Generic & Biosimilar
Medicines Programme
2023
ANALYTICAL FRAMEWORKGeneric & Biosimilar Medicines Programme - 2023 Analytical Framework

ACKNOWLE DG E M E NTS

The Access to Medicine Foundation would like to thank all the representatives of the many different stakeholders who contributed their views to
the development of this framework.
FU N D E RS

This report was created with support from:UK Foreign, Commonwealth, and Development Office
Leona M. and Harry B. Helmsley Charitable Trust
AXA Investment Managers

E XPE RT CO M M IT TE E

AUTH O RS

E D ITO R IAL TE AM

Hans Hogerzeil (Chair)

Claudia Martínez

Eleanor Bley Griffiths

Alex Bernhardt

Danielle Barnum

Tessa Wiles

Esteban Burrone

Camille Romero

Sudarshan Jain

Natalia Sánchez Villalobos

Suzette Kox

Pandora Zilstorff

Nazeem Mohammed
Bart van Osch
Mariana Roldão Santos
Fatima Suleman
Mariatou Tala Jallow
Prashant Yadav
This acknowledgement is not intended to imply that the individuals andinstitutions referred to above endorse the framework for the Generic &Biosimilar Medicines Programme, analyses or results. Decisions regarding inclusion of all feedback were ultimately made by the Access to
Medicine Foundation.

ACCESS TO M E D I CI N E FO U N DATI O N

The Access to Medicine Foundation is an independent non-profit organisation that seeks to transform the healthcare ecosystem by motivating
and mobilising companies to expand access to their essential healthcare
products in low- and middle-income countries.
Naritaweg 227-A
1043 CB, Amsterdam
The Netherlands
For more information about this publication, please contact
Claudia Martínez, Research Programme Manager
cmartinez@accesstomedicinefoundation.org+31 (0) 20 215 35 35
www.accesstomedicinefoundation.org

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Access to Medicine Foundation

Table of contents4	Introduction▶ Bringing generic and biosimilar medicines within reach▶ Understanding access-to-medicine barriers▶ The first-ever framework to track and guide manufacturers’
actions in access▶ Building the framework
13

What the framework measures▶ Scopes and inclusion

17

Analytical framework▶ Expanding access▶ Supply & quality▶ Research & development

26	Appendices38

References

3

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

I NTRO DUCTI O NBringing generic and biosimilar medicines
within reach
Generic medicines account for the vast majority of the global supply of pharmaceuticals.1 Yet, even though generic medicines are generally priced more affordably
than patented originator medicines, there are still huge global access gaps. Many
people living in low- and middle-income countries (LMICs) simply do not haveaccess to an affordable, reliable supply of the medicines they need.

2

As at-scale suppliers of essential medicines, the impact and global footprint ofgeneric medicine manufacturers is immense. Among the medicines included on
the World Health Organization (WHO)’s Model List of Essential Medicines (EML) –meaning that they ought to be available in every country’s health system – only 10%
are on-patent, i.e. covered by a patent that excludes other companies from making
or marketing the drug unless permissions are explicitly granted.3,4 This indicatesthe central role of off-patent medicines, i.e. generics or biosimilars, as essential
treatments across the world. Consequently, if generic and biosimilar medicine manufacturers step up their efforts to expand access to their products to more people
living in LMICs, they can move the dial on access to medicine. Greater action by
these companies, alongside other global health stakeholders such as national governments, is vital to achieving universal health coverage (UHC) and the Sustainable
Development Goals (SDGs), specifically Goal 3.
In recognition of the critical role generic and biosimilar medicine manufacturers
can play in tackling global health inequities by ensuring and expanding access tomuch-needed medicines in LMICs, the Access to Medicine Foundation has launched
the Generic & Biosimilar Medicines Programme. The programme’s first analyticalframework, outlined in this report, will form the basis of a per-company assessment of the actions and strategies of some of the world’s leading generic medicine
manufacturers.
Generic medicine manufacturers have shown their potential to scale up
Past actions from the generics industry show that when efforts are concentrated
and focused, global scale-up of supply is possible. For example, the industry has
been instrumental in scaling global access to quality-assured and low-cost antiretroviral medicines for the treatment of HIV/AIDS. Manufacturers have also createdlower-priced generic versions of sofosbuvir, an essential treatment for hepatitis C,
by engaging in licensing agreements.5–7
During the outbreak of the COVID-19 pandemic, manufacturers leveraged theirat-scale manufacturing capacity to rapidly respond to the crisis. They ensured thatmany existing medicines remained available, despite global supply chain disruptions,and stepped in to manufacture health products for the treatment of COVID-19, suchas dexamethasone.8 Generic medicine manufacturers also helped manufacture andsupply products for COVID-19 through their engagement in non-exclusive voluntary
licences. For instance, several generic medicine manufacturers signed agreementswith the Medicines Patent Pool (MPP) to manufacture and distribute certain antivirals in LMICs, including molnupiravir, remdesivir, and nirmatrelvir.9–11
Challenges and opportunities
There are still many challenges to tackle, and opportunities to seize, in expanding access to generic and biosimilar medicines. While standout examples arehighlighted above, they are few and far between. For many people in LMICs, and4

WHAT ARE GENERIC AND BIOSIMILAR
MEDICINES?
▶Generic medicines are pharmaceuticalproducts developed and manufactured to be
identical to the originator medicine alreadyauthorised and offer the same therapeuticand clinical benefits containing the sameactive pharmaceutical ingredients (APIs),
dose, strength, and route of administration.
They comply with the same stringent rules
and regulations regarding quality, safety andefficacy as the originator product, which has
already been marketed.19 Generic medicines
can be classified as either branded generics(generic medicines with a specific tradename) or unbranded generics (which use theInternational Non-proprietary Name (INN)).
▶Biosimilar medicines are biologicalproducts that are highly similar to an alreadyauthorised biological medicine (the reference
product), which has received approval for
use and market authorisation.20 A biosimilar
medicine is not referred to as a generic ofa biologic medicine, because of the naturalvariability as well as the greater complexity
in the development and manufacturing processes which prevents biosimilar medicinesfrom being replicated exactly.20,21 Biosimilar
medicines offer the same therapeutic efficacy,clinical benefits and safety profile as theoriginal biological medicine.21,22
The Generic & Biosimilar Medicines
Programme focuses solely on generic andbiosimilar medicines that are quality-assured– i.e., those that are required to comply withstringent rules and regulations regarding
quality, safety and efficacy.

Access to Medicine Foundation

particularly for those living in the poorest countries and/or those from vulnerable
populations, including women and children, many generic and biosimilar medicines
are unavailable or unaffordable.
The following pages of this report explore key concerns, including weak supply
chains; quality assurance; variations in pricing and affordability; security of supply;and difficulties in demand-planning and healthcare systems. For people living in
LMICs, one additional difficulty can be that products are not adapted to their needs;
there are challenges and opportunities here, too, in adaptive R&D. For example,
companies can create heat-stable versions of medicines for use in areas without
reliable refrigeration, or can develop practical combinations for certain populations,such as for treating malaria in children and babies.
How biosimilar medicines fit into the picture
In recent years, technological advances, combined with the expiration of patents
for some significant biologic drugs, have ushered in the development of biosimilar medicines (see box, previous page). The introduction of these products canincrease competition in the market, offering the potential for lower prices.12,13 Whilebiosimilars are increasingly used for the treatment of a range of diseases, including
several cancers and autoimmune diseases, these medicines currently have a highprice-point, limiting their reach in LMICs.1,14
However, the biosimilars market is now growing, especially as a number of patents have expired (or are soon set to expire) on blockbuster biologics, including
many essential medicines. More generic and biosimilar companies are engaging inlicensing activities enabling them to develop biosimilars and launch these products
in LMICs, leveraging their commercial capabilities to tap into the growth of the biosimilars market and expand their portfolios to include biosimilar medicines.15–18
Looking ahead
Many people living in LMICs do not have access to quality-assured generic and biosimilar medicines, whether that be because they cannot afford them, or because
the products are simply not available. Without sustained effort and collaboration,
inequalities in healthcare will continue to widen.
Generic and biosimilar medicine manufacturers have huge potential to change
this situation. By design, generic and biosimilar versions of medicines are intended
to be more affordable and accessible than the originator product, but there is now
an opportunity for companies to go further by leveraging their capacity and expertise to ensure their products reach the people who need them. This framework will
set out some of the positive ways generic and biosimilar medicine manufacturers
can improve access to medicine in LMICs, ahead of an analysis of what some of theleading companies are currently doing in each of these areas.

5Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

A fragmented market, with a few key players
The global market for generic and biosimilar medicines is heterogeneous and highly
fragmented with numerous manufacturers supplying at the global, regional, andFIGURE 1 Examples of market share of

local level. This includes large multinational companies with global footprints ingeneric medicines, by volume

contrast to the regional and local players who operate at a comparatively smallerscale within regional and domestic markets.23 People across the world, and particularly those living in LMICs, rely heavily on the supply of generic medicines. The
market share of generic medicines is estimated at 97% for India, 84% for Brazil and
70% for South Africa (see Figure 1).24 Similarly, many of the essential medicines
procured internationally through international pooled procurement schemes are
Brazil: 84%

generic medicines, with generic medicines accounting for an estimated 87% of the

India: 97%

medicine volume procured in the Caribbean region. A significant portion of thisSouth Africa: 70%

25

global supply is manufactured in LMICs, with estimates suggesting that 20% of the
global volume is manufactured in India and subsequently exported to upwards of
200 countries.26

Market growth trends of generic and biosimilar medicines
The global market for generic medicines has grown substantially over the last years

FIGURE 2 The global market value of generic
medicines is growing

and is projected to reach USD 442.3 billion by 2027 (up from USD 311.8 billion in2022), growing at a compound annual growth rate (CAGR) of 7.24% (see Figure

The overall global market
value of generic medicines
was USD 311.8 bn in 2022
and is projected to rise to
USD 442.3 bn in 2027.

2).27–29 This is in part fuelled by the rise in chronic diseases, patent expiries of originator products and efforts by governments to contain healthcare costs.30

Latin America:
USD 37.1 bn to USD 50.7 bn.
2022

2027

Middle East and Africa:
USD 31 bn to USD 42.7 bn.

The global biosimilars market will reach USD 60.8 billion by 2027 (up from USD 13
billion in 2021), growing at a CAGR of 26.1% during 2022-2027 (see Figure 3).31–33

FIGURE 3 The global market value ofIn recent years the biosimilar market has been growing at a rapid rate. This is, inbiosimilar medicines is smaller, but risingpart, due to key blockbuster biologics coming off-patent, which enables biosimilar

rapidly

manufacturers to launch competing products. In particular, the expiry of patents on

The overall global market valueof biosimilar medicines was USD
13 bn in 2021 and is projected torise to USD 60.8 bn in 2027.

key products for non-communicable diseases such as cancer and diabetes has created an opportunity for the launch of more affordable biosimilar versions.33–35 For
example, on-patent cancer medicine pembrolizumab will lose its market exclusivity
in various countries in 2028; this medicine is listed on the WHO EML, and is usedin cancer immunotherapy to treat melanoma, lung cancer, head and neck cancer,
hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast
cancer.36,37

6

2021

2027

Although data for theequivalent time period does
not exist, the market value
for Latin America was USD
517 million in 2018, and is
projected to rise to USD 3.9
bn by 2025. For the Middle
East and Africa, the value
was USD 344.8 million in
2018, with a projection of
USD 2.1 bn by 2025.

