Access to and Management of 2 nd Line Drugs Challenges Summarized at 6 th Meeting, STB Working Group of MDR-TB 20-22 September 2007 - Tbilisi.

Slides:



Advertisements
Similar presentations
EICC Working Hours Taskforce KPI Scorecard
Advertisements

Opening Doors: Federal Strategic Plan to Prevent and End Homelessness
THE INTERNATIONAL DRUG PURCHASE FACILITY-UNITAID Michel D. Kazatchkine, Ministère des Affaires Etrangères, France.
Overview of the Global Fund: Guiding Principles Grant Cycle / Processes & Role of Public Private Partnerships Johannesburg, South Africa Tatjana Peterson,
 Capacity Development; National Systems / Global Fund Summary of the implementation capacities for National Programs and Global Fund Grants For HIV /TB.
Mechanisms for “Better Money” in Financing & Procurement of Reproductive Health Supplies Update Fall 2006 Meeting of the Reproductive Health Supplies Coalition.
1 Business Opportunities Istanbul, Turkey 30 April 2010 Asian Development Bank.
IPC meeting June 2014 Dr Joelle DAVIAUD, Quality Assurance Specialist Model Quality Assurance System for procurement agencies.
Procurement Support Services WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, October 29 th - November 2 nd 2012 Mariatou Tala Jallow.
Access to HIV/AIDS, Tuberculosis and Malaria Medicines. WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies. Geneva, 18 – 22 September.
TBS Meeting Geneva, November 2011 Global Fund Policies and Reporting on Procurement of Health Products WHO/UNICEF Technical Briefing Seminar on Essential.
UN Prequalification: UNICEF Perspective 5 th UN Prequalification stakeholders meeting 11th February 2009.
Management of the Tuberculosis Drug Supply Module 13 – March 2010.
1 PMIG PUBLIC SECTOR PROCUREMENT BEST PRACTICES & LESSONS LEARNED Kevin James Barrie Kroukamp.
African Business Leaders on Health GBC Conference on TB, HIV-TB Co-infection & Global Fund Partnership Johannesburg, October 2010 Technical Assistance.
PROCUREMENT SUPPORT SERVICE WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, November 1 st -5 th 2010 Mariatou Tala Jallow, Manager,
SECTOR POLICY SUPPORT PROGRAMMES A new methodology for delivery of EC development assistance. 1.
Identify the institutions which have a stake in the
Using the levy in order to finance recurring expenditures : the case of the International Drug Purchase Facility-UNITAID Meeting of experts on the solidarity.
Wilbert Bannenberg SARPAM
The Issues of Budgetary Reform Unit 3. PFM Reform – Change Management Module 3.2. Preparing and managing a reform programme.
GLOBAL DRUG FACILITY Improving country access to anti-TB medicines Andrea de Lucia, GDF Team Leader 1 st line Country Support WHO/UNICEF Technical Briefing.
“The causes of Anti-TB medicines shortages in EMR countries and how to avoid them in the future” Khaled Sultan Drug Management Technical Officer, STOP.
QUALITY REPRODUCTIVE HEALTH SUPPLIES Dr Hans V. Hogerzeil Director Essential Medicines & Pharmaceutical Policies.
BUDGETING Reference – Mgmt Accounting –Reddy and Sharma.
Session 11: MDR & XDR-TB: How Can Business Help Stem the Tide?
Good Procurement Practices in National TB Programs
February 21, JAS Consultation between the Government of Tanzania and Development Partners February 21, 2006 Courtyard Hotel, Dar es Salaam.
RHSC Meeting Kampala, May 2010 Quality for Medicines The Global Fund approach Sophie Logez Manager, QA and Data Quality Pharmaceutical Management.
Sources of Limited Access to Treatment High Cost of Treatment Lack of Pilot Projects Lack of Evidence Lack of Policy Lack of Demand.
Paula Munderi Department of Essential Drugs and Medicines Policy World Health Organization Access to essential medicines for HIV/AIDS - update on WHO activities.
Treasury Management at the Global Fund: perspectives.
XIX International AIDS Conference July 22, 2012 Dr. El Hadj Sidi Dah PSM Technical Officer Grant Management Solutions Voluntary Pooled Procurement: Country.
