremljanje prenosa in izvajanja, da bi zagotovili konsistentnost tolmačenja;

( izboljšanje zmožnosti potrošniških organizacij pri podpiranju potrošnikov, delovanje v smislu sistema zgodnjega opozarjanja, da bi odkrili prekupčevalce in spremljali nacionalne politike;

( izboljšanje pravnih sredstev, ki so na voljo potrošnikom, predvsem pri čezmejnih primerih, vključno z dostopom do alternativnega reševanja sporov, razvoj mreže evropskih centrov za potrošnike.

4.2.4. Bolje obveščeni in poučeni potrošniki

To vključuje:

( obveščanje potrošnikov, skupaj z državami članicami, npr. o pravicah in pravnih sredstvih. To vključuje primerjalne teste, primerjave cen in večjo zavest o ponudbah, ki so na voljo po celotni EU;

( razvijanje izobraževanja potrošnikov in nadgradnja pilotnega dela na področju izobraževanja, ki je bilo opravljeno doslej, sodelovanje z nacionalnimi organi pri podpiranju dejavnosti izobraževanja potrošnikov, ki vključujejo evropsko dimenzijo in ukrepov, namenjenih mladim potrošnikom;

( zagotavljanje, da lahko potrošniki na podlagi boljše obveščenosti sprejemajo okoljsko in družbeno odgovorne odločitve o hrani in najbolj ugodnih proizvodih in storitvah, odločitve, ki najbolje ustrezajo ciljem njihovega načina življenja, ter tako razvijajo zaupanje;

( razvijanje zmogljivosti potrošniških organizacij: usposabljanje za pridobitev veščin, znanja, sposobnosti povezovanja in združevanja prizadevanj.

Ocena vplivov kaže potrebo po večjem številu ukrepov in bolj trajnostnih ukrepih na vseh teh področjih. To zahteva več sredstev, kot jih je trenutno na razpolago.

Razvijanje baze znanja, npr. o škodah, storjenih potrošnikom varnosti storitev, zadovoljstvu in zaupanju potrošnikov do trga, do storitev splošnega interesa, ali o informacijski družbi, zahteva hitro nadgradnjo na področju raziskav, ki so bile opravljene doslej.

Usposabljanje za potrošniške organizacije in obveščanje državljanov zahtevata trajnostne napore, ki presegajo sredstva, ki so trenutno na razpolago. Pospeševanje sodelovanja, vključno z razvijanjem mrež, in usposabljanje izvajalcev, da bi zagotovili najboljše izvajanje in čezmejno uveljavljanje na kraju samem, je nujno potrebno, vendar ima svojo ceno. Neprekinjeni napori pri podpiranju potrošniških organizacij zahtevajo dodatna sredstva v razširjeni EU. Za nadaljevanje strategije 2002 - 2007 in za soočanje z opisanimi izzivi so potrebna finančna sredstva, ki v veliki meri presegajo finančna sredstva, ki so trenutno na voljo.

Izvajanje programa in upravljanje s temi dodatnimi viri zahteva učinkovito in strukturirano organizacijo. Razširitev izvajalske zdravstvene agencije, ki bi vključevala oddelek za potrošnike, je stroškovno najbolj učinkovita rešitev.

5. ZAKLJUčEK

Opisani predlogi predstavljajo za EU velik projekt. Predlogi nadgrajujejo delo, opravljeno na področju zdravja in varstva potrošnikov in omogočajo vzpostavljanje novih povezav ter tako ustvarjajo sinergije. Tako se bo izboljšala učinkovitost ukrepov EU in jih naredila bolj vidne. Še pomembnejše pa je dejstvo, da so zdravstveni in potrošniški interesi v središču vsakdanjega življenja ljudi. S postavitvijo zadevnih vprašanj v središče in s predlogi za konkretne ukrepe, ki bodo odgovorili na potrebe in skrbi potrošnikov, bo ta program pripomogel k osredotočanju na državljane pri oblikovanju politik in ponovno povezal EU z njenimi državljani.

PRILOGA 1: The Executive agency of the joint Health and Consumer Programme

To implement the joint Health and Consumer programme, the Commission will be assisted by one single executive agency, which will consist of an extended version of the existing Public Health Programme’s executive agency encompassing the “Consumer Institute”.

To this end, the Commission will propose a modification to Commission Decision 2004/858 of 15 December 2004 creating the Executive agency for the Public Health Programme in order to enlarge its scope of action to supporting the operation of the whole new joint programme.

Without prejudice to this future Decision, it is envisaged that the agency would be organised in two “departments”: the “Health Department” and the “Consumer Institute”. Common actions would be managed jointly by the “two departments”.

The scope of action of the Public Health Programme executive agency created by Decision 2004/858 is limited to “ implementing tasks concerning Community aid under the programme, except for programme evaluation, monitoring of legislation or any other actions which could come under the exclusive competence of the Commission ”. In particular, the agency manages specific projects, deals with procedures linked to the award of contracts and grants and provides “ logistic, scientific and technical support in particular by organising meetings, preparatory studies, seminars and conferences ”.

The “Consumer Institute” part of the agency is intended to support the Commission in carrying out the financial and administrative work on all consumer policy actions envisaged in the Health and Consumer protection Strategy. This would include the organisation of calls for tender and data collection and related work to bolster research and data collection; organisation and practical day-to-day running of programmes to educate and train Member State experts, consumer organisations and their experts; and the dissemination of data and information. The Consumer Institute should actively seek co-operation with other Community bodies and programmes, and notably the Joint Research Centre and the Statistical Office of the European Communities with a view to reinforce synergies in all relevant areas of consumer protection (e.g. exposure, consumer safety, method validation).

As is the case with all executive agencies, the Commission will remain in charge of all policy decisions related to defining and managing policy priorities and action, including the definition of the annual work plan (following the procedure specified in the draft Decision of the European Parliament and of the Council establishing a programme of Community action in the field of health and consumer protection (2007-2013). This would enable the Commission services to focus on policy-related tasks.

PRILOGA 2: Examples of Policy areas and issues where synergies with health and consumer policies can be developed further

Policies | Issues and programmes where synergies should be developed further |

Safety of the food chain | Labelling, alert mechanisms, inspection and control Synergies with Research, Transport, Environment, Agriculture, Education, action on nutrition |

Social policy | Social policy agenda Social security benefits: Regulation 1408/71 and related regulations; European Health Insurance Card Social protection: Open Method of Co-ordination in Health care and long-term care services (within OMC for Social Inclusion and Protection) European Social Fund (ESF) projects to train health professionals Social and health services of general interest Health and safety at work |

Research | Health and consumer research in the 7th framework programme for Research (theme Health research of FP7) Closer co-operation to be built with the Research programme, in particular as regards the following strands of the Health and Consumer programme: “Promote health by tackling determinants”, “Prevent diseases and injuries” (including research on infectious diseases); “Synergies between national health systems”. |

Environment | Environment and Health action plan 2004-2010 |

Information society and Media | eHealth Action Plan (eHealth applications, eHealth conferences) e-communication and consumer rights (Services of General Interest) e-Inclusion and citizenship i2010 – A European Information Society for growth and employment eAccessibility (Policy and Research activities) |

Regional policy | Solidarity Fund Health under the Structural Funds’ new convergence objective 2007-13 Health as a driver of regional development/health infrastructure projects |

Economic policy | Work on long-term budgetary projections of healthcare costs Work with OECD on health studies Macro-economic trends affecting consumer confidence Health and consumer policies as drivers of competitiveness |

Enterprise Policy | Follow-up to the G10 medicines process and implementing the G10 recommendations Joint action on pharmaceuticals and medical devices REACH Pedestrian safety Cosmetics Consumer interests in standardisation |

Internal Market | Services in the Internal Market Recognition of professional qualifications Health insurance Retail financial services Postal services and Services of General Interest Data on consumers in the Internal Market Consumer detriment E-commerce directive |

Transport | European Road Safety Action Programme Transport of dangerous goods Passenger Rights |

Energy | Radiation protection Policy Liberalisation, consumer rights and safety |

Competition | Health services markets Consumer benefits and detriment |

Trade | Position of health services within trade negotiations TRIPS, anti-retroviral drugs, trade in tobacco products Integration of consumer views in the WTO, including the GATS Regulatory dialogues |

External policy | Co-operation with neighbourhood countries |

Development and Aid policies | Action to confront HIV/AIDS, Malaria and Tuberculosis (external action). Shortages of health personnel in developing countries Promotion of civil society input |

Enlargement | Promotion of convergence with the EU acquis on Health and Consumer protection Promotion of economic and social cohesion Strengthening public administrations and institutions in the fields of Health and Consumer protection |

Taxation and Customs Union | Taxes and duties on specific products relevant to health and consumers Custom policies (ensuring provisions on health and safety for third countries’ products entering the EU) |

Agriculture | Quality policy Cross compliance rural development programmes |

Education / Culture | Youth programme, sports/promotion of physical activity Life-long learning, consumer education |

Statistical Programme | Statistics on health, health determinants, health services and food safety Statistics on consumer protection including buying patterns, price comparisons and price convergence for goods and services |

Justice, Freedom and Security | Access to Justice International private law and mediation Action on Drugs abuse: EU Drugs Strategy (2005-2012) and the EU Action Plan on Drugs (2005-2008). Enhancing consumer awareness of crime risks associated with products and services (“crime proofing”) Bioterrorism Trafficking in Human Organs Data protection |

Horizontal policies

Better regulation EU communication Strategy Services of General Interest | Full involvement of health and consumer representatives in the EU policy process Communication strategy includes health and consumer interests Consumer rights in SGIs |

2005/0042 (COD)

Predlog

SKLEP EVROPSKEGA PARLAMENTA IN SVETA

o vzpostavitvi programa ukrepov Skupnosti na področju zdravja in varstva potrošnikov (2007 - 2013)

Besedilo velja za EGP

EVROPSKI PARLAMENT IN SVET EVROPSKE UNIJE STA –

ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti in zlasti členov 152 in 153 Pogodbe,

ob upoštevanju predloga Komisije[13],

ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora[14],

ob upoštevanju mnenja Odbora regij[15],

v skladu s postopkom iz člena 251 Pogodbe[16],

ob upoštevanju naslednjega:

(1) Skupnost lahko prispeva k varovanju zdravja, varnosti in ekonomskih interesov državljanov s pomočjo ukrepov na področju javnega zdravja in varstva potrošnikov.

(2) Zato je primerno, da se ustanovi program ukrepov Skupnosti na področju zdravja in varstva potrošnikov, ki bo nadomestil Sklep 1786/2002/ES Evropskega parlamenta in Sveta z dne 23. septembra 2002 o sprejetju programa ukrepov Skupnosti na področju javnega zdravja (2003 - 2008)[17] in Sklep 20/2004/ES Evropskega parlamenta in Sveta z dne 8. decembra o uvedbi splošnega okvira za financiranje ukrepov Skupnosti v podporo potrošniški politiki v letih 2004 do 2007[18]. Ta sklepa je zato treba razveljaviti.

