MPP logo

SUPPORTING UNIVERSAL
HEALTH COVERAGE

THROUGH AFFORDABLE
MEDICINES

ANNUAL REPORT 2019

Trulli

Marie-Paule Kieny

Chair

Trulli

Charles Gore

Executive Director

MESSAGE

from the Chair of the Governance Board and Executive Director

«2019 has been the year of three P’s for the Medicines Patent Pool – Progress, Partnerships and Prospects. Today, as the world grapples with an unforeseen pandemic of COVID-19, the work of MPP is as important, if not more so, as it was ten years ago when the organisation was founded.»

MESSAGE


from the Chair of the Governance Board and Executive Director

Reflecting on the year that went by, we bring to you our 2019 Annual Report with its theme, “Supporting Universal Health Coverage through Affordable Medicines.”

Health is a fundamental human right, and we strongly believe that all people, irrespective of who they are or where they live, should be able to access health services they need, without suffering financial hardship. Access to safe, effective, quality and affordable essential medicines everywhere is critical to achieve Universal Health Coverage (UHC). Yet, nearly two billion people, a vast majority living in lowand middle-income countries (LMICs), lack access to essential health products and medicines. Today, as we face the COVID-19 pandemic, equitable access to health innovations wherever you live in the world is more relevant than ever.

The Medicines Patent Pool (MPP), through its voluntary licensing and patent pooling model, works to increase access to affordable lifesaving medicines in LMICs. Since 2010, when MPP was founded, our licences have contributed to furthering the global goals in HIV, hepatitis C and tuberculosis. More recently, we have expanded our remit to essential medicines for diseases beyond HIV, TB and hepatitis C, such as diabetes, cardiovascular disease and cancer, and worked with WHO to identify patented molecules in these new disease areas, where licensing could bring significant public health impact.

2019 has been the year of three P’s for the Medicines Patent Pool - Progress, Partnerships and Prospects.

Progress: Between 2012 and 2019, MPP’s work in HIV and hepatitis brought nearly 12 billion doses of treatment to people across 141 countries and generated savings of USD 1.44 billion. In the last six months of 2019 alone, two billion doses of treatment were delivered and USD 210 million were saved. Each dose supplied meant that a life was improved, and each dollar saved meant that more people could be put on treatment.

One of our key licences, with ViiV Healthcare, achieved the five-year milestone in 2019. Currently, through the licence 17 generic manufacturers are authorised to produce and sell low-cost single or fixed-dose combination versions of dolutegravir (DTG), WHO’s preferred first-line treatment for people living with HIV (PLHIV). Through these agreements 103 countries where 89% of PLHIV reside are now procuring lowcost and high-quality versions of this safe and effective HIV treatment.

Another area where we have seen good progress is hepatitis C. Today, in most countries, the price of daclatasvir+sofosbuvir (DAC+SOF) treatment is under USD 100, and over 900,000 curative treatments of DAC alone have been supplied through MPP licences since 2016 in 28 countries. Since the end of 2018, MPP also holds the licence for glecaprevir/ pibrentasvir (G/P) from AbbVie that enables qualityassured manufacturers to develop and sell G/P in 96 LMICs. This pan-genotypic regimen, which shortens the treatment duration to just eight weeks, has a unique value in people with kidney disease as well as in children under 12 years and avoids the need for costly genotyping diagnostic tests. It is currently under development by one of our generic partners, Mylan and we hope more manufacturers will enter this space soon.

None of these successes would have been possible without our partners.

Partnerships: Each partner we work with is a critical piece of the access puzzle, which when put together, makes lifesaving medicines accessible for those in need. From the work of an originator, who develops a drug, to us negotiating a licence, to generics developing affordable quality versions of the drug, to organisations like Unitaid that fund development of paediatric formulations for these medicines, to WHO producing guidelines and recommending the drug, to advocates pushing governments to include the drug in their national guidelines, to procurement agencies like PEPFAR and the Global Fund that buy for countries, the list goes on. It is the joint effort of these stakeholders that maximises efficiencies, reduces costs and ultimately achieves the common mission of saving millions of lives. MPP truly values the work of its partners and in this spirit deepened its collaborations further in 2019.

Through the year, we signed a key licence on sutezolid for TB with Pfizer, expanded the reach of existing licences allowing access to millions of more people, ensured sustainable supply through our generic partners, and continued to identify public health needs closely with experts, civil society and countries. By being a part of various consortia, alongside a multitude of partners, including WHO, we contributed to conversations on issues like drug forecasting and access to paediatric formulations.

Prospects: Looking ahead, we developed a prioritisation framework to assess candidate medicines that could play a major role in MPP’s expanded mandate into new disease areas beyond HIV, hepatitis C and TB. Areas where we have begun discussions with relevant stakeholders are diabetes, cancer and cardiovascular disease. 2019 also marked the beginning of MPP’s exploratory journey into making long-acting technologies – for preventing malaria and TB and treating HIV and hepatitis C – accessible to people living in LMICs. Putting access on the agenda from the very start will go a long way in ensuring no country lags behind in obtaining these potentially game-changing technologies.

