Chiara GEMMA

Policy topics Chiara GEMMA is active on

What Chiara GEMMA has said (11)

• 2024-10-23 “E-002234/2024 Answer given by Mr Várhelyi on behalf of the European Commission 1. The European Medicines Agency (EMA) adopted a positive opinion on 18 June 2015 recommending the granting of the designation of ‘Human plasminogen’ as an orphan medicinal product 1 . On 28 July 2015, the orphan designation (EU/3/15/1511) was granted by the Commission to ProMetic BioTherapeutics Ltd, for human plasminogen for the treatment of plasminogen deficiency 2 . In December 2021, the orphan designation was transferred to Kedrion S.p.A. 3 . Since that date, no application for marketing authorisation of human plasminogen for the treatment of plasminogen deficiency has been submitted to the EMA by Kedrion S.p.A.. 2. In accordance with Regulation (EC) 726/2004 4 , the availability of a new medicine in the EU requires the submission of an application for an authorisation complying with the substantive requirements laid out by Directive 2001/83/EC 5 , a positive outcome of the benefit/risk balance assessment conducted by the EMA and the adoption of a Commission decision granting marketing authorisation. The EU Orphan Regulation promotes the development of treatments for rare diseases through regulatory incentives 6 . The recent proposal for a reform of the EU general pharmaceutical legislation 7 focuses especially on areas where there are no treatment options for patients, including rare disease 8 . 1 https://www.ema.europa.eu/en/documents/orphan-designation/eu3151511-public-summary-opinion-orphandesignation-human-plasminogen-treatment-plasminogen-deficiency_en.pdf 2 https://ec.europa.eu/health/documents/community-register/2015/20150728132605/dec_132605_en.pdf 3 https://ec.europa.eu/health/documents/community-register/2021/20211220154340/dec_154340_en.pdf 4 http://data.europa.eu/eli/reg/2004/726/oj 5 http://data.europa.eu/eli/dir/2001/83/oj 6 eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32000R0141&from=EN 7 Reform of the EU pharmaceutical legislation https://health.ec.europa.eu/medicinal-products/pharmaceuticalstrategy-europe/reform-eu-pharmaceutical-legislation_en 8 https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceuticallegislation_en”
  Pharmaceuticals regulation in EU
• “Thank you, madam chair, and thank you to all the speakers for their interesting contributions. A few comments. While we look at the conclusions of the 20 20 one-twenty 27 strategy, I think it's very important to have an assessment of the results achieved and those questions which are still open. In these last years, we've had important progress in health and safety at work. But in the current context, we know that things have changed drastically digitalization, AI, new forms of work organization, the aging of the active population, a very complex situation in production processes. And so jobs are changing. And for this reason, the next strategic plan has to concentrate less on the production of new rules and more on the results we want to achieve. I think the real challenge is not increasing legislative complexity, but reducing accidents and occupational diseases and fatalities. We have to have there for prevention, education and an effective use of the regulations which we still have in order to improve health at work in a pragmatic and sustainable way, in particular for SMEs, which are very much the backbone of the European production system. In the plenary, the parliament adopted a resolution which puts out this aim of 0. How can we have prevention and have sustainable practices for companies, in particular, these SMEs? And secondly, how would you look at the emerging situation? And how can we deal with these emerging problems and remain competitive? Thank you.”
  EU rules on hazardous working conditions
• “(15:15:11 – 15:17:12): chairman. Colleagues, the commission has presented this proposal for the next European social fund as a significant project for the investment of people. But in its current form, it runs the risk of being an empty letter. It's missing the budget. Without any clear credible financing, this is not really a strategy. It's an empty promise. Secondly, what's presented as a coordination runs the risk of becoming control, strict alignment with the European semester and centralized programming within the NRPPs could reduce the member states' ability to establish their own priorities. The European labor markets are different, and they require flexibility and not standardized governance. Rigidity, for minimum obligatory standards would undermine the flexibility in both investment, social investments, but imposing fixed quotas runs the risk of causing a waste of resources and ignoring national realities. On the other hand, the administrative burden, will only increase More indicators, more reports, more complexity, and this takes time and resources away from getting achieving results in the field. How can we improve this? Well, first of all, we need an autonomous MFF to reduce the administrative burden. We need to guarantee a real flexibility for the national, labor models. We need to have priority for skills, productivity, and demographic resilience and economic competitiveness, not to abstract, objectives, distance from economic reality. We need to promote, the inclusion of people into the labor market, not imposed by a random social goal. So we need to have fewer reports, fewer, regulations, and more results. Thank you.”
