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Contents 1 Panel Description 2 Panel Presentation Slides 3 Notes on panel 3.1 Ellen 't Hoen, Access to Essential Medicines Campaign 3.2 Frederick Abbott, Florida State University Law School 3.3 Dilip Shah, Vision Consulting Group 3.4 Priti Radhakrishnan, The Lawyers Collective 3.5 Barbara Rosenberg, FGV, Sao Paolo 4 Papers and resources 4.1 TRIPS 4.1.1 Papers 4.1.2 Web Resources 4.2 WHO R & D Treaty 4.3 India 4.3.1 Papers 4.3.2 Organizations 4.4 Universities 4.4.1 Papers 4.4.2 Organizations 4.5 General 4.5.1 Papers 4.6 Organizations

Panel Description

The past five years have seen the emergence of a global political commitment to treat both infectious and chronic disease in poor countries. However, the possibility of treatment depends on the availability of affordable medicines. This, in turn, relates to the issue of intellectual property protection for medicines. It is well documented that drug prices drop when countries promote the use of generic medicines. For example, while a one-year supply of brand name antiretroviral therapy for HIV costs upward of $15,000 in the United States, generic competition can reduce this price to as low as $140 in developing countries. If developing countries can successfully promote generic competition, more patients will be able to afford treatment. This panel will consider the question of how poor countries can promote access to essential medicines by studying the example of India. India's generics industry is and will continue to be the key supplier of generic antiretroviral drugs to the rest of the developing world. India is the fourth largest producer of pharmaceuticals in the world - and two thirds of its exports go to developing countries. Consistent with its obligations under the TRIPS Agreement, India enacted a new patent law on January 1, 2005 that recognizes and enforces product patents on medicines. India has pledged to use the flexibilities afforded by the TRIPS Agreement to ensure access to affordable generic medicines. Yet, whereas the language of the TRIPS Agreement and the WTO's Doha Declaration is sympathetic to the issue of access to essential medicines in poor countries, India now faces pressure from the United States to enact "TRIPS-plus" intellectual property laws.

Panel Presentation Slides

Ellen 't Hoen Powerpoint
Ellen 't Hoen PDF

Fred Abbott Powerpoint
Fred Abbott PDF

Dilip Shah Powerpoint
Dilip Shah PDF

Priti Radhakrishnan Powerpoint
Priti Radhakrishnan PDF

Barbara Rosenberg Powerpoint
Barbara Rosenberg PDF

Notes on panel

Comments from the audience:

Richard from CAMBIA-BIOS:

CAMBIA-BIOS is active engaging in opposition in pre and post patent grant. We need to drop the cost and efficiency of this process so that public interest organizations can take on this task. There is a resource that this movement can use. Lack of transparency is critical. Now have “The Patent Lens.” Full public-annotatable and commentable database. Cost-free! May grow with the aid with Indian software companies and looking to add global data. Every paragraph of every patent.

Can also be used to innovate around bad patents.

http://www.bios.net/daisy/bios/50

Q2: How can potential generic companies participate in pre and post patent challenges?

Ellen 't Hoen, Access to Essential Medicines Campaign

Ellen 'tHoen Access to Essential Medicines Campaign

Role of Generic Medicines in India in enabling access to medicines (MSF)

Aids will be used an example of how patents affect access to medicines.

Why was MSF able to start providing these medications?

What changed this? Competition among generic Indian pharma firms lowered the prices. Development of fixed dose therapy. International activism produced financing, workable treatment plans, etc.

This is no longer the case with the adoption of the TRIPS agreement. The globalized standards of IP protection were not the idea of the collective of the WTO. Developing countries have resisted adoption of uniform norms.

We now see the effects of globalized IP norms. When we look at drugs that fall under this new regime, the prices are very high. There are no mechanisms to bring the prices down. The response of the companies is indifferent. They have changed the rules of game to suit themselves. They will not give this up just because they are asked to do so. Consequence is that fewer patients are treated.

Innovations are also not as accessible – such as fixed dose second line drugs, or for example, heat resistant drugs that are desperately needed in Africa.

Even where access can be granted, it imposes new difficulties with getting the medicines to where they are needed. Companies resist shipping medicines to the MSF warehouse where they can be easily distributed to the areas where they are needed.

Another key issue is data exclusivity. This is a clear access to knowledge issue that creates greater difficulty obtaining access to medicines.

