Non-Communicable Disease and Healthcare System Developments
EMA 2025 Annual Report and Regulatory Developments
The EMA Management Board has adopted the Agency’s annual report for 2025, summarising another substantively productive year for EU medicines regulation. Across the calendar year, EMA issued 104 positive recommendations for new human medicines, of which 38 contained a new active substance—a figure indicating continued pipeline activity in novel therapeutic development. Veterinary medicine recommendations reached 30, the highest for a second consecutive year, reflecting sustained momentum in that sector. The full interactive report is scheduled for publication in May 2026.
A significant governance milestone was also marked: the implementation structure for the new EU pharmaceutical legislation is now largely in place, with workstream leads nominated, sponsors confirmed within both EMA and Management Board, and a coordinated framework established among the European Commission, EMA, and national competent authorities. The timeline for mandatory implementation of electronic product information (ePI) has been formalised through a newly adopted roadmap; under the forthcoming legislative framework, ePI will become mandatory for all newly authorised medicines, with an expected improvement in the timeliness and accessibility of product information for patients and healthcare professionals. EMA is monitoring the impact of ongoing Middle East conflict on EU medicines supply chains. While no critical shortages have been confirmed to date, companies have reported varying degrees of disruption to air freight and maritime routes, and rising logistics costs. The European Medicines Shortages Single Point of Contact Working Party and the MSSG Executive Steering Group are monitoring the situation closely; the risk of escalation into critical shortages remains contingent on the persistence of regional disruptions.
Updated Dyslipidemia Management Guidelines
The 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia and the 2025 ESC/EAS Dyslipidaemia Guidelines Focused Update collectively represent the most current consensus on atherosclerotic cardiovascular disease (ASCVD) prevention and lipid management. The guidelines reflect a shift toward more aggressive and individually calibrated lipid-lowering strategies. For secondary prevention in adults with established ASCVD, the American College of Cardiology now targets an LDL-C below 70 mg/dL (1.8 mmol/L) with at least 50% reduction, escalating to below 55 mg/dL (1.4 mmol/L) for patients at very high risk or those not achieving goals on statin therapy alone. The complementary role of non-statin agents—ezetimibe, PCSK9 monoclonal antibodies (alirocumab, evolocumab), bempedoic acid, and inclisiran—is formally reinforced as adjunctive therapy when LDL-C targets are not met with high-intensity statins.
A notable expansion in both guidelines is the broadened indication for coronary artery calcium (CAC) scoring as a risk stratification tool in intermediate-risk and select borderline-risk individuals, with incidental CAC detected on noncardiac CT scans now explicitly recommended to inform therapy initiation or intensification. Both societies emphasize early intervention and the reduction of cumulative lifetime LDL-C exposure, particularly in younger adults and those with subclinical atherosclerosis, reflecting growing evidence from Mendelian randomisation and statin trial data on the duration-dependent nature of ASCVD risk reduction. These recommendations are clinically relevant for a Bulgarian population with persistently high cardiovascular mortality and suboptimal lipid management rates at the primary care level.
Infectious Diseases: Global Perspective
Contact and Sexual Transmission
Measles
Measles transmission is intensifying globally at a level warranting heightened international concern. In the Americas, the epidemiological situation is particularly severe. The United States has reported 1,281 cases as of 6 March 2026, with 89% of cases outbreak-associated—a proportion indicating persistent chains of community transmission under pressure on the country’s elimination status, which was achieved in 2000. Multiple concurrent outbreaks, several originating in 2025 and continuing into 2026, are concentrated in select states with suboptimal vaccination coverage. In Mexico, the outbreak that began in 2025 has now generated 12,963 confirmed cases and 34 deaths in 2026 alone, with the state of Jalisco bearing the greatest burden (3,823 cases; two deaths). Canada is also in active multi-provincial transmission, with 339 confirmed cases as of 2 March 2026 across seven jurisdictions.
The African continental burden remains catastrophic in scale. Africa CDC reported 23,843 cases in 2026 across eight countries, with the Democratic Republic of Congo (DRC) accounting for 20,231 cases and 238 deaths—a case fatality proportion exceeding 1%, consistent with the severe impact of measles in populations with high rates of malnutrition and limited healthcare access. The WHO Pan American Health Organization region documented 2,740 cases in weeks 1–6 of 2026 alone, distributed across Mexico, the United States, Guatemala, Canada, Bolivia, and several other countries. Measles virus, transmitted via the respiratory route with a basic reproduction number (R₀) estimated between 12 and 18, requires population immunity above 95% to interrupt transmission—a threshold persistently unmet in numerous countries worldwide.
