Title: Discussion on the Patents (Amendment) Bill, 2002 (Bill passed).
MR. CHAIRMAN : Now, the House will take up Item No.19, Patents (Amendment) Bill, 2002.
THE MINISTER OF COMMERCE AND INDUSTRY (SHRI MURASOLI MARAN): I beg to move:
“That the Bill further to amend the Patents Act, 1970, as passed by Rajya Sabha, be taken into consideration.”Hon. Chairman, Sir, my brief introduction of this Bill to further amend the Patent Act, 1970 must begin with an acknowledgement of the uniquely constructive debate and support during the passage of the Bill in the Upper House. The Government’s sensitivity to all issues and its responsiveness to suggestions for improvement was equally matched by an appreciation of the need to honour international obligations and chart a clear path for R&D driven economic development.
The Members are aware that the agreement on TRIPS is an integral part of the “take-it-or-leave-it” package finalised in the GATT Uruguay Round and the Draft Final Act signed in December 1993. The Pact itself was signed in Marrakesh on 15th April, 1994. The text of the TRIPS has been described as a masterpiece of ambiguity, couched in the language of diplomatic compromise, resulting in a verbal tight-rope walk, with a prose remarkably elastic and capable of being stretched all the way to Geneva.
Be that as it may, we are required to meet some time-bound obligations in the area of intellectual property protection. The proposed changes in patent law are overdue by nearly two and half years.
In order to do this we must, firstly, carve out a law without permitting any ambiguity under the TRIPS agreement to come in our way so as to safeguard our national security, national interests, public health as also ensure availability of medicines at affordable prices, which is one of the human rights.
Secondly, we need to design a system for a new era of explosions of state-of-the-art technologies, since internationally approved patent protection regime has become the measuring rod of a country’s technological and industrial progress and the protective shield for a knowledge driven economy.
Thirdly, we must take note of the awakening of the conscience of the humanity, which was helplessly watching while millions died and while millions more continued to suffer in silence because of HIV/AIDS. In mobilising this international public opinion, India, along with Brazil and about 55 African countries, took the lead and the result was the path-breaking Doha Declaration on TRIPS and Public Health. This Declaration provides flexibilities and there is a need to make use of them to the fullest possible extent in our law.
And lastly, we have to make the administrative system more user-friendly to facilitate knowledge and creativity driven wealth-creation, economic progress and betterment of life.
I am happy to say that the Bill before the House seeks to meet these objectives. The drafting of the Bill was preceded by extensive broad-based and countrywide consultation with all interest groups. More importantly, this Bill had the benefit of detailed scrutiny by a Joint Committee of Parliament. The JPC has taken full note of all developments in its comprehensive report and provided necessary safeguards, which are required, by availing the flexibilities in full. The Committee held 39 meetings over a period of two years to consider the provisions of the Bill and finalise its views. During its deliberations, the Committee also had meetings with different stakeholders.
The Committee has reinforced the flexibilities already provided in the legislation with a view to address national and public interest requirements/concerns, especially those relating to public health and nutrition. More importantly, the Committee has fully restructured the existing provisions relating to public interest, compulsory licensing, Government use, national security, protection of traditional knowledge and protection of public health and nutrition as contained in Chapter XVI (Working of Patents, Compulsory Licences and Revocation) of the Patents Act.
The Government has decided to accept the Bill, as redrafted by the Committee, virtually in its entirety and totality.
I reiterate my compliments to the Chairman and Members of the JPC for the re-working of the Bill to meet the needs of the nation. I am also pleased to inform this House that prior to consideration of the Bill in the Rajya Sabha, I had again held consultations with Members from the Opposition including Mr. Mani Shankar Aiyar and Mr. Rupchand Pal and we have made further amendments in the legislation. These have already been incorporated.
There are provisions in the Bill providing a wide-ranging and powerful weapon to the Government to extinguish the patentee’s exclusive right immediately and acquire it if the occasion warrants. Let any crisis situation be visualised; the present Bill covers all contingencies.
We have not diluted any of the earlier provisions, nor compromised our positions and interests – rather, we have designed a strong and modern intellectual property Act.
I may further mention upfront that introduction of the product patent regime for drugs, pharmaceuticals and agro-chemicals, is not contemplated in the present Bill because India is not obliged to provide that until 1.1.2005.
As stated in the Upper House, it is now necessary for us to set aside the international and internal ‘pharma politics’ and look at the future. The Indian drug and pharma industry has made the fullest use of the Patents Act of 1970 and we are now not only the net-exporter of generic medicines but also emerging as the new leader of the knowledge-based drug industry in the world, following software and IT. Now is the time for the rest of the industry to come out of its ‘reverse engineering’ mode and move forward into the era of innovative ‘research and development’ mode, clinching the opportunities.
I have no doubt that Indian industry has the necessary strength, capability, dynamic thinking and growing confidence in the advantages of entering a new era. Many Indian companies have pioneered and demonstrated these qualities and they deserve our praise.
Those who want to specialise in generic medicines need not be worried since around 90 per cent of medicines in the world are generic medicines only and the situation is likely to continue to be so since thousands of patents are expiring every year. None of the 279 drugs listed in the National Essential Drug List, 1996 of the Government of India is covered by patents today.
Critics have asserted that vis-à-vis TRIPS the Bill does too much; others have observed that it does too little. If anything, these criticisms confirm the fine balance which the Bill strikes between meeting our international obligations and all of our national concerns. I would categorically state that all aspects and relevant provisions of TRIPS, the Paris convention and other Conventions, post-TRIPS patent laws of different countries and the Doha Declaration have been taken on board. All ambiguities have been removed and available flexibilities are made use of to the maximum to protect the varied interests of our nation.
