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Started 24 hours ago

Petition to Ursula von der Leyen, David Maria Sassoli, Charles Michel, European Commission, European Parliament, Council of the European Union, Emer Cooke

Amyotrophic Lateral Sclerosis CALL FOR ACTION

The Amyotrophic Lateral Sclerosis - ALS - also known as Lou Gehrig's Disease and Charcot's disease, is a relentlessly progressive neurodegenerative disease which attacks motor neurons in the brain - Upper or First Motor Neuron - and in the spinal cord - Lower or Second Motor Neuron - resulting in the wasting away of muscle and loss of movement. Progress is generally rapid, with an average life expectancy of between 2 and 5 years from the onset of symptoms. After 150+ years from first diagnosis, there is no cure at all for ALS! This is astonishing. This is inhuman and simply unacceptable. ALS is 100% lethal. ALS Community too deserves the level of creativity, cooperation, sense of urgency and sense of responsibility shown by the various Ministries of Health of the different countries, the EMA, the FDA, the EU, the Local Regulatory Agencies and the pharmaceutical industry in the COVID19 pandemic. ALS Community is in desperate need of help and EC & EP have the duty and the power to change the outcome of a story that already seems to be written. THE REQUEST is based on 4 pillars Clinical Research Investments to boost Scientific Research - As part of the EU4Health 2021-2027 & Horizon 2020 Project, there must be a dedicated chapter of expenditure to fund scientific research for ALS. The annual budget, owned and coordinated by the European Commission, has to be € 350 M until a cure is found. The European Commission must engage cutting-edge companies to fund & develop drugs as done for COVID19 Vaccines. ALS is not incurable, it is just underfunded - and time is ticking ineluctably. Centre of Excellence for Genetic Research - EU must create a clinical site aimed at sequencing the entire Human Genome. The scope for this initiative is simply invaluable as the potential to discover the pathogenesis and etiology of several diseases is concrete. All inherited forms are genetic but not all genetic forms are inherited. Genome sequencing could open up to the solution not only of ALS but also of multiple diseases such as Frontotemporal Dementia, Alzheimer's, Parkinson, Diabetes and many more. CRISPR based approach could then be key. Centre of Excellence for Regenerative Medicines - EU must create a clinical site aimed at repairing damaged tissues through Stem Cells use. Restoring/reverting damage can give back full functionality. Also in this case, the potential to restore from damages caused by disease or trauma is enormous. Bioengineering and biotechnology approaches are key. Drugs Early Access Allow Use of Experimental Drugs - Considering there is no valid therapeutic alternative, EMA has to grant early/accelerated access - under Conditional Marketing Authorization, for: (i) drugs not yet authorized but undergoing clinical trials; (ii) drugs authorized outside the EU. Medicinal products not yet authorized, can still be in clinical trial phase and have completed studies, at least in Phase 2, that demonstrate adequate efficacy with an acceptable risk profile to support the requested indication. Early/Accelerated Access does NOT jeopardise any trial. Compassionate Use Take-Over - Considering there is no valid therapeutic alternative, given the unique nature of this disease, grant early access - under Compassionate Use, fund by EC for: (i) drugs undergoing phase II or phase III trial as part of an Expanded Access Programme; (ii) drugs to be used for a therapeutic indication other than that authorized; (iii) orphan drugs. Process Simplification Shorten Drugs Evaluation Time (EMA/EC) - Create a dedicated/accelerated pathway for the regulatory process of drugs related to ALS to speed up the overall review and approval. The dedicated pathway for the drugs addressing neurodegenerative diseases has to be managed by a dedicated team (as strengthening of “therapies for neurological and psychiatric disorders” part) and the overall evaluation and approval by EMA must take no longer than 45 days. The following approval by EC must take no longer than 15 days. Streamline Drug Approval Process (with Member States) - EC, EP and EMA must work with member states in order to smooth the adoption of the new drugs, reducing the time-to-market and avoiding redundant steps. After the EMA approval and the EC one, there is very little need to have another end-2-end validation process from the National Regulatory Agency (including a review from the Ethics Committee) and Country Ministry of Health. Family Support Patient’s Family Contribution - In order to support family expenses for the caregiving and the daily tasks, it is fundamental to receive a monthly contribution from the EC. This kind of lump sum is vital to guarantee an adequate standard of life and should be in the range of € 1.500 - € 2.000 per month.   The POWER OF 1 The European Commission must be in charge of centralized investments for coordinated Scientific Research (point 1.1) & Centers of Excellence (points 1.2 and 1.3) in order to establish both a Standardized & Common Framework and an Efficient & Effective end-2-end Workflow, maximizing the return on investments and the researchers’ efforts and reducing the waste of TIME, money as well as redundant studies. The European Commission must consider exploiting and leveraging the existing European Network (e.g. ENCALS, TRICALS) to boost the research and bring it to the next level in order to find a definitive solution.

