WORKSHOP REPORT

Expanding access to high-quality
generic medicines
in low- and middle-income
countries
Publication date: 12 May, 2022

On 6 April 2022, the Access to Medicine Foundation convened a workshop to discuss current andfuture roles and responsibilities of generic medicine manufacturers in improving access to essential
health products for people living in low- and middle-income countries (LMICs). This was anopportunity to explore what companies are currently doing to expand access, to share insights about
the evolving role of generic medicine manufacturers in global health, and to consider expectations for
improving access to medicine.
Participants from eight multinational generic medicine manufacturers joined the virtual workshop,
which was chaired by the Foundation’s Chief Executive Officer Jayasree K. Iyer. Other participants
included experts from global health organisations, procurement agencies, and government bodies.
The generic medicine industry has long played an important role in making essential medicines
available and accessible – and the COVID-19 pandemic has highlighted just how critical that role is.
Generic medicine manufacturers ensured existing medicines remained available in LMICs, despite
disruptions to global supply chains. They stepped in to manufacture the generic medicines (e.g.
dexamethasone) that were used for the treatment of COVID-19 when other treatments had not yet
been developed. Furthermore, in a sign of how the global health landscape is changing, generic
medicine manufacturers have worked with R&D-based pharmaceutical companies to rapidly create
generic versions of patented COVID-19 vaccines and treatments for distribution in LMICs.

Exploring opportunities for the generic industry to tackle global health challenges
In a wide-ranging discussion, the workshop explored how generic medicine manufacturers canleverage their expertise to tackle today’s multiple global health challenges. To open the workshop,
three representatives from the generics industry were invited to speak, before the floor was opened
to participants. The speakers were:•••

Amalia Adler-Waxman, Vice President Global Head, Environment, Social & Governance, Teva
Pharmaceuticals
Vinay Singh, Vice President Business Development Emerging Markets, Sun Pharma
Erika Satterwhite, Head of Global Policy, Viatris

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The workshop was held under the Chatham House Rule, and this meeting report summarises theoutcomes of the discussion. The report captures different points of view, while showcasing a range ofsolutions to resolving access issues.

About this report
The outcomes of the workshop are summarised in the following sections:
1. Defining the changing roles of generic medicine manufacturers in scaling up access2. Identifying viable business models to expand access
3. Toolkit of approaches for expanding access in LMICs
As part of the Foundation’s Strategic Direction for 2022-2026, we are expanding the range ofcompanies and healthcare sectors that we aim to mobilise in the fight against healthcare inequality,
and this will include the generic medicines industry. Informed by discussions in this workshop, as well
as by conversations with a range of experts and stakeholders, the Foundation is developing anassessment framework that will outline the generics industry’s roles and responsibilities in expanding
access to high-quality generic medicines.
For more information or to discuss the contents of this report, please get in touch with Claudia
Martínez via cmartinez@accesstomedicinefoundation.org.
About the Access to Medicine Foundation
The Access to Medicine Foundation is an independent, non-profit organisation based in the Netherlands. It aims
to advance access to medicine in low- and middle-income countries by stimulating and guiding thepharmaceutical industry to play a greater role in improving access to medicine. The Foundation is funded by the
UK and Dutch Governments, the Bill & Melinda Gates Foundation, the Leona M. and Harry B. Helmsley
Charitable Trust, AXA Investment Managers, and the Wellcome Trust.

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1. Defining the changing roles of generic medicine manufacturers in scaling up
accessWorkshop participants discussed the roles and responsibilities generic medicine manufacturers havein ensuring their products reach more people living in LMICs.
•••

Producing affordable medicines at scale: By their very nature, generic medicine manufacturers
have a central role in expanding access to medicine by producing drugs in high volumes, at alower cost to patients and procurers than the originator product. This has been theconventional lens through which the generics industry’s role in access to medicine has beenviewed.
The evolving role of generic medicine manufacturers in access: Generic medicine
manufacturers are starting to expand that business model of 'high-volume / low-cost', finding
new mechanisms to reach more people with their products. For example, issuingsustainability-linked bonds can tie financial performance to achievements in access to
medicine; taking up voluntary licences of on-patent drugs can increase the reach of essential
new medicines within the countries these licences cover; and engaging in adaptive R&D canlead to products better suited to needs of patients living in LMICs. Alongside this, there is a
growing recognition of the importance of local manufacturing, supply chain strengthening
and capacity building, as well as access strategies that take ability-to-pay and other socioeconomic factors into account. Discussions during the workshop highlighted the steps some
generic medicine manufacturers are actively taking to improve access to their products in
LMICs, as explored below.
Fulfilling key roles and responsibilities: The exact extent to which generic medicine
manufacturers have a responsibility to consider access to medicine in LMICs – beyond
affordability – is an ongoing conversation. However, there is a broad consensus that generic
medicine manufacturers have an opportunity to actively expand access to their essential
health products in LMICs and ensure a continuous supply of high-quality generic medicinesand biosimilars.

