Legal and Regulatory Dimensions of Health Governance ... · Policies adopted by public sector ......

Legal and Regulatory Dimensions of Health Governance: Impacts on Health Outcomes Michele Forzley, JD, MPH

World Federation of Public Health Associatons Triennial Meeting April 30, 2009 Istanbul, Turkey i

Copyright MDForzley 2009 2

Rule of Law

Goal - Government bound by the law Order and security Checks and balances – separation of

powers Fairness

Equal and effective application of the law Protection of human rights Civil liberties Access to justice and procedural fairness

Requirements Institutions

Well-functioning courts - predictable and efficient rulings

Effective law enforcement agencies


Basic Sources of Laws and Regulations

International laws – treaties, customary law

Constitutional provisions Statutes Regulations (administrative measures) Court rulings Ordinances Policies adopted by public sector

bodies such as school boards Legal theories and systems


Legal and regulatory dimensions of governance

An approach to solve problems or accomplish goals with rational selections of laws, regulations and jurisdictional authority.

Basic sources of laws and regulations Legal Interventions

Mechanisms - tax, spend, regulate Remedies – sanctions, fines,

suspensions, jail Tools – damages equitable relief

Legal and Regulatory Approach

Solve problems or accomplish goals with rational selections of laws, regulations and appropriate jurisdictional authority.

Apply or augment basic sources of law and regulation.

Utilize interventions based in the law. Mechanisms - tax, spend, regulate Remedies – sanctions, fines,

suspensions, jail Tools damages equitable relief



Existing Best Practice Different law types advance health 1. Health Law defines

Responsibilities of government for the health of the population

Relationship between govt. and the populace

Services to promote the public’s health Powers to coerce individuals and

businesses for communities protection 2. Other realms of substantive law

Criminal Customs Trade Administrative


Existing Best Practice The law is a tool Complement not supplant, can be pivotal Shapes public health infrastructure Promote program goals Bolster or expand spectrum of effective strategies Integrated with legal system - holistic approach Direct or indirect intervention Dimensions of Regulatory Quality

Provides a framework for MOH functions Meets global standards Right for the context Comprehensive Integrated with other ministries

Lit


Existing Best Practice

Ten Essential Public Health Functions (1994 APHA, ASPH ASTHO, et al. )

1 policy development 2 monitor health status 3 enforce health and

safety laws

Essential public health functions (PAHO 2000)

1 Enforcement of public health laws and regulations

2 Health policy development 3 Citizen participation and

empowerment 4 Service quality 5 Equitable access


Existing Best Practice

Core disciplines and competency domains (ASPH 2006)

Competency domains 1 Analytics/Assessment

– define a problem 2 Policy development –

capable of articulating the health, fiscal, legal, administrative, social and political implications of each policy.

3 Leadership and systems thinking skills - use legal and political system to

Stewardship domains (World Health Report 2000)

1 Information and evidence 2 Strategic policy 3 Implementation via

incentives and sanctions 4 Building coalitions and

partnerships 5 Developing a fit between

objectives, structures and cultures

6 Ensuring accountability


Where do we stand now?

“…health sector reformers have only rarely used a governance lens through which to design, implement and assess programs.” HS20/20 Feb. 2008

AiDA Search: Sectors: Health Status: Planned Date: From 2008 to 2015 Keyword: Governance

No results While, USAID Global Bureau is the

champion of governance as an explicit component of health systems agenda, the law is an underutilized tool


A new initiative Add legal and regulatory dimensions to

health sector development and governance. Connect point of entry with needs

Health systems operations, financing and capacity building, other points

Require legal analysis at the start Develop indicators - add to M& E

Consider all options – depends on the point of entry Stand alone interventions Integrate with other interventions

