natgillin/translations-raw huggingface dataset:
In March 2018, the Commission submitted additional written questions to the manufacturer, to its notified body (TÜV Rheinland LGA Products GmbH) and to the Belgian and French authorities.
Za pripomočke z oznako CE, ki pomeni, da je bila njihova skladnost ocenjena, velja prosti pretok v Uniji (člen 4(1)).
They replied to these questions during March and April 2018.
Vendar člen 8 (zaščitna klavzula) Direktive 93/42/EGS določa, da „če kaka država članica ugotovi, da lahko pripomočki […] pri predvidenem namenu in ob pravilni namestitvi, vzdrževanju in uporabi škodljivo vplivajo na zdravje in/ali varnost bolnikov, uporabnikov in, če to pride v poštev, drugih oseb, sprejme ustrezne začasne ukrepe za umik takih pripomočkov s trga ali za prepoved ali omejitev njihovega dajanja na trg ali v uporabo. Država članica nemudoma obvesti Komisijo o vseh takih ukrepih z navedbo razlogov za tako odločitev […]“ (člen 8(1)).
EXAMINATION OF THE JUSTIFICATION FOR THE MEASURE
Komisija mora nato ugotoviti, ali so ukrepi upravičeni (člen 8(2)).
Directive 93/42/EEC establishes a system under which medical devices must meet the essential requirements set out in Annex I to the Directive which apply to them (Article 3, first paragraph).
Države članice morajo torej oceniti, ali lahko določen proizvod škodljivo vpliva na zdravje ali varnost ljudi, in če je tako, sprejeti potrebne ukrepe.
In order to prove compliance with these essential requirements, the manufacturer must follow one of the conformity assessment procedures provided for in the Directive, which allows the CE marking to be affixed to the devices (Article 11 and Article 17(1)).
Tako ocenjevanje lahko od nacionalnih organov zahteva zapleteno tehnično ali znanstveno presojo.
Devices bearing the CE marking indicating that they have undergone a conformity assessment may move freely within the Union (Article 4(1)).
Komisija nadzira upravičenost teh ukrepov, še posebej tako, da se prepriča o utemeljenosti pravnih in dejanskih razlogov za njihovo sprejetje.
However, in accordance with Article 8 (safeguard clause) of Directive 93/42/EEC, ‘where a Member State ascertains that the devices […], when correctly installed, maintained and used for their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service.
V tem okviru ima Komisija široko diskrecijsko pravico.
The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision […]’ (Article 8(1)).
V obravnavani zadevi so francoski organi v odločitvi in obvestilu, ki sta bila priglašena 4. oktobra 2016, ocenili, da zadevna pripomočka lahko pomenita tveganje za zdravje in da ne izpolnjujeta bistvenih zahtev.
The Commission must then determine whether the measures are justified or not (Article 8(2)).
Obstoj tveganja za zdravje in/ali varnost ljudi, ki je med drugim posledica nespoštovanja bistvenih zahtev iz Priloge I k Direktivi 93/42/EGS, pa povzroči uvedbo postopka na podlagi zaščitne klavzule iz člena 8(1) navedene direktive.
It is therefore for the Member States to determine whether a product is liable to compromise the health and safety of persons and, if so, to take the requisite measures.
Zato se v obravnavani zadevi uporabi postopek na podlagi zaščitne klavzule, Komisija pa mora ugotoviti, ali je ukrep, ki so ga sprejeli francoski organi, upravičen.
Such an exercise may entail complex technical and scientific assessments on the part of the national authorities.
Odločitev francoskih organov določa, da se prekine proizvodnja, dajanje v promet, distribucija, izvoz in uporaba pripomočka ter umakne pripomoček pri zadevnih distributerjih.
It is for the Commission to verify whether or not these measures are justified, and in particular to make sure that the legal and factual reasons for their adoption are valid.
Ker Direktiva 93/42/EGS v bistvu določa, da je mogoče medicinske pripomočke dati na trg in/ali v uporabo samo, če izpolnjujejo zahteve iz navedene direktive (člen 2), da države članice ne smejo ovirati dajanja na trg in v uporabo pripomočkov, katerih skladnost z Direktivo je bila ocenjena zaradi dokazovanja izpolnjevanja zahtev (člen 4), in ker člen 8 Direktive zadevni državi članici nalaga, da ob tveganju za zdravje ali varnost sprejme ukrepe „za umik takih pripomočkov s trga, ali za prepoved ali omejitev njihovega dajanja na trg ali v uporabo“, Komisiji pa nalaga preveritev upravičenosti takih ukrepov, se obravnavani sklep Komisije nanaša na ukrep francoskih organov, s katerim se omejuje prisotnost zadevnega pripomočka na trgu.
