Access to and Management of 2nd Line Drugs

Challenges Summarized at 6th Meeting, STB Working Group of MDR-TB20-22 September 2007 - Tbilisi

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Summary

1. Severe shortage of 2nd line medicines

2. Separate Roles of Key Actors

3. Core Problems

4. Recommendations

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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.

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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

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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.