ENGLISH
Romania to negotiate for the first time, at European level, new regulations on patient access to treatments for rare and pediatric diseases
Published
3 years agoon
By
Diana ZaimAccording to national and European experts, access to innovative medicines for Romanian patients suffering from rare diseases can be improved in the coming years, as Romania has for the first time the chance, as a member state of the European Union, to contribute to the revision of the Orphan Medicinal Regulation, which was implemented 20 years ago.
National authorities, European decision-makers, representatives of the pharmaceutical industry responded to the initiative launched by the Media Platform www.caleaeuropeana.ro and the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) and held an open dialogue on the access of Romanian patients to orphan and paediatric medicines, as well as on Romania’s role in the forthcoming negotiations at European level for the revision of the Orphan Medicinal Products Regulation.
To ensure that patients suffering from rare diseases have access to medication, the “Regulation on Orphan Medicinal Products (OMP)” was adopted 20 years ago, introducing specific legislation, a definition of OMP, and a specific committee responsible for OMP at the European Medicines Agency (EMA), as well as incentives to promote the development of treatments for rare diseases.
The role of Romania and Romanian experts in the negotiations held by the European institutions
This more than 20-year-old regulation will be re-evaluated, and this is the first time when Romania, as an EU Member State, will participate in the legislative process in the negotiations at the Council level and subsequently in the negotiations between Council and Parliament by submitting successive positions in the negotiations on the legislative act, according to national interests in the matter.
The review of EU legislation addresses the gaps identified by the evaluation with regard to products and their development for the specific needs of children and patients with rare diseases; early access to treatment for these groups and improvement of approval procedures and reduction of inequalities in access.
The European Commission launched another public consultation on 28 September, which will close on 21 December 2021, on the reform of the overall medicines policy framework as part of the resilience of the EU pharmaceutical sector. Thus, the Permanent Representation of Romania to the EU invites key stakeholders in Romania to participate and get involved and, most importantly, make their voices heard at European level.
What happens after the European Commission presents the legislation
Once the European Commission presents the legislative act to the public, the EU Council and the Parliament will start debating it (co-decision). The French Presidency, which will be at the helm of the Council in the first half of next year, will put the proposal on the agenda with a view to finding a compromise with a qualified majority of the EU 27, and the Parliament in parallel will vote on its position at first reading, initially in the ENVI committee and then in the plenary of the European Parliament.
When the Council reaches an agreement it will start negotiations with the European Parliament, the so-called trilogues, and after several rounds of negotiations, a political agreement will be reached between the two co-legislators. Once agreement is reached, the regulation will be adopted and will enter into force immediately after publication in the Official Journal of the EU with immediate legal effect, provided there are no transitional periods and it is a regulation and not a directive. From the moment the public consultation is closed until the publication of the act, Member States, the Council and the Parliament cannot influence the legislative act, as it is pending and in preparation for adoption by the Commission.
Romania will, for the first time, participate in the legislative process in the negotiations at the Council level and subsequently in the negotiations between the Council and Parliament by submitting successive positions in the negotiations on the legislative act, depending on national interests in the matter.
Negotiations between the Member States at Council level take place between the Member States at three levels: at technical level, by Member States’ experts in the working groups on pharmaceuticals and medical devices; at the level of the Permanent Representatives of the Member States and at ministerial level, the EPSCO Council (health component).
In addition to participating in public consultations, Romania will have a new opportunity to participate, contribute and influence the EU legislative process in order to create optimal conditions for ensuring access to treatment for rare and pediatric diseases for the benefit of Romanian patients and to create the incentive framework necessary for the development of orphan and pediatric products for the pharmaceutical industry.
Romania will also contribute to the initiative “a European Pharmaceutical Strategy” and will support ensuring the availability of innovative and affordable medicines for patients, as well as supporting the competitiveness, innovation capacity and sustainability of the pharmaceutical industry in Romania and in the European Union.
Diana Zaim este foto jurnalist, câștigătoare a Premiul Publicului la European Youth Event 2020, cel mai mare eveniment pentru tineri organizat de Parlamentul European. Absolventă a secției germană-portugheză în cadrul Universității din București, Diana urmează în prezent programul de master ”Relații Internaționale și Integrare Europeană” în cadrul SNSPA. Pasionată de promovarea valorilor europene, Diana este parte a comunității Model European Union, cea mai amplă simulare la nivel european a procesului decizional din cadrul Uniunii Europene.
