Experts of the Ministry of Health of Ukraine may revise the adaptive clinical guidelines for the treatment of patients with epidermolysis bullosa, which was approved in 2016. This was stated by Health Minister Viktor Lyashko at a briefing in Kyiv, UNN reports.
Context
Since 2016, an adapted evidence-based clinical guideline and a protocol based on it, approved by the Ministry of Health of Ukraine, have been in place, based on the 2012 international guidelines for wound care for patients with epidermolysis bullosa (butterfly people).
These documents state that specific dressings from one manufacturer, the Swedish company Mölnlycke Health Care, can be used for wound care. Since then, many certified manufacturers have emerged that produce high-quality and several times cheaper analogues, but because this documentation specifies the manufacturer, others are not actually allowed to participate in public tenders.
The commission was supposed to revise the guideline back in 2019. "The presented adapted clinical guideline should be reviewed no later than 2019 by a multidisciplinary working group with the participation of the chief freelance specialist of the Ministry of Health of Ukraine, practicing physicians providing primary and secondary health care, scientists, health care organizers, representatives of public organizations interested in improving the quality of medical care, etc.", the guideline says.
If we read the standards carefully, they state that they are to be revised, if necessary, every five years. That is, we now have more than 120 experts working on the agreed standards. If there is no decision to make changes, there is no critical need to revise the standard
The Minister noted that he was aware of the situation with the supply of bandages for patients with epidermolysis bullosa. In particular, Lyashko recalled that the issue was considered by the Verkhovna Rada Committee on National Health, and representatives of the Antimonopoly Committee of Ukraine took part in the meeting. By the way, the AMCU told MPs that there is no competition in the market for the supply of bandages.
And the Ministry of Health clearly expressed its position there that the technical requirements for the procurement of bandages needed for these people are constantly prescribed by a group of experts
It is worth noting that the experts mentioned by the Minister are developing the terms of reference for tenders for the procurement of wound care products for patients with epidermolysis bullosa based on the above-mentioned guidelines and protocol. Thus, for more than five years now, an artificial monopoly has been created for one manufacturer, the Swedish company Mölnlycke Health Care, which calls into question the objectivity and impartiality of the experts.
The Minister noted that all patients are currently provided with the necessary bandages.
"The Ministry of Health, together with the State Enterprise "Medical Procurement of Ukraine", is doing everything possible to ensure that these bandages are available. They are of the quality we need," emphasized Lyashko.
Add
Earlier, UNN received information indicating that the Swedish company Molnlycke Health Care, which holds a monopoly position in the Ukrainian market of medical dressings for patients with epidermolysis bullosa, may be involved in financing the public union "Orphan Diseases of Ukraine", headed by Tetiana Kulesha. The union has actually become the mouthpiece of the company, helping to maintain Molnlycke's monopoly on the medical dressings market in Ukraine and lobbying for its interests.
In his public speeches, Kulesha constantly emphasizes that there is no alternative to Swedish bandages and defends Molnlycke products, despite the availability of high-quality and cheaper analogues that are successfully used in other countries.
Experts interviewed by UNN note that the situation around Molnlycke Health Care has clear signs of a conflict of interest and corruption component. At the same time, attempts by other manufacturers to offer alternative dressings for public tenders are blocked due to the influence of Orphan Diseases of Ukraine and its leader.
Former Minister of Health Zoryana Skaletska emphasizedthat the Ministry of Health must look into the situation and do everything necessary to ensure the interests of patients. She emphasized that orphan diseases require special attention, because due to the rarity of these diseases, government agencies may not have enough information to respond quickly.
Recall
UNN launched an investigation to find out how Molnlycke Health Care, a Swedish company specializing in the production of dressings, managed to create a monopoly in the Ukrainian market. After all, the manufacturer has secured absolute dominance in public tenders for the purchase of wound care products for patients with epidermolysis bullosa. For example, they are trying to prevent a Ukrainian manufacturer from entering the market, which offers the same super-thin dressings, but at four times the price. A previous analysis revealed a possible conflict of interest in tender procurement through the public association headed by Tetiana Kulesha. In particular, there are reasonable suspicions that Molnlycke Health Care uses Kulesha to lobby for its own bandages.
For reference: Epidermolysis bullosa is a rare genetic disorder that makes the skin extremely fragile. Such patients are also called butterfly people. Even a slight mechanical impact can cause blisters, open wounds and scars on their skin. This disorder affects not only the skin but also the nails, hair, and mucous membranes. Treatment includes special wound care, the use of protective dressings, drug therapy, and surgery in severe cases. Due to the significant impact on the quality of life of patients, ensuring access to the necessary care is critical. Currently, there are more than 300 such patients in Ukraine.