Romania was one of the poorest EU countries in terms of GDP per capita PPS (purchasing power standard) in 2017 and ranked 26th among the 28 EU member states. Romania's population is aging; the proportion of the population aged 65 and over is expected to increase to 30% in 2050, when Romania will become the 12th “oldest” country in the world. An older population means increased demand for medical services, medicines and medical devices as well as a greater financial burden on the healthcare system in general.
Life expectancy is lower than the European average (79.1 for women and 71.7 for men, compared to an EU 28 average of 83.6 for women and 78.2 for men and Romania has one of the highest infant mortality rates in the EU - 7.0 / 1,000 (down from 7.6 in 2015) vs. 3.6/ 1,000 in the EU28 in 2016.
In the European Health Consumer Index 2017 edition, Romania is also ranked the lowest for prevention. Romania was scored among the worst in Europe both for prevention indicators related to communicable diseases (coverage rate for infant vaccination below 90%) and to non-communicable diseases (e.g. the number of hours of compulsory physical education in school is below 450hrs/10 years).
With 4.5% of GDP allocated to healthcare in 2018, Romania continues to spend less on health than any other country in the European Union. Moreover, healthcare expenditure per capita (983 EUR PPP – Purchasing Power Parity) is also the lowest among European Union countries. While the healthcare budget has steadily increased in the last few years, overall expenditure on health has been marginal.
Source: Calculations based on Eurostat data
Considering the strong economic growth Romania had in the last three years, the FIC considers that this performance should also be reflected in healthcare funding. Assuring an adequate level of funding for the healthcare system with a gradual increase in the share of GDP allocated to healthcare and with a clear aim of reaching the European average by 2020 should be a priority for the authorities. The authorities should also adopt a new set of measures that would assure the long-term financial sustainability of the healthcare system and the development of the private health insurance industry.
Given the current state of the health sector, a review is needed of the mechanism of the claw back tax to address the current dysfunctionalities in its application and to increase predictability and transparency.
Even though the access of Romanian patients to innovative treatments and medicines recorded progress in the last few years, the FIC recommends that this should continue to be a priority for the Government.
Implementation of e-health projects, aimed at modernizing the IT systems in the healthcare sector, should continue to be improved to allow greater accuracy, integration and interoperability of data as well as to support policy decision making in healthcare and value-based healthcare together with increased efficiency of resources management.
A range of measures should be adopted by the authorities in order to provide an adequate number of healthcare professionals within the Romanian healthcare system and reduce their migration: performance related pay, improvement of access to continuous professional development, improvement of the performance appraisal process and human resources analysis.
Timely access to innovation, value-based healthcare, evidence-based decision making, ehealth solutions development and implementation, prevention, health literacy and health promotion should become pillars of all health policies in Romania, with the aim of developing a unitary and integrated concept of prevention, treatment, education and health promotion, involving the main stakeholders in Romania.
Although in the past few years we have seen improvements and there have been several positive changes in the healthcare system, we are concerned that there is a lack of follow-up based on a long-term strategy for healthcare.
In 2018, the FIC concentrated its efforts on developing the project Lideri pentru Excelență în Sănătate (Leaders for Excellence in Healthcare), as a result of several meetings with public authorities, in which the need for leadership in public hospitals was highlighted.
With Romanian patients, as EU citizens, in the spotlight, the FIC will continue its dialogue with the Government and will be a reliable partner in promoting coherence, predictability and stability, which are prerequisites of healthcare reform. The FIC also supports keeping investment at maximum capacity and alignment with the latest technology.
Healthcare systems play a crucial role in supporting human health. “Health financing …a key policy instrument to improve health and reduce health inequalities” says a WHO analysis. Analyses have confirmed on several occasions, following comprehensive studies that, healthcare has a direct and immediate impact on economic growth. According to an IMF study“ the last 150 years has witnessed a global transformation in human health that has led to people living longer, healthier, more productive lives. While having profound consequences for population size and structure, better health has also boosted rates of economic growth worldwide”.
