Bulgarian court ruling widens access to lifesaving drugs

Euractiv

6 days ago

In a significant legal development, Bulgaria's Supreme Administrative Court has overturned a decision by the National Health Insurance Fund (NHIF) regarding a patient with a rare disease's access to medication, opening the door for patients to receive life-saving medications not included in the country's Positive Drug List (PDL).
The ruling could have far-reaching implications for people suffering from rare diseases or cancer who are currently excluded from reimbursement due to regulatory loopholes.
Dr Antoaneta Toncheva, geneticist and member of the Bridges Community Association, welcomed the news.
'This is the best news I've had in weeks! A small-big step that I hope triggers a landslide of change,' she remarked. Reimbursement obstacles
For medicines to be reimbursed, they must be on the so-called 'positive list'. The list determines which medications are fully or partially covered by the state, outlining conditions for prescription, including eligible diagnoses, prescribing specialists, dosages, pricing, and reimbursement levels.
Medications not on this list are generally excluded from public funding. However, it is not the only barrier to access. A 2019 ministerial regulation stipulated that only patients under 18 or those who began treatment before reaching adulthood were eligible for reimbursement. Landmark case
The court ruling concerns a 21-year-old man diagnosed with a rare genetic disease, Neurofibromatosis Type 1 (NF1). This is a genetically rare condition characterised by the development of multiple tumours. They are not malignant, but they have the potential to become so eventually.
The state Health fund had denied funding for his treatment with Koselugo (INN Selumetinib), arguing that under a 2019 ministerial regulation, only patients under 18 or those who began treatment before reaching adulthood were eligible for reimbursement.
However, the court found this regulation to be incompatible with Bulgaria's Health Act, which stipulates that treatment outside the scope of mandatory health insurance must be provided under conditions set by the Minister of Health. The judges ruled that the law takes precedence over the ministerial ordinance. Important precedent
Expert testimony in the case highlighted that without treatment, the patient risks severe disability.
Koselugo blocks specific proteins involved in tumour growth and is expected to reduce the size of plexiform neurofibromas. The court concluded that denying access to the drug based solely on age violated constitutional principles of equality, proportionality, legal certainty, and the protection of legitimate expectations.
'The Constitution obliges the state to protect the health of all citizens without age discrimination,' the ruling states.
The judges emphasised that the goal of public health regulations is to ensure quality and accessible healthcare for all. All insured individuals are entitled to free medical assistance, including prescription and access to approved medications, medical devices, and specialised dietary products for home use.
Therefore, the NHIF director should have applied the law directly rather than relying on the ministerial ordinance, the court argued. 'The fact that the patient is over 18 does not make him any less in need of state-funded medical care,' the ruling reads.
Lawyer Maria Sharkova, who represented the patient, told Euractiv that the ruling sets a precedent for others in similar situations. 'Any patient in need of treatment with a drug outside the list, if it is proven safe and effective, can now rely on this court decision,' she explained. Access improved via courts
At the end of 2024, Bulgaria's Commission for Protection against Discrimination concluded that the state systematically discriminates against patients with rare diseases and cancer. The decision followed a year-long campaign by the Bridges Community Association.
Although the first court ruling upheld the Commission's findings, the Parliament and the Ministry of Health appealed rather than address the legal shortcomings. The case is now awaiting a final decision from the Supreme Administrative Court.
This is not the first time the judiciary has expanded access to healthcare in Bulgaria. In 2024, the Constitutional Court struck down the core financial limits on hospital treatment imposed by the National Health Insurance Fund. As a result, the national healthcare budget increased by 15% within a year, reaching €4.5 billion.
Despite this increase, experts warn that the current budget may still fall short of covering the growing healthcare demands triggered by recent legal rulings.
[Edited by Vasiliki Angouridi, Brian Maguire]