(3) Enotni združeni program bo ohranil bistvene elemente in posebnosti ukrepov na področju zdravja in varstva potrošnikov, hkrati pa bo omogočil kar največje sinergije ciljev in učinkovitost pri upravljanju ukrepov na teh področjih. Povezovanje aktivnosti na področjih zdravja in varstva potrošnikov v en sam program bo pripomoglo k izpolnjevanju skupnih ciljev varovanja državljanov pred tveganji in nevarnostmi, zviševanju sposobnosti državljanov za pridobitev znanja in možnosti odločanja v njihovem lastnem interesu ter vključevanju zdravstvenih in potrošniških ciljev v vse politike in dejavnosti Skupnosti. Združevanje upravnih struktur in sistemov naj bi omogočilo učinkovitejšo izvajanje programa in pripomoglo k najboljši porabi razpoložljivih virov Skupnosti za zdravje in varstvo potrošnikov.

(4) Politike na področju zdravja in varstva potrošnikov imajo skupne cilje, ki se nanašajo na varstvo pred tveganji, izboljšanje odločanja državljanov in vključevanje interesov zdravja in varstva potrošnikov v vse politike Skupnosti, kot tudi skupne instrumente, kot so stiki, izgradnja zmogljivosti za civilno družbo na področju vprašanj zdravja in varstva potrošnikov ter spodbujanje mednarodnega sodelovanja pri teh vprašanjih. Teme kot so prehrana in debelost, tobak in druge s potrošnjo povezane izbire, ki se odražajo v zdravju, so primeri prekrivajočih se vprašanj, ki vplivajo tako na zdravje kot tudi na varstvo potrošnikov. Skupni pristop k tem skupnim ciljem in instrumentom bo omogočil, da se bodo dejavnosti, ki so enake tako na področju zdravja kot tudi na področju varstva potrošnikov, izvajale učinkoviteje. Obstajajo tudi ločeni cilji, ki so povezani z enim izmed področij zdravja in varstva potrošnikov, ki se jih je treba lotiti z ukrepi in instrumenti, specifičnimi za vsako od teh področij.

(5) Usklajevanje z drugimi politikami in programi Skupnosti je ključni del skupnega cilja vključiti zdravje in varstvo potrošnikov v druge politike Skupnosti. Da bi spodbudili sinergije in se izognili podvajanju, je treba primerno izkoristiti druge sklade in programe Skupnosti, vključno z okvirnimi programi Skupnosti za raziskave in njihove rezultate, strukturnimi skladi in Statističnim programom Skupnosti.

(6) V splošnem evropskem interesu je, da so zdravje, varnost in ekonomski interesi državljanov, kot tudi interesi potrošnikov pri razvijanju standardov za proizvode in storitve, zastopani na ravni Skupnosti. Glavni cilji programa so lahko odvisni od obstoja specializiranih mrež, ki prav tako zahtevajo prispevke Skupnosti, da se razvijejo in delujejo. Glede na posebno naravo zadevnih organizacij in v nekaterih primerih posebnih služb, obnova podpore skupnosti za delovanje teh organizacij ni predmet načela postopnega zmanjševanja obsega pomoči Skupnosti.

(7) Izvajanje programa je treba graditi in razširjati na temeljih obstoječih ukrepov in strukturnih programov na področjih zdravja in varstva potrošnikov, vključno z izvajalsko agencijo za program javnega zdravja, ki jo ustanavlja Odločba komisije 2004/858/ES[19], ter jih razširjalo. Izvajanje mora potekati v tesnem sodelovanju s primernimi organizacijami in agencijami, posebej z Evropskim centrom za preprečevanje in obvladovanje bolezni[20], ki ga ustanavlja Uredba (ES) št. 851/2004 Evropskega parlamenta in Sveta.

(8) Ukrepe, ki so potrebni za izvajanje tega sklepa, je treba sprejeti v skladu z Odločbo Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil[21], ob spoštovanju potrebe po transparentnosti in primernem ravnotežju med različnimi cilji programa.

(9) Sporazum o Evropskem gospodarskem prostoru (v nadaljevanju Sporazum o EGP) določa sodelovanje na področjih zdravja in varstva potrošnikov med Evropsko skupnostjo in njenimi državami članicami na eni strani, ter državami Evropskega združenja za prosto trgovino (EFTA), ki sodelujejo v Evropskem gospodarskem prostoru (v nadaljevanju države EFTA/EGP), na drugi strani. Treba je določiti tudi, da mora biti program dostopen za sodelovanje drugih držav, zlasti sosedskih držav Skupnosti, držav, ki so zaprosile za članstvo, držav kandidatk ali držav pristopnic k članstvu v Skupnosti, zlasti zaradi upoštevanja možnih nevarnosti za zdravje, ki lahko izvirajo v drugih državah in imajo vpliv znotraj Skupnosti.

(10) Treba je omogočiti primerne odnose s tretjimi državami, ki ne sodelujejo pri programu, da bi laže dosegli cilje programa, in upoštevati vse zadevne sporazume med navedenimi državami in Skupnostjo. To lahko vključuje tretje države, ki izvajajo dejavnosti skupnega interesa, ki dopolnjujejo tiste, financirane v okviru tega programa, vendar ne vključuje finančnih prispevkov tega programa.

(11) Primerno je razviti sodelovanje z zadevnimi mednarodnimi organizacijami kot so Združeni narodi in njihove specializirane agencije, vključno z Svetovno zdravstveno organizacijo, kot tudi s Svetom Evrope in z Organizacijo za gospodarsko sodelovanje in razvoj (OECD), da bi se program izvajal s kar največjo učinkovitostjo ukrepov, ki se nanašajo na zdravje in varstvo potrošnikov na ravni Skupnosti in na mednarodni ravni, ob upoštevanju posebnih zmogljivosti in vlog različnih organizacij.

(12) Da bi povečali vrednost in vpliv programa, je treba izvajati redno spremljanje in ocenjevanje, skupaj z zunanjimi ocenami izvajanih ukrepov.

(13) Ker države članice zaradi transnacionalne narave zadevnih vprašanj ne morejo zadostno dosegati ciljev predvidenih ukrepov na področju zdravja in varstva potrošnikov, in zaradi možnosti, da bodo ukrepi Skupnosti za varovanje zdravja, varnosti in ekonomskih interesov državljanov bolj učinkoviti kot zgolj nacionalni ukrepi, lahko Skupnost sprejme ukrepe, v skladu z načelom subsidiarnosti iz člena 5 Pogodbe. V skladu z načelom sorazmernosti iz navedenega člena ta sklep ne presega nujnega za dosego teh ciljev.

(14) Komisija mora zagotoviti primerni prehod med tem programom in programoma, ki jih nadomešča, zlasti glede nadaljevanja večletnih ukrepov in struktur za upravno podporo, kot je Izvajalska agencija za Program javnega zdravja -

SKLENILA:

Člen 1

Vzpostavitev programa

S tem sklepom se vzpostavi program ukrepov Skupnosti na področju zdravja in varstva potrošnikov za obdobje od 1. januarja 2007 do 31. decembra 2013, v nadaljnjem besedilu „program“.

Člen 2

Namen in cilji

1. Program dopolnjuje in podpira politike držav članic in prispeva k varovanju zdravja, varnosti in ekonomskim interesom državljanov.

2. Namen iz odstavka 1 se izvaja s pomočjo skupnih ciljev in posebnih ciljev na področjih zdravja in varstva potrošnikov:

(a) Skupni cilji na področju zdravja in varstva potrošnikov, ki se bodo dosegali s pomočjo ukrepov in instrumentov iz Priloge 1 k temu Sklepu, so:

- varovanje državljanov pred tveganji in nevarnostmi, ki so izven nadzora posameznika;

- povečanje zmožnosti državljanov, da bi sprejemali boljše odločitve o svojem zdravju in potrošniških interesih;

- vključevanje ciljev politike zdravja in varstva potrošnikov v splošno politiko Skupnosti.

(b) Posebni cilji na področju zdravja, ki se bodo dosegali z ukrepi in instrumenti iz Priloge 2 k temu sklepu, so:

- varovanje državljanov pred zdravstvenimi nevarnostmi;

- pospeševanje politik, ki vodijo k bolj zdravemu načinu življenja;

- prispevanje k znižanju pojavnosti hudih bolezni;

- izboljšanje učinkovitosti zdravstvenih sistemov.

(c) Posebni cilji na področju varstva potrošnikov, ki se bodo dosegali z ukrepi in instrumenti iz Priloge 3 k temu sklepu, so:

- boljše razumevanje potrošnikov in trgov;

- boljši predpisi na področju varstva potrošnikov;

- boljše izvajanje, spremljanje in pravna sredstva;

- bolje obveščeni in poučeni ter odgovorni potrošniki.

Člen 3

Metode izvajanja

1. Ukrepi za doseganje namena in ciljev iz člena 2 se v celoti poslužujejo primernih razpoložljivih metod izvajanja, vključno z:

(a) neposrednim ali posrednim izvajanjem s strani Komisije na centralizirani osnovi;

(b) skupnim upravljanjem z mednarodnimi organizacijami.

2. Za namene odstavka 1(a) zgoraj finančni prispevki Skupnosti ne smejo presegati naslednjih ravni:

(a) 60 % za ukrep namenjen pomoči za doseganje cilja, ki tvori del politike Skupnosti na področju zdravja in varstva potrošnikov, razen v primerih izredne koristnosti, kjer prispevek Skupnosti ne sme presegati 80 %;

(b) 60 % izdatkov za delovanje organa, ki sledi cilju splošnega evropskega interesa, kjer je takšna podpora nujno potrebna za zagotavljanje zastopanosti interesov zdravja in varstva potrošnikov na ravni Skupnosti ali za izvajanje ključnih ciljev programa, razen v primerih izredne koristnosti, kjer prispevek Skupnosti ne sme presegati 95%. Obnova teh finančnih prispevkov se lahko izvzame iz načela postopnega zmanjševanja.

3. Za namene odstavka 1(a) zgoraj, lahko finančni prispevki Skupnosti, če je to primerno glede na naravo zastavljenega cilja, vključujejo skupno financiranje Skupnosti in ene ali več držav članic ali Skupnosti in pristojnih organov drugih sodelujočih držav. V tem primeru prispevek Skupnosti ne sme presegati 50 %, razen v primerih izredne koristnosti, kjer prispevek Skupnosti ne sme presegati 70 %. Ti prispevki Skupnosti se lahko dodelijo javnemu organu ali neprofitnemu organu, ki ga imenuje država članica ali zadevni pristojni organ in potrdi Komisija.

4. Za namene odstavka 1(a) zgoraj se lahko finančni prispevki Skupnosti dodelijo tudi v obliki financiranja s pavšalnim zneskom, če to ustreza naravi zadevnih ukrepov. Za te finančne prispevke se ne uporabljajo odstotne mejne vrednosti iz odstavkov 2 in 3 zgoraj. Merila za izbor, spremljanje in ocenjevanje teh ukrepov se spremenijo po potrebi.

Člen 4

Izvajanje programa

Komisija zagotovi izvajanje programa v skladu z določili iz člena 7.

Člen 5

Financiranje

1. Finančni okvir za izvajanje programa za obdobje iz člena 1 je 1203 milijone EUR.

2. Letna dodeljena sredstva odobri proračunski organ v okviru finančne perspektive.

Člen 6

Odbor

1. Komisiji pomaga odbor (v nadaljnjem besedilu „odbor“).

2. Pri sklicevanju na ta odstavek se uporabljata člena 4 in 7 Sklepa 1999/468/ES ob upoštevanju določb člena 8 Sklepa. Obdobje iz člena 4(3) Sklepa 1999/468/ES traja dva meseca.