Healthy people are more productive than those affected by various diseases. The Global Competitiveness Report 2018 emphasizes the role of human capital, innovation, resilience and agility, as not only drivers but also defining features of economic success in the 4th Industrial Revolution. Higher competitiveness scores are typically associated with lower poverty. The results of the report reveal that Romania is far from the competitiveness “frontier”—. The country was ranked 52nd / 140, with a relatively low score for healthy life expectancy years, which are one of the factors identified in the report as drivers for productivity and growth. (Romania scored 79.8 points out of 100). With 4.5% of GDP allocated to healthcare in 2018 Romania continues to spend less on health than any other country in the European Union. According to Health at a Glance 2018, Romania ranked 28 in the EU in terms of public funds allocated to healthcare. Even if we take into account private spending, Romania still retains this rank, while the EU 28 average of public funds allocated to healthcare is approx. 8%. Moreover, healthcare expenditure per capita (983 EUR) is also the lowest in the European Union. While the healthcare budget has steadily increased in the last few years, overall expenditure on health has been marginal.
As several scientific studies, have proved, there is a strong connection between the socio-economic development of a country and its investment in healthcare and education. The low investment in healthcare in Romania is reflected in the latest European Health Index (ECHI 2017), in which Romania ranked 34th out of 35 European countries in terms of the quality of its health system. The European Health Index shows that while other European countries have steadily improved their financing, and implemented mechanisms to improve the efficiency of healthcare spending, Romania has continued a descending trend in terms of the quality of its healthcare system. The health status of Romanians has improved, but life expectancy at birth remains among the lowest in the EU. Although people are living longer, coverage is not universal and socioeconomic inequalities in health persist.
Reform of the health system has been constant but frequently ineffective, due in part to a high degree of political instability. Recent reforms have focused on introducing cost-saving measures, and improving access and efficiency”. The low-quality performance provides clear evidence that there is a strong need to reform the financing mechanisms of this sector while allocating additional resources. “Low funding and the inefficient use of public resources hamper the health system. There is a weak link between planning decisions and population health needs, owing to a lack of appropriate information systems.”. Moreover, lack of funds and predictability at all levels, starting with the National Health Insurance Authority (Casa Nationala de Sanatate) and continuing with the Regional health authorities and hospitals can harm continuity of treatment.
The main pillars of the government’s healthcare programme have been to increase the salaries of healthcare professionals and to develop infrastructure. Some progress has been made on increasing patients’ access to medicines, but without coordinated reform of the system, continuity of treatment remains a challenge.
While important efforts have made in the last few years by the Romanian authorities to raise the quality of care and create more efficiency in the healthcare system, Romania needs more investment to close the current healthcare financing gap with other European countries, and also needs to implement e-health solutions aimed at creating more efficiency and transparency in the way current expenditures are conducted. The World Health Organisation (WHO) has estimated that removing wasteful and ineffective treatments can deliver a 20-40% efficiency saving in health spending across Europe. Thus, the Organisation for Economic Co-operation and Development (OECD) countries could gain approximately two years life expectancy by reducing inefficiencies across healthcare systems.
An adequate level of funding for the healthcare system should be ensured with a gradual increase in the share of GDP allocated to healthcare, with a clear aim of reaching the European average by 2020. This strategy should include an effective merging of public and private funding.
Considering the strong economic growth Romania has had in the last three years, the FIC considers that this performance should also be reflected in healthcare funding. Healthcare authorities should change perspective and realise that healthcare is an investment considering that “health affects economic growth directly through labour productivity and the economic burden of illnesses, and indirectly since aspects such as child health affect the future income of people through the impact health has on education”.
Moreover, the FIC considers that the financing mechanism that ensures access for Romanian patients to innovative therapies should be improved. While we acknowledge the efforts made by the Romanian authorities to include new innovative therapies in the reimbursement system in the last few years, Romanian patients still face limitations in terms of access to innovative treatments.
Implementation and adequate financing for the “Innovation Fund” program, which the current Government has committed to for its 2018-2020 program is essential.
There should be a gradual increase in the percentage of GDP allocated to healthcare, in order to close the gap between Romania and other EU countries in terms of healthcare financing;
Healthcare contributions should be collected more efficiently, and the contribution base should be widened by eliminating exemptions. According to Law 95/2005 several categories are exempted from social contributions such as: retired persons, unemployed, persons receiving social assistance, priests and pastors, etc.
