In the past two years there have been several positive developments which the FIC appreciates. The GOR approved the National Strategy for Health (2014-2020) and its implementation plan.
The medical services basic package introduced in 2014 is a major step forward even if it still needs to be accompanied by other measures. The Government has also approved an interim Health Technology Assessment (HTA) Order.
The list of reimbursed medicines has been partially updated and now contains 17 new orphan drugs and 23 innovative one but the prescription protocols still have to be published in order for the new drugs to be available to patients.
It is also a development worth noting that waiting lists for treatment, especially in oncology, have decreased giving patients better access to medical care.
The process of digitalizing the Romanian healthcare system has continued with the development of electronic prescriptions, national health cards and electronic health files.
Despite the strong need for reform of the healthcare system and many public commitments from the Government to do so, advances on many issues has been limited and progress is needed in some key areas. The healthcare system as a whole is not adequately financed. Romanian patients do not have adequate access to medicines for several reasons, one of them being the lack of budgetary resources. This lack of budgetary allocations for regular updates of the reimbursement lists, do not allow Romanian patients the same access to drugs as other EU citizens.
At the same time the Government should ensure full and correct implementation of the medical services basic package together with the reintroduction of copayment and a greater involvement of the private sector (i.e. insurance companies).
In order to address the issues above coherence, predictability and stability should be the prerequisites of healthcare reform. The IT infrastructure of the healthcare sector should be developed to allow better monitoring and greater efficiency in spending (e.g. patient registries, electronic cards) and at the same time healthcare indicators should be used in decision making.
The Government should improvement the financing and predictability of national immunisation programs, to ensure permanent availability of vaccines and diminish the risk of epidemics.
Due to the significant migration of healthcare professionals to Western Europe, the number of doctors in Romania has decreased, making access to healthcare even more difficult.
This directly affects the health of Romanian citizens in the long term. Moreover, the Romanian healthcare system does not place sufficient focus on a healthy lifestyle, or on the prevention and early detection of diseases which, when discovered late, can place the highest burden on the system.
Romania spends less on health than any other country in Europe. There is a strong connection between the socio-economic development of a country and its investment in healthcare and education. As mentioned above, Romania ranks second from bottom, in 35th position, in the European Healthcare Systems Index (EHCI) 2014. While other European countries have regularly increased their expenditure on health in the last few years, Romania is at the bottom of this ranking in terms of health expenditure per capita. In the absence of significant reforms and access to EU funds, there is little room for Romania to increase healthcare spending.
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%) together with an effective combination between public and private funding.
The FIC recognizes that the current difficult economic situation has led to severe constraints on the healthcare budget. However, to ensure quality care for its population, the Romanian authorities should make spending on health a budgetary priority. The GOR should commit to gradually increasing the healthcare budget as a share of GDP to 6% by the end of 2016, with a clear aim of reaching the European average by 2020 (currently 8.75%).
Healthcare contribution 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 (2014-2020).
Funds should be transferred from the state budget to cover the exempted or uninsured population and what is collected from pharmaceutical taxes (claw back) should be reallocated, exclusively, to the medicines budget.
Further measures need to be adopted to increase the efficiency of public health expenditure by developing control mechanisms while informal payments in the system should be legalised, by the introduction of a formal and transparent system of copayment, to correctly reflect the real costs of the medical services.
Access to the market for private insurance companies has to be facilitated by improving fiscal deductions for insurance premiums while fiscal incentives should be offered for private health expenditure made by employers.
The fiscal environment should be improved, to encourage the level of foreign investment in healthcare to be maintained or increased.
The FIC agreed with the introduction of the clawback tax as a temporary fiscal measure. However, more than 5 years have passed since its introduction and the current rate of this tax (25%) on top of usual taxes, sends a strongly negative signal to the business environment, making it more challenging than ever. The low predictability of the budget allocation for drugs is a key concern.
Pharmaceutical companies face a challenge in calculating their future clawback contribution, and consequently in evaluating the financial impact, given the absence of multi-annual budgeting in the public sector. Furthermore, the level of the budget should take into consideration the real needs of the market. The tax has an inequitable impact on drug producers, because they also pay it on distributors and pharmacy margins.