2. Identifying viable business models to expand accessSpeakers and participants had an open conversation about how to find commercially viable businessmodels that balance affordability considerations with the need for sustainable availability and productquality. The workshop explored the issue of healthy market shaping and the roles of different
stakeholders in ensuring effective ecosystems, in order for essential medicines to reach more patientsin LMICs.
“At the end of the day, if we want to ensure sustainable access, it has to have a sustainable businessbehind it.”
“We collectively need to think about: how do we create a thriving market of those kinds of instrumentsthat allow us to launch products fast, at the right kind of prices, and accelerate their uptake?”•

Question assumptions about markets in LMICs: Companies can explore the feasibility of an
expansion into countries that some may assume would not have profitable markets.
Participants talked about taking a ‘leap of faith’, especially when launching a product in acountry where the original brand-name product never launched – but this leap of faith can

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•also be backed up by market research and pilot initiatives to ascertain business potential andfinancial sustainability.
Develop networks and relationships to understand local needs: Developing on-the-groundpartnerships and relationships, for example with hospitals and clinics, can help generic
medicine manufacturers understand the level of demand, raise awareness of particular
medicines, and – more generally – build trust in generic medicines as high-quality products.
Engaging with governmental agencies, civil society organisations, purchasers, hospitals andother relevant stakeholders can improve companies’ understanding of local requirements andinform public-sector tender applications.
⇒ One participant shared a potential solution that can help achieve these goals: startsmall, build capacity, work with regulatory authorities, and understand the market ina particular country before scaling up. This means developing in-country capacity by
manufacturing simpler, low-cost products before widening manufacturing to include
more complex outputs.
⇒ One participant highlighted how social responsibility programmes can offer generic
medicine manufacturers key insights into how to develop viable business models in
LMICs. Learning from these programmes can help companies identify and overcome
local barriers to access, understand the commercial feasibility of operating in LMICs
and make the case for investment in those markets.

“Having a local presence has really helped us, it's given us a platform through which we can quickly
introduce new products into the market, and we can understand what the needs are through ourstrong networks with local hospitals and local government institutions.”•

Apply lessons learned from the ecosystems around HIV, TB and malaria: Over recent decades,
international multistakeholder efforts to tackle HIV, tuberculosis (TB) and malaria have led tothe development of ecosystems specifically focused on ensuring patients in LMICs haveaccess to treatments for those diseases. As part of this, there has been extensive funding
from the global health community, with key initiatives including the Global Fund to Fight
AIDS, Tuberculosis and Malaria and the Global Drug Facility (GDF) for tuberculosis. In theworkshop, participants shared views and insights on what lessons can be learnt from theprogress in HIV, TB and malaria, and how – or whether – they can be applied more widely to
expand access to essential health products in LMICs.
⇒ For companies, the international pooled procurement mechanisms, advance market
commitments and market-shaping facilities built to tackle HIV, TB and malaria havehelped to ensure clarity about demand for products, and greater certainty about
achieving a return on investment. The companies therefore see the commercial casefor manufacturing those products and making them available in LMIC markets.
⇒ One participant pointed out that, for many diseases, and especially for noncommunicable diseases (NCDs), similar international frameworks and ecosystems areunlikely to be established on the same scale. Companies should not solely rely oninternational donor programmes to sustain access, and should be proactive about
pursuing access to essential products outside of these frameworks, while making useof insights gained from working within them.
⇒ Through participation in these disease-specific systems, generic medicine
manufacturers have gained valuable experiences in LMICs that they can apply for

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different disease areas. For example, companies have gained experience inregistration processes and working with local partners, and gained insight into howhealth systems function in LMICs.
⇒ Supranational procurement agencies can help to pool demand and coordinate supply,
providing greater certainty about the market for particular drugs – including those
produced by generic medicine manufacturers. 1“Patients living with HIV, TB and malaria have benefitted tremendously from focused global
attention…. [we need to] build on the learnings from that ecosystem.”“We don't see enormous appetite for donors to come in and establishing a global procurement fundfor NCD medicine... it is going to be very much more about countries developing these ecosystems. If
there is going to be money going in from the public sector, it will be supporting countries to establish
ecosystems and to have a much clearer and much simpler pathway.”•

Look for solutions around payment: It was shared as a common concern among generic
medicine manufacturers that payments for products procured by some lower-income
countries’ governments may be delayed or incomplete. If this happens, the continuous supply
of medicines may be interrupted until the debt is cleared, with negative effects for patients –and companies may become reluctant to enter into new contracts or introduce new products
into those countries. To pre-empt and reduce this risk, generic medicine manufacturers andother stakeholders can seek different ways of working. For example, generic medicine
manufacturers can make use of international procurement organisations, or work moreclosely with national governments on contracts that take into consideration more flexible
payment schemes and payment plans that work for the countries involved.