Add hlth t f t D & G


Success stories: Laws that prevent disease

Smoking bans Zoning and land

use Seat belt and

helmet laws Blood alcohol limits Water fluoridation

Food fortification Childhood

immunization Quarantine Professional

licensing Occupational

safety Product standards


Success stories: Global health issues and the law

Fighting Corruption International Health Regulations Global Strategy on innovation, public health,

and intellectual property Female Genital Cutting MOH transition from service provider to

regulator Nigeria, Albania

NGOs, professional standards and associations

Success stories: Fighting Corruption

Convention Against Corruption 2003 (CAC) Anti-corruption body Code of conduct for public officials Appropriate systems for public

procurement and mgt of public finances Transparency, judicial and prosecutorial

independence, civil society participation Define crimes


Success stories: Fighting Corruption

CAC Applies Where HS20/20 Works HS20/20 Where We Work

http://www.healthsystems2020.org/section/where_we_work/

CAC 2005 – 140 Parties – Tool Kit http://www.unodc.org/unodc/en/treaties/CAC/signatories.html



http://www.unodc.org/unodc/en/treaties/CAC/signatories.html

http://www.unodc.org/unodc/en/treaties/CAC/signatories.html

16

PHEIC Decision Instrument


Success Stories: Global strategy on public health, innovation and intellectual property

Standard setting: Enumerates what is necessary to integrate into national law to balance trade and health in the realm of drug access.

Participation in law making: Promote the active

participation of health representatives in IP related negotiations, in order to reflect public health needs.

Application and enforcement of the law: Strengthen,

educate, train and build capacity on application and management of IP

18

Success Stories: FGC


Success Stories: Legal Competencies Applied

MOH Transition Provider to regulator

Nigerian health insurance industry adopts primary health package

Albanian Health Law Drug law

Prof. Associations,NGOs

•Albanian Pharmacists - Model By Laws - Authority to self

police - Separates from

MOH


How?

Incorporate governance into long term health sector development plans • Centrally-funded mechanisms designed

to provide legal acumen to all projects • Review all projects to identify legal

components • Clarify jurisdictional levels and nature of

support • Direct field support

• Identify and utilize local resources • Build local capacity for now and the future

• Build local legal capacity – short and long

How?

Resource library – health legal materials • Laws, models, guides • Electronic storage and access

Modify/customize existing tools • CAC, Legislative guides

Utilize Legal Competencies • Counseling, interviewing, drafting,

negotiating • Standard operating procedures, policy

manuals based on local law, finding applicable law



Leverage the Law!

Law can play a decisive role in health outcomes.

There are best practices in legal frameworks.

Adding a legal and regulatory dimensions to health governance will strengthen health development

d i

Questions? Contact Information Michele Forzley, JD,

MPH 301- 565-0680

[email protected]

Thank you for

participating today!

mailto:[email protected]


Saudi Arabia says it plans to start regulating the marriage of young girls, amid controversy over a union between a 60-year-old man and a girl of eight.

the country's highest religious authority, the Grand Mufti Sheikh Abdul Aziz al-Shaikh, said it was not against Islamic law to marry off girls who are 15 and younger.

http://news.bbc.co.uk/2/hi/middle_east/7999777.stm

Learning to care online

European School Oncology Online (ESO) Grand Rounds Retinoblastoma in developing countries. How telemedicine may help An ESO CME accredited event. (held in co-operation with Cure4Kids) GR44 - 16 April 2009 - 18:00 -19:00 CET (Geneva Central European Time) Expert: Guillermo Chantada, MD, Hospital Garrahan, Buenos Aires, Argentina To participate in this live session, please register at http://www.e-eso.net (at no cost) and you will receive all the necessary information from the website, on how to participate to the live sessions. For assistance, please contact Cure4Kids by email at [email protected]

http://www.e-eso.net/participant.do?methodcall=control




WFPHA 2009

Legal advice from lawyer

Project II: Women’s Access to Land and Labor Rights in Kenya

Samburu women

Grievances over natural or biological res ources Isiolo cattle Grievances are based on two different features: a) ideas of ownership have

shifted and the state has introduced new rules of ownership that contradict with local views, and b) neighboring communities often base their

understanding of ownership on different value systems.