The Commission enjoys wide discretion in this context.
Iz odločitve, ki so jo priglasili francoski organi, in iz posvetovanj z zainteresiranimi stranmi izhaja, da se izpodbija izpolnjevanje bistvenih zahtev Direktive v zvezi z razmerjem med koristmi in tveganjem ter zmanjševanjem tveganja ter tudi pravilna uporaba standardov.
In the present case, in the decision and note notified on 4 October 2016, the French authorities take the view that the devices in question ‘may pose a risk to health’ and ‘do not comply with the essential requirements’.
Neizpolnjevanje bistvenih zahtev
However, where there is a risk to the health and/or safety of persons, resulting in particular from failure to comply with the essential requirements referred to in Annex I to Directive 93/42/EEC, a safeguard clause procedure may be initiated under Article 8(1) of that Directive.
Bistvene zahteve v zvezi z razmerjem med koristmi in tveganjem
It follows that, in the present case, the safeguard clause procedure applies, with the result that it is for the Commission to determine whether the measure taken by the French authorities is justified or not.
V zvezi s tveganji je treba najprej pojasniti, da so tveganja zaradi zaužitja svinca obsežno dokumentirana, predvsem v publikacijah, ki so navedene v smernici „Guideline for elemental impurities – Q3D“, ki jo je pripravil International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), v poročilu „Report on Carcinogens, fourteenth edition“ Ministrstva ZDA za zdravje in človeške vire, v znanstvenem mnenju „Scientific opinion on lead in food“ Evropske agencije za varnost hrane (EFSA) ter v publikacijah, na katere se sklicuje Uredba Komisije (ES) št. 1881/2006.
It is clear from the decision notified by the French authorities and from the consultations conducted with the interested parties that compliance with the essential requirements of the Directive concerning the risk/benefit ratio and minimising risk and the proper application of standards are being called into question.
Določa dovoljeno dnevno izpostavljenost elementom, ki so toksikološko problematični.
Failure to comply with essential requirements
Za svinec smernica navaja, da ima lahko izpostavljenost temu elementu nevrološke, reproduktivne, imunološke, kardiovaskularne in nefrotoksične posledice, ter določa dovoljeno dnevno izpostavljenost na 5 μg na dan ne glede na pot uporabe.
Essential requirements concerning the risk/benefit ratio
Iz analiz, na katere se sklicujejo francoski organi, je razvidno, da je raven svinca v pripomočku od 16 do 22,9 μg/g.
Section 6 of Annex I to the Directive provides: ‘Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended’.
V zvezi z uporabo smernice ICH Q3D je treba poudariti, da se ta smernica, ki se sicer formalno uporablja za zdravila, nanaša na prisotnost elementov (tudi svinca), ki nimajo terapevtskih koristi (elementarne nečistoče) in so toksikološko problematični v proizvodih, ki se med drugim uporabljajo peroralno.
As regards the risks, it should be pointed out at the outset that the risk caused by the ingestion of lead is widely documented, in particular in the publications cited by the ‘Guideline for elemental impurities – Q3D’ drawn up by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), in the ‘Report on Carcinogens, fourteenth edition’ of the U.S. Department of Health and Human Services, in the ‘Scientific opinion on lead in food’ of the European Food Safety Authority (EFSA) and in the publications cited by Commission Regulation (EC) No 1881/2006.
Zato jo je mogoče obravnavati kot ustrezno za ocenjevanje tveganja v zvezi z uporabo medicinskega pripomočka, ki kot nečistočo vsebuje svinec in je za peroralno uporabo.
In the present case, the device contains lead and is intended to be ingested.
Nazadnje je treba omeniti, da proizvajalec ne izpodbija prisotnosti svinca v pripomočku.
It should also be noted that the public is exposed to lead by many routes (air, water, food), with the result that any additional exposure, such as that caused by use of the device, increases the risk associated with exposure to lead.
Poleg tega proizvajalec ne izpodbija niti sproščanja svinca iz pripomočka, hkrati pa meni, da je to sproščanje šibko.
Moreover, the French authorities refer to the ‘Guideline for elemental impurities – Q3D’ (hereinafter ‘Guideline ICH Q3D’), drawn up by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopted by the European Medicines Agency (EMA) in December 2014 and applied by it to new applications for authorisation to place medicinal products on the market as of June 2016 and to existing authorisations for placing medicinal products on the market as of December 2017.
