ENGLISH
Romania to negotiate for the first time, at European level, new regulations on patient access to treatments for rare and pediatric diseases
Published
2 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
Csaba Borboly, President of Harghita County Council and CoR rapporteur, supports the introduction of an infringement procedure against EU countries that do not seriously consider compensation for damage caused by large carnivores to livestock or crops
Published
2 weeks agoon
March 8, 2024Csaba Borboly, president of Harghita County Council and rapporteur of the European Committee of the Regions (CoR) for the draft opinion on ”Biodiversity protection and coexistence with large carnivores in Europe – challenges and opportunities for local and regional authorities”, supports, among other things, the introduction of an infringement procedure in European legislation against countries that do not take seriously the compensation of damage caused by large carnivores to livestock or crops.
At a local dialogue organised by Harghita County Council and the CoR on 8 March in Miercurea-Ciuc, Csaba Borboly discussed the need to strengthen EU action for a European policy on large carnivores, underlining the transnational nature of the issue of harmonious coexistence with these animals and calling for sustained efforts at European, national, regional and local level to find new ways for the sustainable and safe coexistence of farm animals, humans and large terrestrial, marine and flying carnivores.
Borboly stressed that dialogue with the European institutions is essential to promote these concerns at the European decision-making level. In addition to ongoing negotiations with the European Commission and the European Parliament, he said, regional and local authorities must be actively involved in the process of developing specific solutions. He also stressed the importance of supporting politicians who back these initiatives and underlined the desire to create a platform at the regional level in Harghita County to develop specific solutions.
“With the report, we are in permanent negotiations with the representatives of the European Commission, here I am referring first of all to the Directorate General for Environment where there is a department for biodiversity, and, besides, to the European Parliament where we try to support with arguments the work of the MEPs who support us, and at home we would like to achieve the creation of a regional platform for large carnivores in Harghita County in the framework of the new European platform for large carnivores, where we can elaborate specific solutions. We also hope that the Government and Parliament will consider these things, and in parallel, there are several analyses and studies on what is not working and how we could improve things, and we are trying to formulate amendments to the legislation. Then we go further to the European Union level, where we have the opportunity to present the report when there are preparatory discussions for the decision-making act, then we can regularly present it at the European big platform meetings and at several public policy debates. Now we have Hungary coming up for the EU Presidency in the summer and if the Hungarian Presidency finds the issue important enough to put it on the agenda, then we will most likely have better results. These are the directions we can take”, said the President of Harghita County Council, CoR rapporteur.
He also highlighted the need for a more coherent and coercive approach at the European level in terms of compliance with biodiversity conservation and habitat protection legislation. He stressed that the lack of enforcement levers in international legislation makes it difficult to implement and comply with these rules, insisting on the need to find effective ways to monitor and sanction Member States that do not fulfill their obligations.
“As I said, on many levels we are moving forward and so far we have been able to solve many things at home, for some we have also had political decisions and regulations, for others we have not. I don’t follow that path – what would happen if we didn’t do anything? – we are moving forward. What has changed from the previous report is that we have included a provision saying that it is not okay if a Member State does not take citizens’ problems seriously. There is a new element in this report, to see if we get support from Brussels to launch an infringement procedure against those states that are not serious about providing compensation and solving the whole problem. Because I have worked with many ministers here, all of whom were well-meaning, but somehow in Parliament, here and there, on the stairs of the Academy, some things got bogged down, not all of them, but some of them, and we see that if there is infringement for waste management and everyone takes the position of the righteous, the mayors are fined for things they did not do, or for waste dumps that were there for who knows when; if there is infringement for air, for water, then we need this infringement procedure on this subject too. I believe that the international legislative framework is not complete here, and there is no coercive leverage. We have levers, what species are protected, and how to protect them, but for Articles 14 and 16, for habitats, for ensuring they are respected, for ensuring that human life and health come first, we do not have any levers. This is why I am saying this, when we also have elections for the European Parliament and this is why I wanted to have this debate and I hope that the two representatives of the RMDSZ in the European Parliament will take up this issue”, explained Csaba Borboly.
Finally, Borboly expressed the hope that through sustained efforts at European level and the active involvement of local and regional stakeholders, it will be possible to find appropriate solutions to a complex problem such as the harmonious coexistence of humans, domestic animals, and large carnivores, thus contributing to the conservation of biodiversity and the protection of the interests of local communities.
“The mills are working slowly to solve this problem. Let’s hope that the Environment Ministry and Brussels will be more courageous on this issue. At the moment I don’t see a better solution for this, than just to work together, to collect data, because I see that things are getting simpler ‘to shoot or not to shoot’; if we stick to this it all gets bogged down. If we simplify things to protected-unprotected status again, things get stuck again. There are many facts that people don’t know because we don’t have data. We know how many birds there are at European level, but we don’t know how many bears, and we could list the rest of the things, the compensation, etc. In 2028 the new funding period starts at the EU level, there will be a lot of opportunities, but there is no point in going for separate money for large carnivores then because it is late. Now a solution is being prepared and at these events we attend I see that many geese beat a pig and somehow we have to put our opinion forward in the European Union”, concluded the President of the CJ Harghita and CoR rapporteur.
The event “Biodiversity protection and coexistence with large carnivores in Europe – Challenges and opportunities for local and regional authorities”, held in Miercurea-Ciuc, brought together numerous speakers and addressed various topics related to biodiversity conservation and the relationship with large carnivores.
During the first part of the dialogue, European perspectives were discussed, with presentations and debates given by key figures such as Csaba Borboly, President of Harghita County Council, László Csák, expert, and Robert Zeman from the European Committee of the Regions. Other notable participants were MEP Herbert Dorfmann and Dr Miklós Heltai, Director of the MATE Wildlife Management Institute.