Today, as the world grapples with an unforeseen pandemic of COVID-19, the work of MPP is as important, if not more so, as it was ten years ago when the organisation was founded. Swiftly realising this, MPP’s Board expanded the organisation’s mandate to COVID-19-related treatments and technologies on 31 March 2020, just days after WHO declared the disease a pandemic. With all that we do, we are striving to leave no one behind. And we thank you for joining us in our efforts.

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Trulli

MESSAGE

from the Executive Director a.i. of Unitaid

«When Unitaid founded MPP, many wondered whether the idea of a patent pool for medicines could work. Fast forward ten years, and MPP holds 107 sublicenses with 22 manufacturers and has generated more than USD 1,441 million in savings across a staggering 31 million patients-years of treatment.»

MESSAGE


from the Chair of the Governance Board and Executive Director

In 2019, South Africa announced its switch to a state-of-the-art dolutegravir (DTG)-based HIV regimen that is easier to administer and has fewer side effects. The move will allow one in five people on HIV treatment globally to switch to a simpler, more effective and affordable regimen that also minimizes the development of drug resistance. Behind this milestone is the diligent work of MPP. Its voluntary licensing mechanism complements the joint work by WHO, Unitaid, the Global Fund and PEPFAR in Africa, making it possible for low- and middle-income countries such as South Africa to procure generic versions of DTG.

When Unitaid founded MPP, many wondered whether the idea of a patent pool for medicines could work. Fast forward ten years, and MPP holds 107 sublicenses with 22 manufacturers and has generated more than USD 1.441 billion in savings across a staggering 31 million patient-years of treatment. MPP has also established itself as an authority on patent information through MedsPaL, which provides the latest insights on the licensing status of selected HIV, hepatitis C, tuberculosis and other life-saving medicines in low- and middle-income countries. The platform has become an indispensable resource for a growing number of procurement agencies.

In 2019, MPP’s work was recognized by international forums such as the G7 and the G20, which highlighted its role in improving access to safe, quality medicines that are affordable. These international forums also supported the expansion of MPP’s mandate to the World Health Organization’s (WHO) list of essential medicines as a means of advancing Universal Health Coverage (UHC).

We share MPP’s commitment to promoting UHC and confronting the emerging threat of antimicrobial resistance (AMR), while advancing global goals for major diseases and the 2030 Agenda for Sustainable Development. We are proud to support MPP’s work on HIV, tuberculosis and hepatitis C, and look forward to strengthening our collaboration in the future as new and exciting global health innovations come into being. There is still much to do.

Globally, around four in ten people living with HIV are not accessing antiretroviral treatment, while a mere 20 percent of the people with chronic hepatitis C infection have been diagnosed and only seven percent are treated. On the TB front, more than 95 percent of TB deaths occur in low- and middle-income countries, showing the need to continue developing medicines and tests that are affordable and adapted to the needs of low-resource settings.

In taking stock of the first ten years of MPP, we greet its outstanding achievements and its determination to continue tackling global health challenges – including the COVID-19 pandemic— in collaboration with originators, generic manufacturers and countries. At Unitaid, we remain committed to partnering with MPP to improve and save the lives of millions.

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VISION

Our vision is a world in which people in need in low- and middle-income countries (LMICs) have rapid access to effective and affordable medical treatments and health technologies.

MISSION

Our mission is to increase access to, and facilitate the development of, life-saving medicines for LMICs through an innovative approach to voluntary licensing and patent pooling.
We work with a range of partners — civil society, international organisations, industry, patient groups and governments — to prioritise and license novel and existing medicines and health technologies for people in these countries.

18

products
licensed to MPP

10

patent
holders signed
agreements
with MPP

22

generic
manufacturers
and product
developers
sublicensed
from MPP

140+

active and
ongoing product
development
projects have
led to

72

filings
for HIV products

and

16

filings for
hepatitis C
medicines
with
stringent
regulatory
authorities (SRAs)

IMPACT OF MPP's WORK
from 2010 to 2019

Generic products facilitated by MPP have been distributed in
141 countries, providing treatments to more than
31.4 million patient-years from January 2012 to December 2019

through an average
price reduction of

72%

relative to originator
price

2019At a glance

Dr. Mariângela Batista Galvão Simão, Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals at the WHO joins MPP’s Governance Board as a non-voting participant.
MPP and ViiV Healthcare celebrate the five-year anniversary of their licensing agreements that have helped make dolutegravir (DTG), the recommended WHO treatment, accessible for adults and children in countries with the highest burden of HIV.
DTG, whose rapid access has been driven by MPP’s agreement with ViiV Healthcare, rolls out in South Africa.

