natgillin/translations-raw huggingface dataset:
Najkasneje štiri leta od začetka veljavnosti te direktive Komisija predloži Evropskemu parlamentu in Svetu poročilo o oceni uporabe zaščitnih elementov iz točke (o) člena 54 Direktive 2001/83/ES in oceno njihovega prispevka k zmanjšanju števila ponarejenih zdravil v zakoniti dobavni verigi v Evropi.
No later than four years following the entry into force of this Directive, the Commission shall submit to the European Parliament and the Council an assessment report on the application of the safety features referred to in point (o) of Article 54 of Directive 2001/83/EC and their estimated contribution to the reduction of the number of falsified medicin al products in the legal supply chain in the EU .
Poročilo vsebuje zlasti oceno o tem, ali je priporočljivo razširiti zaščitne elemente na druge kategorije zdravil, tudi na zdravila, ki se ne izdajajo na recept, kot je določeno v naslovu VI Direktive 2001/83/ES.
The report shall assess in particular the advisability of extending the safety features to other categories of medicin al products , including medicinal products not subject to medical prescription as defined in Title VI of Directive 2001/83/EC.
Komisija po potrebi predloži predloge Evropskemu parlamentu in Svetu.
If appropriate , the Commission shall present proposals to the European Parliament and the Council.
Sporazumni predlog spremembe vključuje predloga sprememb 50 (Matias) in 372 (Grossetête).
This compromise amendment covers AM 50 (Matias), 372 (Grossetête)
Predlog Komisije za preprečevanje vstopa ponarejenih zdravil v dobavno verigo opozarja na grožnjo kakovosti in varnost zdravil, ki jih jemljemo, kar med evropskimi državljani povzroča vse večjo zaskrbljenost.
The Commission's proposal on the prevention of falsified medicines entering the supply chain highlights a concern which is getting higher and higher on the agenda of the European citizens: the quality and safety of the medicinal products they are consuming.
Poročevalka zato pozdravlja predlog Komisije za boj proti ponarejenim zdravilom kot nujen odziv na naraščajočo grožnjo zdravju ter za zagotovitev večje varnosti bolnikov.
Therefore the Rapporteur welcomes the Commission proposal to combat falsified medicines as a necessary step to respond to this rising health threat and to better ensure patients’ safety.
V oceni učinka ( SEC(2008)2674 ) je Komisija med drugim zapisala tudi naslednje zelo zaskrbljujoče ugotovitve:
The impact assessment by the Commission ( SEC(2008)2674 ) mentions inter alia the following very alarming observations:
- Strmo je narasla količina ponarejenih zdravil, ki so jih zaplenili carinski organi (2,7 milijona zdravil, zaplenjenih na carinskih mejah EU leta 2006 in 2,5 milijona leta 2007, kar je 384°% več kot leta 2005).
- A sharp increase in seizures of falsified medicines by customs (2.7 million medicinal products at EU custom borders in 2006 and 2.5 million in 2007; an increase of 384% compared to 2005)
- Premik s ponarejanja zdravil, ki jih ljudje jemljejo zaradi svojega življenjskega sloga, k ponarejanju zdravil, ki rešujejo življenja, vključno z zdravili za zdravljenje raka in bolezni srca, psihičnih motenj in vnetij.
- A trend from the falsification of 'lifestyle' medicines to life-saving medicines, including medicines to treat cancer and heart disease, psychiatric disorders and infections.
Zdravljenje s takimi ponarejenimi zdravili je lahko smrtno.
Treatment with such falsified medicines can have fatal consequences.
- Premik proti klasični dobavni verigi.
- A trend towards targeting the classical supply chain.
Poleg interneta, je vse bolj na udaru dovoljena distribucijska veriga.
Besides the internet, the licensed distribution chain is increasingly targeted.
Med trinajstimi državami članicami, ki so poslale podatke, jih je sedem poročalo o primerih ponarejenih zdravil v zakoniti dobavni verigi.
