
Ukrainian patients are hostage to the system: why the Ministry of Health should update medical protocols now
Kyiv • UNN
The Ukrainian healthcare system uses outdated medical protocols that have not been updated for years. The problem is particularly acute in the treatment of epidermolysis bullosa, where a Swedish company maintains a monopoly.
The Ukrainian healthcare system needs to quickly update medical guidelines and protocols. Some of the documents used in practice are morally outdated and do not take into account modern advances in medical science and innovation. This not only reduces the quality of treatment, but also jeopardizes the life and health of patients, UNN writes.
Guidelines and protocols that need to be updated
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 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.
The 2021 European Consensus on Practice Guidelines for the Treatment of Epidermolysis Bullosa published by the European Academy of Dermatology and Venereology advises doctors to use an individualized approach in the treatment of "butterfly people". "The choice of wound treatment strategy should take into account efficacy, patient preferences, and cost-effectiveness," the document says.
The economic feasibility is particularly related 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, the Europeans advise doctors to use gauze if it is not possible to use specialized dressings. 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.
However, in Ukraine, international recommendations are ignored and they stubbornly say that only Swedish dressings can be used for patients with bullous epidermolysis.
A similar situation exists with the treatment of certain types of cancer. Valeriy Zub, a member of the Verkhovna Rada Committee on National Health, Medical Assistance and Medical Insurance, told UNN that there are some protocols for cancer treatment that have been in place since 2007 and 2015. "We have practically worked out 30 nosologies, the most common localizations of cancer. Then we have about 80 forms of cancer, which we plan to add more. And we have initiated that, in principle, if there are large ESMO conferences and so on, if there are any clinical trials that are definitely an evidence base for the effectiveness of a new type of treatment or a new drug, we should introduce it as it is done in most developed countries. Literally within 3-6 months, all changes are made to our national protocols at once," Zub said .
According to him, experts at the state-owned enterprise Expert Center of the Ministry of Health should review medical guidelines every 5 years in accordance with current legislation.
He added that the committee is now working to ensure that national medical protocols can be changed not once every 5 years, but constantly. "And to establish the following norm: if the protocol changes by more than 50 percent, almost completely changing the approach to the treatment of, for example, stomach cancer, then a new protocol is created. If it's less than 50 percent, then you can make changes. You can make them in the notes to add some new drug..." explained Zub.
He reminded that relevant working groups have been set up in all medical areas by order of the Ministry of Health to monitor changes in international protocols.
It should be noted that updating protocols is not just a formality, it is a matter of treatment effectiveness. Every healthcare professional must work according to clear and up-to-date rules to ensure that patients receive the best possible care.
Yana Zinkevych, a well-known volunteer and member of the Verkhovna Rada's specialized committee who has been working with the military and war victims for many years, also emphasizes the importance of up-to-date protocols in providing medical care.
"Generally speaking, it looks like a logical idea. Because the TCCC protocol (Tactical Combat Casualty Care - a protocol that describes the procedure, requirements and provisions governing the provision of medical care to wounded soldiers directly on the battlefield - ed. That is, it is quite appropriate to update our protocols when new international recommendations appear, and not once every 5 years, as it is now," Yana Zinkevych said in a comment to UNN.
Obviously, doctors are often forced to act at their own discretion due to the lack of clear guidelines. This creates risks for patients and at the same time demotivates doctors who cannot rely on official documents adapted to the new realities.
Cooperation with specialized organizations
It is important that the Ministry of Health cooperate with Ukrainian international organizations that can provide technical and methodological support in developing new protocols. The agency should also keep its finger on the pulse and monitor changes in international treatment practices, including those related to epidermolysis bullosa.
"If there is an initiative to update a clinical protocol and there are already more modern approaches, discoveries, science has moved forward, the Ministry of Health does it at the initiative of specialized organizations or on its own initiative," said Dmytro Gurin, a member of the relevant Verkhovna Rada committee.
He also explained the algorithm for making changes to medical records that is currently in place in Ukraine. "The procedure is as follows: 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 that becomes mandatory for all Ukrainian doctors," explained Gurin.
In the case of bullous epidermolysis, according to the MP, first of all, the public organization that deals with orphan patients should pay attention to updating the guidelines. After all, he said, the Ministry of Health is unlikely to oppose the update of medical protocols.
Challenges on the way to change
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 a 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 many times cheaper analogues that are successfully used in other countries.
Experts interviewed by UNNnote 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 due to the influence of Orphan Diseases of Ukraine and its leader.
Former Minister of Health Zoryana Skaletska emphasizedthat 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.