Connect with us

ENGLISH

Ensuring Romanian patients’ access to the latest treatments should be a top priority for the authorities. What Romanian experts call for

Published

on

© European Union, Source: EC - Audiovisual Service

Romania cannot improve its access to the latest innovative medicines without a joint effort of the state institutions in the field and the involvement of patients and industry in solving problems related to access them. According to Romanian national and European experts, Romania lacks financial foresight and a correlation between legislative approaches and patients’ needs.

National authorities, European decision-makers, and representatives of the pharmaceutical industry responded to the initiative launched by www.CaleaEuropeana.ro and the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) and held an open dialogue on the access of Romanian patients to the latest generation of medicines, which is still too limited and difficult compared to other EU Member States.

The main objectives that the Pharmaceutical Strategy for Europe aims to achieve in terms of easy and equitable access to medicines were discussed, as well as what measures need to be taken at national level in order to make timely access of Romanian patients to the latest innovative medicines a reality.

In Europe, patients can wait between 4 months and 2.5 years for access to the same new medicines depending on the country, with Romania ranking last in this ranking. According to the EFPIA PATIENT W.A.I.T. 2020 indicator (published in 2021), countries in North-Western Europe have access to the latest generation of medicines much faster than their neighbours in Southern and Eastern Europe, with patients in some countries waiting more than seven times longer, according to new research. Access is fastest in Germany, with an average of 120 days between marketing authorisation and availability in the country, while Romania ranks last, with an average of 883 days.

Read also: Romanians can wait more than two years for the latest medicines. Delayed access means less chances of survival

All these inequalities among patients in the European Union are intended to be remedied by new strategies and programmes at European level. To this end, the European Commission has launched the Pharmaceutical Strategy for Europe, which is an ambitious project aimed at strengthening the patient focus of the European pharmaceutical system and making it resilient to future health crises. It was adopted last November as a pillar of the European Health Union.

The access to medicines aspects of the Pharmaceutical Strategy for Europe are based on four main themes:

  1. Medicines available in all Member States at the same time (availability)
  2. Medicines at sustainable prices (affordability)
  3. Medicines to be found in local markets (shortages and supply chain)
  4. Boosting competition

On 30 March the roadmap was published and a first public consultation finalised on 27 April to which ARPIM also had a specific contribution, not only as a member of EFPIA. On 28 September 2021, the European Commission published a new public consultation on the review of EU pharmaceutical legislation. The consultation will run until 21 December and will gather views from both the general public and stakeholders.

ARPIM invites all key stakeholders in Romania to contribute to this public consultation. ARPIM will also certainly contribute to this consultation and make its views available to all interested authorities.

Why do we have the EU’s worst access to innovative medicines approved on the European market?

Efforts are being made at European level to find the quickest possible access solutions for patients, but a permanent dialogue is needed at national level between authorities and industry to reap the benefits of these European projects. Ensuring patient access to state-of-the-art treatments should be a common goal and responsibility.

According to ARPIM, improving the framework for access to the latest generation of medicines is influenced by:

●Clear deadlines for updating the List of Reimbursed Medicines, for its publication and for therapeutic protocols in relation to the issuance of the reimbursement decision.
Methodology aligned with international good practice for calculating the budgetary impact of updating the list of reimbursed medicines.
●HTA – operationalisation of the methodology for taking into account studies in current clinical practice: ARPIM is working on a proposal which it will submit for discussion with the relevant authorities as soon as possible.
● Cost-volume contract: clarify and make transparent the methodology for calculating and renegotiating the eligible population, so that all patients who could benefit from treatment or who are already on treatment in the first year of the contract are included when the contract is renegotiated; diversify the contract models, the existing ones are not adapted to chronic diseases with lifelong treatment or orphan drugs, nor to the increasingly personalised treatments that represent the future of medicine.
● Clinical trials – compliance with legislative timelines.
● Establishing cancer patient pathways and priority and emergency access to investigations for suspected cancer (e.g. initiation of treatment within 30 days of presentation to GP/specialist with signs or symptoms indicative of cancer); paying for testing of biomarkers that can guide treatment much faster and improve its effectiveness.
●Identify an access mechanism in situations with no therapeutic alternative between the issuance of the APP by the EMA and the completion of the assessment for reimbursement.
● Accelerate preparations for the implementation of the new European HTA at national level.

