Skaletska: The Ministry of Health should act in favor of patients, not monopolies

The situation with the monopoly of the Swedish manufacturer Molnlycke Health Care on the supply of bandages for patients with the orphan disease epidermolysis bullosa has raised serious questions about the review of medical documentation (the guidelines on which the protocol was based) and the composition of the working groups that form them. As former Minister of Health Zoryana Skaletska noted in an exclusive commentary to UNN, the Ministry of Health must investigate the situation and do everything necessary to ensure the interests of patients.

Context

At its meeting on Thursday, the Verkhovna Rada Committee on National Health considered the situation with the provision of bullous epidermolysis patients with bandages. When discussing the problem, representatives of the Antimonopoly Committee of Ukraine pointed out that there is currently no competition in the supply of bandages, which indicates a monopoly of the Swedish company Molnlycke Health Care and systemic corruption. The MPs have not yet made a decision and have given the Ministry of Health time to study the situation and prepare relevant proposals.

This situation on the market has developed because in 2016, the Ministry of Health approved an adapted clinical guideline for the treatment of patients with epidermolysis bullosa, which recommended the use of dressings from only one manufacturer, the Swedish company Molnlycke Health Care, for wound care. This guideline was based on the 2012 recommendation. This document formed the basis of the clinical protocol  . These documents have not been revised for 9 years, despite the emergence of high-quality and cheaper analogs on the market. According to experts, because of this situation, doctors cannot even officially recommend cheaper but equally high-quality analogs of Swedish bandages to patients, and other manufacturers cannot participate in public tenders.

"We have a lot of approved medical guidelines and protocols. And there is a certain frequency of their revision. Indeed, since 2016, it should have been time to revise this protocol (for the treatment of butterfly people - ed.)," noted Zoryana Skaletska.

She noted that the approval of medical documentation indicating a single manufacturer in 2016 could have been due to the fact that only the bandages of a Swedish company were registered in Ukraine at that time. However, since then, the documents should have been updated to take into account changes in the market and the emergence of new manufacturers. "Revision of guidelines and protocols is a common practice in all developed countries, and the Ministry of Health should adhere to this principle," the former minister said.

Zoryana Skaletska also pointed out that previously, working groups could include people with conflicts of interest, which often led to the creation of artificial monopolies. "This was a serious problem that had to be eradicated. The working groups often included people,  if we take into account previous years, who, let's say, had a certain conflict of interest and should not have been in the commissions, should not have made decisions and voted. And this practice is being eradicated as much as possible," she added.

According to Zoryana Skaletska, it is important that the Ministry of Health convenes a working group and starts reviewing medical records right away. "At the next meeting of the committee, the Ministry of Health should report on the results of the work," she said. Skaletska added that the situation with the documentation should be resolved transparently and with the interests of patients in mind. The Ministry of Health should not only respond to the comments, but also actively improve the review process, ensuring quality medical services for all citizens.

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.

Skaletska also emphasized the importance of partnership between the state and civil society organizations. "NGOs are often the source of information about patients' needs, and this should be a two-way interaction," she added.

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. At the same time, attempts by other manufacturers to offer alternative dressings for public tenders are being blocked due to the influence of Orphan Diseases of Ukraine and its leader.

Recall

UNN launched an investigationto find out how the Swedish company Molnlycke Health Care, which specializes 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.