Work Stream 2: Regulatory Environment Lead

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Quality, affordable
drugs supplied in a
sustained manner
Causes under5 deaths
iCCM of malaria, diarrhea,
pneumonia
Quality, affordable
drugs supplied in a
sustained manner
Quality, affordable
drugs supplied in a
sustained manner
Quality, affordable
drugs supplied in a
sustained manner
Chlorhexidine
End to end
Injectable
antibitiotics,
amoxcillne
ORS, zinc
Learn lessons from successfull commodities such as vaccines, malaria
commodities
Quality, affordable
drugs supplied in a
sustained manner
Private
sector
pharma
Chlorhexidine
Commission
?
Norway
$$$$
End
to end
Injectable
antibitiotics,
amoxcillne
High level
taskforce
UN SG
USAID
ORS, zinc
Quality, affordable
drugs supplied in a
sustained manner
Work on
market shaping
End to end
Commission
Work on incountry
bottlenecks
AU
G8
Work on
market shaping
End to end
Quality, affordable
drugs supplied in a
sustained manner
Work on incountry
bottlenecks
Causes under5 deaths
Supply and
demand/ careseeking
The United Nations Commission on Life-Saving Commodities
for
Women and Children
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• Visit the website of the Commission:
• http://www.everywomaneverychild.org/resou
rces/un-commission-on-life-savingcommodities
THE COMMISSION
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Co-Chairs:
HE Mr. Jens Stoltenberg, Prime Minister of Norway
HE Mr. Goodluck Ebele Jonathan, GCON, President of the Federal Republic of Nigeria
Vice Chairs:
Tony Lake, Executive Director, UNICEF
Dr. Babatunde Osotimehin, Executive Director, UNFPA
Technical Working Group Work Stream Leads:
Market Shaping: Oliver Sabot, Executive Vice President for Global Programs at the Clinton Health Access Initiative (CHAI),
Regulatory: Hans Hogerzeil, Former Director for Essential Medicines and Pharmaceutical Policies, WHO and Professor of Global Health,
Groningen University
Best Practices and Innovation: Patricia Mechael, Executive Director, mHealth Alliance; and Catharine Taylor, Director of the Maternal
and Child Health and Nutrition Program, PATH
Commissioners:
Sir Andrew Witty, Chief Executive Officer, GlaxoSmithKline
Agnès Saint-Raymond, Head of Human Medicines Special Areas, European Medicines Agency
Bob Collymore, Chief Executive Officer, Safaricom
Christopher Elias, President for Global Development, Bill and Melinda Gates Foundation
Dan Brutto, President, UPS International
Gary Cohen, Executive Vice President, Becton Dickson (BD)
Hassan Mshinda, Director General Tanzania Commission for Science and Technology
Heather Bresch, CEO , Mylan Inc
Jamie Cooper-Hohn, President and CEO, Children's Investment Fund Foundation
Jasmine Whitbread, Chief Executive Officer, Save the Children International
Julio Frenk, Chair, Partnership for Maternal, Newborn and Child Health
Kenneth C. Frazier, President and CEO, Merck
Rajiv Shah, Administrator, United States Agency for International Development
Ray Chambers, UN Secretary-General's Special Envoy for Malaria
Li Dongjiu (Robert Lee), President, Shanghai Fosun Pharmaceutical Development Co., Ltd.
M.K. Bhan, Secretary to the Government of India Department of Biotechnology
Michael Anderson, Director-General for Policy and Global Programmes, UK Department for International Development
Per Heggenes, CEO, IKEA Foundation
Teguest Guerma, Director General, AMREF
H.E. Zainab Hawa Bangura, Minister of Health and Sanitation, Sierra Leone
LIFE-SAVING COMMODITIES
RMNCH Continuum of Care
Reproductive health
Commodity
Usage
Female Condoms
Family planning/ Contraception
Implants
Family planning/ Contraception
Emergency Contraception
Family planning/ Contraception
Oxytocin
Post-Partum Hemorrhage
Misoprostol
Post-Partum Hemorrhage
Magnesium sulfate
Eclampsia and Severe Pre-Eclamsia/Toxemia of
Pregnancy
Injectable antibiotics
Newborn Sepsis
Chlorhexidine
Newborn Cord Care
Resuscitation Equipment
Newborn Asphyxia
Antenatal Corticosteroid (ANCS)
Respiratory Distress Syndrome for preterm
babies
Amoxicillin
Pneumonia
Oral Rehydration Salts (ORS)
Diarrhea
Zinc
Diarrhea
Maternal Health
Newborn Health
Child Health
• All product profiles and case studies are
available on the Commission Website:
• http://www.everywomaneverychild.org/resou
rces/un-commission-on-life-savingcommodities/life-saving-commodities
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TECHNICAL WORKING GROUP Work
• Work Stream 1: Market Shaping
• Work Stream 2: Regulatory Environment
• Work Stream 3: Best Practices and
Innovations
TIMELINE
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Key upcoming milestones, events and advocacy opportunities:
– May 15 - Commissioners receive draft recommendations and materials for 22 May meeting
– May 21-26 - World Health Assembly – distribution of information on the Commission and side
event (TBC)
– May 22nd - 2nd Commissioners meeting in New York
– June 14th -15th - Child Survival Forum – discussion of draft recommendations at Commission
focused event
– July 12th- Family Planning Summit
– July 27th -28th – iERG’s draft annual report
– August 1st- Launch of Global Health Policy Forum
– August- Launch of A Promise to Keep
– September- UN General Assembly- Launch of final report of the Commission at the Every
Woman Every Child event
– October- PMNCH Board Meeting in Nigeria
– Executive Board meetings of UNFPA and UNICEF; and African Union meetings.
