The Technical Expert Group on Patent Law Issues, headed by the Council of Scientific and Industrial Research (CSIR)’s ex-Director General Dr. R.A. Mashelkar, has opined to the Government of India that restricting patenting of pharmaceuticals to New Chemical Entities (NCE) and prohibiting the patenting of microorganisms per se, would be violative of the TRIPS agreement. The Group claims that its approach to the issue was guided by “…the need for access of affordable medicines to Indian people at large, encouraging innovation by Indian industry, its current capabilities in R&D, and balancing of India’s obligations under international agreements with the wider public interest”. The main implication of the Mashelkar Group’s report is that product patents can be issued even on older off-patent drugs which have been marginally altered by pharmaceutical firms, thereby giving a monopoly over these drugs to the patent holder. While the Mashelkar Group’s report expresses itself against ‘evergreening’ of patents, its recommendations permit exactly that.
Reactions have been swift and damning. D.G. Shah, secretary-general, Indian Pharmaceutical Alliance (IPA): “As the title suggests, the reference to the group was on ‘patent law,’ but there is hardly any evidence in the report to support its interpretation. Most parts of the report are devoted to narrating the positions of various interest groups, but very little is devoted to what made the Technical Group take the view that to limit patentability to NCEs is not compatible with the TRIPS Agreement.” The Centre for Trade and Development (CENTAD), an NGO working on international trade: “The terms of reference clearly mention that the task was to find whether it would be TRIPS compatible to limit the grant of patent for a pharmaceutical substance to a new chemical entity or to a new medical entity involving one or more inventive steps. However, the committee does not answer this question and also cites so-called national interest to make its recommendation. The national interest argument is based on certain assumptions which are either irrational or highly contestable…The so-called national interest perspective considers only the interests of a few big Indian pharmaceutical companies. There is no reference to public health concerns in the report”. (Business Standard, January 16, 2007)
The Mashelkar Report brings the curtain down on a chapter in the history of intellectual property rights in the country, one that heralded the chicanery of the ‘New’ Left – the old Left reincarnated – in India. If Singur and Nandigram have laid bare the sordid nexus of the Communist Party of India (Marxist) with the neo-liberal forces of corporate India, the CPI(M)’s role in the passage of the Patents (Amendment) Act, 2005 was a curtain-raiser.
Inflexible Flexibilities of TRIPS
The precursor to the Act was the Patents (Amendment) Ordinance issued by the UPA Government on December 26 2004, when everyone’s attention was focused on the devastation wrought by the tsunami. The Ordinance introduced product patents in pharmaceuticals and also in software, chemicals and food, in accordance with the TRIPS Agreement. The new patent regime threatened the very development of science and technology, and also public health by conferring a monopoly over pharmaceuticals on MNCs and other large corporates. The earlier process patent regime in India had resulted in large-scale production of cheap generic medicines by Indian companies which were also widely sold in Least Developed Countries worldwide and particularly in African countries which do not have pharmaceutical manufacturing capacity of their own. The introduction of the Patents (Amendment) Ordinance was therefore widely opposed not only in India, but all over the world. Long before the Ordinance was issued, the head of the World Health Organisation had written to the Union Health Minister advising against a product patent regime that would throttle the availability of cheap generic drugs and thereby adversely affect public health worldwide. Similar views were also expressed even by conservative newspapers like the New York Times in an editorial on the subject of India’s patent laws. Even a thoroughly conservative economist like Jagdish Bhagwati, wrote against the Ordinance in The Hindu. International NGOs and humanitarian groups like Oxfam and Medecines Sans Frontieres (MSF) also opposed the Ordinance. February 26 2005 was observed as a Global Day of Protest against the Patents (Amendment) Ordinance and the design of the WTO behind it. A large number of NGOs, health and legal activists, political parties and their frontal organisations also participated in this protest. The frontal organisations of India’s parliamentary Left – the CPI(M)-CPI-RSP-Forward Bloc held protests under the aegis of the Sponsoring Committee of Trade Unions.
