Greater access to medicines and health technologies for those who need them

Annual report 2022

Foreword: Marie-Paule Kieny and Charles Gore

The Medicines Patent Pool (MPP) is pleased to present its annual report for the year 2022. This year marked a significant period of growth, change, learning, and commitment for the organisation.

Marie-Paule Kieny
Marie-Paule Kieny Chair of MPP's Board
Charles Gore
Charles Gore Executive Director

Message from Unitaid's Executive Director

Together we save lives, with more than 28 million people on HIV treatment; we save time, by speeding up the global health response; and we save money, by shaving billions of dollars off the cost of health products.

Dr. Philippe
Dr Philippe Duneton Executive Director, Unitaid

Our impact

MPP’s voluntary licences have enabled broad access to the best quality-assured, affordable treatments

This has not only saved lives, but money too, in the form of lower costs for national governments and other procurers of medicines.

Our impact

Modelling the impact of our work

Since 2021 MPP has focused on country-level impact, contrasting MPP’s contribution with alternative scenarios in which key WHO-recommended medicines would not have been available through MPP licences. The methodology evaluates the role of MPP licences in supporting expanded generic competition with the resulting effect on reducing drug prices and encouraging increased uptake with beneficial health and economic outcomes.

Uptake of
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By December 2022
billion doses
of treatment supplied by MPP licensees
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By December 2022
billion USD
of actual financial savings made by the international community by accessing MPP-licensed products
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By December 2022
deaths averted
brought by increased access to optimal products recommended by WHO

2022 at-a-glance


20 January:

27 generic manufacturers sign agreements with MPP to produce low-cost versions of COVID-19 antiviral medication molnupiravir for supply in 105 low- and middle-income countries.


3 February:

Afrigen signs grant agreement with MPP to establish a technology transfer hub for COVID-19 mRNA vaccines.


17 March:

35 generic manufacturers sign agreements with MPP to produce low-cost, generic versions of Pfizer’s oral COVID-19 treatment nirmatrelvir in combination with ritonavir for supply in 95 low- and middle-income countries.

22 March:

Update: Ukrainian company Darnitsa signs sublicence agreement with MPP bringing to 36 the number of generic manufacturers to produce generic versions of Pfizer’s oral COVID-19 treatment.


19 April:

MPP and WHO announce names of 15 programme partners that will work with the mRNA Technology Transfer Programme and receive technology transfer and training.


12 may:

WHO and MPP announce agreement with the US National Institutes of Health (NIH) for 11 COVID-19 health technologies.

20 may:

MPP joins ATOM, a new global coalition to increase access to, and the use of, essential cancer medicines in low- and middle-income countries.


13 June:

GAP-f paediatric-DTG Implementation Considerations for National Programmes published.


28 July:

MPP and ViiV Healthcare sign new voluntary licensing agreement to expand access to innovative long-acting HIV prevention medicine, CAB-LA.


13 September:

MPP and MedinCell sign licence agreement for mdc-STM, an investigational long-acting injectable formulation to fight malaria transmission.


4 October:

MPP and Shionogi sign licence agreement for COVID-19 oral antiviral treatment candidate to increase access in low- and middle-income countries.

12 October:

MPP announces its newly-established and fully independent mRNA Scientific Advisory Committee.

20 October:

MPP signs licence agreement with Novartis to increase access to nilotinib for the treatment of chronic myeloid leukaemia. This is the first ever public health-oriented voluntary licence agreement for a cancer medicine.


28 November:

Lancet Global Health publishes MPP’s paper on expanding access to biotherapeutics in low- and middle-income countries through public health non-exclusive voluntary intellectual property licensing.


1 December:

More than 100 low- and middle-income countries have now received the WHO-recommended treatment for HIV thanks to access-oriented voluntary licensing agreements with ViiV Healthcare.

10 December:

MPP Board approves MPP Strategy 2023-2025, officially launched in January 2023.

25 December:

Hetero’s nirmatrelvir/ritonavir COVID-19 product is approved by WHO-PQ, one of 18 COVID-19 products filed in 2022. This was the first filing and subsequent approval under the MPP nirmatrelvir licence; approval took place in record time, just 165 days after filing.


MPP’s licences 2022

For the past 12 years, MPP has applied its voluntary licensing and patent pooling model to secure more affordable access in low- and middle-income countries for life-saving medicines and health technologies.

