Preamble: Pursuant to the Constitution of the Kingdom of Cambodia, in particular Art 48 (1 and 2).

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1 Preamble: Pursuant to the Constitution of the Kingdom of Cambodia, in particular Art 48 (1 and 2). Draft Law on Immunization (as of August 2013) CHAPTER I General Provisions Article 1 - Scope of regulation and subjects of application This Law provides for prevention and control of vaccine-preventable diseases and conditions to ensure the prevention and control of these diseases within the population. This law clarifies the organization of the national immunization activities, ensures that the National Immunization Program is operationalized and guarantees their sustainable financing by the government of Cambodia. The provisions of this Law are of public interest, preferential enforcement and compulsory compliance at health institutions of public, private and social sectors. This law declares that national immunization program is a national high-priority program. Article 2 Interpretation/Definitions of terms - Vaccine means a preparation containing antigens immunizing the body and used for preventive purposes. - Epidemic means the occurrence of an infectious disease in a number of persons exceeding the normal projected number of persons during a particular period and in a given area - National Immunization Program (NIP): has a task to improve child survival and improve maternal and child well-being to reduce mortality rate by countering and eliminating vaccine-preventable diseases. - Mandatory immunization means an obligatory immunization of everyone of vaccination age - Immunization schedule means the schedule of dates and ages of children and women to be involved in statewide immunization. - Target group means people who are recognized by this law and who are entitled to receive a vaccine against such diseases that are controlled through immunization. - Policy means National Immunization Policy. Article 3 All EPI vaccines are compulsory and free of charge for target groups as defined by National Immunization Policy. The list of vaccines and target groups can be revised in accordance with the recommendations of NIP, approval of the National Immunization Council.

2 A child and woman will not be immunized in case of restrictions and other medical reasons as established by the Policy. Medical staff and people who work in environments where they are easily infected shall be immunized with necessary vaccines defined by Ministry of Health. Article 4 The National Immunization Program shall collect data and prepare regular progress reports and strategies of NIP to the Minister of Health through Department of Planning and Health Information. CHAPTER II National Immunization Program and organization of Immunization services - The National Immunization Policy is developed by the National Immunization Council, upon recommendation from the National Immunization Program and approved by the Ministry of Health. - The National Immunization Policy 1) Disseminate the schedule of immunizations 2) defines the target groups for immunization 3) provides the necessary recommendations for safe injections 4) establishes cold-chain standards and vaccine storage conditions 5) sets the conditions for immunization This law creates the National Immunization Council (NIC). The NIC shall comprise the following members: a) Minister of Health - President b) Head of the National Immunization Program - Vice-president c) Member of the Ministry for rural development - Member d) Member of Ministry of Economics and Finance - Member e) Member of Ministry of Education - Member f) Ministry of Information g) Ministry of Justice h) Ministry of Interior i) Budget and Finance department (Ministry of Health) - Member j) Member of Planning and Health Information Commission (Ministry of Health) - Member

3 k) Three persons nominated by the Ministry of Health from among immunization specialists comprising at least one woman - Members l) Director general, General Department of Health Techniques Member Secretary Functions, duties and rights of the NIC: In addition to other functions, duties and powers contained in this Law, the NIC shall have following functions, duties and powers: a) To formulate the national immunization policy and submit to the Royal Government of Cambodia b) Promote partnership among government institutions, parliament, civil society organizations, private sector including business/corporate houses and national and international development partners to make national immunization program technically and financially sustainable. c) Introduce new and improved vaccines into national immunization policy based on burden of diseases, affordability, and cost-benefit analysis of vaccines. d) Request in writing to the concerned body to take necessary action against violator of this Law or rules framed there under. Meeting of the NIC and decision: Meeting of the National Council may be convened as per necessity. Meeting of the NIC may be convened in such date and place as prescribed by the president. Presence of more than fifty percent member out of total members shall be deemed to have attained the quorum for meeting. The president shall preside over the meeting and in case of his/her absence a member selected from among the members shall preside over the meeting. Decision shall be taken on majority votes and the president shall cast decisive vote in case of tie. The NIC may invite specialists or any other official to attend the meeting. The member secretary shall certify the minute of meeting. - Other Ministries and ministerial-level agencies shall, within the scope of their tasks and powers, coordinate with the Ministry of Health in performing management of the prevention and control of vaccine-preventable diseases. Vaccination card Every child and woman shall receive a vaccination card after their first vaccination. Every subsequent vaccination will be entered into the vaccination card. The parents are responsible for keeping the vaccination card updated and for providing it to schools upon the child s enrolment. Vaccination cards are provided for free upon a child s birth at public, private and social (NGOs) health facilities.