  European Semester (social dimension)
• “President, Commissioner, thank you. When we talk about accidents at the workplace and deaths at the workplace, we mentioned statistics. But behind these statistics are people, families that were waiting for their loved one but didn't see him or her come back. More than 3000 people die at the workplace, and there are many more incidents every year. And then we have occupational diseases, often invisible and underdiagnosed. This resolution is based on a very clear and straightforward principle. Safety at work is not a cost. It is a moral, civil, economic responsibility that we shoulder. And the world of work has completely changed. We don't just have the usual risks. We have new types of pressure linked to digitalization algorithms and algorithm management platforms that set the pace and the fact that there is more and more subcontracting and so on and so forth. And then we have young workers that enter the labor market with less experience and therefore with more risk exposure. There are vulnerable. Workers because of this subcontracting, where there is a lack of control and checks. That's why we have to insist on prevention, awareness raising and more inspections. But we have to strike a balance as well. Safety at work isn't protected by criminalising businesses or by pitting workers against production systems, we need proportionate, clear and sustainable rules. And then we also have the proposal to have a World Day where we pay tribute to those who lost their lives at work. The 8th of August, where 262 European workers from different countries lost their lives in Marcinelle, Marcinelle isn't just part of the memory of one country, it's part of our social history. It is the symbol of a Europe that understood the most painful way that freedom of movement for work cannot exist without safety, security and shared responsibility. That is why a memory should be turned into specific commitments.”
  EU policy on employment subcontracting · EU rules on hazardous working conditions
• “President. Vice president. President. Vice president. Colleagues. We can't distribute wealth if it isn't generated in the first place. A policy against poverty has to have this in mind. We want to transform certain things into simple political propaganda. So Indeed dependence is something that you can't get away with, that you can't just toss away if you don't have a situation where you produce, where there are jobs as well. Social conditions and dependence of individuals are the key elements here. In other words, a strategy which doesn't take into consideration the huge differences between regions, rural areas, urban areas is destined to failure, it reducing poverty only on the basis of some sort of structural justice, which involves redistribution and doesn't take into consideration universal aspects that involves everybody is simply an ideological reasoning and will, and it doesn't serve the citizens of Europe. It it doesn't serve those who really have to be taken care of in this.”
  EU social policy (political compass)
• “(15:12:32 – 15:14:57): Thank you, madam chairman. Colleagues, thank you very much for this very substantial work and the ambition therein. The situation is a bit unique because we're awaiting for the conference president's decision, which makes this somewhat vague still. But I would point out that the envelope and the principle of NRPP was adopted in the interim report last year. So I expect there's an agreement between the EPP and the S and D to distribute the reports between them have voted in favor of this interim report. So it's a question of clarifying your internal positions and your respective groups. Our group, can support autonomy and the independence and autonomy of the ESF. Yes. We need a guaranteed envelope, but it's a fund which doesn't rely on a performance based budgetary model. The structure itself is secondary to this question, Question of undermining the budgetary control competence of the parliament, which has been avoided out, including legislative aspects and the binding nature of the European semester. So the money versus reform choice, the only winners out of this would be the stock markets who would decide who decides on the money distribution would be the commission, and that relies on no democratic legitimacy. Our position is very clear. So an autonomous social fund needs to be really autonomous. If it's a question of deciding who's going to decide between employment or autonomy, we need to consider our opinions here. We will agree to the ambition in the report. It's a first step, so we're heading towards autonomy. What's most important for us is the management model. Otherwise, in any case, the parliament will be excluded whether it's autonomous or not with, governance and performance criteria. There will be no democratic control over the social.”
  European Semester (social dimension)
• “Thank you very much indeed, Madam Chair. Thank you very much indeed, Vice President Manzato, when it comes to the social rights pillar, the European Semester continues to formulate recommendations which end up being binding mandatory for member states in areas such as the labour market, minimum wages, as well as collective bargaining, whereas in actual fact, Those are national preserves. So when it comes to public funding, how do you plan to fully apply the principle of subsidiarity? Because these recommendations actually extend beyond the competences of the European Union, particularly when it comes to the sustainability of welfare systems and structural reforms to the labour market. I'd like to move now on to a question for Vice President Dombrovskis. In the first half of 2027, we will see the new rules for economic governance enter fully into force. Member states are already indicating they are struggling to reconcile the budget objectives with the necessary measures required for the green transition and industrial competitiveness, as well as energy resilience. Since that is the case, how do you plan to ensure that the multiannual adjustment programmes do not become a burden on employment policies, and make sure that Member States are due to be able to fund their employment programmes. And how do you plan to justify the kinds of reforms which do not take account of national economic divergences?”
