Bulgaria's telemedicine proposal sparks backlash over state monopoly
In late June, the Bulgarian health ministry unveiled a draft ordinance to regulate remote medical services in the country. Instead of garnering support, the proposal drew fierce opposition from doctors, patients, and legal experts, who argue that the regulation introduces technical and organisational requirements that are nearly impossible to fulfil.
Under the proposed rules, all remote consultations between patients and doctors, or between medical professionals, would have to be conducted exclusively through the National Health Information System (NHIS), a state-run digital infrastructure.
According to Velichka Kostadinova, a lawyer specialised in medical law, this creates a de facto monopoly that could violate EU internal market rules.
'Requiring telemedicine to function solely via the state system contradicts EU legislation because it restricts competition and the free movement of services,' Kostadinova told Euractiv. Low quality and high cost concerns
Kostadinova cited EU Court of Justice case law classifying medical services under Article 57 of the Treaty on the Functioning of the European Union, which guarantees the freedom to provide services across the bloc. 'If the system crashes, there's no alternative. That means a complete shutdown of telemedicine, which could also disrupt cross-border cooperation in the EU, especially in light of the upcoming MyHealth@EU platform,' she warned.
Critics argue that such centralisation will stifle innovation and lead to reduced quality of care. 'Instead of making access to healthcare easier, we are effectively blocking it,' said Kostadinova. 'We risk reaching the absurd point where doctors can't communicate with their patients-not by phone, not through secure electronic platforms.'
Senior officials from Sofia-based hospitals, speaking on condition of anonymity, told Euractiv that the technical requirements proposed by the state would be prohibitively expensive. Hospitals would be required to set up private, offline computer networks and ensure secure data storage across two physically distant servers.
While larger hospitals may be able to shoulder the investment, these conditions are deemed unworkable for doctors in private practice. 'No general practitioner can meet these demands unless they have a bunker filled with advanced tech,' said one Sofia-based GP. 'This goes beyond what is reasonable,' she said.
The draft does include some positive provisions, such as mandatory informed consent from patients and a clear list of medical procedures that cannot be performed remotely, like surgery or the declaration of death. Legal challenges and obscurities
However, the requirement to use only one communication platform is not stipulated in law, Kostadinova noted.
The health minister has the authority to define technical standards for remote care, but not to mandate a single channel for its provision. This opens the door for a potential legal challenge to the ordinance.
Despite the growing role of digital technology in healthcare, the proposed regulation seems to add barriers rather than removing them, observers say. Other EU countries, including France, Germany, Sweden, Greece, and Romania, allow the use of multiple certified platforms, provided they meet national legal requirements.
Authorisation procedures in these countries vary depending on whether the platform employs doctors or simply connects them with patients, and whether services are reimbursed by national health insurance or paid out-of-pocket. But no other EU country has imposed a single-channel restriction.
'There's still no clarity in Bulgaria on who will pay for telemedicine, how, and when,' Kostadinova said.
Tanya Andreeva, a paediatric rheumatologist, told Euractiv that current practice makes even basic online communication between doctors and patients legally dubious.
'I'm not even talking about telemedicine platforms. Patients can't send me a blood test over Viber. If I try to help without charging them, I'm breaking the rules,' Andreeva said. 'If someone checks my phone, filled with images of children's rashes and lab results, I could be accused of being the country's biggest violator.' Health ministry reaction
In its defence, the health ministry argues that the regulation aims to establish clear rules and align the quality standards of remote medical care with those of in-person treatment. 'Given the rising role of telemedicine, this is a timely step to harmonise with EU trends and WHO recommendations,' the ministry said in the explanatory note to the draft ordinance.
While the EU has not yet adopted binding rules on telemedicine, the European Commission and the World Health Organisation have long recognised its strategic importance.
Since the Commission's 2008 Communication on telemedicine and in its more recent 'Digital Compass 2030' strategy, remote healthcare has been framed as a pillar of accessible and sustainable health systems.
The health ministry maintains that its proposal follows guidelines by focusing on universal access, safety, and equality of care. However, critics say the country risks falling behind its EU peers in realising the full potential of telemedicine.
[Edited by Vasiliki Angouridi, Brian Maguire]
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'Requiring telemedicine to function solely via the state system contradicts EU legislation because it restricts competition and the free movement of services,' Kostadinova told Euractiv. Low quality and high cost concerns Kostadinova cited EU Court of Justice case law classifying medical services under Article 57 of the Treaty on the Functioning of the European Union, which guarantees the freedom to provide services across the bloc. 'If the system crashes, there's no alternative. That means a complete shutdown of telemedicine, which could also disrupt cross-border cooperation in the EU, especially in light of the upcoming MyHealth@EU platform,' she warned. Critics argue that such centralisation will stifle innovation and lead to reduced quality of care. 'Instead of making access to healthcare easier, we are effectively blocking it,' said Kostadinova. 'We risk reaching the absurd point where doctors can't communicate with their patients-not by phone, not through secure electronic platforms.' Senior officials from Sofia-based hospitals, speaking on condition of anonymity, told Euractiv that the technical requirements proposed by the state would be prohibitively expensive. Hospitals would be required to set up private, offline computer networks and ensure secure data storage across two physically distant servers. While larger hospitals may be able to shoulder the investment, these conditions are deemed unworkable for doctors in private practice. 'No general practitioner can meet these demands unless they have a bunker filled with advanced tech,' said one Sofia-based GP. 'This goes beyond what is reasonable,' she said. The draft does include some positive provisions, such as mandatory informed consent from patients and a clear list of medical procedures that cannot be performed remotely, like surgery or the declaration of death. Legal challenges and obscurities However, the requirement to use only one communication platform is not stipulated in law, Kostadinova noted. The health minister has the authority to define technical standards for remote care, but not to mandate a single channel for its provision. This opens the door for a potential legal challenge to the ordinance. Despite the growing role of digital technology in healthcare, the proposed regulation seems to add barriers rather than removing them, observers say. Other EU countries, including France, Germany, Sweden, Greece, and Romania, allow the use of multiple certified platforms, provided they meet national legal requirements. Authorisation procedures in these countries vary depending on whether the platform employs doctors or simply connects them with patients, and whether services are reimbursed by national health insurance or paid out-of-pocket. But no other EU country has imposed a single-channel restriction. 'There's still no clarity in Bulgaria on who will pay for telemedicine, how, and when,' Kostadinova said. Tanya Andreeva, a paediatric rheumatologist, told Euractiv that current practice makes even basic online communication between doctors and patients legally dubious. 'I'm not even talking about telemedicine platforms. Patients can't send me a blood test over Viber. If I try to help without charging them, I'm breaking the rules,' Andreeva said. 'If someone checks my phone, filled with images of children's rashes and lab results, I could be accused of being the country's biggest violator.' Health ministry reaction In its defence, the health ministry argues that the regulation aims to establish clear rules and align the quality standards of remote medical care with those of in-person treatment. 'Given the rising role of telemedicine, this is a timely step to harmonise with EU trends and WHO recommendations,' the ministry said in the explanatory note to the draft ordinance. While the EU has not yet adopted binding rules on telemedicine, the European Commission and the World Health Organisation have long recognised its strategic importance. Since the Commission's 2008 Communication on telemedicine and in its more recent 'Digital Compass 2030' strategy, remote healthcare has been framed as a pillar of accessible and sustainable health systems. The health ministry maintains that its proposal follows guidelines by focusing on universal access, safety, and equality of care. However, critics say the country risks falling behind its EU peers in realising the full potential of telemedicine. [Edited by Vasiliki Angouridi, Brian Maguire]