2019At a glance

January
May
July
October
November
December
In line with its mandate expansion beyond HIV, hepatitis C and tuberculosis, MPP publishes a prioritisation framework to assess candidate medicines for new disease areas. The Health Ministers of the G7 and the European Commissioner for Health and Food Safety endorse MPP’s mandate expansion into essential medicines.
G20 Health Ministers lend their support to MPP’s mandate expansion MPP and Pfizer sign a licence agreement to facilitate the clinical development of sutezolid, an investigational drug for TB treatment.
MPP & Cipla sign a sublicence agreement to expand access to Cipla’s LPV/r pellets and support future plans for LPV/r/ABC/3TC (4-in-1) for paediatric use. ViiV Healthcare, MPP and Aurobindo signed a MoU to fast-track the development and uptake of DTG.

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HIV

Know Violeta and
Martina’s stories
read more.

See how MPP’s work is increasing access to HIV medicines in low- and middle-income countries
world map visualisation.

Violeta Ross

DTG making
a difference


By violeta ross

My name is Violeta Ross, I am an anthropologist, a rape survivor and a woman openly living with HIV since 2000. I am from Bolivia and, currently, I serve as the President of the Bolivian Network of People Living with HIV. I led the advocacy for access to ARV medication in Bolivia, the elaboration and approval of the HIV law, and I currently lead the political push for the full sustainability of HIV prevention and care programmes in Bolivia.

In the HIV advocacy world, we continue to say HIV is a chronic disease and manageable. We tell people their lives can continue just as before they learned they are HIV positive, but for many people, the huge impact is not just the HIV positive test, but also the many changes they have to incorporate in their daily life because of the medication. Some medications are so exhausting, and that is why some people decide to stop the treatment.

Bolivia has incorporated dolutegravir (DTG) in its national guidelines and this regimen together with tenofovir and lamivudine is being made available from April 2019.

A huge challenge for people living with HIV is the full exclusion of women between ages of 15-59 years old. We consider this situation a great loss given the effectiveness of DTG in comparison with efavirenz (EFV) and the cost benefit.

Currently, Bolivia purchases TLE (tenofovir/lamivudine/efavirenz) at the price of 77 $US/patient/year. TLD (tenofovir/lamivudine/dolutegravir) will be available cheaper.

I recommend DTG. The reduction of side effects, the effectiveness in controlling the viral load and, therefore, reducing the possibility of resistance are just two powerful reasons. I have been taking TLE since 2005 and I begin to see other side effects and consider this is already too much of the same medication. Following the outcomes of DTG introduction in some African countries, with the support of Unitaid, I fully recommend DTG. We, as people living with HIV, have the right to the best treatment available. EFV was such a treatment in its time, but nowadays I believe there are better options.

DTG’s fewer side effects and the immediate improvement in the quality of life, being able to wake up not feeling dizzy and therefore being able to work normally, stopping being tired all the time, are just some things many people with HIV do not want ever again. In comparison, EFV is a very difficult drug to take; I refer to EFV because TLE is the only regimen available as first line treatment option in Bolivia. As I mentioned earlier, the price is just another good reason in terms of public health investments and outcomes in health.

Regarding the challenges ahead for broader access to DTG in my region, it is the inclusion of women between the ages of 15-59 and the transitioning of people who are already receiving treatment (precisely the ones with more side effects). The HIV guidelines in Bolivia say that treatment naïve patients will access DTG first, but we think the already-treated patients, especially those on EFV, should access DTG first, because they are physically and psychologically exhausted with EFV.

I participated with other advocates around the world in the elaboration of a DTG Advocacy Brief and the literal interpretation of the WHO recommendations seems to be a major issue, it reflects the distrust in women’s choices and the lack of integration of sexual reproductive services with HIV services.

Martina Penazzato

Providing children living with HIV
the best available treatment

By Martina penazzato

When 150,000 additional children get infected with HIV every year and only half of the 1.8 million children living with HIV receive antiretroviral therapy (ART), something needs to be done, and urgently.

Despite some progress in identifying children living with HIV and starting them on treatment, particularly in Eastern and Southern Africa, the situation still remains grim. One missing link is the lack of optimal drug regimens and child-friendly formulations to treat HIV and HIV-associated infections. This lack of ARV drug optimization is consistent throughout Sub-Saharan Africa -- the majority of children are still on sub-optimal, legacy regimens and despite updated policies, transition to more recent optimal formulations continues to be challenged and delayed due to limited availability and supply insecurity.

We know that the development of paediatric medicines lags unacceptably behind that of adults by nearly a decade. Investigating new paediatric versions doesn’t typically come until later stages of mandatory clinical development, and often studies are not designed to efficiently generate the evidence we need to approve and safely use these drugs in children in resource-limited settings. Young children cannot swallow tablets or capsules; liquid formulations are bulky; and acceptable palatability is difficult to achieve. Drug doses need to be tailored to a child’s drug metabolism and weight, requiring dose adjustments and formulation changes as the child grows. Together, each of these hurdles complicate paediatric drug development and further fragment the already small markets for paediatric drugs for HIV, TB and viral hepatitis.

