More comments & information on my previous email:
For the press release from a protest at the Union conference regarding the Global Fund PROCUREMENT CLIFF, go here:
For a presentation from GDF that includes recommendations to national governments, and other actors, including what they are doing to avert problems once countries switch from GDF-supported procurement to national procurement, go here:
For those who could not receive the attachments, I’m pasting below the text from our flyer providing an overview of the problems and what needs to happen regarding the PROCUREMENT CLIFF.
And finally, while GDF is monitoring & reacting to problems with TB commodities, who is playing this role on HIV drugs and diagnostics? For malaria?
Beware of the Global Fund Procurement Cliff
WARNING: A premature shift for countries from the Global Fund to national procurement risks compromising the quality, affordability, and availability of TB medicines in those countries.
The Global Fund & affordable quality medicines
Over the last 16 years, the Global Fund to Fight AIDS, TB and Malaria (Global Fund) has helped to ensure a more affordable, quality, and sustained supply for HIV, TB, and malaria medicines:
· LOWER-PRICES: Coordinating pooled procurement across countries in order to negotiate volume-based discounts.
· COMPETITION: Attracting additional manufacturers, including generic companies, in order to create competition in price.
· QUALITY: Requiring WHO Pre-Qualification (WHO PQ) or approval from a stringent drug regulatory authority (SDRA).
· SUPPLY: Using blanket waivers to address the widespread problem of companies not registering products in countries.
Global Fund co-financing & transition policies
Following a reduction in funding and pressure from donors, the Global Fund revised its co-financing and allocation policies, * accelerating the transition of certain countries (those without a high enough disease burden or those which are considered higher income) from Global Fund support. As another means to compensate for reduced funding, the Global Fund is encouraging co-financing agreements, whereby eligible countries are required to dedicate more domestic funds to the national response, including to support the procurement of medical commodities.
We are bringing attention to how these policies impact the procurement of medicines.
As part of co-financing and the transition process, countries are expected to shift to nationally funded procurement systems, either wholly or partially, for key medicines including TB drugs. This often leads to a loss of access to international mechanisms (such as the Global Drug Facility (GDF).
What’s at risk by shifting to national drug procurement systems?
· AFFORABILITY: Not all countries can access international pooled procurement mechanisms (such as the GDF) or have the negotiating power to secure the most affordable prices.
· QUALITY: Not all countries require WHO PQ or SDRA approval to ensure quality of drugs and diagnostic tools.
· SUPPLY: Not all countries are able to efficiently issue waivers for medical commodities that have not been registered locally, creating delays in accessing supply to TB medicines and diagnostic tools.
What should the Global Fund do?
1. LOOK BEFORE YOU LEAP: Conduct and act upon risk and readiness assessments for countries undergoing transition and/or countries on track to increase co-financing of medical commodities.
2. PROVIDE TRANSPARENCY for co-financing agreements, transition timelines and readiness assessments.
3. PROVIDE BRIDGE FUNDING and flexibilities to allow countries to access GDF or pooled procurement mechanisms (PPM).
4. MONITOR & REPORT on scale up of TB testing and treatment, as well as sickness and death in countries that are co-financing and/or transitioning.
What should countries do?
1. AFFORABABILITY: Change laws as necessary in order to access global markets as an option and provide transparency throughout the procurement and bidding process.
2. QUALITY: Require WHO PQ or SDRA approval, at least for an interim period.
3. ACCESS: Enroll in the WHO Collaborative Registration Procedure to facilitate national registration and reduce onerous regulatory barriers.
4. SUPPLY: Strengthen procurement supply mechanisms and forecasting.
What should donors do?
1. FUND the Global Fund.
2. STOP pressuring the Global Fund to reduce support for procurement of lifesaving quality TB drugs in countries.
3. SUPPORT advocates to play a watchdog role in countries’ procurement.
4. SUPPORT countries in adopting pro-access policies.
5. SUPPORT WHO PQ and incentives for companies to submit to WHO PQ.
* Sustainability, Transitions and Co-Financing policies:
[Please share and excuse duplicates]
Please see below for an open appeal to GFATM and donors regarding the Global Fund PROCUREMENT CLIFF where affordability, quality, and supply of TB drugs and diagnostics are at risk with the rush to switch to national procurement as part of the Global Fund’s co-financing and transition policies. See handout attached for a short overview of the issue.
