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听听President. 鈥� The next item is the debate on the Commission statement on the presentation of the proposal for a Critical Medicines Act ().

听听Oliv茅r V谩rhelyi, Member of the Commission. 鈥� Mr听President, honourable Members, today the Commission adopted the Critical Medicines Act. This proposal is very much needed to ensure security of supply and availability of critical medicines, as well as accessibility of other key medicines where the market is not delivering. This is a priority file for the Commission, which is adopted on its hundredth day as promised.

Why, you might ask? Because medicine shortages are a long standing concern for the EU and our citizens. This concern has been raised multiple times by this House, as well. Enough to mention that a number of shortage notifications has increased substantially and persistently since 2013, reaching the peak in 2019 with close to 14听000 notifications. Enough to mention that most EU countries report increasing numbers of medicine shortages, with the great majority having recorded shortages for 200 or more medicines in 2023.

With the help of this House, we have already taken a number of steps at EU level to improve the situation. Together, honourable Members, we are reforming the general pharmaceutical legislation and have extended the mandate of the European Medicines Agency. These two building blocks establish a regulatory framework to prevent and mitigate shortages during crises and at all times. We have established together a Critical Medicines Alliance, bringing together more than 300 stakeholders from the patient and the scientific communities, health professionals, Member States and industry to explore ways to strengthen the supply of critical medicines in the EU. The Alliance has already provided us with recommendations in its strategic report.

The Critical Medicines Act builds on all this work we have done together. It provides a comprehensive approach to improve the availability of critical medicines and accessibility of other key medicines where there is a market failure. It complements the ongoing revision of the pharmaceutical legislation and aims to reduce dependencies for critical medicines and their ingredients to reinforce the EU's strategic autonomy in health.

It will also have a positive impact on the Union's competitiveness by fostering a more stable and predictable market environment, encouraging investment and supporting innovation in the pharmaceutical sector. The act has different mechanisms to achieve these goals. First, it will facilitate investments for companies that create or increase manufacturing capacity of critical medicines in the EU. It will become possible for these projects to be identified as strategic projects. This will give them easier access to funding and fast-track administrative, regulatory and scientific support.听The Commission has today also published State aid guidance to help Member States to finally support such strategic projects or projects pursuing similar objectives.

Second, the act will increase the resilience of supply chains. Procurers will have to use criteria other than only price in their procurement procedures. For instance, these criteria could be the use of diversified suppliers or contractual clauses on timely delivery. There are also provisions for critical medicines with high dependency on supply from one or from a limited number of countries outside the EU. In this case, procurers will also be required, where justified, to favour suppliers that manufacture a significant proportion of these critical medicinal products in the EU, as long as they comply with the Union's international commitments.

Third, we will offer Member States the possibility to make use of aggregated demands. If interested, EU countries will be able to request support from the Commission to use different collaborative procurement tools, facilitating access to the medicines they need, building on the experience of jointly procuring medical countermeasures.

Finally, the Commission will seek to enhance existing cooperations and conclude new international partnerships to diversify supply chains for these critical medicines. When it comes to the new international partnerships, of course, I very much rely on the candidate countries and countries in our closest neighbourhood who should be in pole position to help us to bring back production in the EU or closer to the EU.

Honourable Members, together, these measures will reduce the EU's dependency on individual suppliers of critical medicines, improve the security of supply of affordable medicines, and increase the EU's manufacturing capabilities. So, to sum up, the Critical Medicines Act ensures that EU patients have access to the medicines they need, when and where they need them at an affordable price. In the current geopolitical context, this has become an even bigger priority.

听听Tomislav Sokol, u ime kluba PPE. 鈥� Po拧tovani predsjedavaju膰i, povjereni膷e, kolegice i kolege, farmaceutska industrija jedan je od najva啪nijih strate拧kih gospodarskih sektora za Europsku uniju. Bilo kakva nesta拧ica lijekova predstavlja zdravstvenu, ali i egzistencijalnu, sigurnosnu prijetnju za Europu.

Na啪alost, Europska unija sve vi拧e postaje ovisna o uvozu lijekova iz tre膰ih dr啪ava, a upravo je nedavna pandemija najbolje pokazala koliko smo ranjivi kad je u pitanju nesta拧ica lijekova i medicinske opreme.

Ovakva situacija dodatno je pogor拧ana zbog geopoliti膷kih okolnosti u kojima se nalazimo. Budu膰i da je do拧lo vrijeme brutalne sile u me膽unarodnim odnosima te se svatko treba pobrinuti, koliko god je to mogu膰e, za vlastite interese.

Krajnje je vrijeme da preuzmemo stvari u svoje ruke, a ovim prijedlogom zakona o kriti膷nim lijekovima 膷inimo korak u pravom smjeru. Zato pozdravljam mehanizme, posebno financijske potpore i ubrzavanje administrativnih procedura za strate拧ke projekte kojima olak拧avamo gradnju tvornica lijekova na europskom tlu.

Tako膽er, podr啪avam zajedni膷ku nabavu kriti膷nih lijekova, 拧to je posebno va啪no za manje dr啪ave poput moje Republike Hrvatske jer time ja膷amo njihovu pregovara膷ku mo膰 i osiguravamo bolje uvjete nabave.

Pri tome izuzetno je va啪no uvo膽enje dodatnih kriterija odabira u javnoj nabavi lijekova osim cijene, poput sigurnosti opskrbe i proizvodnje na europskom teritoriju, 拧to 膰e svakako olak拧ati dostupnost kriti膷nih lijekova za na拧e gra膽ane i smanjiti ovisnost o pojedinim dobavlja膷ima izvan EU-a.

Jedna od stvari koje, me膽utim, nisu toliko nagla拧ene je stvaranje zaliha kriti膷nih lijekova. Ne smije se nikada vi拧e dogoditi da pojedine velike dr啪ave 膷lanice u zdravstvenoj krizi zadr啪avaju klju膷ne medicinske potrep拧tine i time doprinose produbljivanju krize umjesto njenom rje拧avanju. Zato nam treba ja膷anje zajedni膷kih europskih zaliha i koordinacija na razini EU-a kako bi lijekovi i druge medicinske potrep拧tine u slu膷aju nesta拧ice stigli upravo onima koji ih najvi拧e trebaju.

Sve u svemu, pozdravljam ovaj prijedlog jer on doprinosi ekonomskoj sigurnosti EU-a smanjenjem ovisnosti o stranim dobavlja膷ima i osiguravanju stabilne opskrbe. Osim toga, njime 膰e se pove膰ati konkurentnost EU-a na globalnom farmaceutskom tr啪i拧tu, privu膰i ulaganja u istra啪ivanje i inovacije te stvoriti nova radna mjesta.

Vrijeme je da interes Europske unije i na拧ih pacijenata doista postane prioritet i drago mi je da sada idemo u pravom smjeru.

听听Christophe Clergeau, au nom du groupe S&D. 鈥� Monsieur le Pr茅sident, Monsieur le Commissaire, nous sommes cinq ans apr猫s la crise de la COVID-19 et, malheureusement, nous serions probablement confront茅s 脿 la m锚me situation si une nouvelle crise sanitaire arrivait aujourd鈥檋ui, et aux m锚mes d茅faillances dans l鈥檃cc猫s aux m茅dicaments. Nous avons donc besoin de ce texte pour prot茅ger les Europ茅ens et garantir l鈥檃cc猫s aux m茅dicaments, en p茅riode de crise comme en p茅riode normale: c鈥檈st l脿 une question de souverainet茅 de l鈥橢urope. Nous avons besoin d鈥檜ne politique incitative pour encourager la production de m茅dicaments en Europe; cependant, nous n鈥檃vons pas besoin d鈥檜n texte pour l鈥檌ndustrie pharmaceutique, mais bien d鈥檜n texte pour les citoyens.

脌 cette fin, nous devons avoir un cadre rigoureux, clarifier les d茅finitions des m茅dicaments critiques et des p茅nuries, assurer la transparence de la cha卯ne de valeur, avoir des conditionnalit茅s sur les march茅s publics et favoriser des march茅s ou des achats collectifs 脿 l鈥櫭ヽhelle europ茅enne 鈥撎齛utrement dit, la solidarit茅 europ茅enne. Ce qui est le plus important, pour les socialistes, c鈥檈st peut-锚tre de garantir 脿 toutes et 脿 tous en Europe l鈥檃cc猫s aux m茅dicaments 鈥撎齦eur disponibilit茅 un prix accessible, et des stocks disponibles听鈥�, et ce partout, au plus pr猫s des gens. Il s鈥檃git bien, 脿 travers ce texte, d鈥檜ne politique de sant茅 publique autant que d鈥檜ne politique industrielle.