In 2022, we signed four voluntary licensing agreements for the following products:

cabotegravir (CAB) LA for HIV PrEP with ViiV Healthcare;

An extended-release depot of ivermectin as a community level malaria vector control tool, using Medincell’s BEPO® LA platform;

nilotinib for the treatment of myeloid leukaemia with Novartis;

ensitrelvir fumaric acid an oral antiviral to combat COVID-19, with Shionogi.

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Infectious diseases

A total of 12 new generic versions of MPP-licensed HIV products were approved by a ‘Stringent Regulatory Authority’ (SRA) in 2022.

Furthermore, MPP-enabled HIV products have now been sold in 128 out of a possible 146 countries where those products are available for sale. This means that coverage for people living with HIV for these products now stands at 99.4 per cent, well above our target figure.

The average yearly treatment cost of HIV treatment across low- and middle-income countries using MPP-licensed generics’ product for HIV


The average yearly treatment cost using innovators’ product


This means
the average absolute difference is


equivalent to

88.5 %

reduction in price

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In 2022, MPP-enabled generic versions of child-friendly DTG 10mg tablets were sold in 66 countries, which means that 38 more countries were supplied by MPP licensees than in 2021. This covers 31.35 per cent of low- and middle-income country children on antiretroviral treatment.

A closer look: TLD
TLD is a generic HIV combination available in low- and middle-income countries

By 2021 the fixed-dose combination of TLD in a single dosage – developed by MPP’s manufacturing partners – was already reaching almost 20 million people. The number of low- and middle-income countries receiving the WHO-preferred TLD treatment for HIV passed the milestone of 100 countries in 2022. Eleven of MPP’s generic manufacturing licensees have now supplied more than 726 million packs of TLD, which means that it is now the most widely used HIV regimen in the world.

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What our partners say

Having access to high-quality low-cost essential medicines is fundamental for people living in low- and middle-income countries, such as India. TLD is a great example of how, in just a few years, and thanks to agreements between the originator company and MPP, this brilliant innovative treatment was developed by our generic companies and delivered to those in need in the world. I applaud the fact that people living with HIV in more than 100 low- and middle-income countries can now access this treatment.

Mercy Annapoorani is the Director of India’s Paneer HIV AIDS Positive Women Network

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HIV treatment:
Key facts and stats for 2022

In 2022, 12 new generic versions of MPP-licensed HIV products received approval from a stringent regulatory authority (SRA). This included the first SRA approvals received by an MPP licensee for dolutegravir/lamivudine (DTG/3TC), alafenamide (TAF) 25mg and alafenamide/emtricitabine (TAF/FTC). Three of the approvals represented a first SRA approval received by an MPP generic partner for the product in question.

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HCV treatment:
Key facts and stats for 2022

Daclatasvir – or DAC for short – is a curative regimen for HCV infection when used in combination with other medications. It became available for low- and middle-income countries after MPP and originator company Bristol Myers Squib signed a licence agreement in 2016, which enabled generic manufacturers to produce and supply the drug.

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High-quality and affordable access for all children

GAP-f’s focus is to develop and deliver appropriate, high-quality, affordable and accessible medicines for all children.

Collaboration across stakeholder groups identifies gaps, sets priorities for needs, and accelerates product investigation, development and delivery. This in turn helps to bring universal health coverage one step closer to reality.

MPP’s series of contributions to GAP-f’s new Strategy 2022–2024 allows us to continue to help tackle a broader set of diseases; it will bring us closer to our vision for all children to have equitable access to the medicines that are adapted to their needs.

The rapid rollout of paediatric DTG (pDTG) is a priority for children living with HIV. To ensure this transition to pDTG is undertaken safely and effectively, the GAP-f pDTG Task Team – co-led by MPP –developed a series of considerations for national HIV programmes, implementing partners, and service providers.

More about access for children
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Novel medical technologies

CAB-LA to expand HIV prevention options for the most vulnerable

In July, MPP signed a voluntary licensing agreement with ViiV Healthcare for cabotegravir (CAB) long-acting (LA) for HIV Pre-Exposure Prophylaxis (PrEP). Subject to regulatory approvals, this bold move gives the go-ahead for manufacturers in at least 90 low- and middle-income countries to develop and supply CAB-LA to prevent HIV infection.

The negotiation of the licence is an excellent example of MPP’s continued commitment to making innovation available and affordable in low- and middle-income countries.