Out of 13 Member States who had data, seven reported incidences of counterfeit medicinal products in the legal supply chain.
Poudariti je treba, da je po mnenju skupine izvedencev pri Svetovni zdravstveni organizaciji, v mnogih afriških državah, delih Azije in Latinske Amerike na nekaterih področjih lahko več kot 30°% zdravil v prodaji ponarejenih.
It needs to be emphasised that, according to the expert group of the WHO, many countries in Africa, parts of Asia and Latin America have areas where more than 30% of the medicines on sale can be falsified.
Politika preprečevanja ponarejenih zdravil na evropskem tržišču bi morala imeti ugodne učinke tudi za druge regije po svetu, kjer so težave še večje.
Policies to prevent falsified medicines on the European market should also have positive impacts in other regions of the world where the problem is even more prominent.
Bolniki morajo biti popolnoma prepričani, da so zdravila, ki jih jemljejo, dejansko to, kar pričakujejo.
Patients need to be absolutely sure that the medicines they consume are really the medicines they expect it to be.
Uporaba ponarejenih zdravil lahko vodi v neuspeh zdravljenja in ogrozi življenje bolnikov.
The use of falsified medicines can result in therapeutic failure and can put lives at risk.
Poročevalka zato meni, da bi moralo biti glavni cilj direktive varovanje javnega zdravja pred ponarejenimi zdravili.
Your Rapporteur therefore believes that the protection of public health against falsified medicines should be the main focus of the directive.
Ne bi ga smeli obremenjevati z dodatnimi cilji.
This focus should not be troubled by other additional objectives.
Direktiva se ne bi smela ukvarjati z intelektualno lastnino ali patentnimi pravicami, ki so že zajete v drugih posebnih zakonodajnih okvirih.
The directive should not concern intellectual property and patent rights, which are already covered by other specific legislative frameworks.
Dvojna pravna podlaga
Double legal basis
Poročevalka je za direktivo izbrala dvojno pravno podlago.
Your Rapporteur chooses to have a double legal basis for this directive.
Ponarejanje zdravil je kaznivo dejanje, ki bolnike prikrajša za nujno medicinsko zdravljenje ter škodi njihovemu zdravju, včasih pa celo vodi v smrt.
Falsifying of medicinal products is a criminal act that denies patients the necessary medical treatment and is harmful to their health, sometimes even leading to their death.
Opredelitve in odgovornosti
Definitions and responsibilities
Jasne opredelitve obsega, kot tudi različnih akterjev v dobavni verigi, so ključnega pomena za boljše varovanje distribucijske mreže za zdravila.
To be able to better safeguard the distribution network for medicinal products it is crucial to have clear definitions on not only the scope, but also on the different actors in the supply chain.
Kaj je ponarejeno zdravilo?
What is a falsified medicinal product?
Kaj sta zdravilna učinkovina in pomožna snov?
What is an active ingredient or an excipient?
Predlog Komisije tega ne pojasni dovolj.
The Commission proposal does not provide the required clarity.
Enako velja za opredelitve različnih akterjev v dobavni verigi ter pojasnitev njihovih vlog in odgovornosti.
The same applies for the definitions of the different actors in the chain of supply, clarifying their roles and responsibilities.
Bistveno je razlikovati med akterji, ki so uradno priznani – in ki imajo verjetno odgovorno vlogo – in tistimi, ki ne spadajo v to skupino, čeprav so pomembni glede odgovornosti v dobavni verigi.
It is essential to make a distinction between those actors who are already formally recognized - and which role is considered liable - and those who are outside that category, although being relevant to the liability of the distribution chain.
Zato je treba razlikovati med trgovci in posredniki ter pojasniti njihovo vlogo in odgovornost.
Therefore it is important to make the distinction between traders and brokers, as well as to clarify their roles and responsibilities.
Enako velja tudi za druge akterje, kot so prevozniki ali vzporedni trgovci.