听听Ond艡ej Knotek, on behalf of the PfE Group. 鈥� Mr President, Mr Commissioner, the Critical Medicines Act is an extremely important file. The world is in a de- globalisation phase. Dependencies reduction and self-sufficiency have become a logical trend. This for sure includes medicines, their availability and affordability simply matter.

Therefore, we welcome the ambition to maintain a list of critical medicines for which European research and production capacities would be granted. But it is not an easy task. As critical, we consider a wide range of medicines, including those old simple molecules whose production was, due to cost optimisation, transferred outside the EU in the past decades. And now we want them back.

Also, we shall consider what should be the role of the EU here. In my opinion, mainly coordination of fair distribution of supportive projects among Member States to avoid duplication and at the end, after implementation, coordination of logistics of critical medicines.

However, we believe that tools like CMA and Pharma Package can contribute positively to increase medicine supplies resilience on our continent, and in this regard, Mr Commissioner, you have our full support.

However, I would like to extend that attracting private investments of pharma industry in the EU would require at the same time, in parallel, energy cost reductions, decreasing of obligations linked to the medicines lifecycle and also less bureaucracy, which is exactly the opposite of which some of your colleagues, Mr Commissioner, are doing.

听听Ruggero Razza, a nome del gruppo ECR. 鈥� Signor Presidente, signor Commissario, onorevoli colleghi, anzitutto grazie, Commissario, per avere rispettato uno degli impegni che lei aveva annunciato nel corso della Sua audizione, e cio猫 di essere qui entro i 100 giorni e presentare un atto normativo di straordinaria importanza.

Atto normativo che era largamente atteso, non soltanto per ci貌 che 猫 emerso all'indomani della pandemia, quando abbiamo scoperto come Europa che la gran parte della nostra produzione avveniva al di fuori dei 27 Paesi e quindi era difficile un approvvigionamento, soprattutto in momenti di difficolt脿.

Oggi c'猫 una questione molto importante che questo atto inizia ad affrontare ed 猫 quella di rendere competitiva e di rendere realizzabile la produzione di medicinali, soprattutto generici, anche in Europa, mentre oggi sappiamo che la principale criticit脿 sta tutta qui: nel fatto che produrre il farmaco in Europa 猫 diventato antieconomico.

E allora 猫 un lavoro che inizia col Critical Medicines Act, 猫 un lavoro che 猫 stato preso dalla bussola della competitivit脿. Noi siamo ottimisti perch茅 猫 anche questa una questione di sovranit脿.

听听Vlad Vasile-Voiculescu, 卯n numele grupului Renew. 鈥� Domnule pre葯edinte, avem, iat膬, un prim produs legislativ al noii Comisii 葯i 卯i mul葲umesc domnului comisar pentru p膬strarea cuv芒ntului dat 卯n primele 100 de zile. Mul葲umesc, de asemenea, tuturor celor care au contribuit, 卯n special celor din Critical Medicines Alliance. Avem ast膬zi un pas necesar pentru a proteja pacien葲ii din Europa de criza medicamentelor esen葲iale. 脦n Rom芒nia, am fost martorii unor situa葲ii alarmante: spitalele de oncologie din Rom芒nia 鈥� nu 卯n ultimul r芒nd, oncologie pediatric膬 鈥� raporteaz膬 frecvent lipsa medicamentelor esen葲iale pentru diferite tipuri de cancer, compromi葲芒nd astfel 葯ansa copiilor 葯i 葯ansa adul葲ilor la un tratament corect.

Spitalele din Satu Mare din Rom芒nia s-au confruntat de cur芒nd cu lipsa hidrocortizonului. De asemenea, lipsesc 卯n continuare multe medicamente antiepileptice, 卯n special pentru copii 葯i nu numai. Aceast膬 lege propune independen葲膬 strategic膬, coordonare a politicilor de stocuri, produc葲ie european膬 葯i achizi葲ii coordonate 葯i poate, 卯ntr-adev膬r, s膬 scad膬 dependen葲a de lan葲urile de aprovizionare globale 葯i s膬 creasc膬 accesul europenilor la medicamente. Totu葯i, f膬r膬 mecanisme clare de implementare, bugete adecvate 葯i sanc葲iuni pentru nerespectarea obliga葲iilor, acest act risc膬 s膬 r膬m芒n膬 doar o declara葲ie de inten葲ie.

IN THE CHAIR: SOPHIE WILM脠S
Vice-President

听听Tilly Metz, on behalf of the Verts/ALE Group. 鈥� Madam听President, this project is a perfect example of what you get when one writes legislation on the fly and in a hurry. Exactly what I fear has happened. The challenges for availability of critical medicines are enormous in Europe, the expectations of both patient and the pharmaceutical industry regarding effective solutions proposed by the European Union are as great as the challenges. Unfortunately, what has been presented today falls far short from the expectations. The measures proposed are too weak. There is nothing on EU stockpiling, nothing on the public medicine infrastructure, nothing to ensure transparency for the public, nothing innovative in terms of announcing. Nothing that would ensure public support actually translate into the availability of medicines. Only joint procurement and fast-tracking of administrative procedures will not solve the problem. The Critical Medicines Act must become an ambitious legislation to meet citizens' expectations.

听听Catarina Martins, em nome do Grupo The Left. 鈥� Senhora Presidente, Senhor Comiss谩rio, a escassez de medicamentos 茅 um problema crescente na Uni茫o Europeia, h谩 ruturas at茅 em medicamentos para o cancro, e ter ou n茫o acesso 茅 uma lotaria geogr谩fica. E a defini莽茫o de medicamentos cr铆ticos, ela pr贸pria, esquece algumas doen莽as raras ou a sa煤de reprodutiva das mulheres.

脡, portanto, urgente agir.听Mas a proposta da Comiss茫o responde ao fundamental?

A cadeia do medicamento est谩 ref茅m das grandes farmac锚uticas e sujeita 脿 vontade de pa铆ses terceiros. A maioria dos medicamentos gen茅ricos produzidos na Europa depende de subst芒ncias ativas produzidas na China e na 脥ndia.听Garantir a produ莽茫o e o abastecimento de medicamentos exige, por isso, transpar锚ncia, novas regras de mercado, incluindo sobre as patentes, e investimento p煤blico.

Ministros da Sa煤de de 11 Estados鈥慚embros pedem agora que este investimento seja inclu铆do nos programas de defesa. O pedido p玫e o dedo na ferida. Afinal, para o armamento h谩 800 mil milh玫es de euros e para a sa煤de s贸 h谩 restri莽玫es.

E sem capacidade soberana nos medicamentos, como no digital ou na energia, n茫o h谩 seguran莽a na Europa.

听听Adam Jarubas (PPE). 鈥� Pani Przewodnicz膮ca! Panie Komisarzu! Dzi臋kuj臋 za t臋 propozycj臋. Akt o lekach krytycznych to brakuj膮cy element odpowiedzi Komisji Europejskiej na niedobory lek贸w po wykazie i Sojuszu na rzecz Lek贸w Krytycznych. To wi臋ksze bezpiecze艅stwo lekowe Europejczyk贸w.

Co z tego, 偶e wynaleziono lek, 偶e by膰 mo偶e mamy nawet na niego fundusze, je艣li nie jest fizycznie dost臋pny w Europie, bo trafia na inne rynki, jest przedmiotem prac, presji w polityce mi臋dzynarodowej lub dostawy zostaj膮 odci臋te z powodu pandemii, napi臋膰 geopolitycznych, sankcji czy otwartych konflikt贸w.

Europa dzi艣 sprowadza 80% lek贸w lub substancji do ich produkcji. W niekt贸rych przypadkach w og贸le ich nie produkuje i w stu procentach zale偶y od importu. Co je艣li, tak jak z energi膮 z Rosji, przyjdzie nam zmierzy膰 si臋 z dnia na dzie艅 z odci臋ciem importu tych lek贸w. Potrzebujemy zatem ambitnego Critical Medicines Act, kt贸ry jak najszerzej b臋dzie korzysta膰 z propozycji Sojuszu na Lek贸w Krytycznych.

