Romania will host in March 2018 the first NATO Eastern Flank Defence Ministers meeting, in an effort to extend the Bucharest 9 format, a cooperation initiative jointly supported by Romania and Poland.
During the inauguration of the 24th NATO Centre of Excellence – for Military Counter Intelligence (NATO CI COE) – located in Krakow, Poland, the defence ministers of both Romania and Poland, Mihai Fifor and Antoni Macierewicz held a bilateral meeting were they agree to co-organise a defence ministers meeting under the B9 format.
“Minister Mihai Fifor launched the invitation to his Polish counterpart to co-organise a B9 meeting (Bulgaria, Czech Republic, Estonia, Latvia, Lithuania, Poland, Romania, Slovakia and Hungary) at the level of defence ministers in Bucharest in March next year , a proposal accepted by Antoni Macierewicz”, announced the Romanian Ministry for National Defence in a press release.
The meeting aims to push further coordination on the common issues of NATO members from the Eastern Flank.
Launched at the initiative of Romania and Poland, Bucharest 9 (B9) provides a platform for deepening dialogue and cooperation among the participating Allies in order to articulate the specific contribution of these states to ongoing Alliance processes based on their experience and expertise and on their common security interests, in full compliance with the principles of the solidarity and indivisibility of the security of NATO member states.
In this format, two meetings at the level of Heads of State and Government took place in Warsaw (July 2014) and Bucharest (November 2015) and two meetings at the level of foreign affairs Ministers, the first in Bucharest (November 2016) and the second in Warsaw (October 9, 2017).
During the last meeting- at the level of foreign affairs – Romania and the other countries adopted a Joint Declaration in which they underlined that European Defence initiatives must develop in coordination with NATO and that a strong transatlantic link remains essential for Euro-Atlantic security.
On its 25th anniversary, ARPIM launched a working paper with policy makers on health system resilience
On the occasion of 25 years of activity in Romania and involvement in projects that have contributed to increasing access to medicines and quality of life for Romanian patients, the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) has launched a document for collaboration with policy makers, structured on 4 major axes:
- The fourth priority: adequate and predictable financing of innovative medicines and vaccines
- Third priority: Health Innovation Pact | A transparent and evidence-based health system for the benefit of Romanian patients
- Second priority: Stimulating R&D in the innovative pharmaceutical industry
- First priority: Optimal and equitable access to innovation for Romanian patients
The Health Innovation Pact was launched in an online event that brought together voices from political, government and administration, as well as patient representatives, together with manufacturers of innovative medicines.
Watch LIVE the PACT for Health event:
“This is the right time to put Health at the forefront and unite all of us – policy makers, political parties, patient associations, experts, doctors and industry – around this Health Innovation Pact to rapidly improve the health system and meet the expectations of Romanian patients. The new Government has a unique opportunity to analyse, take up and prioritise the measures already identified in the collaborative document we are proposing. Thus, the innovative pharmaceutical industry, which demonstrated unprecedented mobilization during the COVID-19 pandemic, is positioned as a partner in increasing Romanian patients’ access to innovative medicines and therapeutic solutions”, said Alina Culcea, President of ARPIM.
”Partnerships with the pharmaceutical industry are extremely important for access to innovative molecules. Access is only possible with such partnerships. In Romania, we can also find convenient solutions that make it possible for patients to access innovative molecules. We can discuss this quietly once we get through this crisis and I believe we can make it happen,” said the Minister-designate for Health.” – Alexandru Rafila, Minister of Health.
I have been talking about the need for health reforms since the year I was a minister. I believe that more in-depth discussions and legislation that responds to current needs are the solutions that we must find together at this time. The “new” in Romanian health, perceived by our other neighbours as a state of normality, should overcome some barriers. The barriers that you and I have encountered are on two levels: the level of those who approve or are studying these medicines and the level of legislation that must allow these medicines to enter the Romanian market as quickly as possible” – Nelu Tătaru, Chairman of the Health and Family Affairs Committee of the Chamber of Deputies.
