MPP’s strategy

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 Message from the Executive Director

Our Mission and Model 

The Medicines Patent Pool has a clear mission of increasing access and innovation in the fields of HIV, hepatitis C and tuberculosis treatment for people living in developing countries.

Our model is based on the concept of patent pooling and voluntary licensing.

Our Strategy – Partnership

The MPP collaborates with many public health actors including intellectual property (IP) holders, the originator pharmaceutical industry, generic manufacturers, governments, civil society and patient groups, and international organisations. Consultation, negotiation and transparency are our primary operating principles.

Our Four Priority Objectives 

The MPP’s overall strategy has four priority objectives:

First, we seek to conclude public health-oriented and transparent licences to ensure that the maximum number of people living in developing countries can benefit from low-cost treatment;

Second, we strive to speed the availability of new medicines to high-burden countries by decreasing the time from sub-licence signing to generic regulatory submission;

Third, we encourage the development of appropriate formulations more easily administered in low- and middle-income nations such as fixed-dose combinations and paediatric formulations;

Fourth, we enhance the transparency of the intellectual property status of health commodities. The MedsPaL portal, which provides public access to patent and licence status information for HIV, hepatitis C and TB treatments, is a key part of this objective.

Building on Success – Contributing to the United Nations Sustainable Development Goals (SDGs) for Health

The 2015 United Nations Sustainable Development Goals set ambitious targets for improving health outcomes, among them the end of HIV/AIDS and tuberculosis by 2030 and a revitalized push to combat hepatitis. The distribution of better-adapted, lower-cost treatments for HIV, tuberculosis and hepatitis C strongly supports the international community’s new development agenda.

The MPP has been very successful in licensing WHO-recommended and new antiretrovirals, several with the potential to drastically improve standard of care. Going forward in HIV, the MPP will explore novel drugs and delivery systems for in-licensing as we increase our work with developers to bring MPP-licensed treatments through registration and distribution.

With our vast network of generic industry partners, we are currently managing 100 projects to produce both active pharmaceutical ingredients and formulations.

In hepatitis C, ten generic suppliers are now licensed to produce and distribute Bristol-Myers Squibb’s treatment daclatasvir, a new antiviral with the potential of working across all genotypes of the virus. In addition, our licence with Gilead Sciences for tenofovir disoproxil fumarate and  tenofovir alafenamide benefit people living with chronic hepatitis B, a disease that affects 240 million people globally. We plan to begin negotiations with other patent holders in the hepatitis space soon.

The MPP also has signed its first licence for an investigational tuberculosis treatment. If successfully developed in conjunction with other compounds, sutezolid could play a part in a more appropriate, effective response to treating both drug-sensitive and drug-resistant tuberculosis. As a next step, the foundation will approach product developers to move sutezolid through the clinical development process. We expect to licence other TB treatments as well.

Looking to the Future – Expanding Partnership 

Over the forthcoming years, we will continue to work with a broad range of stakeholders to maximise the impact of our work and fulfill our mission.

We will consult with communities and patient groups, especially in developing countries, to understand their current and future treatment needs and license those products with the greatest potential of extending and enhancing lives.

We will maintain our open dialogue with IP holders and industry partners to identify innovative pipeline treatments and delivery systems with the goal of opening negotiations to conclude timely public health-oriented voluntary licensing agreements.

We will explore the possibility of extending partnerships with academic research institutions and universities that may hold key IP for future drug development, building on the models we have established with the University of Liverpool and Johns Hopkins University.

We will work with our generic company partners to ensure timely development programmes and speedy registration with specific attention to facilitating market authorisation at the country level. To achieve this objective, we will also work closely with the World Health Organization (WHO), the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and key national and regional regulatory authorities.

We will expand our work and contribution to partnerships we have jointly initiated such as the Paediatric HIV Treatment Initiative (PHTI) and the 3 P Initiative for TB Drug Development.

The MPP will continue to work closely with other public health bodies including the WHO, the Global Fund, the US President’s Emergency Plan for AIDS Relief (PEPFAR) and particularly UNITAID – our founder and principle funder – to accelerate access to new HIV, hepatitis C and tuberculosis treatments.

We will also expand MedsPaL through partnerships with national patent offices, building on current collaborations with the European Patent Office, the World Intellectual Property Organizaton, Chile’s National Institute of Industrial Property and the Dominican Republic’s National Office of Industrial Property.

New Horizons

The MPP is now exploring how its model might be applied or adapted to improve access to new essential treatments in areas such as oncology and antimicrobial resistance (AMR). Thanks to funding from the Swiss Government, in 2017 the MPP is undertaking a feasibility study to analyse patent pooling and voluntary licensing initiatives for patented medicines on the World Health Organization’s Model List of Essential Medicines.

The MPP will also engage with stakeholders, including patent offices, users, industry and patent experts to review how MedsPaL could expand its activities beyond the three existing disease areas.

Conclusion

These are critical times for global public health. The SDGs provide a clear global plan for action, but securing long-term funding and sustained commitment will be challenging. Ending HIV/AIDS and tuberculosis in this generation, moving toward universal health and essential medicines coverage will require creative ways of partnering for development.

We believe that the MPP’s public health-oriented model is one part of the answer. By working in tandem with developers and communities to expand access to low-cost, quality HIV, hepatitis C and tuberculosis medicines, the foundation supports treatment scale-up in countries hardest hit by these epidemics. The right treatment at the right price and in the right formulation can make a difference in overall efforts to reach the SDGs for health over the coming decades.

We at the MPP are looking forward to making our contribution through the successful implementation of our strategy.

We thank UNITAID for its confidence and continued financial support.

Greg Perry