The second part of the dialogue focused on the situation in Romania and Harghita County, with presentations by officials such as Gabriel Oltean, Ministerial Advisor, and specialists such as Dr. Róbert Szép from the Research and Development Institute for Wildlife Management and Mountain Resources. Also included were perspectives from civil society, represented by Levente Miklós and Hadnagy Lehel.
The dialogue also included video messages from Professor Dr. Ovidiu Ionescu and Dr. Valeria Salvatore, who made important contributions related to the presentation of the Harghita County Regional Platform.
Moderated by journalist Dan Cărbunaru, the event focused on bringing together local and regional authorities, scientific experts and other stakeholders to share experiences and ideas on biodiversity conservation and coexistence with large carnivores, taking into account the Romanian legislative context. Professional presentations and networking sessions resulted in a better understanding of current challenges and possible solutions, as well as the creation of new connections and exchange of ideas among participants.
ENGLISH
Harghita County Council and the European Committee of the Regions organise a local dialogue on biodiversity protection and coexistence with large carnivores in Europe (LIVE, 8 March, 09.00)
Published
2 weeks agoon
March 7, 2024By
REDACTIAHarghita County Council, together with the European Committee of the Regions (CoR), is organising a local dialogue in Miercurea-Ciuc on Friday, 8 March 2024 on the protection of biodiversity and the coexistence of large carnivores in Europe, based on the draft opinion of CoR on this issue, coordinated by the President of Harghita County Council, Csaba Borboly (EPP-RO), as rapporteur.
Entitled “Biodiversity protection and coexistence with large carnivores in Europe – Challenges and opportunities for local and regional authorities –“, the event will start at 09.00 and will be broadcast LIVE on CaleaEuropeană.ro and on the Calea Europeană Facebook page.
The event will address both the European, national, and local dimensions of the topic. The full agenda is available here.
The first part of the dialogue will address the European perspective and will start with a presentation by the rapporteur, President of CJ Harghita Csaba Borboly, followed by a debate with László Csák, who will present the expert’s point of view, and Robert Zeman (CZ/ECR), shadow rapporteur at the European Committee of the Regions.
The panel will also include MEP Herbert Dorfmann and Dr Miklós Heltai, Director of the MATE Wildlife Management Institute.
The second part of the dialogue will address “Protection of biological diversity and coexistence with large carnivores in Romania and Harghita County”. This panel will include:
– Gabriel Oltean, Ministerial Advisor, Ministry of Environment, Water and Forests;
– Levente Miklós, Rural Development Association of Harghita County Council, on “Wildlife damage caused by brown bears in Harghita County. Aggregated data of the last ten years”;
– Director Dr. Róbert Szép, Research and Development Institute for Wildlife and Mountain Resources Management, on “Practical research results of the Institute for Research and Development of Wildlife and Mountain Resources”;
– Hadnagy Lehel, Engineer, Silos Hunting Association, on “To shoot or not to shoot – the situation of bears through the eyes of a game manager in Harghita”;
During this panel, Professor Dr. Ovidiu Ionescu, ICAS, and Dr. Valeria Salvatore, ecologist, Institute of Applied Ecology, Italy, will deliver video messages on “Regional platform support in meeting the challenges posed by coexistence with large carnivores in 2024”.
The local dialogue is moderated by journalist Dan Cărbunaru, director of CaleaEuropeană.ro.
The aim of the event is to bring together local and regional authorities, scientific experts, and stakeholders, providing an opportunity to share experiences and ideas on biodiversity conservation and coexistence with large carnivores, considering Romanian legislation.
Professional presentations in various fields will contribute to a deeper understanding of current challenges and possible solutions, while networking sessions will provide an opportunity to make new connections and exchange ideas.
ENGLISH
PNL: The EPP Congress in Bucharest will bring together 2,000 delegates from 40 countries, including the Presidents of the European Commission and European Parliament and EPP state leaders
Published
3 weeks agoon
February 29, 2024More than 2,000 delegates from over 40 countries, including the President of the European Commission, the President of the European Parliament, heads of state and government, European People’s Party leaders, and European Commissioners from the EPP political family, will meet next week in Bucharest, according to an announcement on Wednesday made by the National Liberal Party, co-host of the political event.
The European People’s Party (EPP) Congress will take place on 6 and 7 March at Romexpo.
“The EPP’s visit to Bucharest is a sign of solidarity of the whole European Union with Romania and the states in the vicinity of the war unleashed by Russia in Ukraine,” PNL said in a statement.
The EPP Congress will prepare the 6-9 June elections for the European Parliament, adopt the manifesto of the European People’s Party and elect the candidate at the head of the list for the European elections and, implicitly, the candidate for the European Commission presidency.
The meeting in Bucharest is hosted by the National Liberal Party in partnership with the European People’s Party.
Bucharest already hosted a congress of the European People’s Party in October 2012.
European Commission President Ursula von der Leyen, European Parliament President Roberta Metsola and Romanian President Klaus Iohannis will be the leaders delivering the closing remarks at the European People’s Party Congress in Bucharest, where the EU’s largest political family will set out its strategy and election manifesto for the 6-9 June European Parliament elections and nominate their lead candidate for President of the European Commission.
The announcement was made earlier this month by the party’s leader, German Manfred Weber, who is also chairman of the EPP group in the European Parliament, during a discussion with Romanian journalists.
The election manifesto of PNL is also expected to be presented in the context of the EPP Congress in Bucharest.
The Congress will be inaugurated by EPP President Manfred Weber and PNL President Nicolae Ciucă, with all the heads of state and government of the EPP member parties who will be present in Bucharest delivering speeches.
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