The same applies for other actors, such as transporters or parallel traders.
Direktiva bi morala preprečiti zmedo in ne sme dovoljevati t.i. sivih območij.
The directive should prevent confusion and should not allow any room for 'grey' areas.
Jasno bi morala določiti, kateri akterji in pod kakšnimi pogoji lahko delujejo na tem področju.
It should clearly identify which actors and under which conditions are able to operate in this domain.
Jasne opredelitve bodo pripomogle k enostavnejšemu izvajanju.
Clearer definitions will result in simpler implementation.
Ponarejanje zdravil ni samo prekršek.
The falsification of medicinal products is not a minor offence.
Je organizirana kriminalna dejavnost, ki ogroža človeška življenja.
It is an organised criminal activity that puts human lives at risk.
Kazni za ponarejanje zdravil morajo biti vsaj enakovredne tistim, ki se ponavadi uporabljajo za nezakonita dejanja, povezana z narkotiki.
Sanctions against falsification should reflect this and should be equivalent to those typically applied for illegal acts related to narcotics.
Ključno je okrepiti ustrezne kazenske določbe iz predloga Komisije.
It is crucial to strengthen the relevant provisions on sanctions in the Commission's proposal.
Zaščitni elementi
Safety features
Države članice razlikujejo med zdravili na recept in zdravili, ki se izdajajo brez recepta, ker je za bolnike tveganje pri zdravilih na recept, ki so ponarejena ali vzeta v napačnih količinah, večje.
Member States make the distinction between prescription and non prescription medicines since prescription medicines result in higher risks for the patient either when falsified or when unduly taken.
Zato morajo biti zaščitni elementi za zdravila na recept obvezni.
Therefore safety features must be mandatory for prescription medicines.
Priznati pa je treba, da bodo zdravila ponarejana samo, če bodo zato obstajali ekonomski razlogi.
It needs however to be recognised that medicines will only be falsified if there are economic reasons for doing so.
Zaradi nizkih stroškov je manj dobičkonosno ponarejati generična zdravila.
Because of the low costs of generic medicinal products it is less profitable to falsify this group of medicines.
Zato poročevalka meni, da se lahko odstopi od meril učinkovitosti za zaščitne elemente za določena generična zdravila ali skupine zdravil, vendar samo, če je to v skladu z oceno tveganja.
Therefore your Rapporteur is of the opinion that, only if this is in accordance with the conclusions of a risk assessment, the performance criteria for the safety features can be waived for certain generic medicinal products or product categories.
Poročevalka tudi predlaga, da se pet let po uveljavitvi te direktive oceni, ali naj bodo zaščitni elementi obvezni tudi za zdravila brez recepta.
Your Rapporteur furthermore proposes to assess within five years after the entry info force of this directive whether safety features should also be mandatory for the so called over the counter medicines.
Ko bolnik vzame zdravilo, užije njegove učinkovine, pa tudi pomožne snovi.
When patients take medicinal products they do not only consume the active ingredients, but also the excipients.
Posledice uporabe ponarejenih pomožnih snovi so dobro dokumentirane.
The consequences of the use of falsified excipients are well documented.
Med primeri hudih posledic je smrt 89 ljudi leta 1995 in vsaj 59 otrok leta 1998 na Haitiju in 30 otrok leta 1998 v Indiji.
Examples of severe consequences include the death of 89 people in 1995, and of, at least, 59 children in 1996 in Haiti, or the death of 30 children in India, in 1998.
Poročevalka je zato pomožne snovi vključila v osnutek poročila.
The Rapporteur therefore included the excipients in the draft report.
Kakovost in pristnost zdravil je treba preveriti.
The quality and authenticity of the falsified medicines should be verified.
Predlog Komisije se ne ukvarja s spletno prodajo, saj jo obravnava kot del nezakonite dobavne verige.
The Commission proposal does not address internet sales, considering it as part of the illegal chain of supply.