Frederick Abbott, Florida State University Law School

Abbott, Frederick M. "Emerging Market Pharmaceutical Supply: A Prescription for Sharing the Benefits of Global Information Flow."

I. Introduction

New information technologies enable individuals in disparate locations to conduct cutting edge research, to move that research into the development and testing of new medicines, to manufacture high quality products and to move those products to patients around the world. Conceptually, the world pharmaceuticals supply market may become increasingly competitive at all stages: basic research, product development, manufacturing and distribution. The diffusion of technological competence to major developing country actors in the pharmaceutical sector, such as India and China, as well as to more specialized actors such as Bangladesh (manufacturing) and Singapore (research), could result in a significant expansion of the pool of products available to treat disease, as well as more affordable prices to consumers.

Ownership of pharmaceutical technology resources is overwhelmingly concentrated in the OECD countries. These resources are protected by legal rights in intangibles and by regulatory and relational barriers to market access. The emergence of developing and middle income country (hereinafter "emerging market country") competitors in the "originator" and "generic" product supply markets will erode profits of OECD-based enterprises. To address this threat, the OECD-based Pharma companies (hereinafter "Pharma") are engaged in a multi-pronged strategic effort to maintain control over the global market. The first part of that strategy involves tightening control over technology assets through laws and regulations governing innovation (i.e. patents) and investment in product development (i.e. data protection). The second part of that strategy involves investment in the emerging market countries to acquire or otherwise exercise control over potential competitors. The third part of that strategy involves maintaining control over national distribution systems so as to provide an embedded source of revenues.

This essay argues that the emergence of wider competition in the quest for new products, the development of those products, the improvement of production technologies and distribution to patients/end-users is strongly in the welfare interest of the global public. It further argues that emerging market countries are not yet at the stage in which the application of competition law will adequately promote and protect domestic pharmaceutical companies. It recommends that emerging market countries adopt industrial policies designed to promote and protect their infant pharmaceutical supply sectors. It recognizes that the United States, among other OECD countries, significantly subsidizes and otherwise protects its pharmaceutical industry and that emerging market countries cannot realistically compete with the advantages presently held by OECD industry without adopting and implementing their own industrial policy measures.

The Pharma companies are engaged in behavior which they consider to be profit maximizing. Profit maximization is argued to be a response to capital markets which allocate investment to industries in accordance with anticipated returns. Jean-Pierre Garnier, Chairman of Glaxo, has made the point that the Pharma companies are not charitable institutions. The interests of wider society in affordable prices and wider access to medicines require that external forces be mobilized to offset Pharma’s profit maximizing conduct, whether those forces are enhanced competition, government regulation or public pressure from NGOs.

The development of a more competitive global pharmaceutical supply market will not be an immediate panacea for significant parts of the world population who are unable to afford medicines, particularly newer ones. National and international policymakers will remain obligated to establish and implement mechanisms designed to make medicines available to those who cannot afford them.

II. Proliferation of Knowledge and Capacity

The Internet and other information flow innovations are rapidly transforming the global market for the provision of goods and services. Differentials in technological capacity between the OECD countries and developing countries are rapidly closing. India already has emerged as a significant base for computer software research and development, and the outsourcing by US-based software companies of development work to India is a source of political concern in the United States. China is supplanting Japan as supplier to the world of middle technology goods. While China's rapid ascendance as a technological power can be attributed to appropriation of OECD technological expertise, as its scientific community further absorbs that expertise it is a certainty that China will itself become a source of innovation.

The development of "new" medicines is complex, time-consuming and carries a high level of risk. The costs of new pharmaceutical product development are high in comparison with middle-technology products. Pharma companies own the overwhelming percentage of existing pharmaceutical technology patents and data protection-based rights. This technology asset base provides a very significant advantage in the development of new drugs which are often based on previously patented technology. The Pharma companies have access to a large capital base in the form of existing assets, and they enjoy access to well-developed capital markets. In the United States, Europe and Japan, the Pharma companies are connected to laboratories at well-financed universities and teaching hospitals. In the United States, the National Institutes of Health (NIH) has an annual budget of $28 billion, most of which is devoted to research on new treatments for disease. The fruits of NIH research are made available in the form of patented technologies to US-based Pharma companies at very low cost.