The agreement also came just seven months after the first regulatory approval of CAB-LA for HIV PrEP anywhere in the world, by the USFDA.

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What our partners say

Afrocab Treatment Access Partnership and our many community partners welcome this announcement regarding the generic licensing of CAB-LA. CAB-LA will undoubtedly have a transformative impact on HIV prevention efforts in our communities. We are pleased to see that Afrocab’s and community partners’ advocacy around CAB-LA access did not go unheard. We now eagerly and anxiously await a bridging price to make CAB-LA accessible in low- and middle-income countries now. We look forward to working with all stakeholders to ensure that the promise of CAB-LA is realised.

Jacque Wambui is an HIV-positive activist currently serving on the AfroCAB Treatment Access Partnership Community Advisory Board

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Long-acting technology licence to help tackle scourge of malaria

September saw the signing of an MPP voluntary licence agreement for mdc-STM with French pharmaceutical company MedinCell. This long-acting injectable formulation may help tackle the transmission of malaria, which tragically remains endemic in 91 countries, home to 50 per cent of the world’s population. According to WHO estimates, 247 million people were infected worldwide with malaria in 2021 , 95 per cent of them in Africa; this led to 627,000 deaths. Children under five are the most vulnerable, accounting for 80 per cent of deaths from the disease.

Following this agreement, MPP can now identify suitable generic manufacturing companies to develop and commercialise this injectable version of ivermectin.

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The following is
a summary of MPP’s activities in the long-acting field:

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Significant MPP article published in ‘The Lancet Global Health’

In 2022, MPP published an important paper in a leading public health journal, Lancet Global Health. Following a request by WHO’s Essential Medicines Expert Committee, we investigated how licensing could improve both affordability and timely access to biotherapeutics in low- and middle-income countries. It was the findings of this investigation that were published by The Lancet Global Health.

This research saw MPP leveraging expert consultations, literature and data analysis, and internal technical knowledge. As a result, various salient elements were identified to encourage greater access to affordable biosimilars in low- and middle-income countries:

  • Prioritising potential biotherapeutic targets according to their potential for public health impact
  • Supporting biosimilar product and clinical development, including through technology transfer to expedite regulatory approval
  • Facilitating biosimilars’ entry and use in low-and middle-income countries by meeting procurement, supply chain and health system requirements
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Focus on partnership

The Access to Medicine Foundation’s research has found that MPP has been the gold standard on voluntary licensing arrangements between originator pharmaceutical companies and generic medicine manufacturers, enabling broad access to people worldwide with a range of treatments. I believe more opportunities exist to use this model for the years to come, saving more lives. We incentivize companies to expand access using methods such as voluntary licensing, and without the MPP, the scale and scope of access will be limited to benefit only a few patients worldwide.

Jayasree K. Iyer is CEO of the Access to Medicine Foundation

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Non-communicable diseases

MPP signs first-ever cancer licence for low- and middle-income countries

Recent years have seen tremendous progress with new technologies to treat cancer. Major challenges persist in low- and middle-income countries, however.

These countries still face great difficulties accessing new-generation cancer medicines – readily available to wealthier nations – that would allow patients to enjoy a better quality of life and to live longer.

Nilotinib is the first cancer licence with a public health focus anywhere in the world

We are delighted that 2022 saw MPP sign the first ever voluntary licence agreement with Novartis to combat cancer in low- and middle-income countries.

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Focus on partnership: The Access to Oncology Medicines Coalition

In May 2022, MPP joined the Access to Oncology Medicines (ATOM) Coalition. Led by the Union for International Cancer Control, the aim of this new global initiative is twofold: to improve access to essential cancer medicines in low- and lower-middle income countries, and to increase the capacity for diagnosing cancer and for the proper handling and supply monitoring of these medicines. MPP’s role in the Coalition is to facilitate affordable access to cancer treatments through non-exclusive licences to generic manufacturers.

The approach that the ATOM Coalition has taken for the acquisition of new medications for cancer patients in low- and lower-middle income countries includes on-patent and off-patent medications. Sustained financially accessible on-patent medicines are only possible through voluntary licences (VLs). MPP’s depth and breadth of experience and knowledge in utilizing VLs for infectious disease makes them the ideal partner for the ATOM Coalition to tackle the complexity and diversity of cancer therapies. Without a full spectrum of medications that MPP’s participation and contribution will create, we would fail to meet the needs of our patients.