The European access to medicines journey must also stop in Romania

The Romanian Parliament is advocating for adequate funding in the future so that all European regulations aimed at facilitating access to innovative treatments are also implemented in Romania, said Alexandru Rafila, Vice-President of the Chamber of Deputies. He also pointed out that there is no correlation between legislative measures and patients’ needs.

The resilience of the health system has many aspects, and one of them is linked to the possibility of providing medical services, of providing treatment to people even in crisis situations. As far as ARPIM and the pharmaceutical industry area are concerned, models of good practice, of partnership should be found to facilitate access to these innovative therapies and to generic and biosimilar products, because, beyond legislative and methodological changes, a model of collaboration between the authorities and the industry must be identified, so that access to appropriate medication, whether the latest generation or generic and biosimilar, is real and not theoretical.

The Ministry of Finance needs to be present in a future decision-making mechanism in order to manage to ensure sustainability and a financial envelope that is bearable for the Romanian budget in the current situation. It is necessary to explore the elaboration of a multiannual budget that would also ensure predictability in the introduction of new molecules in therapeutic areas.

The representative of the Ministry of Health argues that the main challenge of the system is to ensure the treatment of patients with limited resources, which means that attention must be directed towards all types of drugs. On innovation, the Ministry of Health welcomes the EU support and believes that the European project is a very important resource for Romania in the development of the health system. The Ministry has conveyed that it supports the initiative of an open dialogue to find solutions together, thus ensuring patients’ access to medicines. As for the publication of the list of reimbursed and compensated medicines, the updating of Government Decision 720/2008, this is the responsibility of the Directorate of Medical Assistance of the Ministry of Health.

From the patients’ perspective, access means having the right medicine at the right time, without having to struggle

The Association of Patients with Autoimmune Diseases believes that Romania is far from achieving this goal, and that collaboration and transparency should not remain a declarative statement. The Association stresses that these working groups should be formed and function regardless of who is at the head of the Ministry of Health.

According to the patients’ associations’ representatives, Romania lacks a financial forecast. The Ministry of Health, the Health Insurance House and the Ministry of Finance must present a medium and long term strategy, not just an annual budget but 5 and 10 year forecasts and strategies. There was a call for more flexibility on the part of the authorities, the creation of a special body or department in the Ministry of Health or the National Agency for Medicines to deal with the crisis of medicines and medical devices. Reference was also made to exploring the feasibility of a European mechanism for the procurement of monoclonal antibodies and innovative medicines, as was the case for vaccines, because price is a barrier, especially in a country that has the lowest European budget for health and where health system reform is lagging behind.

The Romanian Representation in Brussels calls for the involvement of Romanian stakeholders in an open and constructive dialogue on the issues that shape the EU pharmaceutical framework

According to the Romanian Representation in Brussels, the Pharmaceutical Strategy for Europe is the flagship initiative of the European Commission which contains all projects and initiatives in the pharmaceutical field. It will support patient-centred innovation and enable adaptation to digital and technological change, one of the objectives being to ensure that patients have access to affordable medicines and that healthcare systems remain financially sustainable.

The representative informed that the Public-Private Partnership for Health Research and Innovation Funding, IMI2, is based on perhaps the most important platform at European level for developing the conditions for the availability of innovative medicines and products with a budget of €5.3 billion, 178 projects and 5248 participants. There is also a European Commission expert group on safe and early access of patients to medicines, the STAMP group, which meets regularly, advises and provides expertise to the Commission on EU pharmaceutical policy.

Innovation must start with patients and their needs, the message from Romanian experts in the European Parliament

Health and health service development, investment and innovation stimulation in this sector should be a top priority for policy makers, not only to fight the current pandemic, but also to prepare our health systems to respond to global challenges and future treatments. Romanian experts are calling for a paradigm shift so that Romania’s healthcare system promotes innovation to develop new products and treatments or to improve care.

The Romanian specialists in the European Parliament also ask the European Union to come up with a financial framework to stimulate patient-centred investments and ask for the involvement of the Romanian state in this chapter. The Pharmaceutical Strategy for Europe tries to reduce this gap in terms of access to innovative therapies, but this strategy focuses very much on the period until the marketing authorisation of medicines, and in Romania problems arise after this approval due to legislative syncopations, experts warn.

Collaboration between state institutions in the field and the involvement of patients and industry remain essential to solve problems related to access to innovative medicines.

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.

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

on

© ROSA

The 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.

Continue Reading

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

on

© European Union / Fred Guerdin

Csaba 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.