3. Pri sklicevanju na ta odstavek se uporabljata člena 3 in 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.

4. Odbor sprejme svoj poslovnik.

Člen 7

Izvedbeni ukrepi

1. Ukrepi, potrebni za izvajanje tega sklepa, ki se nanašajo na spodaj navedeno, se sprejmejo v skladu z upravljalnim postopkom iz člena 6(2):

(a) letni načrt dela za izvajanje programa, ki določa prednostne naloge in ukrepe, ki se bodo izvajali, vključno s porazdelitvijo virov in zadevnimi merili;

(b) način ocenjevanja programa iz člena 10.

2. Komisija sprejme vse druge ukrepe, potrebne za izvajanje tega sklepa. O tem se obvesti odbor.

Člen 8

Sodelovanje tretjih držav

Pri programu lahko sodelujejo:

(a) države EFTA/EGP v skladu s pogoji, določenimi v Sporazumu o EGP;

(b) tretje države, zlasti države iz evropskega sosedstva, države, ki so zaprosile za članstvo, države kandidatke ali države pristopnice k članstvu v Evropski uniji, ter države Zahodnega Balkana, ki so vključene v proces stabilizacije in pridruževanja, v skladu s pogoji iz zadevnih bilateralnih ali multilateralnih sporazumov, ki vzpostavljajo splošna načela za njihovo sodelovanje v programih Skupnosti.

Člen 9

Mednarodno sodelovanje

Med izvajanjem programa se spodbujajo povezave s tretjimi državami, ki ne sodelujejo pri programu, in zadevnimi mednarodnimi organizacijami.

Člen 10

Spremljanje, ocenjevanje in razširjanje rezultatov

1. Komisija ob tesnem sodelovanju z državami članicami spremlja izvajanje ukrepov programa glede na njihove cilje. Komisija poroča odboru in obvešča Svet ter Parlament.

2. Države članice na zahtevo Komisije predložijo podatke o izvajanju in učinkih tega programa.

3. Komisija zagotovi, da se program oceni tri leta po začetku izvajanja in po zaključku programa. Komisija sklepe ocene skupaj s svojimi pripombami posreduje Evropskemu parlamentu, Svetu, Ekonomsko-socialnemu odboru in Odboru regij.

4. Komisija javno objavi rezultate ukrepov, izvedenih v skladu s tem sklepom, in zagotovi njihovo razširjanje.

Člen 11

Razveljavitev

Sklepa 1786/2002/ES in 20/2004/ES se razveljavita.

Člen 12

Prehodni ukrepi

Komisija sprejme vse ukrepe, ki so potrebni za zagotovitev prehoda med ukrepi, sprejetimi s sklepoma 1786/2002/ES in 20/2004/ES in ukrepi, ki se izvajajo v okviru tega programa.

Člen 13

Končna določba

Ta sklep začne veljati dan po objavi v Uradnem listu Evropske unije .

V Bruslju,

Za Evropski parlament Za Svet

Predsednik Predsednik

PRILOGA 1–Krepitev sinergij s skupnimi ukrepi in instrumenti

Cilji

1. Varovanje državljanov pred nevarnostmi in tveganji, ki so onstran nadzora posameznika (npr. nevarnosti za zdravje, ki prizadenejo družbo kot celoto, nevarni proizvodi, nepošteno poslovno ravnanje)

2. Povečanje zmožnosti državljanov, da bodo lahko sprejemali boljše odločitve o svojem zdravju in potrošniških interesih

3. Vključevanje ciljev politike zdravja in varstva potrošnikov v splošno politiko Skupnosti

Ukrepi in instrumenti

1. IZBOLJšANJE KOMUNIKACIJE O VPRAšANJIH ZDRAVJA IN VARSTVA POTROšNIKOV Z DRžAVLJANI EU

1.1. Kampanje za večjo ozaveščenost

1.2. Ankete

1.3. Konference, seminarji, srečanja strokovnjakov in interesnih skupin

1.4. Publikacije na temo zdravstvenih in potrošniških interesov

1.5. Zagotavljanje informacij na internetu

1.6. Razvoj in uporaba informacijskih točk

2. VEčANJE VKLJUčENOSTI CIVILNE DRUžBE IN INTERESNIH SKUPIN PRI OBLIKOVANJU POLITIK, POVEZANIH Z ZDRAVJEM IN VARSTVOM POTROšNIKOV

2.1. Spodbujanje in krepitev zdravstvenih in potrošniških organizacij na ravni Skupnosti

2.2. Usposabljanje in izgradnja zmogljivosti za potrošniške in zdravstvene organizacije

2.3. Vzpostavljanje mrež nevladnih potrošniških in zdravstvenih organizacij in drugih interesnih skupin

2.4. Krepitev posvetovalnih organov in mehanizmov na ravni Skupnosti

3. RAZVOJ SKUPNEGA PRISTOPA KOMISIJE ZA VKLJUčEVANJE VPRAšANJ ZDRAVJA IN VARSTVA POTROšNIKOV V DRUGE POLITIKE SKUPNOSTI

3.1. Razvoj in uporaba metod za ocenjevanje učinka politik in dejavnosti Skupnosti na področju zdravja in varstva potrošnikov

3.2. Izmenjava najboljših praks iz nacionalnih politik z državami članicami

3.3. Študije o učinkih drugih politik na zdravje in varstvo potrošnikov

4. SPODBUJANJE MEDNARODNEGA SODELOVANJA NA PODROčJU ZDRAVJA IN VARSTVA POTROšNIKOV

4.1. Ukrepi sodelovanja z mednarodnimi organizacijami

4.2. Ukrepi sodelovanja s tretjimi državami, ki ne sodelujejo pri programu

4.3. Spodbujanje dialoga med zdravstvenimi in potrošniškimi organizacijami

5. IZBOLJšANJE ZGODNJEGA ODKRIVANJA, OCENJEVANJA IN OBVEščANJA O TVEGANJIH:

5.1. Podpiranje znanstvenega svetovanja in ocene tveganja, vključno z nalogami neodvisnih znanstvenih odborov, ustanovljenih s Sklepom Komisije 2004/210/ES[22]

5.2. Zbiranje in primerjanje podatkov ter vzpostavitev mrež strokovnjakov in zavodov

5.3. Spodbujanje razvoja in uskladitve metodologij za ocenjevanje tveganj

5.4. Ukrepi za zbiranje in ocenjevanje podatkov o izpostavljenosti prebivalstva in podskupin kemičnim, biološkim in fizičnim nevarnostim za zdravje

5.5. Vzpostavitev mehanizmov za zgodnje odkrivanje nepričakovanih tveganj in ukrepi proti novo ugotovljenimi tveganji

5.6. Strategije za izboljšanje komunikacije v primerih tveganj

5.7. Usposabljanje na področju ocenjevanja tveganj

6. SPODBUJANJE VARNOSTI BLAGA IN SNOVI čLOVEšKEGA IZVORA

6.1. Analiza podatkov o poškodbah in razvoj smernic za najboljše prakse na področju varnosti potrošniških proizvodov in storitev

6.2. Analiza podatkov o poškodbah in razvoj smernic za najboljše prakse na področju varnosti potrošniških proizvodov in storitev

6.3. Dejavnosti, ki pripomorejo k večji varnosti in kakovosti organov in snovi človeškega izvora, vključno s krvjo, komponentami krvi in prekurzorji krvi

6.4. Spodbujanje dosegljivosti in dostopnosti organov in snovi človeškega izvora visoke kakovosti in stopnje varnosti za namene zdravljenja, po vsej Skupnosti

6.5. Tehnična pomoč pri analizi vprašanj, povezanih z razvojem in izvajanjem politik in predpisov

PRILOGA 2-ZDRAVJE

UKREPI IN PODPORNI UKREPI

Cilj 1: Varovanje državljanov pred zdravstvenimi nevarnostmi

1. KREPITEV SPREMLJANJA IN OBVADOVANJA ZDRAVSTVENIH NEVARNOSTI

1.1. Večanje zmogljivosti za boj proti prenosljivim boleznim s podpiranjem nadaljnjega izvajanja Odločbe 2119/98/ES o vzpostavitvi mreže epidemiološkega spremljanja in obvladovanja nalezljivih bolezni v Skupnosti

1.2. Razvoj strategij in mehanizmov za preprečevanje, izmenjavo podatkov in odzivanje na področju nevarnosti neprenosljivih bolezni

1.3. Izmenjava podatkov o strategijah in razvoj skupnih strategij za odkrivanje in pridobivanje zanesljivih podatkov o zdravstvenih nevarnostih iz fizičnih, kemičnih ali bioloških virov, vključno s tistimi, ki se nanašajo na namerno dejanje sproščanja, ter razvoj in uporaba pristopov in mehanizmov Skupnosti, kadar je to primerno

1.4. Izboljšanje laboratorijskega sodelovanja, da bi zagotovili diagnostične zmogljivosti visoke kakovosti za povzročitelje bolezni po vsej Skupnosti, vključno s strukturo referenčnih laboratorijev Skupnosti za povzročitelje bolezni, ki zahteva povečano sodelovanje Skupnosti

1.5. Razvoj novih in izboljšanih politik preprečevanja, cepljenja in imunizacije, partnerstev in orodij ter spremljanje stanja imunizacije

1.6. Razvoj in izvajanje omrežij stalne pripravljenosti in sistemov poročanja pri neželenih dogodkih, ob uporabi preprečevalnih zdravstvenih ukrepov in snovi človeškega izvora

1.7. Tehnična pomoč pri analizi vprašanj, povezanih z razvojem in izvajanjem politik in predpisov

2. ODZIVANJE NA ZDRAVSTVENE NEVARNOSTI

2.1. Izpopolnjevanje postopkov za obvladovanje tveganja v primerih izrednih zdravstvenih razmer in izboljšanje zmogljivosti koordiniranih odzivov v izrednih zdravstvenih razmerah

2.2. Razvoj in vzdrževanje zmogljivosti za ocenjevanje in odgovarjanje na potrebe in vrzeli pri pripravljenosti in odzivnosti ter hitra in zanesljiva komunikacija in posvetovanje o protiukrepih

2.3. Razvoj strategij komuniciranja v primerih nevarnosti in orodij za informiranje in usmerjanje javnosti ter zdravstvenih delavcev ter izboljšanje ozaveščenosti in medsebojnega delovanja med akterji

2.4. Razvoj strategij in postopkov za načrtovanje, preizkušanje, ocenjevanje in izboljševanje splošnih načrtov ukrepov ob nepredvidljivih dogodkih in posebnih načrtov ukrepov ob izrednih zdravstvenih razmerah in njihove interoperabilnosti med državami članicami ter načrtovanje vaj in testov

2.5. Razvoj strategij in mehanizmov za pregledovanje in izboljševanje razpoložljivosti, ustreznosti in dostopnosti zmogljivosti (npr. laboratorijev) in opreme (detektorji itd.), kot tudi pripravljenosti za hitro odzivanje, zaščitnih zmogljivosti in infrastrukture zdravstvenega sektorja

2.6. Razvoj strategij in mehanizmov za ocenjevanje potrebe po vzpostavitvi javnih zdravstvenih sredstev, ki se lahko v primeru izrednih razmer hitro uporabijo, in njihovo pospeševanje, ter vzpostavitev mehanizmov in postopkov za prenos zdravstvenih sredstev v države prosilke in mednarodne organizacije