In light of the static advantages working in favor of the Pharma companies, it will be difficult for emerging market enterprises to rapidly become competitive in the research and development of new pharmaceutical products (i.e., “originator” products). India-based pharmaceutical companies have focused on improvements to production technologies and are leaders in this area. The Indian government has increased attention to public research and development funding, and Indian researchers are obtaining more pharmaceutical patents. There is less publicly available information about the state of China's domestic pharmaceutical research and development, but there are reasons to believe that the Chinese government is increasing its attention to this sector. Chinese researchers have been responsible for the development of important new technologies in the treatment of malaria. China has a long tradition of attention to medicines and health. The University of Hong Kong, among others, has launched a program to identify the scientific basis underlying the curative properties of traditional Chinese medicines. China also acts as a major supplier of pharmaceutical chemicals to the OECD and therefore is already competent in production technology.

At the high end of the technology spectrum, Singapore has made pharmaceutical research and development a top national priority, investing substantially in the Biopolis research complex. Scientists at that complex were responsible for identifying the genetic markers of the SARS virus well ahead of the timeline generally projected for this task, and they licensed the results to Roche. The Israeli pharmaceutical industry, which so far has largely focused on generic production, is turning its attention to the development of new products. At the lower end of the technology spectrum, Bangladesh, a least developed country, is emerging as a major producer of high quality generic drugs.

In India there is a growing sub-industry of clinical testing subcontractors. Clinical testing of new drugs is the most expensive component of developing such products. Indian subcontractors hold themselves out as a low-cost alternative to clinical testing in the OECD markets.

While the Pharma companies maintain significant technology and capitalization advantages over the pharmaceutical industries of India, China and other emerging market countries, there are good reasons to believe that these advantages will erode over the next decade.

Global pharmaceutical sales are in excess of $500 billion a year. The Pharma companies are well aware of the threat to their global market dominance represented by the emerging market pharmaceutical industries. They anticipated and have been acting upon this threat since the early 1980s. As the pace of change accelerates, largely based on development of new information technologies and enhanced global information flows, the Pharma response is growing in scope and intensity.

III. Strategic Response

A. Protection of Intangible Assets

1. Opening round

In the early 1980s, the Pharma companies initiated efforts to limit competition by tightening worldwide intellectual property standards. A failed effort at the World Intellectual Property Organization (WIPO) resulted in shifting the forum of negotiations to the GATT. The GATT Uruguay Round negotiations, which commenced in 1986, yielded the 1995 TRIPS Agreement, which was a qualified success from the Pharma standpoint.

The TRIPS Agreement established an obligation to provide pharmaceutical product patent protection, subject to a 10-year transitional exemption in favor of developing countries. The transition period allowed Indian manufacturers to improve their generic production technologies, although it did not provide access to the high-value OECD pharmaceutical markets when patent protection was in place there.

However, from Pharma’s standpoint there were several important limitations to the TRIPS Agreement. First, it did not provide protection against the sale of generic drugs to countries where patents had not been obtained. The major Pharma companies traditionally file patent applications in a relatively small number of countries where substantial sales opportunities are foreseen or where competitive producers might emerge. This leaves a fairly wide range for competition from Indian (and other emerging market produced) generic drugs in less affluent markets. Second, the TRIPS Agreement did not include any control over the pricing of patented pharmaceuticals. This was largely a developed country problem. All of the OECD countries outside the United States impose some form of control on drug prices, significantly constraining the pricing power of the Pharma companies. Third, although the TRIPS Agreement requires pharmaceutical product patent protection and data protection, the rules are not airtight. For example, the patent rules do not require countries to offer protection for second medical indications. They also allow significant flexibility in defining inventive step. This allows countries to limit the number of patents by requiring a significant level of innovation over the prior art. With respect to data, protection is only required as to "new chemical entities" and with respect to "unfair commercial use".

2. Second level intangible protections

The limitations of the TRIPS Agreements grew in importance as the pharmaceutical industries of the emerging market countries became more competitive. The first-best tactic for eliminating these limitations would have been negotiation of a second-generation multilateral agreement at the WTO: a TRIPS II. However, in the multilateral setting developing countries were not interested in closing the few openings left to them by TRIPS flexibilities.

The second-best tactic was negotiation of bilateral and regional trade agreements that eliminate or restrict the flexibilities of the TRIPS Agreement. For complex reasons (explored elsewhere) developing countries have been willing to concede TRIPS flexibilities in bilateral negotiations which they will not concede multilaterally. Concessions include tightening standards of patentability, imposing data protection standards that make it difficult to register and market generic drugs, limiting compulsory licensing and parallel trade, and allowing the prosecution of nonviolation nullification or impairment claims. In the FTA between the United States and Australia, US Pharma companies have won the right to challenge Australian price control decisions (which are given affect through determining which drugs are available for insurance reimbursement).

