Innovative approaches to promoting access to medicines

Transcription

1 Innovative approaches to promoting access to medicines Rohit Malpani Director of Policy & Analysis Médecins Sans Frontières- Access Campaign

2 The Access Campaign In 1999, MSF doctors & nurses frustrated at not being able to treat patients because medicines and diagnostic tools: Unavailable Unaffordable Unsuitable Orientation: Innovation & Access

3 Today, a growing injustice confronts us. More than 90% of all death and suffering from infectious diseases occurs in the developing world. Some of the reasons that people die from diseases like HIV/AIDS, tuberculosis, sleeping sickness and other tropical diseases is that--- Life saving essential medicines are either too expensive, are not available because they are not seen as financially viable, or because there is virtually no new research and development for priority tropical diseases. This market failure is our next challenge. Nobel Peace Prize Lecture 1999 Dr. James Orbinski Médecins Sans Frontières International President The challenge however, is not ours alone. It is also for governments, international government institutions, the pharmaceutical industry and other NGOs to confront this injustice. What we as a civil society movement demand is change, not charity.

4 Why? Funding model barrier = Cost R&D Price Product High Prices No R&D for poor markets

5 3P Project - Push, Pull and Pooling Time for TB to do something new

6 The issues MDR-TB treatment Old newest drug in current regimens was introduced 50 years ago Long Treatment takes two years Complex different treatment regimens for individual resistance patterns; about 5 different drugs (14,000 pills), including 8 months of painful injections Toxic extreme side effects include deafness, psychosis, constant nausea and vomiting, hallucinations, weight loss and more Expensive Can cost up to $5000 in drug costs alone Inadequate high default rates and low cure rates (~50%) contribute to further resistance; no paediatric formulations Unproven No randomized clinical trials conducted or planned for the current regimen

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8 Where is the investment? Private sector decreased TB drug R&D from US government funding flat-lining Pfizer withdrew from anti-infectives AstraZeneca withdrew from NTDs, TB & Malaria Otsuka decreased drug discovery efforts, contribution may further decline after development of delaminid is completed Similar situation may occur with J&J and bedaquiline Pipeline gap in phase I: Early-stage & preclinical research- public institutions, small companies or PDPs Eg. Group working on PBTZ169 has had 25M EC funding: they have completed pre-clinical development, but no funding available to enter phase I How do we plug the gap in the funding needs and prevent the flight of private sector investment?

9 Five Steps STEP 1: Incentivise collaborative early-stage research STEP 2: Fortify and accelerate preclinical development STEP 3: Accelerate regimen-based clinical development STEP 4: Secure public funding for clinical trials STEP 5: Allow multiple suppliers

10 Open collaborative model Results from scientific studies & data Candidate drugs / Other technology Open Collaborative Framework* Scientific Data Clinical Study Results Compound Libraries Patents & IP on drugs & other technologies Enabled through Intellectual Property & data pooling Legal right to use data, combine, manufacture and sell products Results from all studies are published * Potentially a virtual model, where different elements are housed in different existing institutions with overall coordination

11 Incentives open collaborative model Indicates Combination Hit to Lead Lead Opt. Pre-clinical Studies GLP Tox Phase I Phase II Phase III Discovery Small, early-stage Milestone Prize (Size 1) mix of small financial and recognition prizes) for licensing the compound to the Open Collaborative Framework Legend Various TB Compounds Milestone Prizes Grant funding Later Stage Preclinical Grant funding for studies from the fund Clinical Development Milestone Prize (Size 2) for entering clinical development (Phase I) Grant funding for Phase III from existing and new Milestone Prize (Size 3) for combination regimen successfully completing Phase II

12 Implementing de-linkage In order to ensure affordability of final products the 3P Project separates (or de-links ) the cost of R&D from the price of the resulting treatments. Prices would be determined independent of the cost of R&D De-linkage paves the way for more rational antibiotic stewardship and negates the need for unnecessary marketing strategies to boost sales.

13 The journey to my cure was a matter of unfortunate events, BUT I survived I m not the only one. I am here on behalf of people devastated by this disease all over the world Change is what I'm hoping for. Better drugs. No toxic drugs. we need a better DR-TB regimen now I ask you to act now, I ask you for change. -- Phumeza Tisile, a former XDR-TB patient cured in MSF clinic, Delivered her intervention in the 67 th World Health Assembly, 2014

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