Dr. Dan Milner is ATOM’s Executive Director

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MPP expands reach by signing first ever licence with Japanese company

Throughout 2022, MPP remained steadfast in its commitment to the development and production of COVID-19 treatment by generic manufacturers in low- and middle-income countries. October saw us sign a licensing agreement with Shionogi, one of Japan’s leading pharmaceutical companies, for their antiviral candidate ensitrelvir fumaric acid (S-217622). Following regulatory approval, Ensitrelvir will act as a COVID-19 treatment to be administered as an oral tablet taken once daily for five days.

Pending regulatory approval, MPP is now authorised to grant sublicences to manufacturers to develop generic versions of the product and supply ensitrelvir in 117 countries.

This means that many more people from low- and middle-income countries will have access to COVID-19 treatment.

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27 generic manufacturers to supply 105 countries with oral COVID-19 treatment

This news came on the heels of a series of notable MPP successes to combat COVID-19 in 2022.

First, in January, we signed agreements with 27 generic manufacturing companies to produce the oral COVID-19 antiviral molnupiravir for supply in 105 low- and-middle-income countries. These sublicence agreements were the result of the voluntary licensing agreement signed the previous October by MPP and MSD, a trade name of Merck & Co.

As with all our non-exclusive sublicences, the agreement allows generic manufacturers to produce both the raw ingredients for molnupiravir or the finished drug itself. The companies offered the sublicence were obliged to meet MPP’s requirements for regulatory compliance, as well as international standards for quality-assured medicines. The companies span 11 countries: Bangladesh, China, Egypt, India, Indonesia, Jordan, Kenya, Pakistan, South Africa, South Korea and Vietnam.

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What our partners say

What we at Hetero find most useful is the support we receive from MPP’s Indian office, this can be on the industry landscape reports with the market share and regulatory approvals of licensed products or providing clarity on the patent situation in different markets. This sharing of scientific and commercial updates gives us a better understanding of the market and our positioning. The MPP team also helps resolve technical issues which may arise in product development and filing with regulatory authorities. What appeals to us in MPP licences is that it ensures a level playing field for all the sublicensees with the terms and conditions, territory, and timelines common to all.

Bhavesh Shah is the Director of International Marketing for Hetero, a generic pharmaceutical company based in India

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mRNA Technology Transfer Programme

  • 15 partnerships established across three continents

  • mRNA manufacturing process now successfully mapped out

  • Laboratory manual for mRNA COVID-19 vaccine preparation at small scale

  • SAMVAC established to enable vaccine pipeline development

  • Achievements on the road to new vaccine candidates

  • Funds secured for South African consortium and local manufacturing

  • Newly-created Scientific Advisory Committee adds technical expertise

More about mRNA Technology Transfer Programme Download this section

Events and activities

February 2022

Dr Tedros Adhanom Ghebreyesus and Minister Meryrame Kitir of Belgium visit Afrigen to underscore the potential to produce vaccines for a wide range of diseases.

MPP held three high level events at the Africa EU Partnership meetings on strengthening Africa’s manufacturing capacity and local production of therapeutics.

April 2022

AFRAVIH – MPP’s Head of Business Development, Sandra Nobre is on a panel talking about local production.

Esteban Burrone delivers a compelling presentation on access to treatment.

May 2022

Tiwa Braimoh speaks at the Interest conference on facilitating access to COVID-19 antivirals and new long-acting HIV agents in Africa.

Guilia Segafredo delivers MPP’s statement at WHA.

Launch of ATOM, a new global coalition to increase access to and the use of essential cancer medicines in low and lower middle-income countries.

mRNA event on the sidelines of WHA at the French Mission in Geneva.

June 2022

Board retreat to Evian to work on MPP’s Strategy 2023-2025.

Unitaid and MPP joint visit with funders from Germany, Canada, Norway and France. Here visiting Aurum Institute in Johannesburg.

July 2022

To mark the partnership between scientists at Afrigen and the National Institute of Allergy and Infectious Diseases (NIAID), partners of the mRNA Technology Transfer Programme are hosting the first scientific colloquium that MPP helped organise.

The MPP team attends IAS 2022 in Montreal.

3D film making with PVA in South Africa and Senegal. The film was launched at UNGA in New York and used at numerous events to explain the work of the mRNA technology transfer programme.

August 2022

Charles Gore and Esteban Burrone attend the G20 3rd Health Working Group in Indonesia.