Proizvajalec hkrati navaja, da so bila tveganja, ugotovljena v poročilih, na katera se sklicujejo francoski organi, torej kardiovaskularne, nevrološke in nefrotoksične posledice zaužitja svinca za človeka, upoštevana v navedbah navodila za uporabo pripomočka, zato je bistvena zahteva iz točke 1 Priloge I k Direktivi izpolnjena; s tem priznava, da uporaba pripomočka pomeni določeno tveganje, hkrati pa meni, da je to tveganje na sprejemljivi ravni.
This Guideline concerns elemental impurities in medicinal products, namely elements which do not provide any therapeutic benefit to the patient, with the result that their levels must remain within acceptable limits.
Poleg tega poročilo laboratorija NAMSA, na katerega se sklicuje proizvajalec, potrjuje obstoj tveganja zaradi prisotnosti svinca v pripomočku, ki pa ga opredeljuje kot nizko.
It establishes a permitted daily exposure for elements of toxicological concern.
Iz navedenega izhaja, da uporaba pripomočka pomeni določeno tveganje za zdravje ali varnost pacientov, proizvajalec pa mora poskrbeti, da je to tveganje v sprejemljivih mejah glede na koristi pripomočka.
For lead, the Guideline indicates that exposure to this element may cause neurological, reproductive, immune, cardiovascular and renal health effects; it establishes permitted daily exposure at 5 μg per day, irrespective of the route of administration.
Kar zadeva koristi, je v skladu z navodilom za uporabo pripomoček namenjen preprečevanju prebavnih motenj, zmanjševanju prebavnih nevšečnosti, ponovni vzpostavitvi prebavnega udobja in zmanjševanju obsega trebuha.
The tests to which the French authorities refer show that the device contains levels of lead between 16 and 22,9 μg/g.
Opozoriti je treba, da naj bi se medicinski pripomoček v skladu s členom 1(2) Direktive uporabljal za medicinske namene.
A course of treatment involving six capsules of 335 mg per day (i.e. 2 g per day), as provided for in the instructions for use of the device, corresponds to an ingested amount of lead of between 32 and 46 μg per day, which is several times higher than the reference threshold of 5 μg per day.
V obravnavani zadevi pa je razvidno, da bi se od štirih trditev iz navodila samo tista v zvezi s preprečevanjem prebavnih motenj morda lahko obravnavala kot medicinska.
With regard to use of Guideline ICH Q3D, it should be pointed out that this Guideline, while it applies formally to medicinal products, concerns the presence of elements (including lead) which do not provide any therapeutic benefit (elemental impurities) and which raise toxicological concerns in products administered orally, amongst other routes.
Ker ni podrobnejših pojasnil v navodilu za uporabo ali tehnični dokumentaciji ter ob upoštevanju drugih trditev in oglaševanja pripomočka, ki se osredotoča na pridobitev ravnega trebuha, je mogoče sklepati, da so zadevne prebavne motnje manjšega značaja.
It may therefore be considered relevant in assessing the risk associated with using a medical device which contains lead as an impurity and which is administered orally.
Skratka, medicinske koristi pripomočka so zanemarljive.
Finally, it should be pointed out that the manufacturer does not contest the fact that the device contains lead.
Na podlagi navedenega so francoski organi upravičeno menili, da pripomoček ne izpolnjuje bistvenih zahtev Direktive v zvezi z razmerjem med tveganji in koristmi.
Nor does the manufacturer contest the fact that lead is released by the device, albeit to a minor extent.
Tako sklepanje potrjuje neizpolnjevanje bistvene zahteve v zvezi s kliničnim vrednotenjem.
Moreover, the manufacturer indicates that the risks identified by the reports cited by the French authorities — namely cardiovascular, neurological and nephrotoxic effects of lead in humans — were taken into account through the indications in the instructions for use of the device, in such a way that the essential requirement of Section 1 of Annex I to the Directive has been met; the manufacturer therefore acknowledges that use of the device poses risks, albeit at an acceptable level.
V obravnavani zadevi je, kakor je navedeno v zvezi s koristmi, pripomoček namenjen preprečevanju prebavnih motenj, zmanjševanju prebavnih nevšečnosti, ponovni vzpostavitvi prebavnega udobja in zmanjševanju obsega trebuha.