To ne odseva dejstva, da je v nekaterih državah članicah spletna prodaja zakonita.
This does not reflect the fact that in some Member States internet sales are legalized.
Dobro znano je, da je internet ena od glavnih vstopnih poti za ponarejena zdravila na evropsko tržišče.
It is well known that internet represents one of the main routes for falsified medicinal products to enter the European market.
Poročevalka je v osnutek poročila vključila določbe, ki obravnavajo to pomembno pot.
Your Rapporteur chooses to include provisions in the draft report to deal with this important route.
Prva prednostna naloga je boljša ozaveščenost javnosti o tveganju, povezanim s spletnim nakupom zdravil.
The first priority is to increase public awareness of the risks of buying medicinal products through the internet.
Vzpostaviti je treba vzgojne programe za dvig ozaveščenosti javnosti o obstoju ponarejenih zdravil in tveganju, ki ga prinaša nakup po nepooblaščenih poteh.
Educational programmes to increase consumer awareness about the existence of falsified products and the risk of buying medicines from unauthorised channels should be put in place.
Druga prednostna naloga pa je zagotoviti, da bodo bolniki lahko prepoznali spletne strani, ki so skladne z ustrezno zakonodajo.
The second priority is to ensure that patients can recognise those sites which are in compliance with the relevant legislation.
Direktiva, ki bi se osredotočala na boj proti ponarejanju zdravil, ne da bi obravnavala internet kot njegovo najpomembnejšo pot, javnosti ne bi bila razumljiva.
A directive aiming at fighting the falsification of medicines, without dealing with internet, the most important route, is not explainable to the public.
Obravnava te poti je med ključnimi temami tega osnutka poročila.
Addressing this route is one of the key issues in the draft report.
Podatki in poročanje
Information and Reporting
Oblikovanje mreže, ki bo povezala Komisijo, Evropsko agencijo za zdravila in pristojne organe v državah članicah, bo izboljšalo izmenjavo podatkov in razumevanje pojava, kar bo pripomoglo k njegovi boljši obravnavi.
The creation of a network between the Commission, the European Medicines Agency and the competent authorities in Member States would help to have more data and a better understanding of the phenomenon so as to better tackle it.
Komisija, Evropska agencija za zdravila in pristojni organi v državah članicah tej mreži letno poročajo o sprejetih ukrepih.
The Commission, European Medicines Agency and the competent authorities in the Member States shall report annually to this network on the actions they have undertaken.
Sodelovanje med različnimi nacionalnimi in mednarodnimi organi za boj proti ponarejanju zdravil je nujno.
Coordination between various national and international bodies involved in fighting falsified medicines is necessary.
Treba je izboljšati mednarodno sodelovanje in razviti ustrezne večstranske mehanizme, ki bodo državam uvoznicam omogočali, da sprožijo preiskavo in prepoznavanje dejanskega vira ponarejenih zdravil na njihovem trgu.
It’s important to improve international collaboration and develop appropriate multilateral mechanisms that will enable importing countries to trigger investigations and identification of the actual source of counterfeit medicines entering their markets.
Inšpekcijski pregledi uvoza
Imports inspections
Direktiva se osredotoča na nadzor kakovosti uvoženih zdravil, saj je to eden od ključnih vhodov za ponarejena zdravila na evropski trg.
This Directive focuses on the quality control of the import of medicinal products, since this is one of the key entry doors of falsified medicines to the European market.
Zato poročevalka meni, da je pomembno vzpostaviti inšpekcijski sistem, ki bo v glavnem temeljil na dobri proizvodni praksi, ki je že določena z mednarodnimi sporazumi.
Therefore your Rapporteur considers it to be crucial to create an inspections system which is mainly based on the Good Manufacturing Practices already defined through international agreements.
Že obstoječe mednarodno sodelovanje in izkušnje držav članic so temelj za okrepljen in učinkovit sistem odkrivanja ponaredkov.