3. Toolkit of approaches for expanding access in LMICs
Building on the discussion around generic medicine manufacturers’ role in access to medicine, several
speakers and participants shared experiences and insights about specific approaches that had been –or could be – taken. They delved into both the challenges and opportunities of particular strategies,
and discussed practical ways in which they can be made a reality.
•

1

Invest in local manufacturing to ensure continuous supply: Local manufacturing of essential
medicines and vaccines, and wider investment in supply chain security, can help safeguard
local availability and ensure that those who need products can access them rapidly – a topic
that was explored in depth during the Access to Medicine Foundation’s April 2022 workshop
on Global Health Security. This is particularly true during times of crisis, and companies andother global health stakeholders are taking lessons from the disruption COVID-19 caused to
global supply chains. To ensure sustainable continuity of supply, generic medicine
manufacturers can develop or scale up local manufacturing capacity in LMICs, either directly
or by working in partnership with local manufacturers.

Global and regional organisations involved in procurement for a range of products targeting different diseases
include United Nations Children’s Fund (UNICEF); United Nations Population Fund (UNFPA); Pan American
Health Organization (PAHO) Strategic Fund; Southern African Development Community (SADC); and Common
Market for Eastern and Southern Africa (COMESA).
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“Incentivising local manufacturing… I think is a really powerful instrument. COVID-19 demonstrated
very clearly to people that global markets are great in good times, and they tend not to work so wellwhen they're particularly put under stress.”••

Consider working with international procurers: There can be positive effects of partnering
early on with procurement agencies – such as global heath bodies, regional initiatives andnational governments – as well as with implementing partners on the ground. For a new
product launch, determining supply logistics early on can help smooth out the process andensure the product reaches the people who need it.
Seize licensing opportunities: Participating in voluntary licences issued by the patent-holder(i.e. a research-based pharmaceutical company) is one way to increase the supply of essential
patented drugs, and make them more widely available and affordable in LMICs. Generic
medicine manufacturers can also seize opportunities where the patent holder has issued a
non-assert declaration (NAD). Not all generic medicine manufacturers are currently set up to
engage in voluntary licensing; but when such companies do step in to improve access to new,patented drugs, those innovative products are more likely to reach patients living in LMICs,
and are more likely to be marketed at an affordable price point.
⇒ In the workshop, participants also raised important issues around transparency, and aneed for greater tracking of whether and how manufacturers are fulfilling licensing
agreements and the outcomes of licences after they are issued. For example, did thelicensee actually file the product for registration and make it available in low-income
countries included within the terms of the licence, or did it only focus on middleincome markets that are typically more lucrative?

“How that licence is implemented by different manufacturers can vary quite widely… fundamentallywhat it [the licence] provides are certain rights, and how those rights are then exercised is critical tothe extent to which that licence will actually result in access at the end of the day.”••Ensure product affordability: Participants in the workshop emphasised the importance ofusing pricing strategies to make their products affordable in LMICs, identifying gaps where
patients are missing out on essential medicines and where the need is greatest. For example,
affordability is a particular problem in low-income countries where people usually pay forcare out of their own pockets. It is also a problem for products for non-communicablediseases, including diabetes - with many people with diabetes in LMICs currently unable toafford insulin.
Explore strategies to overcome registration challenges: Filing for registration is an importantfirst step in making any medicine available in a country, but many products are not filed in
LMICs – including some of the older but essential medicines, like antibiotics. Participants
touched on some of the commercial reasons why companies may not prioritise registration in
LMICs, such as a lack of clarity around local regulatory requirements and capacity from
regulatory authorities to assess dossiers. For example, launching a biosimilar product canrequire resource-intensive clinical trials as part of the regulatory process. However, thediscussion also explored some of the ways in which generic medicine manufacturers canactively work to find solutions. Suggestions included:

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••⇒ Alongside other global health stakeholders, generic medicine manufacturers can
explore ways to streamline registration processes in LMICs, e.g. by applying for WHO
pre-qualification, or by using collaborative registration procedures (for more
examples, see footnote). 2⇒ Generic medicine manufacturers can leverage their local presence in LMIC markets
and work with regulatory agencies to understand regulatory needs.
⇒ Another strategy suggested during the workshop was to prioritise registration inestablished LMIC markets first, and then move on to other less-established markets.
When the originator product was never introduced in a market, explore different approaches:
One of the challenges generic medicine manufacturers can face is that in many LMICs, theoriginator product was neither registered nor structurally introduced by the originatingcompany. This means the generic medicines, when introduced by companies in LMICs, are
not yet fully integrated into the continuum of care. To overcome this hurdle, generic
medicine manufacturers can explore public-private partnerships, and work with local
implementation partners, national governments, and organisations that can help withcapacity building – e.g. around ensuring proper storage, and training nurses and pharmacists
about how and when to use this product. This can reduce the financial burden of launching
the new product, and makes sure it is properly and safely introduced into the continuum ofcare.
Engage in adaptive R&D: Generic medicine manufacturers can address global health R&Dpriorities by adapting products to local contexts and the needs of populations in LMICs. This
could include, for example, developing paediatric formulations that are easier to administerto young patients. While not all generic medicine manufacturers currently engage in adaptive
R&D, some companies take on this role. This is an area with the potential for game-changing
developments that could ensure more people in LMICs have access to medicine.

