The pharmaceutical industry is an important component of health care systems throughout the world; it is comprised of many public and private organizations that discover, develop, manufacture and market medicines for human and animal health (Gennaro 1990). The pharmaceutical industry is based primarily upon the scientific research and development (R&D) of medicines that prevent or treat diseases and disorders. Drug substances exhibit a wide range of pharmacological activity and toxicological properties (Hardman, Gilman and Limbird 1996; Reynolds 1989). Modern scientific and technological advances are accelerating the discovery and development of innovative pharmaceuticals with improved therapeutic activity and reduced side effects. Molecular biologists, medicinal chemists and pharmacists are improving the benefits of drugs through increased potency and specificity. These advances create new concerns for protecting the health and safety of workers within the pharmaceutical industry (Agius 1989; Naumann et al. 1996; Sargent and Kirk 1988; Teichman, Fallon and Brandt-Rauf 1988).
Many dynamic scientific, social and economic factors affect the pharmaceutical industry. Some pharmaceutical companies operate in both national and multinational markets. Therefore, their activities are subject to legislation, regulation and policies relating to drug development and approval, manufacturing and quality control, marketing and sales (Spilker 1994). Academic, government and industry scientists, practising physicians and pharmacists, as well as the public, influence the pharmaceutical industry. Health care providers (e.g., physicians, dentists, nurses, pharmacists and veterinarians) in hospitals, clinics, pharmacies and private practice may prescribe drugs or recommend how they should be dispensed. Government regulations and health care policies on pharmaceuticals are influenced by the public, advocacy groups and private interests. These complex factors interact to influence the discovery and development, manufacturing, marketing and sales of drugs.
The pharmaceutical industry is largely driven by scientific discovery and development, in conjunction with toxicological and clinical experience (see figure 79.1). Major differences exist between large organizations which engage in a broad range of drug discovery and development, manufacturing and quality control, marketing and sales and smaller organizations which focus on a specific aspect. Most multinational pharmaceutical companies are involved in all these activities; however, they may specialize in one aspect based upon local market factors. Academic, public and private organizations perform scientific research to discover and develop new drugs. The biotechnology industry is becoming a major contributor to innovative pharmaceutical research (Swarbick and Boylan 1996). Often, collaborative agreements between research organizations and large pharmaceutical companies are formed to explore the potential of new drug substances.