New alternative funding solutions for healthcare should be identified, with a focus on private contributions, more EU funds in the next programming period as well as public private partnerships.
Funds should be transferred from the state budget to cover the exempted or uninsured population and funds collected from pharmaceutical taxes (claw back) should be reallocated, exclusively, to the medicines budget.
Predictability of the allocation of funding at regional level should be ensured to provide patients access to treatments without restrictions.
The debts of all companies (either public or private) to the healthcare fund should be recovered and a mechanism to monitor their contribution should be put in place.
Electronic tools (including electronic registries), aimed at creating more efficiency, control and transparency over the way the healthcare budget is spent, should be introduced.
The Innovation Fund programme should start to be developed and implemented with sufficient resources to ensure its sustainability and success.
In the short and medium term, the public healthcare system should be supported by adjusting the legal framework so that public clinics and hospitals can carry out private practice for privately insured medical services. This would attract additional financing for public hospitals and would enhance patient satisfaction. In the long run, reform of the health system should entail resizing of the basic package and reintroduction of co-payment. These measures would ensure the long-term financial sustainability of the healthcare system and help the development of the private health insurance industry.
Introduced as a temporary measure in 2009 and amended several times (the latest version of the formula for calculating the tax was established through GEO 77/2011), the clawback tax has become a tool by which the pharmaceutical industry has been forced to take full responsibility for covering the reimbursed medicines funding deficit, in the context of severe under-financing of the reimbursed medicines budget. More than 9 years since its adoption, medicine manufacturers are still covering the full difference between the reimbursed medicines budget set by the budget law and the real consumption on the market. Up to December 2018, the calculation basis for this tax was a budget frozen at the level of 2012 (RON 6 billion), while the real consumption on the market was RON 1.5 billion higher. On 20 December 2019, the Government approved an Emergency Ordinance, which increases the quarterly approved budget (BAT) for medicines covered by the Single National Health Insurance Fund (FNUASS) and the Ministry of Health’s budget. Specifically, starting from the fourth quarter of 2018 and until 31 December 2019, by applying the inflation indices calculated for 2012-2017 by the National Institute of Statistics, the BAT will rise to RON 1.595 billion. By comparison, the BAT’s value from 2012 to date was RON 1.515 million. Over the years, the tax reached unprecedented levels , far more than in any other country in the EU which uses this type of taxation system. The FIC considers that this mechanism is totally unsustainable and the tax is no longer justified, considering the impact it generates on the availability of medicines on the Romanian market as well as the fiscal burden on manufacturing companies. The claw back tax in its present form continues to represent a disproportionate tax on the pharmaceuticals sector, with a corresponding negative effect on investment and the availability of medicines. Elimination of the tax could bring major economic benefits for the Romanian health sector and significant improvements in the quality of care. For instance, according to the IRES survey conducted at the Institute for Public Policy’s request, nearly 2,000 drugs were withdrawn by manufacturers in just two years. Moreover, this trend is increasing, and ultimately has a significant impact on final consumers.
The FIC considers that the reimbursed medicines budget should be readjusted to cover the real needs of the Romanian healthcare system.
Even though the claw back tax was introduced as a temporary measure, it has effectively been made permanent, because it has applied for the last 10 years. It should be abolished or at least replaced by a newly reformed claw back mechanism, which should address the lack of proper financing of the reimbursed medicines budget.
In the short term, the claw back tax should be revised to make it more predictable and fairer, taking into consideration that currently there are many court disputes generated by the lack of transparency in the calculation of the claw-back tax. Hence, it should exclude pharmacy and wholesaler margins and should be applied to the producer’s price.
Another option would be eliminating the claw back tax for essential cheap medicines.
Funds raised from the claw back contribution should be used exclusively for the reimbursed medicines budget and multi-annual budgeting should be introduced to increase predictability.
The budget allocated to medicines should be reconsidered to reflect the real consumption on the market while hospital consumption should be excluded from this tax.
In the long-term, the Romanian authorities should make a commitment to completely remove the claw back tax, considering Romania’s strong economic growth in recent years and projections for the future.
Last but not least, in order to increase transparency, the healthcare authorities should allow an independent audit of the data on which the claw back tax is calculated.
We recognise the progress made by the authorities on access of Romania patients to innovative treatments and drugs but there is still a considerable gap between Romania and the European average.