In the bilateral and regional agreements the data protection hurdle is given effect by the national drug regulatory authority which is responsible for granting marketing approval and registering a medicine. Linking regulatory approval authority to the patent status of medicines enhances the power of the patent holder because an affirmative burden is placed on the generic producer to overcome patent claims before it can market its drug. It also places a burden on national regulatory authorities to determine patent status, a burden which may be very difficult for the typical health regulatory authority to carry.

The effect of the second-best solution is to create additional impediments to the penetration of developing country markets by Indian, Chinese and Israeli generic pharmaceutical companies, among others.

B. Acquisition and Control of Potential Competitors

The greatest threats to OECD dominance of the global pharmaceutical market come from the potential emergence of innovator Indian and Chinese pharmaceutical companies which will similarly be able to take advantage of IP protections, generating substantial research and development and marketing capital. India and China not only possess significant technological infrastructure, but also large and growing domestic markets. Russia, Brazil, South Africa, the Ukraine and a few other countries possess similar, though somewhat less favorable, characteristics for the development of integrated pharmaceutical sectors.

Although the agenda is just now being implemented, it is clear the tactical move of Pharma is to employ accumulated capital stock to acquire and/or control companies based in India and other emerging market countries. This will be combined with "green-field" investments (i.e., new investments not involving existing local enterprises) in these countries. This trend is visible in Glaxo's expanding relationship with one of India's leading independent pharmaceutical companies, Ranbaxy, several of whose senior managers are former Glaxo employees. It is very difficult for independent companies in India to resist the amount of capital available to foreign multinational investors. From the standpoint of a Pfizer or Glaxo, it is preferable to spend several hundred million dollars to acquire control of a potential competitor than to risk the emergence of a strong competitor in the global market.

The growing penetration of the OECD-based Pharma companies in India will be aided by highly paid consultants, accountants and lawyers who earn fees from foreign employers which cannot be matched by the domestic industry. The capacity for the Pharma companies to take control of the domestic regulatory infrastructure by paying the private regulatory elite to influence government policy is a phenomenon evident throughout the developing world. The result is a new class of locally-based service providers with a strong vested interest in the protection of OECD corporate interests.

C. Control over distribution

The pharmaceutical supply market is multilayered. Even if a manufacturer is able to remain independent and overcome patent and data protection barriers, it must still find distributors to place its product on to the national market and, in the case of prescription medicines, physicians to prescribe the medicine and pharmacists to dispense it. In the United States, the major Pharma companies in some cases control large pharmaceutical distributors. In other cases they enter into comprehensive supply contracts with medical service providers. The Pharma companies spend very significant amounts of money to promote their products with physicians and on direct to consumer advertising. Physicians receive ancillary benefits such as vacation-seminars.

It is very difficult for generic drug producers from developing countries to penetrate the OECD distribution systems which are effectively dominated by the major Pharma companies.

The Pharma companies similarly seek to control domestic distribution systems in developing countries. For example, in South Africa the local Pharmaceutical Manufacturers Association is dominated by the major international Pharma companies and plays a significant role in lobbying domestic drug and health care policies.

Perhaps of most importance, the Pharma companies spend tremendous amounts of money lobbying governments around the world. In the United States, they contribute to election campaigns, and lobby Congress and the federal agencies responsible for regulating health care. The recently adopted Medicare Prescription Drug Benefit program is one of the most costly government programs ever adopted. It has been projected to cost the federal government $1.2 trillion over a 10-year period. The terms of the program prohibit the federal government from negotiating the price of drugs with the pharmaceutical industry on behalf of the private insurance companies that will give effect to the program (the so-called "non-interference clause"). This program may be one of the largest government-controlled transfers of wealth from the public to the private sector in human history.

Although there does not appear to be an explicit preference in the program for the purchase of drugs from American-based pharmaceutical companies, because the Pharma companies dominate the originator market and have established contractual relationships for the supply of generic drugs with health care providers, it seems highly likely that American-based Pharma companies will be the greatest beneficiaries of the Medicare Drug Prescription Benefit program.

