The NGO "EpiProsvita," along with partners, is conducting an advocacy campaign for the registration and inclusion of two medications, Clobazam and Ethosuximide, into the National List.
The advocacy campaign is being implemented by "EpiProsvita" within the framework of the project "Znaymy – Change, Educate, Advocate, Mentor Inclusively," executed by the NGO "League of the Strong" with technical support from UN Women in Ukraine and funded by the UN Women's Peace and Humanitarian Fund (WPHF). However, this does not mean that the views expressed during the campaign are officially endorsed or recognized by the United Nations.
The UN Women's Peace and Humanitarian Fund (WPHF) is a flexible and rapid funding instrument that supports quality measures to enhance the capacity of local women in conflict prevention, crisis response, and key peacebuilding opportunities.
Unfortunately, there are so many unregistered medications in Ukraine that adding each one individually to the National List could take over 60 years. Given Ukraine's European integration process, it would be prudent to adapt the National List to the European one and make medications allowed in Europe automatically available and included in the National List now.
To demonstrate the necessity of registering such medications not only for epilepsy patients, which "EpiProsvita" deals with, we initiated a series of interviews with leaders from other NGOs in the medical field.
In this interview, Olena Sotskova, a board member of the NGO "Full Life," shared her thoughts and knowledge. The public organization has been assisting patients with severe and incurable diseases related to inflammatory bowel diseases (Crohn's Disease and Ulcerative Colitis) for 6 years. According to statistics as of the end of 2018, there were 10,456 patients with IBD registered in Ukraine. Over 6 years, the number of patients has significantly increased. Since the beginning of the war, more than 2,000 new patients have been diagnosed.
The organization has implemented several important projects, such as the "Information Support for Patients with IBD" project, which created and filled a website with important informational materials, a YouTube channel, a Facebook page and group, organized 10 times "Patient School" in 4 different regions of Ukraine, and a project funded by the MVF "Activating the Patient Community with Inflammatory Bowel Disease and Increasing Its Social Awareness," aimed at updating and organizing advocacy and patient control among patients with IBD, as well as holding several informal patient meetings and creating a cookbook for patients with IBD. Since the war began, the organization has been involved in obtaining and distributing humanitarian aid and medical products for patients with IBD.
Are there any problems for your patients accessing medicine?
The main problem for patients with ulcerative colitis and Crohn's disease (together IBD) is the lack of a reimbursement program and other ways to obtain medications. All medications are purchased by patients at their own expense. Unfortunately, all medications for treating IBD are expensive, and some patients even refuse treatment because they cannot afford to buy them. The situation is exacerbated by the fact that the disease is incurable, and patients must take medications in various dosages, depending on the condition (remission or exacerbation), throughout their lives.
Currently, in many countries, patients with severe forms of IBD are provided with modern biological preparations that have proven effectiveness and can bring the patient into a state of long-term remission. In Ukraine, biological therapy is unavailable due to high pricing policies and the absence of budgetary programs for purchasing medications for IBD patients.
How critical is the availability of medications for your patients, and what critical medications are currently not in the National List?
Ulcerative colitis and Crohn's disease are incurable, but the patient can receive treatment aimed at suppressing the pathological state of the immune system and healing digestive tract lesions, which helps reduce the frequency of symptoms or/and their disappearance, allowing the patient to achieve a state of long-term remission. Despite the impossibility of complete recovery, the symptoms of the disease and their impact on the patient's life can be minimized with appropriate treatment. That is, treatment needs to be undergone for life.
Patients must take lifelong medications of Mesalazine (active substance), which are used as the main basic therapy for treating IBD. In addition, for severe forms of IBD, doctors prescribe local action hormonal drugs, Budesonide, which are also not in the National List.
Also, the list does not include any biological therapy medications for treating IBD. Only 3 medications (Remicade, Humira, and Entivio) are registered in Ukraine, although significantly more biological therapy medications are used worldwide.
Are medications for your patients included in the Affordable Medicines Program?
No, currently no medication for treating patients with IBD is included in the Affordable Medicines Program.
Do your patients use medications under Decree 1303? Have your patients encountered a lack of budget under this decree, due to which they did not receive necessary medications?
According to Decree 1303, it is possible to purchase medications for children with IBD who have the status of "child with a disability." This works in cities where there are active parents who can advocate for the patient's rights. For adult patients, unfortunately, this decree does not work. First, not all IBD patients have a disability group, and those who do usually have the 3rd group of disability, which does not allow receiving medications under Decree 1303. Secondly, local authorities often say they cannot purchase necessary medications because they are not in the National List or there are no budget funds.
How do you see the solution to the problem of medication availability for patients? Would integration with the European Union help in this matter?
The main reason why Mesalazine and Budesonide medications are still not in the National List is the unwillingness of pharmaceutical company representatives to engage in the evaluation of medical technologies and spend money on it. According to pharmaceutical companies, very few medications are sold in Ukraine, there are no state purchases, so there is no economic sense in spending money on evaluating medical technologies if there are no guarantees that there will ever be budget purchases. The situation is worsened by the fact that the price of these medications in Ukraine is higher compared to European countries, where there are reimbursement programs and state purchases. Patients, looking for a lower price, order contraband medications, mainly from Turkey and Egypt.
In my opinion, if medications have been time-tested, used for many years in Europe, and specified in treatment protocols, and the pharmaceutical company has the appropriate permissions and licenses from the European Union, and imports these medications to Ukraine, why conduct a separate evaluation of medical technologies in Ukraine?
Integration with the European Union would definitely help prevent unnecessary actions and improve patients' access to treatment.
Have you discussed your vision of the situation with the Ministry of Health? Did you receive a response?
We communicated before the war; the Ministry of Health directed us to pharmaceutical companies, which were supposed to undergo the evaluation of medical technologies. It's a closed circle.
Why is it important to include medications for treating patients with IBD in the National List now, not after the war?
Crohn's disease and ulcerative colitis are incurable diseases that predominantly affect young, working-age people, aged 15 to 26 years. Patients in Ukraine are currently in the worst situation compared to patients from other countries, as our people do not have access to treatment. With the onset of the war, the situation has significantly worsened, as many patients have lost their jobs, incomes, and now cannot even afford to buy medications. The lack of adequate treatment will definitely lead to the development of disability in many people, which could have been avoided. This, in turn, will lead to additional budget expenses for maintaining people with disabilities.
Many of our patients who have gone abroad and are receiving appropriate treatment there are unlikely to want to return to a country where there is no access to treatment for the disease.
Currently, the problem with medications is much deeper than their absence in the National List. Most medications for ADVANCE THERAPY (modern biological therapy) are simply not available on our market. Even patients who can and want to buy medications cannot do so. Medications are not available because pharmaceutical companies find it unprofitable (less than 1/3 of the minimum possible manufacturing batch is sold per year), and there are no state purchases for adult patients. What they promise to bring from abroad is not an option at all, as no one but the official supplier can guarantee the preservation of the temperature chain.
Therefore, if we compare Ukraine, in terms of access to treatment for inflammatory bowel diseases, with other countries, we fall under the classification of third-world countries. For example, poor African countries, where patients also do not have access to medications, and many people die or become disabled at a young age.
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