Leki innowacyjne a leki generyczne w przemyśle farmaceutycznym Stanów Zjednoczonych
Innovative Drugs and Generics in the US Pharmaceutical Industry
Languages of publication
The pharmaceutical industry has always been an example of modernity and innovation. Economists point out in their research that patents play a more important role in the pharmaceutical industry than in other technical industries. This is due to the high costs of discovering and developing innovative drugs, though the cost of generic imitation is minimal. The article attempts to define the importance of patent protection and generic regulations for the development of and access to new drugs. Economic aspects of the innovation process and legislative changes concerning generic drugs complement results of the analysis of empirical data. Using this data, the author comes to the conclusion that the implemented changes are negatively correlated with the pharmaceutical companies’ motivation to innovate. Delaying strategies being developed and generic competition have an influence on the strength and extent of their innovation.
- Buchanan J.M., Medical Device Patent Rights in the Age of FDA Modernization: the Potential Effect of Regulatory Streamlining on the Right to Exclude, "University of Toledo Law Review" 1999, nr 30.
- Cutler D.M., McClellan M., Is Technological Change in Medicine Worth It?, "Health Affairs" 2001, nr 5.
- DiMasi J.A., Success Rates for New Drugs Entering Clinical Testing in the United States, "Clinical Pharmacology and Therapeutics" 1995, nr 58.
- DiMasi J.A., Hansen R.W., Grabowski H.G., The Price of Innovation: New Estimates of Drug Development Costs, "Journal of Health Economics" 2003, nr 22.
- Engström ., Jacob J., Lundin D., Sharp Drop in Prices after the Introduction of Generic Substitution, LFN Swedish Pharmaceutical Benefits Board, June 2006.
- Grabowski H., Vernon J., Effective Patent Life in Pharmaceuticals, "International Journal of Technology Management" 2000, nr 19.
- Levin R.D., Appropriating the Returns from Industrial Research and Development, Brookings Papers on Economic Activity, 1987, nr 18.
- Lichtenberg F., Pharmaceutical Innovation, Mortality Reduction, and Economic Growth, NBER Working Paper, 1998, nr 6569.
- Kaitin K., Cost to Develop New Biotech Products is Estimated to Average $1.2 billion, "Tufts Center for the Study of Drug Development" 2006, nr 8.
- Mansfield E., Patents and Innovation: An Empirical Study, "Management Science" 1986, nr 2.
- Pharmaceutical Industry Profile 2008, PhRMA, Washington, March 2008.
- Taylor C.T., Silberston Z.A., The Economic Impact of the Patent System, Cambridge University Press England, 1973.
- Thomas J.R., Pharmaceutical Patent Law, BNA Books, Washington 2005.
- Uevy R., Wickelgren A., Competition Policy Issues for Regulators: A US Perspective on Pharmaceutical Industry Cases before the Federal Trade Commission [w:] Consolidation and Competition in the Pharmaceutical Industry, ed. by H. Kettler, Office of Health Economics, London 2001.
Publication order reference