Transition processes

Key populations can be the first victims of unsuccessful transitions. Because of legal restrictions, social marginalization or prejudice they face increasing difficulties accessing information, harm reduction services for people using drugs, or HIV prevention for sex workers or men who have sex with men (MSM), that NGOs who have lost funding cannot provide anymore.

NGO activities and services in favour of key populations are paramount in achieving progress in the response to the 3 diseases, in the fight against HIV / AIDS in particular. In some countries facing transition though, social contracting has not been put in place in due course, leaving NGOs without access to state funding for service provision.

Integration of HIV, TB or malaria services into national health systems is key to manage transitions, both from an epidemiological perspective to achieve combined treatment delivery, and to ensure people-centred prevention and care. The transition period should be used to integrate services as much as possible in an effort to optimise the use of resources, identify gaps and potential overlaps, and also to optimize the health services coverage /architecture in the country.

Switching to progressive government financing of key interventions is a significant factor of success for transitions. As recipient countries are progressively upgrading to higher income status, they should increase their fiscal capacity in parallel, as well as their ability to finance disease programmes and their health systems at large, thus allowing the Global Fund to dedicate more resources to those countries who need it most.

Gradual integration of prevention, treatment and care costs into national budgets during the transition phase should be considered carefully by stakeholders. Failure to do so would result in inadequate budgeting, and in a possible disruption of service provision to vulnerable and key populations, and possible subsequent resurgence of epidemics. Adequate resourcing is also one of the critical components to training and retaining of qualified medical workers who are the cornerstone of any sustainable health system.

Capturing and analysing data for action is at the core of efficient health interventions. Gathering such data, particularly around key and vulnerable populations who fall through the cracks of official statistics, often relies on non-governmental organisations, who stop collecting information when unfunded, thus rendering epidemics transmissions unchecked for months or years !

Procurement and supply chain management is a key element of successful transitions. The procurement of affordable and quality medicines for prevention, treatment and care of patients is at the core of national HIV / AIDS, malaria and TB programmes. However, transitioned countries with small caseloads of patients sometimes lose timely access to quality prevention tools, diagnostics and treatments at affordable prices, as their orders are considered too small by major pharma companies to raise commercial interest, thus putting transitions at risk. To prevent such difficulties, the Global Fund has recently piloted access to wambo.org (an online platform that allows eligible countries to purchase quality-assured medicines and medical products at negotiated prices) to transitioned countries.

According to WHO, more than 100 countries have incorporated the WHO provisions of Good Practices in the Manufacture and Quality Control of Drugs (“GMP as recommended by WHO”) into their national medicines laws, and more have adopted its provisions in defining their own national GMP rules. But some countries that transitioned had not adhered to the WHO Scheme, as procurement through the Pooled Procurement Mechanism PPM[1] provided all guarantees in terms of quality, delivery lead-time and pricing. Managing their own procurement for HIV and malaria drugs, these countries often had to resort to one-time waivers instead of upgrading their protocols to WHO standards, creating uncertainties as to quality over time.

[1]Establishment in 2009 to guarantee a cost effective and efficient procurement process by compensating for countries’ procurement bottlenecks and supply chain management weaknesses, and facilitating timely access to pharmaceuticals and health products, the PPM is a “Global Fund strategic initiative that aggregates order volumes on behalf of participating grant recipients to negotiate prices and delivery conditions with manufacturers.” In 2018, the Pooled Procurement Mechanism managed US$1 billion in orders, serving grant recipients in 63 countries, and generated US$ 175 million savings.

Legislative barriers due to national procurement regulations in countries facing transition do not always allow direct public procurement of HIV and malaria medicines via tenders, as the PPM was often the sole procurement channel available, guaranteeing quality, timely deliveries and good pricing. Therefore, national laws must be adapted prior to transitioning and include new provisions allowing public procurement of HIV, TB and malaria products through competitive bids. As the PPM should remain available to transitioned countries through the wambo.org platform, beyond the current piloting, this should however be less of an issue in the future for some countries.

The PPM lies on framework agreements with pharma companies, whereby negotiated prices allow recipient (and now some transitioned) countries to avoid paying patent rights. As soon as countries have to procure medicines on their own, they lose access to negotiated prices and have to deal with pharma companies on the basis of the TRIPS agreement[2]. An additional problem lies in commitments imposed by the EU in Association Agreements with neighbouring European countries, under TRIPS. The Agreement on Intellectual Property Rights imposed increased monopoly patent protection periods for pharmaceutical products in many countries, leading to increased pricing of HIV treatment, and in many Low and Medium Income Countries with limited health insurance coverage, to out-of-pocket payments by key and vulnerable populations, and when prices soar, to medicines becoming unaffordable to the poorest.

[2] The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member states of the World Trade Organization (WTO). It sets down minimum standards for the regulation by national governments of intellectual property (IP) as applied to nationals of other WTO member nations. TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994 and is administered by the WTO. It entered into force on 1 January 1995.

In countries where the GF operates, Country Coordinating Mechanisms (hereafter CCMs) were put in place. CCMs are national committees that submit funding applications to the Global Fund on behalf of the entire country. They have also proven as a useful platform for actors from different areas of the national health community – civil servants from Finance and Health Ministries, epidemiologists, faith leaders, representatives of sex workers, women’s rights activists, CSOs etc – to meet, communicate and exchange perspectives.

While CCMs are generally inclusive and operational as long as the GF provides grants to recipient countries, those have no obligation to maintain CCMs in place as such once the GF pulls out, raising questions as to continued inclusiveness of various stakeholders, transparency and ownership of the response in terms of prevention, treatment, or coordination and information-sharing on the long run. Governments should thus put mechanisms in place to ensure that these issues are duly taken care of during and after transitions.