At first blush Dr. David Taylor’s claim that “continuing progress in the pharmaceutical and other health sciences will eliminate disease related mortality and disability in people aged under 75 by 2050” seems a bit unbelievable. Promisingly, he and colleagues at the University College London (UCL) School of Pharmacy and at the London School of Economics (LSE) convincingly support the claim. In a recent report, the authors celebrate the successes of biopharmaceutical progress while highlighting the importance of both continued innovation and greater access. The report meticulously lays out the historic and ongoing interaction between intellectual property rights, global health progress, patient advocacy, ethical obligations, and industry strategy.
The core of the analysis focuses on the extent to which intellectual property rights serve to foster innovation and improve global public health, both today and tomorrow. Taylor et al. recognize that without intellectual property rights private investment in expensive, risky and uncertain biopharmaceutical research and development projects would not take place. Acknowledging that the debate is more nuanced that a choice between firm profits or patient access, the authors argue that alternatives to the existing IPR regime would be unlikely to deliver the therapeutic advances that we enjoy under the current system. Nevertheless, they describe the importance of recent proposals such as the Health Impact Fund and Advanced Market Commitments as valuable additions to IPR based provisions.
Perhaps most salient to the debate over patents and regulatory data exclusivity, is the description of medicines as economic entities and the need for intellectual property rights to assure a return on their development. The report states, “the ‘value’ of medicines lies not so much in the materials they contain but in the scientific challenges and material costs of their development, together with their clinical effectiveness in use”. It is this distinction that lies at the heart of any argument advocating the importance of pharmaceutical patents. The report makes this point beautifully, concisely and convincingly.
While intellectual property rights are essential to medical progress, policymakers must balance the needs of current populations against rewards for innovators as well as the needs of future populations. In this context, the authors note that preserving and sometimes strengthening intellectual property rights are essential to continued innovation. “This is so despite the fact that it in effect involves imposing a temporary ‘tax’ on the use of recent developments in order to encourage desired spending on ongoing research”. These investments are crucial to future global health, especially since biopharmaceutical products are normally relatively inexpensive to make after development and clinical testing are completed, providing low cost resources for long periods of time. Underinvesting in innovation for the future would harm both the interests of patients and the global public. Assuring that such innovation takes place depends upon a strong, effective IP regime today.
The policy analysis is rich in historical details and thorough in its analysis of the access to medicines debate. Taylor et al. provides a valuable perspective on balancing continued incentives to innovate against enhanced public health and improved patient outcomes. This is a valuable resource for anyone interested in pharmaceutical innovation and public health.
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4 comments so far.
Paul ColeFebruary 19, 2014 11:43 am
You would of course have terrible arguments about what are qualifying inventions.
And there may be other special cases. But it is strongly arguable that medicinal and pharmaceutical products are indeed a special case. The cost of making a pharmaceutical is relatively trivial; the value is in the effect produced and the knowledge of the drug and its side-effects. Pharmaceutical companies need to be well-resourced to monitor and take responsibility for the products that they produce, and those processes of monitoring and responsibility are not so effectively performed when a substance becomes generic. We no longer fly 707’s, we no longer drive cars to 1950’s designs, but we still take ampicillin and amoxycillin at need.
AnonFebruary 19, 2014 11:16 am
Interesting thoughts Paul, but do you not risk wholesale fragmentation of patent law if you want to tailor term to individual arts?
Paul ColeFebruary 19, 2014 10:27 am
Patent term for pharmaceuticals is unduly short having regard to the difficulty of development and the benefit to the public. It is also interesting to speculate whether the proliferation of generic manufacturers whose long-term commitment to particular medicaments is questionable is really in the public interest. The author of Desmond the Dinasour (a children’s book) has life + 75 years for her creation whereas the inventors of e.g. ampicillin has 20 years or less, that term being greatly reduced by the need to gain regulatroy approval. A 50 year term for pharmaceuticals would be more realistic, would enable development costs to be recouped over a longer period and would benefit the public by more reasonable prices in the early years after approval.
DaverFebruary 17, 2014 01:05 pm
Agree. The alternative is to encourage companies to retreat to trade secrets which would slow progress of technology and entry of new products on the market, if that is even possible given the current government regime under the FDA.