Istnieje pewien poziom produkcji lek贸w, od kt贸rego zale偶y zdrowie i 偶ycie Europejczyk贸w, kt贸ry wyznacza granice pomi臋dzy prostym biznesem a bezpiecze艅stwem. Potrzebujemy funduszu lek贸w krytycznych, kt贸ry pozwoli zabezpieczy膰 ten poziom w Unii, zasilanego na przyk艂ad z uelastycznienia niewykorzystanych 艣rodk贸w z polityki sp贸jno艣ci lub z procentowego udzia艂u w zliberalizowanej krajowej pomocy publicznej pa艅stw Unii, o co apelowa艂 w swoim sprawozdaniu Enrico Letta. Taki fundusz wzmacnia艂by europejsk膮 autonomi臋 i odporno艣膰 na przysz艂e kryzysy, wojny handlowe i r贸wnowa偶y艂 zaburzenie jednolitego rynku. W pe艂ni popieram ide臋 aktu o lekach krytycznych.

听听Tiemo W枚lken (S&D). 鈥� Frau Pr盲sidentin, liebe Kolleginnen und Kollegen! Arzneimittelengp盲sse k枚nnen f眉r Patientinnen und Patienten zu einer Frage von Leben und Tod werden; deshalb ist es h枚chste Zeit, dass wir dieses Problem angehen. Zwar ver枚ffentlicht die Kommission schon lange eine Liste der kritischen Medikamente, aber wir haben bisher noch keinen Gesetzgebungsvorschlag gehabt. Wir als Parlament haben in der Pharma鈥慥erordnung und auch in der Richtlinie听schon versucht, erste Schritte zu gehen, aber es ist h枚chste Zeit, dass wir dieses dramatische Problem endlich vollumf盲nglich anpassen; deswegen k枚nnen und wollen wir auch Engp盲sse nicht mehr hinnehmen.

Wir brauchen mehr Produktionskapazit盲ten in der Europ盲ischen Union. Wir brauchen eine ausfallsichere Lieferkette, das hei脽t, nicht nur ein Hersteller darf ein Produkt liefern. Und wir m眉ssen die Abh盲ngigkeit von Drittstaaten drastisch reduzieren. Daf眉r brauchen wir gezielte Investitionen, wir brauchen strategische Unabh盲ngigkeit. Es ist gut, dass die Kommission die MEAT-Kriterien endlich wahrnimmt und ernst nimmt und damit nicht nur den Preis als entscheidendes Kriterium hat. Als Sozialdemokratinnen und Sozialdemokraten haben wir das schon lange gefordert, aber die Wahrheit ist auch: Wir werden daf眉r Geld brauchen, und daran m眉ssen wir jetzt gemeinsam arbeiten.

(Der Redner ist damit einverstanden, auf eine Frage nach dem Verfahren der 鈥瀊lauen Karte鈥� zu antworten.)

听听Tomislav Sokol (PPE), blue-card question. 鈥� I'm glad that you support the overall concept and the direction of the Critical Medicines Act, the same as myself, but there is one thing that I think is really missing and that is the provisions on stockpiling.

We remember from the last big crisis that we had a problem that some big Member States essentially kept everything that they could for themselves at the time where some other Member States had much bigger needs and where these medical countermeasures were more necessary there.

So, my question is: would you support that we do whatever we can to add to this Critical Medicines Act also provisions of common stockpiling and more coordination so that we make sure that patients actually get those medicines, which they need in times of crisis?

听听Tiemo W枚lken (S&D), blue-card answer. 鈥� Stockpiling is an essential part, yes, I totally agree and I'm happy that it is also part of the MEAT criteria.

I agree that in some Member States, medicine is more accessible than in others, and this is something we shouldn't accept. We should work together to have a European Union, a true European health Union, where every European citizen has equal access to medicines.

I'm really sure that we as a 合法博彩网站 together can work on this commonly shared aim.

听听Gerald Hauser (PfE). 鈥� Frau Pr盲sidentin, sehr geehrter Herr Kommissar! Bei dem Ziel, gen眉gend kritische Arzneimittel und 眉berhaupt Arzneimittel f眉r die europ盲ische Bev枚lkerung zu haben, wird Sie nat眉rlich jeder unterst眉tzen. Aber der erste Schritt听鈥� das wurde schon angesprochen听鈥� dazu ist, dass man sich einmal bem眉ht, die Wirkstoffe, die zu 80听% von China und von Indien produziert werden, auch in die Produktion nach Europa r眉ckzuverlagern听鈥� 眉ber das m眉sste dann wirklich separat gesprochen werden.

Aber die Frage, die sich mir stellt, ist: Wieso hat man 眉berhaupt diese Allianz gr眉nden m眉ssen? Wir haben ja bereits gen眉gend Gesundheitsbeh枚rden in der Europ盲ischen Union听鈥� neben der Kommission gibt es die EMA, wir haben die Europ盲ische Gesundheitsbeh枚rde, wir haben die HERA. Also wieso gr眉ndet man eine eigene Beh枚rde? Und das wird mir schon eine Spur verd盲chtig. M枚chte man da wieder intransparent arbeiten, weil diese Beh枚rde ja nur beratend t盲tig ist? Und da entsteht dann immer wieder das Problem, dass man sagt, 鈥瀗a, wir sind eh nur beratend鈥�, wissend, dass es hier um ein Milliardengesch盲ft geht.

Und deswegen ist es wichtig, Herr Kommissar, dass man hier die Transparenz voll und ganz walten l盲sst und dass es nicht so wie bei der Beschaffung der COVID-19-Impfstoffe ist听鈥� vollkommen intransparent听鈥� und man die Antwort bekommt: 鈥濪ie Vertraulichkeit muss gewahrt werden.鈥� Deswegen 鈥�

(Die Pr盲sidentin entzieht dem Redner das Wort.)

听听Aurelijus Veryga (ECR). 鈥� Pirmininke, komisare, d臈koju u啪 iniciatyv膮 spr臋sti kritin臈s svarbos vaist懦 tr奴kumo problem膮.

COVID pandemija labai ai拧kiai pademonstravo, k膮 rei拧kia b奴ti priklausomiems nuo tre膷i懦j懦 拧ali懦 gaminamos produkcijos, ta膷iau tuo pa膷iu metu parod臈, kad esant pakankamai valiai Europos S膮junga gali per trump膮 laik膮 mobilizuoti l臈拧as svarbi懦 preparat懦 k奴rimui ir gamybai.

Globalia ekonomika gr寞stas tik臈jimas, kad neb奴tina visko gamintis patiems, nul臈m臈 svarbi懦 veikli懦j懦 med啪iag懦 gamybos i拧k臈lim膮 寞 tre膷i膮sias 拧alis ir su tuo susijusius vaist懦 tr奴kumus. Apie 拧i懦 problem懦 sprendim膮 jau galvojama, ta膷iau a拧 pasigendu suvokimo, kad egzistuoja ir santykinis ypatingos svarbos vaist懦 tr奴kumas, kuris yra susij臋s ne su fiziniu vaist懦 tr奴kumu, o su santykiniu tr奴kumu, kuomet vaistas yra tiesiog ne寞perkamas. Tod臈l a拧 noriu papra拧yti svarstant ypatingos svarbos vaist懦 fail膮 nepamir拧ti inovatyvi懦 vaist懦 ir numatyti galimyb臋 sukurti pagalbos 拧alims mechanizm膮, realizuojam膮 per savanori拧k膮 bendr懦 vaist懦 deryb懦 ir pirkimo mechanizm膮.

听听Olivier Chastel (Renew). 鈥� Madame la Pr茅sidente, Monsieur le Commissaire, chers coll猫gues, l鈥橢urope ne peut plus rester spectatrice de sa propre vuln茅rabilit茅. Nous nous souvenons tous des p茅nuries qui ont frapp茅 notre continent ces derni猫res ann茅es: amoxicilline, traitements contre le cancer, parac茅tamol, anesth茅siants鈥� Autant de m茅dicaments essentiels qui ont cruellement manqu茅, dans nos h么pitaux comme dans nos pharmacies, ce qui a mis des vies en danger. Ces ruptures de stock n鈥檕nt pas touch茅 que des traitements rares; elles ont aussi concern茅 des m茅dicaments de premi猫re n茅cessit茅, dont la disponibilit茅 aurait d没 锚tre une 茅vidence.

Depuis trop longtemps, nous avons laiss茅 nos m茅dicaments critiques devenir les otages des d茅localisations et des tensions g茅opolitiques. D茅pendre de quelques usines 脿 l鈥檃utre bout du monde, c鈥檈st accepter l鈥檌mpuissance face 脿 l鈥檜rgence. L鈥檃cte l茅gislatif sur les m茅dicaments critiques doit donc b芒tir une v茅ritable souverainet茅 pharmaceutique europ茅enne. Cela passera par une l茅gislation ambitieuse: relocalisation strat茅gique des productions, 茅tablissement de stocks de s茅curit茅 et coordination renforc茅e entre les 脡tats membres.

