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Romania has one of the worst performances in the EU when it comes to access to treatments for rare diseases

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To give hope to the 30 million Europeans living with a rare disease, all key players in the health sector, together with the European institutions and the Member States, are trying to step up their collaboration to ensure that patients have on-time access to currently available treatments. The News Platform www.caleaeuropeana.ro brings you the latest updates at European level on patient access to orphan drugs, but especially the situation of Romanian patients, who according to statistics, are among the EU citizens who have access to the fewest innovative treatments and are waiting the longest time for their approval on the market.

Rare diseases are serious conditions, usually of genetic origin, most of which develop in childhood and lead to severe illness in adult life: 1 in 3 children with a rare disease die before their 5th birthday and many more live with debilitating disabilities.

To address this situation and to ensure that patients suffering from rare diseases have access to medication, the “Orphan Medicinal Products (OMP) Regulation” 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 introduction of the above legislation, together with scientific advances, has led to a wave of new treatment options for rare disease patients.

Since the adoption of the Orphan Drug Regulation in 2000, more than 160 OMPs had been approved by the EMA up to 2018.

Despite considerable success so far, there is still a high unmet medical need for rare diseases: only 5% of rare diseases are estimated to have an approved treatment and much remains to be done, not only because of the low prevalence but also because many rare diseases are very complex from a scientific research perspective. Despite this, the existing legal framework has proven its effectiveness (8 orphan drugs approved by 2000, over 160 between 2000-2018). Maintaining the right regulatory, scientific and economic environment for the development of orphan drugs is essential to the mission of developing new treatments for ~95% of rare diseases without a treatment option today.

Romania is lagging behind when it comes to access to treatments for rare diseases. In the European context, our country has one of the worst performances:

There are challenges in terms of access to new orphan treatments and considerable inequalities between the Member States. According to the EFPIA PATIENT W.A.I.T. 2020 indicator (published in 2021), more than 80% of orphan drugs still remain unavailable for many Member States, including Romania, and patients can access them only a few hundred days after official EMA approval.

By 1 January 2021, 13 treatments for rare diseases will be available in Romania, out of a total of 47 adopted by the European Medicines Agency in the period 2016-2019. Therefore, our country has access to only 29% of all orphan drugs, below the European average of 41%. In this sector, Germany is the leader among the Member States in terms of access to orphan drugs, with 45 treatments available to German citizens out of the 47 total approved by the EMA (in the above-mentioned period).

Romanian citizens are three times less likely to benefit from an orphan treatment than a German citizen, but on top of that, for the 13 medicines they can access, they wait on average 868 days, 762 days more than a German citizen.

Germans are the EU citizens who wait the shortest period of time for an innovative treatment that can treat their rare condition, or at least make their life easier. A Romanian suffering from the same rare disease as a German citizen will have to wait on average more than 2 years to start a treatment dedicated to his disease that will give him a chance to live. In turn, a German suffering from the same disease as a Romanian citizen will have to wait on average only 3 months.

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

The Orphan Drug Regulation can play a role in a future EU industrial strategy, helping to promote sustainable innovation. Simply revising the existing intellectual property incentives in the current version of the regulation, designed to support research into new treatment options, will not improve patient access – now or in the future, without understanding the root causes that lead to delays in access to national markets for orphan drugs.

The hopes raised by new treatments can only be achieved if there is also correct and early diagnosis in both children and adult patients. The success and value of the regulation in stimulating the development of new treatments can only be fully realised if patients have access to them, together with the full range of complementary medical services.

Ensuring patients’ access to the new treatments of today and tomorrow should be a shared goal and responsibility. It requires regulators, health system partners, patients, governments and industry working together to find new ways to fund these innovative treatments and to ensure patient access and sustainability of health systems at national level.

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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On its 25th anniversary, ARPIM launched a working paper with policy makers on health system resilience

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© Print screen Live video

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 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:


© Print screen Live video

“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.


© Print screen Live video

 

”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.

Read also: Health Innovation Pact | Future Health Minister Alexandru Rafila: Romania can be a partner for the innovative pharmaceutical industry. We will achieve this objective


“The last 2 years have been quite hard, years in which we have seen the need for collaboration, even if sometimes less accessible, of the authorities with the pharmaceutical industry, with central authorities, with local authorities, in the context that we still want to make an important step in everything that means 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.


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“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

Read also: Health Innovation Pact | Andrei Baciu: By aligning with European standards, Romania becomes attractive to the European manufacturing pharmaceutical industry


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“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.

Read also: Health Innovation Pact | Dr Ioana Bianchi, ARPIM External Relations Director: Innovative medicines bring value across the health system chain


© Print screen live video

“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


 

© Print screen Live Video

”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

Read also: Health Innovation Pact | Prof. Univ. Dr. Dan Dungaciu: Romanians want a country like abroad in healthcare


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“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

Read also: Health Innovation Pact | Rozalina Lăpădatu, President of APPA: Patient associations bring medical education closer to the people


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.

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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

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© European Union 2021 - Source : EC Audiovisual

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.

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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

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© European Union, 2020

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.


© European Union 2021 – Source : EP

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

  1. HERA Board: shapes the strategic direction of EU and national health preparedness and response. Members: Member States, European Commission with European Parliament as observer.
  2. HERA network with similar national or regional authorities: contributes to ensuring medical countermeasures are available and accessible
  3. HERA Advisory Forum with external stakeholders (industry, academia and civil society): advises on planning and implementation of scientific, health and industrial activities of HERA
  4. 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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INTERVIU Eurodeputatul Victor Negrescu: Salariul minim european are menirea să crească standardele sociale în Europa, oferind oportunități egale pentru toți europenii care lucrează în orice stat membru

Alin Mituța1 day ago

Eurodeputatul Alin Mituța: România va deveni un stat sigur pentru fete și femei atunci când vom taxa fiecare violență fizică, sexuală sau emoțională

POLITICĂ1 day ago

Guvernul Nicolae Ciucă a fost învestit de Parlament cu o majoritate covârșitoare. Membrii cabinetului PNL-PSD-UDMR vor depune jurământul la Palatul Cotroceni

EUROPARLAMENTARI ROMÂNI1 day ago

Eurodeputatul Gheorghe Falcă îndeamnă companiile farmaceutice care produc vaccinul anti-COVID-19 să deruleze campanii de informare în statele UE pentru a combate dezinformarea

POLITICĂ1 day ago

Premierul desemnat Nicolae Ciucă, în Parlament: Vom garanta stabilitatea României. Vom asigura respectarea statului de drept și o politică externă bazată pe consolidarea rolului în UE și NATO și a Parteneriatului cu SUA

Marian-Jean Marinescu1 day ago

Marian-Jean Marinescu, către comisarul european pentru energie: Vreau să văd energia nucleară și gazul în viitorul act delegat pentru taxonomie. ”Fit for 55” va determina ”o cerere de energie foarte mare”

ROMÂNIA2 days ago

Virgil Popescu anunță că o companie norvegiană dorește să investească 800 de milioane de euro în România

Daniel Buda3 days ago

Daniel Buda, vicepreședintele Comisiei pentru agricultură, intervenție în PE: Banii acordați prin PAC reprezintă un sprijin real pentru asigurarea durabilității fermierilor și securității alimentare

REPUBLICA MOLDOVA3 days ago

Maia Sandu, la București: Republica Moldova a simţit mereu umărul României alături. Este un moment unic pentru a obține rezultate istorice în relația noastră

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