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MICHELE D Powered By Docstoc
					                                 MICHELE D. FORZLEY, JD, MPH
                                       FORZLEY & ASSOCIATES
                    9039 SLIGO CREEK PARKWAY SILVER SPRING, MD 20901 U.S.A.
                          PHONE: 301-565-0680 MOBILE: 202-459-1370
                              EMAIL: michele@micheleforzley.com

                                            OBJECTIVE

To provide legal advice and consulting services to global and international organizations on
global public health governance, rule of law and legal matters including on international trade,
intellectual property, anti-corruption, and public procurement with an emphasis on
pharmaceuticals.
                                                BIO

Forzley & Associates, founded by Michele Forzley in 1979, advises public and private sector
clients – governments, trade associations, academia, hospitals, international organizations, and
both for-profit and not-for-profits – on matters of health and law. Michele concentrates on legal
and regulatory components in health systems, including: conducting assessments to remove
barriers to access to health products; conceptualizing solutions to counterfeit medical products
and corruption in the health and pharmaceutical sectors; designing and improving pooled
procurement mechanisms; solving trade and health policy issues, such as the determination of
patent and registration status and requirements; and drafting health, drug, and health finance
legislation

                       RECENT LEGAL ADVISORY & CONSULTING PROJECTS AND EXPERIENCE

PRESIDENT’S EMERGENCY PROGRAM FOR AIDS RELIEF                              Roslyn, Virginia
SUPPLY CHAIN MANAGEMENT SYSTEM (PEPFAR)                                    2005 – present

      Legal counsel on intellectual property, trade and procurement issues.
      Procurement team member and donations lead.
      Conducted procurement of generic and branded pharmaceuticals for the diagnosis and
       treatment of HIV/AIDS pursuant to U.S. Federal Acquisition Regulations
      Lead on home-based care kits, donations policy and early stages of registration and
       regulation data base for laws of target countries
      Director Corporate Relations and Social Responsibility

WORLD HEALTH ORGANIZATION DEPT. ESSENTIAL DRUGS                          Geneva, Switzerland
                                                                         2003 – Present
      Legal advisor on drug laws and regulation of drug regulatory authorities
      Selected to participate in WHO Technical Briefing on Medicines, November 2009
      Legal and technical advisor on combating counterfeit medical products, drafting

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        framework international convention to combat counterfeit medical products
       Designed multi-stakeholder solution to counterfeit drug problems for the International
        Conference of Drug Regulatory Authorities (ICDRA, now IMPACT)


WORLD BANK                                                                 Global
                                                                           2007 – Present
       Technical advisor on public sector pharmaceuticals procurement issues, conducting
        comparative analysis of actual and foreseeable obstacles and developing and
        implementing solutions and strategies to reduce barriers to successful public
        procurement
       Developed and implemented solutions to combat corruption and problems in
        pharmaceutical sector and supply chain and acted as principle investigator on health
        sector corruption in Albania
       Developed capacity building program on business skills, practices and the law – an e-
        course providing essential tools in medical products procurement
       Effectively responded to organization requests to develop and implement viable
        solutions via trainings, proposed legislation, documentation and work plans


GLOBAL HEALTH COUNCIL                                                       Washington, DC
                                                                            2007 – Present
       Author of manual on trade and health, pending publication
       Served as public health representative on U.S. Commerce Advisory Committee 15 on
        intellectual property
       Authored policy brief on Tariffs and Non-Tariff Barriers to Drug Access
       Collaborated with Council Director of Research on the development of a trade and health
        agenda
       Followed and developed positions on the WHO Intergovernmental Working Group on
        innovation and intellectual property rights, World Health Assembly Global Strategy.

U.S. PATENT AND TRADEMARK OFFICE,                                           Washington, DC
INT’L. INTELLECTUAL PROPERTY INSTITUTE                                      2002 – present

       Principal investigator and author of report “Use of the Criminal Laws to Protect Public
        Health” and self-study course on drafting of legislation to establish criminal laws related
        to intellectual property infringements risks to public health and safety
       Delivered trainings to law enforcement officials, members of judiciary, intellectual
        property office staff and others on public health and the law
       Developed curricula and presented training programs on public health and counterfeit
        goods in Senegal, Thailand, and Washington, DC


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SUPREME REGULATORY COUNSEL                                              Turkmenistan
                                                                        2009
      Provided technical advice on draft of Turkmenistan national procurement law, aligning
       draft with European Community and World Trade Organization requirements and
       ensuring policy and text coherence with other Turkmenistan laws
      Designed and provided legislative drafting tools and produced report assessing draft and
       recommendations for improvement

CIDC-CONSULTING                                                           Albania
                                                                          2007
      Guided legislative drafting team on production of Albanian draft law on health and drug
       law compliant with European Community standards for presentation to national
       legislature
      Designed and provided legislative drafting tools

PSP-ONE USAID (NOW SHOPS)                                                Washington, D.C.
                                                                         2004 – 2005
      Director of Commercial Alliances
      Designed approach to expand delivery of primary health benefits and reproductive
       health services by private sector in developing countries, such as Philippines, India,
       Central American nations
      Proposed solutions to enhance sustainability of donor-funded social franchises
      Analyzed emerging Nigerian national health insurance plan and proposed inclusion of
       insuring reproductive health benefits through legislative and regulatory framework,
       presenting analysis to industry and Ministry of Health

UNITED NATIONS DEVELOPMENT PROGRAM                                       Washington, DC
AMERICAN BAR ASSOCIATION INTERNATIONAL LEGAL RESOURCE CENTER             2003

      Assessed Ordinance on Prevention and Control of HIV/AIDS in relation to human rights
       and other international laws
      Advised National Assembly of the Socialist Republic of Vietnam on recommendations for
       solutions from a public health and health services delivery perspective

