Romanian experts at national and European level argue that the European Health Emergency Response and Preparedness Authority (HERA) can bring important mechanisms, expected and needed at European level, but which need to be developed in complementarity with existing mechanisms that already have very good results.
National authorities, European decision-makers, representatives of the pharmaceutical industry responded to the initiative launched by Calea Europeană and the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) and held an open dialogue on the role of the new instrument launched by the European Commission, the European Health Emergency Response and Preparedness Authority (HERA), in preventing, detecting and responding rapidly to health emergencies, by collecting information and strengthening the necessary response capacities.
The main lessons learned by the European Union from the beginning of the pandemic to date were discussed, as well as the need to achieve a Health Union, which cannot be possible without the implementation of European mechanisms involving all Member States in preparing a joint response in the event of a future health crisis.
The European executive has succeeded in laying another “milestone of a Health Union” by launching a new instrument, the European Health Emergency Preparedness and Response Authority (HERA). This Authority was launched on 16 September and aims to guide the entire EU health system towards the vision of ‘One Health’. HERA is a key pillar of the European Health Union announced by President von der Leyen in her State of the Union 2020 speech and will fill a gap in EU health emergency response and preparedness.
HERA and its new tasks for a stronger Union in the face of health crises. How HERA becomes a key pillar of the European Union
The Head of the European Commission Representation in Romania, Ramona Chiriac, welcomed the new measures taken by the European Commission to improve the EU’s health security, as this authority is “the result of lessons learnt during the pandemic, which showed the limits of what the EU can do in health crisis situations.”
- HERA reinforces the EU’s powers on health under the existing treaties. HERA’s mandate is forward-looking. HERA’s aim is to anticipate health crises by gathering intelligence, strengthening the necessary response capacity. So far, action in different policies has been taken reactively and not as part of an overall anticipatory management system.
- This will be the new task, to ensure that the European Union and Member States are much better prepared to act in the face of a cross-border crisis, because the pandemic does not stop at national borders or even at European borders. HERA complements the agencies already in place.
The Head of the European Commission Representation in Romania, Ramona Chiriac, also stressed that HERA is chaired by the President of the European Commission, but is constantly mandated by the Council, which means that the will of each Member State is relevant in this construction.
Cooperation with industry within HERA will be essential to develop, manufacture, distribute countermeasures. Such a structured, responsive cooperation mechanism is vital for the implementation of robust supply chain strategies and supply chains with strategically autonomous states.
Since the beginning of the pandemic, Member States have felt the need for a mechanism such as HERA. Romania must have a work core
Valeriu Gheorghiță, President of the CNCAV, present at the debate on the role of HERA, presented a preparedness and response structure in case of a health crisis, based on three pillars that should represent a working core: the prevention part, the pre-hospital part and the hospital part. According to the Romanian specialist, this preparedness and response strategy should have the following structure:
- Prevention strategy: vaccination as an effective means of limiting the spread of contagious disease, complemented by a population education strategy, because accessibility to vaccines is not enough. The population needs to be prepared and to understand that vaccination is a matter of course. Today’s children, who will be tomorrow’s adults, need to understand that vaccination is an added value. For the next health crisis, children must not be exposed to so many misinformation theories. We also need to improve training in diagnostic, surveillance and sequencing capacity: testing and diagnostic capacity is essential.
- Preparedness of the pre-hospital ambulatory medicine system for the identification and treatment of most forms of infections, of infectious diseases that can be very well managed in pre-hospital. There is a need for trained doctors and centres for diagnosis, treatment and access to effective therapies. HERA will enable easy accessibility and a centralised supply chain.
- Hospital preparedness: In pandemic conditions we need to have a response capacity, which means having modular structures and being able to quickly adapt hospital structures to a pandemic crisis or an epidemiological alert.
Stocks of health supplies and medicines were the main challenges during the COVID-19 pandemic
Călin Alexandru, director in the Department for Emergency Situations, says a unified approach is now needed at European level.
The pandemic has highlighted the need for production mechanisms at European level for medical equipment and medicines to ensure that EU citizens can meet their needs in such a situation. An important element that HERA is aiming for is centralised procurement. Romania has so far made centralised purchases, but only at national level. Centralised procurement of vaccines at European level is a very good example of the fact that in such a situation cooperation is mandatory.
There is a need for collaboration and integration of public health response measures and HERA can bring a plus and a positive element. The measures taken by different countries in the first waves of the pandemic were not coordinated and even created difficulties in collaboration within the EU. Measures must be taken in the future that do not affect collaboration, either economic exchanges or the free movement of citizens between countries.
HERA will be the instrument that will ensure the development, production and distribution of medicines, vaccines and other medical equipment among Member States.