Access to Medicine Foundation

Understanding access-to-medicine barriers
The expiry of patents and other exclusivity rights means generic and biosimilar
medicine manufacturers can introduce generic or biosimilar versions to competewith higher-priced originator brands. However, there are still many barriers impacting the expansion of access to cost-effective and quality-assured generic and biosimilar medicines in low- and middle-income countries (LMICs).
Despite their comparatively cheaper prices, generic and biosimilar medicinesremain unaffordable for many
Stark inequalities in the price of medicines, and particularly those medicinesclassed as essential according to the World Health Organization (WHO)’s Model
List of Essential Medicines (EML), mean that many people are unable to accessthe treatments they need. While generic medicines are generally priced lower thanoriginator products, they can still be unaffordable for many people living in LMICs.
In some LMICs, and most notably in Least Developed Countries, essential generic
medicines can cost 20 to 30 times more than a minimum international reference
price – a method for benchmarking and comparing prices of pharmaceutical products amongst countries.38
Affordability concerns are particularly prevalent for products targeting non-communicable diseases (NCDs). For example, in India and South Africa, an essential
treatment for breast cancer can cost around 10 years of average annual wages.37,39
Even older and off-patent essential cancer medicines are associated with catastrophic out-of-pocket expenditures for people living in LMICs.37,39 Many NCDs
require chronic, long-term treatment and care, resulting in high medical costs
across a person’s lifespan, for example diabetes mellitus, which is treated with insulin. Yet, while the availability of several insulin biosimilar versions has led to lower
prices than for originator brands in some LMICs, in some countries the introductionof biosimilars has not been matched by significant price reductions.40,41 There aremany factors that limit the affordability of biosimilar and generic medicines for
NCDs in LMICs, and it is important for companies and other global health stakeholders to address these access barriers.
A market comprised of multiple generic manufacturers is needed for each product, in order to ensure sufficient competition and foster downward pressure on
prices. In the US market for generic medicines, a 39% drop in price is seen after one
entrant; 54% with two; 74% with four; and up to 95% with six or more competitors
entering the same market.42 Conversely, too few players can result in market concentration and monopolies, ultimately jeopardising the supply of affordable essential medicines.43 This is especially concerning for smaller LMICs, where competitionis generally more limited.38
The availability of quality-assured essential medicines remains limited in LMICs
People in LMICs face many challenges in accessing generic medicines, with one of
the core challenges being unavailability. Despite the WHO’s voluntary target of 80%
availability of affordable essential medicines, research from one study showed thatacross the 37 LMICs analysed, the median availability of selected generic medicines
was only 57% in the public sector and 65% in the private sector.44 In particular,
within the public sector of many LMICs, there is often a lack of quality-assured
generic medicines for chronic conditions including cardiovascular diseases, diabetes
and asthma.45
Generic and biosimilar medicine manufacturers can facilitate the availability ofessential medicines by bringing products to market soon after patents have expired,by rapidly filing the product for registration in a range of LMICs and/or applying for7

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

WHO prequalification for eligible products. However, manufacturers may be cautious about entering LMIC markets. For example, when the originator product has
not yet been introduced in LMICs, there can be uncertainty around launching thegeneric version – as the drug is yet to be integrated into the continuum of care, anddemand can be harder to predict. While the regulatory framework for the licensingof generic medicines is well established in most countries, obtaining market authorisation can still be a costly and lengthy process, particularly in countries without
strong national regulatory authorities.46,47
Registration of biosimilar medicines presents a different set of challenges, due
to their complex manufacturing processes and the fact that they are non-identicalto the originator medicine. Manufacturers must demonstrate similarity to the reference biological medicine through analytical comparability, pre-clinical in-vitro andin-vivo comparability and clinical bioequivalence studies, which requires investment
by companies, as well as expertise, capacity and resources within national regulatory agencies to ensure that products meet acceptable levels of quality, safety andefficacy.35,48
Additionally, if the reference product for the biosimilar medicine has not yet
been filed, registering and introducing the biosimilar medicine in the respective
country becomes more complex and challenging. Efforts from governments tostreamline regulatory guidelines, as well as the expansion of WHO’s prequalification
programme to biosimilar medicines, are important steps to facilitate and speed
up regulatory uptake of quality-assured biosimilar medicines in LMICs.49 In recent
years, several key biosimilar products have attained WHO prequalification, including
human insulins and the cancer medicines rituximab and trastuzumab.50,51
In addition to registration, many LMICs face chronic challenges in ensuring a sustainable supply of quality-assured medicines due to stock-outs and a lack of healthcare infrastructure. The supply chain can also be severely impacted when there isan over-reliance on only a few manufacturers of finished products or raw materials,
such as APIs.52 For example, in Zambia one company is responsible for the supplyof 98.7% of contraceptives, and in Senegal there is one company overseeing 72.4%
of medicines for diabetes.38 In 2020, stock-outs, exacerbated by the COVID-19
pandemic, made it virtually impossible to fill prescriptions for psychiatric drugs andoral contraceptives in South Africa.53 To prevent stock-outs companies can takespecific steps, including ensuring sufficient or committed capacity to meet demand,transferring knowledge and expertise to local parties to build local manufacturing
capacity or by leveraging their geographical footprint to rapidly respond to demand
coming from different regions.
Good manufacturing practices are also essential to ensure that medicines are
manufactured at a scale and quality that ensures safe and reliable access. The useof substandard or incorrect APIs, raw materials and packaging components, poor
environmental conditions throughout the manufacturing process, and failure toindicate the necessary storage conditions on the product’s packaging can all impact
and severely jeopardise the quality of products.54 Generic and biosimilar medicine
manufacturers can implement strategies for continually monitoring their manufacturing processes and ensuring that their own facilities and those of third-party
manufacturers comply with internationally recognised quality standards. To ensure
products meet stringent quality standards for international procurement, companies with eligible products can engage in WHO prequalification or seek regulatory
approval through WHO Listed Authorities (WLAs). To help safeguard the qualityof products, efforts can also be made to both improve supply chain management
capabilities and implement strong systems for ensuring drug quality and safety. Thisis particularly important for medicines that require continuous cold-chain storage,such as oxytocin, which if not stored at 2-8°C will degrade and lose its potency.54–56

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Access to Medicine Foundation

Not all products are suited to the needs of people living in LMICs
Health products are only beneficial when they meet the priority healthcare
needs of the population and can be deployed effectively in a particular setting.
Medicines developed for deployment in high-income settings may therefore notalways be appropriate for dispensing in LMICs. As such, when introducing medicines into LMICs, certain adaptations may be necessary to help overcome context-specific access issues. Adaptions may include heat-stable variations, paediatric formulations, fixed-dose combinations or long-acting injectables, and should
consider local needs, gaps in local health-care infrastructure, and environmental
conditions in LMICs.57,58
For example, studies have shown that over half (59%) of healthcare facilities
across certain LMICs lack the reliable electricity supply needed to power cold
chain storage equipment, and similarly, throughout sub-Saharan Africa, only 28%of healthcare facilities have access to reliable electricity.59,60 Such challenges canbe overcome by developing heat-stable formulations for products that currently
require cold chain storage, thereby enabling access for people living in LMICs.
Some products also need to be adapted for different demographic groups,
particularly for babies and children, for whom there are a lack of available andappropriate treatments.57,61 Manufacturers can create palatable flavours anddevelop differing dosages or fixed-dose combinations for paediatric use, which
may improve ease of administration, dose flexibility, and therefore, advancetreatment adherence.61,62 Such examples underscore the importance of adapting formulations for essential medicines and bridging critical gaps in treatment.
Manufacturers can carry out adaptive projects either in-house or through partnerships with other organisations, such as product development partnerships(PDPs).
Vulnerable and underserved populations face particular access-to-medicine
challenges
Many of the world’s most vulnerable people struggle to access the life-saving medicines that they need. The situation is heightened for those in Least
Developed Countries, as they are often overlooked by manufacturers due to a
combination of several or all the barriers highlighted above. Additionally, certain
vulnerable groups, such as women and children (especially girls), members of
the LGBTQIA+ community, people from indigenous and minority communities,
those living with disabilities and/or mental health conditions and populations at
the lower tiers of the income pyramid, may face further barriers to access due
to stigma and economic constraints. For instance, while many essential mental
health treatments are currently available in generic form, between 76% and 85%of people in LMICs with severe mental disorders do not receive the treatment
they need.63 Many of these barriers also extend to people living in conflict zones
or informal settlements, who may lack access to the traditional health system andrely on donations in order to access the medicines they need.
To maximise the availability of their products to the most vulnerable people, generic and biosimilar medicine manufacturers can leverage their at-scale
manufacturing expertise to increase supply or design systems of intra country
differential pricing to reach the lowest economic tiers, either independently or inpartnership with other organisations. They can also engage in donations, which
are particularly relevant in the event of natural disasters, humanitarian crises andother circumstances when needs are high.

9Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

The first-ever framework to track and guidemanufacturers’ actions in accessTo date, there has been no publicly available tool for mapping the efforts ofgeneric and biosimilar medicine manufacturers to make their products moreavailable, accessible, and affordable in LMICs. The goal of the Access to Medicine
Foundation’s Generic & Biosimilar Medicines Programme is to guide and incentivise companies to deepen their efforts to expand access to essential medicines in
LMICs. Generic and biosimilar medicine manufacturers have critical roles to play as
we track progress towards achieving the Sustainable Development Goals (SDGs) by
2030 and attaining universal health coverage (UHC).
The framework will map the actions of a group of companies that are well
positioned to make essential medicines available and accessible to patients living
in LMICs, assessed against the consensus view of the companies’ core roles andresponsibilities in global health, highlighting where greater engagement is urgently
needed and what good practice looks like. Companies will be assessed in threeareas: their capability to expand access to essential products; their capability toensure a continuous supply of quality-assured generic and biosimilar medicines;
and, when applicable, their capability to adapt products to meet the needs of people living in LMICs.
Bringing best practices and opportunities to the fore
The framework will guide an analysis of the access-to-medicine efforts of genericand biosimilar medicine manufacturers. By examining where and how these manufacturers are already taking action, the Generic & Biosimilar Medicines Programme
will bring best practices to wider public attention and facilitate greater information-sharing between companies and other stakeholders. It will build awareness of
issues and best practices by transparently documenting activities of manufacturers
linked to access to medicine, as well as highlight specific opportunities for thesecompanies to focus their efforts and break down access barriers in LMICs.

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Access to Medicine Foundation

Building the framework
The analytical framework for the Generic & Biosimilar Medicines Programme outlines the core roles and responsibilities of generic and biosimilar medicine manufacturers in access to medicine and sets out ambitious but achievable expectations foraction. To develop the analytical framework, the Foundation undertook a process of
examining existing sources and resources coupled with external engagement withkey stakeholders and subject matter experts.
Internal review and insight into generic medicine manufacturers
From December 2021 to February 2022, the Foundation established the broad
parameters for the analytical framework through a feasibility study and review of
relevant literature, comprising of academic papers, peer-reviewed literature andpolicy reports from relevant organisations. The review sought to identify the key
areas where action from companies is most needed.
Initial stakeholder dialogue
In April 2022, the Foundation convened a workshop with experts working with andwithin generic and biosimilar medicine manufacturers and/or industry associations
to discuss the core roles and responsibilities of manufacturers in improving accessto medicine and to identify tangible strategies for future action.64 The workshop
highlighted concrete examples of how companies are currently working to improveaccess to medicine within LMICs and focused on opportunities to further leverage
their capabilities to expand access to medicine beyond their conventional roles inmanufacturing and supplying affordable generic medicines.
Targeted stakeholder engagement process
From April 2022 to July 2022, the Foundation undertook a targeted external stakeholder engagement process to refine the analytical framework and toensure a diverse range of viewpoints and technical expertise were incorporated.
Consultations were held with over 60 experts across the pharmaceutical andaccess-to-medicine ecosystem, including individuals working in industry and tradeassociations, non-governmental organisations (NGOs), global health organisations,research and academic institutions, private organisations, procurement agencies,and governments. This process sought to establish the core roles and responsibilities of generic and biosimilar medicine manufacturers in access to medicine and toensure that the framework is a rigorous tool that can assess company action overtime. The experts consulted provided critical and in-depth insights into specificquestions and concerns, with a focus on company actions that can make a tangible difference. Core topics for discussion included the research areas, themes andassessment parameters for industry analysis.

FIGURE 4 Overview of experts andstakeholders consulted

Partnerships (inc. PDP, PPP): 1%
Governments and regulators: 3%
Procurement agencies and experts
Private organisations, e.g. consultancies
Global health organisations
NGOs

5%
7%

20%

13%
17%
17%

17%

Stakeholders and experts
from industry/trade associations
Clinicians, pharmacists anddisease experts from LMICs
Research and academic institutions

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Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

Role of the Expert Committee
The framework proposals were reviewed by an Expert Committee (EC) comprisedof 11 experts, including from industry associations, the private sector, research
and academic institutions and international and non-governmental organisations.
The EC discussed the areas where issues and uncertainty remained and provided
strategic guidance to ensure the proposals were robust and relevant for company
assessment and represented areas where industry analysis would be the mostchange-making.
Expert Committee members:

12

Hans Hogerzeil, chair

University of Groningen and formerly World Health Organization (WHO)Alex Bernhardt

BNP Paribas Asset Management

Esteban Burrone

Medicines Patent Pool (MPP)

Sudarshan Jain

Indian Pharmaceutical Alliance (IPA)

Suzette Kox

International Generic and Biosimilar Medicines Association (IGBA)

Nazeem Mohammed

Aga Khan Fund for Economic Development (AKFED)

Bart van OschIDA Foundation

Mariana Roldão Santos

World Health Organization (WHO)Fatima Suleman

University of KwaZulu-NatalMariatou Tala Jallow

TalaConsult

Prashant Yadav

Center for Global Development (CGD)Access to Medicine Foundation

What the framework measures
The framework for the Generic & Biosimilar Medicines
Programme assesses company action relating to a specificsubset of diseases and products and within a specific geographic scope. The following pages set out the rationale forthese scopes and how they have been defined.

