Analysis of the Draft Law:
Analysis of the Draft Law
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- Description of the Essence of the Draft Law: Briefly describe the main purpose and subject of regulation of the draft law in 3-5 sentences.
- Description of the Structure and Main Provisions: Review the structure of the draft law (sections, articles), highlight the main provisions and key changes it introduces to the current legislation. Compare with previous versions, if any.
- Identification of Important Provisions: Indicate those provisions of the draft law that may be most important for legislators, experts, businesses, and citizens, considering their interests and possible consequences.
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Analysis of the Explanatory Note:
Analysis of the Draft Law “On Protection of the Population from Infectious Diseases”
Good day! Today we will consider an important draft law concerning the protection of Ukrainians from infectious diseases. Let’s understand its essence, reasons for its appearance, and possible consequences.
1. Essence of the Draft Law
The Draft Law “On Protection of the Population from Infectious Diseases” aims to update and improve legislation in the field of protection against infectious diseases, bringing it into line with modern requirements of the public health system. It is aimed at regulating issues that were not included in the Law “On the Public Health System,” in particular, regarding vaccination and response to side effects.
2. Reasons and Necessity for Adopting the Draft Law (from the Point of View of the Author of the Explanatory Note)
The authors of the explanatory note emphasize that infectious diseases remain a serious threat to the health of the population and the economy of Ukraine. The Law “On Protection of the Population from Infectious Diseases,” adopted in 2000, needs to be updated in accordance with the modern Law “On the Public Health System.” In addition, the authors refer to the positive experience of European countries in the field of vaccination and responsibility for refusing vaccinations, which contributed to increasing vaccination coverage and improving the epidemiological situation. The purpose of the new law is to harmonize Ukrainian legislation with international standards, ensure national security, and create favorable conditions for the development of the healthcare system.
3. Main Consequences of the Draft Law
The draft law has several important consequences that may be of interest to various stakeholders:
- For legislators and experts:
- Alignment of legislation with European standards in the field of healthcare.
- Improvement of the system of prevention and response to infectious diseases.
- For business:
- Establishment of clear requirements for immunobiological preparations and control over their quality.
- For citizens:
- Definition of rights and obligations in the field of protection against infectious diseases.
- Clarification of the procedure for vaccination and response to adverse reactions.
- Implementation of European experience regarding responsibility for vaccinating children.
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Analysis of Other Documents:
Analysis of the List of Acts of the Cabinet of Ministers of Ukraine and Central Executive Bodies
Position of the Author of the Document: The author of the document, in the person of the Acting Director of the Department of Public Health, Tetiana Skapa, undoubtedly supports the Draft Law of Ukraine “On Protection of the Population from Infectious Diseases.” This follows from the fact that the document is a list of necessary changes to existing normative legal acts that need to be made to implement the provisions of the new law. In fact, the document is an action plan for implementing the law in life.
Main Provisions Important for Stakeholders:
- Necessity of Amending Existing Regulatory Acts: The document identifies specific orders of the Ministry of Health that require changes or additions in connection with the adoption of the new law. This is important for legislators, as it shows the scope of the subordinate regulatory framework that will need to be updated.
- Procedure for Storing and Transporting Vaccines: Approval of the updated procedure for ensuring proper storage, transportation, acceptance, and accounting of vaccines is critical to ensuring the quality and effectiveness of population vaccination. This is important for businesses involved in vaccine logistics.
- Form of the Act of Refusal of Vaccinations: Supplementing the procedure for preventive vaccinations with the form of the act and the procedure for its compilation regarding the refusal of vaccinations is important for citizens, as it clearly defines the procedure for exercising the right to refuse.
- National Technical Group of Experts on Immunoprophylaxis (NTGEI): Amendments to the regulation on the NTGEI emphasize the importance of expert support and scientific substantiation of policies in the field of immunoprophylaxis. This is important for experts and scientists involved in policy-making in this area.
- Requirements for Registration of Adverse Events Following Immunization: Approval of requirements for the registration of such events is important for ensuring the safety of vaccination and prompt response to possible complications. This is important for the healthcare system as a whole.
Analysis of Financial and Economic Calculations
Position of the Author of the Document: The author of the document is likely a representative of the Ministry of Health, who is responsible for financial planning and justification of expenses. Support for the draft law is expressed in the detailed calculation of the necessary financial resources for the implementation of the strategic goals provided for by the law.
Main Provisions Important for Stakeholders:
- Financial Justification: The document contains financial calculations necessary for the implementation of the law, including the cost of purchasing vaccines and medicines. This is important for legislators, as it allows them to assess the financial burden of the law on the state budget.
- Strategic Goals and Performance Indicators: The document defines strategic goals, such as ensuring the immunization program and purchasing medicines, as well as performance indicators, measured in thousands of hryvnias. This is important for controlling the efficiency of the use of budget funds.
- Sources of Financing: The calculations show that funding is expected from the state budget.
- Direct and Indirect Costs: The document distinguishes between direct costs (for vaccines and medicines) and states the absence of indirect costs, however, given the experience, unforeseen costs may arise that will require additional funding.
- Impact on the Budget: The document states that there is no direct or indirect impact of the draft act on the revenues and expenditures of the state and/or local budgets, as well as the absence of fiscal risks. This may be subject to debate, as the implementation of the law may have unforeseen financial consequences.
Analysis of the Resolution of the Verkhovna Rada of Ukraine
Position of the Author of the Document: The author is the Cabinet of Ministers of Ukraine, which submits a draft resolution on the adoption as a basis of the Draft Law of Ukraine “On Protection of the Population from Infectious Diseases.” This clearly indicates the government’s support for the draft law.
Main Provisions Important for Stakeholders:
- Adoption as a Basis: The draft resolution proposes to the Verkhovna Rada to adopt as a basis the Draft Law of Ukraine “On Protection of the Population from Infectious Diseases.” This is an important step for further consideration and adoption of the law.
- Finalization by the Committee: The Committee of the Verkhovna Rada of Ukraine on Public Health, Medical Assistance, and Medical Insurance is instructed to finalize the draft law, taking into account comments and proposals. This means the possibility of making changes and additions to the draft law before its final adoption.
