The Doha-Delhi odyssey

The fact that the Doha Declaration on TRIPS allows member-states the flexibility to address issues related to public health and providing medicines to all should be enough ground for a re-look at the Second Amendment to the Patents Act, 1970.

THE high point of social justice and pharmaceutical nationalism was the Hathi Committee Report, which made the little Indian's access to medicinal justice the focus of state policy. The nadir of the people's right to curative care and state facilitation will arrive shortly when, in meek submission to the distortions of the commands of the Trade Related Aspects of Intellectual Property Rights (TRIPS) and the abject acceptance of conquest by patent as an inevitability, Parliament will be pressured to amend the Patents Act, 1970 - a fine piece of legislation - to propitiate the World Trade Organisation (WTO) and the cabal of multinational corporations. Will the Second Amendment to the Patents Act, 1970, not be aborted or averted by valiant battle in the House? I trust that the power of debate and the participatory commitment of the members of Parliament will win. And so, defying despair, I make some substantive suggestions for the wisdom of the House to consider.

The Patents Act, 1970, was parliamentary performance at its best, blending pragmatism, patriotism and eclectic functionalism, and the decades that followed proved, by pharmaceutical progress registered by India, that law to be a tribute to intellectual property jurisprudence. But the TRIPS treaty attempted, with success, a treacherous subversion of India's sound patents justice. The Second Amendment (to the Patents Act, 1970) coming before the Upper House is, as it now reads, a reversal under stress, a farewell with tears, an unhappy drug deal deprivatory of the excellent provisions of the extant law. So, beware before you tamper or surrender, since the first commitment of the Houses is to Indians, not to multinational drug barons who corner, through patents, the medicinal riches and hold to ransom suffering humanity in penury. In Seattle, non-governmental organisations fought the WTO and beat the conspiracy. Then came Doha, an obscure geography for the North to make the South swallow the bitter pill of conquest by IPRs (Intellectual Property Rights). Victory was baulked.

The WTO is the instrument of world capitalism as the Controllerate of the global economy. Doha is where India, conscious of its being vanquished by the General Agreement on Tariffs and Trade (GATT), made valiant protests and combined noises on behalf of the developing countries against the ploys of big business to corner IPRs. Doha was a theatre of diamond-hard dissent and social justice demand by India. Minister Murasoli Maran did us proud. The Indian, in his agricultural interests and health care concerns, is raising his voice of protest against conquest by patents. India, in its Parliament, must resist foreign corporates and GATT predators. Before long what Joseph E. Stiglitz called "IMF riots" will spring into battle when the common people are mortally wounded. Stiglitz was the World Bank's Chief Economist who resigned and later became a Nobel Prize winner. The future shock would be 'Market pricing' unaffordable for common humans, who then riot a la Indonesia and Argentina. (State repression is no solution.) And obedient Indian authoritarians will bring repressive laws. The last paragraph from Pilger's Hidden Agenda tells the subversive truth in the offing:

"Beware the rumbling out there," says the President of the Federal Reserve Bank. "People are dangerously suffering from globophobia," says a senior floor trader in New York. "The magnitude of change in the world economy since the end of the Cold War," wrote the eminent American economist David Hale, "has been so dramatic it has given rise to a new political phenomenon... Voters now view trade issues in terms of domestic class struggle." In his book, Has Globalisation Gone Too Far? another Harvard high priest, Dano Rodrik, wrote, "The international integration of markets for goods, services and capital is pressuring societies to alter their traditional practices (so much that) in return, broad segments of these societies are putting up a fight."

The fight has only just begun.

A rapid survey of the financial developments since the Brettonwoods Conference (1944) begins with the creation of the World Bank and the International Monetary Fund (IMF) and the inauguration of the New Economic Order, which the United States and its allies initiated with the mantras of globalisation, liberalisation and privatisation. The Dunkel Draft Text (DDT), cannily crafted during the Uruguay Round, formed the frame of the Final Act, the GATT Treaties and the WTO. After the Second World War, the U.S. emerged as a superpower with a cosmic mission, obligating it to dominate the economic destiny of humanity. Third World countries were to be economic wards of the U.S., which would intervene when its economic interests necessitated such a course as a global duty, the subversive truth being the power of the multinational corporations to win the market war and maximise profits. Long years ago Calvin Coolidge had said that "the business of America is business". Ralph Nader later drew in his prologue to the book America Inc. the inference that Big Business is government. Woodrow Wilson put it more bluntly:

The masters of the government of the United States are the combined capitalists and manufacturers of the United States. It is written over every intimate page of the record of Congress, it is written all through the history of conferences at the White House, that the suggestions of economic policy have come from one source, not from many sources.... The government of the United States at present is a foster child of the special interests.

