MP: Parliamentary Committee on National Health is working to accelerate updating of medical protocols

MP: Parliamentary Committee on National Health is working to accelerate updating of medical protocols

Kyiv  •  UNN

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The Verkhovna Rada Committee is working on a mechanism to dynamically update medical protocols to quickly adapt to international standards. The changes will apply to all areas of medicine, including the treatment of rare diseases.

Medical protocols in Ukraine need to be constantly updated to meet modern international treatment standards. Current legislation provides for their review every five years, but progressive developments need to be implemented more quickly. The Verkhovna Rada Committee on National Health, Medical Assistance and Medical Insurance is working to develop a mechanism for dynamic updating of national protocols to adapt to new evidence-based treatments and changes in international medical practice. Valeriy Zub, a member of the parliamentary committee, told UNN about this in an exclusive commentary.

Context

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 preference, 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.

Details

"According to our current orders, there are clinical guidelines, and all national protocols are reviewed once every 5 years. In accordance with the current legislation," Valeriy Zub said.

According to him, experts at the state-owned Expert Center of the Ministry of Health should review medical guidelines every 5 years.

Zub said that, for example, 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.

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. It is these working groups that should monitor changes in international protocols. "As a rule, all working groups in each area do this. And, accordingly, the expert center is also responsible for this. If they monitor these changes, they can suggest that the working group revise a protocol," Zub said.

Recall

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 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.