Theme 1: Ethics, Integrity and Anti-Corruption Theme 2: Democracy, Human Rights and the Rule

of Law Theme 3: Justice, Law and Order Theme 4: Public Safety and Security Theme 5: Constitutional Development Theme 6: Quality Legal Services to Government

and the General Public Theme 7: Capacity for Effective Leadership and

Management of Change PARTICIPATING MINISTRIES,

DEPARTMENTS AND AGENCIES AND REPRESENTATIVES - NO health

World development report 2006 : equity and development

makes the case for investing in people, expanding access to justice, land, and infrastructure, and promoting fairness in markets. In the international arena, it considers leveling the playing field in the functioning of global markets and the rules that govern them-and the complementary provision of aid to help poor countries and poor people build greater endowments.

Pillar of justice for the poor

Property rights

The Law and Business Skills: Essential Tools to Reduce Roadblocks in Bank-Financed Procurement of Medical Products

Michele Forzley, JD, MPH Lawyer and Consultant [email protected] 301-565-0680 HDNHE Week 11/11-12/2008


Agenda

Why this study? Approach Framework for the study Problems as described by participants Top Problems Solutions

Focus Business Skills – Remedies for Breach and

CIP The Law – Procurement Law or guidelines

insufficient

Problems as described by informants and reports

The law and guidance

No or inadequate procurement law How to assess – elements What about other laws? Are there

violations? How to manage national law and WB

procedures Guidelines and SBDs “complex,

confusing”

Top Problems - Continued 2nd Information

Little, poor or no information Quantification, qualification, forecasts

Lack of “M” in MIS – inadequate management

No standardization or collection across ALL players

3rd Governance No, old or inadequate procurement laws Lack of other laws or their potential

violation Internal governance processes

Solutions to Top Problems

The Law and Business Skills: Essential Tools for Improvement of Procurement Business Skills The Law, Legal Infrastructure and Use

of Lawyers

Business Skills Procurement

A basic business transaction A contract for the Purchase/Sale of Goods.

Basic four in a contract for purchase/sale of goods. Price Quantity Description – what are you buying? Specifications/quality – the details

All else is optional! = Special conditions in SBDs

Business Skills Most PMP = international business

transaction. Of total WBPMP value 46% ICB, 40%

DIR DIR - unknown % international v domestic

Long standing business customs or practices and laws.

Extensive uniformity and harmony in the rules. Convention on International Sale of

UNCITRAL: International Standards

UNCITRAL Model Law on Procurement of Goods, Construction and Services 1994

Convention on the Int’l Sale of Goods – 71 members

1980 Agency in the Int’l Sale of Goods Products Liability Uniform Rules on Contract Clauses for an Agreed Sum

Due upon Failure of Performance Credits, Guarantees, Bills of Exchange, Notes Carriage of Goods by Sea – Hamburg Rules E-Commerce, electronic signatures

What to do if there is a breach by Seller.

1. Deliver on time 2. Failure to deliver on

time 3. Deliver by new date 4. Failure to deliver by

new date 5. Deliver non-

conforming goods 6. Cure AND

compensation for any damages

7. No cure 8. Fundamental breach

SELLER

1. Accept and pay 2. Notice of extension of

time to new date 3. Accept and pay 4. Avoid contract – no

pay 5. Non-fundamental

breach – notice of non conformity

6. Pay 7. No pay 8. Notice of avoidance

and no pay

BUYER

What to do if there is a breach by Buyer.

1. Deliver as required 2. Non-fundamental

breach – Notice of suspension

3. Deliver 4. Fundamental

breach- declare contract avoided – no delivery

SELLER

1. Failure to perform an obligation OTHER than payment

2. Perform 3. Pay 4. No pay and

compensate for damages

BUYER

Governance Governance problems span the steps. Governance should be a constant

theme of all solutions. What is governance?