“We need to identify a partnership that has the right impact, a partnership that defines the missing cog that is most appropriate to prioritise at this time. We want to create all the conditions to standardise access and standards of health services at European level. The current context is forcing us to modernise and align legislation with European standards.
If we do not have practices and legislation aligned with the practices of other Member States, it is clear that Romania cannot keep up with the access to medicines that other countries offer their patients. By aligning with European standards, Romania becomes attractive to the whole manufacturing industry, which will bring real benefits to patients. Such a pact and initiative can solve important barriers and problems. ” – Andrei Baciu, State Secretary in Ministry of Health
“Adequate and effective funding for health care and better health policies lead to better health outcomes, but they also lead to improved economic and fiscal indicators. I would like to stress that medicine should not be seen as a box isolated from the rest of the health system. Innovative medicines bring value throughout the health system. From reducing side effects, to reducing hospital days and the need for medical procedures in hospital,” said Dr Ioana Bianchi.
“The health crisis caused by the pandemic and the measures taken by the European Commission to support Member States and to improve coordination at EU level have put us firmly on the path towards a Health Union. Innovative therapies are not reaching European patients with the same speed, and some may not have access at all due to shortages. In addition, health systems and patients are finding it difficult to bear the costs of medicines” – Ramona Chiriac, Head of the European Commission Representation in Romania
Read also: Health Innovation Pact | Ramona Chiriac, Head of EC Representation in Romania: Innovative therapies are not reaching European patients with the same speed. Pharma industry part of the solution
“I unquestionably believe that innovation underpins the evolution of medical science and practice. Let’s face it, medical research has transformed our lives in the most profound ways and continues to do so at an ever-increasing pace. The evolving dynamics of new personalised therapies, new methods of diagnosis and intervention in complex cases, even with the support of artificial intelligence, telemonitoring, teleconsultation I think are enlightening examples, even the development and so rapid development of effective vaccines against SARS-CoV-2 is further proof. The healthcare system is under more pressure to innovate than ever before. I believe that with the right political support (…) we can ensure the sustainability of the new paradigm of care. For this we need a health innovation pact that allows us to address the multiple challenges of capitalising on innovative concepts and that can really support the transfer of innovation into clinical practice” – Diana-Loreta Păun, Presidential Adviser
“At the moment, the Romanian patient does not have access to about 40% of the innovative products that are currently used in Western Europe, there are many reasons for this, but if we look at the other aspects, including our legislation, I think we have a lot to do” – Laszlo Attila, Secretary Senate Health Committee
”The major concern of the Romanian citizen is related to health: “64.3% of the Romanian respondents to the Public Health Barometer believe that health is the most acute problem they face today. Thus, if there is something to be done to satisfy the majority of the population and to have the highest level of public visibility, it must be done at health level. The most effective, including politically, is to start with health. The population at the 65% level is looking at health. This is the sociological reality”, said Prof. Univ. Dr. Dan Dungaciu
“Innovation saves lives. There are many patients with autoimmune diseases who 15 years ago had no treatment options at all, or only had access to treatments with many side effects, and now they are benefiting from all these innovative therapies that have practically changed their lives, made them forget they have a chronic disease and can now do what they never dreamed of years ago. It is clear that we need access to innovation, it is clear that we need more education on the innovation side. That’s what we do as a patient association, we try to bring as much information as possible to people. The pandemic has kick-started a medical education system and that is a good part of the pandemic, because it has forced an openness to medical topics. I hope that mechanisms will be found to increase access to innovative therapies”, said Rozalina Lăpădatu, President of the Association of Patients with Autoimmune Diseases
ARPIM 25 years
The Romanian Association of International Pharmaceutical Manufacturers (ARPIM) – an organisation that supports the common objectives of the 27 leading international pharmaceutical companies producing original medicines in Romania – celebrates its 25th anniversary this year. During all this time, the main objective of the Association has been to increase the access of Romanian patients to medicines, to improve the quality of life of patients and implicitly to increase the life expectancy of Romanians, through collaboration and partnership with all the actors involved in the field.