Il ne s鈥檃git pas seulement d鈥檜n enjeu industriel; il s鈥檃git 茅galement d鈥檜n imp茅ratif de sant茅 publique.

听听Ignazio Roberto Marino (Verts/ALE). 鈥� Signora Presidente, signor Commissario, onorevoli colleghi, discutiamo di come condividere fucili e cannoni, strumenti di morte. Ma gli strumenti di vita? Che valore ha un'Unione europea se un bambino in uno dei nostri Paesi pu貌 accedere a un farmaco salvavita e in un altro no? Se la nostra salute dipende dal mercato, dagli interessi, dai confini?

Abbiamo visto cosa significa essere impreparati, lo abbiamo visto col Covid: mancavano le mascherine, i medicinali essenziali, i respiratori. Oggi in alcuni ospedali continuano a mancare farmaci oncologici, farmaci salvavita. L'Europa, culla della sanit脿 pubblica, non pu貌 diventare il continente delle disuguaglianze sanitarie.

Il Critical Medicines Act 猫 un passo ma non basta. Dobbiamo trasformarlo in realt脿, perch茅 milioni di cittadini aspettano risposte e molti, nell'attesa, muoiono, signor Commissario.

La salute non 猫 un privilegio: 猫 un diritto; un diritto che siamo chiamati a proteggere adesso, ora, qui! Dobbiamo ambire all'indipendenza strategica, non solo sulle armi, ma anche sui farmaci.

听听Ond艡ej Dost谩l (NI). 鈥� Pan铆 p艡edsedaj铆c铆, nedostatek z谩kladn铆ch l茅膷iv je selh谩n铆m hospod谩艡sk茅 politiky Unie. D艡铆ve jsme byli ve v媒rob臎 sob臎sta膷n铆, dokonce jsme m臎li i st谩tn铆 zdravotnick茅 z谩sobov谩n铆, kter茅 m臎lo ty sklady, kdy啪 se tady mluvilo o z谩sob谩ch. Nyn铆 jsme z谩visl铆 na dovozu 煤膷inn媒ch l谩tek z Asie, jeho啪 p艡eru拧en铆 by bylo fat谩ln铆. Proto pragmaticky vyz媒v谩m osoby odpov臎dn茅 za zahrani膷n铆 politiku, aby se zdr啪ely obchodn铆ch v谩lek se st谩ty, na nich啪 jsme v l茅c铆ch z谩visl铆, co啪 je zejm茅na 膶铆na.

Za druh茅, vyz媒v谩m k odstran臎n铆 t臎ch regulac铆, kter茅 br谩n铆 obnov臎 v媒roby z谩kladn铆ch l茅膷iv v Evrop臎, jako tomu b媒valo, abychom se z谩vislosti na dovozu postupn臎 zbavili. Za t艡et铆, l茅膷iva vn铆mejme jako strategickou komoditu d暖le啪it臎j拧铆 ne啪 zbran臎. Nedostatek antibiotik jsme m臎li v roce 2023 a v暖bec to nebylo p臎kn茅. M铆sto bilion暖 na ReArm proto dejme rad臎ji prostor rozvoji vlastn铆 farmaceutick茅 v媒roby.

A za 膷tvrt茅, mnoh茅 v媒padky jsou ve skute膷nosti d暖sledek poru拧en铆 hospod谩艡sk茅 sout臎啪e. Ty l茅ky jsou, ale kv暖li distribu膷n铆m monopol暖m se nedostanou do men拧铆ch l茅k谩ren a k pacient暖m. K potla膷en铆 tohoto ne拧varu u啪 Komise d谩vno pravomoci m谩, jenom je mus铆 za膷铆t pou啪铆vat. Tak to d臎lejme!

听听Andr谩s Tivadar Kulja (PPE). 鈥� Eln枚k Asszony! Mindannyian eml茅ksz眉nk a j谩rv谩ny legs枚t茅tebb pillanataira, amikor a tag谩llamaink 茅s azok k贸rh谩zai k茅ts茅gbeesetten pr贸b谩ltak gy贸gyszerekhez jutni, 茅s az ell谩t谩si l谩ncok hi谩nyoss谩gai miatt emberek haltak meg. A t枚redezett szab谩lyoz谩si k枚rnyezettel, orsz谩gokon 谩tny煤l贸 strat茅gi谩k n茅lk眉l egy kr铆zis idej茅n 茅rt茅kes id艖t vesz铆t眉nk, mik枚zben a tag谩llamok egym谩ssal versengenek. Mindannyiunk sz谩m谩ra vil谩gos, hogy 枚sszefog谩sra van sz眉ks茅g az 茅letment艖 茅s kritikus fontoss谩g煤 gy贸gyszerek biztos铆t谩sa 茅s igazs谩gos eloszt谩sa 茅rdek茅ben. Az Uni贸nak kez茅be kell vennie az ir谩ny铆t谩st, hogy el茅rhet艖 茅s megfizethet艖 gy贸gyszereket biztos铆tson az 谩llampolg谩raink r茅sz茅re.

Ehhez elengedhetetlen, hogy 枚sszehangoljuk a szab谩lyoz谩st, 枚szt枚nz艖 k枚rnyezetet teremts眉nk az innov谩ci贸nak, bele茅rtve az antibiotikum-kutat谩st. Meg kell 艖rizn眉nk 茅s meg kell er艖s铆ten眉nk az Eur贸p谩n bel眉li gy贸gyszergy谩rt谩st, hogy cs枚kkents眉k a kiszolg谩ltatotts谩gunkat. A kritikus fontoss谩g煤 gy贸gyszerek eset茅n egy k枚z枚s k茅szenl茅ti tartal茅kot kell l茅trehoznunk, amely biztos铆tja, hogy a tag谩llamokban ne forduljanak el艖 谩tmeneti gy贸gyszerhi谩nyok. 脡s k眉l枚n枚s figyelmet kell ford铆tanunk az 谩rva gy贸gyszerekre 茅s a ritka betegs茅gek kezel茅s茅re. Ehhez 枚sszehangolt fell茅p茅sre 茅s tag谩llamokon 谩tny煤l贸 finansz铆roz谩si programokra van sz眉ks茅g. A Critical Medicines Act garant谩lja ezeket, 茅s biztos铆tja, hogy Eur贸p谩ban t枚bb茅 ne forduljanak el艖 a pand茅mia alatt tapasztalt gy贸gyszerhi谩nyok. Mert a nap v茅g茅n egyetlenegy dolog sz谩m铆t, hogy rendelkez茅sre 谩ll a gy贸gyszer, amivel meg tudjuk menteni a beteg 茅let茅t, vagy nem.

听听Nicol谩s Gonz谩lez Casares (S&D). 鈥� Se帽ora presidenta, se帽or comisario, por fin tenemos esta Ley de Medicamentos Esenciales, que es un paso m谩s en esa Uni贸n Europea de la Salud que queremos construir y que construimos en gran medida a trav茅s de los efectos de la COVID鈥�19 y de los pasos que dimos en el pasado, por ejemplo con una lista de medicamentos esenciales o con una plataforma de seguimiento de la escasez de f谩rmacos.

Pero ahora vemos claramente que la escasez de f谩rmacos es tambi茅n uno de los talones de Aquiles de la seguridad en Europa. Tanto que hablamos de defensa, recordemos que la seguridad es un concepto m谩s amplio y que tiene que ver tambi茅n con el suministro de f谩rmacos para actuar ante las enfermedades de los europeos y europeas. No lo olvidemos, porque la seguridad de las cadenas de suministro no puede quedar solamente en manos de las ayudas de Estado o de la simplificaci贸n administrativa. Hacen falta fondos europeos para fomentar esta autonom铆a estrat茅gica y creo que falta ambici贸n en la propuesta. Esperamos mejorarla en este Parlamento, pero, desde luego, esos medicamentos esenciales, adem谩s, deben ser fabricados en Europa en la medida de lo posible.

听听Marie-Luce Brasier-Clain (PfE). 鈥� Madame la Pr茅sidente, Monsieur le Commissaire, chers coll猫gues, notre syst猫me de sant茅 est en crise, nos h么pitaux et nos pharmacies manquent de m茅dicaments. Des d茅cennies de d茅sindustrialisation et de d茅pendance aux importations, notamment depuis la Chine et l鈥橧nde: voil脿 o霉 nous m猫nent la libre concurrence et la recherche du moindre co没t. L鈥檃cte l茅gislatif sur les m茅dicaments critiques repose sur une approche technocratique et centralis茅e. Mutualiser les stocks 脿 l鈥櫭ヽhelle europ茅enne ne garantit en rien le bon fonctionnement de nos syst猫mes de sant茅, dont la gestion reste nationale.