Following a resolution at the 69th World Health Assembly in 2016 “Promoting innovation and access to quality, safe, efficacious and affordable medicines for children”, WHO and partners have increased their efforts to deliver on this global commitment and have scaled up activities to ensure that better medicines become available for children. As a result, the Global Accelerator for Paediatric Formulations (GAP-f) network was born and is now being operationalised in collaboration with partners including the Medicines Patent Pool. GAP-f provides a sustainable mechanism dedicated to ensuring that the most needed optimal paediatric formulations across various diseases, including HIV, are developed against the highest standards of safety and efficacy and made available in appropriate formulations to children in a timely manner.

GAP-f works across the life cycle of drug development, bringing efficiency through enhanced coordination between stakeholders to:
•  prioritise and evaluate new products, establishing dosing, safety and efficacy (when needed) across all relevant weight bands;
• develop these prioritised products more rapidly through various partnerships and following the highest standards;
•  introduce and deliver these products in an accelerated and coordinated manner that includes appropriate safety monitoring at the point of delivery.

If we are to truly leave no one behind, we must put the world’s most vulnerable and marginalised – including children – at the top of the agenda. GAP-f is a perfect vehicle for just that.

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Choose product:

dolutegravir (DTG) adult and paediatric 50mg

tenofovir disoproxil fumarate/lamivudine/ dolutegravir (TDF/3TC/DTG – TLD)

tenofovir alafenamide/ emtricitabine/dolutegravir (TAF/FTC/DTG)

atazanavir/ritonavir (ATV/r)

lopinavir/ritonavir (LPV/r)

lopinavir/ritonavir (LPV/r) paediatric

COVERED TERRITORY
94
COUNTRIES

FILED IN
19
COUNTRIES

APPROVED IN
40
COUNTRIES

SUPPLIED IN
86
COUNTRIES

High-income countries

Low- and middle-income countries

COVERED TERRITORY
94
COUNTRIES

FILED IN
21
COUNTRIES

APPROVED IN
39
COUNTRIES

SUPPLIED IN
65
COUNTRIES

High-income countries

Low- and middle-income countries

COVERED TERRITORY
87
COUNTRIES

FILED IN
18
COUNTRIES*

APPROVED IN
8
COUNTRIES

SUPPLIED IN
3
COUNTRIES

High-income countries

Low- and middle-income countries

*For confidentiality purposes, countries will be disclosed
when approval from a stringent regulatory authority (SRA)
for this product will have been granted to more than one licensee.

COVERED TERRITORY
54
COUNTRIES

FILED IN
13
COUNTRIES

APPROVED IN
32
COUNTRIES

SUPPLIED IN
77
COUNTRIES

High-income countries

Low- and middle-income countries

COVERED TERRITORY
54
COUNTRIES

FILED IN
4
COUNTRIES

APPROVED IN
57
COUNTRIES

SUPPLIED IN
91
COUNTRIES

High-income countries

Low- and middle-income countries

COVERED TERRITORY
102
COUNTRIES

FILED IN
2
COUNTRIES*

APPROVED IN
11
COUNTRIES

SUPPLIED IN
12
COUNTRIES

High-income countries

Low- and middle-income countries

*For confidentiality purposes, countries will be disclosed when approval from a stringent regulatory authority (SRA)
for this product will have been granted to more than one licensee

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71M
PEOPLE HAVE
CHRONIC
HEPATITIS C
INFECTION

Significant
proportion developing:

liver
cancer

CIRRHOSIS

Direct acting antiviral
medicines (DAAs)

CURE
>95%
OF PATIENTS

diagnosis and treatment
is low in low- and
middle-income countries,
where people with
the virus live

2015

19%

LIVING WITH
HEPATITIS C VIRUS
(HCV) INFECTION
knew their diagnosis
of which 38% were treated

THERE IS STILL
A MAJOR GAP TO
ACHIEVE
THE 80% TREATMENT
TARGET BY 2030

3Data from the World Health Organization,
Hepatitis C Fact Sheet, July 2020
(last accessed on 21 September 2020)

HEPATITIS C

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See how MPP’s work is increasing access to Hepatitis C medicines in low- and middle-income countries
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Simon Beddoe

Fighting India’s
Silent Epidemic


BY SIMON BEDDOE

They were doing an annual routine blood test – they do 20 or 30 tests for a thousand rupees (approx. USD 14). My wife was doing these, and she insisted I do it too, because I had been losing a lot of weight rapidly and, just out of curiosity, I said ok,” said Simon Beddoe from India. “The result was really a shock for me. I freaked out, my wife freaked out. I didn’t expect it. I last presented as a drug user 15 years ago. Till today, I haven’t had the audacity to share with my extended family, like my brothers, sisters, because it’s too freaky for them to imagine that I had hepatitis C, that I almost died and that I still have what’s left of a liver cirrhosis.

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV) that can result in acute and chronic hepatitis with a range of illness – from mild disease to life-threatening condition. Hepatitis C is also a major cause of liver cancer. Globally, an estimated 71 million people have chronic hepatitis C virus infection3 . And in 2016, approximately 399,000 people died from the disease3 , mostly from cirrhosis and primary liver cancer. In India, an estimated 6-12 million people are infected with HCV4, including 37.2% of people who inject drugs (PWID)5. Direct-acting antiviral (DAA) medicines recommended by the World Health Organization can cure more than 95% of HCV-infected people, yet in 2017, as little as 7% of people with hepatitis C infection received treatment. Affordability of these medicines remains a critical bottleneck.