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ENGLISH
Op-Ed | German Foreign Minister marks 20 years since EU’s biggest enlargement: The generations before us created a Europe of freedom. Our task is defending Europe
Published
8 hours agoon
April 29, 2024By
REDACTIAAnnalena Baerbock, German Federal Minister for Foreign Affairs
With the European anthem ringing in their ears and fireworks lighting up the night sky, complete strangers embraced each other. I joined hundreds of people back then, on 1 May 2004, on the Oder bridge between Frankfurt in eastern Germany and Słubice in western Poland in celebrating this special European moment. East and West were united in the European Union at long last. Around 75 million people in Czechia, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovenia, Slovakia and Cyprus became part of the EU family on that night. Our neighbours in Bulgaria, Romania and Croatia also joined them later on.
It was the courageous responsibility and vision of the people in the accession countries – from the Baltic region to the Mediterranean Sea – that made this great celebration possible back then. They had embarked upon the long and difficult road of reform and harmonisation with determination.
For me as Germany’s Foreign Minister, 1 May reminds us that each generation has its task. The generations of our parents and grandparents recognised after the Second World War that reconciliation is the basis for a European community of peace. We Germans must never forget that especially we, who brought war and destruction to so many people, were thus able to find the path to peace and friendship. The generations before us created a European Union of freedom – for living, working and doing business – from the Atlantic up to the border with Russia.
The generation of the major round of enlargement had to have the courage back then not to be deterred by pushbacks or populist slogans. Like in Germany, where in times of high unemployment the fear of the “Polish plumber” was stoked. The job of politicians, however, is, as former Federal President Walter Scheel once put it, “to do the right thing and make it popular”, as opposed to giving in to moods and letting ourselves be driven by them. If social media had already existed at that time, then I wonder whether the debate would have perhaps had a different conclusion. But nothing hopeful can grow from hatred, populism or naysayers.
Our generation now faces the task of defending and strengthening the peace and freedom project that is Europe, even though this takes incredible strength. After all, Putin’s war of aggression against Ukraine is a most brutal reminder that our peace, freedom and prosperity in Europe cannot be taken for granted. What guided the generations before us in building our united Europe is what we also need today to protect our Europe, namely courageous responsibility and vision.
As the European Union, we are defending our values and our security together with friends and allies and are standing firmly by Ukraine’s side – for as long as it takes. By the side of a country that, for over two years now, has made the very greatest sacrifices for a future in freedom and democracy – and which is now itself taking big strides towards EU accession.
At the latest since Russia’s war of aggression against Ukraine, we know that today the expansion of our EU is a geopolitical necessity, too. Political and geographical “grey zones” in the Balkans or in the east of the EU are highly dangerous. We cannot afford such grey zones as for Putin they are an invitation to interfere and destabilise.
The European Union stands for freedom, democracy and the rule of law. Just like 20 years ago, once again today millions of Europeans see an opportunity and a promise in becoming EU citizens. And we cannot afford once again to make an entire generation sit in the EU’s waiting room, as in the countries of the Western Balkans. We must not pass up the opportunity to make our Union bigger and stronger – and therefore also more secure. Our Union of peace and freedom is open for new members.
However, in order for the accession of further countries to the Union to be successful, we must ensure that the EU remains capable of taking action both internally and externally. We will continue to develop our EU with all due resolve to this end. Even if we have intense debates about how time and again – as is to be expected in a big family. The wealth of experience of the EU members that have joined the Union since 2004, countries that successfully mastered a long transformation process, is particularly valuable here.
In order for our Union of freedom to accomplish this task for our generation, we must reform it. To my mind, this includes reducing the scope for vetoes in the Council. We must remain capable of action also in a future Union potentially numbering over 35 members. This includes reaching decisions more often with a large majority as opposed to achieving unanimity. Even if this means that Germany – like any other member state – can also be outvoted. We must address enlargement and reform with determination.
Showing courageous responsibility means today that we must make our European Union fit to take in new countries already in this decade. So that people can embrace each other once again, with the European anthem ringing in their ears, united in our growing European family.
