MEETING REPORT

From insulin to glucose selfmonitoring devices: ramping up
access along the diabetes
continuum of care
Publication date: 27 July 2023

On 15 June 2023, the Access to Medicine Foundation convened an all-day roundtable to discuss
practices and solutions for improving access to essential treatment and health commodities forinsulin-dependent people living with diabetes (PLWD) in low- and middle-income countries (LMICs).
The latest in the Foundation's series of Amsterdam Sessions, this was one of the first opportunities tobring together people involved in diabetes treatment, diagnostics and strategy. In addition torepresentatives of some of the leading manufacturers of insulins and glucose self-monitoring devices
for diabetes, participants included experts from global health organisations, procurement agencies
and government bodies. The event was chaired by the Foundation’s Chief Executive Officer Jayasree
K. Iyer.
For many years, the discussion around access to diabetes care has focused on insulin. But insulin can
only be effective when administered correctly – i.e., at the right dosage, and with an appropriatedelivery device. This requires access to monitoring devices (e.g. blood glucose monitoring devices orcontinuous glucose monitoring devices) and delivery devices (e.g. needles). In order to ensure
equitable access to diabetes care, it is necessary to look beyond treatment and also consider all
diabetes-related health products across the continuum of care for PLWD. While there has beenpromising progress, huge numbers of PLWD in LMICs still lack access to the full range of products theyneed to stay healthy and keep their diabetes under control, and many more do not have access to achoice of products, which is something that all patients deserve.
Taking a holistic approach means not only ensuring access to the treatments and devices needed, butalso systemic support through stronger supply chains, sustainable business models and local capacity
building. While acknowledging difficulties such as a lack of sound infrastructure and immature
markets for some products, companies can take steps to ensure every PLWD, no matter where they
are, can access the diabetes care they need.

Practical solutions for improving access across the continuum of care
The event aimed to generate practical next steps and commitments from manufacturers and otherstakeholders, to foster solutions, models and partnerships to scale-up access to both insulins andglucose self-monitoring devices for PLWD in LMICs. The programme started with an introductory
presentation, followed by two moderated discussions and two breakout groups on different themes.
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Joining us as moderators and guest speakers during the event were:• Andreas Altemark, Global of Market Access, Roche Diabetes Care Solutions, Roche
Diagnostics• Dr Malick Anne, Head of Non-Communicable Disease Control Division, Ministry of Health,Senegal (virtual participation)• Loren Becker, Senior Director, Global Health Policy, Eli Lilly• Bashier Enoos, Technical Officer, Integrated Service Delivery at World Health Organization(Access to NCD Medicines and Health Products)• Adrian Gut, Senior Director International Access and Government Affairs, Dexcom• Nicolai Haugaard, Vice President and Global Head of Health Equity, Novo Nordisk• Jenna Mezhrahid, Senior Manager, Global Markets Team, Clinton Health Access Initiative• Edith Mukantwari, Executive director, Africa Diabetes Alliance & person living with diabetes,
Uganda• Richard Neci Cizungu, Executive Director of the Ecumenical Pharmaceutical Network (virtual
participation)• Prof Eva Njenga, Consultant Physician/Endocrinologist, Chairman of the Kenya Diabetes
Management & Information Centre• Fiona Olivier, Global Head / Vice President, Corporate Affairs, General Medicines, Sanofi• Sylvia Brachet, Cardio-metabolic Therapeutic Area Lead Global Health Unit, Sanofi• Charles Toomey, Co-Founder, Action4Diabetes• Beatrice Vetter, Deputy Director, Non-communicable Diseases Programme, FIND
The event was held under the Chatham House Rule, and this meeting report summarises theoutcomes of the discussion. The report captures different points of view and shares practicalsolutions different stakeholders could take forward, develop and implement.

About this report
The outcomes of the Amsterdam Session are summarised in the following sections:
1. Engage and involve people living with diabetes
2. Develop business models and products specifically for LMICs
3. Increase the involvement of and partnership with device manufacturers
4. Shape a collaborative supply chain to the last mile
5. Scale up healthcare capacity locally to support Universal Healthcare (UHC)

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1. Engage and involve people living with diabetes
There was a clear call to action for all parties to involve people living with diabetes in discussions
around access to insulin and glucose self-monitoring devices, in government-led or company-led
initiatives, and in the development of new business models. PLWD need to be integrated in theecosystem and empowered in their own care. Participants reflected on what needs to change tomake this more of a reality.
•••