Andrea Caffo
107 supporters
Update posted 1 week ago

Petition to Mario Draghi, Luigi Di Maio

STOP alla protezione dei brevetti per i vaccini anti-covid: tuteliamo la salute pubblica

STOP alla protezione dei brevetti per i vaccini anti-covid: tuteliamo la salute pubblica. [ENGLISH BELOW] "Nella crisi dobbiamo stare dalla parte dell'umanità". Mary Robinson, ex presidente dell'Irlanda e Alto Commissario delle Nazioni Unite per i diritti umani. Il divario nei tassi di vaccinazione contro il COVID-19 tra paesi ricchi e poveri cresce ogni giorno. Tedros Adhanom Ghebreyesus, Direttore Generale dell’Organizzazione Mondiale della Sanità (OMS), ha sottolineato ad aprile 2021 che solo lo 0.3% di tutti i vaccini fino a quel momento somministrati nel mondo sia stato diretto a persone che vivono in paesi poveri. Un gruppo di 100 premi nobel e 75 ex leader mondiali ha stimato che 9 persone su 10 nei paesi a basso reddito non riceveranno neanche una dose di vaccino nel 2021. Nessuno sarà al sicuro dal COVID-19 finché tutti non avranno accesso al vaccino. Mentre il virus dilaga in enormi bacini di popolazione non vaccinata, rimane anche la possibilità che ulteriori varianti emergano aggravando la situazione catastrofica che il virus ha già creato nel mondo. Le morti non rallenteranno. Le comunità e le economie non potranno veramente iniziare a riprendersi dalla pandemia e ripartire finché non sarà garantito ovunque l’accesso universale al vaccino. E questo deve accadere il più velocemente possibile. Ma il controllo dei brevetti da parte di alcune aziende farmaceutiche costitisce una barriera alla rapida e ampia condivisione delle conoscenze sui vaccini e ostacola un veloce aumento di scala della produzione, che sono invece essenziali per garantire un accesso globale ed equo alle vaccinazioni anti-COVID e sconfiggere questo virus. La protezione dei brevetti sulle tecnologie mediche anti-COVID è difesa e sostenuta, tra gli altri, dal governo italiano e dai governi dell'Unione Europea, che si oppongono alla sua temporanea sospensione, contribuendo alla perdita di migliaia di vite umane in nome della tutela degli interessi delle case farmaceutiche. Basta guardare a ciò che sta accadendo attualmente in India per comprendere quanto il COVID-19 sia ancora fuori controllo, specialmente nelle aree in cui i vaccini non stanno raggiungendo abbastanza velocemente le persone più a rischio. "Quindi si tratta di rimuovere temporaneamente la protezione dei brevetti per i vaccini anti COVID-19, giusto?". Questa è l'idea. Ma nazioni potenti, tra cui l'Italia e gli altri paesi della UE, si rifiutano di sostenere la deroga alla rimozione della protezione della proprietà intellettuale dei vaccini contro il COVID-19, la cosiddetta "deroga (o waiver) ai TRIPS", proposta da India e Sudafrica già dall’Ottobre 2020.Molti paesi, inclusa l’Italia, si rifiutano di appoggiare la deroga, nonostante già 100 governi nazionali, centinaia di organizzazioni della società civile e il Direttore Generale dell'Organizzazione Mondiale della Sanità li esortino a farlo. Questa deroga temporanea alla protezione della proprietà intellettuale per gli strumenti di lotta contro il COVID-19 permetterebbe di facilitare i trasferimenti rapidi di tecnologia in modo che i prodotti medici, compresi i vaccini, possano essere creati più rapidamente e con costi accessibili da più soggetti produttori in tutto il mondo, rafforzando la continua lotta contro il COVID-19. Questa deroga sarebbe prevista solo fino a quando le persone, in tutto il mondo, saranno protette da una immunità di gregge globale. L'Italia deve