The Drug Lag: A 20-Year Analysis of Six Country Markets

Abstract

The sensitive nature of pharmaceuticals and the high cost of research and commercialization to introduce new products have led to numerous regulations intended to ensure the availability of safe and effective drug products. An unintended result has been to increase the cost of product introductions into various markets. The authors empirically test the relationship among the types of regulation, pharmaceutical product introductions, and the timing of their entry into the six largest country markets from 1970 to 1989. Surprisingly, the findings show that the type of regulation affects timing more than the number of new product introductions. The authors address the drug lag across the largest country markets on a product level over a period of 20 years. They discuss important potential implications for public policy and society.

Innovation in Indian Pharmaceutical Industry: Impact of Changing Regulatory Regime

“…This gives rise to enormous possibility of unauthorized working of inventions or piracy of industrial designs, infringement or passing off the trademarks, etc. at the international level [48]. In such situations, rights of a person with respect to his intellectual property require more protection by way of stringent intellectual property law [49][50][51][52].…”

Market Responsiveness to Societal Interests

“…Intellectual property rights offer pharmaceutical firms protection of their economic assets while product regulatory approval provides an entry barrier of competition and the lack of such laws in developing countries deters HIV drug availability (Hammer 2002). However, studies of the effects of regulation on new product innovation provide mixed results (Popper and Nason 1994;Jaffe and Palmer 1997). Many firms believe that the costs of regulation outweigh its benefits and support self-regulation or actively lobby governments for deregulation.…”

Antineoplastic drug access in Thailand

“…This delay, even considering as a safety measure for consumers, was documented as "drug lag" relative to other industrialized countries; and was confirmed by several studies in the year 1970s and 1980s. The similarity of these measurement has, later, been adopted by other countries (Popper & Nason, 1994;S. O. Schweitzer, H. Salehi, & N. Boling, 1985).…”

“…However, the delay for launching new cardiovascular drugs in India, which is lagged as compared to the United States and European Union, has impacts on health outcomes remains to be established (Kataria, Mehta, & Chhaiya, 2013). The study of 20-year of data for six countries has revealed a certain extent of drug lag; which may have been resulted from national formula, National health plan, generic substitutes, and patent protection and regulation (Popper & Nason, 1994). Manufacturing Process (GMP), pricing approval, document authentication and harmonization are identified (Wileman & Mishra, 2010).…”