Sans r茅industrialisation, pas de production. Elle passe par la priorit茅 donn茅e 脿 nos entreprises dans les march茅s publics, par la relocalisation, chaque fois qu鈥檈lle est possible, de la production de m茅dicaments et de principes actifs et par la protection de nos int茅r锚ts strat茅giques contre les pratiques commerciales d茅loyales et la pr茅dation 茅conomique. Nous voulons relancer la production en Europe et r茅duire nos d茅pendances. Comment garantir qu鈥檜ne gestion centralis茅e respectera la souverainet茅 des 脡tats? La Commission assumera-t-elle un virage protectionniste, quitte 脿 revenir sur certaines r猫gles du commerce international? Le d茅fi est de taille.

听听Laurence Trochu (ECR). 鈥� Madame la Pr茅sidente, Monsieur le Commissaire, mes chers coll猫gues, l鈥橴nion europ茅enne, nous avait-on promis, nous assurera comp茅titivit茅, bien-锚tre et r茅silience. Pourtant, nous voil脿 oblig茅s aujourd鈥檋ui de traiter du sujet central des m茅dicaments, en commen莽ant par les plus critiques. Serions-nous devenus un continent du tiers-monde?

Puisqu鈥檌l faut r茅pondre 脿 ce probl猫me, faisons-le en essayant, pour une fois, de ne pas r茅pondre aux erreurs du pass茅 par une fuite en avant. Il nous faut r茅duire notre d茅pendance aux pays asiatiques et d茅velopper notre propre industrie pharmaceutique 脿 l鈥櫭ヽhelle europ茅enne, mais pas au prix de la souverainet茅 des nations 鈥撎齭acrifi茅e par l鈥檃cte l茅gislatif sur les m茅dicaments critiques, qui pr茅cise que les stocks d鈥檜n 脡tat membre ne doivent pas pouvoir porter pr茅judice 脿 un autre听鈥� ni au prix de la transparence 鈥撎齫ui a tant fait d茅faut lors de l鈥櫭﹑id茅mie de COVID-19, ce qui a provoqu茅 une d茅fiance g茅n茅ralis茅e des Europ茅ens vis-脿-vis de leurs dirigeants sur ces sujets.

Rien dans l鈥檃cte l茅gislatif sur les m茅dicaments critiques ne cherche 脿 y rem茅dier de mani猫re concr猫te. La protection de la sant茅 des Europ茅ens doit, elle aussi, se d茅barrasser des id茅ologies, accepter l鈥檈xistence d鈥檌nt茅r锚ts divergents au sein de l鈥橴nion et laisser aux nations europ茅ennes le monopole de leurs comp茅tences propres.

(L'oratrice refuse de r茅pondre 脿 une question carton bleu de Sieper.)

听听Veronika Cifrov谩 Ostriho艌ov谩 (Renew). 鈥� V谩啪en谩 pani predsedaj煤ca, v谩啪en媒 komis谩r, mil铆 kolegovia, sila a konkurencieschopnos钮 Eur贸py nespo膷铆vaj煤 len v nav媒拧en铆 obrany, ale aj v posilnen铆 zdravotnej starostlivosti na拧ich ob膷anov a ob膷ianok. Na Slovensku sa 木udia v zdrav铆 do啪铆vaj煤 v priemere 57 rokov. V najlep拧ej krajine 脷nie je to a啪 70. Tento rozdiel nie je len 拧tatistika. Je to 13 rokov plnohodnotn茅ho 啪ivota s rodinou, s de钮mi, s vnukmi a vnu膷kami. Je to 13 rokov v plnom zdrav铆, ktor茅 n谩m ch媒baj煤.

Jedn媒m zo sp么sobov, ako tieto nerovnosti vyrovna钮, je spolo膷n媒 eur贸psky pr铆stup k r媒chlej拧ej dostupnosti liekov. Pand茅mia COVID-19 n谩m uk谩zala, ako r媒chlo a ne膷akane m么啪eme 膷eli钮 kritick茅mu nedostatku liekov, a nem么啪eme si dovoli钮 by钮 z谩visl铆 od dod谩vok z tret铆ch kraj铆n, ako je 膶铆na 膷i India. Mus铆me investova钮 do eur贸pskych kapac铆t na v媒robu liekov, podpori钮 v媒skum a zabezpe膷i钮 dostupnos钮 liekov pre v拧etk媒ch. To v拧ak zvl谩dneme len spolo膷ne. Obrana, 谩no, konkurencieschopnos钮, 谩no, no rovnak茅 谩no plat铆 pre kvalitn煤 zdravotn煤 starostlivos钮 pre v拧etk媒ch ob膷anov a ob膷ianky Eur贸py.

听听Oliver Schenk (PPE). 鈥� Frau Pr盲sidentin, meine Damen und Herren, Herr Kommissar! Die Liste kritischer Arzneimittel ist mittlerweile 眉ber 270听Wirkstoffe und Substanzen lang, darunter einfache Hustens盲fte f眉r Kinder, und macht die Dringlichkeit f眉r den Critical Medicines Act deutlich. Globalisierung und starker Kostendruck haben zu einer Abwanderung der Produktion und zu einer Konzentration auf wenige Hersteller in China und Indien gef眉hrt.

Aber Lieferengp盲sse sind vermeidbar. Sie sind das Ergebnis von politischen Rahmenbedingungen, die die nationale und europ盲ische Politik setzen. Wir k枚nnen diese Rahmenbedingungen 盲ndern; der CMA wird dazu einen Beitrag leisten. Wir k枚nnen die Abh盲ngigkeiten reduzieren und stabile Lieferketten schaffen, wenn wir sie f眉r uns f眉r eine starke, nachhaltige und international wettbewerbsf盲hige Pharmaindustrie in Europa einsetzen. Die aktuellen Engp盲sse sind ein wake鈥�up call. Europa braucht eine starke Pharmaindustrie. Dazu m眉ssen wir Industrie鈥�, Forschungs鈥� und Gesundheitspolitik zusammen denken, die gesamte Wertsch枚pfungskette in den Blick nehmen und die richtigen Signale an die Unternehmen aussenden.

Wir m眉ssen bei kritischen Wirkstoffen und Antibiotika, von denen heute zwei Drittel in Asien produziert werden, Anreize f眉r eine eigene Produktion in Europa schaffen. Daf眉r brauchen wir finanzielle Anreize, und wir brauchen schnellere Genehmigungsverfahren, die unternehmerisches Engagement honorieren. Meine Erwartung an den CMA ist deshalb ganz klar: Er muss einen Beitrag zur besseren Verf眉gbarkeit von Arzneimitteln durch Anreize f眉r mehr Produktion, stabilere Lieferketten und mehr Solidarit盲t untereinander liefern.

听听Nikos Papandreou (S&D). 鈥� Madam President, Commissioner, the Critical Medicines Act is our answer to shortages and supplies and less dependence on China and India. Very simple to say that.

What medicines are we talking about? Basic ones like penicillin, amoxicillin, but even infusions for chemotherapy.

The task will not be easy. We have many instruments at our disposal. We have the new pharma legislation. We have our effort on competition, AI effort and innovation. We're trying the Capital Markets Union. We want to industrialise. I don't even know if it's bringing back pharma to Europe. It's creating new pharma in Europe. It's not only reshoring. We are not going to use tariffs. We are going to produce it in our own country. We'll succeed on some. We won't succeed on others. That's how it works.

But I think today we heard that everybody agrees with the CMA with its own criticisms. So I think we're on a good road. Congratulations for bringing this in time. And we're all here to work with you for the health of European citizens.

听听Vikt贸ria Ferenc (PfE). 鈥� Eln枚k Asszony! Az elm煤lt 茅vekben az ell谩t谩si l谩ncokban tapasztalhat贸 probl茅m谩k miatt a kritikus gy贸gyszerek hi谩nya egyre gyakoribb谩 v谩lt. Ennek okai a geopolitikai t茅nyez艖k, mint p茅ld谩ul az orosz-ukr谩n h谩bor煤 vagy a koronav铆rus j谩rv谩ny, valamint a termel茅s 茅s az alapanyagok beszerz茅s茅nek t煤lzott koncentr谩ci贸ja 脕zsi谩ban. A Kritikus Gy贸gyszerek Sz枚vets茅ge keret茅n bel眉l az 茅rdekelt felek kifejezhett茅k v茅lem茅ny眉ket 茅s k铆v谩ns谩gaikat. 脺dv枚z枚lj眉k, hogy a Bizotts谩g lefolytatta ezt a p谩rbesz茅det, 茅s javaslata reflekt谩l a strat茅giai jelent茅sre.