2.7. Vzpostavitev in vzdrževanje usposobljene in stalno razpoložljive ožje skupine strokovnjakov za javno zdravje za globalno hitro napotitev na kraje hudih zdravstvenih kriz, skupaj z mobilnimi laboratoriji, zaščitno opremo in izolacijskimi zmogljivostmi

Cilj 2: Pospeševanje politik, ki vodijo k bolj zdravemu načinu življenja

3. SPODBUJANJE ZDRAVJA Z OBRAVNAVANJEM DEJAVNIKOV ZDRAVJA

Ukrepi bodo podprli pripravo, razvoj in izvajanje dejavnosti, strategij in ukrepov v zvezi z dejavniki zdravja, tako da bodo obravnavani:

3.1. Dejavniki zdravja, povezani z odvisnostmi, predvsem tobak, alkohol in druge snovi, ki povzročajo odvisnost

3.2. Dejavniki zdravja, povezani z življenjskim slogom, predvsem prehrana in telesna dejavnost, spolno in reproduktivno zdravje

3.3. Socialni in ekonomski dejavniki zdravja, s posebnim poudarkom na neenakosti pri zdravju in na učinke socialnih in ekonomskih dejavnikov na zdravje

3.4. Okoljski dejavniki zdravja, s posebnim poudarkom na učinku okoljskih dejavnikov na zdravje

3.5. Kakovost, učinkovitost in stroškovna učinkovitost intervencij na področju javnega zdravja

3.6. Podpora za dejavnosti ozaveščanja javnosti, ukrepi usposabljanja in izgradnje zmogljivosti, ki so povezani s prednostnimi nalogami iz prejšnjih odstavkov

3.7. Tehnična pomoč pri analizi vprašanj, povezanih z razvojem in izvajanjem politik in predpisov

Cilj 3: Prispevanje k znižanju pojavnosti hudih bolezni

4. PREPREčEVANJE BOLEZNI IN POšKODB

Ob usklajenosti z delom na področju dejavnikov zdravja bo program podpiral:

4.1. Razvoj in izvajanje ukrepov na področju hudih bolezni posebnega pomena glede na skupno bolezensko breme v Skupnosti, kjer lahko ukrepi Skupnosti proizvedejo pomembno dodano vrednost k nacionalnim naporom

4.2. Pripravo in izvajanje strategij in ukrepov na področju preprečevanja bolezni, posebej z ugotavljanjem najboljših praks in razvijanjem smernic in priporočil, vključno s sekundarnim preprečevanjem, testiranjem in zgodnjim odkrivanjem

4.3. Izmenjavo najboljših praks in znanja ter usklajevanje strategij za pospeševanje duševnega zdravja in preprečevanje duševnih bolezni

4.4. Pripravo in izvajanje strategij in ukrepov na področju preprečevanja poškodb

4.5. Podporo za izmenjavo znanj, ukrepe za usposabljanje in izgradnjo zmogljivosti, ki so povezani z zadevnimi boleznimi in preprečevanjem poškodb

Cilj 4: Izboljšanje učinkovitosti zdravstvenih sistemov

5. DOSEGANJE SINERGIJ MED NACIONALNIMI ZDRAVSTVENIMI SISTEMI

5.1. Omogočanje čezmejnega nakupa zdravstvenega varstva in oskrbe, vključno z zbiranjem in izmenjavo podatkov, da bi omogočili delitev zmogljivosti in uporabo čezmejne oskrbe

5.2. Izmenjava podatkov o mobilnosti zdravstvenih delavcev in obvladovanje njenih posledic

5.3. Vzpostavitev sistema Skupnosti za sodelovanje referenčnih centrov in drugih struktur sodelovanja med zdravstvenimi sistemi več kot ene države članice

5.4. Razvoj mreže za krepitev zmogljivosti za razvijanje in izmenjavo podatkov in ocen o zdravstvenih tehnologijah in metodah (ocena zdravstvenih tehnologij)

5.5. Zagotavljanje podatkov o zdravstvenih sistemih in medicinski oskrbi pacientom, delavcem in oblikovalcem politik, v povezavi s splošnimi ukrepi za informiranje na področju zdravja, vključno z mehanizmi izmenjave in širjenja podatkov z akcijskim načrtom za območje evropskega e-Zdravstva

5.6. Razvoj instrumentov za ocenjevanje učinkov politik Skupnosti na zdravstvene sisteme

5.7. Razvoj in izvajanje ukrepov za pospeševanje varnosti in visokokakovostne oskrbe pacientov

5.8. Podpora razvoja politike na področju zdravstvenih sistemov, zlasti v povezavi z odprto metodo usklajevanja zdravstvenega varstva in dolgotrajne nege

Ukrepi, ki prispevajo k vsem zgoraj navedenim ciljem:

6. IZBOLJšANJE INFORMIRANOSTI IN ZNANJA O ZDRAVJU ZA RAZVOJ JAVNEGA ZDRAVJA

6.1. Nadaljevanje razvoja trajnostnega sistema za spremljanje zdravja, ob posebnem upoštevanju zdravstvenih neenakostih in pokrivanja podatkov o zdravstvenem stanju, dejavnikih zdravja in poškodbah; nadaljnji razvoj statističnega dela tega sistema z uporabo Statističnega programa Skupnosti, kadar je to potrebno

6.2. Zagotavljanje drugega znanja, povezanega z zdravjem

6.3. Določanje dodatnih zadevnih kazalcev

6.4. Razvoj primernih mehanizmov za poročanje

6.5. Omogočanje rednega zbiranja zadevnih podatkov, skupaj s Statističnim programom, mednarodnimi organizacijami, agencijami in s pomočjo projektov

6.6. Podpiranje analize zdravstvenih vprašanj Skupnosti s pomočjo rednih zdravstvenih poročil Skupnosti, ohranjanje mehanizmov za razširjanje informacij kot je portal Zdravje, podpora konferenc za soglasje in ciljno usmerjene kampanje za informiranje, usklajene med zainteresiranimi stranmi

6.7. Osredotočanje na zagotavljanje rednih in zanesljivih virov informacij za državljane, oblikovalce politik, paciente, oskrbovalce, zdravstvene delavce in druge zainteresirane strani

6.8. Razvoj strategij in mehanizmov za preprečevanje, izmenjavo podatkov in odzivanje na področju redkih bolezni

PRILOGA 3: Potrošniška politika–Ukrepi in podporni ukrepi

Cilj I - Boljše razumevanje potrošnikov in trgov

Ukrep 1: Spremljanje in ocenjevanje razvoja trgov, ki vpliva na ekonomske in druge interese potrošnikov, vključno z anketami, popisom in analizo pritožb potrošnikov, analizo čezmejnega trženja in nakupov podjetje-potrošniku, ter ankete o spremembah v strukturi trgov.

Ukrep 2: Zbiranje in izmenjava podatkov in informacij, ki dajejo bazo dokazov za razvoj potrošniške politike in za vključevanje potrošniških interesov v druge politike Skupnosti, vključno z anketami o vedenju potrošnikov in podjetij, raziskavami v zvezi s potrošniki in drugimi tržnimi raziskavami na področju finančnih storitev, zbiranje in analiza statističnih in drugih zadevnih podatkov, katerih statistični del se bo razvijal z uporabo Statističnega programa Skupnosti, kadar bo to primerno.

Ukrep 3: Zbiranje, izmenjava, analiza podatkov in razvoj orodij za ocenjevanje, ki dajejo bazo znanstvenih dokazov o izpostavljenostjo potrošnikov kemikalijam, ki se sproščajo iz proizvodov.

Cilj II - Boljša zakonodaja na področju varstva potrošnikov

Ukrep 4: Priprava zakonodajnih in drugih regulativnih pobud in pospeševanje samoregulativnih pobud, kamor spada:

4.1. Primerjalna analiza trgov in regulativnih sistemov

4.2. Pravno in tehnično strokovno znanje in izkušnje za oblikovanje politike na področju varnosti storitev

4.3 Tehnično strokovno znanje in izkušnje v povezavi z ocenjevanjem potrebe po standardih za varnost proizvodov in oblikovanje osnutkov zahtevkov za standardizacijo CEN

4.4 Pravno in tehnično strokovno znanje in izkušnje za oblikovanje politike na področju ekonomskih interesov potrošnikov

4.5 Delavnice z zainteresiranimi in strokovnjaki

Cilj III - Boljše izvajanje, spremljanje in pravna sredstva

Ukrep 5: Usklajevanje nadzornih in izvršilnih ukrepov, povezanih z uporabo predpisov o varstvu potrošnikov, kamor spadajo:

5.1 Razvoj in vzdrževanje orodij informacijske tehnologije (npr. podatkovne baze, informacijski in komunikacijskih sistemi)

5.2. Usposabljanje, seminarji, konference o izvrševanju

5.3. Načrtovanje in razvoj skupnih izvršilnih ukrepov

5.4. Skupni pilotni izvršilni ukrepi

5.5. Analiza težav pri izvajanju in rešitve

Ukrep 6: Finančni prispevki za posebne ukrepe skupnega nadzora in izvrševanja za izboljšanje upravnega in sodelovanja pri izvrševanju na področju predpisov Skupnosti o varstvu potrošnikov, skupaj z direktivo o splošni varnosti proizvodov, in drugi ukrepi, povezani z upravnim sodelovanjem.

Ukrep 7: Spremljanje in ocenjevanje varnosti neprehrambenih proizvodov in storitev, kamor spadajo:

7.1. Okrepitev in razširitev obsega in operacij sistema za opozarjanje RAPEX, ob upoštevanju razvoja na področju izmenjave podatkov pri spremljanju trgov

7.2. Tehnična analiza opozoril

7.3. Zbiranje in ocenjevanje podatkov o tveganjih, ki jih povzročajo nekateri potrošniški proizvodi in storitve

7.4. Nadaljnji razvoj mreže za varnost potrošniških proizvodov, kot je določeno v Direktivi 2001/95/ES Evropskega parlamenta in Sveta[23]

Ukrep 8: Spremljanje delovanja in ocenjevanje učinkov shem za alternativno reševanje sporov na potrošnike

Ukrep 9: Spremljanje prenosa in izvajanja zakonodaje o varstvu potrošnikov s strani držav članic, predvsem direktive o nepoštenem poslovnem ravnanju, in nacionalnih potrošniških politik

Ukrep 10: Zagotavljanje posebnega tehničnega in pravnega strokovnega znanja in izkušenj potrošniškim organizacijam, da bi podprli njihov prispevek pri ukrepih izvrševanja in spremljanja

Cilj IV - Bolje obveščeni in poučeni ter odgovorni potrošniki

Ukrep 11: Razvoj in vzdrževanje enostavno in javno dostopnih podatkovnih baz, ki pokrivajo uporabo zakonodaje o varstvu potrošnikov in zadevne sodne prakse

Ukrep 12: Informacijske dejavnosti o ukrepih na področju varstva potrošnikov, predvsem v novih državah članicah, ob sodelovanju z njihovimi potrošniškimi organizacijami

Ukrep 13: Izobraževanje potrošnikov, vključno z ukrepi, usmerjenimi na mlade potrošnike, ter razvoj interaktivnih orodij za izobraževanje potrošnikov

Ukrep 14: Zastopanje interesov potrošnikov Skupnosti v mednarodnih forumih, vključno z mednarodnimi organi za standardizacijo in mednarodnimi trgovinskimi organizacijami