For example, out of 62 innovative drugs approved by EMA after 2009 that werew analyzed by IQViA only 24 are reimbursed in Romania. This is comparable to the CEE average, but significantly behind Western European standards. Moreover, on average it takes 43 months to achieve permanent reimbursement after European Medicines Agency (EMA) approval in Romania, almost 50% longer than in Bulgaria or the Czech Republic.
Health Technology Assessment continues to be at an early stage of development. The Government has expressed the willingness to implement a more sophisticated HTA methodology. In the past couple of years, the reimbursement list has been updated several times and, thus, some innovative medicines have become available for Romanian patients. In 2018, the Government introduced 33 unconditional INNs and 8 conditional INNs.
Nevertheless, the process continues to be slow, for several reasons: one particular problem is that in some cases, after some medicines receive the reimbursement decision, prescription protocols are often released very late (in some cases more than 4-5 months after the decision for inclusion on the list of reimbursed medicines).
New mechanisms for access to innovative medicines have been put in place and the budget for innovative medicines, financed through cost-volume and cost-volume-result contracts, has been increased. These mechanisms are increasing access to new therapies, covering areas like hematology, oncology, rare diseases and cardiovascular diseases, under conditions of efficiency, financial sustainability and predictability of costs in the health system.
However, at the level of hospitals there are barriers to treatment due to difficulties in getting the proper budgetary allocation from regional health authorities as well as different procedures and understanding of the public procurement procedures applicable for the medicines included in the cost-volume contracts.
Source: Calculations based on IQVIA, Access to innovative medicines in Romania, 2018
Access for Romanian patients to innovative treatments should be a national priority, whatever government is in power.
The NHIH budget for medicines should be correlated with GDP growth and updated yearly.
The new HTA methodology should minimise the gap between treatment options available in Romania compared with other EU countries.
New Managed Entry Agreements together with electronic registries should be put in place;
Value based healthcare principles and mechanisms should be adopted by the healthcare authorities
There should be better predictability of the funds allocated for the implementation of cost-volume contracts at regional level.
Guidelines on the procurement of medicines included in cost-volume contracts should be issued by the National Health Insurance Authority (Casa Nationala de Sanatate) and the National Authority for Public Acquisitions.
Prevention and immunisation policies should be promoted.
Screening programmes should be introduced for the early detection of serious diseases like tuberculosis, cancer, and hepatitis, which represent a huge burden for the healthcare system.
The Romanian National Health Insurance Authority (NHIH) has developed three major projects related to e-health. Two of them have been financed with European Union funds: the e-prescription (implemented in 2012) and the electronic health record (implemented in 2014); one is self-funded – the e-health card (introduced in May 2015). Currently, the electronic card is the only way to obtain prescriptions drugs. Moreover, all subsidised medicines are available only through this card which is the access key to the national health insurance system (except for emergency medical services). All these systems are integrated into the existing centralised sole integrated information system (SIUI). The Reporting and e-Invoice project started in 2013 as part of the extension of the SIUI system to Romania. It includes a web-based connection of health institutions for reporting purposes (including expense forms and invoices). Reporting of activity and subsequent invoicing will be carried out based on xml and zip uploads (by type of activity) made by medical providers.
Despite the integrated systems, there are many complications which generate problems in data crosschecks and delays of several days in processing information. SIUI is also currently the focus of a DNA (National Anticorruption Directorate) investigation into the former NHIH general manager.
1. The e-Prescription - SIPE (Sistemul Informatic de Prescriptie Electronica) project started in 2012 and became operational in 2014 under the regulation of NHIH for the public and private medical sector (under NHIH contract). The objective of SIPE is to track patients’ medical records, report payments and prevent fraud. Currently the platform manages subsidized prescriptions. In 2018, the system continues to malfunction frequently, affecting the activity of healthcare professionals and the way data is centralized; there is a platform that registers all these setbacks (www.siui-monitor.ro).
2. The patients’ electronic health files project (DES), launched in 2014, aims to include information on medical treatment as well as on each patient according to the health e-Card stored data. The most important feature should have been the electronic medical registry of all the patients in the country. Even though a Government decision has been issued that all doctors should upload the information about patients, only the doctors who are under a contract with NHIH are doing it. The accuracy of data in the system should be improved with the extension of monitoring to the overall prescription process.
