The rights of butterfly people are ignored: what is happening in the market of dressings for patients with epidermolysis bullosa

The rights of patients with epidermolysis bullosa, known as “butterfly people,” continue to be violated due to an artificial monopoly on the medical bandage market. The situation, which should serve as an example of support for socially vulnerable groups, instead demonstrates unjustified state spending and corruption risks organized by a foreign manufacturer.

Monopoly, as set forth in the documentation

The Swedish company Mölnlycke Health Care dominates the Ukrainian market of dressings for patients with epidermolysis bullosa. The reason for this is not only the quality of the products, but also the fact that its name is directly included in medical documentation. In the adaptive clinical guideline approved in 2016, a special commission specified the name of the dressings that can be used to treat wounds of patients with epidermolysis bullosa. The manufacturer, a Swedish company, was listed alongside the dressings.

Given that this guideline was based on international recommendations from 2012, we can assume that there were not many manufacturers of quality products at that time, so the best one as of 2016 was chosen for patients and no alternatives were specified.

In addition, in the guideline itself, the Commission noted that the document should be revised no later than 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, practitioners providing primary and secondary health care, scientists, health care organizers, representatives of NGOs interested in improving the quality of medical care, etc.”, the guideline says.

Back in 2016, it was already clear that the global pharmaceutical market, like the Ukrainian one, was developing rapidly and that analogs of the proposed bandages would appear.

Despite this, the Commission has not yet revised the adapted clinical guideline, although more than 5 years have passed since it expired.

Why is the review delayed?

Looking a little deeper into the situation, it becomes clear that the monopoly exists not only in the bandage market. There are many dermatologists in Ukraine who treat skin diseases. However, for some reason, the Ministry of Health recognizes only one doctor, Inna Gedeon, when it comes to bullous epidermolysis.

She positions herself as the head of the bullous epidermolysis department of the National Children's  Specialized Hospital “Ohmatdyt”, although in fact she simply rents the premises from them. By the way, according to UNN's sources , it was Gedeon who had the decisive word in the preparation of the guidelines, which are not currently being reviewed by the Ministry of Health. In addition, she herself is involved in the preparation of technical specifications for public tenders and thus ensures the monopoly of Mölnlycke Health Care.

No choiceNo choice

Currently, there are more than 300 patients with epidermolysis bullosa in Ukraine. This is a rare genetic disease 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.

Depending on the situation, the bandages used to treat the wounds of the “butterfly people” are changed every 1-3 days. Since not all patients are able to travel to Kyiv every day, they have to look for doctors who will agree to do this. [UNN spoke to several patients and they said on the basis of anonymity that it is difficult for them to receive proper medical care, because “Gideon has locked everything up.

They assume that she is lobbying the Ministry of Health for her exclusive right to provide medical care to patients with epidermolysis bullosa.

The “butterfly people” say that the doctor is turning them against any analogs of Swedish bandages, assuring them that they will not work. “She just tells everyone that other bandages are bad and they don't fit,” one of the patients told UNN .

Thus, “butterfly people” become hostage to the influence of one person who deprives them of their right to choose.

What international practice says

UNN managed to find the “Best Practice Guideline for Skin and Wound Care in Epidermolysis Bullosa” developed in 2017 by an international consensus in London. Experts from Ireland, Denmark, the United Kingdom, India, and the United States participated in the preparation of the document. The guideline also includes the experience of people living with epidermolysis bullosa and their caregivers.

The first recommendation that catches the eye is that experts advise doctors to take into account the financial situation of patients, as not everyone can afford expensive treatment and care. “Cost is always a factor that should be considered in any healthcare recommendation, and this is especially true for the treatment of epidermolysis bullosa, where a huge number of expensive dressings may be used over the course of a lifetime,” the international consensus guideline says.

The section “Skin and wound care: general principles” states that doctors should use atraumatic dressings to treat affected skin areas. Experts also advise doctors to listen to the patient and caregiver, as most people with epidermolysis bullosa try out and choose a dressing method that helps avoid injury.

“A thorough discussion usually reveals which products patients use in certain cases, and the physician should be prepared to accept this... In addition, physicians should educate patients about wound care and provide information about new products as soon as they are available on the market,” the international consensus guideline says.

What is the exit

Despite the fact that in Ukraine, medical documentation on the treatment of “butterfly people” has not been reviewed for more than 5 years and patients and the state have become hostages to one doctor and one manufacturer, the Ministry of Health does not see this as a critical problem.

Commenting on the situation, Ukrainian Health Minister Viktor Liashko said that the documentation would be reviewed when it is critically needed. “If we read the standards carefully, it says that they are to be revised every five years if necessary. 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 this standard,” Lyashko said.

Until this happens, patients continue to be convinced that they can only use Mölnlycke Health Care, and that bandages from other manufacturers are “bad.” Meanwhile, the state is losing money from the state budget, because manufacturers who offer the high-quality bandages that butterfly people need, but at a much lower cost, are unable to enter the market.

Therefore, the current situation on the market for butterfly headbands requires immediate intervention. It is necessary to:

• Conduct an independent audit of the commission's work.
• Review medical records with regard to available alternatives.
• Introduce transparent mechanisms for the procurement of medicines.
• Expand the number of specialists involved in the treatment of patients with epidermolysis bullosa.

Butterfly people deserve a decent life and affordable treatment. And the state should provide them with this without artificial obstacles and corruption schemes.