TABLE 1 Scopes for the Generic & Biosimilar Medicines ProgrammeCompany inclusion

An initial group of five generic and biosimilar
medicine manufacturers selected based on a combination of global revenue, dominance in regional
markets and relevance of product portfolios forlow- and middle-income countries.

Disease scope

82 diseases, conditions and pathogens:• 22 communicable diseases;• 18 non-communicable diseases;• 20 neglected tropical diseases;• 10 maternal and neonatal health conditions;• 12 priority pathogens.

Geographic scope

108 low- and middle-income countries.

Product scope

102 off-patent essential health products listed on
the 22nd World Health Organization Model Listof Essential Medicines. The products included
represent those with proven affordability andavailability issues in low- and middle-income countries. For each company, up to five in-licensed
products are also in scope.

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Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

Scopes and inclusion
Company inclusion
The Generic & Biosimilar Medicines Programme assesses a core group of genericand biosimilar medicine manufacturers on their policies and practices in improving
access to medicine for people living in low- and middle-income countries (LMICs).
Considering their portfolios, resources, global reach or local presence, these companies have clear opportunities and responsibilities to increase access to medicine.
Companies are selected for inclusion based on a combination of criteria. These
include whether they ranked in the top 10 by global revenue; hold dominant positions in key regional markets; possess a relevant product portfolio for people living
in LMICs; possess a specific dominance in one or more disease areas; and/or are
identified by external stakeholders or industry experts as priorities for inclusion.
The selection of companies included within the programme’s scope may evolvein future based on changing market dynamics, e.g., divestments, mergers andacquisitions.
For the first company analysis based on this Analytical Framework, theFoundation will focus on five generic and biosimilar medicine manufacturers,
highlighted in blue in Table 2. Specifically, these companies are Cipla, Hikma, Sun
Pharma, Teva, and Viatris.
For future analyses based on this Analytical Framework, and for subsequentassessments as part of the Generic & Biosimilar Medicines Programme, the companies in scope may include, but are not limited to: Aché; Aspen; Aurobindo; Biocon;
and EMS.

TABLE 2 Generic and biosimilar medicine manufacturers in scope of
the programme
Name

Country

Stock exchange

Ticker2021 revenue (Bn USD)

Cipla LtdIND

NSE, Mumbai

CIPLA

2.921

Hikma Pharmaceuticals plc

JOR/GRB

LondonHIK

2.553

Sun Pharmaceutical Industries Ltd

IND

NSE, Mumbai

SUNPHARMA

5.188

Teva Pharmaceutical Industries Ltd

ISR

New York/Tel Aviv SE

TEVA

15.878Viatris Inc.

USA

NASDAQ

VTRS

17.886

Aché Laboratorios Farmaceuticos

BRA

N/a

N/a

0.723

Aspen Pharmacare Holdings Ltd

ZAF

Johannesburg

APN

2.368

Aurobindo Pharma Ltd

IND

NSE, Mumbai

AUROPHARMA

3.148

Biocon Ltd

IND

NSE, Mumbai

BIOCON

0.988

EMS S.A

BRA

N/a

N/a

0.822

Disease scope
The disease scope of the Generic & Biosimilar Medicines Programme is deliberately broad to ensure that all the policies and actions of the generic and biosimilar
medicine manufacturers are considered and captured following the same inclusion
criteria as set out in the methodology report for the 2022 Access to Medicine
Index.65 However, in contrast to the Index methodology, Disease X* is excluded
and coronaviral diseases are only included for in-licensed products - as no products for these diseases are currently listed on the World Health Organization(WHO)’s Model List of Essential Medicines (EML). As such, the Generic & Biosimilar
Medicines Programme considers 82 diseases, pathogens and conditions. One of

14*Disease X is defined by WHO as a pathogen currently unknown to cause humandisease that could cause a serious international epidemic.

Access to Medicine Foundationthese diseases is cancer, which encompasses 19 different sub-types. A full list of
the diseases (including cancer types), pathogens and conditions included within thescope of the programme can be found in appendix I.
Defining the disease scope of the programme
To define the disease scope and pinpoint those diseases, pathogens, and conditions for which
greater access to medicine is the most urgent, the Foundation used data on disease burden andincidence rates, together with independent prioritisations. Data from the Institute for Health
Metrics and Evaluation’s 2019 Global Burden of Disease study was used to outline the DisabilityAdjusted Life Years (DALYs). For cancer, data from the Global Cancer Observatory 2020 wasused.66,67

Geographic scope
The Generic & Biosimilar Medicines Programme measures the actions and practicesof generic and biosimilar medicine manufacturers in countries where the need forincreased access to medicine is the most urgent. The country scope for the programme follows the same inclusion criteria as set out in the methodology report forthe 2022 Access to Medicine Index.65 As such, the Generic & Biosimilar Medicines
Programme includes 108 LMICs. A full list of the countries included within thescope of the programme can be found in the appendices.
To define the geographic scope, the Foundation outlined three criteria for inclusion: (1) countries’ level of income (gross national income per capita); (2) level ofdevelopment, and; (3) scale and scope of inequality. Assessments for each country were based on data from the World Bank, the United Nations Development
Programme (UNDP) and the United Nations Economic and Social Council(ECOSOC).
Defining the geographic scope of the programme
Step 1: All countries classified (according to World Bank data) as low income or lower-middle
income were included;68
Step 2: 	All countries defined (according to the UNDP’s Human Development Index) as having low
or medium human development were included;69
Step 3: 	All high-development countries with a high inequality-adjusted HDI ratio (HiHDI) as
defined by the UN Inequality-Adjusted Human Development Index were included;69
Step 4: 	All least developed countries as defined by ECOSOC were included.70

FIGURE 5 Countries in scope of the Generic & Biosimilar Medicines
Programme

Legend: Basis for inclusion*● World Bank income classification● UN Human Development Index● UN Inequality-Adjusted Human
Development Index● ECOSOC LDC List*T
 he latest country income anddevelopment classifications are available
through the World Bank and UNDP data.
Due to scaling, countries may not be
visible on the map (e.g., Tuvalu)

15

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

Product scope
The Generic & Biosimilar Medicines Programme product scope includes 102 essential off-patent generic and biosimilar medicines used to treat a broad set of diseases. The Foundation developed this list following an extensive prioritisation process that included an in-depth review of peer-reviewed literature on each productand consultations with clinical subject matter experts. The products listed within
the product scope thereby represent products with pressing accessibility, availability, and/or affordability issues in LMICs.
To guide the inclusion of products for the programme, the Foundation developed
a prioritisation model outlining specific criteria. A full list of the products included
within the scope of the programme can be found in the appendices.
Product prioritisation process
For a product to be included within the product scope:• The product must be a medicine* or a contraceptive device**.
• The product must be listed on the 2021 WHO Model List of Essential Medicines or the 2021
WHO Model List of Essential Medicines for Children***.71,72• The product must be either a first- or second line treatment or indicated as standard ofcare as per treatment guidelines as listed by either the National Institute for Health andCare Excellence (NICE), Centers for Disease Control and Prevention (CDC) or the WHO.71–74
Specifically for cancer products, the European Society for Medical Oncology (ESMO) andNational Comprehensive Cancer Network (NCCN) guidelines were followed, and for antibiotics, the WHO’s 2021 AWaRe classification was used.75–77• The product must be off-patent. To cross-reference the patent status of each product datafrom MedsPal by the Medicines Patent Pool (MPP), Pat-Informed by the World Intellectual
Property Organization (WIPO), the Orange Book by the Food and Drug Administration(FDA) was used.4,78,79 Additionally, country specific databases were further cross-referenced, which included the Patent register by Health Canada and Intellectual Property
Database of South Africa among others.80,81• There must be evidence of access gaps for the product in LMICs. Such information was
sourced and cross-referenced through an in-depth review of peer-reviewed literature andpublic information for each product seeking to uncover robust evidence of access gaps.
• To be eligible for inclusion, the product must have been selected as a priority product by
one of the external stakeholders, in-country experts or pharmacists, disease specialists
and/or by one of the global health organisations consulted by the Foundation.
• For each company, up to five in-licensed products are also in scope. These have been (orwill be) chosen in consultation with the companies. Please see appendix V for further
information.

* Vaccines, both preventive and therapeutic, diagnostics, vector control products, microbicides, platform technologies and medicines used only for symptomatic relief are excluded from the product scope.

16**For contraceptives, only devices (such as
the implant) are considered. Instruments,
apparatuses, appliances, and other similaror related articles intended to be used tocontrol contraception (e.g., condoms, diaphragms or hormone-delivery contraceptive rings) are excluded.

*** Certain exceptions were made for asubset of the HIV/AIDS products, as multiple stakeholders emphasised the importance of these products despite them
not being listed as fixed combinations
on the WHO EML or WHO EML paediatric. Specifically, this refers to (1) dolutegravir (DTG)/lamivudine (3TC) (or emtricitabine (FTC))/tenofovir alafenamide(TAF) (DTG+XTC+TAF); (2) abacavir/lamivudine/dolutegravir (ABC+ 3TC+DTG);
and (3) darunavir/ritonavir (DRV/r), all ofwhich are listed on the 22nd WHO EML
or the 8th WHO EML for children but notnecessarily as combinations.

Access to Medicine Foundation

Analytical framework
The analytical framework identifies and outlines three areas
where generic and biosimilar medicine manufacturers have a
responsibility to improve access to medicine in low- and middle-income countries (LMICs).
This includes EA) Expanding Access; SQ) Supply & Quality;
and RD) Research & Development (R&D). These three areas,
referred to hereafter as ‘Research Areas’, represent thosewhere companies have the greatest opportunities to improveaccess to medicine, and where an assessment of company
activity could have the greatest impact. Each Research Area
includes specific themes with corresponding assessment
parameters to assess manufacturers’ actions and to identify
tangible opportunities for improvement (see table 3).

TABLE 3 Overview of Research Areas and themes
E XPAN D I N G ACCESS
Themes in this research area:
EA1. Access-to-medicine strategy
EA2. Product registration
EA3. Expanding access & pricing strategies
EA4. Engaging in licensing activities
EA5. Improving product availability
SU PPLY & Q UALIT Y
Themes in this research area:
SQ1. Demand planning & data sharing
SQ2. Delivery performance
SQ3. Stockouts & shortages mitigation
SQ4. Manufacturing quality-assured products
SQ5. Safeguarding quality & safety of marketed products
R ES E ARCH & D E VE LO PM E NT
Themes in this research area:
RD1. Adaptive R&D
RD2. Access planning

How we assess companies
The framework was developed to measure, analyse andevaluate the various strategies generic and biosimilar medicines manufacturers employ to expand access to medicine
in LMICs. In recognition of the heterogeneity amongst manufacturers, a tailored assessment approach dependent on
the individual characteristics of each manufacturer will beapplied. As such, companies will be assessed against theirindividual capability to expand access to medicine in LMICs. In
addition, the framework will highlight best practices amongst
the manufacturers and identify specific opportunities for
improvement for each manufacturer.

17

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework
EXPANDING ACCESSThe Expanding Access Research Area considers the steps that generic and biosimilar medicine
manufacturers can take to ensure that their products are registered, produced at scale, andpriced affordably to address demand, especially for vulnerable populations in LMICs.
PRI O RIT Y TH E M ES FO R ASSESSI NG CO M PAN I ES’ ACTIVITI ES
Registration as a gateway to improving accessguarantee that medicines will be accessible and affordable for

Before a company can launch its product in any given country,

all patients across the income pyramid. Companies can imple-

the company must first file that product for registration, e.g.,

ment access strategies and enact policies to ensure that theirwith the country’s national regulatory authority, or via the

products are available and affordable to most people, includ-World Health Organization (WHO) Collaborative Registration

ing the poorest and most vulnerable. For instance, by pricing

Procedure (CRP). When more products are registered in atheir products responsibly and implementing policies thatcountry, this enables greater choice – and more equitabletake into account payers’ ability to pay, both at the country

access to products – for governments, pooled procurementlevel and for different populations groups within each country,

agencies, and ultimately patients themselves. It can also resultcompanies can ensure broad access to their products. The

in greater market competition, leading to lower prices.

Generic & Biosimilar Medicines Programme will assess theAs such, the framework will assess the efforts companies

strategies used by companies to expand access and afforda-

undertake to register quality-assured generic and biosimilarbility for their products in the LMICs where access gaps are

medicines in LMICs. It will consider each company’s capacity

greatest.

for registration based on in which of the 108 LMICs in scopeit has previously filed at least one product. When assessing

Leveraging licensing opportunities

companies’ registration strategies, particularly for biosimilar

Until the market exclusivity period for a patented productproducts for which registration in LMICs might present spe-

expires, generic and biosimilar medicine manufacturers arecific challenges, the analysis will also consider the regulatory

unable to launch an off-patent version (although with certain

maturity of the country and the availability of a reference

exceptions, for instance, under the Agreement on Trade-

product, among others.