ARPIM members are constantly investing in research and development in order to provide doctors and patients with original and innovative medicines that save thousands of lives every year.
EXCLUSIVE INTERVIEW with European Commissioner Thierry Breton: A lesson learned from the crisis is that not one single country could win in today’s world
Interview conducted by Robert Lupițu
One of lessons learned from the COVID pandemic crisis is that not one single country could win in today’s world, said European Commissioner Thierry Breton in an exclusive interview for CaleaEuropeană.ro, granted during his visit in Bucharest for meetings with political top officials to discuss the worrying situation of the pandemic and the low vaccination rate.
Calling for “political courage” on the part of decision-makers to implement the green certificate, Thierry Breton also called on Romanian citizens to get vaccinated, saying he was concerned about the situation in our country.
“I am worried, to tell you the truth. We are in a difficult situation. That’s why I come here to help, to support. Of course it is the responsibility of the country and I don’t want to interfere, but we are Europeans, we are friends, we are together, we understand each other. (…) You know that the vaccine works. You know that today we already have 3 billion people on our planet who have been vaccinated and it works. It has no side effects – explain this to your parents, if they hesitate, explain it to your grandparents! Because, after all, it can save lives and it can save us. (…) It will be very sad to have people die just because they didn’t make the effort to go and get vaccinated. Do it. It is in your hands,” said the European Commissioner.
He also spoke highly of Romania’s “digital strength”, welcoming the fact that Bucharest will host the EU’s new Cyber Security Competence Centre. This “demonstrates what I knew, even before I was commissioner, the strength of Romania, with fantastic engineers, extremely good digital engineers, very good companies, including unicorns,” Breton stressed.
Also responsible for the European Defence Fund component of his portfolio as commissioner, Thierry Breton said of Romania’s military mobility projects that he wanted to ensure that “together we can develop not only the right infrastructure but also the right technology for tomorrow”.
Finally, the European Commissioner for the Internal Market stressed the priority of improving the resilience of the strategic supply chain in the context of a partnership between the European Commission and industry. He cited the semiconductor crisis, but also the lessons learned from the crisis on the health side. “To tell you the truth, who would have thought 18 months ago that Europe would become the pharmacy of the world? We have. We did it for our European citizens and for the world”, he added
“We have many other areas where we are working, but we are working out just to secure our supply chain. This is a lesson that we have learned from the crisis and by the way, not one single country could win in today’s world. This is why we are so lucky and fortunate to be all together, Europeans”, concluded Thierry Breton.
CaleaEuropeană.ro: Commissioner Breton, your visit to Bucharest is the first one since President von der Leyen gave the green light for the National Recovery and Resilience Plan for Romania. And it did so in in one of the most important hospitals in the fight against COVID. What is your evaluation after today’s discussions with Romanian officials about the worrying situation in regards to the pandemic?
Thierry Breton: I’m worried, to tell you the truth. We are in a difficult situation. First, we have a new wave of this pandemic coming. This is called the fifth wave and it’s coming everywhere but of course, countries where which have already a good vaccination rate are much more well preserved and people don’t go to hospital. They could get to disease but they don’t go to hospital. Unfortunately, for countries who are below 50% of the population, like in Romania, being vaccinated, then we see a number rising. And that’s terrible because we know that this is a dangerous disease. And we know also that we have the solution. And the solution is vaccination. Today, Europe is at more than 72-73% and it’s true that in Romania we are below 50 percent. This is why I come here to help to support. Of course it is the responsibility of the country and I don’t want to interfere, but we are Europeans, we are friends, we are together, we understand both. And my message is please address this, especially for the young generation. You know that the vaccine is working. You know that today we have already 3 billion inhabitants of our planet which have been vaccinated and it’s working. No side effect – Explain this to your parents if they hesitate explain this to your grandparents. Because at the end of the day it can save lifes and it can save us. So the message is very simple. We have the tool, we need to accelerate. The doses are here, we do not lack the vaccine. We are very lucky in Europe. We’re sending everywhere on the planet, because we have more dozes that we need. But we need to use it. It will be very sad that we have people dying just because they didn’t make the effort to go to be vaccinated. Do it! It’s in your hands!