Ukrep 15: Usposabljanje za zaposlene pri regionalnih ali nacionalnih potrošniških organizacijah ter potrošniških organizacijah Skupnosti in drugi ukrepi za izgradnjo zmogljivosti

Ukrep 16: Finančni prispevki za skupne ukrepe z javnimi in neprofitnimi organi, ki tvorijo mreže Skupnosti za zagotavljanje informacij in pomoči potrošnikom, da bi jim pomagali uresničevati pravice in pridobiti dostop do primernega reševanja sporov (Evropska mreža centrov za varstvo potrošnikov)

Ukrep 17: Finančni prispevki za delovanje potrošniških organizacij Skupnosti, ki predstavljajo interese potrošnikov pri razvoju standardov za proizvode in storitve na ravni Skupnosti

Ukrep 18: Finančni prispevki za delovanje potrošniških organizacij Skupnosti

Ukrep 19: Zagotavljanje posebnega tehničnega in pravnega strokovnega znanja in izkušenj potrošniškim organizacijam, da bi podprli njihovo sodelovanje in vložek v proces posvetovanja o zakonodajnih in nezakonodajnih političnih pobudah skupnosti na zadevnih področjih, kot je politika notranjega trga, storitve občega interesa in 10-letni okvirni program o trajnostni proizvodnji in potrošnji

Skupno vsem ciljem

Ukrep 20: Finančni prispevki za posebne projekte na ravni Skupnosti ali na nacionalni ravni za podporo drugim ciljev politike varstva potrošnikov

LEGISLATIVE FINANCIAL STATEMENT

1. NAME OF THE PROPOSAL :

Health and consumer protection programme 2007-2013

2. ABM / ABB FRAMEWORK

Policy area: Health and Consumer Protection (SANCO, Title 17)

Activities: Public health / Consumer protection:

3. BUDGET LINES

3.1. Budget lines (operational lines and related technical and administrative assistance lines (ex- B..A lines)) including headings :

Current budget lines:

ABB 17 03 01 01 Public health (2003-2008)

ABB 17 01 04 02 : Public Health – Expenditure for Administrative management

ABB 17 01 04 30 : Public health –Operating subsidy to the Executive Agency for the Public Health Programme. This line should to be renamed and should receive appropriations from the lines ABB 17 01 04 02 : Public Health – Expenditure for Administrative management and ABB 17 01 04 03 : Community activities in favour of consumers – Expenditure for Administrative management.

ABB 17 02 01 : Community activities in favour of consumers

ABB 17 01 04 03 : Community activities in favour of consumers – Expenditure for Administrative management

A new budget structure will be defined after approval of the Interinstitutional Agreement on Financial Perspective 2007-2013.

3.2. Duration of the action and of the financial impact:

Total allocation for action : 1203 € million for commitment

Period of application:1 January 2007 – 31 December 2013

3.3. Budgetary characteristics:

Budget lines | Type of expenditure | New | EFTA contribution | Contributions from associated countries | Heading in financial perspectives |

17 03 01 01 | Non-comp | diff | NO | YES | YES | No 3 |

17 01 04 02 | Non-comp | Non-diff | NO | YES | YES | No 3 |

17 01 04 30 | Non-comp | Non-diff[24] | YES | YES | YES | No 3 |

17 02 01 | Non-comp | diff[25] | NO | YES | YES | No 3 |

17 01 04 03 | Non-comp | Non-diff[26] | NO | YES | YES | No 3 |

4. SUMMARY OF RESOURCES

4.1. Financial Resources

4.1.1. Summary of commitment appropriations (CA) and payment appropriations (PA)

EUR million (to 3 decimal places)

Total number of human resources* | 79 | 83 | 87 | 91 | 95 | 95 | 95 |

* of which 20 new posts with a breakdown of 4 new posts each year from 2007 to 2011

5. CHARACTERISTICS AND OBJECTIVES:

5.1. Need to be met in the short or long term

The Communication and the programme proposal bring together Public Health and Consumer protection policies and programmes under one framework to make EU policy work better for citizens. Many objectives of health and consumer actions under Treaty articles 152 and 153 are shared: promoting health protection, information and education, safety and integration of health and consumer concerns into all policies. Health and consumer policies also use many similar types of actions to pursue their objectives e.g. information to citizens, consultation of stakeholders, mainstreaming activities, risk assessment. Bringing the two areas together will thus lead to greater policy coherence, economies of scale and increased visibility.

5.2. Value added of Community involvement and coherence of the proposal with other financial instruments and possible synergy

The EU, national and regional authorities, citizens, businesses and civil society have a role to play in improving the health, wellbeing and welfare of European citizens. There are however several shared health and consumer policy challenges that only action at EU level can tackle. Greater mobility and more communication have benefited citizens. But they have also increased the risk of spreading health threats such as SARS and other communicable diseases (which cannot be addressed by individual Member States alone) and scams e.g. from bogus lotteries. The complexity of modern life has brought more choice for citizens. But it has also made it harder for them to make the best choices.

The proposed strategy and programme aim to implement articles 152 and 153 of the Treaty as regards Community action on health and consumer protection, by complementing national action with value-added measures which cannot be taken at national level .

Bringing health and consumer protection under a common framework will lead to important synergies in terms of objectives and actions, and enhance policy coherence . Merging the two programmes will also streamline administrative procedures (with a common set of tools and a unified budget) and increase visibility of policy actions vis-à-vis European citizens and within the EU institutions.

The joint Health and Consumer programme builds on the two existing programmes and maintains their core elements. It also expands health and consumer protection activities and builds bridges between the two in order to respond to stakeholders’ concerns.

Clearly, EU action on food safety also has an important contribution to making citizens healthier, safer and more confident. The Commission will build synergies with food safety policy which is not explicitly covered in this strategy, for example when working on nutrition.

Synergies will be ensured with other major instruments. One of the common objectives of the proposed health and consumer programme is to mainstream health and consumer interests in other policies to reflect the obligations of articles 152 and 153 of the Treaty. Actions will be developed building on and extending current activities.

For example health has been more closely associated to the Structural Funds and the research programme when designing the new legal bases. Particular attention has also been given to ensure synergies with the Solidarity Fund. Similarly, consumer interests have to be integrated into areas of policy such as the development of the internal market, competition or services of general interest.

5.3. Objectives and expected results of the proposal in the context of the ABM framework

The overall goal of the EU Health and Consumer Policy is to improve the quality of life for EU citizens, in terms of their health and their consumer interests. This will contribute to making Europe’s citizens healthier, safer and more confident, providing the means for economic and social inclusion, and thus giving substance to EU citizenship. As regards health, progress towards meeting this goal will be assessed with the Healthy Life Years Structural Indicator .

Protection and promotion of health and consumer interests depends on many factors. Citizens themselves, through their own choices, can improve their health and protect their interests as consumers. But much depends on external factors that public policy needs to address.

5.3.1. Core joint objectives

•EU Health and Consumer policies have three core joint objectives :

1. Protect citizens from risks and threats which are beyond the control of individuals and that cannot be effectively and completely tackled by individual Member States alone.

2. Increase the ability of citizens to take better decisions about their health and consumer interests. This means increasing the opportunities they have to exercise real choice and also equipping them with the knowledge they need.

3. Mainstream health and consumer policy objectives across all Community policies in order to put health and consumer issues at the centre of policy-making. The EU Treaty recognises this by requiring that all policies take health and consumer interests into account[27].

5.3.2. Areas of synergy

There are a number of areas of synergy between EU Health and Consumer policies. There is therefore much scope for complementary actions with common objectives to be undertaken as outlined below.

• Improve communication with EU citizens. The aim is to improve the delivery of information citizens need to manage their health and consumer interests and to listen better to their concerns and feed this into policy-making.

• Increase civil society and stakeholders’ participation in EU policy-making. The aim is to improve consultation to ensure their close participation in policy-making. Activities would include promoting civil society networking, wider public consultations and better representation in consultation bodies. Civil society needs active, expert and articulate voices for health and consumer interests at EU level. There is still a lack of a stable and credible EU consumer movement with grassroots, resources and voice, and this cannot be ignored in the Member States. Similarly, on health there is a need to increase stakeholders’ input into policy-making.

• Develop a common approach for integrating health and consumer concerns into other EU policies , i.e., to deliver within the Commission the integration of health concerns and consumer interests into other policies and to develop ideas and share best practice with Member States on how to develop this at national level. In the health area , there is a need to develop Health Impact Assessment as an evaluation tool. There is also much scope for achieving synergies with other policies, including social policy (Health Insurance card, health and safety at work); Information society (eHealth applications); Environment (Environment and health action plan); Research (health research in the framework programmes); Development (HIV/AIDS); Regional policy (health in the Structural Funds) and many others.

In the consumer area, most EU policies that regulate or intervene in markets or which affect citizens’ rights (data protection, copyright, access to justice) have a profound effect on consumer outcomes. The main current areas are competition policy, information society and essential services (or services of general interest), where core universal services need be established and maintained. Issues related to standardisation and developing of information society are also of key importance to consumers.

• Enhance scientific advice and risk assessment. Tackling problems that might impact on health and safety requires good independent scientific advice and thorough risk assessment. Risk assessment is therefore a fundamental element of the joint programme. Proactive risk management measures will be taken by encouraging the early identification of emerging risks; analysing their potential impact; promoting information exchange on hazards and exposure; fostering harmonised approaches to risk assessment across different sectors; promoting training and exchange schemes for assessors; and improving communication between risk assessors and stakeholders.

• Promote the safety of products and substances of human origin. Activities would include best practice exchange, awareness raising, implementation guidelines, training and networking, joint surveillance and enforcement projects and systematic development of product safety standards, as regards the following two categories:

• General product safety, which is a common thread running through consumer actions.

• Safety of products that impact directly on health, including those derived from substances of human origin (such as blood, tissues and cells) that are not tradable for profit. The aim is to support Member States’ implementation of Community legislation and to promote the accessibility of these products.

• To promote international cooperation, including co-operation with international organisations and third countries in the areas of health and consumer protection.

The EU must take a bigger role in international health and tackle global health issues more. Measures foreseen include taking steps to strengthen co-operation with the WHO and with the OECD. The EU must also support candidate countries as well as neighbouring countries on key public health issues and in developing their health systems. Measures foreseen include bilateral initiatives with enlargement and neighbouring countries, exchange of good practices and assistance in tackling health crises.

On consumer affairs , international regulatory cooperation is increasingly necessary in areas such as product safety and in dealing with rogue traders. At the multilateral level, the relationship between trade and consumer interests is growing. International Regulatory cooperation also needs to be complemented by dialogue between civil society and their involvement (e.g. in standardisation).

5.3.3. Public health objectives

First, to protect citizens against health threats .

Second, to promote policies that lead to a healthier way of life.

Third, to contribute to reducing the incidence of major diseases in the EU.

Fourth, to contribute to the development of more effective and efficient health systems .

Fifth, to support the objectives above by providing health information and analysis .

Progress towards these objectives will lead to enabling European citizens across the EU to enjoy healthier and longer lives and will contribute to reducing the gap in life expectancy and health status between Member States. Improvements will be monitored through the short list of Community health indicators[28] and the “healthy life years” structural indicator.