Cristian Bușoi MEP, Chairman of the European Parliament’s Industry Committee, explained the benefits of HERA for the resilience of Member States’ health systems.
- HERA is a key pillar of the European Health Union which President von der Leyen announced in her annual speech as being of paramount importance for the European Union to be much better prepared in the future against health emergencies. HERA is not the only answer. We also have the EU health programme, EU4Health, which is totally different from the health programmes of the past. Decisions on health remain with the Member States, but the EU and the European institutions aim to contribute more and more in the years to come.
- HERA will prevent, detect and respond quickly to health crises. HERA will also have to anticipate certain potential health threats and crises. HERA will be that instrument that will ensure the development, production and distribution of medicines, vaccines and other medical equipment among Member States.
HERA, along with other European health initiatives, is essential for countries like Romania
Andrei Baciu, State Secretary of the Ministry of Health, reiterated the importance of HERA for a European Union better prepared to face new health threats, as well as Romania’s essential role in the HERA working groups.
- HERA can be an extremely good opportunity for Romania because it will accelerate the development of internal mechanisms that mirror the work that HERA does. Romanians expect a high level of performance and Romania’s membership of such a European mechanism will force progress in Romania.
- HERA, along with other European health initiatives, are essential for countries like Romania and the benefits of these efforts can be seen in everyday life. Such mechanisms are really the ones that have made it possible for Romania to have vaccines at the same time as any other Member State.The European Health Emergency Preparedness and Response Authority (HERA), essential for countries like Romania.
Romania has started the designation process and is aware of everything that is going on. Work is underway to set up these task forces. There is a lot of activity. Romania is already part of all the mechanisms within HERA and is on track with everything that has been requested so far.
Moreover, the Ministry of Health wants to make the most of these opportunities that this European initiative represents, precisely in order to generate in Romania a health system that can provide European advantages.
The Ministry of Health has said that it is essential for Romania to be part of such mechanisms, but the big problem in our country is that there is no institutional culture to learn from the difficulties we are going through. We have so many things to learn and so many things to improve in European health systems, and the most important advantage of this authority is that it institutionalises this ‘lessons learned’ mechanism and then comes up with concrete proposals.
National legislation must be drawn up to regulate the powers of each institution
The ANMDMR has informed its colleagues in the specialist structures about the HERA regulations. According to the ANMDMR representative, a crucial importance for HERA is the collaboration between HERA and national authorities. Even the Medicines Agency will be involved in this process, but at the moment it is not clear how. ANMDMR argues that a national regulatory act will have to be developed to regulate the tasks of each institution. Different aspects need to be regulated in order to be able to implement the regulation at national level as well. The ANMDMR will indirectly provide support in the working groups within HERA.
In order to ensure a rapid launch and building on the HERA incubator launched in February 2021, HERA will be established as an internal Commission structure and will become fully operational in early 2022. Its operation will be reviewed and adapted annually until 2025, when a full review will be carried out.
MEP Vasile Blaga: Firm decisions are needed to boost vaccination in Romania. We cannot afford new pressure on the health system
MEP Vasile Blaga (PNL, EPP) believes that “firm decisions are needed to stimulate vaccination in Romania”, stressing that “we cannot afford a new pressure on the health system like in wave 4”.
“The year 2021 ends primarily under the sign of the pandemic generated by COVID 19. We all know the effects of wave 4 in Romania. Even if at the moment the figures are in reasonable ranges, what is happening in countries with high vaccination rates is a warning signal for the new wave of the pandemic. Authorities in Bucharest need to take firm decisions to increase vaccination rates. There is no time for hesitation. Sceptics should take a closer look at the fact that despite high infection figures, the number of deaths and serious cases is low in countries with high vaccination rates. This is where the effectiveness of vaccines can be seen,” said Blaga.
He said that the Romanian health system can no longer afford an over-supply such as in wave 4, which had a major and totally unfair impact on all sick people in Romania.
“We must activate the community spirit in Romania and realise that the fact that we vaccinate helps our neighbours, including the fact that a potential infection with Covid 19 does not deny access to hospital to a patient with a chronic disease,” the MEP added.
“The decision of each of us on vaccination has knock-on effects”, concluded Vasile Blaga.
MEP Vasile Blaga: Eliminating gender gaps in the European labour market – a priority for the European Parliament
Closing the gender gap in the European labour market was at the top of last week’s plenary agenda, said MEP Vasile Blaga (PNL, EPP) on Monday.
The European Parliament’s last plenary session this year put gender inequality in the European labour market on the agenda. Statistics show that at EU level there is still a pay gap of more than 14 percentage points (14.1%) between men and women and a wider pension gap of almost 30 percentage points, both to the disadvantage of women. Moreover, the report voted on at the last plenary session of the European Parliament also notes that women face a precarious situation in the labour market.