CaleaEuropeană.ro: Despite being the 6th largest EU country, Romania has the second lowest vaccination rate against COVID-19 with only 7 million people who got the jab. Where did we got it wrong and what should be the next steps to booster the campaign, including tackling disinformation?
Thierry Breton: Well, disinformation is everywhere. And we know that disinformation is on the networks. I mean, other platforms. I mean, we have to educate our young generation but also everybody to say: “It’s not because you see an information, an Instagram or whatever, on Twitter, that it is true”. I mean, you should have your own judgment. And today, we are able in vaccination to have our own judgment, because we have now 3 billion individuals with who have been vaccinated without any single side effect, except that it’s working and I don’t go to hospital anymore. So it’s working. This is a true information. Everything else is of course, fake news and disinformation. But it’s true everywhere, not only in Romania. So, what should we do? It’s only one thing to do. First, it’s not my responsibility to say this, is the responsibility of the member states. But again, I’m here to see if we can support, if you need more vaccines, if you need more logistics. Unfortunately, we know that because of its low vaccination rates, we see hospitals in a very difficult situation. Probably one of the most tense in Europe. So we are sending help to support here. It’s common, we are European we are all together in European solidarity. But of course, I mean, being European means that we need to act as European helping each other. But you know, when you go to be vaccinated, you do it for you, you do it for others, you do it for your family, for your friends. You do it also for Europe, because we are Europeans. And we know that as long as we we still have some clusters. Of course, when you have only 50% of the population being vaccinated and there is a wave, then it’s a big cluster potentially in a big country like Romania. So that’s a problem. So do it also for Europe, because at the end of the day, we know that what saves us against the virus is definitely to be all together European vaccinated at the same time.
CaleaEuropeană.ro: You asked for political courage for the ongoing parliamentary debate on implementation of the digital COVID certificate – do you feel assured after today’s meetings?
Thierry Breton: Well, you know, I say this in general, I think it’s important because I know that sometimes especially in this very special situation we have to take a difficult decision. Of course, we would prefer to not use the digital certificate. But we know only for a few weeks doing this, having a digital certificate like we have today in 27 members but also because our European digital certificate works so well. while preserving our fundamental rights. I want to give you an information: 75 countries accepted our digital certificate. So it’s not only Europe, we did it, but it’s working so well that when preserving of course our right our sovereignty, our autonomy, our identity, other countries adopted it. So I think that yes, maybe some we say it’s a little bit against my freedom, but I make this effort for maybe a few weeks, because I know that it is a tool which will help us together in solidarity, to make sure that we protect ourselves, that we’ll be able to continue to live, we will continue to guarantee that we are not a risk cause and then the economy will be able to continue. Because if we enter into a new lockdown, not only it will be a tragedy for us as persons, it could be a tragedy also economically for us as a continent.
CaleaEuropeană.ro: Your discussions with Romanian officials took place in the midst of both a political and governmental crisis. Is the European Commission worried about the overall landscape in Romania? Also, some of the ideas born from the negotiations between political families was the re-opening of NRRP negotiations. What is the European Commission’s message on this?
Thierry Breton: I think we don’t have to enter into the politics of member states. We are big democracies, and this is why Europe is what it is. It’s extremely important. It’s true that we have a special democratic moment now in Romania. We hope that we will have very soon a stable government that’s extremely important for us and for the country. It’s important also, including for what we spoke, about the vaccination campaign and for all the reforms. But you know, the plan has been adopted.