For the Left, the main point of opposition was the ‘TRIPS-plus’ measures in the Ordinance i.e. the clauses in the Ordinance that went much beyond even the requirement of TRIPS, especially the clauses that allow for ‘evergreening’ of patents. The Left argued that the Indian Government was not making use of ‘flexibilities’ available in TRIPS and was unnecessarily allowing TRIPS-plus measures. They had no basic opposition to TRIPS or the product patent regime that it mandated. On the contrary, the Left actively promoted the illusion that the written rules of WTO and TRIPS would provide the maneuvering space for ‘our’ companies to compete on par with global pharmaceutical giants. The Left’s position was one of protecting a vaguely defined ‘national interest’ and protecting the Indian pharmaceutical industry, which has the “ability to service the health needs of the country”. Its position was that while being a member of WTO, the Indian Government must demand review of TRIPS, as mandated in the TRIPS Agreement and must not concede more than what TRIPS requires. (‘Left Parties Note on Third Patents (Amendment) Bill’, People’s Democracy, Vol. 28 No. 47, November 21, 2004)
In reality, interpreting the text of the TRIPS agreement and its ‘flexibilities’ is a mug’s game. Whenever countries have tried to take advantage of such ‘flexibility’, they have been targeted by MNCs and governments of imperialist countries acting on their behalf, led by the US. The much-acclaimed Declaration on TRIPS and Public Health in the Doha Ministerial Meeting of WTO in 2000 was a short-lived victory and was rendered hollow by the bilateral bullying tactics of the US government and the MNCs. This bullying forces developing countries to adopt ‘TRIPS-plus’ measures – measures that are not required even by the TRIPS Agreement – which will further favour MNCs. (‘US Bullying on Drug Patents: One Year After Doha’, Oxfam Briefing Paper 33, 2002) The response of the aspirant capitalist classes of the Third World has been two-pronged, involving both conflict and collaboration with global pharmaceutical majors, and the governments and multilateral bodies that further their interests. Thus, on the one hand, the strategies adopted by the top Indian pharmaceutical companies in recent years have included export-led growth through subsidiaries or acquisitions in high-margin markets, partnering with MNCs through licensing, collaborative R&D or co-marketing arrangements, and contract research and manufacturing. On the other hand, Indian generic drug makers who have successfully developed alternative processes for the manufacture of patented drugs have been aggressively challenging patent claims and trying to have longer exclusivity periods. MNCs in turn see major cost advantages in outsourcing manufacturing and clinical research to Indian companies. Studies indicate that a handful of large domestic pharmaceutical firms have the capacity to use their aptitude for reverse engineering for new drug discovery. They are in turn selling these new molecules to MNCs for further development and sale. The Indian Government is in turn providing a range of tax concessions to encourage such R&D. (Ernst & Young Global Pharma Report 2004; IMS Pharma 16 June 2000; ‘Pharmaceuticals: Uneasy Alliance’, Economic and Political Weekly Editorial, October 19, 2002). Commerce Minister Kamal Nath put it thus, “…the transformed Indian pharma industry is itself looking for patent protection – particularly the bio-tech sector, in which India has aggressive prospects”. With an Intellectual Property protection framework in place, he said that the pharma industry could take advantage of the huge scope for outsourcing of clinical research.
The companies and the Commerce Minister spoke the language of the market. The CPI(M) provided it the cloak of ‘national interest’. The fulminations of a decade earlier, when the Indian ‘bourgeois-landlord state led by the big bourgeoisie’ was ‘surrendering’ to imperialism, turned into an obfuscating ‘protection of national interest’. But it was still the language of opposition and resistance to the Ordinance route that the Government had taken.