“Together with the EPP Group in the European Parliament, I voted in favour of the report on gender equality to draw attention once again to the fact that Member States must come up with concrete proposals to minimise gender inequalities and to strongly support women’s rights in the European Union”, said the EPP MEP for CaleaEuropeană.ro.
The report adopted in the European Parliament also focuses on eradicating violence against women, a phenomenon which has increased significantly during the pandemic.
“Abuse against women must be vigorously prosecuted and the perpetrators must be investigated and punished without hesitation. Moreover, monitoring and protection programmes for victims of domestic violence need to be improved in order to minimise this phenomenon”, added Vasile Blaga.
In a non-legislative report adopted last Wednesday by 500 votes to 105 with 87 abstentions, MEPs reiterated that equal pay and equal treatment are an essential prerequisite for women to enjoy equal rights, economic independence and professional fulfilment.
They call on Member States to take practical measures to ensure that women have equal access to the labour market and jobs and that they enjoy equal pay and equal rights as workers. For example, to achieve this, sanctions should be imposed on companies that do not comply with labour law. In this respect, MEPs welcome the Commission’s proposal for mandatory pay transparency measures. However, they stress that pay transparency alone will not be enough to address deep-rooted gender inequalities.
A government project to digitise healthcare is needed. More calls from Romanian experts at national and European level
The COVID-19 pandemic has highlighted the need for a health system that can cope with paradigm shifts in remote healthcare, and telemedicine has been a great help to patients as well as doctors over the past two years. Thus, the digitalisation of the health system and health services is a topic of interest at European and national level. However, there is an uneven development of digitisation and e-Health solutions in EU countries in Central and Eastern Europe, according to a report by PricewaterhouseCoopers, for the European Federation of Pharmaceutical Industries and Associations (EFPIA).
National authorities, European decision-makers, 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 European opportunities for digitisation of the healthcare system in Romania, but also on the steps that our country needs to go through in the digital transition so that Romanian patients can benefit in the coming years from easy access to healthcare and telemedicine.
The main lessons learned by the European Union since the beginning of the pandemic and until now were discussed, as well as the need to accelerate the digital transition in the European Union’s health systems, but especially the importance for the Romanian authorities, regardless of political colour, to establish a unitary strategy for the digitisation of health, a strategy that coordinates the institutions in the field and is connected to European directives.
The digitisation of the Romanian health system must allow transparent access to reliable data which must be published in formats suitable for secondary use, for epidemiological or health policy analysis.
Topics of interest for Romania in the field of digitisation of health can be (non-exhaustive list): European Cancer Knowledge Database; European Cancer Imaging Initiative; Cancer Management Inequalities Registry in Member States; Connecting e-prescribing and electronic patient record systems between Member States; Connecting and exchanging information between reference centres for rare diseases; Participation in transnational registries in the field of chronic diseases; National/transnational remote medical consultations and second opinion in imaging or pathology; Evaluation of health apps for reimbursement, etc.
Develop a government project covering the key issues for digitisation in health, needed
Prof. Dr. Adrian Streinu-Cercel, President of the Health Committee of the Romanian Senate, calls for a government project covering the key aspects of digitisation in health: “To be an integrated system it has to start from one head, i.e. the Romanian Government. If we don’t decide what we want this digitisation to look like, it will be everyone with their own database, everyone with their own application.”
- We have the opportunity to do a very good job from the beginning and for that we all have to sit around the same table, regardless of political colours, and discuss how we want this national digitisation programme to look like and how to integrate with other countries, if we want that.
Romania needs to establish a National Contact Point to align our country with European directives
Ștefan Busnatu, advisor for digitisation to the Minister of Health, set up a digitisation strategy for the health system a year ago, which unfortunately has not been integrated into the NRDP.
- We need to establish a National Contact Point, which will deal with the whole digitisation component in order to be aligned with the Brussels directives and all the European reforms. The National Contact Point is a three million euro project, which theoretically has to be taken on by someone. At the moment the CNAS have sent the assumption from a coordination point of view. It is important to decide where it would be most coherent to create the National Contact Point in Romania for digitisation and digital transformation.
The time has come for telemedicine to offer patients a better quality of life, while giving doctors new tools
Adela Cojan, President of the National Health Insurance House, reviewed the latest national milestones for the digital transformation of Romania’s healthcare system. A Memorandum has been signed at governmental level for tripartite participation to access European funds for the development of the project “IT systems for connecting to the electronic health record the providers of paraclinical services, specialist outpatient, rehabilitation, home care, providers of clinical services, palliative, medical devices or emergency consultations at home”, being basically an extension of the electronic health record, which was initially designed only on family medicine and hospitals.