The problems we raise in this letter are not theoretical. According to the Global Drug Facility, within the past 12-18 months:
15 countries have had TB DRUG STOCK OUTS in EECA, Asia, and Africa
8 countries have had FAILED TENDERS for TB DIAGNOSTICS in EECA, Asia, and Africa
29 countries have procured TB DRUGS of UNKNOWN QUALITY in EECA, Asia, Africa, & Latin America
6 countries have procured TB drugs and diagnostics not recommended in WHO testing & treatment guidelines in EECA, Asia, and Africa
21 countries have procured TB drugs and diagnostics at prices (well) above lowest world-wide prices in EECA, Asia, Africa, & Latin America
Amb. Deborah Birx, US Global AIDS Coordinator, U.S. Department of State, USA
Dr. Jim Yong Kim, President, World Bank
Dr. Tereza Kasaeva, Director, Global TB Program, WHO
Mr. Peter Sands, Executive Director, Global Fund Against HIV, TB, TB, and Malaria
Mr. Lelio Marmora, Executive Director, UNITAID
Ms. Stéphanie Seydoux, Ambassador for Global Health, France
Mr. Daniel Graymore, Head of Global Funds and Senior Representative in Geneva, DFID, United Kingdom
Dr. Gerd Müller, Minister for Development and Economic Cooperation, Germany
Mr. Hans-Peter Baur, Deputy Director General for Democracy, Human Rights, Social Development and Digital World, Federal Ministry for Economic Cooperation and Development (BMZ), Germany
Ms. Amy Baker, Director General, Health and Nutrition, Global Affairs, Canada
Ms. Marja Esveld, Senior Global Fund Program Coordinator, Ministry of Foreign Affairs, Netherlands
Dr. Lucica Ditiu, Executive Director, Stop TB Partnership
Kieran Daly, Deputy Director, Global Policy and Advocacy, Bill & Melinda Gates Foundation
Please see below for cc list
October 26, 2018
OPEN APPEAL: URGENT NEED TO ADDRESS THE GLOBAL FUND PROCUREMENT CLIFF FOR TB
We are writing to urge you to take prompt action following the United Nations High Level Meeting on TB to address the grave risks posed to countries that are rapidly shifting from pooled procurement of TB medicines and commodities, supported by the Global Fund to Fight AIDS, TB and Malaria (Global Fund), to national procurement.
Over the last 16 years, the Global Fund has helped to build ‘healthy markets’ for HIV, TB, and malaria by coordinating pooled procurement across countries, attracting additional manufacturers, encouraging submission to and procurement of medicines approved by the WHO Pre-Qualification Project or stringent drug regulatory authorities (SDRAs). In addition, commodities procured from the Global Fund enjoy a waiver which helps to address the common problem of pharmaceutical corporations not registering their products in all countries the Global Fund supports. Taken together, these strategies help ensure that essential, quality-assured medicines are accessible for people in need.
Donors have provided billions of dollars to create the current markets that have, in turn, facilitated access to affordable, quality-assured medicines. The success in this area has been unprecedented, but these gains are now threatened with current trends in decentralized procurement, fragile procurement systems, and market fragmentation.
An increasing number of countries are moving away from the Global Fund procurement mechanisms as a part of the implementation of the Global Fund’s Sustainability Transition and Co-financing (STC) policy.
This includes eligible countries (classified as having high disease burden and low income) that are co-financing greater proportions of medical commodities, as well as countries slated for transition from future Global Fund support. Many of these countries face serious challenges with rapidly switching to national procurement systems for first- and second-line TB drugs and diagnostics.
Many of the countries affected have national procurement systems that are not designed to access international pooled procurement mechanisms, nor do they have the negotiating power to attract suppliers to bid for their tenders or secure the most affordable prices should any suppliers decide to bid. Also, many countries do not require WHO Pre-Qualification or SDRA approval to ensure continuity in quality of the products, nor are they able to efficiently issue waivers for medical commodities that have not been registered, effectively preventing participation in pooled procurement mechanisms.