Flexibility of the Left
But this was to be short-lived. On March 22, 2005, the Left performed a breathtaking political somersault and voted for the Patents (Amendment) Bill 2005 in Parliament. The BJP had announced its opposition to the Bill out of sheer opportunism, having supported the UPA at every preceding stage up to the issuance of the Ordinance. There was every possibility of the Bill not being passed in the Budget session at all and the Ordinance lapsing. The Left rushed to the rescue of the Congress in the Lok Sabha and voted for the Bill on March 22, 2005. On March 23, the Martyrdom Day of Bhagat Singh, the Left paid their respects to him by safely passing the Bill in the Rajya Sabha. Behind this magnificent volte-face was the new General Secretary of the CPI(M). The Hindu editorialized, “Mr. Karat, in fact, was instrumental in narrowing the differences with the Central Government by extending support for the Patents (Amendments) Bill in return for crucial concessions such as the exclusion of embedded software from the patents regime and the redefinition of “new inventions.” (‘Karat At The Helm’, April 13, 2005)
The Left claimed that the Bill passed had incorporated amendments proposed by the Left parties, which were “an attempt to provide for the maximum safeguards in the new Act making use of flexibilities available in the TRIPS agreement”. They claimed that the Government was forced to accept the amendments because of sustained pressure by the Left parties and the countrywide campaign against the Ordinance; and that the incorporation of the amendments was “a major advance for those who have been campaigning for the safeguarding of national interests.” (‘Amendment to the Indian Patents Act: The Battle is Joined, the War is Not Over’, People’s Democracy, March 27, 2005 – statement issued at the press conference of the four Left parties – CPI(M), CPI, Forward Bloc and RSP – held at the CPI(M)’s national party office in Delhi, AKG Bhavan, on March 23, 2005)
So what were these amendments?
- The most significant of them, in retrospect, was the amendment to remove applied computer programmes and embedded software from the ambit of product patenting, the demand for which had been raised by a section of the Indian software industry.
- An amendment to limit the grant of patents for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps, as well as another Amendment to prevent patenting of micro-organisms, was accepted by the Government, at the same time, these two Amendments were referred to the Expert Group headed by Dr. Mashelkar, which has now ruled them incompatible with TRIPS. Incidentally, it is well-known that Dr. Mashelkar has for long been a staunch proponent of the new patents regime and has changed the basic character of CSIR institutions accordingly during his tenure. If there was any hope that the amendments would be upheld, it would have to stem from the other four members of the Committee. But overall, the Group seems to have thought that TRIPS has much less ‘flexibility’ than the Left saw in it.
- The last significant amendment was one which allowed pre-grant opposition of patents. For this to work effectively, the Patent Office has to adequately and swiftly publicise patent applications so that they can be efficiently contested. But the philosophy of the new patent regime is to grant patents in the shortest possible time and with minimum impediments. To this end, the US Patent and Trademark Office has entered into an MoU with the Government of India to improve the ‘efficiency’ of the Indian patent system.
In sum, the Left’s myth of the ‘flexibilities’ of TRIPS have been busted yet again by the hard realities of the global market. The power of capital sets the rules of the game, and not an undefined ‘national interest’. The Commerce Ministry that pilote the Amendment Act and the Mashelkar Group can hardly be called ‘imperialist agents’. It will suffice to say that the Indian pharmaceutical industry is interested only in the global market, of which the Indian market is a part. For Indian corporates, the ‘national market’ is a reserve market, to be used as a bargaining chip to secure market concessions from global powers, in what can only be an asymmetrical contest. Even the Union Commerce Minister made this aggregate interest of the Indian corporates behind the Patents (Amendment) Bill 2005 clear when he said that its content was “not externally driven, it is nationally driven. It suits us to have a modern patent regime in line with what most countries in the world have already adopted, including China and Brazil”. (‘Enough Safeguards in Patents Act to Prevent Price Rise – Domestic Pharma Industry Interests Fully Protected: Kamal Nath’, Commerce Ministry Press Release, April 4, 2005)
Losing the Battle in Delhi to Win the War in Geneva
Criticised by NGOs like Medecines Sans Frontieres for ushering in a TRIPS-compliant product patents regime in the pharmaceutical sector, the CPI(M)’s counter-arguments flowed, specious and self-contradictory, all the time masking the fact that it had succumbed to the TINA argument to the WTO. To wit, (i) if the Left had not supported the Bill with these cosmetic amendments, the BJP and Congress would have joined hands later and have passed a worse Bill (Prabir Purkayastha, ‘Patents Amendments and the International NGOs’, People’s Democracy, April 3, 2005), (ii) not passing the Patents (Amendment) Bill would result in WTO sanctions against Indian pharmaceutical exports and cross-sectoral sanctions, the same argument used by Kamal Nath while issuing the earlier Ordinance and which had then been vehemently opposed by the Left with examples of several countries having missed WTO deadlines and not experiencing sanctions, (iii) “the arena of forcing a change in TRIPS and WTO is Geneva and not New Delhi”. (ibid.)