Look at care more holistically. Participants talked about the importance of taking holistic
approaches, including addressing comorbidities that PWLD might face, and the impact thesecan have on their lives and ability to access care. Companies, implementation partners andnational healthcare delivery agencies could consider different distribution channels that makeit easier for people to access integral care, such as direct home delivery, community spaces
and healthcare facilities.
Keep the patient perspective at the centre. To truly understand indirect costs to PLWD
beyond the direct costs of medicines and devices, such as the time and financial burden of
traveling to seek care, companies can actively engage and listen to the experiences of people
living in LMICs who have diabetes, and integrate them into their strategies and initiatives.
→ Because of the social context and the legacy of social stigma, limited awareness, andlimited treatment options, the status quo is that PLWD in LMICs are often discouraged
from seeking care and can feel isolated. Companies can address this by being intentional
about ensuring the voices of PLWD are incorporated into their strategies, and prioritisingpeople’s needs when implementing initiatives.
→ Companies can also be more proactive about responding to issues reported by patients in
LMICs; for example, many PLWD in Africa have found that insulin dosage calculations
developed in the West are not directly transferable, leading to issues with managing theircondition.
Support patient education, where ethical and appropriate. There is an overall need forpatient education in LMICs, so PLWD can be empowered in their own care. However,companies must act responsibly and avoid conflicts of interest (COI) when participating inpatient education initiatives.

“Patients need to be at the centre of these things, we need them to be able to be empowered. This
needs to be an intentional effort.”•

Support efforts to improve diagnosis and create clarity about demand. Companies can
support initiatives to improve screening capacity and ensure timely diagnosis for PLWD in
LMICs. Companies can rise to the challenge of meeting the increased demand for theirproducts that comes from those who have now been accurately diagnosed.

2. Develop business models and products specifically for LMICs
To ensure PLWD in LMICs have continuous, long-term access to essential diabetes products, such as
insulin and glucose self-monitoring devices, companies need to develop and implement sustainablebusiness models. Participants from industry shared insights about the different approaches theircompanies are taking, while participants from LMICs reflected on the impact of those approaches andthe opportunities for change.
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•Move beyond philanthropy. Philanthropic approaches can be relatively short-term and often
limited in scale. While these programmes increase access to quality-assured medicines inmany cases, access often disappears as people graduate out of these programmes (e.g. as
participants age out of paediatric programmes). There is also a huge impact on participants if
companies withdraw from a country, without having first transitioned to a sustainable model.
→ One participant highlighted that donation-based programmes for insulin in one Africancountry have led to the growth of a healthier, more competitive market for other products
involved in the diabetes continuum of care, e.g. glucometers. This could be an indication that
donation-based models can lay groundwork for facilitating the availability of a broader rangeof essential health products.
• Develop financially sustainable business models. Speakers from industry emphasised that,while there does need to be some level of profit for a company when doing business in an
LMIC (outside of donation-based models), this business does not necessarily need to generate
as much profit as in a higher-income country.
→ Some companies are rolling out innovative business models in LMICs in which existingproducts are offered at more affordable prices.
→ Internal buy-in is more likely if a company’s access-focused initiatives are financially netpositive. Securing executive and CEO-level buy-in is vital when exploring new sustainablebusiness models and access-to-medicine approaches.
“Sustainability means it works from mid-term and long-term perspective, not just focusing on one
element but really providing a comprehensive solution. Donations can be part of it for some time, butthere needs to be some level of revenue.”•

Monitor and evaluate new approaches. Some participants urged companies to design
monitoring and evaluation of any new business activities into the process. Companies candevelop plans to assess the impact and communicate transparently about the progress andoutcomes, preferably in partnership with an independent third party.
→ When exploring business models that could potentially be more sustainable, participants
mentioned the benefit of starting small, tangible and specific before scaling up. This canmake it possible to measure progress and show change clearly, providing evidence for
expansion.
“We need testing, evidence and to discuss things openly.”••

Consider facilitating factors for LMIC-specific business models. Some of the factors
participants discussed include working with partners in LMICs (e.g. including distributors andministries of health), improving screening, capacity building, and tailoring efforts to the local
setting to ensure a strong supply chain to the last mile.
Develop quality-assured products specifically for LMICs. Developing products that are tailoredto the needs of people living in LMICs, and/or the financial capability of LMIC markets, canhelp increase affordability.
→ For example, if simpler and cheaper-to-produce designs for glucose self-monitoring
devices can be introduced, this would increase affordability in LMICs.
→ The development of access brands is an option companies can pursue. One insulin
manufacturer stated that it can take a long time to launch an access brand, especially inmultiple countries, due to regulatory bottlenecks.