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TECHNICAL WORKING GROUP Work
Stream 1: Market Shaping
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Lead: Oliver Sabot, Executive Vice President for Global Programs at the Clinton Health Access
Initiative (CHAI)
Key issue: One key challenge affecting many of the commodities is insufficient market
dynamic; for example on the supply side, a lack of manufacturers producing commodities, or
in regards to demand, the lack of knowledge around the availability of commodities. This
group will therefore look into market shaping opportunities. This includes strategies and
implementation plans to create an enabling environment that helps ensure an appropriate
supply of quality and affordable products. This work stream will explore opportunities in
creating such an enabling environment for the 13 identified commodities through changes
and developments in health policy, innovative financing mechanisms, supply chain
strengthening, and regulatory approaches.
Key next steps:
Develop an overall framework to diagnose and categorize market problems and propose
specific interventions to address the market issues
Create a comprehensive tool-kit that can be used to address bottlenecks and market
problems.
Test the toolkit on 2 or 3 sample products from the Commission list of 13 to determine
validity of the framework and toolkit.
Provide the specific recommendations based on results of analysis.
Work Stream 2: Regulatory
Environment
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Lead: Hans Hogerzeil, Former Director for Essential Medicines and Pharmaceutical Policies,
WHO and Professor of Global Health, Groningen University
Key issue: Critical bottlenecks affecting the commodities are also found in the regulatory
environment, which is shaped by the requirements of National Medicine Regulatory
Authorities (NMRA). These typically have oversight in three essential areas of making a
quality medicine available in the marketplace: assuring the quality and efficacy of medicines;
providing necessary authorizations for distribution of the medicine; and supporting eligibility
for procurement with public funding. Each country has unique requirements that
manufacturers must meet, including separate, detailed dossiers and possibly physical
inspections of the manufacturing facility. Approval from the WHO prequalification system or
another recognized stringent regulatory authority is also required for publicly funded
procurement. Regulatory processes are a critical value-added function, but they represent
significant investments, and sometime have the unintended effect of limiting the
participation of smaller manufacturers.
Based on review of the case studies the following regulatory challenges were identified
Registration of new dosing/ formulas
Changing classifications to Over the Counter (OTC)
Changes related to WHO’s Essential Medicines List
Poor matching between disease burden and scalability of regulatory changes
Work Stream 2: Regulatory
Environment
• Key next steps:
• Continue discussions and collaboration with WHO, Paediatric
medicines Regulators' Network (PmRN) (includes members
from 26 countries), national and regional regulatory
authorities, as well as with Commissioner Ms Agnès Saint
Raymond.
• Identify short vs. long term interventions and
recommendations that include
• i) Simplification of regulatory procedures such as
introduction of one, simple file for regulators that help them
make a proper but more rapid risk assessment to ensure rapid
uptake of low-risk commodities; and
• ii) Identification and sharing of best practices with regards
to OTC status.
Work Stream 3: Best Practices and
Innovations
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Leads: Patricia Mechael, Executive Director of the mHealth Alliance and Catharine H. Taylor,
Catharine Taylor the Director of the Maternal and Child Health and Nutrition Program at PATH
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Key issue: This stream of work will focus on the following areas that show potential for rapidly
increasing access to and use of the commodities, building on findings and recommendations from
the Innovations Working Group of the UN Commission on Information and Accountability:
Innovative Technologies that may facilitate access to a product, such as better medical devices,
packaging, and formulations, as well as complementary technologies such as mobile phones or
SMS.
Strategies to Create Demand amongst healthcare professionals and/or patients/caregivers, such as
better communications, training, user fee waivers, cash transfers, or insurance schemes.
Innovations for Scaling Up access to a given commodity at a local level, based on a systematic
analysis of existing interventions to overcome bottlenecks in public sector, private sector, and at
community level. Key next steps
Enhance linkages to the Innovations Working Group of the Every Woman Every Child movement;
Synthesise existing innovative approaches to provide context including scope, and identification of
gaps and opportunities and gaps.
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TIMELINE
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Key upcoming milestones, events and advocacy opportunities:
– May 15 - Commissioners receive draft recommendations and materials for 22 May meeting
– May 21-26 - World Health Assembly – distribution of information on the Commission and side
event (TBC)
– May 22nd - 2nd Commissioners meeting in New York
– June 14th -15th - Child Survival Forum – discussion of draft recommendations at Commission
focused event
– July 12th- Family Planning Summit
– July 27th -28th – iERG’s draft annual report
– August 1st- Launch of Global Health Policy Forum
– August- Launch of A Promise to Keep
– September- UN General Assembly- Launch of final report of the Commission at the Every
Woman Every Child event
– October- PMNCH Board Meeting in Nigeria
– Executive Board meetings of UNFPA and UNICEF; and African Union meetings.
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