The 2030 Agenda for Sustainable Development recognizes the fundamental impact that healthy lives have on the entire spectrum of human development. Sustainable Development Goal 3 (SDG3) captures the global ambition to end some of the major epidemics of poverty by 2030, including tuberculosis (TB), malaria and neglected tropical diseases (NTDs). In turn, underlying targets stress the need for universal health care coverage for all citizens, and for stronger health systems that enable access to essential health services and technologies. Dig even deeper and SDG3 calls for more research and development (R&D) on new medicines, diagnostics and vaccines: critical innovations that fill current gaps in health care and keep national programmes one step ahead of shifting epidemics. Addressing these aspects will be of critical importance in helping low- and middle-income countries achieve not only SDG3, but also other health targets of the SDGs.
While the central importance of health and the priority directions to safeguard it are clear, multiple stakeholders must collaborate to strengthen capacities along a series of cross-sectoral ‘pathways’ to reach these targets.
On the side-lines of the 2017 Prince Mahidol Award Conference (PMAC) in Bangkok, the Access and Delivery Partnership (ADP) convened a diverse, cross-disciplinary group of experts to explore together how more innovative, enduring linkages can be forged between health R&D and promoting access and delivery of new health technologies.
Connecting the dots across the identification, development, access and delivery continuum for health technologies – and across institutions, sectors and countries – is crucial to ensuring equitable health outcomes among vulnerable communities.
“If we want to see LMICs achieve UHC, much more investment is needed to develop more effective and efficient health technologies,” said Dr Mandeep Dhaliwal, Director of the HIV, Health and Development Group at UNDP.
“There is no point in investing in the development of new health technologies unless you also build the capacities of countries to ensure access and delivery to the communities who need them most.”
“In the world today there exists fragile states as well as vulnerable groups – even within countries that have achieved economic growth,” added Dr Eiji Hinoshita, Director of the Global Health Policy Division, International Cooperation Bureau, Ministry of Foreign Affairs of Japan. “UHC is therefore important because it focuses on every individual.” Not only are marginalized populations in low- and middle-income countries (LMICs) disproportionally burdened by TB, malaria and NTDs, they are also often excluded from accessing appropriate diagnosis and treat- ment where they exist.
Interview with Dr. Eiji Hinoshita, Director of Global Health Policy Division at the Ministry of Foreign Affairs, Japan, on the efforts of the Government of Japan in supporting health systems strengthening in low– and middle-income countries towards achieving universal health coverage.
Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.
(SDG Target 3.8)
The first panel discussion focused on how linkages between health R&D – and ultimately new product development – and the specific needs of vulnerable populations can be ensured. New and better innovations are required to address some of the biggest disease burdens as well as new elimination goals, but how can innovation also improve affordability, accessibility and effectiveness, when compared to current standards of care?
Commenting from the perspective of a product development partnership, Dr Hayato Urabe, Director of Investment Strategy and Management, at the Global Health Innovative Technology (GHIT) Fund, reflected on the experience of GHIT in establishing and investing in around 70 projects so far.
“Aligning many partners with the same, shared goal has been one of the bottlenecks we have faced. We work with government and multilateral agencies, around 16 industry sponsors, and with civil sector organisations,” he said. “All have different objectives and varying incentives and at times it feels like ‘alchemy’ aligning them.”
Interview with Dr. Hayato Urabe, Director of Investment Strategy and Management at the GHIT Fund, on the important investments that the GHIT Fund is making in the development of new health technologies, and in ensuring they reach people in need.
“Defining clear target product profiles – or TPPs – is essential from the outset,” added Jean-Michel Piedagnel, Head, South-East Asia Regional Office of the Drugs for Neglected Diseases Initiative (DNDi). “And involving endemic countries and clinicians, who will ultimately deliver the innovation, so that the ideal product can be designed and developed. Dialogue with civil society or patient groups is also essential to get information on barriers and where the problems lie, such as with cost.”
Mr Piedagnel argued that some middle-income endemic countries may be particularly important for delivering innovation when there is no market, as established R&D systems cannot be relied upon. “There is competence in Thailand, Malaysia, Brazil, in Kenya, and in India. Because they are outside of international funding eligibility, they may be a great place to carry out and deliver R&D at a lower cost.”
Innovation for promoting access, delivery, health systems and domestic capacity development may be just as important as developing or generating new products, according to Dr Solomon Nwaka, Executive Director of the African Network for Drugs and Diagnostics Innovation (ANDi).