Related Aspects of Intellectual Property Rights (TRIPS)). By

The framework will also evaluate companies’ engagement

engaging in licensing agreements directly with originatorin mechanisms designed to facilitate the registration ofcompanies or through organisations such as the Medicines

quality-assured products in LMICs. For instance, this includes

Patent Pool, as well as taking advantage of non-assert decla-

generic and biosimilar medicines eligible for the WHO pre-rations, whereby the patent-holder commits not to enforce

qualification of Medicines Programme (e.g., trastuzumab,

its patent in certain countries, companies can develop genericrituximab, and insulin) and/or medicines eligible for theversion of medicines before the patent expires and poten-

WHO CRP.

tially expand access to affordable, quality-assured products in

Similarly, the framework will assess whether companies

LMICs. The Generic & Biosimilar Medicines Programme will

engage in other mechanisms to facilitate registration of theirassess and analyse the types of licensing agreements that

products, such as regional joint assessments; the European

generic and biosimilar medicine manufacturers are involved

Medicines Agency’s EU-Medicines for all (EU-M4all) proce-in, specifically focusing on companies’ actions after signing

dure; or the Swissmedic Marketing Authorisation for Global

these agreements. For instance, this may include their efforts

Health Products (MAGHP) procedure, which is currently

to file for registration and improve the availability of patented

being piloted in the East African Community.

medicines in the territories within the scope of the license.
Exploration into the potential of licensing biologics to sup-Examining efforts to expand access and productport the early entrance of affordable biosimilar medicines inaffordability

LMICs has also begun.14​ As such, in the future the Generic &Generic and biosimilar medicine manufacturers can use a

Biosimilar Medicines Programme will track and evaluate howvariety of strategies to improve the availability and affordabil-companies with biosimilar products within their portfolios

ity of their products to maximise patient reach in LMICs, fromparticipate and engage in these agreements.

applying equitable pricing strategies (meaning strategies thattake into account payers’ ability to pay), to participating inApproaches to improving product availability

public or private partnerships and/or pooled procurement

Generic and biosimilar medicine manufacturers can employ amechanisms, and donation programmes.

variety of strategies to improve product availability in LMICs,

In many countries, the prices of generic medicines are18

including leveraging their manufacturing capabilities andsubject to mandatory control mechanisms that result in lower

strengthening their supply chain capacity. For instance, they

prices compared to originator medicines. However, evencan invest in local manufacturing or further expand their local

when pricing control mechanisms are in place, there is no

and/or regional presence in LMICs. Such efforts may include

Access to Medicine Foundation

investing in or setting up manufacturing or packaging facilities

or engaging in partnerships with local stakeholders to

in LMICs, which can establish a stronger and more solidified

strengthen their distribution capabilities. Such initiatives arepresence ensuring that production occurs closer to where theimportant, as the lack of well-functioning and resilient supply

products will be distributed.82–84​ Similarly, manufacturers canchains may also contribute towards the poor availability oftransfer technical knowledge and/or expertise to other man-essential medicines in LMICs.38,86,87​ As such, the Generic &ufacturers who have a local or regional presence in LMICs.85​

Biosimilar Medicines Programme will examine manufacturers’

Supply chain strengthening is another way manufacturers candiffering strategies that aim to improve product availability

increase product availability, for example by optimising andwithin LMICs.

investing in their supply chain management skills and logistics

Theme
EA1.

Description

Rationale

Access-to-

The company has a clear long-term strategy for improving access

When companies have well-integrated and comprehensive

medicine

to medicine that is aligned and/or integrated within its corporate

access-to-medicine strategies, this demonstrates the com-

strategy

strategy and business model. Well integrated and comprehensive

pany’s overall commitment to increase access to medicine

strategies will aim to sustainably increase access to medicine withthrough sustainable channels and indicates how access iscommitments to increase patient reach, will have measurable

relevant for the long-term growth of the company. Whenand time-bound objectives for improving access to medicine thatthese strategies include measurable and time-bound objec-

are publicly reported and will have director and/or board leveltives that are publicly reported, and when such strategies

responsibility for access to medicine initiatives.

include director and/or board level responsibility for achieving defined access-to-medicine goals, this increases thelikelihood of the access-related initiatives being achieved.

EA2.

Product

The company files its generic and biosimilar* medicines for

Product registration in local markets is a vital step towards

registration

registration within the LMICs in scope, prioritising countries withmaking medicines available in a country. When a company

the highest disease burden and unmet needs.

files products for registration in multiple LMICs where the

The company participates in mechanisms designed to facili-disease burden is high for the particular disease targetedtate broad product registration in LMICs and seeks approval fromby the product, this demonstrates a commitment to reachauthorities such as the European Medicines Agency (EMA) and/or

patient populations in need and to provide access to its

other WHO Listed Authorities (WLAs).

products.

Such mechanisms might include:• The WHO Collaborative Registration Procedure for WHO
Prequalified products,

Participation in mechanisms designed to facilitate
broad product registration, such as WHO’s prequalificationand collaborative registration procedure (CRP), the EMA• The WHO Collaborative Registration Procedure for Stringent

EU-Medicines for all process (EU-M4all) and regional joint

Regulatory Authorities (SRAs) approved and/or assessed

assessments, can facilitate the timely availability of prod-

products,

ucts while ensuring that they are safe and meet stringent• The Regional Joint Assessments, such as the ASEAN Joint

quality standards for international procurement.

Assessment, The African Regional Joint Assessment initiatives,
the CARICOM Joint assessment,• The European Medicines Agency EU-M4all (formerly Article 58),
• Swissmedic Marketing Authorisation for Global Health Products(MAGHP) procedure.
* Registration of biosimilar medicines requires specific assessment/evaluation
defined by the unique characteristics of biological medicinal products andmanufacturing processes.

19Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

Theme
EA3.

Description

Rationale

Expanding

The company makes efforts to expand access to and ensure

When a company addresses the accessibility and afforda-

access &affordability of their generic and biosimilar products for peoplebility of its products, this can help improve access and­pricing

living within the LMICs in scope. The company demonstrates

product reach across the income pyramid for people living

strategies

evidence of the following:in LMICs. Generic and biosimilar medicine manufacturers,• Efforts (alone or in partnership) to expand patient access toin most cases, improve product affordability by increasing

products through the implementation of access strategies (e.g.,competition in the market for off-patent medicines. This,

pricing strategies, patient assistance programmes and tenders,

however, on its own, offers no guarantee that medicines

public or private partnerships, participation in pooled procure-will be accessible and affordable. Generic and biosimilar

ment mechanisms, donations) and the geographic scope of

medicine manufacturers can use a variety of strategies tothese methods.

improve the products availability and affordability for all• How the company considers ability to pay of the different payer

segments of a population and ultimately maximise patient

types in the public sector (reimbursement authority) and/or

reach, for example, by applying pricing strategies thatthe private sector (private insurance or self-pay) when setting

consider different payers’ ability to pay, participating inprices, including the magnitude of price reductions (where

public or private partnerships and/or pooled procurement

applicable).

mechanisms and donation programmes.

• The number of patients who have benefitted during the periodof analysis and evidence of plans to increase patient reach in the
coming years.
EA4.

Engaging

The company engages in voluntary licensing agreements, either

While the responsibility to issue voluntary licences andin licensing

directly with originator companies or through organisations such

NADs lies with the patent-holder, i.e. the originator

activities

as the Medicines Patent Pool (MPP), and leverages non-assert

company, generic and biosimilar medicine manufacturers

declaration (NADs) opportunities to improve the availability of

have a vital role to play in ensuring that licences and NADs

patented products in LMICs. It also makes efforts to maximise

ultimately increase access to medicine in LMICs. Whenregistration and availability of products in the territories covered

generic and biosimilar medicine manufacturers launchby these agreements.

products covered by licences or NADs, and when they
engage with originators on agreements that are transparent and include terms that cover the needs of populationsin LMICs, this can improve the affordability and availabilityof medicines. As part of licensing agreements, generic andbiosimilar medicine manufacturers may also be the recipients of technology transfers, which may help improvegeneral and/or specific knowledge for the development of
products.

EA5.

Improving

The company makes efforts (alone or in partnership) to improve

Ensuring quality-assured products are available to those

product

the availability of products within the LMICs in scope throughwho need them requires strong supply chains, including

availability

activities such as, but not limited to:timely delivery and proper management and distribution.

• Scaling up or developing its local manufacturing presence/

While the management and distribution of products partly

capacity in LMICs in scope. This might include, but is not limitedlies under the scope of national authorities and originator

to, utilising its established manufacturing presence to improvecompanies, generic and biosimilar medicine manufacturers

product availability or setting up new manufacturing and/can contribute to strengthening local supply and distribu-

or packaging facilities in LMICs (for instance with third-party

tion capabilities by participating in initiatives to localise

manufacturers).

production or by working with partners to strengthen• Engaging in technology transfers, whereby the company
transfers knowledge and/or expertise to local manufacturers in
LMICs.
• Building supply chain capacity in LMICs in scope, in areas suchas distribution and logistics. Such efforts can be carried out in
partnership with local stakeholders (e.g., ministries of healthand public procurement, logistics and distribution agencies).
• Other initiatives aimed at improving availability of products in
LMICs, whether alone or in partnership.

20

supply, among others.

Access to Medicine Foundation
SUPPLY & QUALITYThe Supply & Quality Research Area focuses on companies’ processes to ensure quality in the
manufacturing of their products, as well as processes to ensure continuity of supply. It also
captures how generic and biosimilar medicine manufacturers leverage their expertise andresources to address local barriers to access.
PRI O RIT Y TH E M ES FO R ASSESSI NG CO M PAN I ES’ ACTIVITI ES
Collaboration to align supply and demandCompanies should also work in collaboration with procure-

Demand for essential products can outstrip supply for various

ment partners by communicating potential delays to deliver-reasons, including inaccurate demand forecasting, disruptions

ies in a timely manner and implement action plans to address

to manufacturing and sudden peaks in demand, like thosethem. Such actions are critical to ensure a secure supply ofseen during the COVID-19 pandemic. While stakeholder col-health products in LMICs within tendering agreements, andlaboration is necessary to address these challenges, generic

to allow procurers, alongside local stakeholders, to effectively

and biosimilar medicine manufacturers can implement specificplan for the distribution of products at the country level.

strategies to improve supply security in low- and middle-in-

The Generic & Biosimilar Medicines Programme will assesscome countries (LMICs). Having an internal forecasting andwhether generic and biosimilar medicine manufacturers

demand planning system allows companies to accurately plandeliver according to plan on tenders to ensure security offor their production and ensure they have sufficient capability

supply of off-patent medicines to LMICs.

to meet future demand at the global, regional, and local levels.
Such systems can also inform companies’ processes to scale

Efforts to prevent and mitigate stockouts and shortages

up production whenever shortages are forecast.

of essential medicines

To increase the likelihood that potential shortages are

There is a vast array of strategies generic and biosimilar med-

detected and prevented, companies can also take steps toicine manufacturers can use to ensure people living in LMICs

share data and align information on supply and demand withhave access to a sufficient supply of quality-assured products.

relevant stakeholders, such as governments, procurement

To prevent the risk of shortages, companies can build up

agencies and other partners. Data sharing might include infor-

safety stocks of APIs and raw materials, while also ensuringmation on the company’s internal supply plans, their sourc-that sufficient buffer stocks of finished products are available

ing of key materials (inc. active pharmaceutical ingredientsto serve the regions and countries in which they operate. For(APIs), key starting materials and excipients) and other poten-

instance, steps to decentralise production by producing fromtial issues which might affect product supply.

regional sites and hubs can strengthen security of supply andreduce the impact of disruptions, as can strategies to engage

Delivering responsibly on supply commitments

in multiple sourcing of critical components, and collaboration

Off-patent medicines in LMICs are largely procured throughwith partners to be able to meet surges in demand.

tendering mechanisms, whereby the procurement agency,

Stakeholders consulted by the Foundation recommended aoften the public sector, purchases large quantities of quali-

nuanced approach to assessing the activities of manufactur-

ty-assured medicines at fixed prices by awarding the contract

ers that have vertically integrated supply chains and control

to the supplier and/or suppliers that are best able to meet thevarious steps of the production process, such as APIs, formu-

criteria of the tender.38​ International agencies that purchaselations, manufacturing, packaging, and distribution processes.

essential products on behalf of LMICs, such as UNICEF, theThis is because they might have greater ability to control and

Pan-American Health Organization (PAHO) and the Global

improve the efficiency of the supply chain. The Generic &Fund, also play an important role in making essential products

Biosimilar Medicines Programme will assess whether and how

available at affordable prices. Both national and international

the manufacturers employ strategies to ensure a continuous

procurers can increase access to quality-assured generic

supply of products to prevent and mitigate shortages andmedicines by streamlining and reducing the administrative

stockouts.

burden of tendering procedures, awarding tenders to suppliers in a timely manner, providing adequate lead times based

Manufacturing quality-assured medicines and quality

on accurate forecasting of demand and ensuring that suppli-

assurance strategies

ers are paid on time. ​Well-functioning healthcare systems are reliant on the avail-38

When manufacturers supply via tenders set-out by gov-

ability of quality-assured medicines, especially those classed

ernments or national and international procurers, they mustas “essential medicines” by the WHO. Generic and biosimilar

ensure that they are able to meet their supply commitments

medicine manufacturers must therefore ensure that theirand fulfil the terms of tendering contracts, which includes

products are effective, safe and quality-assured.

supplying medicines in the quantities ordered, at the rightlocations, and following the agreed-upon timeframes.