Mpox
Both monkeypox virus (MPXV) clade I and clade II continue to circulate globally, with evolving transmission dynamics distinguishing the two clades. Clade II, circulating globally since 2022, maintains its established epidemiological profile outside Africa: cases reported predominantly in adults (99%), males (97%), with 89% reporting sexual contact with men. In African clade II outbreak settings—notably Ghana, Guinea, and Liberia—the demographic profile differs, with cases reported among young adults of both sexes, and sexual contact identified as the primary transmission mode.
Regarding clade I in Africa, the five highest-burden countries since 2025 remain the DRC, Uganda, and Burundi, followed by Kenya and Madagascar. In the most recent six-week period ending 1 March 2026, Madagascar led with 357 confirmed cases and the DRC followed with 216, with all other countries reporting fewer than 100 cases in the same period. Importantly, the overall decreasing trend in African clade I cases that began in May 2025 continues through March 2026. Outside Africa and the EU/EEA, clade I cases have been reported in a geographically broad range of countries including Thailand, India, the United Kingdom, the United States, Canada, China, the United Arab Emirates, Qatar, Brazil, Switzerland, Australia, Japan, Mexico, and Nepal, among others. The emergence of clade Ib transmission within sexual networks—documented now across multiple non-African countries, including secondary household transmission in Germany, Belgium, Ireland, the UK, China, Qatar, and Australia—represents a qualitatively new and epidemiologically significant development. Transmission events have universally involved close contact, with no deaths reported in these secondary events.
Vector-Borne Transmission
Chikungunya
An outbreak of chikungunya virus disease in the Seychelles, detected in late 2025, aligns with a broader pattern of regional spread throughout the Indian Ocean: Réunion (France) experienced a major outbreak in 2025. Chikungunya virus is transmitted primarily by Aedes aegypti and Aedes albopictus mosquitoes, with an incubation period of two to twelve days. The acute illness is characterised by sudden fever and severe, often debilitating polyarthralgia that can persist for months to years; case fatality is low in immunocompetent individuals but complications can be severe in neonates, the elderly, and those with comorbidities. The Seychelles outbreak is generating a high volume of travel-associated cases exported to Europe, discussed in the EU/EEA section below.
Infectious Diseases: European Union / European Economic Area
Respiratory and Droplet Transmission
Influenza and Respiratory Viruses
Respiratory virus activity across the EU/EEA is undergoing clear seasonal decline, with primary care consultation rates for acute respiratory illness (ARI) returning to baseline levels in more than half of reporting countries by Week 11. Influenza virus circulation continues to decrease: pooled ILI/ARI test positivity for influenza fell to 11% in Week 10 (median; IQR 15.3–12%), down from 21% the prior week, and hospitalisations are concurrently decreasing, with adults aged 65 and above accounting for the majority of severe acute respiratory illness (SARI) admissions. Influenza A remains overwhelmingly dominant (99% of typed influenza specimens in primary care), with A(H3) comprising 54% of subtyped A strains in Week 10. Among genetically characterised A(H3) viruses across the 2025/26 season to date, subclade 2a.3a.1(K) accounts for 89% of sequences, indicating strong clonal dominance. A(H1N1)pdm09, classified within subclade 5a.2a.1(D.3.1) in 96% of characterised strains, represents the secondary influenza A lineage. All-cause mortality as monitored through EuroMOMO remains at expected levels across all age groups, indicating that the 2025/26 influenza season, while intense at its peak, has not produced excess mortality at the population level beyond expected seasonal patterns.
Respiratory syncytial virus (RSV) represents a notable exception to the general respiratory decline: RSV circulation remains elevated despite the broader downward trend in influenza. RSV-related hospitalisations remain above expected levels, with children under five years of age accounting for the majority of SARI admissions attributable to RSV. In hospital surveillance, RSV test positivity was 17% in Week 10 (median; IQR 15–37%), with RSV-B comprising 57% of typed RSV specimens in SARI settings. SARS-CoV-2 activity remains low across all age groups and reporting systems.
Contact and Sexual Transmission
Mpox (EU/EEA)
Since 1 February 2026 and as of 12 March 2026, 230 mpox cases have been reported from 14 EU/EEA countries, led by Spain (57), Germany (49), France (31), and Italy (27), with Ireland and the Netherlands each reporting 12. The overall trajectory shows a deceleration following January’s peak: 85 clade I cases were reported in January, decreasing to 60 in February, though Germany demonstrated a countercurrent increase (from 10 in January to 18 in February), as did France and Austria. Cumulatively, 264 mpox clade I cases have been reported to TESSy since August 2024, across 13 EU/EEA countries, of which all but the first case detected in Ireland are classified as clade Ib.
