The Ministry of Health should review outdated protocols, but in the situation with bullous epidermolysis, new international recommendations have been ignored for the sixth year

The Ministry of Health is obliged to monitor modern international practices and update medical protocols if science and medicine have taken a step forward. This opinion was expressed in an exclusive comment to UNN by Dmytro Hurin, a member of the Verkhovna Rada of Ukraine Committee on Public Health, Medical Care and Medical Insurance.

Context

As early as 2016, a special commission approved an adapted clinical guideline that recommends using only products from the Swedish company Molnlycke Health Care for the treatment of wounds in "butterfly people". This document was based on recommendations and conclusions collected in 2012. It was supposed to be reviewed in 2019, but this did not happen. The commission has not updated its recommendations for more than five years, despite the existing latest experience of international colleagues, which suggests the presence of corrupt motives in its inaction. In 2017, this guideline formed the basis of the medical protocol for the treatment of patients with bullous epidermolysis. Thus, "butterfly people" in Ukraine were deprived of the right to choose medical means for wound treatment, as no analogues of the Swedish dressings were indicated in the documentation.

The European Consensus on Practical Advice for the Treatment of Bullous Epidermolysis from 2021, published by the European Academy of Dermatology and Venereology advises doctors to use an individual approach in the treatment of "butterfly people". "The choice of wound treatment strategy should take into account effectiveness, patient preference and cost-effectiveness", the document states. 

The economic feasibility is in particular related to the fact that patients with bullous epidermolysis have to use a multitude of dressings for wound treatment throughout their lives, and some manufacturers, such as Molnlycke Health Care, are very expensive. 

At the same time, European doctors in the guideline indicated a whole range of dressing manufacturers that can be used in the treatment of wounds in patients with bullous epidermolysis. That is, they give patients the opportunity to choose the medical device that suits them best. Moreover, Europeans advise doctors that if it is not possible to use specialized dressings, to use gauze. The 2024 clinical practice guideline for the treatment of bullous epidermolysis in newborns, published in the British Journal of Dermatology, proposes a similar approach to prevent skin injury in children wearing diapers.

But in Ukraine, international recommendations are ignored and they stubbornly insist that only Swedish dressings can be used for patients with bullous epidermolysis.

Details

"If there is some initiative to update the clinical protocol and there are already more modern approaches, discoveries, science has moved forward - the Ministry of Health does this on the initiative of specialized organizations or on its own initiative", said Dmytro Hurin.

According to him, the Ministry of Health may not review guidelines and protocols if there are no new discoveries about a particular disease, and the old rules remain relevant.

At the same time, he added that the ministry monitors new guidelines that appear in world medicine.

"I think they just didn't get around to it, there are a lot of problems that need to be solved during the war. By procedure, it is done this way: a number of clinically recognized protocols are selected worldwide and on their basis a special multidisciplinary group of specialists develops a new unified clinical protocol, which becomes mandatory for all Ukrainian doctors", Hurin explained.

In the case of bullous epidermolysis, according to the MP, the public organization that deals with orphan diseases should primarily focus on updating the guidelines. Because, according to him, the Ministry of Health is unlikely to oppose the updating of medical protocols.

Reminder

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 bullous epidermolysis, may be involved in financing the public union "Orphan Diseases of Ukraine" led by Tetiana Kulesh. The union has actually become the mouthpiece of the company, which helps maintain Molnlycke's monopoly in the medical dressings market in Ukraine, and lobbies for its interests.

In her public speeches, Kulesh constantly emphasizes that there are no alternatives to Swedish dressings, and defends Molnlycke's products, despite the presence 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 a corruption component. At the same time, attempts by other manufacturers to offer alternative dressings for public tenders are blocked thanks to the influence of "Orphan Diseases of Ukraine" and its leader.

Former Minister of Health Zoriana Skalska emphasized that the Ministry of Health must necessarily sort out the situation and do everything necessary to protect the interests of patients. She stressed that orphan diseases require special attention, as due to the rarity of these diseases, government agencies may not have enough information for a quick response.