مالکیت معنوی، MNE های دارویی و جهان در حال توسعه

The paper examines the structure of pharmaceutical R&D funding, spillovers and public–private-academic research linkages in the developing countries. The paper also examines several policy options aimed at mitigating the trade off between the twin and often conflicting objectives of preserving incentives for the multinational enterprise (MNE) innovation and making patented drugs accessible to the poor countries at affordable prices. The paper argues for a vastly expanded size and scope of public-academic-nonprofit funding of R&D, whose results could become a global public good. Finally, the paper suggests that the international business scholars further explore the implications of the strong private–public-academic linkages found in the pharmaceutical research combined with the trends towards open innovation and economic development.

In poor and rich countries alike, perhaps nowhere is the tension between markets and public policy greater than in the global pharmaceutical industry comprising of traditional pharmaceutical firms as well as biotechnology firms specializing in pharmaceuticals. At the center of this tension is the need to preserve incentives for innovation by granting patents, while at the same time keeping the price of prescription drugs affordable. Several international business (IB) scholars have revisited this classic conflict between markets and public policy and brought it to the forefront of academic discourse and raised questions about the role of multinational enterprises (MNEs) in the development of emerging economies (Ghauri & Buckley, 2006). Buckley and Casson (2003) note that academic research in IB is increasingly divorced from the political, social, and economic issues involved in globalization. These issues go to the heart of the MNE's strategy, structure and performance as well as its legitimacy and sustainability in its current form (Ghauri & Cao, 2006). As Rugman and D’Cruz (2000) note, in the flagship model of the MNE, which dominates many industrial networks, particularly in pharmaceutical industry, non-business players such as the public sector, nonprofits and universities have no influence over strategy. Lodge and Wilson (2006) maintain that the traditional ideas from which corporations have derived their legitimacy – property rights, efficiency of the market, and technological progress, for example – are not sustainable as sources of legitimacy. The basic problem, as Dunning and Narula (2004) suggest, is the fundamental difference in the objectives of MNEs and the democratic national governments. The objective of the MNE is to maximize its shareholder welfare, while the objective of the national government is to maximize the welfare of its citizens (Ghauri & Buckley, 2006). Few issues in recent years have generated and continue to generate more North–South economic debate and controversy than the 1994 Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs). TRIPs are now a key part of the trading system under the World Trade Organization (WTO) framework. For the purpose of this paper, the term “intellectual property” (IP) refers to all technology-based intangible assets of a firm: an idea or a design for a new product or a process, a new molecular entity, a computer software package, and the like (Rao & Klein, 1994). The TRIPs agreement involves more than the narrow issue of trade flows between nations. Indeed, the term “trade related” is something of a misnomer in the sense that the agreement requires sweeping changes in the IPR regimes of many developing countries with important implications for economic development. The agreement has implications for the benefits of MNE innovation, funding and location of R&D, MNE linkages with the public sector, academic institutions and foundations, technology transfer and spillovers. In the context of pharmaceutical MNEs, the implications of the TRIPs agreement go to the heart of the health of nations via its potential impact on innovation and the price of patented drugs. Broadly, it is the impact of TRIPs on developing countries and development, rather than trade, on which this paper is focused. It is the negative impact of extending strong IPRs to the developing country firms which causes continuing opposition to TRIPs. On the other hand, the first world's multinational enterprises argue that extending strong IPRs to the developing countries would bring them greater inflow of FDI in production and transfer of technology, all of which help raise the living standards in these countries (Mansfield, 1994). The debate between North and South concerning the application of TRIPs to the developing world's pharmaceutical industry, which survives and even thrives on rapid and low-cost imitations, is particularly acrimonious. The larger issue for the developing world is the potential negative impact of TRIPs on drug prices and the health and welfare of its population. The main purpose of this paper and its contribution is to address, conceptually and empirically, the North–South debate over the TRIPs within the larger context of improving the health and living standards of the developing nations and the MNEs’ critical role in it. Health is central to economic development as it is to economic welfare in poor and rich nations alike. According to the United Nations's millennium goals that it aimed to achieve by 2015, four out of the eight goals are related to health issues which include reduction in the spread of HIV and AIDS and malaria ( The Economist, 2007). Surprisingly, IB scholars, despite their unique inter-disciplinary orientation and the obvious importance of the topic to the IB discipline, appear to have given scant attention to the issue. While much of the previous literature on this subject (Kremer, 2002, Lanjouw, 1997 and Lanjouw, 2005; Vachani & Smith, 2004; for example) has focused on the effect of TRIPs on the price of prescription drugs in the poor countries, this paper examines the structure of pharmaceutical R&D funding, spillovers and policy options that could mitigate the difficult tradeoffs between incentives for innovation and affordable drug prices. In examining these issues the paper benefited much from the works of Lanjouw, 2003 and Lanjouw, 2005, Kremer (2002), Ghauri and Buckley (2006), and Kremer and Glennerster (2004).

The case for a vastly expanded public–private-nonprofit role in all forms of medical research, the world over, is very strong, in light of the spillovers that the private sector cannot appropriate and the large social rate of return, which in the U.S. was estimated at roughly 68% or more than five times the private rate of return (Lichtenberg, 2003). Ironically, the case for strong intellectual property protection (IPR) in the form of patents also rests on this large divergence between social and private rate of return to investment in pharmaceutical R&D. The marginal social rate of return on pharmaceutical innovation should be even greater for the developing countries, given the poor health conditions. With respect to TRIPs, by now several scholars (e.g., Hall, 2001 and Kremer, 2002; Kremer & Glennerster, 2004; Lall, 2003 and Lanjouw, 2003) seem to be in agreement that harmonization of patents is both unworkable and costly for several reasons, particularly for poor countries. They include extreme differences in the technological effort of countries, differences in the costs and benefits of IP protection and the difficulty in enforcement. Still, the TRIPs agreement brings to the attention the inherent tradeoff between the need to preserve incentives for the private-sector innovation and keep the prices of essential drugs affordable to poor countries. Unfortunately, most policy options, like most drugs, produce undesirable side effects one cannot ignore. Differential pricing could help mitigate the tradeoff problem, at least in the short run, but it needs to be disguised by means of creative marketing strategies (e.g., branding and packaging). Expanding the scope and size of public-academic-nonprofit sector funding, push as well as pull programs, the world over, in areas MNEs find unattractive is a longer term sustainable solution, provided the results become a global public good. While there is evidence that the public sector R&D is less efficient compared with the private-sector R&D (Nadiri, 1993), given the large divergence between private and social returns to pharmaceutical innovation, medical research programs seeking to advance health should not be judged on private returns alone.