The epidemiological profile of clade I cases within the EU/EEA has undergone a decisive qualitative shift since October 2025. Of 148 cases with sexual behaviour data available, 129 (87%) were men who have sex with men (MSM), and among 97 MSM cases with travel information, 78 (80%) were due to local transmission—no link to affected African countries. Several countries have reported MSM cases directly or indirectly linked to travel to Germany, suggesting Germany may be functioning as a regional amplification node within European sexual networks. Vaccine coverage remains suboptimal: among 86 MSM cases with vaccination records, 59 (69%) were unvaccinated. ECDC maintains its risk assessment of moderate for MSM and low for the general population in the EU/EEA, with the caveat that considerable uncertainty persists regarding the relative transmissibility and severity of clade Ib versus the established clade IIb. Household secondary transmission has been documented in Germany, Belgium, and Ireland, though the number of secondary cases per event has been low (range: 1–6). No clade Ib deaths have been reported in EU/EEA settings. Pre-exposure vaccination (PPV) strategies prioritising gay, bisexual, and transgender individuals and MSM remain the central public health countermeasure.
Measles (EU/EEA)
In January 2026, 173 measles cases were reported by 12 EU/EEA countries, with Italy (84 cases, of which 73 laboratory confirmed and five involving healthcare workers), Spain (48 cases), France (12 cases), Romania (nine cases), and Belgium (seven cases) accounting for the majority. Sixteen countries reported zero cases. Over the preceding twelve-month period (February 2025 through January 2026), 30 EU/EEA countries collectively reported 6,037 measles cases, of which 4,866 (80.6%) were laboratory confirmed. Age distribution reveals bimodal vulnerability: 37.3% of cases occurred in children under five years, and 37.8% in individuals aged 15 years and above. The highest notification rates were observed in infants under one year (185.5 cases per million) and children aged 1–4 years (94.6 cases per million). Of cases with known vaccination status, 77.7% were unvaccinated—a proportion reinforcing that the current resurgence is substantially driven by immunity gaps rather than vaccine failure.
Six deaths were reported during the twelve-month period (case fatality rate 0.099%), attributed to France (four deaths), Romania (one), and the Netherlands (one). In 2026, the most concerning national development is an emerging cluster in Madrid, Spain, where 24 cases in weeks 1–7 already exceed the city’s entire 2026 total for the prior year, with multiple family clusters identified. Spain overall reported 81 cases from 1 January to 1 March 2026, an increase of 49 cases in a single reporting interval. Germany reported 38 confirmed and probable cases in weeks 1–10 of 2026. England (outside the EU/EEA) reported 195 laboratory-confirmed cases between 1 January and 2 March 2026, with 73% involving children under ten years and an ongoing outbreak in North London driving the increase.
Vector-Borne Transmission
Chikungunya (EU/EEA – Travel-Associated, Imported from Seychelles)
Since November 2025, more than 110 travel-related chikungunya virus disease cases have been reported by 13 EU/EEA countries among travellers returning from the Seychelles—a pattern with no historical precedent, as no comparable cases were reported from this source in preceding years. The peak travel season to the Seychelles falls between February and April, temporally coincident with the current reporting period, which elevates the risk of continued importation during remaining weeks of this period. ECDC assesses the likelihood of onward transmission within mainland Europe as currently low, as environmental conditions—specifically, Aedes mosquito activity—are not favourable at this time of year. Travel medicine clinics and returning travellers should nonetheless be informed, and vaccination may be considered in accordance with national recommendations.
Infectious Diseases: Bulgaria
Bloodborne Transmission
Fecal-Oral Transmission
Campylobacteriosis
Campylobacteriosis continues to demonstrate a striking year-over-year excess that has persisted throughout the surveillance year. In Week 11, 11 confirmed cases were reported—a two-case decline from Week 10 (−15% week-over-week), indicating a modest deceleration in weekly incidence but no resolution of the underlying trend. The year-to-date cumulative total of 108 cases is 157% higher than the 42 cases registered in the same eleven-week period of 2025. Regional distribution in Week 11 places cases in Varna (five cases) and Sofia-oblast (six cases), a concentration in these two districts that warrants further investigation for shared source exposures, given that campylobacteriosis—caused primarily by Campylobacter jejuni and C. coli, thermophilic organisms acquired principally through the consumption of undercooked poultry, contaminated water, or contact with animal reservoirs—typically presents as sporadic foodborne infection with incubation of two to five days, acute self-limiting enteritis, and occasional bacteraemia or reactive arthritis in at-risk individuals. The magnitude and persistence of the year-over-year excess suggests either a change in reporting practices, a change in exposure patterns (dietary, agricultural, or water supply), or both, and merits formal epidemiological investigation.
Salmonellosis
Following a low-activity period, salmonellosis registered a sharp week-over-week rebound in Week 11: 12 confirmed cases were reported, up from five the prior week—a 140% increase. While the year-to-date total of 98 cases remains modestly below the 110 cases recorded in the corresponding period of 2025 (−11%), the magnitude of the single-week spike warrants monitoring in the context of approaching spring, a season associated with increased salmonellosis transmission through food preparation practices and temperature-facilitated bacterial proliferation in the food chain. Geographic distribution in Week 11 is dispersed across at least ten districts, with Stara Zagora and Targovishte each reporting two cases and the remainder representing single-case occurrences, which is more consistent with multiple independent point sources than a single outbreak.
