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Time for a rethink: why the pharmaceutical R&D system needs to change

As more drugs companies pull out of research into so-called poor country diseases, Katy Athersuch of Médecins Sans Frontières argues for a new way of incentivising innovation

Two events over the last couple of weeks have shone a spotlight on what is wrong with the current model of medical innovation. The first was the reported statement by Bayer CEO Marijn Dekkers that its cancer drug Nexavar was not developed “for the Indian market” but for “Western patients who can afford this product”.

The second event was the announcement by AstraZeneca that it is closing its TB, malaria and neglected tropical diseases R&D facility and will no longer be carrying out early stage research in these areas. This announcement follows Pfizer’s exit from the anti-infectives R&D field altogether last year.

What do we learn from this?

We learn that we need a new model for R&D – one that doesn’t deliberately exclude the poor, uninsured and underinsured from sharing in the benefits of innovation; won’t bankrupt public health care systems; and one that will deliver the much-needed breakthroughs that people in developing countries are still waiting for.

We face a major challenge, for example, with drug-resistant forms of tuberculosis – one we are badly equipped to tackle since we don’t have the right tools with which to do so. Multidrug-resistant (MDR) TB treatment is particularly difficult; it requires two years, including eight months of daily injections and more than 14,600 pills to swallow, many of which have toxic side effects such as deafness, psychosis and severe nausea. What is worse, the success rate is unacceptably low; less than half of patients are cured, and costs for current treatment can be high, over S$5,000.

Finding an effective treatment regimen for this deadly disease would be somewhere near the top of a public health priority list; yet where is the investment? Only 32% of the estimated funding needed for TB drug development was met in 2012, and 61% of this came from the public and philanthropic sectors. There is some optimism for TB treatment because, for the first time in 50 years, two new drugs have come to the market. Yet if we look closer, this optimism is misplaced. TB must be treated with a combination of drugs, but a lack of collaboration and transparency, due to patent barriers erected by companies, means that clinical trials to test the new drugs in combinations to ensure they are safe in new, better regimens will not be completed for several years. How long will patients be asked to wait? How many will die waiting?

Unless we separate the financing of R&D from the incentive of high prices we will not be able to fix this broken R&D system. TB patients will continue to be failed, and cancer patients in developing countries will continue to be overlooked by pricing structures focused on wealthy countries – where people are increasingly unable to afford to pay the $100,000 price tags which are now common. The industry must embrace alternative incentive mechanisms that will provide the much-needed breakthroughs in innovation at a price everyone can afford. Burying heads in the sand while millions of people are excluded from the benefits of innovation is no longer acceptable.

Katy Athersuch is Medical Innovation and Access Advisor, Médecins Sans Frontières Access Campaign

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