1 Oct 2005 WHO/STB/THD World Health Organization 4 th Meeting of Subgroup on laboratory capacity strengthening Paris, France, October Ernesto Jaramillo.
Lucile de Comarmond Chief Pharmacist Workshop on Impact of TRIPS/IP on Access to Medicine September 2014.
Treating MDR-TB A Challenge Throughout ECA Public Health Practice II.
April_2010 Partnering initiatives at country level Proposed partnering process to build a national stop tuberculosis (TB) partnership.
BUILDING PARTNERSHIPS FOR HEALTH SYSTEMS STRENGTHENING Partnership between the Government of Lesotho and CHAL B.B.P. RAMASHAMOLE.
Overview of the Global Fund Procurement and Supply Management Issues Workshop for LAC Consultants th July 2009 Pharmaceutical Management Advisory.
Quality Assurance for pharmaceutical products in international procurement Approach of major donors and procurers Core presentation prepared by Sophie.
AMC Governance and Institutional Support. Objectives Build on existing capacity Ensure appropriate independence and credibility through transparency,
TNCM Oversight Committee and GF Flow of Funds Presentation to DPG-Health May 6, 2015.
“Progress Update / Disbursement Request” (PU/DR) PSM Section PSM section, R-7 Malaria Sept 17,2011.
From 3by5 to Universal Access to HIV/AIDS Treatment: AMDS Technical Briefing Seminar for Consultants on Procurement and Supply Management for HIV, TB and.
Quantification of Antimalarials PSM Workshop Nairobi, Kenya February 21, 2006.
Global Fund Assessments Part II: Understanding Assessment Results Geneva – December 2005.
Philippe Duneton11 February 2009 Deputy Executive Secretary 5th Consultative Stakeholder Meeting UN Prequalification of Diagnostics, Medicines & Vaccines.
1 SUPPLY DIVISION Procurement and Supply Management Technical Assistance.
TBS 2008-H. Tata & M. Babaley Mapping and In-depth Assessment of Medicines Procurement and Supply Systems WHO Technical Briefing Seminar 17 th -21 st November.
Working Draft - Last Modified :21:46 Printed UNITAID action plan - pediatric TB 0 “Securing timely access to quality, affordable TB drugs”
WHO EURO In Country Coordination and Strengthening National Interagency Coordinating Committees.
Consultant Advance Research Team. Outline UNDERSTANDING M&E DATA NEEDS PEOPLE, PARTNERSHIP AND PLANNING 1.Organizational structures with HIV M&E functions.
Report of the 2nd ad hoc Committee on the TB epidemic Jaap F. Broekmans STOP TB Partner’s Forum NEW DELHI June 2004.
TB infection control and prevention of XDR Group II.
TBS Meeting Geneva, November 2010 Procurement and Supply Management Policies WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies, November.
Achievements and impacts of WHO prequalification to date MSF perspective Carine Werder MSF international pharmacist coordinator Geneva, 11 th February.
Drug Management of Second-line anti-TB drugs through the Green Light Committee mechanism for programmes funded by the Global Fund to Fight Against AIDS,
Page 0 UNITAID’s Strategic Approach to HIV Diagnostics  Washington DC 22 July, 2012 XIX International AIDS Conference Brenda Waning.
TECHNICAL Review: M&E Strategy and Indicators DR HARRIET KIVUMBI, PUBLIC HEALTH SPECIALIST, ACCESS-SMC.
Welcome. Contents: 1.Organization’s Policies & Procedure 2.Internal Controls 3.Manager’s Financial Role 4.Procurement Process 5.Monthly Financial Report.
PFM reform – change management Module 3.2 Preparing and managing a PFM reform programme 1.
Development of Country-Specific Plans for TB Drug Selection and Use China, Brazil, and Indonesia.
PROCUREMENT SUPPORT SERVICE
Global Drug Facility An innovative approach to supplying anti-TB drugs
Inter-Agency Guidelines for Good Procurement of Pharmaceuticals
Access to Medicines for HIV/AIDS, Tuberculosis and Malaria.
GDF Quality Assurance Processes
MARKETING, PURCHASING AND PRODUCTION (7 - 9%)
Consolidated Technical Support Plan for AIDS
TOTAL COST CONTROL ON CONSTRUCTION PROJECTS
Presentation transcript:

Access to and Management of 2 nd Line Drugs Challenges Summarized at 6 th Meeting, STB Working Group of MDR-TB September Tbilisi

2 Summary 1.Severe shortage of 2 nd line medicines 2.Separate Roles of Key Actors 3.Core Problems 4.Recommendations

3 Rationale There is a severe imbalance in the supply-demand dynamics for second-line line anti-TB drugs. The scale of the imbalance, however, is unclear and the factors behind it vary from country-to-country. There is a global shortage of quality assured second-line TB drugs for patients in approved GLC programs. Country shortages often result from the global shortage. Shortages are also caused or amplified by: –registration restrictions and import barriers of governments, –poor forecasting and order placement by programs, –complicated, time-consuming financial transactions between partners and agents, and –delays in disbursements from donors and financing mechanisms.

4 Implications Relevance of GLC at stake Reputation of GDF and role in second-line line drug procurement at risk Global Fund funding for important GLC- approved programs at risk High level negotiation with Global Fund on revised payment procedures required

5 Roles of Key Actors Green Light Committee (GLC) – Responsible for reviewing, assisting, approving and monitoring and evaluating MDR-TB management programmes; approval allows release of Global Fund and UNITAID monies for purchase of second-line drugs; the GLC is not responsible for drug procurement. Global Drug Facility (GDF) – Responsible for providing drug forecasts to procurement agents and suppliers; contracting procurement agents (IDA); ensuring, via contracted agents/suppliers, delivery of drugs to GLC-approved programs; ensuring the high quality of drugs supplied. The World Health Organization (WHO) – Department for Essential Drugs and Medicines Policy (EDM) – Responsible for pre-qualification of suppliers and products to ensure that products meet international standards of quality before they are procured. GLC approved programs and governments – Responsible for planning patient enrolment and treatment; forecasting drug needs; communicating forecasts and delivery schedules to IDA; coordinating with financing mechanisms to ensure payment in advance of supply; facilitating timely registration and importation of drugs; properly managing drugs received. Donors and financing mechanisms (governmental and non-governmental) – Responsible for approving and overseeing expenditures; releasing funds upon demand; advocating with other key actors to eliminate bottlenecks to ensure the greatest possible impact. Manufacturers of finished products and APIs: Receipt of orders for drugs; timely delivery at reasonable prices.

6 Core Problems 1. Opaque Market 2. Short-term paralysis in the flow of second line drugs 3. Barriers, Costs of Entry & Uncertain Returns for Industry

7 1. Opaque Market Administrative barriers and costs of entry, uncertain returns for suppliers; Delays in placement, payment or receipt of orders; No accurate, reliable quantification of current global demand; No process for short- and longer-term forecasting; Inability to estimate the timing and reliability of demand by individual recipients (programs and governments); No strong player to assure rapid payment and assume risk e.g. for advance purchase commitments.

8 Recommendations of Stop TB Working Group on MDR-TB Immediately form an ad hoc task force to document the current supply-demand imbalance, including an assessment of available funding, and prepare 2- and 5- year forecasts. Clarify budget needs to create a transparent, well-defined, regularly updated source of market information.

9 2. Short-term paralysis in flow of 2nd line drugs Demands for high quality second-line drugs currently outstrips capacity; Sub-optimal logistics, communications and response-time between key actors has exacerbated supply shortages; Lack of firm demand forecasts and sporadic order placement means irregular manufacturing stream; Inadequate GLC-approved supply impacts disbursements and overall programme performance.

10 Recommendations of Stop TB Working Group on MDR-TB Establish and successfully manage UNITAID-funded buffer stock (constituting a supply of 800 patient treatments for 6 months). Based on demonstrated success; –pursue increased buffer stock size, when deemed effective. Immediately prepare and negotiate firm orders with current suppliers of drugs in tightest supply. Work with large financing mechanisms (Global Fund and UNITAID) to achieve flexibility on payment mechanisms; –pursue underwriting advance purchase commitments to eliminate financial transactions as a bottleneck. Evaluate overall procurement model for second-line drugs to identify and address procedural deficiencies i.e.: –lack of tendering for second-line suppliers, –heavy reliance on non-contractual suppliers to meet country needs, –prioritizing low prices over constancy and predictability of supply, – limited engagement of GDF as an intermediary between procurement agents and programmes.

11 3. Barriers, Costs of Entry & Uncertain Returns for Industry Technical requirements of production and high capital cost, scarcity of raw materials; Shelf-life risks; Expensive and slow pre-qualification and approval process; High costs of country registrations and import licenses; Registration used as to protect local industry More attractive, predictable, captive, domestic and international markets.

12 Recommendations of Stop TB Working Group on MDR-TB Establish clear, reliable forecasts of demand – available to all. Ensure measurable commitment from WHO/EDM to proactively assist suppliers of second-line anti-TB drugs to attain prequalification status for their products. EDM, in close co-operation with GDF, should offer an 18-month window to encourage and expedite prequalification via a tiered approval process and identify ways to subsidize national and international suppliers willing to enter into the WHO prequalification process. Will require financial support for subsidies. Encourage countries to more actively facilitate registration and importation of quality-assured 2nd line drugs or, more drastically, waive registration requirements altogether for WHO prequalified suppliers. Generate advocacy for designation of new drugs for use in TB/MDR-TB.