International practice of treating “butterfly people” is being updated, but in Ukraine it is frozen in time

International practice of treating “butterfly people” is being updated, but in Ukraine it is frozen in time

Kyiv  •  UNN

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The clinical guideline for the treatment of epidermolysis bullosa in Ukraine has not been updated since 2016. This creates a monopoly for the Swedish company Molnlycke and limits patients' choice of medicines.

The international practice of treating "butterfly people" is constantly being updated. However, in Ukraine, the 2016 clinical guideline for the treatment of epidermolysis bullosa has not yet been revised, despite the requirement to do so in 2019. This document restricts patients in the choice of medicines, creating a monopoly of the Swedish company Molnlycke Health Care. The lack of updates and the closed nature of the market raise questions about corrupt motives and jeopardize the quality of patient care. UNN continues to look into this situation, which affects hundreds of "butterfly people" across Ukraine.

The focus is on the issue of a clinical guideline that has become the basis for a monopoly in the market. Back in 2016, a special commission approved an adapted clinical guideline that recommends using only products from the Swedish company Molnlycke Health Care to treat butterfly wounds. This document was based on recommendations and findings collected in 2012. It was supposed to be revised in 2019, but this did not happen. The Commission has not updated its recommendations for more than five years, despite the latest experience of its international colleagues, which suggests that there are corrupt motives for 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 products for wound treatment, as no analogues to Swedish dressings were specified in the documentation.

This medical documentation is used to prepare the terms of reference for tenders held by the state enterprise Medical Procurement.  Year after year, the terms of reference specify that bandages from a Swedish company must be purchased. One of the main points in the tender documentation is that the bandages must have a clinical trial certificate. This seems rather strange, given international practice.

Does gauze need clinical trials?

UNN has at its disposal the official position of the European consensus on practical advice on the treatment of epidermolysis bullosa from 2021, published by the European Academy of Dermatology and Venereology.

So, it advises doctors to use an individualized approach in the treatment of "butterfly people." "The choice of wound care strategy should take into account efficacy, patient preferences, and cost-effectiveness," the document says.

The economic feasibility is in part due to the fact that patients with epidermolysis bullosa have to use many wound dressings throughout their lives, and some manufacturers, such as Molnlycke Health Care, are very expensive.

At the same time, European doctors in the guideline specified a number of manufacturers of dressings that can be used to treat the wounds of patients with epidermolysis bullosa. That is, they allow patients to choose the medication that suits them best.

Moreover, Europeans advise doctors to use gauze if it is not possible to use specialized bandages.

Paraffin-impregnated gauze (meaning petroleum jelly or liquid paraffin - ed.) can be used if modern dressings are not available: they should be changed daily

- the European consensus guidelines say.

The 2024 clinical practice guideline for the treatment of epidermolysis bullosa neonatorum, published in the British Journal of Dermatology, suggests a similar approach to preventing skin injury in diapered children.

"Place a soft, paraffin-soaked pad  over diaper wounds. The use of paraffin-soaked gauze is a cost-effective alternative because dressings need to be changed at each diaper change," the document says.

At the same time, none of the above documents refers to clinical trials, because gauze does not require them.

This raises a number of logical questions about the situation in Ukraine. Why does the State Enterprise "Medical Procurement" demand data on clinical trials of bandages from manufacturers? Why does the Ministry of Health not see the artificial monopoly of the manufacturer? Why does the Ministry of Health not see that there have long been cheaper, equally high-quality bandages on the market, but the state spends huge amounts of money on Swedish products? And finally, why are Ukrainian "butterfly people" deprived of the right to know about similar products and the right to choose them?

And all of this is taking into account the fact that the Ukrainian adapted clinical guideline explicitly states that patients should be given the right to choose the drugs that are best for them.

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 emphasized that 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 patients' quality of life, ensuring access to the necessary care is critical.