Romania was one of the poorest EU countries in terms of GDP per capita PPS (purchasing power standard) in 2015 and ranked 27th among the 28 EU Member States. Romania's population is aging; the proportion of the population over 50 years of age is expected to increase from 36% in 2015 to 43% in 2020. An older population means increased demand for drugs as well as a greater financial burden on the healthcare system.
Life expectancy is lower than the European average (78.7 for women and 71.4 for men, compared to an EU 28 average of 83.6 for women and 78.1 for men) and Romania has the highest infant mortality rate in the EU - 8.4 (down from 9.2 in 2013) / 1,000 vs. 3.7/ 1,000 in the EU28 in 2014.
Moreover, in Romania there is a notable difference between life expectancy and life expectancy in good health; a large part of the population spends a significant part of life in morbidity and disability (13.0 years for men and 20.8 years for women).
All these factors highlight the need for prevention, education and financing in the healthcare system, which in the long term, would translate into an improvement in health indicators.
Public spending on drugs per capita in Romania is about 2.5 times lower than the EU average. The total state budget allocated for healthcare in 2016 was 31.1 bn RON (7 bn EUR) and is divided as follows: National Health Insurance Authority (CNAS) 23.4 bn RON (5.3 bn EUR); Ministry of Health 7.7 bn RON (1.7 bn EUR).
Source: National Budget Law
Although in the past few years we have seen significant improvement and there have been several positive changes in the healthcare system, we are concerned that there is a lack of a long-term strategy, due to the frequent priority changes.
In 2016, the FIC concentrated its efforts on the project “Doctors in Romania,” hence raising public awareness of the issue and encouraging the government to focus on it as part of its long-term strategy.
The result was a series of events throughout the country which offered training to doctors on issues such as HC management, in order to increase their retention rates.
In 2017, the healthcare budget has increased to 4.15% of GDP and, according to the Government’s strategy the funding will focus on infrastructure and an increase in healthcare salaries, while the budget for reimbursed medicines will remain flat as for the last five years.
Introduction of a more comprehensive fiscal deductibility for health insurance premiums as of 2016 has increased access to private insurance companies within the healthcare system and created the premises for a greater satisfaction of the population
The new Government’s key priorities for 2017 have been stated per quarter and put in place as announced. The top two priorities per quarter are as follows:
Source: Government’s programme 2017-2020
Based on these priorities, in 2017 the FIC will continue to focus on:
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, keep investment at a maximum capacity and align with the latest technology.
With 4.15% of GDP allocated to healthcare in 2017, Romania continues to spend less on health than any other country in the European Union. According to Health at a Glance 2016, Romania was in last place in the EU in terms of public funds allocated to healthcare. Even if we take into account private spending, Romania still retains this low position, while the EU 28 average of public funds allocated to healthcare is approx. 8%. Moreover, healthcare expenditure per capita (816 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 2016), in which Romania came last out of 35 European countries in terms of the quality of its health system. While other European countries have steadily improved their financing, and implemented mechanisms to improve the efficiency of healthcare spending, Romanian has fallen place since the 2015 edition and 4 places since 2014. This poor performance provides clear evidence that there is a strong need to reform the financing mechanisms of this sector while allocating additional resources.
Romania should put more effort into closing the existing healthcare financing gap with other European countries while implementing e-health solutions aimed at creating more efficiency and transparency in the way current expenditures are conducted. An adequate level of funding for the healthcare system should be ensured with a gradual increase in the share of GDP allocated to healthcare to 6% by 2019, with a clear aim of reaching the European average by 2020. This strategy should include an effective combination between public and private funding.
While, the FIC recognises that the difficult economic situation Romania faced during the financial crisis led to severe constraints on the healthcare budget and other spending, nevertheless in the last two years the Romanian economy has performed very well, with the strongest growth in the EU. This positive economic outlook should lead to improved healthcare funding. Healthcare authorities should start to see healthcare as 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”.
At the same time, at a local level, 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, the country still does not have a sustainable system. Implementation and adequate financing for the “Innovation in Health” program, which the current Government has committed to for its 2017-2020 programme is essential.
Healthcare contributions should be collected more efficiently and the contribution base should be widened by eliminating exemptions. New alternative funding solutions for healthcare should be identified with a focus on private contributions and more EU funds in the next programming period.
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.
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 aimed at creating more efficiency, control and transparency in the way the healthcare budget is spent should be implemented.
Informal payments in the system should be legalised, by the introduction of a formal and transparent system of co-payment, to correctly reflect the real costs of medical services.
The Innovation in Health program should start to be developed and implemented with sufficient resources to ensure its sustainability and success.
In the short and medium term, the public health 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 supplementary 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 cost of reimbursed medicines, in the context of severe under-financing of the reimbursed medicines budget. More than 8 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. The calculation basis for this tax is a budget frozen at the level of 2012 (RON 6 billion), while the real consumption on the market is RON 1.5 billion higher.
The tax reached an alarming level of 18.9% in the last quarter of 2016, far more than in any other country in the EU which uses this type of taxation system. While the FIC understood the need for the introduction of this tax as a temporary measure, it should now be reformed, bearing in mind Romania’s strong economic growth in the last two years. The clawback tax in its present form represents a disproportionate burden on the pharmaceuticals sector, with a corresponding negative effect on investments which could bring benefits for public health. The FIC considers that the reimbursed medicines budget should cover the real needs of the Romanian healthcare system.
The Romanian authorities should make a commitment to withdraw the clawback tax, considering Romania’s strong economic growth in recent years and projections for the future. In the short term, before its withdrawal, the claw back tax should be revised to make it more predictable and fair. Hence, it should exclude pharmacy and wholesaler margins and should be applied to the producer’s price.