Companies must implement strategies to ensure their
manufacturing sites are consistent with the international

21

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

standards on current Good Manufacturing Practice (cGMP)

partners; and ensure traceability and transparency of theand address any variabilities across their production facilities

source of their products. The Generic & Biosimilar Medicinesand manufacturing sites. They can also implement strategies

Programme will assess manufacturers’ quality assurance

and processes to address product recalls and mitigate the cir-strategies, and their efforts towards ensuring the production

culation of substandard medicines; take steps to strengthenof quality-assured medicines.

their quality assurance systems or those of in-country

Theme
SQ1.

Description

Rationale

DemandThe company has internal forecasting and demand planning

When companies have forecasting and demand planningplanning &systems in place to ensure a stable supply of quality-assured

systems in place it can contribute and lead to appropriately

data sharing

medicines efficient to predict and meet future demand. It engages

aligned supply and demand. This ensures that the correctin bilateral data-sharing with relevant external stakeholders

quantities of essential medicines are supplied. Similarly,(including government agencies, hospitals, warehouses, wholesal-

potential supply chain disruptions can be anticipated, anders, or other relevant networks) to align supply and demand. Suchthe continuity of supply can be maintained when companies

data-sharing might include information regarding the company’s

engage with the relevant stakeholders on their forecasting

supply plans, sources and process of sourcing of key materials

and demand planning systems, share their market intelli-(including APIs, key starting materials and excipients), and othergence data and outline any potential disruptions.

issues which might affect the supply of its products.
SQ2.

Delivery

The company fulfils supply commitments made to national andTo ensure the continued and timely supply of quality-as-

performanceinternational procurement agencies (e.g., UNICEF, the Global

sured products to LMICs, companies have an important role

Fund, etc.) to ensure the continued and timely delivery ofin complying with delivery commitments made to procure-quality-assured products to LMICs. It presents evidence of thement agencies. Delivering products in the appropriate quan-following:tities and timeframes, as well as disclosing when potential• Having systems in place to actively monitor and review its inter-delays occur, helps international and national procurement

nal delivery performance, for instance, by tracking on-time-in-agencies effectively plan for distribution of products andfull delivery (OTiF), Line-Item Fill Rate (LIFR) or other metrics.

ensure patients have access to the right medicines, at the• The extent to which, and how regularly, the company communi-

right time.

cates issues that might affect the timely delivery or fulfilment of
the contracts’ terms to the procurement partner.
• The actions that the company implements when delays
occur that are within the responsibility of the company or its
contracted third-party suppliers (e.g., delays in delivery due to
production/paperwork issues, freight issues, export licences).
SQ3.

Stockout &The company employs a range of strategies to ensure a continu-

Supply inefficiencies can be caused by many events

shortages

ous supply of products and to prevent shortages and stockouts.

occurring upstream and downstream in the supply chain,

mitigation

Such strategies may include:

including failure in manufacturing processes by the main

• Maintaining a sufficient stock for critical components andmanufacturer or its third-party affiliate, scarcity of APIs

conducting regular audits of its stock.
• Holding regional stocks and/or making efforts to decentralisestocks of critical components.
• Implementing strategies to promote supplier diversity, foras external events such as climate disasters or unexpected
events affecting different levels of the supply chain. When
companies implement specific mechanisms to prevent

example by working with multiple upstream suppliers and/or

stockouts and shortages, this can help ensure a sufficient

sourcing from local suppliers.

and reliable supply of products in LMICs.

• When applicable, implementing strategies to scale up production of APIs (when vertical integration is in place).
• Other initiatives to fulfil emergency orders and/or surges indemand, alone or in partnership with relevant international,
national or local stakeholders.

22

and high dependency on just a few API suppliers, as wellAccess to Medicine Foundation

Theme
SQ4.

Description

Rationale

Manufacturing

The company has systems in place and employs a range ofWhen companies implement systems and strategies toquality-­

strategies to ensure, maintain and/or improve the production

ensure that medicines are consistently produced to strin-

assuredof quality-assured products at its own and third-party manu-

gent international standards on cGMP at their own (andproducts

facturing sites. Strategies are consistent with the international

third-party) manufacturing sites, this can help minimise thestandards on current Good Manufacturing Practice (cGMP) andlikelihood that substandard medicines will reach patients.

are accepted by recognised national and international authorities,
such as the US Food and Drug Administration (FDA), European
Medicines Agency (EMA) and WHO. It adopts concrete strategies
to limit variability in manufacturing processes between manufacturing sites, with the aim of ensuring that quality-assured
products are guaranteed for delivery across all geographic
regions. It ensures that stringent quality standards are upheld by
suppliers and when sublicensing production or specific activities
to third-party manufacturers.
SQ5.

Safeguarding

The company reports concrete systems to ensure the quality

When companies implement quality assurance strategies,

quality &and safety of marketed products. It presents evidence of thethis ensures that the quality of all marketed products issafety offollowing:

maintained. In the event of a recall, companies must havemarketed• A process to identify and address complaints concerning poten-

processes in place to ensure that these happen in a timely

products

tially substandard products, including a system for recallingand efficient manner. Labelling products with data that

products from the market promptly and effectively and alerting

enables tracking the source (e.g., final manufacturing plant)

the appropriate authorities.

allows for the identification and tracking of products for• Strategies to mitigate the circulation of substandard andwhich quality concerns arise. Companies should also imple-

falsified medicines, including to which authorities and/or

ment strategies to mitigate the circulation of substandard

organisations the company reports encounters of substandard

and falsified medicines, for example by efficiently alertingor falsified medicines.

the relevant authorities to ensure that timely action is• Efforts to disclose the source of finished products, including

taken.

specifying the primary manufacturing plant and disclosure of
product components and materials that are third-party sourced.

23

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework
RESEARCH & DEVELOPMENTThe Research & Development (R&D) Research Area considers companies’ R&D activities
aimed at adapting products for low- and middle-income settings and vulnerable populations,as well as looking at the plans that companies develop during the R&D phase to make theiradapted products accessible in low- and middle-income countries (LMICs) once launched.
PRI O RIT Y TH E M ES FO R ASSESSI NG CO M PAN I ES’ ACTIVITI ES
Capturing companies’ R&D activities

on R&D differ and cannot be compared like-for-like. As such,

For many diseases, the medicines that exist are insufficiently

the analysis will focus on and spotlight specific examples oftailored to meet the needs of people living in LMICs; forcompanies’ late-stage adaptative R&D projects, including theexample, if a product requires access to continuous cold

pathogens, conditions and diseases targeted and the types

storage, people living in areas without reliable electrical infra-of adaptations made. When applicable, it will also highlight

structure will face additional access barriers. While innovative

whether such projects focus on priority R&D gaps defined by

R&D is typically not a core activity for generic and biosimilar

WHO and/or Policy Cures Research.

medicine manufacturers, some manufacturers have alreadyshown the value they can add within this space by engaging

Planning for access to ensure public health needs arein adaptive R&D to make versions of products more suitableconsidered during product development

for use in resource-limited settings. Indeed, some companies

Access planning during R&D is important to ensure the avail-have begun expanding their R&D capabilities in-house orability, accessibility and affordability of products in LMICs

through new partnerships and strategic acquisitions.

once they reach the market. When generic and biosimilar

Having reviewed such developments with stakehold-medicine manufacturers develop adaptive R&D projects,

ers, and drawing on strategic guidance from the Expert

either in-house or in partnership, it is crucial that they plan

Committee, the Generic & Biosimilar Medicines Programme

for access during the project development phase to ensure

will highlight specific examples of companies’ efforts fortimely access to the products in LMICs. Companies should

adaptive R&D. Adaptive R&D is defined as making adaptations

have an overarching framework or policy in place to ensure

to existing medicines, which may include, but are not limited

that access planning is considered for all R&D projects from

to: new formulations; new fixed-dose combinations of exist-

Phase II of clinical development (also referred to as late-stage

ing chemical or biological entities; or the repurposing of anclinical projects). Furthermore, the companies should haveexisting product for additional indications.

project-specific access plans in place for each late-stage R&D

All companies in scope of the programme have R&D facili-

project in their pipeline. As such, the Generic & Biosimilarties in order to perform research to demonstrate the equiva-

Medicines Programme will assess whether and how the man-lence of new products to the originator or reference product,ufacturers who have adaptive R&D projects in their pipeline

so all companies potentially have the capacity to engage inhave made commitments, implemented strategies or are

adaptive R&D. However, the analysis based on this frameworkengaging in efforts that plan for access early in the develop-

will acknowledge that manufacturers’ capabilities and focus

ment phase for these projects.

Theme
RD1.

Adaptive R&D

Description

Rationale

The company has adaptive R&D projects in their pipeline - where

Medicines are only useful when they meet demographic

applicable – to develop products suited for low- and middle-in-needs and can be deployed effectively in a particular set-come settings and for vulnerable populations. Projects can beting. When manufacturers adapt their products to differingdeveloped in-house or through collaborative R&D. This canenvironmental conditions (e.g., heat-resistant formula-include, but is not limited to:tions), specific demographic segments (e.g., children) or• Adaptations to formulations (e.g., heat-stable formulations,create new formulations (e.g., fixed-dose combinations),

oral formulations, long-acting formulations, new fixed-dose

this can help to address context-specific access issues.

combinations);• Adaptations targeting specific populations (e.g., paediatricpopulations).

24

Access to Medicine Foundation

Theme
RD2.

Description

Rationale

Access

The company considers access planning* for its adaptive R&D

Companies can ensure that their products quickly

planning

projects in their pipeline. This includes whether and how thereach the people who need them by planning for accesscompany:

during clinical development (starting from Phase II). To• Has a policy/framework in place during the development phasestrengthen the potential impact on public health, the(i.e., R&D), to ensure that equitable access is planned for allcompany’s access plans should include not only commit-

projects in development, both in-house and collaboratively, forments to filing the product for registration in LMICs, butpeople living in LMICs. This is called ‘company-wide R&D accessalso measures that go beyond this to ensure affordability

planning’.*and supply. For instance, such measures could include• Ensures that all late-stage** adaptive R&D projects areequitable pricing strategies, meaning strategies that

supported by project-specific access plans, to ensure future

consider different payers’ ability to pay; sufficient supply

availability, affordability, and/or accessibility of the to-becommitments; and applying for WHO prequalification.

product in LMICs in scope. This is called ‘project-specific R&D

Such planning can help those in LMICs to gain rapid,

access planning’.

affordable and reliable access to products following their* Access plans are plans made during the R&D stage to ensure the productwill become accessible in LMICs. Access plans can be developed in-house orin collaboration with external stakeholders and include commitments andstrategies to increase the availability, affordability and supply of medicines in
LMICs in scope.
**Late-stage refers to projects in Phase II and III clinical trials and those thatwere approved during the period of analysis. This theme relates to plans toensure access upon approval to products in the pipeline.

market entry.

25Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

APPE N D I CESAPPE N D IX I . D I S E A S ES I N SCO PE O F TH E G E N E R I C & B I OS I M I L AR M E D I CI N ES PRO G R AM M E

The disease scope for the Generic & Biosimilar Medicines Programme includes 82 diseases, conditions and pathogens as
defined in the 2022 Access to Medicine Index.65 However, in contrast to the Index methodology, Disease X - defined by theWorld Health Organization (WHO) as a pathogen currently unknown to cause human disease that could cause a serious international epidemic – is excluded,88 and coronaviral diseases are only considered for in-licensed products. Cancer is counted as
one non-communicable disease within the disease list; this encompasses 19 specific sub-types of cancer.
TABLE 4 Disease scope
Diseases, conditions and pathogens in scope of the Generic & Biosimilar Medicines Programme.
Rationale for inclusion

Rationale for inclusion

●

●

●
●
●

●
●

●

●

●
●

●

●

●

●

●

●

●

●

●

●

●
●
●

●

●

●

●
●
●

●
●

●

●

Zika

●

Non-Communicable Diseases
Alzheimer’s disease
Anxiety disorders
AsthmaBipolar disorder
Cancer‡Chronic obstructive pulmonary­disease (COPD)
Diabetes mellitus
Endometriosis
Epilepsy
Hypertensive heart disease
Ischaemic heart disease
Kidney diseases
Migraine
Schizophrenia
Thalassemia
Sickle cell disease
StrokeUnipolar depressive disorders

●
●
●
●
●

●

●
●
●
●
●

●

●

●

●

●

●
●

Dengue and Chikungunya
Dracunculiasis
Echinococcosis

●

●

●

●

Food-borne trematodiases
Human African Trypanosomiasis
Leishmaniasis
Leprosy
Lymphatic filariasis
Mycetoma, chromoblastomycosis andother deep mycoses
Onchocerciasis
RabiesScabies and other ectoparasites
Schistosomiasis
Snakebite envenoming
Soil-transmitted helminthiasis
Taeniasis/cysticercosis
Trachoma
Yaws

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

Stakeholder
consensus**●

R&D priority*●

WHO-identified NTD or
MNH condition●≥95% disease burden incountries in scope●

Neglected Tropical Diseases
Buruli ulcer
Chagas disease

Top ten DALY burden incountries in scope

Stakeholder
consensus**

R&D priority*

WHO-identified NTD
or MNH condition

Tuberculosis
Viral hepatitis (B and C)
Yellow fever≥95% disease burden incountries in scope

Bunyaviral diseases
Coronaviral diseases*
Enteric diseases
Diphtheria
Emergent non-polio enteroviruses
Filoviral diseases
Henipaviral diseases
HIV/AIDS
Leptospirosis
Lower respiratory infections
Malaria
Measles
Meningitis
Pertussis
Rheumatic fever
Sexually transmitted infections (STIs)†
TetanusTop 10 DALY burden incountries in scope

Communicable Diseases
Arenaviral haemorrhagic fevers (Lassa
fever)●

Reproductive, Maternal and Newborn Health Conditions●●
Birth asphyxia and birth trauma●
Contraceptive methods●●
Hypertensive disorders of pregnancy●●
Abortion and miscarriage●●
Maternal haemorrhage●●
Maternal sepsis●●
Neonatal sepsis and infections●●
Obstructed labour●●
Other neonatal conditions●●
Preterm birth complications●●●

Priority pathogens
Acinetobacter baumannii (carbapenem-resistant)Campylobacter spp. (fluoroquinolone-resistant)Enterobacteriaceae (carbapenem-resistant, 3rd generation●

cephalosporin-resistant)●●●Enterococcus faecium (vancomycin-resistant)●

Haemophilus influenzae (ampicillin-resistant)●●●

Helicobacter pylori (clarithromycin-resistant)
Neisseria gonorrhoeae (3rd generation cephalosporin-resistant,fluoroquinolone-resistant)Pseudomonas aeruginosa (carbapenem-resistant)* Only in scope for in-licensed products.
† Excludes HIV/AIDS.
‡ Includes 19 cancer types: bladder; brain, nervous system; breast; cervical;
colorectal; gallbladder; head and neck; Kaposi sarcoma; leukaemia; liver; lung;non-Hodgkin lymphoma; oesophageal; ovarian; prostate; stomach; thyroid;
uterine; osteosarcoma.

26

Salmonella spp. (fluoroquinolone-resistant)
Shigella spp. (fluoroquinolone-resistant)
Staphylococcus aureus (methicillin-resistant, vancomycin-intermediate andvancomycin-resistant)
Streptococcus pneumoniae (penicillin-non-susceptible)

Access to Medicine Foundation
APPE N D IX I I . CO U NTR I ES I N SCO PE O F TH E G E N E R I C & B I OS I M I L AR M E D I CI N ES
PRO G R AM M E

The geographic scope for the Generic & Biosimilar Medicines Programme consistsof 108 countries as included in the 2022 Access to Medicine Index.65

TABLE 5 Geographic scope
Countries in scope of the Generic & Biosimilar Medicines Programme.**East Asia & Pacific

Peru

UMIC

GuineaLIC

Cambodia

LMIC

Suriname

UMIC

Guinea-Bissau

LIC

China

UMIC

Venezuela

UMIC

Kenya

LMIC

Lesotho

LMIC

Indonesia

LMIC

Kiribati

LMIC

Middle East & North Africa

Korea, Dem. People’s Rep.

LIC

Algeria

Lao PDR

LMIC

Micronesia, Fed. Sts.

LMIC

Mongolia

LMIC

Myanmar

LMIC

Papua New Guinea

Liberia

LIC

LMIC

Madagascar

LIC

Djibouti

LMIC

Malawi

LIC

Egypt, Arab Rep.

LMIC

Mali

LIC

Iran

LMIC

Mauritania

LMIC

Iraq

UMIC

Mozambique

LIC

LMIC

MoroccoLMIC

Namibia

UMIC

Philippines

LMIC

Palestine, State of/ West Bank Gaza

LMIC

Niger

LIC

Samoa

LMIC

Syrian Arab Republic

LIC

Nigeria

LMIC

Solomon Islands

LMIC

Tunisia

LMIC

RwandaLIC

Thailand

UMIC

Yemen, Rep.

LIC

São Tomé and Principe

LMIC

Timor-Leste

LMIC

Senegal

LMIC

Tonga

UMIC

South Asia

Sierra Leone

LIC

TuvaluUMIC

Afghanistan

LIC

Somalia

LIC

Vanuatu

LMIC

Bangladesh

LMIC

South Africa

UMIC

Vietnam

LMIC

BhutanLMIC

South Sudan

LIC

India

LMIC

Sudan

LIC

Europe & Central

Maldives

UMIC

Swaziland/Eswatini

LMIC

Armenia

UMIC

Nepal

LMIC

Tanzania

LMIC

KosovoUMIC

Pakistan

LMIC

Togo

LIC

Kyrgyz Republic

LMIC

Sri Lanka

LMIC

UgandaLIC

Moldova

UMIC

ZambiaLMIC

Tajikistan

LMIC

Sub-Saharan Africa

Zimbabwe

LMIC

Turkmenistan

UMIC

AngolaLMIC

Ukraine

LMIC

Benin

LMIC

Uzbekistan

LMIC

Botswana

UMIC

Burkina Faso

LIC

Latin America & Caribbean

BurundiLIC

BelizeLMIC

Cabo Verde

LMIC

Bolivia

LMIC

Cameroon

LMIC

BrazilUMIC

Central African Republic

LIC

Colombia

UMIC

Chad

LIC

Dominican Republic

UMIC

Comoros

LMIC

Ecuador

UMIC

Congo, Dem. Rep.

LIC

El Salvador

LMIC

Congo, Rep

LMIC

Guatemala

UMIC

Côte d’Ivoire

LMIC

GuyanaUMIC

Equatorial Guinea

UMIC

Haiti

LMIC

Eritrea

LIC

Honduras

LMIC

Ethiopia

LIC

Mexico

UMIC

Gabon

UMIC

Nicaragua

LMIC

GambiaLIC

Paraguay

UMIC

Ghana

LMIC

*UMICs were included based on their
UNDP Human Development Indexgroup and inequality-adjusted Human
Development Index.

LIC
Low-income country
LMIC
Lower-middle income country
UMIC
Upper-middle income country*
World Bank income classifications (FY2022)**Country classifications on this pagewere corrected on 13 April 2023.

27

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework
APPE N D IX I I I . PRO D U C T PR I O R ITI SATI O N PRO CESS AN D PRO D U C T SCO PE FO R
TH E G E N E R I C & B I OS I M I L AR M E D I CI N ES PRO G R AM M E

The product prioritisation process for the Generic & Biosimilar Medicines
Programme outlines and identifies the inclusion and exclusion criteria for the product scope of the programme.

TABLE 6 Product prioritisation process
Product is a medicine*

Product is listed on the WHO Model List of Essential
Medicines - 22nd list, 2021 and the WHO Model List of
Essential Medicines for Children - 8th list, 2021

Is the product a first- or second-line treatment (FLT/SLT)?

Is the productoff-patent

YES

Is there robust evidenceof an access gap in
LMICs?

NO
Product excluded

NO
Product excluded* Excludes vaccines and diagnostics but includes contraceptive devices.

28

YES

Is the product prioritisedby an external stakeholder, in country expert,
and/or external global
health organisation?

NO

YES

Product includedin scope of the
programme

Access to Medicine Foundation
APPE N D IX IV. PRO D U C TS I N SCO PE O F TH E G E N E R I C & B I OS I M I L AR M E D I CI N ES
PRO G R AM M E

The product scope for the Generic & Biosimilar Medicines Programme includes
102 off-patent essential health products. Products were identified through theProgramme’s product prioritisation process and are listed following the WHO’s latest list of recommended International Non-proprietary Names (INN). 89 The productscope will be updated for future iterations of the analysis, considering updates tothe WHO Model List of Essential Medicines (EML) and shifting priorities within the
global health community.

TABLE 7 Product scope
Products in scope of the Generic & Biosimilar Medicines Programme.
International Non-

International Non-

proprietary Name (INN)

Diseaseproprietary Name (INN)

Diseasebevacizumab

Cervical, ovarian, colorectal and liver

fluoxetine

Unipolar depressive disorders, anxiety

cancercapecitabine

Breast, colorectal and stomach cancer

carboplatin

Cervical, breast, ovarian, head and neck,

cisplatin

disorders
sertraline

disorderslung, osteosarcoma, prostate, brain,

diazepamAnxiety disorders, epilepsy

nervous system and bladder cancer

fluphenazine

Schizophrenia

Cervical, head and neck, brain andpaliperidone

Schizophrenia

nervous system, lung, osteosarcoma,

haloperidol

Schizophrenia, bipolar affective

ovarian and stomach cancer
cyclophosphamide

Unipolar depressive disorders, anxiety

Leukaemia, breast, brain and nervous

disorderrisperidone

system and non-hodgkin lymphoma

Schizophrenia, bipolar affective
disorderdocetaxel

Breast, prostate and stomach cancer

lamotrigine

Epilepsy

doxorubicin

Leukaemia, kaposi sarcoma, breast andsodium valproate

Epilepsy, bipolar affective disordernon-hodgkin lymphoma cancer

carbamazepine

Epilepsy, bipolar affective disorder

Leukaemia, lung, osteosarcoma andsumatriptan

Migraine

beclometasone

Asthma, chronic obstructive pulmonary

etoposide

ovarian cancer
fluorouracil

Breast, colorectal and stomach cancer

gemcitabine

Ovarian, lung and breast cancerhydroxyurea

Leukaemia and sickle cell disease(hydroxycarbamide)
methotrexate

diseasebudesonide

diseaseformoterol/budesonide

Leukaemia, osteosarcoma and breast
canceroxaliplatin

Colorectal and stomach cancer

paclitaxel

Cervical, ovarian, breast, kaposi sarLeukaemia and non-hodgkin lymphoma

Asthma, chronic obstructive pulmonary
diseaseipratropium bromide

Asthma, chronic obstructive pulmonary
diseasesalbutamolcoma and lung cancer
rituximab

Asthma, chronic obstructive pulmonary

Asthma, chronic obstructive pulmonary
diseasetiotropium

cancerAsthma, chronic obstructive pulmonary
diseasetamoxifen

Breast cancer

gliclazide

Diabetes mellitus

trastuzumab

Breast and stomach cancer

insulin injection (soluble)

Diabetes mellitus

amlodipine

Hypertensive heart disease

intermediate-acting insulin

Diabetes mellitus

amlodipine/lisinopril

Hypertensive heart disease

long-acting insulin analogues

Diabetes mellitus

enalapril

Hypertensive heart disease

metformin

Diabetes mellitushydrochlorothiazide

Hypertensive heart disease

misoprostol

Maternal haemorrhage

lisinopril

Hypertensive heart diseaseoxytocin

Maternal haemorrhage

lisinopril/hydrochlorothiazide

Hypertensive heart disease

tranexamic acid

Maternal hemorrhage

telmisartan

Hypertensive heart diseasecalcium gluconate

Hypertensive disorders of pregnancy

telmisartan/amlodipine

Hypertensive heart disease

hydralazine

Hypertensive disorders of pregnancy

telmisartan/

Hypertensive heart diseasemagnesium sulfate

Hypertensive disorders of pregnancy

methyldopa

Hypertensive disorders of pregnancy
Preterm birth complicationshydrochlorothiazide
valsartan

