Accurate and Reliable TB Medicines Forecasts and New WHO Prequalification Fees Among Suppliers’ Top Concerns
04 May 2017 - Lao PDR - More than 25 partner organizations gathered in Luang Prabang, Lao PDR for the 2017 Annual Global Drug Facility (GDF) Suppliers Meeting on 25 - 27 April. Participants included representatives from generic and innovator manufacturers of anti-tuberculosis (TB) medicines, freight forwarding and logistics companies, quality control agencies, IDA Foundation, Vietnam and Lao PDR National TB Programs (NTPs), WHO, the Global Fund, USAID, the US Pharmacopeia’s Promoting the Quality of Medicines program, and GDF staff.
A one-day TB Medicines Quality Workshop was held on 25 April with the aim of introducing new suppliers to quality assurance policies and procedures of donors and GDF. The two-day GDF Suppliers Meeting followed on 26-27 April where participants were updated on market trends for TB medicines, new GDF initiatives, and progress against existing initiatives. The forum allowed for an open exchange among participants on challenges and solutions encountered as partners work toward a common goal of promoting access to quality-assured TB medicines.
Key initiatives presented by GDF included: strategic positioning of GDF to play a more prominent role in information sharing, policy making, and stakeholder consultation; the launch of a new Strategic Rotating Stockpile of second-line medicines expected to reduce lead times to less than three months for 60% of GDF orders; and technical assistance to NTPs towards increasing procurement frequency, improving quantification, and expediting transition to new WHO-recommended TB regimens, medicines, and formulations.
Presentations from GDF highlighted market trends, most notably projected changes in demand for: key second-line medicines as NTP’s adopt shorter regimens for drug-resistant TB; new, optimized pediatric, fixed-dose formulations; and rifapentine-isoniazid for the treatment of latent TB infection.
Over the course of the three-day meeting, manufacturers noted two main concerns, namely: the need for longer-term, more reliable TB medicines forecasts to improve production planning; and the structure, cost, and implementation process for new WHO Prequalification Fees for medicines that went into effect in January 2017.
Order cancellations and postponements as well as last-minute, urgent orders were discussed as challenges that lead to inaccurate medicines forecasts. Root causes thought to contribute to these challenges include ambitious treatment targets in Global Fund concept notes, pressures to spend and not lose funds as Global Fund grants near closure, inconsistent quantification methods used across partners, procurement inefficiency (buying 18-24 months’ worth of medicines at one time), and insufficient data collection and early warning systems in countries. GDF made a commitment to work with the Global Fund and other partners to address these issues towards the provision of more predictable and reliable medicines forecasts.
Concerns around newly instituted WHO Prequalification Fees for medicines were centered on the fee structure, the cost of the fees, potential impacts of the fees, and risk management during implementation. Suppliers raised the most concern around low-volume TB medicines such as pediatric medicines for which there is already little incentive to produce. Several suppliers noted the new WHO Prequalification fees have already caused them to rethink their business model and willingness to develop and produce certain low-volume TB medicines. GDF and WHO agreed to discuss the issue in more detail and convene a follow-up meeting or tele-conference with TB medicines suppliers.