A betegek helyzet茅nek jav铆t谩sa 茅rdek茅ben kiemelten fontos a gy贸gyszerek el茅rhet艖s茅ge 茅s megfizethet艖s茅ge, mik枚zben biztos铆tjuk az eur贸pai gy贸gyszeripar versenyk茅pess茅g茅t 茅s rezilienci谩j谩t. Fontos hangs煤lyozni, hogy a Critical Medicines Act ne n枚velje az adminisztrat铆v terheket, 茅s ne legyen jogi 谩tfed茅s, p茅ld谩ul a gy贸gyszercsomaghi谩nnyal foglalkoz贸 r茅sz茅vel. 脺dv枚zl枚m a bemutatott javaslatot, 茅s k枚sz枚n枚m V谩rhelyi biztos 煤rnak 茅s csapat谩nak, hogy ilyen gyorsan elk茅sz铆tett茅k azt.

听听Michele Picaro (ECR). 鈥� Signora Presidente, onorevoli colleghi, fino a quando possiamo tollerare le carenze di farmaci essenziali in Europa? Colleghi, questa crisi 猫 un problema strutturale che mette a rischio la salute dei nostri cittadini.

Il nostro obiettivo 猫 un'Europa indipendente nella produzione di farmaci, perch茅 la salute non pu貌 dipendere da attori esterni. 脠 una questione di sicurezza e sovranit脿 per tutti gli Stati membri: senza un'industria forte e autonoma restiamo esposti a vulnerabilit脿 inaccettabili.

Per questo motivo vigileremo affinch茅 il Critical Medicines Act persegua due obiettivi fondamentali strategici: il primo 猫 evitare nuove sovrastrutture burocratiche e valorizzare gli strumenti di monitoraggio e risposta gi脿 esistenti; il secondo 猫 rafforzare l'autonomia strategica dell'Europa, garantendo sicurezza sanitaria e leadership globale nel settore, sia nella produzione di farmaci essenziali che nello sviluppo delle innovazioni future.

E per riuscirci abbiamo bisogno di strumenti concreti, incentivi alla propriet脿 intellettuale, norme sugli appalti pubblici che premino l'innovazione e procedure di approvazione pi霉 rapide per i farmaci innovativi.

听听Elena Nevado del Campo (PPE). 鈥� Se帽ora presidenta, se帽or铆as, se帽or comisario, yo creo que el mensaje es claro y es casi un谩nime: Europa tiene que ser autosuficiente y, con esta ley que se presenta hoy, la Comisi贸n debe asegurar que el acceso de los ciudadanos a los medicamentos esenciales est谩 garantizado.

La escasez de medicamentos esenciales se ha convertido en un desaf铆o en la Uni贸n Europea. Las cadenas de suministro fr谩giles y dependientes suponen una vulnerabilidad para nuestros sistemas de salud y nuestros pacientes. Es esencial fortalecer la innovaci贸n, la producci贸n y la distribuci贸n dentro de la Uni贸n Europea, como se est谩 haciendo, por ejemplo, en mi tierra, Extremadura, donde empresas como Natac est谩n innovando en el sector vegetal y est谩n ayudando en la fabricaci贸n de medicamentos hu茅rfanos听como los que tratan la ataxia de Friedreich.

La Ley de Medicamentos Esenciales es muy necesaria. Sabemos qu茅 hay que hacer; d铆ganos, se帽or comisario, cu谩ndo y c贸mo, porque se necesita ya, no le quepa la menor duda.

听听Marta Temido (S&D). 鈥� Senhora Presidente, Senhor Comiss谩rio, a proposta de lei dos medicamentos cr铆ticos 茅 uma pe莽a essencial da arquitetura da nossa seguran莽a e defesa comuns, como aprendemos durante a pandemia da COVID鈥�19.

Conhecemos, nos nossos pa铆ses, a experi锚ncia da rutura de medicamentos vitais (como anest茅sicos, antibi贸ticos, mesmo insulina), como conhecemos o diagn贸stico das nossas fragilidades: depend锚ncia de menos de um punhado de origens geogr谩ficas em mat茅rias鈥憄rimas e eros茫o da base industrial europeia.

A nossa a莽茫o 茅 urgente porque os resultados exigem tempo, e as respostas legislativas s茫o mesmo a parte mais f谩cil daquilo que precisamos de fazer. Sim, precisamos de uma lista de medicamentos cr铆ticos, de stocks de conting锚ncia, de novas pr谩ticas de aprovisionamento p煤blico. Precisamos mesmo de investir no fabrico europeu.

Mas n茫o basta. Precisamos de reconhecer que apenas com uma coordena莽茫o e investimento europeus comuns poderemos ser bem鈥憇ucedidos nesta estrat茅gia, e que a disponibilidade de medicamentos no mercado n茫o serve os cidad茫os europeus, se o acesso, sob o ponto de vista da comportabilidade financeira, estiver em causa.

Sim, precisamos tamb茅m de falar do pre莽o dos medicamentos, e estes s茫o aspetos dos quais n茫o vamos desistir.

听听螠喂蠂维位畏蟼 围伪蟿味畏蟺伪谓蟿苇位伪 (PPE). 鈥� 螝蠉蟻喂蔚 螤蟻蠈蔚未蟻蔚, 魏蠉蟻喂蔚 螘蟺委蟿蟻慰蟺蔚, 伪尉喂蠈蟿喂渭慰喂 蟽蠀谓维未蔚位蠁慰喂, 蟺蟻伪纬渭伪蟿喂魏维 蠂伪委蟻慰渭伪喂 纬喂伪 蟿喂蟼 蟺伪蟻蔚渭尾维蟽蔚喂蟼 蟺慰蠀 维魏慰蠀蟽伪 蟽蠂蔚未蠈谓 伪蟺蠈 蠈位慰蠀蟼 蟿慰蠀蟼 蟽蠀谓伪未苇位蠁慰蠀蟼. 螚 谓慰渭慰胃蔚蟿喂魏萎 蟺蟻蠈蟿伪蟽畏 纬喂伪 蟿伪 蠁维蟻渭伪魏伪 魏蟻委蟽喂渭畏蟼 蟽畏渭伪蟽委伪蟼 伪蟺慰蟿蔚位蔚委 苇谓伪 渭蔚纬维位慰 尾萎渭伪 纬喂伪 蟿畏谓 蔚谓委蟽蠂蠀蟽畏 蟿畏蟼 蟽蟿蟻伪蟿畏纬喂魏萎蟼 伪蠀蟿慰谓慰渭委伪蟼 蟿畏蟼 螘蠀蟻蠅蟺伪蠆魏萎蟼 螆谓蠅蟽畏蟼 蟽蟿慰谓 蟿慰渭苇伪 蟿畏蟼 蠀纬蔚委伪蟼. 违蟺慰纬蟻伪渭渭委味蠅 蟿畏谓 伪谓维纬魏畏 纬喂伪 蟿畏谓 魏慰喂谓萎 蟺蟻慰渭萎胃蔚喂伪 蠁伪蟻渭维魏蠅谓, 喂伪蟿蟻喂魏蠋谓 蟺蟻慰渭畏胃蔚喂蠋谓 魏伪喂 蟽蠀蟽魏蔚蠀蠋谓. 螠苇蟽蠅 伪蠀蟿萎蟼 未喂伪蟽蠁伪位委味慰蠀渭蔚 蟿畏谓 苇纬魏伪喂蟻畏 魏伪喂 慰喂魏慰谓慰渭喂魏维 蟺蟻慰蟽喂蟿萎 蟺蟻蠈蟽尾伪蟽畏 蟽蔚 伪谓伪纬魏伪委伪 蠁维蟻渭伪魏伪 纬喂伪 蠈位伪 蟿伪 魏蟻维蟿畏 渭苇位畏.