Since then, the might of the MNCs has grown to gargantuan dimensions. This market theology has now become world religion and the New Testament consists of TRIPS and Trade-Related Investment Measures (TRIMS). Gullibly, India became a party to GATT and WTO. Ralph Nader, with an unerring sense of anticipation wrote:

An unprecedented corporate power grab is underway within the Uruguay Round negotiations of a new version of the General Agreement on Tariffs and Trade. By clever manipulation of free trade symbols and dependency between nations, multinational corporations hope to harmonise downwards consumer protection, environmental and worker safety standards and wage levels. Special burdens are in store for Third World countries, whose sovereignty the multinational companies are hoping to further erode.

While the U.S. itself has declared that it could ignore WTO directives when they counter its interests and its laws, what is disheartening vis-a-vis Third World countries like India is that:

The U.S. can use the trade agreement to force open markets of the developing countries. "The United States would be most likely to use provisions of the new trade agreement to force open the markets of India and other developing nations that have a history of using local laws to block U.S. products," Matsui said.

It may be useful to remember that the signature of a Minister, in purported exercise of his power under the Constitution, cannot subvert or transgress its basic structure. It is for the Supreme Court to uphold the constitutional values and enforce constitutional limitations. That is the essence of the Rule of Law, as laid down in S.R. Bommai. So viewed, the treaty-making power (read Articles 73 and 253 together) cannot override the basic obligation of the state conferred as the fundamental rights of the people. After a detailed study, a People's Commission on GATT (I happened to be its chairman) took the view that "if the Constitution is what the judges have told us and the text of the Preamble explicates it, the TRIPS pact, vis-a-vis Indians, will in all probability be ultra vires. Perhaps the court may take a different view, but a possible view expressed in the Report of 1996 is a cautionary signal that fundamental rights be not breached by the Second Amendment to the Patents Act, 1970.

This divagation is to stress the prospect of potential violation by the Houses enacting amendatory provisions that appear to contravene Articles 19 (freely to manufacture or do pharma business) and 21 (right to health with reasonable access to curative drugs) apart from being a travesty, through big monopoly, of the social justice essence of the Preamble to the Constitution. Let us view, through the lens of egalitarian ethos and the social justice ethic of the Constitution, TRIPS. The Doha Meet on TRIPS offered semantic alleviation in the direction of better health destination.

It is somewhat surprising that the Doha Declaration finds no reference in the Joint Parliamentary Committee (JPC) Report. Of course, in the thoroughgoing parliamentary scrutiny of the clauses of the Bill, for sure, Doha will figure in a big way, what with the 'flexibility' writ into the Declaration. True, the language used is somewhat dubious and the deletion in the final text of the term 'public interest' is deleterious. Even so, the ministerial meet imparts some flexibility to member-states to address issues related to public health and providing medicine for all. There is explicit recognition of the gravity of the public health problems affecting developing countries. There is stress on the need for medicinal availability for HIV/AIDS, malaria et al but also on patents for development of new medicines. Moreover, there is recognition of "the concerns about the effects of patents on prices. The TRIPS Agreement, after Doha, does not and should not prevent members from taking measures to protect public health". For this, the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all. Doha Declaration reaffirms the right of WTO members to use to the full the provisions in the TRIPS Agreement which provide flexibility. It is Delhi's need to gain an ell out of every inch conceded at Doha. Let us not be pessimistic.

TRIPS does allow countries to override patents in special circumstances. Dr. Yusuf Hamied, Chairman of Cipla Ltd and a seasoned pharmaceutical statesman, argues (and I agree):

Laws of compulsory licensing should be of a permanent nature, that is, licence of right and payment to the inventor. Nobody disputes the fact that the inventor deserves to be paid a royalty. But we cannot afford a monopoly. Consider this. According to World Bank figures, 350,000 fresh AIDS cases per day are being added in India. By 2005, the country will have 35 million AIDS cases, which is more than in Africa. In Africa, 10,000 AIDS patients die every day. And yet, when Cipla offered the anti-AIDS drug at competent prices, we were not allowed to sell. Though the court case in this regard has been withdrawn, even now we are not allowed to sell there, as the situation has not been designated a 'national emergency' by the country. But wouldn't such a move be in the 'public interest'.