Having thus far argued that its mobilisation was to pressurise the Indian Government to take full advantage of the ‘flexibilities’ of TRIPS, the Left argued that “the TRIPS agreement itself places severe limitations on our ability to enact national legislations that address public interest…the ultimate aim should be to overturn the TRIPS agreement and bring it out of the WTO.” (‘Amendment to the Indian Patents Act: The Battle is Joined, the War is Not Over’, People’s Democracy, March 27, 2005.) Yet, in the same breath, the Left argued that they would “continue to apply pressure on the government through mass mobilisation to balance its position on IPRs in favour of the Indian people” (ibid.) So TRIPS was both ‘flexible’ and ‘inflexible’, the Left would mobilise to ‘balance’ the interests of the people and the interests of MNCs and corporates, while at the same time strive to bring TRIPS out of the WTO! Having fully collaborated with the Congress in the Indian Parliament while it had the opportunity to uphold the public weal and oppose the Patents Bill, the Left argued that it would force a change in WTO negotiations. To Medecines Sans Frontieres, till the other day an ally in the fight against the Patents Ordinance, a Left columnist posed loaded queries: whether western NGOs wanted Indian pharmaceuticals to be denied a place in the global market due to WTO sanctions, what action had NGOs from imperialist countries taken against TRIPS in their home countries etc.?
Can the Left Be Reformed?
“Can the Left be reformed?” is the question asked both by civil society activists and by long-time fellow-travellers of the Left who are discomfited by Singur and Nandigram. For the latter especially, articulating the question is itself a painful process after a lifetime of loyalty. Will questioning the Left weaken it and open the floodgates to neoliberalism, they wonder.
The short answer to the question is that the Left, in the current form to which it has grown and developed, cannot reform itself. If the old Left’s political objective was retaining power in Bengal, Tripura and Kerala with sham anti-Congressism and underhand deals with the Centre, the ‘New’ Left has set its sights on a role at the Centre. The ‘New’ Left’s political vision is one of partnership with corporates in the world of ‘inevitable’ globalisation. The Left leadership is therefore practising duplicitous politics; it is fully committed to liberalisation, privatisation and globalisation. It sees these as ‘inevitable’. Its main objective is to remain in power in the States and enhance its say at the Centre. As Prakash Karat puts it, the Left wants to put forth ‘policy alternatives’. But in the age of neoliberalism, when corporates have a powerful and overt say in policymaking, it cannot but acquiesce to their demands and see ‘logic’ in them. What the patents imbroglio and the ongoing SEZ and land acquisition debates show is that there is no real policy alternative, what the Left does is hardly different from what others do. At the same time, the Left needs to keep its flock together and its electoral base, for that gives it salience in India’s electoral democracy as it exists today. To its support base, it needs to continue speaking the language of resistance. Hence, it holds token demonstrations, issues statements, and works with civil society in the World Social Forum. The contradictions between its actions in these two spheres show up as doublespeak. This was very apparent in its role in the Patents (Amendment) Bill and in the land acquisition debate now. While its role in Singur and Nandigram is stark, its role in amending the patent regime is disguised in technicalities. But the underlying reality is the same. What the Left is quickly embracing is neoliberalism, and this has been well understood by the proponents of neoliberalism. As Manmohan Singh said to the CEO of McKinsey, Rajat Gupta in an interview in 2005, “Our colleagues who are in government in West Bengal . . . do appreciate the need for labor market flexibility. It is my task to carry conviction to our Left colleagues in Delhi. I haven’t given up, and I am confident that when all things are considered I think the reform will have more broad-based support. Our coalition today represents nearly 70 percent of the Indian electorate, so we may be slow moving, but if we build a consensus, that will be far more durable than any other mechanism that I know of”. (The McKinsey Quarterly, 2005 Special Edition: Fulfilling India’s promise)
TINA Without the Left?