- The societal and economic benefits of the widespread use of telemedicine are practically enormous. At the moment we are far from being fully in the middle of their use, but I believe the time has come for telemedicine to offer patients a better quality of life, while giving doctors new tools. It is a challenge, there have been reservations, but now in the areas where we have introduced remote consultations they have been widely accepted, which is why we have also extended them in the regulations for next year.
Lack of interoperability of databases in the healthcare system, one of the critical issues
Adrian Hatos, Chairman of the Committee for Science, Innovation and Technology in the Romanian Senate, says that one of the critical problems facing the entire public system in Romania, not only the medical system, but also the administration and education, is the interoperability of databases or the interoperability of data in general in the medical system, which makes it impossible to access and use data: “We have the possibility of datafication, big data techniques and remote communication in education or medicine. The problem in Romania is primarily institutional and human rather than technical.”
- So far there have been public and European financial resources for digitisation. We need to look at the problem of working with so many database systems that cannot communicate with each other. We have the opportunity of RRF funding, but also the implementation of a governmental Cloud to force the creation or implementation of a data infrastructure that is unitary, standardised at national level, so that we can communicate in the various structures and take advantage of the opportunities that telemedicine offers.
- The digital transition must also include changing the attitude of doctors and patients towards technology.
- The Committee on Science, Innovation and Technology of the Romanian Senate can initiate legislation and support legislation in this area. It can initiate debates in the Senate on digitisation in health.
Patient registers, the most important thing today when it comes to digitising health
Felicia Ciulu Costinescu, Director, Medical Technologies Evaluation Directorate, National Agency for Medicines and Medical Devices of Romania (ANMDMR), says that digitisation of healthcare has become a necessity for facilitating the patient pathway in the healthcare system and has become more important in the context of the pandemic.
- ANMDMR experts are active and present in Brussels working groups of the European Medicines Agency (EMA) or the European Commission, including in task forces dedicated to digital transformation: “This concern comes from the need to provide EU patients with innovative solutions and emerging technologies. All this can only be achieved by transforming and optimising regulatory processes, improving centres of expertise, providing digital solutions and building an e-learning ecosystem. All of this requires investment over time, but the process has been started and will bring the benefits it was designed to deliver.
- The digitisation paradigm is a complex one. Patient registries are the most important thing at the moment when we talk about digitising health. The need for these registries is even greater as very high-cost personalised therapies are knocking at the door. These registries will be useful when we want to have access to some data. Interconnecting them with both national and existing European health platforms. The main aim is to develop a common dataset to support the reimbursement decision as well as to support technicians to have easy access to medical data.
- Digital technologies, intelligent data collection and integration are the present and the future for patient access to personalised, effective and safe treatments.
The leadership of the Romanian Digitisation Authority (ADR) gave details of the objectives of the RegInterMed project in its message to the expert meeting on 14 December. According to the ADR, in October the Ministry of Health put the specifications of the RegInterMed project out to public consultation.
- The project will implement 100 disease registers for 18 specialities. These will be established separately during the implementation period. In addition, 4 specific registers will be implemented for the INSP (Register “reporting biocidal substances”, Drinking water quality register (RECAP), National operational computerised register of occupational diseases, Register on the management of waste resulting from medical activity).
- It will have a working meeting on Wednesday 15 December with the new management delegated by the Ministry of Health for this project.
The European Commission is exploring the possibility of European patient registers, but the condition is that national registers exist in all EU countries
Cristian Bușoi MEP, Chair of the Industry and Research Committee of the European Parliament’s ITRE Committee, as the European Parliament’s rapporteur for the EU health programme, EU4Health, insisted that one of the priorities of this programme is digitisation in health at European level and the creation of the EU Health Data Space, which is an initiative of the European Commission that he supports.
- We also advocated that money from this programme should fund interoperability between different e-health systems at national level, such as electronic patient registers to be interconnected and prescription, which is an e-health solution found in most European countries and this needs to be interconnected.
- The European Commission is looking at the possibility of European patient registries, but the condition is that there should be national registries in all EU countries, at least for cancer and rare diseases where the number of patients is not so large, it would be easier to manage these patients. At European level, digitisation in health is an essential component. EU4Health can only give a general outline, just as the EU Health Data Space will create some rules for governance, for interoperability.
- Romania needs to prioritise these projects in order to be able to use European funding.
Romania has all the necessary tools to digitise its health system and to offer Romanian patients European and quality conditions in terms of health and telemedicine. It is essential that decision-makers and politicians have forward-looking projects adapted to European requirements so that Romanian patients can benefit from the opportunities of the digital transition.
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