Legalization of Clobazam and Ethosuximide

The Ukrainian organization "Epiprosvita," along with its partners, is conducting an advocacy campaign for the registration and inclusion of two medications, Clobazam and Ethosuximide, in the National List. The advocacy campaign is implemented by "Epiprosvita" as part of the project "ZNAMY - change, educate, advocate, mentor inclusively," implemented 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, the views and content expressed during the campaign are not officially endorsed or recognized by the United Nations.

The UN Women's Peace and Humanitarian Fund (WPHF) is a flexible and responsive financing tool that supports quality measures to enhance the capacity of local women in conflict prevention, crisis response, emergency situations, and key peacebuilding opportunities.

Unfortunately, there are so many unregistered medications in Ukraine that adding each one to the National List could take over 60 years. Considering Ukraine's European integration process, it would be practical to adapt the National List to the European one and make medications approved 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" addresses, we initiated a series of interviews with leaders of 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 helping 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 registered in Ukraine with IBD. The number of patients has significantly increased over six years. More than 2,000 new patients were diagnosed since the beginning of the war.

The organization has implemented several important projects, including the "Information Support for IBD Patients" project, which created and filled the organization's website, YouTube channel, Facebook page, and group with essential information; organized "Patient School" ten times in four different regions of Ukraine; a project funded by the IMF "Activation of the IBD Patient Community and Increasing Its Social Awareness," aimed at updating and organizing advocacy and patient control among IBD patients; and held several informal patient meetings and created a cookbook for patients with IBD. Since the war began, the organization has been involved in obtaining and distributing humanitarian aid and medical supplies for IBD patients.

Are there any problems with your patients' access to medicine?

The main problem for patients with ulcerative colitis and Crohn's disease (collectively IBD) is the absence of a reimbursement program and other ways to obtain medications. All drugs are bought 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 medication at various dosages, depending on their condition (remission or exacerbation), for life.

Currently, in many countries, patients with severe forms of IBD are provided with modern biological medications that have proven effectiveness and can induce long-term remission. In Ukraine, biological therapy is unavailable due to high pricing policies and the absence of government procurement programs for these medications.

How critical is the availability of medications for your patients, and which critical medications are currently not included in the National List?

Ulcerative colitis and Crohn's disease are incurable, but patients can receive treatment aimed at suppressing the pathological state of the immune system and healing lesions in the digestive tract, which helps reduce the frequency of symptom manifestations or their disappearance, allowing the patient to achieve 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. Therefore, treatment is needed throughout life.

Patients must take Mesalazine (active ingredient) drugs for life, which are used to treat IBD as the main basic therapy. Additionally, for severe forms of IBD, doctors prescribe local action hormonal drugs, Budesonide, which are also not included in the National List.

Also, the list does not include any biological therapy drugs for treating IBD. In Ukraine, only three drugs (Remicade, Humira, and Entyvio) are registered, although many more biological therapy drugs are used worldwide.

Are the medications for your patients included in the Affordable Medicines Program?

No, currently no drug for treating IBD patients is included in the Affordable Medicines Program.

Do your patients use medications under Resolution 1303? Have your patients encountered a lack of budget under this resolution, causing them not to receive the necessary medications?

According to Resolution 1303, it is possible to purchase medications for children with IBD who have "disabled child" status. This works in cities where there are active parents who can advocate for patient rights. For adult patients, unfortunately, this resolution does not work. First, not all IBD patients have a disability group, and those who do are usually in the 3rd group of disability, which does not allow them to receive medications under Resolution 1303. Second, local authorities often say they cannot purchase the necessary medications because they are not included in the National List, or there are no budget funds available.

What do you see as a 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 included in the National List is the unwillingness of pharmaceutical companies to engage in medical technology assessment and spend money on it. According to pharmaceutical companies, a very small number of medications are sold in Ukraine, there are no state procurements, so there is no economic sense in spending money on medical technology assessment if there is no guarantee that budget procurements will ever occur. The situation is worsened by the fact that the price of these drugs in Ukraine is high compared to European countries, where there are reimbursement programs and state procurements. Patients, looking for a lower price, order contraband drugs, mainly from Turkey and Egypt.

In my opinion, if the drugs have been time-tested, used for many years in Europe, and are included in treatment protocols, and the pharmaceutical company has the appropriate permits and licenses from the European Union, and imports these drugs into Ukraine, why is there a need to conduct a separate medical technology assessment in Ukraine?

Definitely, integration with the European Union would help prevent unnecessary actions and improve patients' access to treatment.

Did you discuss your vision of the situation with the Ministry of Health? Did you get a response?

We communicated before the war; the Ministry of Health referred us to pharmaceutical companies, which were supposed to undergo medical technology assessment. It's a closed loop.

Why is it important to include medications for treating IBD patients in the National List now and 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 position 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, income, and now cannot even afford to buy medications. The lack of adequate treatment will definitely lead to 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 moved 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 drugs for ADVANCE THERAPY (modern biological therapy) are simply not available on our market. Even patients who can and want to buy the drugs cannot do so. The drugs are not available because it is unprofitable for pharmaceutical companies (less than 1/3 of the minimum possible batch is sold per year), and there are no state procurements 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 maintenance of the temperature chain.

Therefore, if you compare Ukraine's access to treatment for inflammatory bowel diseases with other countries, we fall under the classification of third-world countries. For example, poor countries in Africa, where patients also do not have access to medications, and many people die or become disabled at a young age.

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