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→ Participants identified coordinated registration as a facilitating factor, which could be
supported by World Health Organization (WHO) prequalification programme for insulins,
and its future expansion to include glucose monitoring devices.
Engage in local manufacturing to ensure sustainable supply. It was argued that, whencompanies invest in manufacturing their products in LMICs or nearby regions, this can be apositive way of developing long-term sustainability by building capacity and security of supply(see section 4).
Collaborate to increase impact. There are many promising initiatives underway individually,
and the topic of partnership came up throughout the discussions. It is important to ensure
initiatives take different perspectives into account: patient groups, healthcare providers,ministries of health (and other governmental departments such as finance), NGOs, WHO andcompanies – including both insulin and device manufacturers. Collaboration can help break
down silos that can exist when each organisation is following its own agenda.
→ There was a clear call to begin by looking at existing mechanisms and partnerships – suchas the Coalition for Access to NCD Medicines & Products – and build on those bycommunicating and encouraging others to join.
→ One participant suggested creating a consortium of companies to enable knowledge
sharing and avoid duplication of efforts. While collaboration was widely welcomed, there
was concern about anti-trust and not cutting out competition.
→ Participants highlighted the role of the WHO Global Diabetes Compact, particularly its"Access to essential diabetes medicines and associated health technologies" workstream.
The Compact sets distinct targets and provides a platform for engagement with theprivate sector, including representatives from international business associations,
pharmaceutical companies, and the health technology industry.
Collect more accurate data in LMICs. It is a common approach to make decisions based on
extrapolating from small quantities of data about diabetes in LMICs. However, participants
called for greater effort to gather accurate data, pointing out that this approach would not be
considered acceptable in high-income countries (e.g. in Europe). There is an opportunity towork with patient organisations to get better data.
→ Companies can proactively engage in collaborative efforts with national governments andlocal implementing organisations, sharing data on demand forecasts, even in situations
where exact volumes cannot be guaranteed.
Explore digital solutions that work for people in LMICs. Most people have a mobile phone andparticipants noted the importance of using available technology rather than designing new
approaches. For example, digital solutions could facilitate glucose monitoring in rural areas bycommunity health workers and help track outcomes.

3. Increase the involvement of, and pursue partnership with, device
manufacturers
Much of the access conversation to date has been around insulin, with the spotlight on how to
expand affordable and reliable access to insulin in LMICs. But taking a holistic approach to ensuring
PLWD can keep their insulin levels under control means also ensuring the affordability andaccessibility of glucose monitoring devices. The discussion covered both traditional blood glucose
monitoring (BGM) devices and continuous glucose monitoring (CGM) devices, acknowledging that thesituation differs due to various factors, including the maturity of the market and cost of production.
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••Increase access to devices across all levels of care. Glucose monitoring devices should beavailable at health care facilities. However, it is also vital to ensure that devices are madeavailable at lower levels of care and in the community, e.g. for home-based and self-testing,and that this is understood as a priority for PLWD. Demand for a greater quantity of devices
would also improve volume predictability for suppliers, and may lead to more availability andaffordability in the market.
Ensure devices supplied in LMICs are quality-assured. There was discussion around the qualityof some BGM devices and strips available on the market in some LMICs and a lack ofcompatibility between strips and devices from different brands.
→ There is a need for more clarity about who is, and who should be, regulating the qualityof diagnostics and devices, e.g. BGMs.
→ WHO is urging companies to participate in prequalification of glucose monitoring devices,
once this option is made available. There is an opportunity for companies to provide
feedback on experiences of the prequalification process.

"Who is checking the quality of the glucometers [in LMICs]? Which devices should patients be using?"••

Address affordability. Test strips vary greatly in price, both between and within countries; inone country, an organisation observed prices ranging from USD 0.06 - 0.88 per strip. And ataround USD 50 in many LMICs, CGM sensors are unaffordable for many people. Companies
could:→ Lead by example and lower their prices to a more affordable level. This requires insightnot just into the cost of manufacturing, but also into what payers are able to pay –including governments procuring for the public sector, and individuals purchasing in theprivate market.
→ Optimise the supply chain, including by partnering with distributors to secure volumeindependent prices. Examples were shared of successful partnerships between
companies and delivery organisations with distributors, and such approaches should be
examined and replicated where possible.
Ensure CGMs are part of the discussion about access in LMICs. CGMs are so far mainly
available to PLWD in high-income countries, and even in these countries there are still
significant access issues. In LMICs, access to CGMs is currently very limited, and there is very
low availability. Manufacturers of CGMs are new to these markets, and most do not yet havea strong presence in LMICs to draw upon.
→ One aspect consider is the need for CGM users to have continuous access to support
platforms, and to engage in a long-term relationship with the device manufacturer. Thismeans that there is additional cost and commitment needed from the device
manufacturer when launching the product in a new market. There is also the concern
about whether local healthcare capacity is strong enough to support users of thisproduct.
→ However, participants were optimistic about progress and pointed out that as technology
continues to develop, CGMs will become simpler and less costly to manufacture, easier to
distribute, and easier to use.