In addition, a report from the NAMSA laboratory cited by the manufacturer acknowledges that there is a risk associated with the presence of lead in the device, while describing this risk as low.
Toda v sklepih poročila o kliničnem vrednotenju, ki ga je na zahtevo proizvajalca izvedel laboratorij NAMSA in se nanaša na vse razpoložljive podatke, je navedeno, da so bile analizirane tri trditve (zmanjševanje prebavnih nevšečnosti, pomoč pri zmanjševanju obsega trebuha, omogočanje hitrega izboljšanja prebavnega udobja) in da sta s kliničnimi podatki podprti samo dve trditvi, povezani z zmanjševanjem prebavnih nevšečnosti in obsega trebuha.
It follows from the above that use of the device poses a risk to the health or safety of patients which the manufacturer is responsible for keeping within acceptable limits in relation to the benefits provided by the device.
Četrta trditev v zvezi s preprečevanjem prebavnih motenj v sklepih navedenega poročila o kliničnem vrednotenju ni omenjena.
As regards the benefits, according to the instructions for use, the device is intended to ‘prevent digestive problems, reduce digestive discomfort, restore digestive comfort and reduce abdominal circumference’.
Proizvajalec torej ni predložil kliničnih podatkov v podporo obstoja vseh navedenih koristnih učinkov, zlasti obstoja koristnega učinka v smislu preprečevanja prebavnih motenj.
In the absence of details in the instructions for use or technical documentation and in view of the other claims and the advertising for the device focusing on obtaining a ‘flat stomach’, it is fair to assume that the digestive problems in question are nothing out of the ordinary.
Bistvene zahteve v zvezi z zmanjševanjem tveganj
All in all, the device appears to be of little benefit in medical terms.
Iz zgoraj navedenega izhaja, da uporaba pripomočka pomeni določeno tveganje za zdravje ali varnost pacientov (točke 20–26), ki ga mora proizvajalec kar najbolj zmanjšati.
In view of this, the French authorities were able to conclude that the device does not comply with the essential requirements of the Directive with regard to the risk/benefit ratio.
Poleg tega je svinec v delu 3 Priloge VI k Uredbi (ES) št. 1272/2008 opredeljen kot strupen za razmnoževanje, po mnenju Evropske agencije za kemikalije (ECHA) pa je „substance of very high concern“, zato mu je treba posvetiti posebno pozornost.
This conclusion is confirmed by the failure to comply with the essential requirement concerning clinical evaluation.
Zgoraj navedene bistvene zahteve lahko za proizvajalca medicinskega pripomočka pomenijo, da mora izbrati serije surovin, ki so glede strupenih snovi, ki jih vsebujejo, najmanj tvegane, torej, da mora preveriti koncentracijo škodljive snovi v serijah surovin ter izbrati serije, katerih koncentracija je združljiva s stanjem tehničnega razvoja.
Section 6a of Annex I to Directive 93/42/EEC provides: ‘Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X’.
V obravnavani zadevi surovina v sestavi pripomočka, tj. glina, vsebuje škodljive snovi, zlasti svinec, v koncentracijah, ki lahko nihajo, ker gre za surovino naravnega izvora.
Section 1.1 of Annex X (clinical evaluation) to the Directive provides: ‘As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data’.
Tako francoski kot belgijski organi izpostavljajo veliko nihanje vsebnosti svinca v različnih serijah želatinskih kapsul pripomočka.
In the present case, as regards the benefits, the device is intended to ‘prevent digestive problems, reduce digestive discomfort, restore digestive comfort and reduce abdominal circumference’, as indicated above.
Proizvajalec je imel možnost, da pred proizvodnjo preveri vsebnost svinca v različnih serijah gline in izbere samo tiste serije, pri katerih bi nizka vsebnost svinca zagotavljala, da bi bila koncentracija v želatinskih kapsulah, proizvedenih iz te surovine, nižja od mejne vrednosti po smernici ICH Q3D.
The assessment of the clinical data therefore does not confirm that the device complies with the essential requirement relating to the risk/benefit ratio.
Proizvajalec torej ni kar najbolj zmanjšal tveganja v zvezi s prisotnostjo svinca v pripomočku z izbiro serij surovin, ki bi omogočale proizvodnjo pripomočka z vsebnostjo svinca, ki bi bila nižja od mejne vrednosti iz smernice ICH Q3D.
In view of this, it was possible to conclude that the device does not comply with the essential requirement relating to the clinical evaluation, in connection with the essential requirement relating to the risk/benefit ratio.