cambiare la sua posizione rispetto alla deroga ai TRIPS. E deve spingere l'Unione Europea a fare lo stesso. Il rifiuto di molti paesi, compresa l’Italia e gli altri membri della UE, di sostenere la deroga ai TRIPS protegge solo gli interessi delle grandi aziende farmaceutiche coinvolte nella produzione dei vaccini anti-COVID. Alcune di queste aziende stanno già realizzando enormi profitti sui vaccini, hanno visto il valore delle loro azioni salire alle stelle durante la pandemia e sono spesso arrivate alla produzione delle tecnologie su cui reclamano la proprietà intellettuale e i brevetti grazie a ingenti finanziamenti pubblici erogati dagli Stati con le tasse pagate dai cittadini. Continuare a sostenere la protezione dei brevetti per i vaccini anti-COVID significa scegliere di non tutelare la nostra salute pubblica, lasciando una gran parte del mondo nell’attesa di ricevere vaccini fondamentali per la prevenzione, che non arriveranno probabilmente prima del 2024. Nel frattempo le persone continueranno ad essere infettate e a morire, mentre nuove varianti del virus continueranno a comparire. Dobbiamo quindi lavorare insieme per sconfiggere davvero la pandemia da COVID-19, perché solo quando avremo tutti accesso ai vaccini potrà iniziare la vera ripartenza. Dobbiamo lavorare insieme per il bene comune, per proteggere le vite umane e non gli interessi delle aziende farmaceutiche. 'IL VACCINO PER IL COVID-19 DEVE ESSERE VISTO COME UN BENE PUBBLICO GLOBALE, UN VACCINO PER LA GENTE'. ANTÓNIO GUTERRES, SEGRETARIO GENERALE DELL'ONU (VERTICE GLOBALE SUI VACCINI, 4 GIUGNO 2020) Cosa chiediamo: Chiediamo al governo italiano, nelle persone del Presidente del Consiglio Mario Draghi e del Ministro degli Esteri Luigi Di Maio di: Dichiarare pubblicamente il proprio SOSTEGNO alla deroga TRIPS per tutte le tecnologie mediche anti-COVID.. Rendere effettiva questa posizione l'8 MAGGIO 2021 alla riunione dei leader UE-India a cui parteciperanno i 27 Capi di Stato e di Governo degli Stati membri dell'UE, Charles Michel, Presidente del Consiglio Europeo, e Ursula Von Der Leyen, Presidente della Commissione Europea. Ribadire questo sostegno quando l'Italia e la Commissione Europea ospiteranno insieme il Global Health Summit a Roma il 21 maggio 2021. Incoraggiare attivamente le loro controparti europee a sostenere la deroga TRIPS. Firma e condividi questa petizione e aiutaci a fare in modo che il governo italiano stia dalla parte giusta della storia nella lotta contro la pandemia di COVID-19. Coalizione Italiana Libertà e Diritti civili  --------------------------------------------------------- STOP protection of patents on COVID-19 vaccines: let's protect public health “We have to be on the side of humanity in a crisis.” Mary Robinson, former President of Ireland & UN High Commissioner for Human Rights. The gap in COVID-19 vaccination rates between rich and poor countries is growing every day. The Director-General of the World Health Organization (WHO) Tedros Adhanom Ghebreyesus said in April 2021 that only 0.3% of the vaccines administered around the world so far had gone to people in low-income countries. A group of 100 nobel laureates and 75 former world leaders have estimated that “9 out of 10 people in low-income countries will not receive a vaccination in 2021".  None of us are safe from COVID-19 until everyone has access to the vaccine. While COVID-19 is rampant the chance for additional mutations to emerge and add to the destruction across the world remains. Deaths will not slow and communities/economies cannot truly begin to recover from the pandemic until ALL of us, across the world, get vaccinated. This needs to happen as FAST as possible.  