“Many years ago, the [CGM] devices were complex and hard to use. Now the technology is easier forend users. We are moving towards devices that are less costly, easier to use and to distribute.”•

Bring insulin and devices together. Speakers and participants recognised the potential benefitof pharmaceutical companies partnering with device companies. For example, this could
involve a "co-packaging" solution including, insulins, glucose monitoring devices and

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associated health commodities, and other essential health products needed by people livingwith diabetes.
“As a pharmaceutical company it’s difficult for us to say we can provide devices, because we don’t
make them. Our aim is to call on devices companies to join us and give patients access to affordable
devices. If they are open to same approach, that’s great!”

4. Shape a collaborative supply chain to the last mile
Supply and distribution are essential elements in securing the availability of, and access to, insulin anddevices. Even if a product is available on the market in a given country, PLWD may need to travel long
distances to collect insulin or access a monitoring device, and when they arrive they might find the
product is no longer available. They may also find that prices are marked up, for example at a local
pharmacy. Discussions centred around how to ensure products reach the people who need them, atprices they can afford.
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Understand the current state of the supply chain through research and data collection. All
those involved need to take accountability for their role in the supply chain to ensure it isrobust enough to serve the people who need care.
→ There were calls to make use of existing initiatives and structures, which requires
mapping, monitoring, documenting and reporting. Some supply chain mapping efforts areunderway, looking at governance, supply and price mark-ups.
→ Long-term understanding of the changing supply chain requires visibility. Logistics
information systems and systems to track products through the supply chain could be
helpful here.
→ With more (and earlier) diagnosis, there will be a need for scale-up in manufacturing tomeet increased demand. Forecasting would be helpful; and to be reliable, it should bebased on high-quality, interoperable data. There are many sources of data currently
available, and participants suggested looking at this first.
“Until we understand the current situation, we won’t necessarily know how to tackle it.”••

Learn from supply chain management and distribution in other areas. Although there are
specific challenges in optimising the supply chain for diabetes products, those involved insupplying and distributing diabetes products – such as insulin and monitoring devices – canlearn from success stories for other types of products.
→ For example, there has been progress on ensuring a steady supply of products todiagnose and treat HIV and tuberculosis (TB) in LMICs. This is due, in part, to coordinatedprocurement and global funding mechanisms. While the global funding may not be
available for diabetes, participants mentioned that the improvements in the supply chainsfor HIV and TB products could provide learnings for the supply of products for noncommunicable diseases (NCDs), including diabetes. Aggregating demand via coordinatedprocurement and data sharing could also be explored.
→ Other industries, such as fast-moving consumer goods (FMCG), have tested different
models for last-mile distribution. It may be possible to overlay the mapping behind those
approaches with health data to find solutions.
→ Similarly, different countries’ approaches could provide insights applicable elsewhere,
such as systems for managing stock across the supply network in Saudi Arabia.
Partner with local manufacturers and distributors to minimise mark-ups. The mark-up of
prices is a major issue for insulin and devices. Participants noted mark-ups of as much as

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800% on insulin, depending on location and whether buyers are public or private institutions.
While it is difficult for companies and governments to control mark-ups, participants
recognised that to reach affordability, companies can work together with partners in the
supply chain with a shared goal. This includes bringing companies along the entire supply
chain on board with new business models.
→ One company reported that it has been able to reduce mark-ups from 40% to 20% by
working with distributors to secure them higher volume. A country survey supported thiswith evidence of some pharmacies reducing shelf prices by 40%, but not all are buying
into the mission.
→ One company put logistics cost into cost of distribution to the end user through anagreement between the manufacturer and distributor – e.g. a product is USD 1, and 7
cents of that is for logistics.
→ One other dimension to tackling mark-ups is the integral role of PLWD themselves. For
example, individuals or patient groups can campaign on issues related to price capping
and retail prices, or they can use online marketplaces and forums to increasetransparency and highlight pharmacies where pricing is lower or higher.
Engage in local manufacturing. Local manufacturing in LMICs can make supply chains moresustainable and empower the countries involved. In Africa, the Pharmaceutical Manufacturing
Plan for Africa aims to strengthen local pharmaceutical production and improve public healthoutcomes by enhancing sustainability in the supply chain and empowering participating
countries. Capacity building is a critical element, and working with organisations like WHO
and, in the future, the African Medicines Agency (AMA), will be an important step.
→ A participant from one company shared their approach to manufacturing in a lowermiddle income country in Africa, highlighting that local investment needs local
commitment; setup can make products more costly initially. Long-term sustainability
requires a commitment to support that with financing so that the project can succeed,
and the cost does not get passed on to patients.
→ Participants discussed how, when collaborating with local manufacturing partners,
companies can share skills and technology. Companies can also provide support to theirlocal manufacturing partners in attaining WHO prequalification. These approaches canfoster growth, boost manufacturing capacity, and improve access to quality-assured
products in LMICs.
Use digital tools to increase supply chain traceability and accountability. Mobile phone use ismore widespread than ever in LMICs, and participants identified an opportunity to use thetechnology for multiple supply-related purposes.
→ Offer an alternative way to buy products directly or through resellers, via apps or mobile
finance. For example, there is an online market for glucometers and strips in Indonesia.
Generic product portfolios in online markets could give people direct access to those
products at set prices.

