Technology In Society, Vol. 19, No. 1, pp. 53-55, 1997 Copyright 0 1997 Elsevier Science Ltd

Prink%in-Great Britain. All rights reserved 0160-791X/97 $17.OO#MO

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Pergamon

Mark Horn

Intellectual Property Protection

The pharmaceutical industry is increasingly an internationally-focused, research-intensive enterprise focused on the discovery and development of sophisticated, innovative products. It is among the largest supporters of bio- logically-based research and development, and among industries spends a relatively large percentage of total sales on research and development. As medical problems constitute a major source of morbidity for populations and expense for governments, the effort to address these problems through innovative medicines and devices, which are among the safer and more cost effective solutions, can be adopted as a rational, global strategy in which the research-based industry clearly must play a major role.

It is therefore worthwhile to examine and evaluate impediments that exist in current systems and structures that interfere with the ability of what is a global industry to utilize, most efficiently, its resources, both human and financial, and to access worldwide markets. These impediments, whether officially sanctioned or not, impose burdensome costs on global scientific development, economic growth and public health. Policymakers should con- sider removing such impediments wherever possible.

It is, for example, intrinsically desirable to bring the benefits of scientific discoveries to all of our citizens who can potentially benefit. It is likewise desirable for global industries, particularly those involved in innovative, tech- nologically sophisticated pursuits, to operate in diverse environments. For pharmaceuticals and devices, this global operation confers benefits both upon the parent organization (generally based in the developed world), which can access local expertise, learn about its new operating environ- ment, and expand its pool of technical talent, and upon the recipient coun- try, which gains from the investment in personnel and infrastructure, and

Mark L. Horn is Director of Medical Practice and Science Policy in the Corpor- ate Strategic Planning and Policy Group at Pfizer, responsible for worldwide scienta@ research policies. Prior to joining Ppzer, Dr Horn was in the private practice of internal medicine and rheumatology. He is on the voluntary teacb- ing faculty at Mount Sinai School of Medicine and is an attending physician at both Mount Sinai and Elmburst Hospitals in New York City. Dr Horn is a member of the Board of Directors of the Irvington Institute for Immunological Research. He ho& a medical degree from New York University School of Medi- cine and trained in internal medicine at The Mount Sinai Hospital and in rheumatology at the UCLA Center for the Health Sciences.

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54 Mark Horn

whose citizens gain experience in high-technology industries, increased economic opportunities, and access to innovative products and services.

In order for this process to work efficiently, it is critical that adequate protections for intellectual property be established and rigorously enforced. Recent trade agreements, namely NAFTA and GAIT, move in appropriate directions, despite inordinately long transition time frames embraced by the GATT agreements. The practical implications of the failure to establish and enforce appropriate protections for intellectual property are clear. A recent study conducted by the World Bank asked U.S.-based pharmaceutical compa- nies about their willingness to transfer proprietary technologies abroad to either an unrelated company or their own, wholly owned subsidiary. While India fared worst, with 81% of the companies expressing an unwillingness to transfer proprietary information even to a wholly owned subsidiary, even the mean for the sixteen nations surveyed, though a bit more reassuring (38% of the companies would resist the transfer of technology even to their own subsidiaries) suggests that a substantial problem exists.

It is worth considering precisely what this unwillingness to invest implies about what is denied to the populations and nations involved. International engagement of these companies offers access to world class technology and research techniques, well paid jobs, and economic growth as well as the medical products themselves. The companies lose as well, since their ability to benefit from the intellectual capital resident throughout the world is impeded as is their access to growing markets. The bottom line, that there is a positive correlation between protection of intellectual property rights, the growth of foreign investment and the growth of GNP should be carefully reviewed by all bodies interested in global cooperation in science, engineer- ing and medicine.

Access to Products and Services

From the perspective of an organization that exists to discover, develop and ultimately market innovative high-technology and therefore often expensive products, the worldwide focus on health care costs is a mixed blessing. Certainly, expenditures must be focused, appropriate and reasonable; always a desirable goal but now an essential one in a time of constrained budgets and ever-growing, chronically ill populations. It is critically important that individuals and organizations dedicated to the advancement of science and the public health (goals which are clearly congruent) help to guard against policies which, in the name of cost efficiency, so constrict access to advanced therapies that they impede scientific research and harm the public health by lessening the economic viability of products and services that may appear more expensive in the short run but ultimately have the potential to save both lives and money. There is a developing medical literature which suggests that this is beginning to occur and the trends in this direction will likely grow as budgetary pressures increase. As governments and various third parties who pay for health care increasingly and aggressively seek to

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control their costs by limiting access to the sophisticated products of medi- cal research, it will fall to the scientific and medical communities to defend the value of their work and the research infrastructure itself. We must pre- serve and nurture the global facility to continue to make scientific progress, progress that, as the frightening rise in antimicrobial resistance indicates, will be increasingly vital if we are to avoid medical catastrophe. Govern- ments will be seeking the counsel of the worldwide community of scientists and physicians, who must be prepared to speak strongly and consistently if the damaging effects of budgetary constraints are to be effectively contained.