“The Ministry of Health should review outdated protocols, but in the situation with epidermolysis bullosa, new international recommendations have been ignored for the sixth year. Medical protocols for the treatment of epidermolysis bullosa in Ukraine have not been updated since 2016. European recommendations suggest the use of various manufacturers of bandages, while in Ukraine only Molnlycke products are allowed.”, — write on: unn.ua
Context
Back in 2016, a special commission approved an adapted clinical guideline, which recommends using exclusively the products of the Swedish company Molnlycke Health Care for the treatment of “butterfly people” wounds. This document was compiled based on recommendations and findings gathered in 2012. It was supposed to be revised in 2019, but it did not happen. The commission has not updated its recommendations for more than five years, despite the latest experience of international colleagues, which suggests the presence of corruption motives in its inaction. In 2017, this guideline formed the basis of a medical protocol for the treatment of patients with epidermolysis bullosa. In this way, “butterfly people” in Ukraine were deprived of the right to choose medical means for treating wounds, because no analogue of Swedish bandages was indicated in the documentation.
The 2021 European consensus on practical advice on the treatment of epidermolysis bullosa published by the European Academy of Dermatology and Venereology advises doctors to use an individual approach in the treatment of “butterfly people”. “Choosing a wound management strategy should take into account efficacy, patient preferences, and cost-effectiveness,” the document states.
The economic feasibility is particularly related to the fact that patients with epidermolysis bullosa have to use many wound dressings during their lifetime, and some manufacturers, such as Molnlycke Health Care, are very expensive.
At the same time, European doctors in the guidelines indicated a number of manufacturers of bandages that can be used in the treatment of wounds of patients with epidermolysis bullosa. That is, they give patients the opportunity to choose the medicine that suits them best. Moreover, Europeans advise doctors to use gauze if it is not possible to use specialized bandages. A 2024 clinical practice guideline for epidermolysis bullosa of the newborn, published in the British Journal of Dermatology, suggests a similar approach to prevent skin injury in children who wear diapers.
But in Ukraine, international recommendations are ignored and they stubbornly say that only Swedish bandages can be used for patients with epidermolysis bullosa.
Details
“If there is some initiative, for example, if some clinical protocol needs to be updated and there are already more modern approaches, discoveries, science has moved forward, then it is initiated and done accordingly. After all, such a clinical protocol is considered outdated, or rather, the guidelines are outdated,” said Dmytro Gurin.
According to him, the Ministry of Health may not revise the guidelines and protocols if there are no new discoveries regarding this or that disease, and the old rules remain relevant.
At the same time, he added that the ministry monitors new guidelines that appear in global medicine.
“I think that it’s just not enough. And according to the procedure, it’s all done like this: a number of international protocols are introduced there, and in this way we update, in principle, in a broad sense, the basic set of protocols, we give Ukrainian doctors access to international protocols. And after that , as it will be approved, doctors will initiate a new unified clinical protocol,” Gurin explained.
In the case of bullous epidermolysis, according to the people’s deputy, the public organization dealing with orphaned patients should first of all pay attention to updating the guidelines. After all, according to him, the Ministry of Health is unlikely to oppose the updating of medical protocols.
We will remind
Earlier UNN received information indicating that the Swedish company Molnlycke Health Care, which occupies a monopoly position on 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 Tetyana Kulesha. The union actually became the mouthpiece of the company, which helps to maintain Molnlycke’s monopoly on the market of medical bandages in Ukraine, and lobbies for its interests.
In his public speeches, Kulesha constantly emphasizes that there is no alternative to Swedish bandages, and defends Molnlycke products, despite the presence of high-quality and cheaper analogues that are successfully used in other countries.
Experts interviewed UNNnote that the situation surrounding Molnlycke Health Care has clear signs of a conflict of interests and a corruption component. At the same time, attempts by other manufacturers to offer alternative bandages for government tenders are blocked due to the influence of “Orphan Diseases of Ukraine” and its leader.
Former Minister of Health Zoryana Skaletska emphasized that the Ministry of Health must understand 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, state bodies may not have enough information for a quick response.