螜未喂伪委蟿蔚蟻伪 纬喂伪 蟿伪 渭喂魏蟻蠈蟿蔚蟻伪 魏蟻维蟿畏 渭苇位畏, 蠈蟺蠅蟼 畏 蟺伪蟿蟻委未伪 渭慰蠀 畏 螝蠉蟺蟻慰蟼, 畏 魏慰喂谓萎 蟺蟻慰渭萎胃蔚喂伪 蠁伪蟻渭维魏蠅谓 渭蟺慰蟻蔚委 谓伪 魏维谓蔚喂 蟿蔚蟻维蟽蟿喂伪 未喂伪蠁慰蟻维 蟽蟿畏 未喂伪胃蔚蟽喂渭蠈蟿畏蟿伪 魏伪喂 蟽蟿慰 魏蠈蟽蟿慰蟼 蟿蠅谓 蠁伪蟻渭维魏蠅谓 纬喂伪 蟿慰谓 伪蟽胃蔚谓萎. 韦伪蠀蟿蠈蠂蟻慰谓伪, 蟺蟻苇蟺蔚喂 谓伪 未喂伪蟽蠁伪位委蟽慰蠀渭蔚 蠈蟿喂 畏 伪蟽蠁维位蔚喂伪 蟿蠅谓 蠁伪蟻渭维魏蠅谓 伪魏慰位慰蠀胃蔚委 蟿伪 伪蠀蟽蟿畏蟻维 魏蟻喂蟿萎蟻喂伪 蟺慰蠀 胃苇蟿慰蠀渭蔚 纬喂伪 蟿畏谓 蠀纬蔚委伪 魏伪喂 蔚蠀畏渭蔚蟻委伪 蟿蠅谓 蟺慰位喂蟿蠋谓 渭伪蟼. 螣喂 蟺蟻蠅蟿慰尾慰蠀位委蔚蟼 蟿畏蟼 螘蠀蟻蠅蟺伪蠆魏萎蟼 螆谓蠅蟽畏蟼 苇蠂慰蠀谓 萎未畏 伪蟺慰未蔚委尉蔚喂 蠈蟿喂 慰喂 魏慰喂谓苇蟼 未蟻维蟽蔚喂蟼 蔚蟺喂蟿蟻苇蟺慰蠀谓 蟿伪蠂蠉蟿蔚蟻蔚蟼 魏伪喂 蟺喂慰 伪蟺慰蟿蔚位蔚蟽渭伪蟿喂魏苇蟼 伪谓蟿喂未蟻维蟽蔚喂蟼 蟽蔚 蠀纬蔚喂慰谓慰渭喂魏苇蟼 魏蟻委蟽蔚喂蟼 魏伪喂 蟺蟻慰魏位萎蟽蔚喂蟼. 危伪蟼 蔚蠀蠂伪蟻喂蟽蟿蠋.

听听Liesbet Sommen (PPE). 鈥� Voorzitter, commissaris, elke dag opnieuw zien wij dat de wereldorde verschuift en dat internationale samenwerking steeds moeilijker wordt. Als EU zullen wij voor strategische sectoren sterk moeten zijn en onze eigen boontjes moeten doppen. Zo ook voor de farmaceutische industrie. Want elke dag opnieuw ervaren zorgverleners en pati毛nten tekorten aan geneesmiddelen. Dat is een groot probleem.

De geopolitieke instabiliteit, gecombineerd met onze afhankelijkheid van China en India op het vlak van geneesmiddelen, maakt ons kwetsbaar. Zeker in tijden van hybride oorlogsvoering. Want 茅茅n geopolitiek evenement, 茅茅n zotte beslissing van een bepaalde beleidsmaker of 茅茅n probleem in een fabriek hier ver vandaan kan ons in een ongeziene gezondheidscrisis storten. Dat is een groot probleem. Geneesmiddelentekorten kunnen mensenlevens kosten. Reden te meer om dit in Europa samen aan te pakken met de volle impact van onze interne markt.

Catch-the-eye procedure

听听S茅rgio Humberto (PPE). 鈥� Cara Presidente, Caro Comiss谩rio, caros colegas, numa Uni茫o Europeia com sistemas de sa煤de diversificados, o Critical Medicines Act permite uma resposta mais eficiente a emerg锚ncias sanit谩rias e, por isso, os meus parab茅ns.

Vivemos num tempo em que o acesso a medicamentos essenciais 茅 mais urgente do que nunca e n茫o podemos, como j谩 disseram os meus colegas, estar dependentes de pa铆ses como a China ou a 脥ndia, que fornecem entre 60听% a 80听% das subst芒ncias ativas utilizadas na produ莽茫o de medicamentos na Europa.听Esta depend锚ncia exp玫e-nos a riscos significativos, como vimos no caso da pandemia da COVID鈥�19, quando as interrup莽玫es nas cadeias de abastecimento resultaram em faltas de medicamentos essenciais.

O Critical Medicines Act tem um papel crucial para garantir que todos, mesmo todos, tenham acesso a medicamentos essenciais, reduzindo a nossa vulnerabilidade e refor莽ando a nossa autonomia, sa煤de p煤blica e seguran莽a.

听听Sebastian Tynkkynen (ECR). 鈥� Arvoisa puhemies, l盲盲kkeiden saatavuus kriiseiss盲 on j盲senvaltioiden elinehto. Sen on oltava varmaa 鈥� ei toivotaan toivotaan -hommaa. EU puskee parhaillaan l盲盲kkeiden toimitusketjuja paremmiksi, mutta tekemist盲 viel盲 riitt盲盲.

Korona-ajan alku paljasti heikkoutemme. Tarvittavat v盲lineet olivat Kiinassa ja eurooppalaiset paniikissa. Sama ei saa en盲盲 toistua.

Kuten moneen muuhunkin asiaan, eurooppalaiset tehtaat ovat vastaus t盲h盲nkin. Vahva ja itsen盲inen l盲盲keteollisuus, joka ei kuikuile it盲盲n taikka l盲nteen. Euroopan ei pid盲 olla maanosa, joka j盲盲 aina pahan paikan tullen odottelemaan apua. Se, jos mik盲, on heikkoutta.

Ja muistakaa, juuri nyt on tekojen hetki. Jos toimet aloitetaan seuraavan kriisin vy枚ryess盲 p盲盲lle, silloin on jo my枚h盲ist盲.

听听Raquel Garc铆a Hermida-Van Der Walle (Renew). 鈥� Madam President, in 2023, when the United States reversed Roe v Wade, it had a direct effect on the accessibility of abortion medication in the EU, because American states 鈥� fearing further restrictions on abortion medication 鈥� stocked up. And that led to shortages, for example in France.

Now, the worldwide backlash against abortion, in combination with increasingly restrictive US policies, could lead to stockpiling again and shortages. And that is why I urge this Commissioner to aim to include mifepristone and misoprostol on the list of essential medications.

As the Commissioner himself said, it's about providing critical medication there and where needed. And if we don't do this, we really risk a lot of women conducting unsafe, not legal or illegal abortions at home, especially in those Member States where this right is severely restricted.

听听Marc Botenga (The Left). 鈥� Madame la Pr茅sidente, 茅coutez, c鈥檈st en effet hallucinant de s鈥檌maginer que, sur un continent aussi riche que le n么tre, les m茅dicaments les plus essentiels, du parac茅tamol 脿 l鈥檃moxicilline, manquent, et que l鈥檃nn茅e pass茅e, dans mon pays, la Belgique, 1听famille sur听3 a 茅t茅 confront茅e 脿 de telles p茅nuries et听n鈥檃 pu avoir acc猫s 脿 certains m茅dicaments parce qu鈥檌ls 茅taient indisponibles.

Ce n鈥檈st pas tellement la faute des Indiens ou des Chinois, non: c鈥檈st la faute des Europ茅ens. Pourquoi? Parce que nous sommes d茅pendants en premier lieu des choix que font les grandes multinationales pharmaceutiques. Ce sont elles qui d茅cident quoi produire, o霉 produire, combien produire et 脿 quel prix vendre,听m锚me lorsqu鈥檈lles ont re莽u des subventions publiques 脿 la recherche ou 脿 la production.

Ce qu鈥檌l faut casser aujourd鈥檋ui, c鈥檈st le monopole qu鈥檕nt ces entreprises, et pour ce faire les ONG, les associations et m锚me les syndicats nous ont d茅j脿 donn茅 la marche 脿 suivre: il s鈥檃git de cr茅er une infrastructure publique pour la recherche et le d茅veloppement en Europe. C鈥檈st possible. Vous trouvez 800听milliards pour les armes; vous allez bien trouver quelques milliards pour la sant茅. Qu鈥檈st-ce que vous attendez?

听听Lukas Sieper (NI). 鈥� Frau Pr盲sidentin, liebe Menschen Europas, Herr Kommissar! Stellen Sie sich vor, jemand in Ihrer Familie braucht dringend ein Medikament, aber in Ihrem Heimatland gibt es das gerade nicht, w盲hrend es im Nachbarland in rauen Mengen vorhanden ist. Absurd, leider aber bittere europ盲ische Realit盲t. Und ironischerweise erlaubt das EU-Recht genau das: Alle vier Grundfreiheiten des Binnenmarkts kennen Ausnahmen aus Gr眉nden der 枚ffentlichen Gesundheit.

