Post on 29-Apr-2018
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
Copyright MDForzley 2009 3
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
Copyright MDForzley 2009 4
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
Copyright MDForzley 2009 5
Copyright MDForzley 2009 6
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
Copyright MDForzley 2009 7
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
Copyright MDForzley 2009 8
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
Copyright MDForzley 2009 9
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
Copyright MDForzley 2009 10
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
Copyright MDForzley 2009 11
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
Copyright MDForzley 2009 12
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
Copyright MDForzley 2009 13
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
Copyright MDForzley 2009 15
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
Copyright MDForzley 2009 17
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
Copyright MDForzley 2009 19
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
Copyright MDForzley 2009 20
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
Copyright MDForzley 2009 21
Copyright MDForzley 2009 22
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
mforzley@comcast.net
Thank you for
participating today!
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 help@cure4kids.org
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.
The Law and Business Skills: Essential Tools to Reduce Roadblocks in Bank-Financed Procurement of Medical Products
Michele Forzley, JD, MPH Lawyer and Consultant mforzley@comcast.net 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
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
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
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 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
• 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
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