ENGLISH
ANPC Romania launched investigations into potential unfair commercial practices of online shopping platforms Temu and Shein
Published
6 days agoon
April 23, 2024The National Authority for Consumer Protection (ANPC) is currently carrying out an action to check shopping sites and apps that operate as an online marketplace, Temu and Shein, ANPC informs in a press release.
“The action focuses on possible unfair commercial practices of merchants, in relation to consumers, likely to distort, essentially, their economic behavior, namely potential violations of horizontal legislation on product safety and consumer protection (unauthentic discounts) and aggressive practices – manipulative interfaces (dark patterns), pressure-selling, rewarding the involvement of a person with a product or service with a prize (gamification), but also other aspects (for example, related to product safety),” the institution’s statement reads.
In this context, the ANPC advises consumers who buy online from these sites to carefully inform themselves, before purchasing a product, about its characteristics, prices displayed, delivery costs, information about the trader or the available payment methods.
Before concluding the purchase, consumers should check whether the trader’s website provides correct and complete information on: his identification details (name, postal and e-mail address, telephone number, company registration number, tax registration number, etc.); the essential characteristics of the product; the price including all taxes; delivery charges, if applicable; payment and delivery terms; the period of validity of the offer or price; the existence and the exercise of the right of unilateral termination of the contract.
“The ANPC recommends that if you encounter a problem when shopping online, you should try to resolve it directly with the economic operator by amicable means. If this does not work, you can contact the Alternative Dispute Resolution Directorate of the ANPC https://anpc.ro/ce-este-sal/, in the case of economic operators with registered offices in Romania. If the economic operator has its head office in another European country, you can contact the European Consumer Centre in Romania https://eccromania.ro/, which helps you free of charge when you have a consumer protection problem with a product or service purchased in another European country, informs you free of charge about your rights when travelling in another European country and offers you free support if you have a complaint against your economic operator in order to resolve the problem. If no other means of redress is possible, you can submit a complaint by going to https://sesizari.anpc.ro/, in the case of economic operators with registered offices in Romania”, the Consumer Protection press release points out.
ENGLISH
Romanian Space Agency and University Politehnica of Bucharest, joint workshop dedicated to identifying innovative solutions and facilitating partnerships between public and private actors in the fields of cybersecurity and space
Published
1 month agoon
March 20, 2024The Romanian Space Agency (ROSA) and the National University for Science and Technology Politehnica Bucharest, with the support of the EU Cybersecurity Competence Centre (ECCC), organised on Wednesday, 20 March, a workshop on “Cybersecurity and Advanced Space Technologies”, to explore innovative solutions and to stimulate strategic actions, as well as to facilitate the forging of partnerships between public and private actors in the fields of cybersecurity and space.
The workshop hosted by the National University for Science and Technology Politehnica Bucharest was held in a hybrid format, with the participation of representatives from academia, ROSA and ECCC, the Ministry of Internal Affairs, the Ministry of National Defence, the National Cyber Security Directorate, but also from the private sector, with companies such as certSIGN, Thales, CS Group Romania, Eviden or AROBS, which are active in the digital transformation, big data, encryption, software solutions development, electronics and cybersecurity markets.
The discussions, open to stakeholders from the industry, research sphere, academia and students of the National University for Science and Technology Politehnica Bucharest, focused on current trends in advanced space technologies, in particular on redefining and strategically strengthening the cyber resilience of critical infrastructures and services in space taking into account lessons learned from large-scale incidents on Earth; the role of technological innovation in preventing and countering cyber risks and threats, as well as managing future challenges and exploiting opportunities to create robust defence mechanisms.
Also, Romanian companies with a tradition in the IT&C field highlighted tangible results achieved for the development and innovation of the field and for the extension of technological solutions to the space domain, as well as the partnerships established with public and private stakeholders, both at national and European level, aimed at researching and developing innovative technological solutions for civil and military applications.
Finally, discussions also focused on the collaboration between the cybersecurity and space domains, with an emphasis on identifying the most appropriate pathways for cooperation between the two industries to address common cyber risks and challenges, e.g. based on a risk assessment model or through a cyber security operations centre serving entities in a common administrative area.
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