Diese Regelungen aus dem letzten Jahrhundert geh枚ren abgeschafft,听denn gerade bei lebenswichtigen Arzneimitteln ist die 枚ffentliche Gesundheit keine nationale, sondern eine europ盲ische Frage. Den Critical Medicines Act begr眉脽e ich ausdr眉cklich, aber seien wir ehrlich: Wenn wir wirklich eine europaweite Versorgung sicherstellen wollen, dann m眉ssen wir tiefer ansetzen und endlich die legislativen Wurzeln von Ausnahmen in den europ盲ischen Vertr盲gen selbst beseitigen.

Die Pandemie hat uns gezeigt: Krankheiten kennen keine Grenzen, und so sollten wir auch in Europa keine kennen. Denn Medikamente m眉ssen dorthin, wo die Menschen sie brauchen听鈥� ganz ohne Grenzen.

听听Peter Agius (PPE). 鈥� Napprezza li l-Kummissjoni 偶ammet kelmitha u ning魔aqad mas-sens ta' ur摹enza biex a魔na na魔dmu fuq li摹i Ewropea dwar id-disponibilit脿 tal-medi膵ini. Jiena 摹ej minn Malta, g魔alina l-joint procurement li sar fil-COVID kien essenzjali u rridu narawh isir aktar sistematikament. Irridu nindirizzaw l-istockpiling. Bla dubju. Imma摹inaw, ta' spiss f'Malta medi膵ini out of stock, mentri l-istess medi膵ina jkollhom bil-qabda l-Italja u Franza u l-臓ermanja.

G魔andna wkoll dimensjoni interna u esterna ta' din l-issue. Wara kollox g魔a膵-膵ittadin qed nitkellmu fuq disponibilit脿. Internament, g魔andna l-pakkett tal-farma膵ewti膵i li g魔adu jqassam is-suq f'market authorisations g魔al kull pajji偶. Dan qed jippenalizza bil-kbir g偶ejjer b魔al Malta. Dan suppost suq wie魔ed. 摩bieb tieg魔i, jekk ti摹u Malta tisimg魔u 魔afna l-kelma out of stock, fl-isptar, fl-ispi偶eriji, out of stock. Ejja na魔dmu flimkien biex ikollna Suq Ewropew g魔all-Medi膵ini g魔all-Ewropej kollha.

听听Kate艡ina Kone膷n谩 (NI). 鈥� Pan铆 p艡edsedaj铆c铆, na z谩klad臎 toho, co jsme tady dnes sly拧eli, se ob谩v谩m velk茅 byrokratick茅 z谩t臎啪e, kter谩 u膷in铆 n谩vrh prost臎 nerealizovateln媒m. Rychlost mus铆 j铆t ruku v ruce s efektivitou. A stejn臎 tak bychom se m臎li zamyslet nad t铆m, co v拧echno jsme si tady v posledn铆 dob臎 schv谩lili, proto啪e ono to m谩 vliv na to, jestli tady ty firmy p暖jdou nebo nep暖jdou, nebo jestli v暖bec n臎jak媒 farmaceutick媒 pr暖mysl bude schopn媒 v Evrop臎 obst谩t. My neust谩le p艡ij铆m谩me dal拧铆 a dal拧铆 p艡edpisy, ale pot茅 se div铆me, 啪e tady ty firmy nejdou, respektive, 啪e i kdy啪 budeme vytv谩艡et ve艡ejn茅 podniky, tak v podstat臎 nevytvo艡铆me podm铆nky pro to, aby v暖bec mohly b媒t na 煤zem铆 Evropsk茅 unie 啪ivotaschopn茅.

Tak啪e poj膹me se zamyslet nad t铆m, co jsme ud臎lali. Poj膹me 拧krtat, poj膹me mazat na拧i legislativu, poj膹me vytv谩艡et podm铆nky. A posledn铆 v臎c, vy jste tady v拧ichni mluvili o tom, 啪e pot艡ebujete pen铆ze. My tady rozhazujeme ka啪d茅 plen谩rn铆 zased谩n铆 stovky miliard. Dejme je kone膷n臎 na n臎co u啪ite膷n茅ho! A toto je u啪ite膷n谩 v臎c. Toto jsou l茅ky 啪ivot zachra艌uj铆c铆 a ne zbran臎, kter茅 zab铆jej铆.

(End of catch-the-eye procedure)

听听Oliv茅r V谩rhelyi, Member of the Commission. 鈥� Madam President, honourable Members, I want to thank you for this debate. It seems that we have already started negotiating the proposal. I'm very glad to see the very high interest it has generated from this House. And I think we all agree that this act has the potential to significantly increase the resilience of our health care systems so that our patients will have the medicines when they need it, where they need it, and as they need it.

One should not forget about the other proposal, which is the reform of the EU pharmaceutical legislation. This House has already managed to come to an agreement. I hope that we will have very quickly an agreement also in the Council, so that these two pieces of legislation can go hand in hand and help us to create the security of supply across the board and in every Member State, because it is very clear also from this debate, the immense risk the shortages of critical medicines can create. And we have seen this already in the COVID crisis.

Now, maybe to respond to one of the key issues that was mentioned here by Mr Sokol. And then there was an exchange between him and Mr W枚lken about the stock planning. Just to make it very clear. We have clear provisions now so that when Member States are setting their own rules, when it comes to the security of supply, they will be required by this law to come forward with programmes and to communicate this to the Commission, but also to other Member states. And when they do that, they have to be mindful when defining the scope of which products are covered, but also in terms of the timings or the time periods necessary, that it has to be proportionate. It has to be done in a transparent and in a solid way so that they are not putting risks on other Member States. I think this is a topic which we have all seen during the COVID crisis, but it is a reoccurring one, and this is why we have included this in the proposal itself.

Now, one of you also mentioned the issue of orphan drugs. I would also add the need for new antibiotics. This is why we have enlarged the scope of the act to cover all potential products, where we will have a critical need emerging so that we will be much faster to react to any problems on the market. And we will be able to deliver these products much faster.

And finally, on the points raised by many about transparency. I think it is very clear that this Commission aims for full transparency when it comes to the implementation of this act. This is why joint procurement is the key tool through which we are going from where the conditions and costs are going to be public, as it is the case in any procurement. Same goes for the facilities created through the possibility of providing State aid for re-attracting manufacturing capacities in the EU. I think the State aid rules already have a very high level of transparency in the European Union.

听听President. 鈥� The debate is closed.

Written Statements (Rule 178)

听听Dan-艦tefan Motreanu (PPE), 卯n scris. 鈥� Numeroase state membre ale Uniunii Europene, inclusiv Rom芒nia, se confrunt膬 cu dificult膬葲i majore 卯n aprovizionarea cu medicamente esen葲iale, cauzate de perturb膬ri 卯n lan葲urile de aprovizionare, cre葯terea costurilor 葯i dependen葲a de importuri din afara UE. 脦n Rom芒nia, situa葲ia este agravat膬 de retragerea unor medicamente generice din cauza pre葲urilor reglementate, ceea ce afecteaz膬 disponibilitatea tratamentelor pentru pacien葲ii cu boli cronice 葯i afec葲iuni acute. Propunerea de ast膬zi a Comisiei Europene privind Actul legislativ pentru medicamentele critice reprezint膬 un pas promi葲膬tor 卯nainte. Crearea unei liste europene a medicamentelor esen葲iale 葯i implementarea unor mecanisme de stocare strategic膬 sunt m膬suri necesare pentru prevenirea penuriilor 葯i pentru garantarea accesului continuu al pacien葲ilor la tratamente indispensabile.

脦n acest context, doresc s膬 subliniez necesitatea implement膬rii unui plan ambi葲ios de investi葲ii, 卯n special 卯n perspectiva noului Buget UE 2028-2034, care s膬 combine fonduri europene cu reglement膬ri flexibile privind ajutoarele de stat, pentru a consolida 葯i extinde capacit膬葲ile de produc葲ie farmaceutic膬 pe teritoriul Uniunii Europene. State precum Rom芒nia, care beneficiaz膬 deja de infrastructur膬 industrial膬 farmaceutic膬, centre universitare de excelen葲膬 葯i un capital uman specializat, trebuie s膬 devin膬 piloni esen葲iali 卯n asigurarea securit膬葲ii farmaceutice a Europei.