The already existing international cooperation, together with the experience in the Member States are key anchors for a strengthened efficient detection system of falsifications.
Predlog Komisije ne obravnava nadzora distribucije ponarejenih zdravil v tretje države.
The Commission proposal does not address the control and distribution of falsified medicines to third countries.
Težko je pojasniti, zakaj so tako stroge določbe za odkrivanje odgovornih za ponarejena zdravila, ki vstopijo na evropski trg, in ni nobenih določb za zdravila, ki jih izvažamo v tretje države v Afriki, Južni Ameriki ali Aziji.
It is difficult to explain why we have stringent provisions for medicines that enter the European market in order to find the responsible actors if medicines are falsified, but no provisions for medicines which are exported to third countries in Africa, South America or Asia.
To znatno slabi možnosti, da bi Evropa vztrajala pri tesnejšem mednarodnem sodelovanju.
This significantly weakens the possibility for Europe to insist on stronger international cooperation.
Pri proizvodnji zdravil in njihovi distribuciji iz Evropske unije v tretje države je treba spoštovati ista merila kot pri uvozu.
The manufacturing and the distribution of medicines from the EU to third countries must obey the same criteria as applied for the import.
To bi okrepilo naš prispevek k boju proti zločinskem ponarejanju zdravil v nekaterih tretjih državah, kjer je po ocenah Svetovne zdravstvene organizacije ta problem zelo pereč.
This would strengthen our contribution to fight the criminal falsification of medicines in several third countries where, according to WHO estimates, the problem is very serious.
Sklepne ugotovitve
Final remarks
Direktiva obravnava nekaj nasprotujočih si interesov.
Within this directive several often contradictory interests are at the stake.
Za nekatere akterje je rešitev v zmanjšanju števila posrednikov; drugi bi raje ohranili obstoječe postopke, ne da bi bili udeleženi pri delitvi odgovornosti ali stroškov.
For some actors the solution involves the reduction of intermediaries; others would prefer the maintenance of the already existing procedures without taking part in the sharing of responsibilities or costs.
Nekateri podpirajo načelo, da se mora ta direktiva osredotočiti na tveganja, povezana z izdelki; drugi, da bi se morala osredotočiti na tveganja, povezana z dobavno verigo.
Some actors support the principle that this Directive should focus on the risks of the products; some support the focus on the risks of the chain.
Poročevalka je prepričana, da bi ta direktiva morala upoštevati različne interese, osredotočiti pa bi se morala na naš skupen interes, t.j. varnost bolnikov.
Your Rapporteur truly believes that the directive should take into account the different interests, but that it should focus on our common interest - patient safety.
To je vodilno načelo predlogov sprememb iz osnutka poročila.
This is the guiding principle for the amendments in the draft report.
Vstop ponarejenih zdravil v zakonito dobavno verigo ogroža celoten evropski farmacevtski sistem, saj spodkopava zaupanje, ki ga imajo državljani v kakovost zdravil, ki so jim na voljo v lekarnah in na drugih zakonitih mestih dobave.
The entry of falsified medicinal products into the legal supply chain is a threat to Europe's entire pharmaceutical system because it undermines public confidence in the quality of the medicinal products available in pharmacies and other legal sales outlets.
V vseh evropskih državah je število ponarejenih zdravil vse večje.
The number of falsified medicinal products is rising sharply in all of the Member States.
Po ocenah Svetovne zdravstvene organizacije je 1 % zdravil, ki jih zakonita farmacevtska dobavna veriga danes proda evropski javnosti, ponarejenih.
The WHO estimates that 1% of the medicinal products currently sold to the European public through the legal supply chain are falsified.
To lahko pomeni, da utegnejo ponarejena zdravila vsebovati sestavine, tudi učinkovine, ki so slabše kakovosti ali ponarejene, jih v zdravilih sploh ni ali pa so v napačnih odmerkih.
