14 November 2016
The Romanian Country Coordination Mechanism for the HIV/AIDS and Tuberculosis Programs (CCM) acknowledges the Global Fund’s Eligibility Policy and the global strategy and allocation-based approach to the new financial allocation for the eligible countries components (HIV/AIDS, tuberculosis or malaria) for the 2017-2019 period. We, the representatives of the CCM, greet the decision to maintain Romania eligible for the TB component based on high burden of the disease.
In view of the upcoming 36th Meeting of the Global Fund Board on the 16th and 17th of November, we, representatives of the Romanian CCM, express our deep concern related to the disconnection between eligibility and potential allocation in the new programming period.
Considering Romania‘s TB endemic and global eradication objectives, the Romanian CCM restates that current and future external funding are critical for achieving the targets of the 2015-2020 National Strategic Plan for Tuberculosis Control in Romania. Even though progress has been made, TB incidence in Romania is the largest in EU28 for both new cases and for relapses. Romania continues to have some of the highest TB rates in the WHO European Region, reporting 12,000 new cases annually (12,498 in 2014/12,001 in 2015) and 1,055 deaths in 2015. Romania has the highest number of drug-resistant TB cases in the EU and an estimated number of deaths from TB almost seven times higher compared to EU/EEA average (5.5%ooo, respectively 0.8%ooo–data for 2014), although TB deaths decreased in Romania from 6 %ooo in 2012 to 5.3%ooo in 2015. The most TB affected population groups are in rural areas, in poorer regions, men, Roma and homeless people. More than 650 children are affected by TB every year (about 4.3% of all new cases).
Major challenges in TB control in Romania are:
- Universal access to rapid and complete diagnosis – particularly for multidrug resistant TB and extremely resistant %TB- is not in place, even though important steps have been done through the international funded projects. The Romanian MoH initiated centralized procurement for rapid diagnostic consumables, yet there is a significant need for equipment, funds for all needed consumables or access to trained and qualified human resources.
- Access to timely and complete treatment for multidrug resistant TB and extremely resistant is still limited: most of the M/XDR TB needed drugs are considered off-label and/or not registered in Romania; therefore they cannot be procured and/or reimbursed from public sources/MoH funds. Even though MoH and the Romanian NTP identified a solution, the revision of the legislative framework is still pending (health technology assessment procedures needs significant updates and revisions).
- Integrated TB-HIV services (including IDUs) need further improvement and collaboration between TB Programme, HIV Programme and civil society.
- The model concerning ambulatory provision of TB health services cannot be implemented independent of reforms of the healthcare system and significant changes of present legislation, therefore further in-depth analysis and expert work shall be performed.
- Innovative approaches tackling the most vulnerable populations affected by TB shall be widened, best models and practices shall be rolled out at national level, despite the limited funds available from public sources.
- Advocacy, communication and social mobilization shall be reinforced, and civil society needs capacity building as to perform advocacy to change the necessary legislation in place.
Thus, multi-stakeholder engagement and multiple sources of funding (public budget, structural funds, Norwegian support and Global Fund grants) are required aiming at controlling and finally eradicate TB in Romania. To turn the tide against TB and MDR TB and sustain TB control progress, financial allocation is required for the implementation of comprehensive reforms and improvement of the health system capacity to control TB. There is still a critical gap between the funds allocated by the Romanian Government from public sources and the final allocation needed to achieve the objectives of the National Strategic Plan:
- Ensuring universal access to rapid diagnosis methods for DS-TB and M/XDR-TB by 2020;
- Diagnose at least 85% of all estimated DS-TB and MDR-TB cases ;
- Successfully treat at least 90% of new culture positive TB cases and 85% of all retreatment cases by 2020;
- Successfully treat 75% of MDR-TB cases by 2020;
- Reduce overall TB mortality rate to 4.3 per 100 000 population by 2020;
- No more affected families facing catastrophic costs due to tuberculosis;
- Case notification rate of all forms of TB per 100,000 population – bacteriologically confirmed plus clinically diagnosed, new and previously treated cases will decrease from 73%ooo in 2013 to 46.59%ooo by 2020.