                              LEGISLATIVE AND GENERAL COUNSEL EXPERIENCE
      Maryland General Assembly and Dept. on Aging, 2003-2004
      Maryland Dept. of Human and Health Services, Adult Mental Health and Substance
       Abuse Services, 2002-2003
      Office of Global Health, U.S. Dept. of Health and Human Services, 2001-2002
      St. Jude Research Hospital, 2003-2005
      George Washington University Health Plan, 2001 (plan closed)
      Independent General Counsel 1979-1999
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                                    PROFESSIONAL AFFILIATIONS
      World Federation of Public Health Assoc.,
      Member, U.S. Department of Commerce Task Force on Counterfeit Medical Products
      Reviewer on Law and Public Health Issues, Journal of Public Health
      American Bar Association, Vice Chair of International Life Sciences and International
       Health Committee
      Society for International Development

              SELECTED TRAININGS, CURRICULA DEVELOPMENT, AND PUBLIC SPEAKING ENGAGEMENTS
Curricula development & educator experience
    Adjunct professorships and related experience
           o Visiting distinguished Professor Widener School of Law, Health Law Institute
               2007- current
           o Howard University MPH Advisory Board, 2004-2006
           o Adjunct Professor of International Business Transactions at the New England
               School of Law in Boston, MA 1998-1999
           o Adjunct Professor of Mergers and Acquisitions Lubin Graduate School of Business
               at Pace University 1982-1983
    Development of curricula for web-based presentations and online educational tools,
       including:
           o The use of criminal law to protect public health; legislative drafting and policy
               making guide on line self paced tutorial
           o Rule of law and public health – webinar Business Skills, Practices & the Law:
               Essential Tools in Medical Products Procurement – webinar for World Bank
           o Model International Legal Agreements Series (MILAS): an online tool kit of
               documents to be used in international trade and self-guided explanatory material
               to enable the user to immediately employ the contents.

Speaking engagements & trainings
    World Health Organization Lawyers Working Group, “ The role of lawyers in health”
    Southwestern University of Political Science and Law, China, “Rule of Law as a Benchmark
      for Health Sector Reform”
    US Library of Congress Global Legal Information Network “Health Legal Information”
    World Health Organization Secretariat “Governance and Global Public Health”
    Global Health Council and Women in International Trade “The Nexus of Trade and
      Health”
    DC Fellows- Research Triangle Institute “Legal and Regulatory Dimensions of Health
      Governance”
    World Bank HDHNE Learning Week “Demystifying Pharmaceutical Procurement”
    Widener School of Law – Health Law Institute “Hot Topics in Global Public Health and the
      Law”
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   Widener School of Law – Faculty Meeting “Health Sector Corruption and the Role of the
    Law”
   US PTO and WIPO Academy – Counterfeit Goods and Public Health
   ASEAN & USPTO Bangkok “Public Health and the Enforcement of IP Rights
   US PTO /World Intellectual Property Organization – Academy “Public Health and Safety
    and Intellectual Property Rights”
   US Patent and Trademark Office Law Enforcement Division “A Primer on Public Health for
    Lawyers”

                                           PUBLICATIONS
                                 Full list available on request
   What public health needs to know about trade, a book to be published by the Global
    Health Council
   Combating Counterfeit Drugs: A Concept Paper for an International Framework
    Convention and Related Strategies
   Counterfeit Goods and the Public’s Health and Safety - Web based training module
   Use of the Criminal Laws to Protect Public Health
   Impact of Tariffs and Non-Tariff Barriers on Access to Essential Drugs for the Poorest
    People, a Global Health Council Policy Brief, September 2007
   Improving Transparency in the Pharmaceutical Sector: Report On the Study to Identify
    and Strengthen Decision Points against Corruption in Albania
   Private Provider Networks: The Role of Viability in Expanding the Supply of Reproductive
    Health and Family Planning Services, PSP-One, USAID
   Home-Based Care Kits- How to Sustain this Solution to Increasing Access to Treatment,
    Supply Chain Management System, (PEPFAR) Working Paper
   The World Trading Organization and Public Health – What does trade have to do with
    health?, Global Health Link, Issue #124, November-December 2003
   A Tool for Mental Health Legislation – integrate principles of public health and human
    rights
   International Comparative Analysis of Complementary and Alternative Medicine
    Regulatory Schemes
   Internet Jurisdiction Project, International legal materials on telemedicine
   Winning in Foreign Markets, Your Global Guide®
   Bylined author – over 60 articles 1993-2000 The Exporter Magazine: Markets and
    Marketing
   Model International Legal Agreements Series (MILAS), on-line model international
    business legal agreement database with distance educational materials
   Handbook on Customs & International Trade Law, 2nd edition




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                                           EDUCATION
JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH, Baltimore, Maryland
Master’s of Public Health, 2003

INTERNATIONAL COURT OF JUSTICE, Den Hag, Netherlands
Private & Public International Law, 1984 and 2000

NEW ENGLAND SCHOOL OF LAW, Boston, Massachusetts
Juris Doctor, 1976

SIMMONS COLLEGE, Boston, Massachusetts
Bachelor of Arts, major sociology and economics 1973

                                     PROFESSIONAL LICENSURE
New York State Bar, 1978
Massachusetts State Bar, 1977
US District Court of New York Eastern and Southern Districts, 1979
US Court of Appeals 2nd Cir. 1986
Maryland Election Judge, since 2004

                            LANGUAGES AND COMPUTER SKILLS
Language: Native English speaker; working knowledge of French, Spanish and Arabic.
Computer: Microsoft Word, Excel, Power Point, Access, Project, and Outlook




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