Hypertensive heart disease

dexamethasone

bisoprolol

Hypertensive heart disease and ischae-

ethinylestradiol/levonorgestrel Contraceptive methods

mic heart disease
metoprolol

Hypertensive heart disease and ischaemic heart disease

atorvastatin

Ischaemic heart disease

warfarin

Strokeetonogestrel (implant)

Contraceptive methods

levonorgestrel

Contraceptive methods

tenofovir disoproxil fumarate

Hepatitis B

daclatasvir

Hepatitis C

daclatasvir/sofosbuvir

Hepatitis C

29

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

International Nonproprietary Name (INN)

Diseaseribavirin

Hepatitis C

sofosbuvir

Hepatitis C

sofosbuvir/velpatasvir

Hepatitis C

abacavir/lamivudine

HIV/AIDs(ABC+3TC)
abacavir/dolutegravir/lamivu-

HIV/AIDs

dine (ABC+DTG+3TC)***
darunavir/ritonavir (DRV/r)***

HIV/AIDs

dolutegravir (DTG)/lamivu-

HIV/AIDs

dine (3TC) (or emtricitabine(FTC))/tenofovir alafenamide(TAF) (DTG+XTC**+TAF)***
dolutegravir (DTG)/lamivu-

HIV/AIDs

dine (3TC) (or emtricitabine(FTC))/tenofovir disoproxil
fumarate (DTG+XTC**+TDF)
artemether/lumefantrine

Malariaazithromycin*

Trachoma, yaws, enteric diseases andsexually transmitted infections (STIs)

ivermectin

Lymphatic filariasis, onchocerciasis(river blindness), scabies and otherectoparasitoses, soil transmitted
helminthiasis

amphotericin B

Leishmaniasis, antifungal infections

praziquantel

Schistosomiasis, taeniasis/cysticercosis

amikacin

Bacterial infection

ampicillin

Bacterial infection

benzathine-benzylpenicillin

Bacterial infection

benzylpenicillin

Bacterial infection

cefalexin

Bacterial infection

cefazolin

Bacterial infection

chloramphenicol

Bacterial infection

clindamycin

Bacterial infection

cloxacillin

Bacterial infection

doxycycline

Bacterial infection

gentamicin

Bacterial infection

nitrofurantoin

Bacterial infection

phenoxymethylpenicillin

Bacterial infection

procaine-benzylpenicillin

Bacterial infection

spectinomycin

Bacterial infection

sulfamethoxazole/

Bacterial infection

trimethoprim
trimethoprim

Bacterial infection

metronidazole

Bacterial infection and parasitic
infectionisoniazid

Tuberculosis

linezolid

Tuberculosis

rifampicin

Tuberculosis

sulfamethoxazole/trimeth-Used for prevention of HIV-related

oprim/isoniazid/pyridoxine

opportunistic infections such ashydrochloride

tuberculosis* Antibiotic not listed in the Access category as per the WHO AWaRe classification, but indicated for the treatmentof certain Neglected Tropical Diseases inscope: Trachoma & Yaws

30** XTC indicates that the X could be an F
for emtricitabine or a 3 for lamivudine*** Not on WHO EML but high priority for
SH and strong evidence to include

Access to Medicine Foundation
APPE N D IX V. M E TH O D O F PRO D U C T S PECI FI C ANALYS I S FO R TH E G E N E R I C &B I OS I M I L AR M E D I CI N ES PRO G R AM M E

For the first evaluation of companies under this framework, the Foundation will
carry out an in-depth analysis of a subset of 10 of the products in scope, per company. This analysis will look at the company’s actions and initiatives to expand
access to each of these products in LMICs. Each company will be provided withthe opportunity to collaboratively select these products in consultation with theFoundation. The company-specific product selection will include off-patent medicines as identified in the programme’s product portfolio and that represent thedifferent therapeutic areas in which the company is active and, if applicable, covernon-communicable diseases, communicable diseases, neglected tropical diseases,
and maternal health products.
Additionally, a maximum of five in-licensed products will be included for an analysis of companies’ activities and efforts to expand access in their role as licensees.
These are products for which the generic or biosimilar medicine manufacturer hasentered into a licence via the Medicines Patent Pool and/or directly with the originator company.

31

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework
APPE N D IX VI . E LI G I B I LIT Y O F R& D PROJ EC TS FO R I N CLUS I O N I N TH E G E N E R I C & B I OS I M I L AR
M E D I CI N ES PRO G R AM M E

To determine the eligibility of the R&D projects, the following inclusion criteria apply, and as further outlined in figure Appendix VI, Table 8:
1. The company must have commercialisation rights in at least one country in scope of the programme;
2. The project must target a disease, condition or pathogen listed within the disease scope of the
programme;
3. The project should fall within the product types in scope of the programme;
4. The project must be in the pipeline during the period of analysis;
5. Projects should be adaptations for existing products (for example: new/adapted formulations; new/adapted dosage regimens; or adaptations to facilitate use in LMICs, such as heat stable/fixed dosecombinations).
Note: the Generic & Biosimilar Medicines Programme considers projects that meet the criteria outlined
above. When applicable, examples of late-stage adaptive R&D projects that target priority product gaps
identified by WHO and/or Policy Cures Research (as defined in APPENDIX VII) will be highlighted.

TABLE 8 R&D inclusion and exclusion criteria

Does/will your company have commercialisation rights
for the project in any of the LMICs in scope?

No

ExcludeYes
Does the project target a disease,condition or pathogen in scope?

No

ExcludeYes
Is the project a medicine or a device
for reproductive health?

No

ExcludeYes
Is the project in the pipeline during
the period of analysis?*No

ExcludeYes
Is the formulation already approved
for the target indication?

Yes

ExcludeNo
Is your project a...

New/adapted formulation of apreviously approved INN (e.g.,
specifically for paediatricpopulation)?

New/adapted dosage regimen for apreviously approved INN that willease administration/adherence in
LMICs (e.g., reduced frequency)?

Yes

Yes

Include* The period of analysis is 1 January 2020 - 30 April 2023.

32

Product adaptation that will
facilitate use in LMICs (e.g., heatstable formulation or new fixed
dose combinations)?
Yes

No

ExcludeAccess to Medicine Foundation
APPE N D IX VI I . R& D PR I O R IT Y PRO D U C T GAPS FO R TH E G E N E R I C & B I OS I M I L AR M E D I CI N ES PRO G R AM M E

The Generic & Biosimilar Medicines Programme considers R&D priorities as those identified and listed by the WHO and/or Policy
Cures Research, an independent research group. The following lists were used to determine priority product gaps:• WHO Priority Pathogen List;90• WHO R&D Blueprint;91• Policy Cures Research G-FINDER emerging infectious diseases;92• Policy Cures Research G-FINDER sexual & reproductive health;93• Policy Cures Research G-FINDER neglected diseases.94
TABLE 9 Priority gaps for R&D
R&D Priority Lists

Gap identified

WHO R&D Blueprint●

Crimean-Congo haemorrhagic fever●●

Rift Valley fever●●

Severe fever with thrombocytopenia syndrome (SFTS)●

Arenaviral haemorrhagic fevers(Lassa fever)
Bunyaviral diseases

Other bunyaviral diseases
Buruli ulcer
Cancer●●

HPV-related cervical cancer (1)Chagas disease●●

Contraceptive methods (2)Coronaviral diseases

Dengue and Chikungunya
Enteric infections●

Middle East respiratory syndrome coronavirus(MERS-CoV)●●Severe acute respiratory syndrome (SARS)●●Coronavirus disease 2019 (COVID-19)●

Other highly pathogenic coronaviral diseases●

Chikungunya●

Dengue●Cholera (3)●Cryptosporidiosis (3)●Shigellosis (3)●Typhoid and paratyphoid fever (S. typhi, S.
paratyphi A)●

Non-typhoidal S. enterica (NTS)●

Emergent non-polio enteroviruses(including EV71, D68)
Filoviral diseases

Henipaviral diseases

●

Ebola

●

●

Marburg●●

Other filoviral diseases

●

Nipah

●

●

Other henipaviral diseases●●

HIV/AIDS (4)●Human African trypanosomiasis
Hypertensive disorders ofpregnancy●

Pre-eclampsia (5)●Leishmaniasis●

Leprosy●

Lymphatic filariasis
Malaria
Maternal haemorrhage
Mycetoma, chromoblastomycosis
and other deep mycoses

WHO Priority
Pathogens List

G-FINDER Emerging
Infectious Diseases

G-FINDER Sexual &Reproductive Health

G-FINDER Neglected
Diseases

R&D priorities: R&D analysis●

Specific disease target

Medicines

Group Disease

Devices (for reproductive health only)

Restricted gap*●

P. falciparum●

P. vivax●

Postpartum haemorrhage (6)●Cryptococcal meningitis●

Mycetoma●* A restricted gap is defined as the situation in which a gap for a therapeutic area exists,
but the gap is restricted to certain circumstances. For example, a restricted gap maysolely refer to certain subtypes of a disease or for a specific population. R&D projects
that target indications with restricted gaps are only considered as ‘priority R&D’ if they
address these specific gaps.

33

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework
Gap identified

R&D Priority Lists●●

Sexually transmitted infections(STIs)

Gonorrhoea (7)

●

HSV-2

●

HTLV-1●

Syphilis (8)●Other STIs (9)Soil transmitted helminthiasis●

Hookworm diseases●

Strongyloidiasis●

Trichuriasis●

Ascariasis●

Snakebite envenoming (10)●Taeniasis/cysticercosis●

Tuberculosis (13)●

Viral hepatitis (B and C)

Hepatitis B (11)●Hepatitis C (12)●Zika
Other prioritised antibacterial-resistant infections (13)Acinetobacter baumannii(carbapenem-resistant)●Campylobacter (fluoroquinolone-resistant)●Enterobacteriaceae (carbapenem-resistant,
3rd generation cephalosporin-resistant)●Enterococcus faecium (vancomycin-resistant)●

Haemophilus influenzae (ampicillin-resistant)●

Helicobacter pylori (clarithromycin-resistant)●

Neisseria gonorrhoeae (3rd generation cephalosporin-resistant, fluoroquinolone-resistant)●Pseudomonas aeruginosa(carbapenem-resistant)●

Salmonella spp. (fluoroquinolone-resistant)●●

Shigella spp. (fluoroquinolone-resistant)●●

Staphylococcus aureus (methicillin-resistant,vancomycin intermediate and resistant)●

Streptococcus pneumoniae(penicillin-non-susceptible)●

General notes:• In addition to the above diseases and specific targets, the priority lists also include products targeting multiple included diseases.
• In some cases of duplicates (an R&D gap has been identified on more than one list) one
list may define specific restriction for this gap. The Programme will consider projects targeting either the general gap or restricted gap equally.
(1) HPV-related cancer priority R&D
restrictions are in place for medicines(ONLY includes medicines to clear or prevent HPV infection; anti-neoplastic drugs
for cervical cancer are EXCLUDED).
Includes devices that either clear HPV
infection or treat cervical lesion.
(2) Contraceptive methods are restricted
to on-demand (requiring action at thetime of intercourse or pericoitally for
efficacy [e.g., emergency contraception]), short-acting (working for <1 year
but do not require action at the time ofintercourse [e.g., injectable hormones]),long-acting reversible (working for ≥1 year
[e.g., implants; IUDs]) and permanent (irreversible) methods.
(3) Restrictions for cholera, cryptosporidiosis and shigellosis are in place for medicines (ONLY includes pharmacological interventions that target the patho34 gen. Supportive therapies [e.g., zinc treat-●

WHO Priority
Pathogens List●

Schistosomiasis

WHO R&D Blueprint●

Scabies

G-FINDER Emerging
Infectious Diseases

R&D priorities: R&D analysis

Onchocerciasis

G-FINDER Sexual &Reproductive HealthSpecific disease target

G-FINDER Neglected
Diseases

Medicines

Group Disease

Devices (for reproductive health only)

Restricted gap

ment, oral rehydration therapy, or otherfluid and nutritional supplements] are
EXCLUDED).
(4) HIV/AIDS priority R&D restrictions for
medicines only includes LMIC-specificlabel expansions of new medicines (e.g.,changes in manufacturing, recommended
patient population and/or formulation for
medicines after they have been approved)
and formulations for LMIC use (e.g., paediatric or slow-release formulations; fixeddose combinations; low-dose drug formulations for prophylaxis; long-acting injectables for treatment or prophylaxis).
(5) ONLY includes R&D for medicines toprevent and/or treat pre-eclampsia and/or eclampsia that offer improvements
over existing products and therapies. This
includes R&D for novel or existing (re-purposed) drugs, as well as research into
magnesium sulphate dosing regimens.
(6) R&D for postpartum haemorrhage• Where WHO priority pathogens are linked to specific diseases without reference to a
specific form of antibacterial resistance, these gaps are defined separately for both thedisease and for the antibacterial-resistant priority pathogen.
• Priority R&D product gaps may be updated as new iterations of priority lists are
updated. Any changes that would result in the exclusion of a priority R&D project will be
discussed internally, with any resulting changes communicated to companies.
devices ONLY includes devices to treat
PPH by targeting the underlying pathophysiology (e.g., uterine atony).
(7) Medicines for gonorrhoea MUST prevent or treat antimicrobial-resistantgonorrhoea.
(8) Medicines for syphilis MUST preventor treat late latent, tertiary, maternal orcongenital syphilis.
(9) Other STIs are defined as STIs that
disproportionately affect populations in
LMICs, including but not limited to trichomoniasis, chancroid, Mycoplasma genitalium, lymphogranuloma venereum andgranuloma inguinale (donovanosis).
(10) Snakebite envenoming priority R&D
is restricted for medicines (ONLY includes
medicines being developed specifically for
LMIC needs [e.g., antivenoms incorporating small-molecule inhibitors, heat-stablevenom-agnostic oral medicines to slow
neurotoxicity and antivenom immunoglob-

ulins based on the venom of snakes from
LMICs]).			
(11) Medicines for hepatitis B ONLY
include LMIC-specific label expansions of
new medicines and formulations for LMIC
use (e.g., curative therapies; medicines forpreventing mother-to-child transmissionof HBV; long-acting treatment formulations). Medicines that are biologics mustat a minimum provide coverage across
HBV genotypes prevalent in LMICs (A, B,
C, D, E, F, H and/or I).
(12) Medicines for hepatitis C ONLY
include LMIC-specific label expansions of
new medicines and formulations for LMIC
use (e.g., fixed-dose combinations).
(13) While M. tuberculosis has been
listed as a priority pathogen by WHO,
this pathogen is assessed separately as
tuberculosis.