5.3.4. Consumer policy priority areas:

• Better understanding of consumers and markets,

• Better consumer protection regulation

• Better enforcement, monitoring and redress,

• Better informed and educated consumers

Actions will contribute to ensure an equally high level of protection for all EU consumers, wherever they live, travel to or buy from in the EU, from risks and threats to their interests. Action covers the safety of goods and services; the fairness of commercial practices and contractual rights for consumers; affordable access to essential services, protection from rogue traders and access to effective means of redress. This should result in reducing the lack of confidence of consumers in the internal market and enabling them to make free and informed choices from an appropriate range of products . This, in turn, will boost competition and make a significant contribution to the competitiveness of EU businesses .

Actions will also contribute to increase the capacity of consumers to promote their own interests, as individuals or though consumer organisations, i.e., helping consumers help themselves. This means equipping consumers with the tools they need to take better and more rational decisions in the internal market. This includes the provision of information to consumers about their rights, means of redress but also products and the opportunities of the internal market. This also implies a clear role for the representatives of consumers, properly resourced and with sufficient expertise.

5.4. Method of Implementation (indicative)

Show below the method(s)[29] chosen for the implementation of the action.

X Centralised Management

X Directly by the Commission

ٱ Indirectly by delegation to:

X Executive Agency

ٱ Bodies set up by the Communities as referred to in art. 185 of the Financial Regulation

ٱ National public-sector bodies/bodies with public-service mission

ٱ Shared or decentralised management

ٱ With Member states

ٱ With Third countries

X Joint management with international organisations (relevant organisations in the areas of health and consumers)

6. MONITORING AND EVALUATION

6.1. Monitoring system

The Commission monitors the most pertinent indicators throughout the implementation of the new joint programme. The indicators hereunder listed are related to the objectives described under part 5.3 .

Objectives | Indicators |

Strengthening synergies for policy delivery |

Improve communication with EU citizens | number of campaigns number of conferences & participants number of publications satisfaction with portal, n. of users number information points’ users |

Increase civil society and stakeholders’ participation in EU policy-making | number of public consultations, meetings, number of conferences and participants number of responses to open consultations number of members of consultation bodies, number and regularity o meetings |

Develop a common approach for integrating health and consumer concerns into other EU policies | Number of joint measures with other DGs Number of ISC on which DG SANCO is consulted/Number of SANCO responses to other DGs Health Impact assessments undertaken Explicit references to health policy objectives in other policies |

Enhance scientific advice and risk assessment | Number of scientific opinions given Community guidelines or decisions embodying the scientific opinions |

Promote the safety of products and substances of human origin | Number of product safety standards developed |

Promote international cooperation | Number of initiatives with International organisations Number of initiatives with third countries |

Health |

protect citizens against health threats | ECDC becomes operational European co-ordination capacity for responding rapidly to threats is in place Number of projects in this area |

promote policies that lead to a healthier way of life | Number of new measures proposed and carried out in new strategies Number of projects in this area Number of events Number of thematic platforms created Number of information/awareness raising publications and target audience reached |

contribute to reducing the incidence of major diseases | Number of new measures proposed and carried out in new strategies Number of projects in this area Number of information/awareness raising publications and events and target audience reached |

improving effectiveness and efficiency in European health systems | Number of centres of reference identified Number of countries participating in HTA network Number of assessment reports |

For all health objectives : Health information and knowledge | Number of projects in this area Number of information/awareness raising publications and events and target audience reached Number of hits in health portal Number of Health reports |

Consumer policy |

A better understanding of consumers and markets | Level of knowledge-base activity (number of reports and data analysis) integration of the data and analyses into consumer-related Commission initiatives |

Better consumer protection regulation | Level of consumer satisfaction on legislation, opinions on infrigements. Businesses’ opinions on the impact of legislation |

Better enforcement, monitoring and redress | Measure of consumers’ satisfaction evaluation of the efficiency of the different tools, instruments and networks |

Better informed and educated consumers | Measure of knowledge and satisfaction of consumers on consumer policy and consumer protection |

The implementation of the Community programme entrusted to the executive agency is subject to the control of the Commission and this control is exerted according to the methods, the conditions, the criteria and the parameters which it lays down in the act of delegation defined by Council Regulation (EC) N° 58/2003 laying down the statute for executive agencies to be entrusted with certain tasks in the management of Community programmes[30], Article 6 (3).

6.2. Evaluation

6.2.1. Ex-ante evaluation

This programme proposal is built on a series of existing Community programmes and measures, some of which have been operational for many years, and which have been the subject of a comprehensive sequence of evaluations, as well as a substantial corpus of experience of administering and implementing the programmes in the Commission (and a former technical assistance office) and within the Member States and other participating countries (particularly the candidate countries).

The new programme was designed taking into account in particular the experience gained through implementing the programmes on public health 2003-2008 and the Consumer Policy Strategy 2002-2006.

The hypothesis of taking no action was considered:

• No action means failure to meet the provisions of articles 152 and 153 of the Treaty.

• No action means that the Commission would not meet the requirement of having a proper legal basis for consumer protection and for health actions during the period 2007-2013 as imposed by the new financial perspectives. (The Health Programme expires at the end of 2008; the consumer programme at the end of 2007). This would make it very difficult to fulfil various legal obligations.

• No action would mean that it would not be possible to take action to increase consumers’ confidence in goods and services from other Member States with consequent implications for the effectiveness of the single market. This would cause problems for business which would continue to be confronted with a fragmented market.

• No action would mean that the Commission would not fulfil its commitment to present a health strategy, following an open consultation in 2004, intended to help prepare the ground for a new strategy. In terms of effects on health, some serious negative impact would arise following the expiry of the current health programme. Health protection in Europe would be undermined as essential health threat surveillance systems and alert mecanisms would find it difficult to operate. There would be inadequate information about important health trends and developments as mechanisms to collect and analyse the data would not function effectively. This would make it harder for health authorities to plan and develop policies and for citizens to take decisions. There would also be a great reduction in actions against trans-frontier health threats eg HIV/AIDS and bioterrorism.

• No action would also mean that the Commission stopped work in areas of central concern to its citizens daily lives and thus lost the possibility to increase visibility and to demonstrate the relevance of its action to them.

Building a joint programme will:

• help bring citizens’ issues to the forefront of the EU agenda by providing a joint framework for two policies that impact on citizens’ day-to-day life.

• generate synergies , exploiting the common objectives of articles 152 (public health) and 153 (consumer protection) of the Treaty (e.g. health protection, citizens’ information and education, mainstreaming) and common elements of work under health and consumer policies (e.g. co-operation with Member States, contacts with civil society, risk assessment, international dimension).

• enhance the coherence of EU policies , in response to Treaty articles 152 and 153, which require the integration of health and consumer interests in other policy areas.

• streamline and simplify administrative and budgetary procedures making Community action more visible, transparent, operational, effective and also flexible (one single programme, one set of procedures, common set of tools, one budget line).

In addition the existing executive agency for the public health programme could have its current mandate adapted to be able to ensure the management tasks of the new programme, including budgetary tasks, which would constitute the best management instrument at the disposal of the Commission[31]. This will in particular ensure :

- Multiplier effect (leverage) enabling the Commission to concentrate on its core competencies;

- Effectiveness and flexibility in the implementation of outsourced tasks;

- Simplification of the procedures used;

- Proximity of the outsourced action to the final beneficiaries.

(a) In the public health area

The public health programme 2003-2008, adopted in September 2002,[32] represents a major step forward for the implementation of the provisions of Article 152 of the EC Treaty. It provides for the integrated development of a strategy aimed on the one hand at ensuring a high level of health protection in all Community policies and actions and, on the other, at supplementing and coordinating policies and actions carried out by the Member States in the field of health surveillance and information systems, combating transmissible diseases and disease prevention.

In designing the new joint programme proposal, special attention was given to building upon the experience acquired during the first years of operation of the 2003-2008 programme, as well as to integrating the work carried out in various consultations, fora and groups.

Preparatory work on the health strategy

An open consultation on the future Health Strategy was launched in July 2004. The consultation was carried out on the basis of a public consultation document published on the web-site. All interested parties from the public health area, public bodies, interest groups and individual citizens, were invited to participate in the consultation, by means of a written contribution. Almost 200 contributions from national and regional authorities, NGOs, universities, individual citizens and companies have reached the Commission, Following the analysis of the results, a number of policy priority areas have been identified making it necessary to re-orient existing work in order to refine the policy priorities. The result is available in the Commission website[33].

Approximately 1/4 of all respondents including Ireland, Sweden, the Netherlands, Germany, the UK, Lithuania Malta and Poland urged the EU to pro-actively promote health and prevent illness. Measures proposed include the need to focus on children and teenagers, to implement a nutrition/obesity strategy, to tackle smoking and alcohol, to address a wide range of issues affecting health and to act on important diseases including cancer, respiratory and cardiovascular diseases.

Approximately 1/5 of all respondents including France, Germany, Ireland, the Netherlands, Sweden, Finland and Lithuania asked the EU to mainstream health . Respondents urged the Commission to implement a comprehensive and coherent EU approach to health, encompassing policies as diverse as Education, Trade, Internal Market, Social, Environment, Agriculture, External, Transport and Regional development. Several respondents including France, Ireland, Sweden and Finland raised the need for a Health Impact Assessment system.

The need to position health as a driver of economic growth and to disseminate evidence was raised by Ireland, France, the Netherlands, Malta and the UK. Some NGOs and Germany, Ireland and Sweden asked for health to become part of the Lisbon agenda .

Many stressed the need to address health inequalities by increasing funding for health. Respondents also urged the EU to involve stakeholders more closely in policy-making , to support the civil society, to take a stronger role on international health and to step up efforts in the analysis and dissemination of data.

Finally, many respondents also urged the EU to increase resources allocated to health, for the Public Health Programme to better serve policy priorities, to improve dissemination of project results, to cover neighbouring countries and to increase co-funding.

Respondents raise a large number of additional specific issues including the need to focus more on mental health, the challenges posed by an ageing population, the need to increase quality in healthcare, to secure patients’ rights and safety, to set clear rules for patient and professional mobility, for health technology assessment and research.

Health systems

In 2003, a high level reflection process on patient mobility and healthcare developments in the EU was launched at ministerial level. Working groups composed of Member State health ministers or senior representatives, and stakeholders met throughout the year. In December 2003, a ministerial level meeting including ministers from acceding countries, adopted a report containing 19 recommendations for action at EU level. The Commission responded in presenting three Communications[34] in April 2004. To take forward these recommendations, a High Level Group on health services and medical care was established with working groups on the following areas : cross-border healthcare purchasing and provision, health professionals, centres of reference, health technology assessment, information and e-health, health impact assessment and health systems, patient safety. A report setting out progress at this stage and orientations for future work was endorsed by the Council in December 2004. The need to take forward work on the cooperation of health systems justifies the creation of a new action strand under the selected option.

Involvement of stakeholders

Health policy making must respond to the needs and concerns of citizens. It is necessary to build up the organisations representing patients and those developing the public health agenda so that civil society is able to make the constructive contribution needed to public health policy.

Currently, patient groups and non governmental organisations in the health field can find it difficult to develop initiatives at EU level and to stabilise their organisations because they have inadequate resources.

For example active participation in the EU Health policy forum, which brings stakeholders together to discuss policy issues, requires a level of organisational capacity and resources that many NGOs lack. Associations are not funded for their core work as such, because the legal basis of the Public Health Programme 2003-2008 does not allow such direct funding. The Commission is therefore proposing operational grants as well as project grants to provide core funding to certain NGOs, including patient groups, in order to help them develop their organisational capacity and put themselves on a sound basis.