  European Semester (social dimension)
• “Thank you chairman. Thank you to our guests for these very exhaustive and stimulating presentations made today. But allow me to thank in particular Doctor Miliori, who is an outstanding director of the Polyclinico, the Polyclinic in my city Bari. He is a point of reference not only for our area but also in terms of the national and international debate on the sustainability of health systems and the roles of health professionals. The issue we've been discussing today has been raised by the experts very clearly and also other speakers talking about crucial issues for all of us. In other words, the shortage of health professionals, the aging of the workforce. Some of the figures mentioned in particular by Doctor Miliori are really alarming in our country. But also there are still structural obstacles to the access to the profession, for example the bottleneck of specializations. All of that together means that the sustainability of our care systems is at risk. In the south, these difficulties are also linked with the phenomenon of depopulation that you referred to as well and youth migration that makes it even more difficult to guarantee the essential health services. Now certainly the solutions we need have to be flexible but there will also be market led as well. I'm thinking of certain steps that could be taken to make university courses more attractive. We had certain suggestions being made about that. But also working conditions could be rendered more compatible with family life, which is all too often sacrificed because of the difficult working hours and the low salaries. Last but not least, I think we need to better coordinate university training, specialization, and the real needs of each country or each health system. To conclude then, I would just like to ask a question: how could we encourage professionals to remain, particularly young people, in those areas which are being most affected by depopulation? Thank you.”
  EU policy on aging workforce and pensions
• “President. Mr. president. Commissioner, when we talk about abuse of children, we are not talking about numbers. We're talking about children who are silent, who are shamed, whose injuries can never be overcome. A world where the grown ups close their eyes or there's too much bureaucracy and red tape. Every child has a right to grow up in a world full of love, of safety, of respect. So these abusers are not just crimes, their invisible injuries which affect the lives of the innocent forever. It's not enough to compromise. We have to have exemplary instruments in force. We need to have alliances between families and schools. On this point, we should have no blurred areas. There's no left, no right, just humanity. Defending children means defending the foundation of our society. Any delay, any omission is a collective defeat because every child who is forced into silence should enjoy more support from us.”
  Safety features & content control for child protection online
• “(15:50:55 – 15:53:03): Thank you, chairman. Thank you, colleagues. The commission's proposal introduces a useful framework, but the decisive factor is how it will be applied to work as we wanted to stress in our amendments. It needs to be anchored in three criteria, efficiency, proportionality, and respect for member states' competencies. A performance system without measuring concrete results, competition, inclusion, but the framework cannot represent greater burden administrative burden today to complex reduces provisions reduces the efficiency for the SMEs or local authorities undermining the efficiency. In this context, there's also a broader risk that is of a progressive centralization, a too rigid system based on standardized measurements undermine the social model. Indicators are a key point here. They need to be pertinent. They need to be limited and used in a flexible manner. Otherwise, they're no longer useful for evaluation and simply are operational for slowing the whole procedure down. The same is true for the subsidiarity principle. The performance framework cannot be used to introduce even indirectly standards or conditions in areas which remain national competence, in particular in the labor market and social policies. And finally, it's right to strengthen the focus on employment, competitiveness, and inclusion as well as people with disabilities. But all of this needs to be very specific by linking this all to the results. The goals need to be very clear, a budget which works better and which is more transparent and simpler to apply because the efficiency of in a European expenditure depends at the end of the day, on member states' capability of using it properly. Thank you.”
  EU expenditure on social policy · EU political integration
• “President. Commissioner. You might be called a hypochondriac or said you've got a low pain threshold. These are the kind of things that women hear all of the time, this very superficial, uh, derisory statements. But this is a very painful disease. Endometriosis affects 40 million women in Europe, and it means for many women, it is painful even to be sitting up. Uh, migraine or menstrual pains. Even infertility can be the consequence. This is an invalidating illness and it has to be taken into serious consideration. If this affected men at the same prevalence, we would already have uniform guidelines in place. Early diagnosis and guaranteed access to to care and protections in the workplace, but for women, there's nothing. It's high time that the European Union recognised endometriosis as a public health priority, and started to promote a European strategy. We need more research, we need more information for doctors, and we need specific policies to recognise the rights of women who are suffering, and that includes workplace rights. We cannot simply allow millions of our citizens suffering invisible pain. Let's break down the wall of silence here in Europe. Thank you very much.”
  Gender roles, equality and inclusion