“Unless the countries affected by these diseases are sufficiently empowered with the necessary capacity to actually drive innovation, to drive health systems, we will not achieve the SDGs,” said Dr Nwaka. “Collaboration in endemic countries tends to be largely North–South, and with a focus on R&D, including clinical trials. When the trial is completed, partners leave and we are back at square one.”
Dr Nwaka contended this leaves weak partnerships and few strong institutions inside many developing countries. “As a result, South–South collaboration is practically non-existent, particularly in Africa. There are some regional networks for innovation in the Asia region, and some attempts have also been made in Latin America. We cannot do sustainable innovation like that, without more established local capacity.”
Dr. Soloman Nwaka, the executive director of African Network for Drugs and Diagnostics Innovation (ANDi), emphasised the need to align innovation with access, by building the necessary capacities and partnerships in developing countries.
In the public sector, end-to-end development is impossible to achieve because the entire chain is fragmented, and there are still critical steps we rely on the private sector to fulfil.
Dr Solomon Nwaka, Executive Director, ANDi.
The second panel explored access, introduction and scale-up of new medicines, vaccines and diagnostic tools in LMICs. What are the key factors that can promote or impede the effective access and introduction of new health technologies?
This dialogue first recognized that R&D and promotion of access to medicines are complex issues, and moving them forward with only the efforts of the public sector is impossible. “It is indispensable for the private sector to participate in this field,” argued Dr Hinoshita. “As a result, the incentives for private sector engagement are very important.”
Shifting to the public sector experience in Thailand, where UHC has been achieved for the entire population of 68 million people, Dr Kriang Tangsanga, Chair of the Committee for the National Essential Drugs List in Thailand, shared his views on the responsibility of government to achieve a balance between effectiveness and affordability of health technologies. “In Thailand, we set up a semi-independent agency to take care of the essential medicines issue…[This agency] is chaired by the Deputy Prime Minister, and also involves representatives of patient groups; and we share decisions with clinical specialists.” said Dr Tangsanga.
Using the example of introducing the Xpert TB diagnostic test machine in Indonesia, Dr Yodi Mahendradhata, Director of the Centre for Health Policy and Management, at the Universitas Gadjah Mada in Indonesia, described some additional bottlenecks encountered as the country moves towards its goal of UHC by 2019. “Acceptability of innovations and technologies among various stakeholders is important, including acceptability to clinicians, who may lack confidence in a new technology. As a result, they may express a lack of willingness to integrate it.”
Readiness to integrate new technologies can also be a challenge, not least because they may be introduced before the necessary considerations, such as the human resource and facility capacities, are available. In the Indonesia case, the absence of an adequate referral mechanism was not addressed before the new TB diagnostic approach was introduced. Outside of the major urban areas, local capacity for maintenance and troubleshooting of new equipment was also inadequate.
“We also overlooked patients in the private sector; as the new technology was only introduced into the public sector, missing those in the private facilities,” said Dr Mahendradhata.
“National ownership of new technologies – and that of leaders in particular – is critical. Innovations must address the needs of national programmes, and cannot be driven from outside.”
The panel closed with a discussion of essential innovations that are needed around various forms of learning and sharing experiences at three specific levels.
Public–private partnerships (PPPs), such as the Global Fund, DNDi and GHIT have demonstrated capacity to transform health for millions of people. “What can countries learn from PPPs about achieving results through partnership? In terms of scale, efficiency and in terms of sustainability?” asked Dr Dhaliwal.
“Similarly, we can share South–South learning on efficiencies achieved across countries. Such as the African Union Model Law on Medical Products Regulation, which provides a framework for the 53 African Union Member States on an enabling regulatory environment to ensure delivery of quality, safe and efficacious medical products and technologies.”
“And can we get better value by looking at ways we can improve the supply chain? Going country-by-country is going to lead to an expensive, longterm effort, but smart South–South exchanges might make faster progress possible.”
Dr. Mandeep Dhaliwal, director of HIV, Health and Development Group, UNDP, and Chair of ADP Advisory Group, highlighting the need to address regulatory barriers to promote access to new health technologies.
In closing the session, Dr Tenu Avafia, Team Leader for Human Rights, Law and Treatment Access, in the HIV, Health and Development Team of UNDP, reiterated the commitment by member states to “Leaving no one behind” and extrapolated that to SDG3. “If we delve into the SDG3 targets, we see that there are strong commitments by states to incentivise R&D, especially for diseases that predominantly affect developing countries, and to UHC, including increasing access to affordable health technologies. Each requires innovation in basic R&D, in methods of delivery and in the breadth and cross-sectoral variety of essential partnerships.”
We have 13 years to go to achieve the SDGs. That requires moving the needle on SDG3. The commitment has been made,
we have to do it.
Tenu Avafia, UNDP.