Only over the last couple of years a few government hospitals have slowly started shifting from PEG-Interferon to DAAs. I started talking to people and doctors to ask how I could access these effective medicines. Then reality struck. DAAs costs nearly 15,000 rupees per month (USD 210). Even though I was earning a good salary as a project manager, I still couldn’t afford the money needed to pay for my own DAAs. Many people in India don’t even earn that much money in a month.

I was lucky enough to get information that it was being given free in one of the government hospitals and then started my journey of engaging directly with the Indian healthcare system. After spending hours and sometimes days in hospital queues, hunger pangs and countless stockouts, I did avail free treatment. Initially, I didn’t feel like I was getting better. For the first couple of months I was very depressed, I wasn’t feeling too good. But things improved after the first couple of months.

Now, my mission is to push for all PWIDs in India to be diagnosed and treated. And thankfully, the National HCV programme has put in the numbers we suggested based on our evidence. So, in India now we have about 40% of PWIDs who are HCV-positive. Some 80,000 PWIDs, who were just like me, are going to be treated for free in the next two years – so it’s really exciting.

We have put the target of 40,000 PWIDs on free DAAs in year one – and that’s the focus right now. It (hepatitis C) just broke me as a worker but it kind of gave me a renewed purpose, especially for this agenda because up until I was diagnosed, the agenda was more holistic harm reduction in every facet, in every component – but when I was diagnosed, treated and cured, I thought this specific agenda certainly deserves more focus.

There is a long way to go. Elimination of viral hepatitis is possible and 65% reduction in hepatitis C-related deaths by 2030 is achievable, but only if the recommended lifesaving medicines are affordable for everyone, everywhere.

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4 National Action Plan combating viral hepatitis in India, Ministry of Health and Family Welfare, Government of India, 2019
5 High burden of HCV disease and poor access to HCV services among people who inject drugs in India: A cross-sectional study among 14,481 drug users across India

Choose product:

daclatasvir 30mg and 60mg

daclatasvir + sofosbuvir (DAC + SOF)

COVERED TERRITORY
112
COUNTRIES

FILED IN
23
COUNTRIES

APPROVED IN
28
COUNTRIES

SUPPLIED IN
25
COUNTRIES

High-income countries

Low- and middle-income countries

COVERED TERRITORY
97
COUNTRIES

FILED IN
15
COUNTRIES*

APPROVED IN
7
COUNTRIES

SUPPLIED IN
5
COUNTRIES

High-income countries

Low- and middle-income countries

*For confidentiality purposes, countries will be disclosed
when approval from a stringent regulatory authority (SRA) for this product will have been granted to more than one licensee.

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2018

87%

OF NEW TB CASES
OCCURRED IN
30 HIGH TB BURDEN
COUNTRIES,

WHICH ARE ALL LOW- AND
MIDDLE-INCOME COUNTRIES

TUBERCULOSIS (TB)

TOP INFECTIOUS
DISEASE KILLER

and the leading killer
of people living with HIV

10

MILLION

FELL ILL WITH TB

including

1.1 MILLION

CHILDREN

6 Data from the World Health
Organization, Tuberculosis Fact Sheet
(website accessed on 21 September 2020)

MULTIDRUG-RESISTANT TB(MDR-TB)
A PUBLIC HEALTH
CRISIS AND A HEALTH
SECURITY THREAT

484 000

NEW CASES

with resistance to rifampicin
-the most effective first line
drug, of which 78% had MDR-TB

1.5 M DIED

FROM THE DISEASE,

INCLUDING

205 000
CHILDREN

ENDING THE TB EPIDEMIC
BY 2030 IS AMONG THE
HEALTH TARGETS OF THE
SUSTAINABLE DEVELOPMENT
GOALS.

TO MEET THIS TARGET,
FASTER-ACTING, BETTER
THERAPIES TO TREAT TB ARE
URGENT, PARTICULARLY
FOR MDR-TB.

TUBERCULOSIS

Know Endy’s story
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See how MPP’s work is increasing access to Tuberculosis medicines in low- and middle-income countries.
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Endalkachew Fekadu
Demmisse

The road ahead - Quality affordable
treatments for tuberculosis


By Endalkachew Fekadu Demmisse

I am a pharmacist who was diagnosed with multidrug-resistant (MDR) TB in Ethiopia in 2005. At a time when there was no system in place to treat drug-resistant TB (DR-TB), meant that I was reliant on donated drugs from a non-governmental organisation based in the United States. I was just a campus second year student when I contracted TB. After two courses of struggle with first-line drugs, I developed DR-TB which was resistant to all drugs. It was like a death sentence because nobody could afford the second-line treatment. To make the long story short, I was lucky enough to get those medications with donors’ help. With the grace of God and the support of my family, I survived and slowly recovered from terrible medication side effects. My treatment lasted two full years, with a bunch of drugs and painful injections.