Government effectiveness Accountability Regulatory quality Rule of law

The Law is Fundamental National laws

Procurement law – insufficient by itself! Aligned with other laws such as DRA Coordination across ministries

Other laws – contracts for sale of goods, DRA

Corruption UN Convention against Corruption OECD Convention Against Bribery

Counterfeits

Objectives of procurement law Maximizing economy and efficiency in

procurement Fostering participation by suppliers and

contractors thereby promoting international trade

Promoting competition Providing for the fair and equitable treatment

of all suppliers Promoting the integrity of, and fairness and

public confidence in, the procurement process

Achieving transparency in procedures

Essential minimum features to achieve the objectives PREAMBLE GENERAL PROVISIONS METHODS OF PROCUREMENT AND

CONDITIONS (ICB, NCB, LIB, ISH,DIR) TENDERING PROCEEDINGS

SOLICITATION OF TENDERS, APPS TO PREQUALIFY

SUBMISSION OF TENDERS EVALUATION AND COMPARISON OF

TENDERS PRINCIPAL METHODS FOR SERVICES PROCEDURES FOR ALTERNATIVE

METHODS OF PROCUREMENT

Use Lawyers and Law Tools

Terms of Reference – Rule of Law Local capacity building – local lawyers Document drafting and review National law revision, legislative drafting and

alignment with international standards Operational level general legal advice

Problem solving and management of breaches

Law Tools On-line tool kit – Model International Legal

Agreement Series (MILAS) Country status reports - assess legal

Conclusions

PMP is a basic business transaction. Apply basic business practices and rely

on well known rules. Rule of law and regulatory

infrastructure are essential to solving problems of procurement. Procurement law and WB Guidelines are

not enough. Enhance the rule of law. Build legal capacity - use lawyers and law

The case of PROMESE/CAL in the Dominican Republic

Originally established in 1984 as the Essential Drugs Program (known by its acronym in Spanish PROMESE)

Weak regulatory framework Main objectives:

1. Procurement of a set of basic drugs at low costs

2. Distribution to the general populatio (mostly concentrated in large urban centers

President Office

PROMESE

Network of state owned pharmacies

No legal autonomy, directly dependent

on the office of the President Acting outside the scope of health

sectoral policies and public health care providers (focus on state owned pharmacies)

Little or no information was disclosed with high risk of becoming a tool for

li t li i

2000-2001

• Development of new role as key stakeholder in health sector policies

2004-2008

• Building institutional capacity and greater autonomy • Development of business model with clearer

accountability lines and more transparency

2008-2012

• Modernization of management processes • Improving competitiveness of biddings and

distribution

New regulations for PROMESE (2000):

Maintains publicly owned pharmacy network

Strengthens its role as main procurement

agency for the public sector

Incorporates a new role as central agency in charge of storage and distribution logistics for public providers

In 2001 two new laws are enacted providing the basis for:

Universal health insurance Decentralization of health care providers

New overs and control boards are created

Emphasizes the stewardship of MoH over

PROMESE Does not resolve overlapping roles

General Health Law

Universal Health

Insurance Law

Delivery Of

Health Care

2000-2001


2004-2008



2008-2012


distribution

New administration overhauls

management, improves technical expertise and incorporates quality assurance measures

Initiates process of greater autonomy while strengthening with other sectoral stakeholders and within the framework f th t d hi f M H ( j

Takes advantage of new public sector reforms including changes to public procurement regulations, consolidates and improves national bidding

Initiates process of transparency and accountability: publication of more information including revenues and budgets, institutional and individual client support

planning by objectives and multi

New memorandum of understanding with SENASA (the national health insurance for the poor and public servants) to provide all drugs for the insured population

Development of new coordination tools with emerging public networks of providers to strengthen links including planning and M&I systems

International bidding participation in

2000- 2001


2004-2008



2008-2012


distribution

Integrated management mechanisms to better serve decentralized providers (inpatient and outpatient) an integrate supply chain of supplies of for the insured and insured yet to be developed

Information systems that permit link to identify prescribing physicians and individual clinic documents in the process of being developed

Delivery of pharmaceutical to rural areas

Legal and Regulatory Dimensions of Health Governance ... · Policies adopted by public sector ......

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