Respiratory and Droplet Transmission
Varicella
Varicella activity surged in Week 11, with 688 cases registered—an increase of 164 cases over the 524 recorded in Week 10, corresponding to a 31% week-over-week rise. This is the most substantial single-week increase of 2026 to date and likely reflects accumulating school-age susceptible cohorts as the academic term progresses and household transmission chains intensify. The year-to-date total of 6,557 cases nonetheless remains 6% below the 6,986 cases registered in the same period of 2025, suggesting that while this week’s spike is notable, the overall 2026 varicella season has not yet exceeded the prior year’s baseline. The geographic distribution is wide: Sofia-grad accounts for the largest share (195 cases, approximately 28% of the national total), followed by Blagoevgrad (71), Kyustendil (46), Plovdiv (41), Shumen (31), and V. Tarnovo (26), with cases reported in virtually all districts. This nationwide distribution is consistent with varicella’s high transmissibility (R₀ of 10–12 in susceptible populations) and the absence of universal childhood vaccination in Bulgaria. Complications—most notably secondary bacterial infections, pneumonia, and encephalitis—occur predominantly in adults, immunocompromised individuals, and neonates.
Contact and Sexual Transmission
The pattern of sexually transmitted infections (STIs) in Bulgaria in 2026 continues to reflect a marked expansion in gonorrhea and chlamydial infection compared with 2025 baselines, a trend that has been consistent across preceding weeks of the year.
Gonorrhea
Seven confirmed cases of gonorrhea were registered in Week 11, representing a three-case increase from Week 10 (+75% week-over-week). Year-to-date, 48 cases have been reported—a 243% excess over the 14 cases documented in the same period of 2025. Neisseria gonorrhoeae infections are of particular public health concern given rising international rates of antimicrobial resistance, including extensively drug-resistant (XDR) strains, and the potential for sequelae including pelvic inflammatory disease, ectopic pregnancy, and epididymo-orchitis. Bulgarian surveillance does not routinely report antimicrobial susceptibility data alongside case notifications, representing a surveillance gap with direct relevance to treatment guidance and resistance monitoring.
Urogenital Chlamydial Infection
Seven confirmed cases of urogenital chlamydial infection were registered in Week 11, down three from the prior week (−30% week-over-week). Despite this single-week decline, the cumulative year-to-date total of 68 cases exceeds the 29 cases in the same period of 2025 by 134%. Chlamydia trachomatis remains the most commonly reported STI in EU/EEA countries, and its frequently asymptomatic clinical course—particularly in women—complicates ascertainment and likely results in substantial underreporting. The sustained year-over-year increase in Bulgaria may reflect genuine increase in transmission, improved testing uptake and detection, or both.
Syphilis
Six confirmed cases of syphilis were reported in Week 11, up two from the prior week (+50% week-over-week). The year-to-date total of 71 cases is 17% below the 86 cases registered in the same period of 2025, indicating that unlike gonorrhea and chlamydia, syphilis is not demonstrating a comparable year-over-year increase. Congenital syphilis notifications through Week 11 total six cases in 2026 (compared with nine in the same period of 2025), indicating a modest but continued burden of vertical transmission that warrants ongoing attention given its preventability through antenatal screening and treatment.
Vector-Borne Transmission
Chikungunya (Imported)
One confirmed case of chikungunya was registered in Bulgaria in Week 11, bringing the year-to-date national total to four—compared with zero cases registered in the same period of 2025. The emergence of cases in 2026, in the context of the ongoing Seychelles outbreak and the more than 110 travel-associated cases reported across 13 EU/EEA countries, strongly suggests a travel-associated origin, consistent with the March peak travel period to the Indian Ocean region. Chikungunya is not endemic in Bulgaria, and onward mosquito-borne transmission is not anticipated in March, given that Aedes albopictus populations are not yet active in the country. Nonetheless, clinicians should be alert to the syndrome in returning travellers and ensure accurate case classification and reporting.
Lyme Borreliosis
Two confirmed cases of Lyme borreliosis were recorded in Week 11, representing a two-case decline from the prior week. The year-to-date total of 37 cases is 23% above the 30 cases registered in the same period of 2025. While week-to-week fluctuations in Lyme borreliosis are expected and this single-week change does not reach the reporting threshold, the year-over-year accumulation is consistent with early-season tick activity that has been observed in preceding weeks, likely reflecting earlier Ixodes ricinus emergence in response to milder late-winter temperatures. The March period corresponds to the beginning of the primary tick activity season in Bulgaria, and the Lyme borreliosis trend will require monitoring as warmer months approach.