Meeting during UNGA New York – Ensuring justice, equity and human rights in responses to global health threats – A discussion on the WHO mRNA tech transfer programme included: Adam Taylor, Washington Post; Charles Gore, MPP; Loyce Pace, US Government; Hon Minister Joe Phaahla MOH, South Africa; Winnie Byanyima, ED UNAIDS; Petro Terblanche, CEO Afrigen; Peter Maydarbuk, Public Citizen.

October 2022

MPP’s Expert Advisory Group meets in person in Geneva to look over upcoming projects.

MPP team meets with the Global Health 50/50 team at the World Health Summit in Berlin

Marie-Paule Kieny moderates an important session of the mRNA Technology Transfer Programme at the World Health Summit in Berlin

Giulia Segafredo talks to participants on the MPP work in Cancer at the World Cancer Congress, Geneva.

October 2022

Esteban Burrone talks on affordability and availability of cancer treatments.

For the announcement of the nilotinib licences Charles Gore hosts event in MPP offices.

MPP’s licence agreement signed with the National Insitutes of Health under the auspices of the World Health Organisation’s COVID-19 technology access pool (C-TAP) for several COVID-19 technologies is selected as a “Deal of Distinction” award winner by the Licensing Executives Society.

December 2022

At the Buyer Seller Forum in Cape Town, South Africa, the MPP team carries out interviews with partners and staff on the supply of HIV treatment in LMICs and for World AIDS Day. MPP records messages from its generic manufacturing partners supplying HIV medicines all around the world, including in LMICs.

At the Desmond Tutu Health Foundation in Masiphumelele, South Africa, the MPP team carries out interviews for World AIDS Day with clinical trial participants and health workers from the adolescent clinic.

Charles Gore speaks at USP Global Health vaccine manufacturer workshop in Cape Town.

December 2022

Sébastien Morin attends the High-Level dialogue on paediatric treatment in Rome.

MPP manages a booth at the World Science Forum in Cape Town. Over 200 people came to see the virtual reality films and President Cyril Ramaphosa also came by.

MPP helps host a dinner at Afrigen where Dr Jerome Kim, Director General of the International Vaccine Institute (IVI) spoke on mRNA vaccines.

Mila Maistat presents MPP work at EECA Interact, Latvia.

February 2022

Focus on partnership


MPP joined the following consortiums:

  • The LA PrEP Coalition is convened by Unitaid, WHO, UNAIDS, and the Global Fund, with AVAC serving as the Secretariat. This coalition was essential for MPP to secure the CAB-LA for PrEP licensing agreement.

  • The Global Diabetes Compact Forum is the forum of civil society built as a pillar of the WHO Global Diabetes Compact.

Patent offices
  • Overall, MPP sent 32 requests to national patent offices with detailed patents or patent applications to be updated, all with the support of the World Intellectual Property Organization.

Civil society
  • Engagement with African Community Advisory Boards, AIDS Vaccine Advicacy Coalition, AWCPAB and several other organisations took place as part of establishing the LA PrEP Coalition. This included playing a key role in various AfroCAB- and AVAC-led community advisory board meetings.

  • Equally importantly, MPP also participated in two ITPC-led regional community advisory boards: in Latin America and the Caribbean (LATCA CAB, in person) and Middle East and North Africa (MENA CAB, virtually).

Focus on the future

In 2022, MPP worked on its new strategy, taking time to review our work with both board and staff, fully developing our new approach

Discover our 2023-2025 strategy

Five crucial dimensions will guide our work, defining where and how MPP fulfils its mandate

  • Diseases and indications

    We will target disease areas where we have already achieved impact, and new areas where licensing could contribute to affordable access.

  • Health tools and technologies

    We will strengthen our focus on more complex technologies that cover long-acting formulations, mRNA vaccines and biologics.

  • Product lifecycles

    We will explore licensing upstream to further reduce the time from product approval to affordable access, and continue supporting downstream access in LMICs.

  • Our spectrum of activities and services

    We will support an enabling environment for licensing, negotiate licences and technology transfer agreements that facilitate the development of affordable health products, map key patents and foster strategic partnerships for access.

  • Breadth and scope of licences

    MPP’s licensing standards are internationally recognised as the most transparent and access-friendly in the global health sector. We will continue to explore ways to enable more people in LMICs to benefit from our licences, adapting them to other disease areas and complex technologies.

More about our strategy
Medicines patent pool
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