Patients demand to unblock budget purchases of innovative medicines
A coalition of patient organizations, which unites groups of patients in need of innovative treatments, is demanding the unblocking of budgetary purchases of such medicines.
At a press conference at Interfax-Ukraine on Tuesday, Ihor Ohorodniychuk, a partner at OMP law firm, explained that budget purchases of innovative drugs were blocked after amendments were made to Government Resolution No. 333. These changes allowed local authorities to purchase medications not included in the National List of Essential Medicines with their own funds and to purchase innovative medicines if a Health Technology Assessment (HTA) has been conducted and a corresponding program is in place within local budgets.
"Amendments to Resolution No. 333 require compliance with HTA recommendations. However, local authorities are unable to follow these HTA recommendations because the resolution states that managed access agreements (MAAs) must be negotiated. But local administrations cannot sign MAAs; they can only conduct tenders. MAAs fall under the Ministry of Health's jurisdiction," he said.
"To avoid legal issues, local administrations are simply doing nothing. They fear legal repercussions. Amendments need to be made to Resolution No. 34 to address this legal contradiction," the lawyer said.
Patient organizations have appealed to the Cabinet of Ministers and the Ministry of Health, demanding that regional purchases be unblocked. They specifically request that local authorities receive clarifications on how to apply HTA recommendations and that decisions on drug procurement should take into account the clinical effectiveness of the medicine, as determined by an authorized body.
Viktor Serdiuk, President of the Ukrainian Charitable Organization "Council for Patients' Rights and Safety," noted that this legal contradiction prevents local authorities from purchasing necessary medications.
"There are officials in the Ministry of Health who are ensuring that local authorities cannot spend their funds. They could spend millions on road repairs, but not UAH 80,000 on melanoma treatment. The local communities have the money, but they can't spend it or purchase medications. We demand the suspension of this regulation," he said.
Anna Uzlova, CEO and Co-founder of the Inspiration Family Foundation to support adult cancer patients, pointed out that neither the National List of Essential Medicines nor the list of medicines purchased through the state budget includes medicines that are part of global treatment protocols.
"Today, we are facing a situation where it's impossible to procure these medicines due to ambiguous wording in the legal framework," she said.
Tetiana Kulesha, Chairperson of the Board of the Public Union "Orphan Diseases of Ukraine," emphasized that patient organizations fought hard when the National List was introduced in Ukraine, a list that does not include a single innovative drug. This has left patients with orphan diseases, those with rare forms of cancer, and cancer patients without access to treatment.
"Unfortunately, with each passing year, patients have less and less access to therapies available in Europe," she said.
Kulesha also clarified that, in addition to oncology drugs, the procurement of medicines for patients with juvenile rheumatoid arthritis (JRA), rare rheumatological diseases, acromegaly, pulmonary hypertension, and epidermolysis bullosa has been completely halted.
Volodymyr Redko, Executive Director of the Association of Pharmaceutical Research & Development (APRaD), remarked that "unfortunately, many of the medications currently used for treatment in Ukraine are quite outdated."
"Modern medicines do exist, but the question is how to physically gain access to them," he concluded.