3. The e-Health cards began to be distributed from September 2014. However, there is no medical data registration on the card. The card is used for accessing medical services and authentication of the patient. Even though the use of e-Health cards is mandatory in Romania, there are still several medical units that do not have card readers.
Future developments envisaged by the Ministry of Health:
The FIC recommends that the healthcare authorities should adopt a Healthcare Digital Strategy, following models from other European countries.
Electronic registries should be developed and introduced as soon as possible to create more efficiency in the way financial resources in healthcare are spent, increase transparency and gather supporting data for better healthcare policy decision making.
The reporting requirement should be introduced as soon as possible, irrespective of whether or not the doctor has a contract with NHIH. It is important that all medical records from all medical care providers should be available in the database.
A 24/7 professional maintenance service is also a paramount requirement to ensure a functional system that would ease the operational burden on doctors.
Interoperability and data sharing to private health care payers of medical records (rights and health expenses) should be enabled and extended to facilitate payment for medical services and medication in addition to the basic package. The adoption of patient registries should be included in the government healthcare strategy, integrated with the other e-Health tools already implemented and should be seen as an important milestone in creating data to support healthcare policy decisions while creating more efficiency and transparency in budget resource allocation.
Romania faces a major crisis caused by a lack of healthcare professionals: in 2014 there were an average of 2.6 healthcare professionals per 1,000 inhabitants, compared to the EU average of 3.4. Moreover, we are facing a major imbalance in the distribution of medical staff between regions of Romania and within the same region between counties (for example, a significant number of counties have less than 2.6 doctors per 1,000 inhabitants, whereas some of them have less than 1 doctor per 1,000 inhabitants). The migration rate is 9% compared to the EU average of 2.5%. In 2015, there were more physicians leaving the country than new graduates so the situation is likely to deteriorate further.
The low level of access to healthcare professionals due to migration has a direct effect on the long-term health of Romanian citizens. Moreover, the lack of specialists in public health is severely restricting the possibilities for reform of the healthcare system. Consequently, the FIC believes that it is critical for the authorities to take steps to deal with this problem, bearing in mind that a healthy business environment depends on a healthy community.
Performance related pay should be introduced in the healthcare sector. The number of available places in medical schools should be increased to bring training of medical professionals into line with the population’s real health needs.
The access of healthcare professionals to continuous professional development should be improved. The social importance of healthcare professionals should be acknowledged and the role of professional associations in reforming the system should be enhanced. The healthcare system can only be reformed by healthcare professionals.
Better training, continuous medical education, higher performance indicators and standardised evaluation processes will lead to better performance of healthcare professionals, enabling them to gain a better image, respect and public recognition. However, a higher budget allocation for salaries is ultimately essential to ensure the retention of healthcare professionals.
The public health system should be decentralized, as this would also lead to more entrepreneurial management of each medical facility and higher human resources retention rates. National Academic evaluating committees should be set up to issue mandatory professional criteria and curricula per speciality and set up the basis for a more accurate and consistent professional evaluation process.
There is a need for national, regional and international cooperation in the development and implementation of the best policies in relation to evidence-based strategies for human resources in health. Currently, the Ministry of Health does not cooperate and communicate with the NGO sector. This should be changed. For years, several reputable NGOs have been developing training programs for medical professionals, innovative services for patients, as well as setting out standards and treatment guides. These NGOs have also been lobbying for better access to treatment and improved patient care. The Ministry of Health should become more open to the expertise developed by the NGO sector. It could allow for a percentage of its programmes (especially in prevention, health education, training and patient support) to be developed and implemented in partnership with civil society, according to national health strategies and plans and keeping in touch with the needs of local communities.
The National Healthcare Strategy provides for extensive measures designed to alleviate the impact of migration of doctors and ultimately to reverse the trend. These measures are set out in the second Annex of the strategy and should be implemented as soon as possible.
The information flow on health workers needs to be improved by adjusting the mechanism of collecting, processing, analyzing and disseminating data on human resources in health so that the planning and distribution of the workforce is carried out correctly. Furthermore, we need to support human resources analysis and research activities to identify evidence-based policy options.