What concessions have been wrung in the Doha Declaration must be fully exploited with inventive and imaginative pragmatism. For instance, Sushil Suri of Morepen Labs takes the view that the Declaration has opened doors to India to make inroads. Likewise, D.G. Shah, Secretary-General, Indian Pharmaceuti-cal Alliance, has struck a promising note on Doha. It is unambiguously stated in the Declaration that each member-country has the right to grant compulsory licences and will have the freedom to determine the grounds upon which each licence can be granted. It is thus beyond doubt that the flexibilities are not limited to "national emergencies or circumstances of economic urgency". What justifies such situations is for Parliament and government to clarify and codify. Adequate availability or just price could be a valid ground for compulsory licencing. This is amply covered even under Article 5A of the Paris Convention. TRIPS (Article 2) does not derogate from the existing obligations under the Paris Convention. Article 31b of the TRIPS Agreement allows the issue of compulsory licence on an expeditious basis in circumstances of national emergency or extreme urgency.

The constellation of benign provisions Sections 86, 87 and 88 of the Patents Act, 1970, in particular Section 8 (1), can survive any MNC challenge once we grasp the public interest dimension of the Doha pro bono annotation of the TRIPS Agreement. Mark you, Brazil has a specific provision for local working of patents in that country after three years of grant of patent. India is thus not alone in making a self-defensive humanitarian clause. A clear case for incorporating automatic licence of right provisions, given courage, conscience, compassion and national commitment.

The Drug Divide between the North and the South in the pharma sector cannot continue to the detriment of developing countries using harsher versions of the TRIPS Treaty, but must be spanned by softer interpretations of the Doha flexibility. A lot of leeway has been built into the Declaration but the proof of the pudding is in the eating and here comes the great challenge to Parliament and its dynamic ability to liberalise the TRIPS toughness and import the dialectics of Doha into the new patent process under legislative passage.

INDIA has been, as a nation, trapped into TRIPS and stripped of its sovereign power to defend the people's right to life in good health (an inviolable basic feature) and easy pharmaceutical access. Honourable members will not give in, while making life-giving law, to macro-corporates that have clout with the WTO. Do remember that the legislative power of parliamentarians obligates them to defend the people of India. "The fault, dear Brutus, is not in our stars but in ourselves, that we are underlings" may be history's hard verdict if, yielding to GATT audacity, we oblige Mega-pharma Incorporated with a pusillanimously pliant patent law. Never.

The Doha Declaration, in its parsimonious compassion, has relaxed the textual rigidity of TRIPS and plainly accorded primacy for public health over commercial interests. But the JPC proceeds on the pre-Doha hardcore view of TRIPS. The Declaration, in a mood of binding generosity, observes:

We recognise the gravity of the public health problems affecting many developing and least developed countries, particularly those suffering from HIV/AIDS, tuberculosis, malaria and other epidemics.

We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.

In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement which provide flexibility for this purpose.

I agree with patent law specialist N.J. Zaveri's criticism of the Amendment Bill:

The bill proposals make no exception from procedural requirements of Section 87, even in cases of 'national emergency' or 'extreme urgency'. Even after the issue of the gazette notification and declaration by the government of such situations, the proposed Sections 92 and 87 require the same procedure to be followed by the Controller of Patents with the right of appeal to the Appellate Board as per section 117A, involving delays of not less than two years - when every day's delay adds to the death toll in thousands.

In fact, according to Zaveri, just about anybody can oppose the grant of compulsory licences under Section 87 of the draft Bill.

The pre-Doha orientation of the Bill assumes significance in the context of the fact that multinational pharmaceutical companies, which hold roughly 80 per cent of the drug patents currently in force globally, maintain prices at 20-40 times their costs. Obviously, Zaveri says, the multinationals will oppose and obstruct any use of the patented invention for production, sale or distribution of the patented product under compulsory licences; government/third party use or parallel import provisions.

Given the circumstances, Zaveri has urged a review not only of the pending Bill, but of the Patent Act, 1970, as the safeguards available under it will also fail in the face of the power "ruthlessly exercised" by the multinational patent holders.

B.K. Keayla, a powerful and well-informed campaigner for a fair patent regime, and Dr. S. Vedaraman, former Director-General of Patents and crusader for pharma justice, hold the erudite view that pharmaceutical equity is still possible, given political will. I repeat what I wrote earlier on this issue:

Beware! To genuflect before Big Powers and consent by legislative action, to pollute our salutary patent law and policy only to placate the drug multinationals and GATT-WHO treaty commands is a kind of dependencia syndrome which we must resist.

In Doha, at the WTO meet, India battled bravely. In Delhi, in Parliament, no retreat on vital issues can be contemplated. We must win, never wilt.

Justice V.R. Krishna Iyer is a former Judge of the Supreme Court.