In a perverse extension of the slogan popularised by Margaret Thatcher, the official Left in India perpetuates the myth that there is no alternative to itself. Let us look at the reality. Public healthcare is all but absent in India. Public health expenditure as a proportion of GDP has been relentlessly falling. Under the influence of liberalisation, privatisation and globalisation policies, there is a further attempt to reduce Government expenditure on healthcare. News channels regularly put out stories of people at the mercy of the completely unregulated private sector in healthcare, suffering, dying, and turning to crime to meet their healthcare expenses. The story of successive Governments’ lame efforts to control pharmaceutical prices merits a separate telling. It will suffice to say that over and above the huge margins and malpractices that abound in the pharmaceutical trade, the prices of both common generic drugs and new inventions are set to sharply increase under the new patents regime, and especially if the Government amends the law on the basis of the Mashelkar Group’s recommendations. The MNC Novartis has filed a suit against the very clause of the Patents (Amendment) Act, 2005 that the Mashelkar Group has now found non-compliant with TRIPS. The simple, unalterable fact is that it is the so-called Left that passed a Bill in Parliament to introduce a WTO-compliant product patent regime and no amount of verbal acrobatics can cover this up. The ‘TINA without the Left’ logic among a section of civil society activists fighting neoliberalism is strangely defeatist. The Left will continue to reach out to intellectuals and activists. The latter need to be much more sceptical of the Left, post-Patents Act, post-Singur, and post-Nandigram. The struggles against the various attacks of neo-liberalism are very concrete ones- whether in the fields of health or education, or against land-grab. Civil society activists can no longer surrender a leading role in these struggles to the Left. In particular, they will have to insist that demands and memoranda be democratically and transparently discussed and drafted, uncontaminated by TINA to neoliberalism/globalisation and the urgency to ‘provide’ jobs, education or healthcare within the ‘realities’ of the neoliberal framework. Above all, the capacity of ordinary people for sacrifice and political struggle should not be under-estimated. It is in the ordinary citizen’s interest to fight against the product patent regime in toto and not just against the Mashelkar Group’s recommendations. The era of convergence of the citizens’ interest and the ‘national interest’, where a large public sector and the private sector supplied reverse-engineered generics at a relatively low price (by world standards) to a sheltered national market, is well and truly over. The big sharks among the corporates are swimming in the sea of the global market, bargaining with the bigger sharks, with the nation-state as legislative ally. The moment a section of Indian pharma enters into new partnerships with MNCs to use the Mashelkar report, that will become the new ‘national interest’, the new ‘inevitable reality’ to bow to. Such are the slippery slopes of neoliberalism.
The Left is very firmly a party of this established order. To be out of power and work as an organising force at the grassroots for resistance against neo-liberalism is unthinkable for it. But the need to build up an alternative politics right from the grassroots and patiently organise has never been greater.
Rajesh Ramakrishnan is an engineer-turned-development consultant who has also worked in the NGO sector. Involved in democratic movements, he has a keen interest in Marxism and political economy.