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 consumption in the previous year of the claw back calculation and hospital consumption should be excluded from this tax.
To increase transparency, the healthcare authorities should allow an independent audit of the data on which the claw back tax is calculated.
The FIC welcomes the provisions included in the new Government Program on the regular updating of the reimbursed medicines list. Romania definitely needs to close the existing gap with other European countries in terms of access to innovative treatments. Nevertheless, even though several innovative medicines have been introduced into the reimbursement system since the end of 2014, 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). Moreover, adequate access to drugs also involves an adequate pricing policy which should ensure the economic sustainability of the products.
Furthermore, funding of the medicines budget should be steadily increased, given that Romania has one of the lowest expenditures on pharmaceuticals per capita in Europe. Other factors include unsustainable HTA and CV/CVR methodologies, the long process of negotiation of CV/CVR agreements as well as the lack of clear deadlines to ensure rapid and efficient access of a medicine to the market (from submission of the reimbursement file to effective reimbursement). The FIC acknowledges the efforts made by the authorities in the last 2 years in this process, but we consider that the reform should be speeded up to ensure rapid access for Romanian patients to innovation.
Access for Romanian patients to innovative treatments should be a priority.
All subsequent legislation/steps needed to make reimbursement effective should be put in place (e.g. cost-volume, prescription protocols).
The reimbursed medicines list should be updated regularly, in line with existing legislation which states that this should take place twice per year, to ensure proper access for Romanian patients to innovative treatments.
Romania, as a member of the European Union, is aligning itself to the EU’s overall vision for the future of health care. An Integrated Single Health Care Information System- SIUI (Sistemul Informatic Unic Integrat) has been introduced at the CNAS and healthcare providers level. Nevertheless, Romania is facing significant challenges in its current IT system infrastructure, due to still incomplete deployment of existing projects, the current heterogeneous information management systems used by medical service network providers, and the need to integrate new private Health Care Payers into the existing Health Care Value Chain.
The e-Prescription -SIPE (Sistemul Informatic de Prescriptie Electronica) – project, which started in 2012, became operational in 2014 under the regulation of the Romanian National Health Insurance Authority (CNAS) for the public and private medical sector (under a CNAS contract). The objective of SIPE is to track patients’ medical records, report payments and prevent fraud. Currently the platform manages reimbursed prescriptions. Major setbacks have included faulty Internet access in rural areas, while several updates have been needed to the input forms leading to a data quality problem. In 2017, the system continues to be frequently interrupted due to system errors, affecting the way in which healthcare professionals conduct their activity and the way in which data is centralised. However, the accuracy of data in the system should be improved with the extension of monitoring to the overall prescription process in 2017.
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.
Health e –Cards – Under a project started in 2013, cards began to be distributed from September 2014. Without medical data registration on the card, the national Health e-Card is used for access to medical services and authentication of the patient. Since May 2015, the use of health e-Cards has been mandatory in Romania. Major setbacks have included a delay in several medical units acquiring national health e-Card readers.
The patients’ electronic health files project, launched in 2014, aimed to include information on medical treatment as well as on each patient according to the health e-Card stored data. However, three years after its launch, the programme still presents malfunctions and has not been fully introduced.
Patient registries are another important electronic tool used extensively by EU member states in the management of their healthcare systems, but are almost inexistent in Romania. These electronic systems are widely valued for providing data which can be used in policy decision making while creating more efficiency in terms of health expenditure. In 2014 (according to a project co-funded by the E.U. Horizon 2020 Research & Innovation Program), in Europe, at country level, approximately 651 patient registries were in place, for different diseases, with France (130), Germany (115), the UK (70), Italy (70) and Spain (53) in the lead. Unfortunately, Romania has only one functional patient registry, covering Rheumatoid Arthritis, with other registries in place which are not fully operational. These registries can have a critical role in ensuring accurate observation of the course of a disease, the assessment of clinical outcomes, effectiveness and safety of treatment, the assessment of economic outcomes as well as examination of associations between care and outcomes. This allows more informed clinical and policy decision-making.
The SIUI should be extended with the registration and follow-up of individual rights to receive medical services according to the yearly basic medical package to be integrated into the Health Care Information System.
The reporting obligation should be implemented, i.e. the integration and aggregation of all medical records from all medical care providers to the correct individual level of detail (consumption, payment, user rights).
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. In the short term, patient registries should be developed to ensure evidence based decisions on healthcare. This process could start with a pilot phase (in some key therapeutic areas), to be widely extended at a later stage. The adoption of patient registries should be included in the government healthcare strategy, integrated with the other e-Health tools already implemented and 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. 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.
Healthcare professionals should be separated from other public sector employees in terms of wage policy and their access 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 the healthcare professionals.
Better training, continuous medical education, higher performance indicators and standardised evaluation processes will lead to better performance by 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 decentralised 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.
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.
Public Health in Romania could significantly benefit from a shift of the healthcare system towards prevention and health promotion. 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 2016 edition, Romania is also ranked in last place for prevention. One of the main weaknesses identified in this area is the low coverage rate for infant vaccination (below 90%, one of the lowest in Europe).
A Eurohealthnet report funded by the European Commission, reviewing Public Health Capacity in the European Union and published in 2014, has identified the following weaknesses in Romania:
In this context, the FIC has recommended since 2015, in its White Book, the development of a unitary and integrated concept of prevention and health promotion at central level, involving all main stakeholders and providing efficient mechanisms of performance monitoring.
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 programs. The Ministry of Health has setup 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 finalised 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 proposes 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:
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 of the Government Decision for the final round of debate is currently pending on 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.
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.
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 organisations.