The Romanian authorities should make a commitment to the eventual withdrawal of the clawback tax, when the economic conditions are right, and until then it should be revised to make it more predictable and fair. The clawback tax should exclude pharmacy and wholesaler margins and should be applied to the producer’s price.
The funds raised from the clawback contribution should be used exclusively for the drugs budget and multi-annual budgeting should be introduced to increase predictability. The budget allocated to drugs should be reconsidered to reflect consumption in the previous year of the clawback calculation and hospital consumption should be excluded from the this tax.
In order to increase transparency, the healthcare authorities should allow an independent audit of the data on which the clawback tax is calculated.
Romania ranks second from the bottom, in 35th place, in the European Healthcare Systems Index (EHCI) 2014, just above Bosnia and Herzegovina and below Bulgaria and Serbia . In terms of access to innovative medicines, Romania ranks among the last countries in Europe. According to an EFPIA report from 2011, Patients W.A.I.T. Indicator, the average time between the date of EU MA and the “accessibility” date at local level was 458 days in the case of Romania, one of the longest waiting periods in the EU.
Since 2008, Romania has rarely updated its list of medicines for which patients can be reimbursed under the health care system. Currently, approximately 100 medicines and new treatments are awaiting approval by the GOR as reimbursable to the patient. The FIC welcomes the adoption of a new Health Technology Assessment (HTA) methodology, in 2014, and the approval for reimbursement of 17 new orphan drugs as well as a further 23 innovative medicines, last year. Nevertheless, even if the 23 medicines are soon approved for reimbursement, the prescription protocols are currently lacking, making the access of patients to these treatments impossible. Moreover, for other major therapeutical areas, cost-volume agreement procedures have not started.
Access of 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 reimbursement list should be updated regularly, twice per year according to current legislation, to ensure proper access for Romanian patients to innovative treatments.
Romania, as a member of the EU, is aligning itself to the EU’s overall vision for the future of health care. Since 2014, an Integrated Single Health Care Information System- SIUI (Sistemul Informatic Unic Integrat) has been in the process of introduction. Nevertheless Romania is facing significant challenges in its current IT system infrastructure, due to the 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 medical sector and private medical sector (under the condition of a CNAS Reimbursement Agreement). The objective of SIPE is to track patients’ medical records, report payments and prevent fraud. Currently the platform manages compensated prescriptions. Major setbacks have included faulty Internet access in rural areas, while several updates have needed to be performed on the input forms leading to a data quality problem. The accuracy of data in the system should be improved in 2015 with the extension of monitoring to the overall prescription process.
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 performed 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, and the process is expected to be complete by April 2015. Without medical data registration on the card, the Health e-Card is used for access to medical services and authentication of the patient. Starting from May 2015, the use of health e-Cards will become mandatory in Romania. Major setbacks have included the delay of several medical units in acquiring health e-Card readers. As a mitigation measure, National House for Health Securities (CNAS) has introduced these criteria as mandatory for access to CNAS funding.
The Patient Registries project became operational in 2014 in the public sector and should be progressively deployed. This should include information on medical treatment as well as personal patient information according to the health e-Card stored data.
In relation to the report presented at the eHealth Forum in May, 2014 (a project co-funded by the E.U. Horizon 2020 Research & Innovation Programme), in Europe, at country level, approximately 651 patient registries are 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 provision of all Health Care Providers with IT capabilities, as well as card reader deployment and usage for all family doctors. These simple setups can enable the use of existing health IT integrated systems by all players along the value chain, providing expected outcomes. Training and acquisition funding programs would also be beneficial.
Extension of the SIUI with the registration and follow-up of individual rights to receive medical services according to the yearly basic medical package in the Health Care Information System.
Development of e-prescriptions for uncompensated prescriptions, as well as a move to use of electronic format for notes authorising absence from work for medical reasons and medical referrals (for hospitalization/ investigation etc…) to enhance efficiency, aid the collection all necessary data, avoid fraud and properly monitor medical services included in the basic medical package or /and complementary medical services.