 

Continue Reading

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

on

© Consiliul Județean Harghita

Harghita 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.

Continue Reading

Facebook

Concrete & Design Solutions

Concrete-Design-Solutions
ROMÂNIA13 hours ago

Ministrul Apărării a discutat cu ambasadoarea SUA despre planurile de modernizare a Bazei 57 Aeriene Mihail Kogălniceanu

U.E.14 hours ago

„Frâna datoriei” este o frână pentru inflație, susține ministrul german al Finanțelor. Germania are cel mai mic scăzut al inflației din ultimii trei ani

ROMÂNIA14 hours ago

Ministrul Culturii Raluca Turcan anunță lansarea aplicației mobile Patrimonium, pentru creșterea accesului la cultură

U.E.15 hours ago

Scholz îndeamnă Israelul la reținere după respingerea „cu adevărat impresionantă” a atacului iranian

MAREA BRITANIE17 hours ago

Ministrul de externe britanic îndeamnă Israelul să fie „inteligent” și să nu escaladeze tensiunile cu Iranul

ROMÂNIA17 hours ago

Premierul Marcel Ciolacu, întâlnire cu președintele Congresului Mondial al Ucrainenilor: Lucrăm împreună pentru a asigura drepturi egale pentru minoritățile naționale din România și Ucraina

INTERNAȚIONAL18 hours ago

Olaf Scholz transmite că mașinile chinezești vor fi binevenite pe piața germană, dar atrage atenția asupra practicilor comerciale neloiale: Concurența trebuie să fie corectă

INTERNAȚIONAL19 hours ago

Volodimir Zelenski dă drept exemplu sprijinul oferit de aliați Israelului pentru a solicita mai mult ajutor militar pentru Ucraina: ”Unitatea” între aliaţi ”oferă cea mai bună apărare”

U.E.19 hours ago

Franța va face „totul pentru a evita o conflagrație” în Orientul Mijlociu și îndeamnă Israelul „să nu răspundă prin escaladare, ci mai degrabă prin izolarea Iranului”

CONSILIUL DE SECURITATE20 hours ago

Secretarul general al ONU lansează un apel la ”reținere maximă” după atacul Iranului asupra Israelului: ”Nici regiunea, nici lumea nu-şi pot permite mai mult război”

ROMÂNIA17 hours ago

Premierul Marcel Ciolacu, întâlnire cu președintele Congresului Mondial al Ucrainenilor: Lucrăm împreună pentru a asigura drepturi egale pentru minoritățile naționale din România și Ucraina

NATO4 days ago

Klaus Iohannis explică de ce România nu a investit 2,5% din PIB pentru apărare în 2023: Inflația, lipsa lichidităților la momentul achiziției și a echipamentelor militare

PARLAMENTUL EUROPEAN6 days ago

Regele Philippe al Belgiei, în plenul PE: „Europa și întreaga lume au mare nevoie de speranță”

NATO6 days ago

“România – NATO, 20 ani”. Premierul Marcel Ciolacu: Ancorată ireversibil în comunitatea euro-atlantică, România este o ancoră strategică a NATO pe flancul estic

ROMÂNIA1 week ago

Premierul Marcel Ciolacu subliniază că institutele de la Fundeni reprezintă priorități pentru investițiile în sănătate: Nu putem face sănătate performantă în clădiri de 65 de ani

ALEGERI EUROPENE 20241 week ago

Ciolacu, întâlnire cu Scholz la Palatul Victoria: România mizează pe susținerea Germaniei pentru aderarea completă la Schengen și dezvoltarea economiei

ROMÂNIA2 weeks ago

Marcel Ciolacu, la depunerea listei alianței PSD-PNL la europarlamentare: Venim cu o ofertă europeană de stabilitate și de construcție

ROMÂNIA2 weeks ago

Ministrul Bogdan Ivan: Prin mințile geniale ale tinerilor cercetători, Romania devine una din cele mai importante țări din regiune și chiar un potențial hub pentru tehnologii emergente, cercetare și inovare

NATO2 weeks ago

Un discurs cât pentru istoria de 75 ani a NATO. Stoltenberg: Europa are nevoie de SUA pentru securitatea sa. Influența aliaților europeni multiplică puterea Americii

CONSILIUL EUROPEAN2 weeks ago

Klaus Iohannis: Viitoarea agendă strategică UE trebuie să se concentreze pe “consolidarea construcţiei europene” privind securitatea, apărarea și extinderea Uniunii

Trending