Falsified medicinal products may contain sub-standard or falsified ingredients, or no ingredients or ingredients in the wrong dosage, including active ingredients.
Kljub temu, da je pojav v Evropi v primerjavi z drugimi deli sveta, zlasti z Afriko, še vedno omejen, nekaterih dejavniki kažejo, da bo morala Evropska unija nujno hitro in strogo ukrepati.
Although the scale of this problem is still relatively small in Europe when compared with other parts of the world, such as Africa, a number of factors point to the need for swift, rigorous action by the European Union.
Prvi zaskrbljujoč dejavnik je, da se je vrsta tveganja spremenila: prej so ponarejali v glavnem tako imenovana zdravila „življenjskega sloga“, zdaj pa se močno povečuje število ponaredkov inovativnih in življenjsko pomembnih zdravil.
The first concern is the fact that the risk profile has changed: while in the past most of the medicinal products that were counterfeited were 'lifestyle' drugs, counterfeiting of innovative and life-saving drugs is now increasing sharply.
Drugič, ta pojav že ima zaskrbljujoče razsežnosti.
Second, the problem has already taken on worrying proportions.
Evropska komisija ocenjuje, da se proda 1,5 milijona škatlic ponarejenih zdravil v zakoniti dobavni verigi v Evropi.
The Commission puts the number of boxes of falsified medicines sold within the legal supply chain each year in Europe at 1.5 million.
Še bolj zaskrbljujoče je, da se njihov obseg vsako leto poveča v povprečju za 10–20 odstotkov.
The fact that volumes are increasing on average by 10-20% per year is of still greater concern.
Ob 10-odstotnem deležu rasti naj bi se število škatlic ponarejenih zdravil, ki se prodajo v zakoniti dobavni verigi, v letu 2020 povzpelo na 42 milijonov.
With a growth rate of 10%, the number of boxes of falsified medicines in the legal supply chain would reach 42 million by 2020.
Po drugih, bolj pesimističnih ocenah naj bi bila rast 30 %, pri čemer bi bilo prodanih škatlic ponarejenih zdravil 192 milijonov.
Other, more pessimistic, estimates put the growth rate at 30%, which would increase that number to 192 million.
Kot parlamentarni odbor, pristojen za industrijo in raziskave, ne moremo podcenjevati hude nevarnosti, ki jo pomeni ta pojav ne samo za javno zdravje, temveč tudi za enega izmed vodilnih sektorjev evropske industrije.
In our capacity as members of the committee with responsibility for industry and research, we cannot afford to ignore the serious threat that falsified medicines pose not just to public health but also to one of the leading sectors of the EU economy.
Skupne naložbe sektorja v raziskave in razvoj znašajo več kot 26 milijard evrov, kar pomeni 17 % evropskih odhodkov.
The industry invests at total of more than EUR 26 billion per year in research and development (17% of spending for the EU as a whole).
Pomembno je torej preprečiti nepošteno konkurenco, ki jo povzročajo tuji proizvajalci z dajanjem aktivnih farmacevtskih učinkovin na evropski trg, pri čemer se ne preveri, ali so izdelani v skladu z dobro proizvodno prakso.
It is therefore important to prevent unfair competition from non-Community producers who place active pharmaceutical ingredients on the EU market without it having been properly ascertained whether those producers comply with good manufacturing practice.
Tako bi obenem zavarovali tudi zdravje državljanov.
This will at the same time serve to protect public health.
Čeprav je Evropska komisija s tem predlogom sprejela in privzela pomisleke, ki jih je izrazil Evropski parlament v pisni izjavi št. 61 iz leta 2006 o aktivnih farmacevtskih učinkovinah, ostajajo nekatera vprašanja, ki bi jih bilo dobro pojasniti in okrepiti.
Although the Commission has, in its proposal, taken over the concerns Parliament voiced in Written Declaration 61/2006 on active pharmaceutical agreements, a number of points still need to be clarified and fleshed out.