It is easy to underestimate the value of small steps and incremental improvements to existing technologies. However, it is a mistake to dismiss these advances. The case for protecting incremental innovation is laid out in a new publication by the Fraser Institute, in which a thorough analysis of both the economic and the therapeutic value of follow-on pharmaceutical innovation is provided. The piece answers those critics who argue that the industry wastes resources on duplicative research to develop “me too” drugs.
Sir Isaac Newton once stated, “If I have seen far, it is by standing on the shoulders of giants.” This sentiment clearly describes pharmaceutical innovation which is an inherently dynamic process; one innovation builds on another and improvements draw from a long history of earlier technological advances. Innovation happens both in leaps and bounds, so-called radical innovation, as well as in small steps, incremental innovation. In 2012, 45 new drugs gained regulatory approval from the US FDA, the highest number since 1997. Currently there are 907 biologics, medicines and vaccines in development, targeting more than 100 diseases. [1] A great deal of this innovation may be considered incremental, resulting in so-called ‘me-too’ or follow-on drugs. These are therapies that largely replicate the action of existing drugs.
All innovation is valuable to the economy and to patients, whether in the form of breakthrough discoveries or incremental innovations. Importantly, the majority of existing therapies currently in use are incremental innovations. As evidence of their therapeutic value, a recent study finds that 63% of the drugs on the World Health Organization’s Essential Drug Lists are follow-on drugs [2], and close to one-quarter of the therapeutic indications described are treated by drugs initially indicated to treat a different disease or condition [3]. The value of such innovation is best measured through the improved health outcomes for patients. Given that those who most vehemently oppose protection for incremental innovations frequently cite the need for treatments for neglected diseases and maladies of the developing world, it is important to note that many of the treatments that do exist for the world’s most vulnerable populations are themselves incremental innovations. Please consider the following: while ritonavir is a first-line treatment of HIV/AIDS the original medicine required refrigeration, making its treatment less accessible in developing countries lacking widespread refrigeration. Then in 2010, a heat-stable version was introduced, greatly improving access for developing country patients. Clinical trials are underway to explore the effects of the antifungal medicine ravuconazole against the pathogen that causes Chagas disease, a neglected tropical disease affecting nearly 10 million people. [4] Improvement innovation led to the development of a new formulation of two anti-malarial drugs, artesunate and amodiaquine, reducing dosing regimens from eight tablets a day to two. [5] In addition, a 1998 patent awarded to two Los Alamos National Laboratory bio-engineering researchers, Mark Bitensky and Tatsuro Yoshida, allows for the preservation of red blood cell quality and prolongs post-transfusion in vivo survival by depleting the oxygen in the blood at the time of storage, significantly increasing the shelf-life of donated blood. As noted by WIPO (2005), “many follow-on and patented innovations might contribute in a positive way to the improvement of public health and also to economic development, and that some forms of adaptive innovation may be especially relevant to meeting neglected health needs.”
Beyond the therapeutic value these drugs provide, they convey other benefits as well. Incremental innovation provides physicians with the flexibility to treat the individual needs of diverse patients with precision. Specifically, incremental innovation may deliver a host of additional benefits for patients: increases the number of available dosing options, uncovers new physiological interactions of known medicines, encourages children’s compliance through reformulations, increases the shelf-life or heat-stability of a given medicine to ensure effectiveness in diverse environments, and allows for the elimination or treatment-limiting drug reactions or side effects. In addition, incremental innovation in the pharmaceutical industry delivers cost savings through the price competition that results from the availability of multiple drugs in a single therapeutic class. While critics argue that incremental innovation represents a waste of resources and generates minor improvements, not worthy of patent protection, the evidence indicates that these criticisms do not withstand close scrutiny. It is essential to recognize the value of these treatments and those that will build upon them in the future. They must be protected and incentivized. The future of public health is at stake.
Sources:
1- Pharmaceutical Research and Manufacturers of America (PhRMA). “Medicines in Development: Biologics,” 2013. Available at: http://phrma.org/sites/default/files/pdf/biologicsoverview2013.pdf
2 - Cohen, J., and K. Kaitin. “Follow-On Drugs and Indications: The Importance of Incremental Innovation to Medical Practice,” American Journal of Therapeutics, vol.15, 2008, pp.89-91.
3 - Wastilla, L.J., M.E. Ulcickas, and L. Lasagna. “The World Health Organization’s Essential Drug List. The Significance of Me-Too and Follow-On Research,” Journal of Clinical Research and Drug Development, 1989, vol.3, pp.105-115.
4 - International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). “Incremental Innovation: Adapting to Patient Needs,” January 2013. Available at: www.ifpma.org/fileadmin/content/Publication/2013/IFPMA_Incremental_Innov...
5 - Ibid.