Within the last six months, we have witnessed acute problems resulting from countries having to switch to national procurement systems without the necessary regulatory frameworks in place: first-line TB drug stock ruptures have occurred in Eastern Europe due to lack of registered drugs; pediatric ARV formulations stockouts in South Asia have occurred because a national competitive bidding process awarded the tender to a company that couldn’t deliver the product; and stockouts of ARVs occurred in an impoverished country in West Africa that was asked to co-finance procurement beyond its capacity.
In addition to these national level problems, we are also concerned that countries leaving global pooled procurement mechanisms risks segmenting and destabilizing the fragile TB and drug-resistant TB (DR-TB) medicines market, resulting in fewer suppliers, higher prices, and a less stable supply.
Therefore, we are urging global health actors and donors to act with a sense of collective responsibility to address the risks of reduced access to affordable quality TB medicines at the national and global levels. We recommend:
1. The Global Fund carry out more rigorous risk and readiness assessments that take local procurement mechanisms into consideration, for countries facing gradual procurement co-financing, as well as countries in transition, and to make these assessments transparent and publicly available.
2. All relevant actors, including WHO, donors, affected countries, and the Global Fund act upon these assessments by developing and/or strengthening mitigation strategies to proactively monitor and address risks to the availability of commodities and scale up of treatment programs. These should cover high prices, quality concerns, barriers preventing countries from accessing pooled procurement, and weak national procurement and regulatory systems and procedures.
3. All relevant actors support national governments to adopt pro-access procurement policies, including utilizing pooled procurement mechanisms, requiring WHO Pre-Qualification or stringent drug regulatory approval in drug tendering processes, enrolling in the WHO Collaborative Registration Procedure, and ensuring transparency throughout the procurement process.
4. The Global Fund increase flexibility in itsprocurement co-financing agreements with countries and strive to defer such agreements, where needed, until countries are able to enact necessary changes in national laws to put some of these procurement policies in place.
As members of civil society, treatment providers, and non-governmental organizations committed to the fight against tuberculosis (TB), we will continue to press for access to affordable, quality medicines and commodities.
While we have engaged constructively with the Global Fund on these issues, we believe these concerns deserve increased attention and urgent action from additional actors.
We strongly encourage the engagement of the above actors to coordinate the assessment of risks, and support of mitigating strategies in light of these concerns.
We request you to kindly direct your responses to Erica Lessem, Deputy Executive Director for Programs TAG, at , and
Sharonann Lynch, HIV & TB Policy Advisor MSF Access Campaign, at .
AIDS and Rights Alliance for Southern Africa (ARASA)
Global Coalition of TB Activists
Global Network of People Living with HIV (GNP+)
International Indigenous Working Group on HIV & AIDS
Médecins Sans Frontières (MSF)
TB Europe Coalition
Treatment Action Group (TAG)
Wote Youth Development Projects (WOYDEP)
Ms. Cheri Vincent, Chief, Infectious Diseases Division, USAID
Dr. Ren Mingui, Assistant Director General for Communicable Diseases
Dr. Gottfried Hirnschall, Director of the HIV/AIDS Department and the Global Hepatitis Programme (GHP), WHO
Dr. Suzanne Hill, Director of Essential Medicines and Health Products Department, WHO
Amb. Eric Goosby, UN Special Envoy on Tuberculosis
Mr. Matthew MacGregor, Senior Project Lead Sustainability, Transition and Co-financing, Global Fund
Ms. Mariatou Tala Jallow, Senior Manager, Global Sourcing of pharmaceuticals and health products at the Global Fund,
Dr. Brenda Waning, Chief, Global Drug Facility (GDF)
Ms. Sarah Boulton Global Health Funds Team Leader, Global Funds Department, DFID, United Kingdom
Mr. Jean-François Pactet, Assistant Director, Human Development, Ministry for Foreign Affairs, France
Ms. Maurine Murenga, Communities Delegation Representative to the Global Fund Board
Mr. Mike Podmore, Developed Country NGO Delegation Representative to the Global Fund Board
Mr. Allan Maleche, Developing Country NGO Delegation Representative to the Global Fund Board
Mr. Harley Feldbaum, Head of Strategy and Policy, Global Fund
Mr. Eliud Wandwalo, Senior TB advisor, Global Fund
Communication focal points of the Global Fund board constituencies