How to analyze immunization legislation

1. Legislative Text Analysis
Dr. Michael McQuestion
Dr. Cliff Kamara
Ms. Dana Silver
Sustainable Immunization Financing Program
Anglophone African Peer review workshop
Nairobi, Kenya
27 October 2015

2. 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

3. 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

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

5. 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

6. Declarative Provisions

7. Free Vaccination Text: Examples

8. 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

9. Financial Provisions

10. 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)

11. 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)

12. 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

13. Operational Provisions

14. 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)

15. Immunization Schedule Text:
Examples

16. 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)

17. 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)

18. Thank you!

19. 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