Access to Medicine Foundation
APPE N D IX VI I I . D E FI N ITI O N S FO R TH E G E N E R I C & B I OS I M I L AR M E D I CI N ES PRO G R AM M E

Access plans*

Biosimilar*

Access plans are plans made during the R&D stage to ensure

A biosimilar medicine is a biological product that is highly

the product will become accessible in low- and middle-income

similar in terms of its efficacy, clinical benefits and safety tocountries (LMICs). Access plans can be developed in-house oran already licensed biological medicine referred to as the ref-in collaboration with external stakeholders and include com-

erence product. Biosimilar medicines are not referred to as

mitments and strategies to increase the availability, affordabil-

generic medicines, due to the natural variability as well as the

ity and supply of medicines in LMICs in scope.

greater complexity in the development and manufacturing
processes which prevents biosimilar medicines from being

Active pharmaceutical ingredient (API)*replicated exactly.

The active pharmaceutical ingredient (API) is the active
pharmaceutical component of a medicine that carries out its

Branded generic*intended effects. Some medicines, such as combination ther-

A generic medicine which is branded and marketed under aapies, have multiple active ingredients that target multiple

specific trade name.

disease pathways and/or symptoms. The inactive ingredientsof a medicine are referred to as excipients.

Conflict of interest*
A conflict of interest is the conflict that arises when the com-

Access-to-medicine strategy*

mercial interests of a company are potentially at odds with

A strategy specifically intended to improve access to med-

the interests of the partnership, the partner (i.e. local stake-icine, that includes all the typical elements of a strategy (aholders), or the health and well-being of the population theclear rationale, targets, objectives and expected outcomes). In

partnership intends to help.

LMICs where the company operates, the strategy may apply
to a defined set of diseases, products or therapeutic areas, or

Demographic factors*

to the whole pipeline and portfolio.

Characteristics of a population such as age, sex, income level,
education level, employment, etc.

Ad hoc donation programmes*
A gift of products that does not form part of a clear, defined

Disability-Adjusted Life Year (DALY)*

long-term strategy to control, eliminate or eradicate a dis-

The disability-adjusted life year (DALY) is a measure of dis-ease. This may include a company donating a range of med-ease burden that combines disease-associated mortality andicines based on the explicit needs of a country. Donations

morbidity. It is the sum of the number of years of life lost

made during emergency situations, such as conflicts and nat-

(YLLs) and years lived with disability (YLDs). DALYs allow

ural disasters, are also included here..

comparison of disease burden across different populations
and health conditions across time. One DALY equals one lost

Adaptive R&D*

year of healthy life.

R&D adaptations to existing medicines. This includes new formulations, new fixed-dose combinations of existing chemical

EU-Medicines for all (EU-M4all)or biological entities, a new target demographic, or the repur-

The EU-M4all procedure is a mechanism in which theposing of an existing product for additional indications.

European Medical Agency (EMA) issues opinions in cooperation with the World Health Organization (WHO) on medicines

Affordability*

intended for use in LMICs outside the EU to address public

A measure of the payer’s ability to pay for a product (whether

health priorities. (Definition from EMA, 2022)

or not they are the end user).
Essential medicine
Affordability*

Essential medicines are those that satisfy the priority health-A measure of the payer’s ability to pay for a product (whether

care needs of the population. They are selected with dueor not they are the end user). Pharmaceutical companies use

regard to disease prevalence and public health relevance,

many different criteria to assess affordability.

evidence of efficacy and safety and comparative cost-effectiveness by the WHO. They are intended to be available inBase of the income pyramid*functioning health systems at all times, in appropriate dosage

The base of the income pyramid, also referred to sometimes

forms, of assured quality and at prices individuals and healthas the working poor, designates the four billion people living

systems can afford. (Definition from WHO, 2022)

on an average of USD 1-5 per day.

* Working definition, used for analysis.

35

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

Exclusive licence*

International Non-proprietary Name (INN)*

Exclusive licences are licensing agreements where the licen-

A name given to pharmaceutical products and active pharma-sor (usually the patent-holder) grants the licensee (usuallyceutical ingredients for identification purposes. All INNs are

the generic medicine manufacturer) permission to manufac-

unique and are globally utilised.

ture and supply generic versions of a patented medicine. Thisis granted on an exclusive basis, and according to the terms of

National Regulatory Authority

the licence.

National Regulatory Authorities (NRAs) are the national agencies responsible for ensuring that pharmaceutical products

Equitable pricing strategies*

released for public distribution are evaluated properly andA targeted pricing strategy which aims at improving access tomeet international standards of quality and safety and effi-

medicine for those in need by taking affordability for individ-

cacy. (Definition from WHO, 2022)

uals and healthcare systems into account in a manner that is
locally appropriate.

National reimbursement authorities*
Governmental bodies with the authority to control, approve

Falsified medicine*and determine pricing and reimbursement of medicinal prod-

A medicine which is deliberately and fraudulently mislabelleducts in a country.

with respect to identity and/or source. Falsified medicines
may contain no active ingredient, the wrong active ingredientNon-assert declaration*or the wrong amount of the correct active ingredient.

A declaration where a rights holder commits not to enforce
their patents in certain stated countries allowing generic

Generic medicine*

medicines manufacturers to produce or supply the medicine

Pharmaceutical product developed and manufactured toin those countries without the fear of an infringement suit.

be identical to the originator medicine already authorised.

Immunity from suit is an alternative agreement to non-assert

Generic medicines offer the same therapeutic and clinicaldeclaration, whereby the patent holder waives the right tobenefits containing the same active pharmaceutical ingredi-sue, subject to certain terms and conditions.

ent (API), dose, strength, and route of administration. Generic
medicines are manufactured in compliance with the same

Non-exclusive voluntary licences*stringent rules and regulations regarding quality, safety andNon-exclusive voluntary licences are defined as the licences

efficacy as the originator medicine.

which enable - on a non-exclusive basis, and according to
the terms of the licence agreed - the manufacture andGeneric manufacturing*

supply of generic versions of patented medicines by other

Manufacturing of pharmaceutical products by a genericmanufacturers.

medicine manufacturer which does not hold the patent forthe product (produced under voluntary license or based on

Off-patent medicine*

Trade-Related Aspects of Intellectual Property Rights (TRIPS)

A medicine whose granted patent protection has expired

flexibilities etc.), or to a product whose patent has expired.

and is no longer protected by or exclusive marketing rights.
Patent protection typically lasts for 20 years and is specificGood Manufacturing Practices*to each country.

Good manufacturing practice (GMP) is a system employed
to ensure that products are consistently produced and con-

On-patent/patented medicine*trolled according to appropriate quality standards. Within

A patented or on-patent medicine is one which has received

pharmaceutical production this serves to minimise risks suchexclusivity rights, allowing the patent holder to prevent or

as unexpected contamination, incorrect labelling or incor-

stop others from making, using, selling or importing the medi-

rect dose of the active ingredient. GMP covers all aspects ofcine within the country that granted the patent.

pharmaceutical production (e.g., starting materials, premises, equipment, training and personal hygiene of staff) andPatient assistance programmes*

includes processes that provide documented proof that

Programmes initiated by pharmaceutical companies whichcorrect procedures are consistently followed at each step ofprovide financial assistance or free of charge medicines for a

the manufacturing process. GMP guidelines are establisheddefined patient population with limited ability to pay.

and overseen by regulatory agencies in individual countries orregions, as well as the WHO.

* Working definition, used for analysis.

36

Access to Medicine Foundation

Period of analysis*

Un-branded generic*

For the first iteration of company profiles, the time period for

A generic medicine which is sold and marketed under thewhich data will be analysed covers company activities which

International Non-propriety Name (INN).

must have been ongoing between January 2020 and April
2023. Projects that have ended before January 2020 and

Universal healthcare coverage

projects initiated after April 2023 are not included.

Universal healthcare coverage means that all people haveaccess to the health services they need, when and where

Priority R&D*

they need them, without financial hardship. It includes the

R&D that addresses product gaps that are needed by people

full range of essential health services, from health promotion

living in LMICs due to ineffective, maladaptive or non-existent

to prevention, treatment, rehabilitation, and palliative care.

products for certain diseases, conditions and pathogens in the[Definition from WHO, 2022]

scope of the Programme. These product gaps are defined as
being those listed in a series of six priority lists developed by

Vulnerable populations*

WHO and Policy Cures Research, an independent research

Vulnerable populations represent people at greater risk ofgroup.

facing stigma and additional barriers to access due to social,economic or health considerations. These can include, but

Product Development Partnership*

are not limited to, children, girls and women, members of the

Product Development Partnerships (PDPs) take the form of

LGBTQIA+ community, people living with HIV, etc.

centralised non-profit organisations that facilitate financial
risk-sharing across the public and private sectors by pooling

WHO Collaborative Registration Procedure (CRP)

and sharing resources, both tangible and intangible, for the

The WHO Collaborative Registration Procedure (CRP) is a

development of medicines, vaccines and other health tools.

procedure launched by the WHO which aims to expedite registration of prequalified finished pharmaceutical products. It

Pooled procurement*

accelerates registration through improved information shar-

A process through which a buyer pulls together demand toing between the WHO prequalification system and national

increase the total quantity of a specific product to include in

regulatory authorities (NRAs). By leveraging assessment anda tender, in order to benefit from better procurement condi-

inspection outputs already produced by WHO prequalifica-

tions and economy of scale.

tion, and thereby eliminating duplicative regulatory work, it
speeds up in-country registration of quality-assured products

Public-private partnership*

and contributes to their wider availability. (Definition from

A public-private partnership (PPP) is a partnership between

WHO, 2022)

one or more public organisations and the private sector forproviding a public asset or service, in which the private party

WHO Model List of Essential Medicines (WHO EML)

bears significant risk and management responsibility, andThe WHO EML is a list published every two years by the

remuneration is linked to performance. The Benchmark also

WHO, which lists all essential medicines recommended to beconsiders a partnership between a non-profit organisation

available in functioning health systems at all times. (Definition

and the private sector to be a PPP.

from WHO, 2022)

Structured donation programmes*

WHO prequalification*

A gift of products for which a defined strategy exists as to the

A scheme run by the WHO, which certifies (i.e., prequalifies)

type, volume and destination of donated products. Structured

products for a limited number of diseases including HIV/donation programmes are long-term, are targeted based on

AIDS, malaria, tuberculosis, neglected tropical diseases, diar-country needs, and are usually targeted to control, eliminate

rhoea, influenza and reproductive health. The assessment

or eradicate a disease.

consists of a dossier assessment for the specific product anda site inspection against international GMP standards. UN

Substandard medicines*

Organizations and other major international entities involved

Also called ‘out of specification’, these are authorised medicalin purchasing medicines for consumption in Africa require

products that fail to meet either their quality standards or

WHO prequalification when procuring all of the products inspecifications, or both. [Based on WHO, 2017]

the categories covered.

* Working definition, used for analysis.

37

Generic & Biosimilar Medicines Programme - 2023 Analytical Framework

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