CaleaEuropeană.ro: So no-reopening of NRRP negotiations?
Thierry Breton: It will not be a reopening, of course not, but it has to be applied now very quickly. And we hope that yes, Romania with a new government will be better to put this in place as soon as possible because end of the day, it is just the interest of course of Romanian people. And the stronger Romania will be, the better it will be for Romania better so for Europe.
CaleaEuropeană.ro: At the level of the European Commission you cover a very wide portfolio, with the single market at its helm, but with clear distinct pillars: Digital Europe, cyber resilience, industry, military mobility. What is your expectations from Romania towards a digital transition and with the hosting of EU’s cyber centre?
Thierry Breton: First, I’m very happy and proud that Romania will host the Digital Cyber Center because it demonstrates what I knew, including before I was a commissioner, the strength of Romania, with fantastic engineers, extremely good in digital, very good companies, including unicorns. I visited a very famous one this morning in Bucharest. This is why we are very happy that Romania will be the center of our cyber resources and maybe defense, too. So I don’t have any expectation. I have some hope that we will be able to enhance it. I am convinced that we’ll be able to do it because this is a big strength of Romania. Some don’t know that Romania is so good at it. I know it especially because in my life I was a finance minister, but also a CEO in a digital company. And I always admire the quality of engineers here. So I’m very happy and I’m convinced that it is the beginning of a big, big thing.
CaleaEuropeană.ro: And with regards to military mobility, you discussed this topic with Defense Minister Ciucă. What can the European Commission do to support Romania’s infrastructure projects, especially for the Black Sea region?
Thierry Breton: I know that’s a very important project. I mean, everything which is here is part of the big plan for Romania. So I believe it’s a good thing. But of course, this is Romania’s priority. And my mission as a commissioner in charge of defense in the Commission, especially the European Defense Fund, is also to make sure that we will be able to develop together not only the right infrastructure, but also the right technology for tomorrow and this is also something which is probably as important as infrastructure.
CaleaEuropeană.ro: The single market, the industry and supply chain were affected during this crisis. Also, the medical urgency – from medical equipments to treatments and vaccines – has proved how important is the partnership between the decision makers and the industry for our resilience. What is the European Commission prepared to do to strengthen this partnership further in order to achieve this resilience goal?
Thierry Breton: This is a really, you know, in our industry strategies, we have many, many things at stake. But let’s say the most important thing for me today that we learned from this crisis, which is of course is not over, is to enhance the resilience of our strategic supply chain. And we have some strategic supply chains today that could be a little bit at risk. Of course, we spoke about health, but now we have been able to do whatever is necessary. To tell you the truth, who could have believed 18 months ago that Europe will become the pharmacy of the world? We did it. It wasn’t the case 18 months ago. We did it for our European citizens and for the world. We have also a problem of supply chain in semiconductors. We are working hard to make sure that we are able to relocate some activities and to be covered, so net exporter of chips which is extremely important. We have many other areas where we are working, but we are working out just to secure our supply chain. This is a lesson that we have learned from the crisis and by the way, not one single country could win in today’s world. This is why we are so lucky and fortunate to be all together, Europeans.
CaleaEuropeană.ro: Thank you very much, Commissioner Breton, for this interview.
Thierry Breton: Thank you.
HERA, the European Commission’s landmark project for health security, will be shaped with the help of Romania and the rest of the EU states
More than a year and a half ago, when European citizens still did not have a vaccine with which they could immunise themselves against COVID-19 and when the European Union was “anesthetized” in its responses to the unprecedented crisis caused by the new coronavirus, the European Health Union was just a plan on paper.
The European executive has succeeded in setting another “building block of a stronger Health Union” by launching a new instrument, the European Health Emergency Preparedness and Response Authority (HERA), to prevent, detect and respond rapidly to health emergencies, which will anticipate threats and potential health crises by gathering intelligence and strengthening the necessary response capacities.