Need for additional budget and added-value

The programme proposal reinforces the existing three strands of the Public Health Programme (Information, Health threats and promoting health through addressing health determinants). The programme also includes three new action areas which are essential to respond to the needs identified: response to health threats, prevention of diseases and co-operation between health systems. Below are the main reasons why an additional budget is needed and the added value of Community action:

First, the current health budget is too limited to fully comply with Treaty provisions . For example, the Community has a Treaty obligation to protect citizens against health threats . Threats such as SARS show the need for increased EU capacity to help Member States react to such threats and to co-ordinate a response in order to minimise the risk of spread of infection within the EU. The current budget does not enable the Community to effectively pursue this obligation. The Treaty also foresees Community action to encourage Members States’ co-operation on health. However, so far, co-operation has been limited to the High Level Group on health services which has no operational budget.

Second, the three new strands also reflect existing Commission engagements and policy developments. The Commission strategic objectives for 2005-2009 stress the importance of countering threats to citizens’ health and safety at EU level: hence a new strand on reaction to threats which requires substantial resources. The new strand on health systems co-operation responds to Member States’ requests and the Lisbon process conclusion that European support to improve health systems is “ envisaged and can provide important added value”. The strand on preventing specific diseases responds to repeated requests and to the outcome of the open consultation on health. In addition, the first two strands (reaction to threats and health systems co-operation) also correspond to two areas where the Community Health mandate would be expanded in the Constitution.

Third, as underlined in the Lisbon process , there is a need to reduce the major differences between Member States in terms of life expectancy, health status and health systems capability. Following enlargement, supporting in particular the new Member States to develop their health systems requires additional resources. In addition to infrastructure investment to which the Community Structural Funds can contribute, there is a need for the Community to help these countries in terms of training, expertise, capacity building, preparedness, prevention and promotion, as well as a need for analysis on their health investment needs.

Finally, the EU population ageing and its potential impact on the sustainability of public finances, not least from the relative decline in the working population, requires EU action to help Member States cope with this challenge.

Cost-effectiveness

Improving cost-efficiency is one of the main reasons for bringing together the existing Health and Consumer programmes into a single framework. The overall programme will benefit from economies of scale and from the streamlining of administrative and budgetary procedures, including common tools. Using the same tools and procedures on common actions will lead to savings in terms of organisation and management tasks and will therefore translate into a cost/input reduction. The extension of the existing Public Health Programme executive agency to support the whole of the proposed programme will also lead to savings in terms of input as regards tasks related with tendering and organisation of meetings. The outsourcing of such administrative tasks to the executive agency will also enable the Commission to focus on policy making and conception tasks, including developing significant links with other policies.

In the health part, more emphasis will be put on highly visible large-scale projects, which should result in a better cost-efficiency ratio (small scale projects are more labour intensive and necessarily with more limited results). In addition, the programme foresees improving the way projects results are exploited and disseminated, which will increase projects’ impact and visibility. The outsourcing of administrative tasks will enable the Commission to focus on ensuring that health crises and emergencies are better handled, that project results are better disseminated, to expand work with stakeholders and to develop policy work on e.g. health inequalities, ageing and children’s health, which are not limited to a specific programme strand.

(b) Consumer protection

• Relevance of the consumer policy part of the new Programme

The Consumer Policy Strategy which was initiated in 2002 brought several major improvements to the functioning of European Consumer policy, in particular with:

- putting into place a mid-term programme (5 years were foreseen from 2002 to 2006);

- being flexible: a rolling plan of actions, revised every 18 months is annexed to the programme;

- putting emphasis on a need for a knowledge-based consumer policy;

- developing capacity building actions in favour of consumer associations;

- developing education actions, in particular towards young consumers;

In addition, the new joint programme tackles issues mentioned in previous evaluations (see 6.2.2.b)):

- combine the consumer policy programme or strategy and its related financial framework;

- increase the budget devoted to consumer policy;

- better match the implementation of the consumer programme or strategy with available human resources with the use of a new “Consumer Institute” department within the existing executive agency;

- improve enforcement: this is one of the major consumer policy objectives of the new programme.

• Added value

For consumer policy in particular, the increase in budget will allow a better implementation of its main objectives. Indeed, there will be no major changes in these objectives compared to the Consumer Policy Strategy 2002-2006. However, the new budget allocation will provide means to put a clear emphasis on three major areas / objectives, namely:

- Knowledge base (“a better understanding of consumers and markets”)

- Enforcement (“better enforcement, monitoring and redress”)

- Empowerment of consumers (“better informed and educated consumers”)

These three major objectives will receive the large majority of funds available under the operational budget.

Better added value will also be reached with the leverage effect made possible with the existence of the “Consumer Institute” department of the executive agency. It will increase both the operational capacities for consumer policy and the policy and analysis capacities of the Commission services.

• Cost-effectiveness

Therefore, cost-effectiveness of the consumer policy part of the new joint programme benefits from the leverage effect provided with the existence of the “Consumer Institute” department of the executive agency. There is no dispersion. As we mentioned, priority areas remain broadly comparable to the ones of the Consumer Policy Strategy. Now that several pilot actions tested under the Consumer Policy Strategy have proven their interest, it is time to amplify this effort. This is what should allow an extended operational budget and the administrative capacity of the executive agency’s “Consumer Institute” department.

6.2.2. Measures taken following an intermediate/ex-post evaluation (lessons learned from similar experiences in the past)

(a) Ex post evaluation of the former 8 public health programmes

The role of the European Community in the field of public health, as defined by the Treaty, is to complement Member States’ action by promoting research, providing health information and education, encouraging cooperation and fostering policy coordination among Member States through incentive measures. An evaluation of the 8 Community programmes of 1996-2002 was carried out in 2004[35]. The main objective was to assess whether the goals were achieved in the EU through these action programmes and to locate the genuine added value of European intervention in the field of public health.

The evaluation shows that the Programmes had an overall positive added value and calls for further investment by the EU in Public Health. It gives a number of recommendations : some of the issues raised have already been addressed when building the Public health programme 2003-2008. However room for improvement remains for the following areas:

- develop a complete and coherent theory of action for the general public health framework;

- clarify the priorities the programme seeks to meet and the levels targeted;

- be structured and research synergies and complementarities between the policy instruments and the research areas;

- in the area of health determinants, redirect a substantial part of the new programme towards the aspects of these diseases which have not been fully researched and towards tackling the issue of diseases from a preventive point of view;

- to allow more room, in cases regarding the share of responsibilities between the EU and the Member States, for a re-orientation of the EU priorities towards emerging issues and innovative approaches;

- to maximise the possibilities to exchange information and knowledge between Member States, notably to allow bridging the gap between countries lagging behind the most advanced states, specially considering the recent enlargement;

- to set up a systematic internal and external communication policy;

- to enhance training activities, as it is the most valuable way of disseminating methods and best practices;

- to reserve financing in the new programme for the effective and large networks, i.e. which are representative in terms of partners involved and coverage of the EU as a whole, so to ensure their sustainability.

These recommendations will be reflected as far as possible in the construction of the new programme.

(b) Consumer protection

Consumer protection policy can build on the lessons taken from former programmes, in particular the Consumer policy action plan 1999-2001[36] and the Consumer policy Strategy 2002-2006[37]. Some measures which were recommended in the ex-post evaluation of the Consumer Policy action plan had already been integrated in the Consumer Policy Strategy. Some specific evaluations have been carried out and were taken into account.[38]

An ex-post evaluation[39] of the Consumer policy action plan draws the following recommendations (abstract):

“Definition of the action plan

1. Develop more flexible action plans , capable of reacting to new situations but stable enough to ensure the continuity of the Commission policy strategy.

2. Combine the consumer policy action plan or strategy and its related financial framework into one document , with the objective that they should be of equal duration and that there is good coherence of the planned actions.

Generation of broader impact

3. Make a very clear distinction between a policy document like the action plan - being a sort of declaration of intent - and a management plan - providing information on the progress of outputs and impacts .

4. Better match the implementation of the Commission consumer policy (that has ambitious objectives) with DG SANCO (limited) human and financial resources . For the Commission, this means:

- Define priorities.

- Be clear to consumer organisations on what is the role and what are the priorities of the Commission on consumer policy, in particular regarding the funding of and assistance to consumer organisations.

- Strengthen co-operation with Member States in particular within co-operation on administrative enforcement.

- Build on existing infrastructures and networks created either by other DGs or by Member States.

- Make the other DGs more aware of consumer interests and encourage direct contacts between them and the consumer organisations.

- Increase the budget of DG SANCO .

5. Optimise the complementarities and synergies between the different networks or entities contributing to the implementation of the Commission consumer policy.

6. Reinforce the partnership with field organisations through:

- Reinforced participation of the consumer organisations in the policy-making process .

- More transparent communication to consumer organisations .

- The increased role of the Euroguichets, the EEJ-Net, the International Consumer Protection and Enforcement Network (ICPEN), consumer associations , etc.

7. Reinforce communication with Member States and consumer organisations and between Member States and consumer organisations through exchanges on:

- priorities and consumer needs at European and national/regional level.

- Commission actions and the progress made by the Member States and consumer organisations on the implementation, use and enforcement of the Commission actions and possibly on related best practices.

8. Improve enforcement through:

- Continuing the work initiated during the action plan on co-operation in enforcement.

- Sustaining the development of consumer organisations in the countries lacking effective enforcement, such as in the new Member States.

9. Wherever possible, repeat the well-structured approach used during the revision of the General Product Safety Directive , which was based on the preliminary study of the needs for improvement, good co-operation with the Member States and the consultation of stakeholders.

10. Continue to base the development of actions on informed judgement through the use of the knowledge-base and the making of impact assessments and evaluations ( ex-ante and ex-post ).

Impact assessment framework

11. Regularly assess the impact assessment framework , for instance every two years, in order that it reflects changing consumer policy objectives, the emergence of new key issues (to be measured to know whether the Commission consumer policy is successful in supporting its objectives) or improvements in data availability.

In its concluding remarks, the Report on the implementation and evaluation of Community activities 2002-2003 in favour of consumers under the general framework as established by Decision 283/1999/EC[40] underlined the following elements:

"With respect to the previous years, expenditure commitments in 2002 and 2003 were generally more policy-driven than was the case in 1999-2001. This is in large part the result of the Consumer Policy Strategy 2002-2006, which defined clear objectives and a more coherent approach to consumer policy. In particular, actions to build up a knowledge-base for consumer policy have increased in importance with respect to previous years. As they become available, the results feed into policy development and financial programming. This trend was further strengthened with the entry into force of Decision 20/2004/EC that substitutes Decision 283/1999/EC. The new framework provides support only for actions that support EU consumer policy.

Efforts to rationalize and improve the efficiency of the European Consumer Centers and Extra-Judicial networks have led to a decision to merge the two into a single structure. The results of evaluations are also prompting efforts to better focus the activities of the network on assistance with cross-border consumer problems. A planned review of the function of the networks within the larger framework of consumer redress instruments, including small claims and injunctions/class actions by consumer organizations, will help to better define consumer needs to which the networks aim to respond.

With respect to European level consumer associations, the experience with AEC has proved that, in spite of the financial support provided from the Community budget, the feasibility of an effective second general consumer organization at EU level is low and that the national consumer associations that are not part of BEUC do not have the means to manage an effective EU-level organization.