Now, I coordinate a community organisation called Volunteer Health Services, which provides continued professional treatment support for TB patients, promoting patient-owned care. TB treatment has also come a long way. New medicines mean that people with multi-drug resistant TB can be treated with shorter better-tolerated therapies, the cost of these treatments are coming down, and countries like mine are starting to fund TB programs. But there is still a long way to go. I believe more can and should be done to make MDR-TB treatments available and affordable to those in need. MPP voluntary licensing mechanism can play a role in bringing quality affordable treatments to those who need them. I am hopeful that we will see more TB treatments made available through MPP in years to come.

Tuberculosis remains the world’s top infectious disease killer claiming 1.5 million lives and making 10 million people ill each year7. MDR-TB is a looming public health crisis, with an estimated 484,000 new cases resistant to rifampicin, the most effective firstline TB drug7 . In Ethiopia, as of 2018, there were 165,000 TB cases in the country8.

7 Tuberculosis, World Health Organization
8 WHO Global Tuberculosis Report 2019 – Country profiles

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MPP’s
role in improving
Tuberculosis Treatment Access


MPP works to improve access to new treatments for both MDR and drug-
susceptible TB. We also aim to facilitate the development of new regimens by
licensing TB drugs that are still under development.

Sutezolid
In October 2019, MPP signed a licensing agreement with Pfizer to facilitate the clinical development of sutezolid, an investigational medicine for the treatment of TB.

Charles
Knirsch
MD, MPH, Medical/Clinical Global Health Partners Lead, Emerging Markets, Pfizer Inc.

“We recognize there is an important patient need for new tuberculosis treatments, and this partnership with Medicines Patent Pool will help provide researchers globally with an opportunity to partner in and to further progress the clinical development of sutezolid.

If sutezolid advances further in clinical development for the treatment of multi-drug and extensively drug resistant tuberculosis, we believe this partnership could be a significant step forward with regards to advancing global public health and aiding the interests of patients with tuberculosis who may benefit greatly from the development of this potential treatment option.”

MPP had already signed a licence with Johns Hopkins University in 2017 covering sutezolid in combination therapy, which did not include preclinical and clinical study data. This added element provided by the Pfizer-MPP licence can facilitate faster development of sutezolid. Sutezolid is an oxazolidinone antibiotic in the same class as the commercially available and WHO-recommended MDR-TB treatment linezolid. The drug candidate reached phase IIa clinical development. However, there has been no further development of the treatment since 2013.

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Prioritisationand essential medicines

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Long-actingtherapeutics

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MedsPaL

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Prioritisation
and Essential Medicines

PRIORITISATION FRAMEWORK

In 9 May 2019, MPP published a prioritisation framework outlining a methodology for assessing candidate medicines that could play a major role in MPP’s expanded mandate into new disease areas beyond HIV, hepatitis C and tuberculosis.

The publication of the framework followed an announcement in May 2018, that MPP would expand its mandate following a recommendation from WHO to explore a role for MPP in relation to other patented essential medicines.

Through evaluation with a set of criteria, the framework identified, as priorities for in-licensing by MPP, candidate medicines used in the treatment of cancer, diabetes, heart and other diseases.

The criteria sought to evaluate the public health and clinical relevance; access challenges; and MPP value add of expanding access to specific patented essential medicines, through detailed answers to the following questions:

  • How important is the medicine for LMICs?
  • Are there access challenges in LMICs?
  • Are MPP licences likely to lead to public health impact?

Essential Medicines

In July 2019, WHO released its newly updated 21st WHO Model List of Essential Medicines (EML) and 7th WHO Model List of Essential Medicines for children (EMLc), in which key treatments and combinations licensed to MPP have now been included: hepatitis C treatment glecaprevir/pibrentasvir (G/P), antiretroviral regimen tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) and HIV medicine dolutegravir 50mg for children above 25kg.

Updated every two years, the WHO EML and EMLc contain critical data informing national essential medicine lists, procurement and supply of medicines, and clinical decision-making.

Other key patented medicines for treating cancer and cardiovascular diseases, for reproductive health, and new antibiotics have also been added to the lists. MPP will explore, with patent holders, opportunities to accelerate access to these products in LMICs through its public health licensing model.

“Licensing through the MPP could, for example, contribute to facilitating access to some of the cancer medicines, the novel oral anticoagulants, the new antibiotics and the heat-stable formulation of carbetocin.”

• Report from the 22nd WHO Expert Committee on the Selection and Use of Essential Medicines (p.15)

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Expanding
Access to Long-acting
therapeutics

The field of long-acting (LA) therapeutics is emerging as the next frontier for healthcare management. By offering sustained and controlled release of medicines, LA technologies make it easier to administer the right dose of treatment, thus improving adherence, reducing the risk of taking medicine incorrectly and the associated increase in drug resistance. The LA therapeutics landscape is particularly dynamic as several stakeholders are joining efforts to accelerate the development of LA products. It includes funders, product development partnerships, industry, academia, policy makers, civil society and patient groups, as well as specialist consortia and working groups. Long-acting therapeutics are already blooming in the fields of contraception, harm reduction, diabetes and mental health, among others. The technologies include novel delivery systems, such as transdermal patches, implants, depots and intra-uterine devices.

