Доступність ліків як результат механізмів реімбурсації та медичного страхування – питання для дискусії
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Дата
2023
Науковий керівник
Укладач
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E-ISSN
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Видавець
Анотація
Доступність ліків, їх кількість, якість, відповідна документальна організація щодо
дистрибуцій, зберігання та продажу – одне з пріоритетних завдань системи охорони
здоров’я кожної держави. У країнах Європейського Союзу значну частку витрат на
забезпечення лікарськими засобами покриває держава, реалізуючи принцип рівного
доступу населення до ефективних лікарських засобів за доступною ціною, що лежить в
основі механізмів ціноутворення та реімбурсації. Для забезпечення цих завдань існують
вимоги, викладені в Директиві 89/105/ЄС від 21.12.1989 р. «Про прозорість заходів при
ціноутворенні на лікарські засоби та їх включення до системи загального медичного
страхування», які мають за мету забезпечити розвиток фармацевтичної галузі як в
напрямку розробки дорогих інноваційних препаратів, так і всебічного забезпечення
пацієнтів якісними генериками. Таким чином, головним механізмом щодо забезпечення
доступності лікарських засобів та виробів медичного призначення для населення
являється програма реімбурсації - повне або часткове відшкодування суб’єктам
господарювання, які здійснюють діяльність з роздрібної торгівлі лікарськими засобами,
вартості лікарських засобів або медичних виробів, що були відпущені пацієнту на
підставі рецепта, за рахунок коштів Державного бюджету України, а основним завданням
нормотворчої діяльності залишається всебічне її регулювання.
Availability of medicines, their quantity, quality, and appropriate documentation organization regarding distribution, storage, and sales – is one of the priority tasks of the healthcare system of each country. In European Union countries, a significant portion of expenditures for ensuring pharmaceutical supplies is covered by the state, implementing the principle of equal access of the population to effective medicines at an affordable price, which underlies the mechanisms of pricing and reimbursement. To achieve these goals, requirements are outlined in Directive 89/105/EEC of December 21, 1989, «On the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the system of national health insurance», aimed at promoting the development of the pharmaceutical industry both in the direction of developing expensive innovative drugs and in providing patients with quality generics. Thus, the main mechanism for ensuring the availability of medicinal products and medical devices for the population is the reimbursement program – the complete or partial refunding to entities engaged in retail trade of medicinal products, of the cost of medicinal products or medical devices dispensed to patients based on prescriptions, at the expense of the State Budget of Ukraine. The main objective of regulatory activities remains comprehensive regulation. Individual healthcare questions, including the provision of medicinal products, have been explored in the works of Yu. Bytiak, V. Kolpakov, R. Maidanyk, O. Myronets, I. Seniuta and others. The purpose of this publication is to review the normative and legal regulation of the reimbursement mechanism and practical implementation issues. Different countries establish their own reimbursement mechanisms, which vary in terms of funding sources, reimbursement conditions, price regulation methods, selection criteria for medicinal products, and key nosologies for treatment. The recipients of such systems may include socially vulnerable segments of the population, individuals suffering from severe or chronic illnesses, as well as various types of pharmaceutical assistance such as inpatient and outpatient care. Depending on the specifics of healthcare systems in different countries, different compensation mechanisms may be used. For example, this may involve the reimbursement of the cost of medicines for insured individuals, where the patient’s treatment expenses are covered by the insurance company or compensated to pharmacy establishments, with settlements being made between the insurance fund, healthcare facility, and pharmacy based on contracts. In Ukraine, in the absence of a mandatory medical insurance system, the reimbursement process operates in the form of the state program «Accessible Medicines», where the state compensates pharmacy establishments for the full or partial cost of medicines from the respective list.
Availability of medicines, their quantity, quality, and appropriate documentation organization regarding distribution, storage, and sales – is one of the priority tasks of the healthcare system of each country. In European Union countries, a significant portion of expenditures for ensuring pharmaceutical supplies is covered by the state, implementing the principle of equal access of the population to effective medicines at an affordable price, which underlies the mechanisms of pricing and reimbursement. To achieve these goals, requirements are outlined in Directive 89/105/EEC of December 21, 1989, «On the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the system of national health insurance», aimed at promoting the development of the pharmaceutical industry both in the direction of developing expensive innovative drugs and in providing patients with quality generics. Thus, the main mechanism for ensuring the availability of medicinal products and medical devices for the population is the reimbursement program – the complete or partial refunding to entities engaged in retail trade of medicinal products, of the cost of medicinal products or medical devices dispensed to patients based on prescriptions, at the expense of the State Budget of Ukraine. The main objective of regulatory activities remains comprehensive regulation. Individual healthcare questions, including the provision of medicinal products, have been explored in the works of Yu. Bytiak, V. Kolpakov, R. Maidanyk, O. Myronets, I. Seniuta and others. The purpose of this publication is to review the normative and legal regulation of the reimbursement mechanism and practical implementation issues. Different countries establish their own reimbursement mechanisms, which vary in terms of funding sources, reimbursement conditions, price regulation methods, selection criteria for medicinal products, and key nosologies for treatment. The recipients of such systems may include socially vulnerable segments of the population, individuals suffering from severe or chronic illnesses, as well as various types of pharmaceutical assistance such as inpatient and outpatient care. Depending on the specifics of healthcare systems in different countries, different compensation mechanisms may be used. For example, this may involve the reimbursement of the cost of medicines for insured individuals, where the patient’s treatment expenses are covered by the insurance company or compensated to pharmacy establishments, with settlements being made between the insurance fund, healthcare facility, and pharmacy based on contracts. In Ukraine, in the absence of a mandatory medical insurance system, the reimbursement process operates in the form of the state program «Accessible Medicines», where the state compensates pharmacy establishments for the full or partial cost of medicines from the respective list.
Опис
Ключові слова
доступність лікарських засобів, реімбурсація, медичне страхування, охорона здоров’я, правове регулювання, availability of medicinal products, reimbursement, health insurance, healthcare, legal regulation
Бібліографічний опис
Правова держава = Сonstitutional State