5. Scale up healthcare capacity locally to support Universal Healthcare (UHC)
There is a continued call for governments to prioritise diabetes, make policies to improve access tocare, and invest. With those facilitating factors in place, governments could partner with industry
more effectively. Several speakers shared their companies’ integration of capacity building efforts andother healthcare system strengthening work.
“We have to voice our collective thoughts that insulin, delivery devices and blood glucose monitoring
devices need to be part of UHC in order to be affordable, and people need to know their entitlements.”
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••Show the value of diabetes care. Participants suggested to carry out more impact analyses ofclinical outcomes to show governments the added value of diabetes care. There is a potential
role for industry to provide that evidence, which could in turn establish demand, increase
volume and decrease unit cost.
→ For example, research in Tanzania showed how much money the government could saveby avoiding complications through proper diabetes monitoring and treatment.
Support training of healthcare professionals to improve sustainability. As governments set up
diabetes centres with monitoring and treatment capabilities in more rural areas to improveaccess, healthcare professionals (HCPs) or community health workers need to be trained sothat there is long-term sustainable access.
→ A co-financing role was suggested for industry partners, with the acknowledgement thatcompanies want to do more than provide money. Participants discussed rethinking
models to bring initiatives into a broader context – for example by coordinating
community-level screening.
→ Participants discussed the need for training incentives for HCPs, such as payment or
accreditation. They also discussed professionalisation among volunteers and the benefitof recognising them as community health workers to boost esteem for the role andstimulate professional development.
→ However, there is a potential conflict of interest: training is the responsibility of
governments. This makes government buy-in critical, and participants highlighted thattraining should be prioritised, nationalised and certified centrally. If the impetus and input
for training comes from companies, it will be important that these companies incorporatetransition plans from the beginning, so that others – for example governments – can takeon the role in the long term.

“We are doing projects [for health system strengthening], but the question is, who is going to continue
financing these projects in the future?”••

Communicate needs in terms of procurement processes in LMICs. Participants highlighted theneed for governments to provide more clarity on specifications for public tenders andprocurement practices, and for companies to proactively communicate their needs. This canhelp streamline procurement processes, enhance transparency and increase efficiency. Someparticipants from global health organisations and local implementing organisations shared
how they are already assisting LMIC governments in restructuring tenders and optimising
their investments.
Coordinate to help governments navigate initiatives. A first step for industry partners could
be to identify synergies – many companies are already working on the ground, and alignmentof objectives and coordination of efforts could be helpful for governments as well as being
more effective.
→ There is a risk of such conversations being halted due to companies’ differing interests. To
overcome this, a programme with concrete objectives looking for funding could be
effective.
→ One participant suggested bringing together key stakeholders from governments and key
leaders from industry to solve issues where activities overlap.

“Governments have multiple partners knocking on their doors. If they [companies and organisations]pool resources to come together to governments, it can be less confusing.”

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Next steps
The Access to Medicine Foundation will continue to facilitate these conversations with an emphasison action and progress, to make sure people living with diabetes get the care they need. Towards theend of the event there was a strong call to action for companies to “be brave”, to sometimes take aleap of faith and embrace collaboration. Throughout the day, there were instances of organisations
identifying opportunities to work together, and it is hoped that these conversations will develop into
partnerships and solutions. The insights in this report will also inform the Foundation’s ongoing
research and analyses.
For more information or to discuss the contents of this report, please contact Claudia Martínez at
cmartinez@accesstomedicinefoundation.org.

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