Evaluations and critical assessments have provided the basis for a substantial reorientation of information and education actions. The pilots of the new actions will be subject of interim evaluations to measure if they deliver improved impact.

With respect to specific projects, this instrument appears to be more effective as a means of supporting national consumer organizations and other NGO’s than as a policy tool, and its concrete impact on the level of consumer protection in the EU is found to be scarce. In that light, new instruments to support the work of consumer associations, in particular the capacity building actions as introduced by Decision 20/2004/EC, deserve to be given a higher priority."

6.2.3. Terms and frequency of future evaluation

Details and frequency of planned evaluation:

The Commission will draw up two successive evaluation reports based on an external independent evaluation, which will be communicated to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions.

Mid-term report : the first evaluation will be undertaken after the mid-point of the programme. The object of this report is to provide an initial assessment of the impact and effectiveness of the programme on the basis of the results obtained. Any changes or adjustments that are deemed necessary will be proposed by the Commission for the second half of the programme.

Final Report : An external evaluation report covering the entire period of operation of the Programme will be carried out, to assess the implementation of the Programme.

Furthermore, the Commission plans to audit beneficiaries in order to check that Community funds are being used properly. The results of audits will form the subject of a written report.

Evaluation of the results obtained:

Information providing a measure of the performance, results and impact of the Programme will be taken from the following sources:

- statistical data compiled on the basis of the information from application dossiers and the monitoring of beneficiaries' contracts;

- audit reports on a sample of programme beneficiaries ;

- use of the results of the executive agency’s evaluations and audits.

7. Anti-fraud measures

All the contracts, conventions and legal undertakings concluded between the Commission and the beneficiaries under the programme foresee the possibility of an audit at the premises of the beneficiary by the Commission’s services or by the Court of Auditors, as well as the possibility of requiring the beneficiaries to provide all relevant documents and data concerning expenses relating to such contracts, conventions or legal undertakings up to 5 years after the contractual period. Beneficiaries are subject to the requirement to provide reports and financial accounts, which are analysed as to the eligibility of the costs and the content, in line with the rules on Community financing and taking account of contractual obligations, economic principles and good financial management.

8. DETAILS OF RESOURCES

8.1. Objectives of the proposal in terms of their financial cost

Commitment appropriations in EUR million (to 3 decimal places)

8.2. Administrative Expenditure

8.2.1. Number and type of human resources

Types of post | Staff to be assigned to management of the action using existing and/or additional resources (number of posts/FTEs) |

Other staff [3] financed by art. 17 01 04/05 |

TOTAL | 79 | 83 | 87 | 91 | 95 | 95 | 95 |

The calculation includes the existing resources devoted to the two current programmes, and the new requested staff, subject to agreement under the annual procedure of resources allocation (APS/PDB). The increase in the Commission staff is needed to. undertake the conceptual and strategic preparatory work, specially during the first years of the programme, and to exploit the results coming from the programme and proposals. More over, the work on developing enforcement cooperation with Member States, as well as the intensification of capacity-building activities aimed at consumer organisations will require strengthening of Commission resources

It does not include the executive agency’s staff.

8.2.2. Description of tasks deriving from the action

The joint programme will build on the two existing programmes (and maintain their core elements), put forward new action strands and expand on existing activities respectively on health and on consumer protection.

As regards Health , the joint programme reinforces the existing three strands of the Public Health Programme (Information, Health threats and promoting health through addressing health determinants). It also proposes three new action areas: rapid response to health threats, prevention of diseases and co-operation between health systems.

As regards consumer protection, the joint programme reinforces and re-focuses the themes of the current programme (high common level of consumer protection; effective enforcement and the proper involvement of consumer organisations). A higher priority is given to information and education and improving the understanding of how markets function to the benefit of business and consumers.

The current executive agency will also be extended to deal with Consumer issues. An extension of the executive agency, to be called “ Consumer Institute ”, will enable the Commission to carry out projects which had so far only be done at the pilot project level (e.g. education tools) and to be the necessary scale and visibility to actions meant to strenghthen the “knowledge base” for consumer policy making (e.g. price surveys, quality of products) or to develop capacity building actions (training of consumers’ organisations staff, of enforcers from the Member States).

The existence of the “Consumer Institute” will enable an increase in the visibility and the impact of such actions, and it will free resources in the Commission to make use of these actions, in particular the knowledge base ones, for policy development..

8.2.3. Sources of human resources (statutory)

(When more than one source is stated, please indicate the number of posts originating from each of the sources)

X Posts currently allocated to the management of the programme to be replaced or extended

( Posts pre-allocated within the APS/PDB exercise for year n

X Posts to be requested in the next APS/PDB procedure

( Posts to be redeployed using existing resources within the managing service (internal redeployment)

( Posts required for year n although not foreseen in the APS/PDB exercise of the year in question

8.2.4. Other Administrative expenditure included in reference amount (XX 01 04/05 – Expenditure on administrative management)

EUR million (to 3 decimal places)

Officials and temporary staff (17 01 01) | 6,048 | 6,48 | 6,912 | 7,344 | 7,776 | 7,776 | 7,776 |

Staff financed by Art 17 01 02 (auxiliary, END, contract staff, etc.) (specify budget line) | 2,484 | 2,484 | 2,484 | 2,484 | 2,484 | 2,484 | 2,484 |

Total cost of Human Resources and associated costs (NOT in reference amount) | 8,532 | 8,964 | 9,396 | 9,828 | 10,26 | 10,26 | 10,26 |

- Calculation – Officials and Temporary agents

Calculation includes overheads expenses and is based on the average cost in the Commission

Calculation– Staff financed under art. XX 01 02

Calculation includes overheads expenses and is based on the average cost in the Commission

8.2.6 Other administrative expenditure not included in reference amount

EUR million (to 3 decimal places)

|2007 |2008 |2009 |2010 |2011 |2012 |2013 |TOTAL | | 17 01 02 11 01 – Missions |0,750 |0,754 |0,758 |0,761 |0,765 |0,769 |0,773 |3,795 | | 17 01 02 11 02 – Meetings & Conferences; and Committees |2,000 |2,010 |2,020 |2,030 |2,040 |2,051 |2,061 |10,121 | | 17 01 02 11 04 –Studies & consultations |0,600 |0,603 |0,606 |0,609 |0,612 |0,615 |0,618 |3,036 | | 17 01 02 11 05 – Information systems | 0,750 |0,754 |0,758 |0,761 |0,765 |0,769 |0,773 |3,795 | | 2. Total Other Management Expenditure (XX 01 02 11) | 4,100 |4,121 |4,141 |4,162 |4,183 |4,204 |4,225 |20,748 | | 3. Other expenditure of an administrative nature (specify including reference to budget line) | | | | | | | | | | Total Administrative expenditure, other than human resources and associated costs (NOT included in reference amount) | 4,100 |4,121 |4,141 |4,162 |4,183 |4,204 |4,225 |20,748 | |

Calculation - Other administrative expenditure not included in reference amount

The needs for human and administrative resources shall be covered within the allocation granted to the managing Directorate-General in the framework of the annual allocation procedure.

[1] Nova ustava bo okrepila pooblastila iz Pogodbe, tako da bi določala „cilj Unije je krepitev miru (…) in blaginje svojih narodov“ (člen I-3) in razširila pooblastila Skupnosti na področju zdravja (člen III-287). Listina o temeljnih pravicah nadalje določa: „Vsakdo ima pravico do preventivnega zdravstvenega varstva in do zdravniške oskrbe (…). Pri opredeljevanju in izvajanju vseh politik in dejavnosti Skupnosti se zagotavlja visoka raven varovanja zdravja ljudi“ (člen II-95).

[2] Sklep 858/2004/ES.

[3] Med procesom razmišljanja o zdravju, sproženem julija 2004, je nastalo skoraj 200 prispevkov.

[4] Oceno opravil Deloitte, 2004.

[5] SEC(2005) 160, 28.1.2005.

[6] Sporočilo za spomladansko zasedanje Evropskega Sveta COM(2005) 24, 2.2.2005.

[7] Strateški cilji 2005 - 2009, „Evropa 2010“, 2005.

[8] Uredba (ES) št. 851/2004.

[9] Odločba 2119/98/ES.

[10] Skupaj s Strategijo EU proti drogam 2005 - 2012.

[11] Skupaj z ukrepom „Podlaga skladne evropske politike za zunanje ukrepe v boju proti HIV/AIDS, malarija in tuberkuloza“, COM(2004) 726 končno.

[12] COM(2004) 301 in COM(2004) 304.

[13] UL C […], […], str. […].

[14] UL C […], […], str. […].

[15] UL C […], […], str. […].

[16] UL C […], […], str. […].

[17] UL L 271, 9.10.2002, str. 1. Odločba, kakor je bila spremenjena z Odločbo 786/2004/ES (UL L 138, 30.4.2004, str. 7).

[18] UL L 5, 9.1.2004, str. 1. Odločba, kakor je bila spremenjena z Odločbo 786/2004/ES.

[19] UL L 369, 16.12.2004, str. 73.

[20] UL L 142, 30.4.2004, str. 1.

[21] UL L 184, 17.7.1999, str. 23.

[22] UL L 66, 4.3.2004, str. 45.

[23] UL L 11, 15.1.2002, str. 4.

[24] Non-differentiated appropriations hereafter referred to as NDA.

[25] Non-differentiated appropriations hereafter referred to as NDA.

[26] Non-differentiated appropriations hereafter referred to as NDA.

[27] Articles 95, 152 and 153 of the Treaty of the Union.

[28] http://europa.eu.int/comm/health/ph_information/indicators/indicators_en.htm.

[29] If more than one method is indicated please provide additional details in the "Relevant comments" section of this point.

[30] OJ L 11, 16.1.2003, p. 1.

[31] See also the study "Cost-effectiveness assessment of externalisation of European Community' s public health action programme" by Eureval-C3E, of 21.6.2002.

[32] Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008), OJ L 271, 9/10/2002.

[33] http://europa.eu.int/comm/health/ph_overview/strategy/reflection_process_en.htm.

[34] COM (2004) 301 final, COM (2004) 304., COM (2004) 356.

[35] Deloitte report of 2004 : “Final Evaluation of the eight Community Action Programmes on Public Health (1996-2002) – web link : http://europa.eu.int/comm/health/ph_programme/evaluation_en.htm.

[36] http://europa.eu.int/comm/consumers/cons_int/serv_gen/links/action_plan/ap01_en.pdf.

[37] http://europa.eu.int/eur-lex/pri/en/oj/dat/2002/c_137/c_13720020608en00020023.pdf.

[38] Evaluation of 1995-199 subventions to consumer organisations operating at European level , final report, The evaluation partnership, 16 November 2001; Ex-ante budgetary evaluation of a possible merger of EEJ-Net and the ECC network and assessment of the pilot phase of the EEJ-Net, final report, EPEC, July 2004; Evaluation of the financial support for specific projects article 2c) of Decision 283/1999/EC , Yellow Window, final report, 13 October 2004; Intermediate evaluation of European consumer centres’ network (Euroguichets) , CIVIC, final report, 10 November 2004.

[39] Ex-post evaluation of the Consumer Policy action plan 1999-2001 , final report, Bureau Van Dijk Management Consultants – 16 December 2004.

[40] To be adopted by the Commission.