Finalisation of the deployment of the e-Prescription along with the e-Invoice and the e-card for all medical services providers in the public and private system and integration of this information into the Patient registry (E-file).
Implementation of the reporting obligation, the integration and aggregation of all medical records from all medical care providers to the proper individual level of detail (consumption, payment, user rights).
Enabling and extending interoperability and data sharing to the private health care payers of medical records (rights and health expenses) to facilitate the payment of medical services and medication in addition to the basic package.
Development of patient registries, for key therapeutic areas, to ensure evidence based decisions on healthcare.
Romania faces a major crisis caused by a lack of healthcare professionals: in 2011 there were an average of 2.5 healthcare professionals for 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 2013, there were more physicians leaving the country than new graduates so the situation is likely to deteriorate further.
Romania’s GDP would increase by 6%, if the country had a labour force with a health status similar to the EU average. Instead it is losing around EUR 18.6 billion (15% of 2010 GDP) of economic output over the medium to long term, as a result of the poor health of its population.
The low level of access to healthcare professionals due to migration has a direct effect on the long term health of Romanian citizens. 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.
Since the last edition of the White Book there have been no significant shifts of the Romanian healthcare system towards prevention and early detection which could have a major impact on public health. The overall allocation of resources should strike an appropriate balance between curative healthcare, disease prevention and health promotion to address current and future health needs. This was also recommended by the World Bank in 2011: “In addition, we are recommending to design and implement Health in All Policies (cross-sectoral population preventive programs), including legislation to reduce risk factors (e.g. tobacco taxes, banning tobacco in public spaces, etc.) and national communications campaigns, and targeted population-based and individual-based preventive interventions and programs to reduce high prevalent risk factors and increase cancer screening, vaccination and growth monitoring.”
The recently launched National Health Strategy 2014-2020 establishes as one of its main objectives the decrease of the burden of non-communicable diseases through national, regional and local preventive programs. Although the Strategy involves three strategic directions, most resources are allocated for the development over the next few years of the capacity of primary healthcare staff, while the other two directions - capacity development of the national health promotion network and an increase in knowledge and awareness within the population – do not benefit from the same level of resources.
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 specialty and set up the basis for a more accurate and consistent professional evaluation process.
Cross cooperation should be set up between Romanian and foreign academic structures to expose Romanian talents to the highest technologies and procedures. Team work and interdisciplinary cooperation should be taught and sought after at every stage of medical care, so that they become important factors in evaluating healthcare professionals’ performance and patients’ feedback. Immigration and visits by doctors to Romania could maintain the balance between entry and exit from the system, provided that performance and training standards are met.
Of the diseases which have the highest impact on Romanian public health, only cancer is specifically and comprehensively considered. Other important non-communicable diseases, such as cardiovascular diseases are approached only through current national health programs.
The key to achieving successful results with prevention and health promotion initiatives will be the development of integrated programs, covering all diseases which place a high burden on the health system.
Effective implementation of this strategic area would require the development at central level of a unitary concept of health promotion, adapted to the specific needs of the Romanian health system, covering the main topics and involving all the main stakeholders. A setting based approach should be clearly defined, including other settings besides schools, such as local communities and workplaces.
A unitary and integrated concept of prevention and health promotion should be developed at central level to facilitate the implementation of the National Health Strategy 2014-2020. The concept should involve all the main stakeholders and provide efficient mechanisms of performance monitoring.
Funding for the development of strategic prevention and health promotion programs should be increased, in balance with the resource allocation planned for the development of the capacity of primary healthcare staff. An incentive system can be defined for general practitioners to be actively involved in education and prevention programs, including vaccination.
Integrated programs tackling the main behaviours which generate risk (focusing on eating habits, tobacco and alcohol consumption as well as physical exercise) could be developed to promote a healthy lifestyle.
More resources have to be allocated to increase the level of health literacy of the Romanian population – especially in rural areas and the awareness about the importance preventing communicable diseases should be raised.