In the coming years, LA products will be developed for infectious diseases. An access plan is essential to make sure these new products are available as soon as possible to all who need them, including affordable and adapted options for those living in LMICs. To date, LMICs tend to lag behind when it comes to access to new medicines. Longacting therapeutics combine one or more active pharmaceutical ingredients formulated into a technology to deliver treatment or prophylaxis. MPP, with its proven model in voluntary licensing model is a natural player in this landscape. MPP is exploring the use of its expertise in in- and out-licensing, identification of development and commercialisation partners, technology transfer facilitation, and advocacy to support efforts to making these technologies available and affordable to everyone, everywhere.

MPP’s work in long-acting therapeutics includes:

• Mapping of the long-acting space
• Reaching out to IP holders to ensure accelerated access to LA technologies in LMICs
• Building a user-friendly online repository of information on LA technologies with potential impact in LMICs, enabling information exchange and collaboration

The long-acting exploratory phase

MPP’s LA exploratory phase started in July 2019. It aims to explore how the MPP model can be applied to LA technologies. This exploratory phase is being conducted in close partnership with key stakeholders, by engaging with community representatives, donors, subjectmatter expert consortia such as the Centre of Excellence for Long-acting Therapeutics, the Long-acting/extended release antiretroviral research resource program , and other players from academia and industry. MPP is exploring the possibility of facilitating long-acting product development and securing commercial partners to ensure that products become accessible and affordable where they are needed, including through the negotiation of agreements as appropriate.

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MedsPaL
The Medicines Patents and Licences Database

MPP’s Medicines Patents and Licences database (MedsPaL) is a free resource that provides information on the intellectual property status of selected patented essential medicines in LMICs. MedsPaL was launched in October 2016 focusing on medicines for three diseases: HIV, hepatitis C and tuberculosis.

In December 2017, it was expanded to cover all patented medicines on the WHO EML. After the new WHO EML was released in July 2019, MedsPaL was updated to include patent information on 18 newly-listed medicines.

MPP collects patent and licensing data through collaboration agreements with regional and national patent offices. In 2019, MPP signed three new agreements with the Eurasian Patent Office (EAPO), the Egyptian Patent Office (EGPO) and Peru’s National Institute for the Defense of Free Competition and the Protection of Intellectual Property (INDECOPI).

regional patent offices WITH AGREEMENTS WITH MPP
• African Regional Intellectual Property Organization (ARIPO)
• Eurasian Patent Office (EAPO) – since March 2019
• European Patent Office (EPO)

national patent offices WITH AGREEMENTS WITH MPP
• Argentina’s National Institute of Industrial Property (INPI)
• Brazil’s National Institute of Industrial Property (INPI)
• Chile’s National Institute of Industrial Property (INAPI)
• Dominican Republic’s National Office of Industrial Property (ONAPI)
• Ecuador Industrial Property Institute (SENADI)
• Egyptian Patent Office (EGPO) – since June 2019
• El Salvador’s National Registry Center (CNR)
• Peru’s National Institute for the Defense of Free Competition and the Protection of Intellectual Property (INDECOPI) – since January 2019
• South Africa’s Companies and Intellectual Property Commission (CIPC)
• Uruguay’s National Directorate of Industrial Property (DNPI)

As of October 2019, the database includes patent and licensing data covering over 8,200 national patent applications on approximatively 100 priority medicines (200 formulations) in more than 130 LMICs.

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WHO ARE WE

Governance

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Expert Advisorygroup

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The team

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Governance

The Governance Board is MPP’s governing body and its highest authority for making decisions. Among its key duties are to set MPP’s policies and strategies, oversee its work plan and financial matters, and monitor and evaluate its performance.

Marie-Paule Kieny
Chair

Charles Clift
Vice-Chair

Manica Balasegaram
Member

Mo Barry
Member

Patrizia Carlevaro
Member

Claudia Chamas
Member

Anban Pillay
Member

Jayashree Watal
Member

NON-VOTING PARTICIPANT:
Dr Mariângela Batista Galvão Simão

Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals, WHO

HIGHLIGHT

• Dr Mariângela Batista Galvão Simão, Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals at the WHO accepted MPP’s invitation in March 2019 to represent the WHO on MPP’s Governance Board.

• The 24th and 25th MPP Governance Board meetings were held on April 8-9 and October 14-15, 2019 respectively.

• The Board voted unanimously to renew the memberships of Ms. Jayashree Watal, Dr. Brian Tempest, Dr. Claudia Chamas, Dr. Marie- Paule Kieny, Dr. Patrizia Carlevaro and Dr. Thamizhanban (Anban) Pillay. The Board also renewed the chairmanship of Dr. Kieny. Dr. Brian Tempest resigned from the MPP Governance Board in September 2019.