Public Health in Romania could significantly benefit from a shift of the healthcare system towards prevention and health promotion, while developing the capacity of the Romanian healthcare system to decrease the burden of disease through prevention and early detection.
Currently, most resources are allocated to hospital care, but a proactive and robust Public Health System, prepared to address current as well as future health needs, should keep an appropriate balance between curative healthcare (whether inpatient or outpatient) and preventative care.
In the European Health Consumer Index 2017 edition, Romania is also ranked in last place for prevention. Our country was scored among the lowest in Europe both for prevention indicators related to communicable diseases (coverage rate for infant vaccination below 90%) and to non-communicable diseases (e.g. the number of hours of compulsory physical education in schools is below 450hrs/10 years)
Although, Romania has put in place the National Health Strategy 2014-2020, which aims to improve health education and promotion, access to these continues to be unequal, especially within vulnerable groups.
In February 2016, the Ministry of Health, together with the Presidential Administration, launched the Integrated Multiannual Plan for Health Promotion (PNPS) for public consultation. The plan was drafted based on the National Health Strategy 2014-2020, which established as one of its main objectives a decrease in the burden of non-communicable diseases through national, regional and local preventative programmes. The Ministry of Health has set up a Health Promotion working group including, besides its own experts, representatives of the Ministry of Education, the National Public Health Institute, the WHO, UNICEF and the FIC. The working group has finalized the detailed version of the PNPS as well as a draft of a Government Decision for the approval of the plan and for the setting-up of a National Coordination Mechanism for Health Promotion.
The PNPS aims to develop for the first time in Romania a unitary, multi-sectoral and integrated concept of health promotion at national level, aligned with the UN Sustainable Development Goals and with the key principles of the WHO. The plan ensures a strategic framework for:
Building capacities (with a focus on multi-sectoral cooperation and community empowerment) to promote health in all policies and maintain health as a main priority on the public agenda.
Raising awareness among the population and policy makers of health as an asset and on the importance of adopting healthy lifestyles, based on an approach including schools, cities and other local communities, as well as hospitals and workplaces.
Setting the right priorities for covering the preventable diseases with the highest burden and adapting actions to combat these in relation to the dynamics of their prevalence among the Romanian population (e.g. cardiovascular diseases, cancer, mental health disorders etc).
Optimizing existing resources and ensuring mechanisms for sustainable funding for HP activities.
The National Coordination Mechanism for Health Promotion should be overseen by a Joint Ministerial Committee which should ensure a multi-sectoral approach for health in all policies.
The publication of the draft Government Decision for the final round of debate is currently pending the approval of the new Minister of Health.
The PNPS and the associated legal framework should be released soon, for a final round of debate, which should include all main governmental and nongovernmental stakeholders.
Sustainable development of Prevention and Health Promotion should start with capacity building, especially of the Public Health Network, of the Education Network and of communities.
Furthermore, awareness of the importance of health as an asset and of methods of disease prevention should be raised to a higher level among specific population groups as well as among policy makers.
More resources should be allocated to increasing the level of health literacy of the Romanian population – especially in rural areas. A partnership with the Ministry of Education and introduction of dedicated school programmes, following models from various EU countries could be an efficient solution.
Health Promotion and Prevention activities should adjust to the dynamics of the prevalence of preventable diseases and cover those with the highest burden. Besides cardiovascular disease, cancer and musculoskeletal disease, depression has become one of the top reasons for disability in EU countries. Romania is no exception and should step up its efforts to bring the metal healthcare system up to date. Moreover, Romania should focus on reducing the burden of tuberculosis care.
The development of strategic documents such as the Multiannual Plan for Health Promotion should support the subsequent financing of the prevention and health promotion programs. Funding should not be limited to the Ministry of Health’s budget, but should also include EU Funds, Local Authorities’ Budgets and contributions by other governmental authorities or private organizations.
Large education projects, funded by the EU could be an important measure for preventing chronic diseases. Specific topics: healthy lifestyle, with components (nutrition, physical activity, reducing alcohol consumption, lowering stress, and stopping smoking) should be addressed. Partnership with scientific societies could be an advantage. Education about a healthy lifestyle could be the first measure for preventing chronic diseases.