National sources cover more than 80% of TB control financing in Romania. Still, internationally funded projects, in particular the Global Fund ones, significantly contributed over the last ten years to a better access to care, quality diagnostic, adequate treatment, better successful treatment rates for M/XDR TB patients. From 2004 up to present, around 12,000 Romanian patients and their families were saved from the catastrophic costs due to TB (12,000 new cases in 2015 compared to 24,000 new cases in 2004), the mortality decreased from 9.2%ooo in 2004 (1,500 deaths) to5.3%ooo in 2015 (1,055 deaths). Over 50,000 persons had have access to rapid diagnostic and over 2000 patients have been enrolled in complete and correct treatment schemes due to the international support, and around 70% of theM/XDR TB patients have been cured (vs. 20% – the cure rate of MDR TB patients treated from NTP financial sources). More than 6,000 TB patients received/receive psychological, social and/or peer-support services. Without comprehensive support and coordinated support from all sources, those results wouldn’t have been possible.
The Romanian CCM emphasizes the right of the TB patients to proper treatment, as to avoid TB related deaths and family dramas such as Iulian’s, a 45 years old XDR-TB patient dying in Moroieni TB hospital as he was waiting for his treatment. Families like Iulian’s will no longer suffer such dramas due to the fact that proper treatment schemes are now available with external support. However, his 2 little daughters, in the absence of continuation of GFATM support, might share the same fate.
The National TB Program recognizes the important contribution of external funding in TB control. “The TB control measures in Romania are supported financially both by governmental and external sources and due to comprehensive support the overall incidence of tuberculosis in Romania is in steady decline. However, Romania is ranked first (with the highest level of incidence) in the EU and 7th in the WHO Europe Region. The high number of cases of resistant tuberculosis registered in Romania requires urgent application of emergency measures in order to achieve TB eradication in Romania, an unfeasible goal in the absence of external financial support”, Dr. Gilda Popescu, Manager “Marius Nasta Institute.
“The standard treatment for TB with sensitivity has dramatically fallen in incidence of TB and maintained within manageable limits the number of cases of MDR / XDR TB. Although the number of cases remains constant, the last national drug resistance survey for first line anti TB drugs shows an amplification of the resistance profile. In the absence of full access of TB patients with MDR / XDR to all medications as per the international guidelines, hundreds of lives will be lost and the phenomenon of MDR-TB / XDR would increase”, Dr. Victor Spinu, TB Program Coordinator.
Considering all of the above, the members of the Romanian Country Coordination Mechanism for the HIV/AIDS and Tuberculosis Programmes strongly believe that, with only 753 EUR/per capita/per year as public health expenditure, compared to the EU average of 2193 EUR, Romania cannot properly fight the TB endemic without external support. Therefore, the Global Fund allocation for the next 2 years would boost reform initiatives targeting: universal access to treatment and diagnostic, strengthening of the ambulatory TB care, innovative best practices addressing the most vulnerable populations at risk, strengthening of the civil society, improving the knowledge and awareness of the general population and patients regarding TB and their rights, and nevertheless improving the legislative framework.
In conclusion, the Romanian CCM urge the members of the Global Fund Board to make inclusive decisions regarding the funding allocation for the 2017-2019 programming period, and to consider that, supporting the fight against TB in Romania in the years to come, means direct and responsible contribution to the sustainability of all investments done to date, to a smooth transition of responsibility towards a country with limited resources yet with proved will to change and to improve the life of its citizens. Most important, the Global Fund further support means lives saved in Romania and continuity of prevention, also diagnostic, treatment and care for the most vulnerable persons affected by tuberculosis.
The Romanian Country Coordination Mechanism
 Global Fund Eligibility Policy, as set forth in Annex 2 to GF/B35/06 – Revision 1 and approved by the Board in April 2016 under decision point GF/B35/DP07.
 TB National Programme data
 European Centre for Disease Prevention and Control/WHO Regional Office for Europe. Tuberculosis surveillance and monitoring in Europe 2016, page 80
 Onela, wife of Iulian: What am I to do if my children will have the same disease as their father? As the doctor told me that this might happen, as we are poor. What if no drugs will be available and my children will die? I would not be able to suffer… I’ll take the days before… I cannot see my children dying.
 OECD (2014) Health at a glance: Europe 2014, OECD Publishing