Ukrainian patients are held captive by the system: why the Ministry of Health must update medical protocols without delay.

The Ukrainian healthcare system urgently needs updates to its medical guidelines and protocols. Some of the documents currently in use are outdated and do not reflect the latest advancements in medical science and innovations. This not only diminishes the quality of care but also jeopardizes the lives and health of patients, writes UNN.

Guidelines and protocols in need of updating

As far back as 2016, a special commission approved an adapted clinical guideline recommending that "butterfly people" should exclusively use products from the Swedish company Molnlycke Health Care for wound treatment. This document was based on recommendations and findings gathered in 2012. It was supposed to be revised in 2019, but this did not happen. The commission has not updated its recommendations for over five years, despite the availability of the latest experiences from international colleagues, which raises suspicions of possible corruption motives behind its inaction. This guideline was the foundation for the medical protocol for treating patients with bullous epidermolysis in 2017. Consequently, "butterfly people" in Ukraine have been deprived of the right to choose medical supplies for wound care, as no alternatives to the Swedish dressings were specified in the documentation.

The European consensus on practical recommendations for treating bullous epidermolysis from 2021, published by the European Academy of Dermatology and Venereology, advises doctors to adopt an individualized approach in treating "butterfly people." "The choice of wound treatment strategy should consider efficacy, patient preferences, and cost-effectiveness," the document states.

Economic feasibility is particularly relevant as patients with bullous epidermolysis must use numerous dressings over their lifetime, and some manufacturers, such as Molnlycke Health Care, offer very expensive options.

Meanwhile, European doctors have listed numerous manufacturers of dressings that can be used for treating wounds in patients with bullous epidermolysis. This allows patients to select the medical supplies that suit them best. Furthermore, Europeans recommend that doctors use gauze if specialized dressings are unavailable. The 2024 clinical practice guideline for treating newborns with bullous epidermolysis, published in the British Journal of Dermatology, proposes a similar approach to prevent skin injuries in children wearing diapers.

However, in Ukraine, international recommendations are ignored, and there is a persistent insistence that only Swedish dressings can be used for patients with bullous epidermolysis.

A similar situation exists in the treatment of certain types of cancer. As Valery Zub, a member of the Ukrainian Parliament's committee on national health, medical care, and health insurance, told UNN, there are some cancer treatment protocols that have been in effect since 2007 and 2015. "We are currently working on about 30 of the most common cancer localizations. Next, we have around 80 types of cancer that we plan to supplement. We initiated that if major conferences like ESMO occur and clinical studies are conducted that provide evidence for the effectiveness of a new treatment or drug, we should incorporate those changes into our national protocols, as is done in most developed countries. Literally, within 3-6 months, all changes are made to our national protocols," Zub explained.

According to him, specialists from the state enterprise "Expert Center of the Ministry of Health" are required to review medical guidelines every five years per current legislation.

He added that the committee is working to allow for continuous updates to national medical protocols rather than just every five years. "We should establish a norm: if a protocol changes by more than 50 percent, indicating a nearly complete change in the treatment approach, for example, for stomach cancer, then a new protocol should be created. If it changes by less than 50 percent, then amendments can be made. These can be added in the notes to include a new drug..." Zub clarified.

He reminded that relevant working groups have been established for all medical areas by the Ministry of Health's order to monitor changes in international protocols.

It is important to note that updating protocols is not just a formality; it is a matter of treatment effectiveness. Each healthcare worker must operate under clear and modern rules to ensure patients receive the best possible care.

Yana Zinkevich, a well-known volunteer and member of the relevant committee in the Parliament, who has worked with military personnel and war victims for many years, also emphasizes the importance of current protocols in providing medical assistance.

"Overall, it seems like a logical idea. Because the TCCC protocol (Tactical Combat Casualty Care - a protocol that describes the procedures, requirements, and regulations governing medical assistance to injured soldiers directly on the battlefield) is relevant. Therefore, it is quite appropriate to update our protocols whenever new international recommendations emerge, rather than every five years as it is now," noted Yana Zinkevich in a comment to UNN.

Clearly, doctors are often forced to act on their own discretion due to the lack of clear recommendations. This creates risks for patients and simultaneously demotivates medical professionals who cannot rely on official documents adapted to new realities.

Collaboration with specialized organizations

It is crucial for the Ministry of Health to collaborate with Ukrainian international organizations that can provide technical and methodological support in developing new protocols. The ministry should also keep its "finger on the pulse" and monitor changes in international treatment practices, including for bullous epidermolysis.

"If there is any initiative to update the clinical protocol and there are already more modern approaches and discoveries, as science progresses - the Ministry of Health should act on the initiative of specialized organizations or on its own initiative," said Dmitry Gurin, a member of the relevant committee in Parliament.

He also explained the process for making changes to medical documentation that is currently in place in Ukraine. "According to the procedure, everything is done this way: a number of globally recognized clinical protocols are selected, and based on them, a special multidisciplinary group of specialists develops a new unified clinical protocol, which becomes mandatory for all Ukrainian doctors," Gurin explained.

In the case of bullous epidermolysis, according to the deputy, public organizations dealing with orphan diseases should primarily focus on updating guidelines. After all, he stated, the Ministry of Health is unlikely to oppose the updating of medical protocols.

Challenges to change

Earlier, UNN received information indicating that the Swedish company Molnlycke Health Care, which holds a monopoly in the Ukrainian market for medical dressings for patients with bullous epidermolysis, may be involved in financing the public union "Orphan Diseases of Ukraine," led by Tatyana Kulesha. The union has effectively become a mouthpiece for the company, helping to maintain Molnlycke's monopoly in the Ukrainian medical dressing market and lobbying for its interests.

In her public statements, Kulesha consistently emphasizes that there are no alternatives to Swedish dressings and defends Molnlycke products, despite the existence of high-quality and significantly cheaper alternatives used successfully in other countries.

Experts interviewed by UNN note that the situation surrounding Molnlycke Health Care shows clear signs of a conflict of interest and contains corruption elements. At the same time, attempts by other manufacturers to offer alternative dressings for government tenders are blocked due to the influence of "Orphan Diseases of Ukraine" and its leader.

Former Minister of Health Zoryana Skaletska noted that the Ministry of Health must investigate the situation and take all necessary actions to protect patient interests. She emphasized that orphan diseases require special attention, as the rarity of these conditions may hinder government bodies from responding swiftly.