HERA will anticipate threats and potential health crises, through intelligence gathering and building the necessary response capacities. When an emergency hits, HERA will ensure the development, production and distribution of medicines, vaccines and other medical countermeasures – such as gloves and masks – that were often lacking during the first phase of the coronavirus response. HERA is a key pillar of the European Health Union announced by President von der Leyen in her 2020 State of the Union address and will fill a gap in the EU’s health emergency response and preparedness.
“HERA is another building block of a stronger Health Union and a major step forward for our crisis preparedness. With HERA, we will make sure we have the medical equipment we need to protect our citizens from future health threats. HERA will be able to make swift decisions to safeguard supplies. This is what I promised back in 2020, and this is what we deliver” – Ursula von der Leyen.
Before crises: preparedness
- HERA will work closely with other EU and national health agencies, industry and international partners to improve the EU’s readiness for health emergencies.
- HERA will carry out threat assessments and intelligence gathering, develop models to forecast an outbreak and, by early 2022, identify and act on at least three high impact threats and address possible gaps in medical countermeasures.
- HERA will also support research and innovation for the development for new medical countermeasures, including through Union-wide clinical trial networks and platforms for the rapid sharing of data.
- HERA will address market challenges and boost industrial capacity. Building on the work done by the Task Force for Industrial Scale up of COVID-19 vaccines, HERA will establish a close dialogue with industry, a long-term strategy for manufacturing capacity and targeted investment, and address supply chain bottlenecks for medical countermeasures.
- HERA will promote procurement and tackle challenges related to their availability and distribution and increase stockpiling capacity to avoid shortages and bottlenecks in logistics.
- HERA will also strengthen knowledge and skills on all aspects of medical countermeasures in Member States.
During a health crisis: emergency response
In case a public health emergency at EU level is declared, HERA can quickly switch to emergency operations, including swift decision making and the activation of emergency measures, under the steer of a high-level Health Crisis Board. It will activate emergency funding and launch mechanisms for monitoring, new targeted development, procurement and purchase of medical countermeasures and raw materials.
The EU FAB facilities, a network of ever warm production capacities for vaccines and medicines manufacturing, will be set in motion to make available reserved surge manufacturing capacities, as well as emergency research and innovation plans in dialogue with Member States.
The EU production of medical countermeasures will be boosted and an inventory will be established of production facilities, raw materials, consumables, equipment and infrastructure in order to have a clear overview of EU capacities.
HERA cannot function without the help of Member States. The work of HERA will be carried out by four main working groups
- HERA Board: shapes the strategic direction of EU and national health preparedness and response. Members: Member States, European Commission with European Parliament as observer.
- HERA network with similar national or regional authorities: contributes to ensuring medical countermeasures are available and accessible
- HERA Advisory Forum with external stakeholders (industry, academia and civil society): advises on planning and implementation of scientific, health and industrial activities of HERA
- Health Crisis Board: coordinates action in response to a crisis. Members: Member States, European Commission with involvement of other institutions
How HERA will be financed
HERA activities will rely on a budget of €6 billion from the current Multiannual Financial Framework for the period 2022-2027, part of which will come from the NextGenerationEU top-up.
Other EU programmes such as the Recovery and Resilience Facility, REACT-EU, Cohesion Funds and the InvestEU Progamme inside the EU, and the Neighbourhood, Development and International Cooperation Instrument outside the EU, will also contribute to support the resilience of health systems. Together with the above €6 billion the total support will thus amount to almost €30 billion under the next financing period and even more if we consider investments at national level and in the private sector.
To ensure a swift launch and building on the HERA incubator launched in February 2021, HERA will be set up as an internal Commission structure. It will be fully operational early 2022. Its functioning will be reviewed and adapted on an annual basis until 2025, when a full review will be carried out.
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