The role of intellectual property in the battle against malaria

Author:Sylvie Fonteilles-Drabek - Jaya Banerji - David Reddy
Position::Executive Vice-President and Head of Legal - Director of Communications and Advocacy - Chief Executive Officer, Medicines for Malaria Venture (MMV)
SUMMARY

Commercial drug research and development (R&D) requires serious investment yet promises uncertain returns. By at least one estimate (The Tufts Center for the Study of Drug Development), the average cost of developing a new drug has risen more than three-fold in 13 years – from USD802 million in 2001 to USD2.6 billion in 2014. This figure factors in the cost of the many unpredictable failures... (see full summary)

 
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So research costs are high, but if a drug succeeds, returns on investment can be huge. Successful blockbuster drugs, though not too common, generate sales of more than a billion dollars annually. It is therefore not surprising that R&D is driven and shaped by the worldwide legal recognition and protection of patents for compounds, processes and products, as these will confer on patent owners the right to prevent others from making and selling the patented product, and allow them to recoup their significant investment. Once drugs lose patent protection, companies lose control over production, because most drugs are easy to copy and can be marketed for a fraction of the originator price. The price of the cholesterol-lowering drug Lipitor, for example, recently fell by 95 percent in the face of generic competition.

Logically in such a system, the cost of developing a new drug has been too high for any substantial innovation for Type III diseases which are overwhelmingly incident in developing countries. The return on investment for these diseases is close to zero because patients cannot afford to pay high prices for the drugs they need. While this lack of innovation was largely true until the late 1990s, when the antimalarial drug pipeline was virtually empty, a look at the today’s global antimalarial portfolio shows that there are over 40 antimalarial projects either in the preclinical or clinical phases, or already approved by stringent regulatory authorities and registered. All of these drugs are developed with a strict eye to costs — with prices set at a level affordable for all public sector health services, and with distribution requirements suited for all endemic countries.

The vast majority of these projects are the result of a partnership between a pharmaceutical company and Medicines for Malaria Venture (MMV), a product development partnership.

MMV’s partnership model

MMV* was created to fill the gap left by market failure due to lack of drug research for malaria, a disease whose victims cannot afford quality treatment. When launched in 1999, MMV had one single goal – to work with partners, from both public and private sectors, to discover, develop and deliver new and effective antimalarials at the lowest prices practicable; in other words, to cure and save the lives of the most vulnerable. It remains focused on this goal.

The only way MMV could make a difference to the malaria burden was by building strong alliances.

MMV not only...

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