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Expert Advisory Group & Scientific Advisory Panel

In July 2019, MPP initiated a reorganisation of its Expert Advisory Group (EAG) and created the Scientific Advisory Panel (SAP). The EAG advises the Governance Board and the Executive Director on licence negotiations, and assesses whether the terms and conditions of the proposed licence agreements meet the key requirements as set out by MPP’s Statutes. Individual members of the EAG are also consulted by the Executive Director in their particular area of expertise that is relevant to the work of MPP. MPP’s EAG convened its annual meeting in December 2019. The SAP is composed of a pool of subject-matter experts who provide guidance and critical insights to the EAG and the Executive Director.

EAG members

ChairMaximiliano Santa CruzSanta Cruz IP,
Chile

Members:

Zeba Aziz Hameed Latif Hospital,
Pakistan.

Peter Beyer World Health Organization,
Switzerland.

Alexandra Calmy Hôpitaux Universitaires de Genève,
Switzerland.

Emer Cooke World Health Organization,
Switzerland.

Carlos Correa (until 31 December 2019) – South Centre,
Switzerland.

Akthem Fourati UNICEF,
Denmark.

Jan Gheuens Former Bill & Melinda Gates Foundation,
USA.

Manuel Gonçalves Co-Chair of Advisory Board of Institute of Hygiene and Tropical Medicine,
Portugal.

Martha Gyansa-Lutterodt Ministry of Health,
Ghana.

Jordan Jarvis London School of Hygiene and Tropical Medicine,
United-Kingdom.

Giten Khwairakpam AmfAR’s TREAT Asia Programme,
Thailand.

Gugu Mahlangu The Medicines Control Authority,
Zimbabwe.

Valérie Paris OECD,
France.

Fatima Suleman University of KwaZulu-Natal,
South Africa.

Ellen‘t Hoen Global Health Law Unit of the University Medical Centre Groningen,
The Netherlands.

Sasha Volgina GNP+,
The Netherlands.

SAP members

Helle Aagaard – ReAct – Action on Antibiotic Resistance
Labeeb Abboud – International AIDS Vaccine Initiative
Isabelle Andrieux-Meyer – Drugs for Neglected Diseases Initiatives (DNDi)
David Beran – Hôpitaux Universitaires de Genève
Mark Blockman – Stellenbosch University
Grania Brigden – TB Union
Jennifer Cohn – Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)
Prabhakaran Dorairaj – Director Centre for Control of Chronic Conditions, PHFI
Philippa Easterbrook – World Health Organization
James Elliot – Trustee t+ International
Nathan Ford – World Health Organization
Gavin Giovannoni – Blizard Institute of Cell and Molecular Medicine
Sergey Golovin – Treatment Preparedness Coalition in Eastern Europe and Central Asia
Rajeev Gupta – Eternal Hospital Jaipur
Juzar Hooker – Aga Khan University Hospital
André Ilbawi – World Health Organization
Kees de Joncheere – Pharmaceutical Policy Consultant
Sylvia Kehlenbrink – Brigham and Women’s Hospital
N. Kumarasamy – Chennai Antiviral Research and Treatment (CART) Clinical Research Site
Karine Lacombe – Saint-Antoine Hospital (AP-HP)
Joanna Laurson-Doube – Multiple Sclerosis International Federation
Gilberto Lopes – Sylvester Comprehensive Cancer Center
Nicola Magrini – World Health Organization
Yehoda Martei – UPENN Oncology Perelman School of Medicine
Salome Meyer – Cancer Alliance Iheanyi Okpala – University of Nigeria
Nelson Juma Otwoma – National Empowerment Network of People Living with HIV/AIDS (NEPHAK)
Anthony Oyekunle – University of Botswana
Pablo Perel – London School of Hygiene and Tropical Medicine
Roberto Reis – Center for Technological Development in Health at Oswaldo Cruz Foundation
Gojka Roglic – World Health Organization
Gracia Violeta Ross Quiroga – Bolivian Network of Positive People
Paul Ruff – University of Witwatersrand Faculty of Health Sciences
Lawrence Shulman – UPENN Abramson Cancer Centre
Ursula Theuretzbacher – Center for Anti-Infective Agents
Wim Vandevelde – European AIDS Treatment Group
François Venter – University of the Witwatersrand
Matteo Zignol – World Health Organization

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The team
MPP Culture and values

In 2019, we carried out a number of workshops and worked to collectively define the values that are important to us. We took time to learn about each other and explore better ways of working that would help us accomplish our mission.

We strive for excellence in our work and foster a positive organisational culture through transparency and open communication. We hold ourselves accountable to the highest standards, respecting individuality and encouraging innovation. We offer support to our partners as we share our learnings with the aim of accelerating access to treatment. In all what we do, we all do our best to stretch our own ability and capacity.

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Financial statements

for the year ended 31 December 2019
and Report of the Statutory Auditor