4 When a child receives an immunization it shall be marked in the Immunization Register. If a vaccination card is lost, it will be renewed using the data in the Immunization Register. The Ministry of health shall develop additional necessary regulations and policy based on the NIP. CHAPTER III Licensing, purchase, availability of vaccines - The NIP is responsible for calculating necessary quantity of vaccines and vaccine related supplies and requesting sufficient quantity to immunize the target groups every year. The Ministry of Health is responsible for ensuring that sufficient vaccines are procured and made available for immunizing the population. - The central medical store (CMS) is in charge of safe storage, transportation and distribution of vaccines and vaccine-related supplies in accordance with technical and safety standards at the central/national level. The CMS shall distribute vaccines in accordance with NIP or health facilities request. - Health facilities at the sub-national levels are responsible for implementation of immunization activities and use of vaccines and medical bio-products within their professional scope according to the National Immunization Policy. - The provincial health departments are responsible for safe storage and distribution of vaccines in the province, district EPI managers are responsible at the operational district level, and the health center managers are responsible at the health center level. - Only vaccines recognized by WHO shall be allowed for use in NIP, other vaccines imported by private sector shall be approved by MoH for public and private use. - Vaccines administered in private institutions, will be approved by the MOH. Private immunization providers will only operate after signing a Memorandum of Understanding with the Ministry of Health. - Imports, distribution and Use of other vaccines by public and private sectors shall be permitted by MoH. CHAPTER IV Surveillance and Control of Vaccine Preventable Diseases - The surveillance and reporting system is described in the National Immunization Policy - NIP is responsible for the active surveillance of all vaccine-preventable diseases included in the National Immunization Program as described in the National Immunization Policy - All public and private sector providers of immunization will report to the MOH on coverage rates, outbreaks, adverse events following immunization. Public and private providers will register the children immunized in the National Register and state the immunizations in the target groups vaccination card. CHAPTER V Information and Education on Vaccination - The National Center for Health Promotion in collaboration with NIP under the guidance of the Ministry of Health shall carry out information and education campaigns in order to inform the population on a regular basis about 1) vaccination activities; 2) importance

5 of vaccinating children and other target groups; 3) side-effects and complications that may arise; 4) dates and locations for vaccination days and campaigns - The Ministry of Health will collaborate with the Ministry of Education, Youth, and Sports to introduce information on vaccination as part of the core school curriculum. - The Ministry of Information shall inform the public on immunization by disseminating information about NIP s campaigns. CHAPTER VI Financing - The government shall have sufficient fund to implement annual immunization activities including the cost of vaccines, vaccine-related equipment, cold-chain equipment, distribution and logistics costs at the central level. - Immunization Trust Fund is made out of: 1) the national budget 2) amounts received from foreign governments, international and bilateral organizations, non-governmental organizations for immunization 3) Amounts received as fines for non-compliance (see penalty provisions) 4) Likewise, all donations to that are received by the State for NIP shall be transferred to this Immunization Trust Fund. 5) Amounts received from other sources, as determined by Sub-decree - Ministry of Economy and Finance shall manage Immunization Trust Fund and allocate priority budget in accordance with annual budget plan of NIP. - Budget from the sources above shall not be used in contradiction to the purpose of this law. - Ministry of Economy and Finance shall impose taxes and levies of vaccines, vaccinerelated supplies and equipment necessary to carry out vaccinations (transportation equipment, cold-chain equipment); and these taxes and levies shall be the responsibility of the government. CHAPTER VII Penalties and sanctions - Using expired vaccines to immunize target group population, shall be punishable. - Non-respect of counter-indications can be punishable. - Parents who do not immunize - Ministry of health shall by Sub-decree determine the sanctions and penalties for noncompliance with this Law. CHAPTER VIII Final provisions

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