“Through active partnerships we can take the most innovative ideas from around the world and use
our development capabilities to create targeted products that bridge the gaps in access for LMICs.”•

2

Contribute to local capacity-building in LMICs: Generic medicine manufacturers can play animportant role in building up the skills and knowledge of personnel involved in the
manufacture or distribution of their products, and healthcare professionals who administer orprescribe their products. For example, companies with antibiotics in their portfolios have aclear role to play in educating healthcare workers on antimicrobial resistance andstewardship, thereby also protecting the longer-term effectiveness of their product. As
discussed above, forming public-private partnerships with implementing organisations canalso ensure a product is successfully introduced into a new market.

To facilitate authority assessments, generic medicine manufacturers can engage more systematically withmechanisms designed to facilitate product registration in low- and middle-income countries. They can also seek
approval from Stringent Regulatory Authorities (SRAs) recognised by the World Health Organization. Suchmechanisms might include: The World Health Organization’s (WHO) prequalification system; The WHO
Collaborative Registration Procedure, The African Medicines Regulatory Harmonization (AMRH) programme;
The African Medicines Agency (AMA); or the European Medicines Agency (EU-M4all, or article 58)
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Three key takeaways
Generic medicine manufacturers have a central – yet evolving – role in the global health landscapeand are well-placed to seize opportunities to make their products more available and accessible in
LMICs. This workshop explored the role of the generics industry in improving access to essential
health products in low- and middle-income countries (LMICs), both today and in the future.
The Access to Medicine Foundation is now expanding its work to mobilise generic medicine
manufacturers to ensure greater access to generic medicines in LMICs. The Foundation will
engage companies that hold dominant positions in key regional markets, including some of the largest
players in the generic sector, to monitor companies’ actions in access, identify opportunities to bridge
key access gaps, and capture best practices. Points raised during the workshop will help to inform thedevelopment of this new research programme. The three key takeaways from the workshop are:1. Generic medicine manufacturers have more opportunities in ensuring access to medicine, beyond
their conventional role. By manufacturing drugs at high volumes and selling them for relatively low
costs, the generics industry inherently expands access to medicine. However, simply producing ageneric product does not guarantee access to that product in LMICs – and this is especially the casewhen it comes to low-income countries. As indicated by participants in the workshop, generic
medicine manufacturers increasingly acknowledge and embrace the proactive role they can take inexpanding access to medicine globally, beyond the traditional high-volume / low-cost business model.
2. Viable business models that build in access to medicine can, and should, be developed. Generic
medicine manufacturers can develop business models with long-term sustainability of access at theircore, reconciling the need for commercial viability with approaches that result in greater access togenerics and biosimilars in LMICs. Over recent decades, multistakeholder efforts to ensure universal
access to treatments for diseases including HIV, TB and malaria have led to valuable insights, some ofwhich can be used to inform strategies more widely; but viable business models can also be identified
and implemented in disease areas that have not received such international attention and funding.
Workshop participants highlighted a range of approaches to expanding access sustainably, including
engaging in public-private partnerships to participate in regional procurement initiatives and build
local capacity. There are ways to explore whether a new approach is viable, such as by starting smalland scaling up; in other cases, companies can take a ‘leap of faith’.
3. Generic medicine manufacturers can build on their strengths to overcome challenges specific to
LMICs. Particular challenges exist in LMICs that can deter generic medicine manufacturers, such as
registration hurdles and lower commercial market potential. One common challenge is that, when theoriginal brand-name product was not introduced or made widely accessible in many LMICs, launching
the generic version in those countries can be a more uncertain prospect – as the drug is not yet
integrated into the continuum of care, and demand can be harder to predict. To overcome suchchallenges and provide equitable access to their products, companies can capitalise on their at-scale
manufacturing expertise and adaptive R&D capacities, while also developing new approaches tosupport broad access and affordability. For example, they can enter into partnerships to better
understand demand for the product, and therefore align supply; they can leverage collaborative
registration procedures; and they can adapt products to better suit the needs of patients living in
LMICs.
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