Proizvajalec pripomočka lahko na podlagi zgoraj navedenih bistvenih zahtev med različnimi surovinami izbere tisto, ki je najmanj tvegana, kar zadeva strupene snovi, ki jih vsebuje.
Essential requirements relating to minimising risk
V točki 7.1 Priloge I k Direktivi je namreč določeno, da je treba „posebno pozornost […] posvetiti […] izbiri uporabljenih materialov, zlasti kar zadeva toksičnost […]“.
Section 7.2 of Annex I to Directive 93/42/EEC provides: ‘The devices must be designed, manufactured and packed in such a way as to minimise the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product.
V obravnavani zadevi imajo druge surovine, na primer aktivno oglje, simetikon ali dimetikon, podobne lastnosti kot glina in bi proizvajalec z njimi lahko dosegel zatrjevani medicinski namen svojega pripomočka, tj. preprečevanje prebavnih motenj.
Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure’.
Te druge surovine ne vsebujejo svinca in zato ne morejo povzročiti tveganja, ki ga povzroča zadevni pripomoček.
Section 7.5 of Annex I to the Directive provides: ‘The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device.
Vendar proizvajalec ni raziskal drugih surovin, ki niso okužene s strupenimi snovmi (glej njegovo elektronsko sporočilo z dne 30. marca 2018).
Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances […]’.
Zato s tem ni kar najbolj zmanjšal tveganja zaradi prisotnosti svinca v pripomočku.
Annex I to Council Directive 67/548/EEC has become Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council.
Na podlagi navedenega so francoski organi upravičeno menili, da pripomoček ne izpolnjuje bistvenih zahtev Direktive v zvezi z zmanjševanjem tveganja.
It follows from the above that use of the device poses a risk to the health or safety of patients (points 20-26), which it is the manufacturer's responsibility to reduce to a minimum.
Ugovori proizvajalca v zvezi z neizpolnjevanjem bistvenih zahtev
Moreover, lead is described as a substance toxic to reproduction in Part 3 of Annex VI to Regulation (EC) No 1272/2008; it is also considered to be a ‘substance of very high concern’ by the European Chemicals Agency (ECHA), which justifies special attention being paid to it.
Proizvajalec izpodbija uporabo smernice ICH Q3D.
For the manufacturer of a medical device, the above-mentioned essential requirements may involve choosing batches of raw materials posing the least risk in terms of the toxic substances which they contain, i.e. verifying the concentration of a harmful substance in the batches of the raw material and selecting the batches showing a concentration which is compatible with the state of the art.
Navaja zlasti, da se smernica ne uporablja ratione materiae, ker se uporablja za zdravila, niti ratione temporis, ker se uporablja za nove vloge za dovoljenja za promet z zdravili od junija 2016 in za obstoječa dovoljenja za promet z zdravili od decembra 2017, ter da je njena uporaba v nasprotju z načeli zakonitosti in pravne varnosti.
In the present case, the raw material which forms part of the composition of the device, namely clay, contains harmful substances, in particular lead, in concentrations which may vary as it is a raw material of natural origin.
Kljub temu pa uporaba smernice ICH Q3D spada v okvir člena 8(1) Direktive, ki državi članici nalaga sprejetje ustreznih začasnih ukrepov, če ugotovi, da lahko medicinski pripomoček pomeni tveganje za varnost in/ali zdravje, in ki ne omejuje elementov, na katere se lahko država članica opira pri dokazovanju obstoja tega tveganja.
The French authorities, like the Belgian authorities, have shown that there is a high degree of variation in the lead levels of different batches of capsules of the device.
Poleg tega je smernica, ki se sicer uradno uporablja za zdravila, iz zgoraj navedenih razlogov (točka 24) primerna tudi za ugotavljanje tveganja zaradi prisotnosti svinca v medicinskem pripomočku, če gre za podobno situacijo kot pri zdravilih.
The manufacturer had the option of checking the lead content of the different batches of clay prior to manufacture and of selecting only those batches whose low lead content would have guaranteed that the capsules manufactured from this raw material contained a concentration lower than the threshold in Guideline ICH Q3D.
Zato je uporaba smernice pravno utemeljena in predvidljiva.
However, under the contract between the manufacturer and its supplier, the batches of raw material were tested to determine their lead concentration and the manufacturer accepted batches whose lead concentration did not exceed 15 ppm, which equates to 15 μg/g.
Proizvajalec izpodbija uporabljeno metodo za ocenjevanje tveganja.