Legislative Text Analysis

Dr. Michael McQuestion Dr. Cliff KamaraMs. Dana Silver

Sustainable Immunization Financing ProgramAnglophone African Peer review workshop

Nairobi, Kenya27 October 2015

Overview

• Each country has a unique set of legislative and regulatory documents aand has used particular strategies and processes to create them

• The documents were written and championed by some combination of government officials, external experts and legislators

Overview

• Legislative provisions relevant to immunization may be – the subject of freestanding vaccine laws– inserted into more general health laws– contained in detailed regulations

accompanying more general health laws– issued by ministerial or presidential decree

Overview

• Legislation should be distinguished from more detailed regulations needed to implement the legislation

Vaccine legislation

• Lessons and best practices from other nations’ vaccine laws, decrees, and policies can be used to create similar legal frameworks

• Trumbo et al. provide the classification and definitions of vaccine legislation provisions used in this analysis, which are based largely on the Global Vaccine Action Plan (2010-2020) recommendations

“Governments have a responsibility to ensure that the citizens are immunized and their chief means of doing so is public health legislation.”

-Trumbo et al., 2012

Declarative Provisions

Free Vaccination Text: Examples

Compulsory Vaccination“In accordance with this Act, vaccinations against disease is mandatory if deemed necessary by the National Commission on Vaccination and Epidemiology…” -Costa Rica National Immunization Law

“Children and pregnant women are obliged to use vaccines and medical bio-products for infectious diseases under the expanded program on immunization.” -Vietnam Law on Prevention and Control of Infectious Diseases (2007)

“Every person on the territory of Georgia is obliged to: Receive the vaccination when there is an outbreak or wide spreading or possible epidemic of communicable disease, providing that there are no side effects; Receive the preventive vaccination when involved in the activity associated with the high risk of spreading the communicable disease. -Georgia Public Health Law

Financial Provisions

Budget Line Text: Examples

“To ensure the financial sustainability, the Government of Sri Lanka will ensure a separate budget line for the [National Immunization Programme] within the National Budget. This budget line will be reviewed annually with a view of achieving [Programme] objectives.

-Sri Lanka draft National Immunization Policy (2014)

“A special fund shall be established for immunization. The special fund shall consist of the state centralized budget, local budget and other sources…”

-Mongolia Immunization Law (2000)

“A national vaccination fund shall be created whose financial source will come from the Ministry of the Treasury, with a permanently assigned Line Item with a specific destination…”

-El Salvador Vaccination Law (2009)

Tax Exemption Text: Examples“All imported and locally purchased vaccines, machinery necessary for its maintenance and transportation and all materials for immunization programs of the Ministry of Health or of the Social Security Fund are exempted from all taxes, surcharges and customs duties.”

-Costa Rica National Immunization Law

“The purchase, sale, national production, and import of vaccines… as well as the procurement and maintenance of necessary cold chain equipment and consumables, are exempt from customs duties, tax payments, contributions, and obligations.”

-Cameroon Immunization Provisions

“Vaccines and provisions acquired by the MOPH for the purposes of the EPI will be exempt from all fiscal encumbrances, whether taxes, rents, customs duties, or special contributions.”

-Madagascar Draft Immunization Law (2012)

Supply Mechanism Text: Examples“All purchases of syringes and vaccines and /or donations to Enlarged Immunization Program will be made through the Convention Rotating Fund, PAHO / WHO.”

-Bolivia Immunization Law (2005)

“The non-profit-making organization shall organise a competition (by inviting relevant experts and a representative from the Ministry of Welfare) regarding the acquisition of vaccines for the implementation of the State Immunisation Programme...”

-Latvia Vaccination Regulations

“The Government purchases vaccines through the UNICEF procurement mechanism…”

-Comprehensive Multi-Year Plan of the National Immunization Programme of Armenia  

Operational Provisions

Regulatory Oversight Text: Examples

“Ensure the supply of vaccination and biomedicine meets state standards, and its transportation and storage meet necessary conditions and hygienic requirements.”

-Mongolia Government Resolution on Immunization Fund (2001)

“State Provides: Organization and supervision of the vaccination defined by the national calendar of the preventive vaccination; Procurement of all necessary preparations for the vaccination, supervision on their storage and transportation.”

-Georgia Public Health Law

“Government ensures availability of safe immunization materials, quality, effective, affordable, and equitable for the community…”

-Indonesia Health Law (2009)

Immunization Schedule Text: Examples

Enforceability Text: Examples

“The presentation of an updated vaccination card will be a mandatory requirement to enter kindergarten, primary school, and orphanages…”

-Honduras Executive Decree

“In case those who violated immunization legislation can not be held criminally liable, following penalties shall be imposed by a relevant judge or state inspector: a fine; a fine with the offender compulsorily involved in catch-up immunization and made to pay the related expenses for the violation…”

-Mongolia Immunization Law (2000)

Existence of NITAG: Examples

“In order to professionally evaluate the issues related to vaccination and the State Immunisation Programme and to provide proposals for the solution thereof, as well as in order to evaluate orders for vaccines, the Minister for Welfare shall establish the State Immunisation Advisory Council and approve its by-laws. Members of the Council shall not receive remuneration for their work in the Council.”

-Latvia Vaccination Regulations

“To provide technical advices on immunization services to the Government of Nepal, an independent National Immunization Advisory Committee shall be formed and the composition, duty and responsibilities shall be as prescribed.”

-Nepal draft Immunization Bill (2015)

Thank you!

PEFA standards• Credibility of the budget - The budget is realistic and is implemented as

intended• 2. Comprehensiveness and transparency - The budget and the fiscal risk

oversight are comprehensive, and fiscal and budget information is accessible to the public.

• 3. Policy-based budgeting - The budget is prepared with due regard to government policy.

• 4. Predictability and control in budget execution - The budget is implemented in an orderly and predictable manner and there are arrangements for the exercise of control and stewardship in the use of public funds.

• 5. Accounting, recording and reporting – Adequate records and information are produced, maintained and disseminated to meet decision-making control, management and reporting purposes.

• 6. External scrutiny and audit - Arrangements for scrutiny of public finances and follow up by executive are operating