Generic-substitution laws are an important tool for controlling drug prices. Such laws mandate or authorize the pharmacist to substitute generic versions of patented drugs prescribed by physicians, unless specifically directed otherwise by the physician. The Pharma companies have argued that such laws interfere with their trademark rights. Even though generic-substitution laws are common in the OECD, including among the states of the United States, a specific challenge was made against the introduction of such a law in South Africa based on alleged trademark rights in the case brought by 39 pharmaceutical companies against the Government. That challenge was withdrawn along with all of the other ill-founded claims.

The single most important item on the current Pharma agenda is the elimination of pharmaceutical price controls, particularly in the OECD markets. The companies argue that because the United States does not control pharmaceutical prices while other OECD countries do control such prices, the United States is effectively subsidizing the research and development interests of other OECD countries. They argue that removal of price controls would eliminate the apparent failure of research and development burden sharing. Implicit in that argument is that prices for pharmaceuticals in the United States would be lower if they were higher in other OECD countries. Because Pharma companies control the OECD market for new products, the net effect of eliminating price controls would be to disproportionately increase Pharma profitability as compared with emerging market producers, thereby reinforcing Pharma advantages.

IV. Implications for Consumer Welfare

As India, China, Israel, Singapore and other emerging pharmaceutical R&D centers increase their capacity for bringing innovative products to market, it seems likely that the pace of innovation on a global scale will increase and the public as a whole will benefit from the introduction of new therapeutic treatments. If the diffusion of technology to emerging pharmaceutical R&D centers is sufficiently powerful, it is possible that we could enter a new era of technology-based competition in the pharmaceutical sector based on a significant increase in the number of products available for treatment in a particular therapeutic class. If there are a number of competing products in a therapeutic class, even if those products are patented, an increase in price-based competition would be expected, leading to lower prices. The possibility for competition within therapeutic classes provides a good reason for preferring that enterprises in emerging markets remain independent of the Pharma companies.

To the extent that emerging market enterprises survive as independent entities, they will seek patent protection for their inventions and attempt to preserve supra-competitive rates of return for as long as possible. They will charge the price the market will bear, with particular aim at the high-value markets of the OECD. In this respect, there is no reason to assume that enterprises in emerging markets such as India and China will behave differently than OECD-based Pharma companies. Problems of access to newer medicines among poorer segments of the global population may not be dependent upon which country is the source of that medicine, but rather whether governments are willing to take steps to promote access.

The preservation of independent pharmaceutical enterprises in emerging markets is more likely to affect pricing and availability in the generic than in the originator products sector. That is, it is critical that a significant number of well-financed generic producers participate in the global supply market because this is what constrains prices and enhances availability. Because high profits from the originator product sector are used to finance the establishment of distribution arrangements in the generic sector, it is important that the emerging market independents are active in both segments of the market. Independent Indian pharmaceutical companies, today mainly active in producing generic products, are deeply concerned that by acquiring significant stakes in the local market, better financed OECD-based Pharma companies will be able to drive them out of business. If this happens, the resulting decline in generic competition will push prices up worldwide.

The greatest potential threat to global consumers of pharmaceutical products is that the OECD-based Pharma companies will succeed in foreclosing competition in the market for generic products, inter alia, by driving independent generic producers in emerging market countries out of business. They may accomplish this using the threefold strategy discussed above, namely by preserving static technological leads through strengthened intellectual property protection, acquiring and/or controlling potential competitors and dominating distribution systems.

V. Preserving the Fruits of Global Information Flows

The problem faced by emerging market pharmaceutical industries in competing with the Pharma companies may broadly be described as a competitive markets problem, but not in the sense that the problem may be redressed solely by the application of traditional competition law principles. There are two reasons for this. First, and perhaps most important, is that the Pharma companies possess very significant advantages in the form of ownership of technology, access to capital markets and government subsidies which create a playing field that is not level. It is difficult to place the problems facing emerging market pharmaceutical industries squarely within the boundaries of traditional competition law, nor do the solutions lie there. Second, even if the problems might be redressable as traditional problems of anticompetitive conduct, there would still be considerable difficulty with redressing them.

Regarding redress of anticompetitive conduct, most developing country governments, including those of the major emerging pharmaceutical supply enterprises such as India and China, have only rudimentary competition law infrastructures. There is very little political impetus at the international level for the development of a multilateral competition law infrastructure that might overcome weakness at the individual nation state level. In addition, the OECD countries have adopted policies that encourage their enterprises to engage in anticompetitive conduct in developing country markets. United States