News

27 July 2023

The Ombudsman Diana Kovacheva referred the Minister of Health Prof. Dr. Hristo Hinkov about dozens of complaints from diabetic citizens, who sounded the alarm that the pharmacy network lacked life-sustaining insulins for the treatment of diabetes mellitus. Prof. Kovacheva requested checks on the specific complaints and, if any omissions or violations were found, she insisted on immediate measures to address them.

One of the missing medicinal products is “Ozempic 1 mg solution for injection”, the so-called pen, which is widely used by many people not for its intended purpose, but for quick and sharp weight loss. Thus, people who really need it, given their illness, are left without treatment.

“The lack of this medicine and the inability to find an adequate substitute endangers the lives of Bulgarian citizens who need it,” complained a citizen from the city of Ruse to the Ombudsman, and demanded to be informed “when deliveries to pharmacies in Bulgaria will be organised”. He is worried because he heard information about an expected delivery in early August, but it was said to be delayed by two weeks, and he asks if that is really the case. Many other complaints related to the shortage of this drug.

 “As national Ombudsman, I would like to once again express my strong concern about the complaints and signals received by the institution from citizens regarding the lack of medicinal products in the pharmacy network, including insulins, and about the violation of the rights of patients and health insured persons and in this connection once again I strongly recommend that measures be discussed and taken to ensure, in the long term, the citizens’ right of access to medicinal products used for their treatment. I would like to draw attention to the fact that the indicated treatment is life-sustaining, and its interruption, as well as the change of therapy, poses serious risks to the life and health of the patients,” the Ombudsman wrote to Minister Hinkov.

Prof. Kovacheva informed him about a number of cases of victims from across the country who were looking for a different type of insulin of a specific pharmaceutical company, such as the slow-acting Tresiba 100 IU/ML, the fast-acting Fiasp 100 IU/ML, Humalog 3 ml, Novorapid, Insulatard etc.

She pointed out that in the 2022 Ombudsman’s Annual Activity Report, she made a recommendation for analysis of the reasons for the lack and shortage of medicinal products in pharmacies to be made, for measures to be taken, including regulatory changes, to prevent them, and for a flexible mechanism to ensure their timely provision.

Among the signals illustrating the big problem with the lack of insulin in the country is that of a citizen from the town of Rila with type 1 diabetes since 2004, who complained to the public defender that for a year she had had a problem finding Tresiba insulin of the company Novo Nordisk.

She writes: “Today, I decided to seek help from somewhere after another search of pharmacies in the town of Rila, the city of Blagoevgrad and the city of Sofia. I called the Drug Agency maybe 10 times after they referred me to different numbers explaining the problem, and from all the callers I got the same answer that they had no registered insulin shortage alert and that they did not monitor the companies, and then I asked them who should report the insulin shortage, and I got the answer that the alert should be filed by the supplier company. After talking to them, I decided to call the Ministry of Health, and from there I got the same answer - they cannot help me with anything, I should look for Drug Agency again, they also gave me a number to call. I called and got the same answer from there – they do not control the deliveries and there is nothing they can do to help. Then I decided to call Novo Nordisk, and a woman answered my call but she did not introduce herself, after an explanation from my side she told me that they had restocked the insulin and that there was no problem with that drug. I tried to explain to her again, but she did not give me a chance and hung up on me,” the citizen complains, asking for help “to deal with the institutions, transparent procedures and affordable insulin for all people with diabetes”.

A woman from the city of Kardzhali asks the Ombudsman for assistance “to normalize the supplies of the slow-acting insulin Tresiba 100 IU/ML and the fast-acting insulin Fiasp 100 IU/ML”.

A man from Sofia warns that “every year, for several months, life-saving preparations for diabetes and other chronic diseases regularly disappear from the pharmacy network”. He is worried because the 3ml Humalog has been missing again for two months, as well as a few more insulins.

“I need Humalog to live. I use an insulin pump and I need 6 or more vials of insulin per month. Until recently, there was also a lack of Kalymin, which has no substitute and is critical for the rare disease Myasthenia Gravis, from which my partner suffers. Insulins are difficult to replace and take at least a month due to administrative requirements and conditions that are checked and approved by medical committees. But this is not always possible, because not all insulins are well accepted by the body, and the replacement can be an extremely difficult and health-threatening process,” writes the Sofia resident and requests a ban on the parallel export of insulins, Kalymin and other critical medications, because many Bulgarian citizens depend on them to be able to work and live. He also insists that all life-saving drugs for diabetes, cancer and other chronic diseases for which life-saving drugs are prescribed be included in the banned drugs list.

Another citizen from the town of Harmanli asks for information about missing Fiasp and Tresiba insulins in the pharmacy network in his town and points out that “the problem is intermittent and every month there is a delay in getting the relevant medicines by people in need, in the specific case with Diabetes type 1!”

In a complaint from the town of Stamboliiski, a citizen writes on behalf of hundreds: “For half a year now, diabetic persons treated with Tresiba insulin have been returned by pharmacies saying that the necessary insulin is missing from the pharmacy network and to check regularly for its delivery.” Every passing month, instead of normalising the situation, it becomes more and more difficult. Yesterday (21 July 2023), for the third month in a row, insulin was missing from “my” pharmacy, I was forced to visit 5 other pharmacies in the vicinity and called over 20 pharmacies throughout Plovdiv, but the search ended without result. Insulin was not available, and it is not even known when or if it will be available soon. This is not a problem only for the city of Plovdiv, but for the whole country! The quantities they supply are extremely insufficient and diabetic people almost have to compete to see who gets it first. This is not a medication that we can replace with an analogue, nor can we skip taking it!”.

Also, a woman from the city of Varna alerts about the shortage of some of the insulins in the pharmacy network there: Tresiba, Fiasp, Novorapid and Insulatard. She emphasizes that “insulin is vital for a diabetic person and when it cannot be provided on time, the outcome may be fatal. In the last month in more than 10! pharmacies in the city of Varna, I received the answer “Tresiba is missing from the warehouses”. The problem is not only in Varna, but also in other cities of the country. Please, carry out inspections and take urgent measures so that thousands of diabetic persons in Bulgaria (among them not a small number of children!!!) can receive the vital medication on time and in the necessary quantities”.

These are just a small fraction of the complaints made by citizens to the Ombudsman, in which people complain about their rights as patients being violated, that they are being discriminated against and their lives threatened because of the “negligence of the institutions”.

“In regard to the above complaints, being concerned about the rights of the citizens and with the understanding that the issues affecting them should be considered by the bodies and institutions fairly, impartially and within a reasonable period of time, pursuant to the Ombudsman Act, I recommend you to order checks on the above issues, in a short period of time, and if omissions and violations are found, to take appropriate measures, and I expect the citizens to be informed in detail about the questions raised by them and the measures discussed and taken to resolve them,” the Ombudsman also wrote to the health minister.