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Pharmaceutical innovations are currently guided by a patent system, [1] the patent system protects the innovator of medicines for a period of time. The patent system does not currently stimulate innovation or pricing that provides access to medicine for those who need it the most, It provides for profitable innovation. [2] As of 2014 about $140 Billion is spent on research and development of pharmaceuticals which produces 25-35 new drugs. Technology, which is transforming science, medicine, and research tools has increased the speed at which we can analyze data but we currently still must test the products which is a lengthy process. [3] Differences in the performance of medical care may be due to variation in the introduction and circulation of pharmaceutical innovations. [4]
A decline in research and development has been coined as Eroom's Law. [5][6]
Current Model
editThe FDA has implemented the Breakthrough Therapy Designation which should help bring new needed products to the market faster. [7] One of the key concerns in the current patent system is that an innovation patent is overly generous given that it has a very low inventiveness threshold. [8]
The Medicines Patent Pool (MPP), is a United Nations-backed organisation founded in July 2010[9] and based in Geneva, Switzerland. The MPP aims to improve access to appropriate, affordable HIV medicines and technologies for people living with HIV in developing countries. Working in partnership with a range of stakeholders, the MPP opens the door to generic low-cost production of key HIV therapies as well as fixed-dose combinations and paediatric formulations by creating a pool of relevant patents for sub-licensing and product development.
Measurement
editKristopher J. Hult has proposed a new measurement based on novel and incremental innovation. The model predicts a decline of 40% for the 2010s. [10]
One current way to measure is the Internal rate of return, which is used to measure and compare the profitability of investments. Reuters used the method to measure 2012 and found that the rate fell from 7.7% to 7.2%. [11]
Barriers
editRegulatory uncertainty is one area that stifles innovation. The approval processes are becoming increasingly complex. [12]
Proposed Models
editThe Health Impact Fund (HIF) is a proposed pay-for-performance mechanism that would provide a market-based solution to problems concerning the development and distribution of medicines globally. It would incentivize the research and development of new pharmaceutical products that make substantial reductions in the global burden of disease. The HIF is the creation of a team of researchers led by the Yale philosopher Thomas Pogge and the University of Calgary economist Aidan Hollis, and is promoted by the non-profit organization Incentives for Global Health (IGH).[13]
References
edit- ^ Review of the Innovation Patent System (PDF). 2014. p. 2. ISBN 978-0-9804542-7-7.
{{cite book}}: line feed character in|title=at position 25 (help) - ^ Pogge, Thomas, Medicine for the 99 percent, retrieved 2015-04-15
- ^ Milet, Sylvain. "MedidataVoice: The Next Wave Of Pharmaceutical Innovation: An Interview With Bernard Munos". Retrieved 2015-04-15.
- ^ "The timing of introduction of pharmaceutical innovations in seven European countries - Westerling - 2014 - Journal of Evaluation in Clinical Practice - Wiley Online Library". doi.wiley.com. Retrieved 2015-04-15.
- ^ Feyman, Yevgeniy (13 April 2015). "Is Pharmaceutical Productivity In Decline? Maybe Not". Forbes. Retrieved 16 April 2015.
- ^ Feyman, Yevgeniy (2012). "Eroom's Law in pharmaceutical R&D". Nature Reviews Drug Discovery. doi:10.1038/nrd3681.
- ^ Milet, Sylvain. "MedidataVoice: The Next Wave Of Pharmaceutical Innovation: An Interview With Bernard Munos". Retrieved 2015-04-15.
- ^ "Review of the Innovation Patent System" (PDF). www.acip.gov.au. Retrieved 2015-04-15.
{{cite web}}: line feed character in|title=at position 25 (help) - ^ http://www.unitaid.eu/images/EB11/05%20_eb11%20res.5%20implementation%20of%20patent%20pool.pdf
- ^ Hult, Kristopher. "Kristopher J. Hult: Research". University of Chicago - Department of Economics.
- ^ "Measuring the return from pharmaceutical innovation 2012". Reuters. Retrieved 16 April 2015.
- ^ "measuring the return from pharmaceutical innovation 2014" (PDF). www2.deloitte.com. Retrieved 2015-04-15.
- ^ Hollis, A; Grootendorst, P; Levine, DK; Pogge, T; Edwards, AM (2011). "New approaches to rewarding pharmaceutical innovation". Canadian Medical Association Journal. doi:10.1503/cmaj.100375.