But patent protection, enjoyed by pharmaceutical companies, is being defended and supported by the Italian and EU governments (amongst others), presenting a barrier to vaccine knowledge being shared as quickly and widely as possible, and preventing global and equal access to vaccinations. Thousands of lives are being lost in the delay to contain COVID-19 in the name of protecting pharmaceutical companies’ interests. We need only look at what is currently happening in India to see how out of control COVID-19 still is, especially in areas where vaccines are not reaching people fast enough. “So let’s temporarily remove patent protection for COVID-19 vaccines, right?” That’s the idea. But powerful nations including Italy and the EU are REFUSING to agree to remove intellectual property protection from COVID-19 vaccines. They are doing this by refusing to agree to the “TRIPS waiver” being proposed by India and South Africa. And they are refusing even in the face of 100 national governments, hundreds of civil society organisations and even the Director-General of the World Health Organization urging them to do so. This provisional waiver on intellectual property protection for vaccines fighting COVID-19 will only temporarily set aside certain intellectual property rules under the TRIPS Agreement and facilitate fast technology transfers so that medical products, including vaccines, can be produced quickly and affordably by many manufacturers around the world in the continued fight against COVID-19. It will waive these rules until widespread vaccination is in place across the globe.  Italy must reverse their opposition to the TRIPS waiver. And it must push the European Union to do the same.  The refusal of Italy and the EU, amongst some other powerful opponents, to support the waiver only protects the interests of large pharmaceutical companies, some of whom are making large profits on vaccines, and many of whom have enjoyed skyrocketing share prices during the pandemic, leaving a large part of the world to wait for access to vaccines, likely until 2024, while people continue to perish. We need to work together to defeat the COVID-19 pandemic, because it is only when we’re all vaccinated that true recovery can begin. We must work together for the common good rather than working together to protect the interests of pharmaceutical companies, ahead of human lives. ‘A COVID-19 VACCINE MUST BE SEEN AS A GLOBAL PUBLIC GOOD, A PEOPLE'S VACCINE’ UN SECRETARY-GENERAL ANTÓNIO GUTERRES (GLOBAL VACCINE SUMMIT, 4 JUNE 2020)  What we are calling for: We are calling on the Italian Government, namely Prime Minister Mario Draghi and Minister for Foreign Affairs Luigi Di Maio, to: Publicly declare SUPPORT for the TRIPS waiver. Make their support clear on MAY 8, 2021 at the EU-India leaders' meeting attended by the 27 Heads of State and Government of the EU Member States, Charles Michel, President of the European Council, and Ursula Von Der Leyen, President of the European Commission. Reiterate this support when Italy and the European Commission jointly host the Global Health Summit in Rome on May 21, 2021. Actively ENCOURAGE their European counterparts to support the TRIPS waiver. Sign this petition and help us ensure that the Italian government is on the right side of history in the fight against the COVID-19 pandemic. Italian Coalition for Civil Liberties and Rights (Coalizione Italiana Libertà e Diritti civili - CILD)

Coalizione Italiana Libertà e Diritti civili
53,187 supporters