The Bill also reflects the united will and wisdom of the JPC. Its multi-dimensional issues have been discussed extensively many times earlier. I, therefore, pray for constructive consensus and endorsement from all sections of the House. Let us take India forward even while letting the world know that Indian democracy correctly honours its international commitments.
With these words, I place the Bill before this august House and as it is a national endeavour, I appeal for support transcending party-lines.
MR. CHAIRMAN : Motion Moved:
“That the Bill further to amend the Patents Act, 1970, as passed by Rajya Sabha, be taken into consideration. ”
SHRI RUPCHAND PAL (HOOGLY): Mr. Chairman, Sir, I have been associated with this issue for quite a number of years. When I first raised the issue in the Private Members’ Resolution about the issues involving the Dunkel proposals, at that point of time, hardly we were aware of all the dangers inherent in the proposals.
As you know, the TRIPS part of WTO agreement came only at a later date and still now there are questions how and why TRIPS should be made a part of the WTO agreement. I am not elaborating that point because the debate and discussions are taking place among the experts. WTO agreement being a very complex sort of document, it is never possible for people belonging to any particular discipline to unravel all the intricacies rather mysteries and behind the scene manoeuvres and the hidden agenda whatever you call it. As we go on looking at several provisions of not only WTO but also TRIPS, we do find that the conspiracies are unravelling in the matter of interpretation of the provisions.
Sir, in the beginning, it was said that TRIPS agreement is a part of the WTO agreement. It was to provide better health opportunities, better scientific research, better agricultural production, sharing of technologies and transfer of technologies, but, today, we find that it has never happened in the matter of transfer of technology. The developed countries are as reluctant as they have been earlier and we are at the receiving end. We continue to be at the receiving end. The WTO as also the TRIPS are heavily biased against the developing countries and the poorer countries of the world. It has been once again emphasised in spite of the small gains we have made at Doha. Of course, I do not want to under-estimate the achievement, but still whatever has been said there can be interpreted in a different way. In one place it is said that we agree with the TRIPS agreement. It should not prevent Members from taking measures to protect public health. But again in another place, it is being said that the WTO Members have the right to use the full the provisions in the TRIPS agreement. In the TRIPS agreement it is stated that the steps can be taken to protect the public health interests, but again and again provisions were coming which actually just take away the right to provide health care for poor countries like India and other developing countries.
As you know, Sir, there have been debates and discussions at very important levels. There is a reference to the introduction of a Declaration made by a group of people, including eminent jurists, economists, bureaucrats and people associated with the deliberations in connection with the WTO and all that. There is a letter from Shri V.R. Krishna Iyer, addressed to the Parliamentarians, which says:
“By prohibiting the Controller of patents from granting any patent application on food, drug and medicine, till a new Patents Act was enacted to suit the genius of India, what was the situation in this country?”After all, we reached a goal in the form of an Act of 1970 which was, throughout the world, recognised as a model Act. We are deviating from that 1970 Act which had tried to provide protection not only to our health care needs but also to our pharmaceutical industry. Now we find that our own pharmaceutical industry will be in jeopardy and will have to face unequal competition. I have amendments which I am giving below on issues which have not been addressed properly. Although some of the major concerns have been addressed both in the Joint Committee Report as also subsequently by the Minister when some of us had a meeting with him, yet I believe that the concept of compulsory licensing and the right of the Government have not been adequately addressed, as it has been done in France.
I have mentioned certain other things as you have noted, in the Report of the Standing Committee, in the form of a Note of Dissent. This concerns the licence of right that if anyone is not producing as such, fulfilling the needs of a particular situation prevailing in a particular country like India, what will happen? I want to move an amendment and I believe that the issue has not been addressed properly, I want that after waiting for a specified period, the Government will have the power and no provision in the TRIPS can stand in the way. If France can do certain things, if Argentina can do certain other things, if Brazil can take up their own national cause, why can we also not do it? I do not intend to be harsh, but in the name of the TRIPS compliance, sometimes we have noticed that when our country has been asked to comply with certain options, even before considering the options we have surrendered and later on when there have been criticism from several important quarters, from experts and others, the situation has been tried to be salvaged, but it could not be salvaged at that point of time. The damage had already been done. Our minds had already been known to others. Sometimes it is said that if we do this, if we do that, then we shall earn a bad name in the comity of nations, that India is a country which has not looked into the several provisions of TRIPS; their sole aim to see they are TRIPS compliant. Who is taking care of the WTO provisions? Is America doing it? Say, in the case of steel, say, in the case of many other issues – I am not elaborating that – they are interpreting things according to their own will, according to their own law. They do not believe in multilateralism in trade at all and they are acting at the instance of the multinational companies only. I have serious objection to the tenure of the patent and my Note of Dissent covered particularly this area among some other important areas of concerns which have been discussed at national level by experts, by international bodies.
What was that? It was the term of the patent protection. The term of the patent protection available shall be 20 years from the date of filing the patent application or eight to ten years from the date of sealing of the patent, whichever is shorter. That was my concept. That was my note of dissent. What is the objection of the Government? I need to be convinced; although there have been people associated with it who wanted to convince me that it cannot happen. I had gone through the patent laws that have been passed, that are in the process of being passed and also the future considerations of many countries. Very many countries have taken a stand. Why can’t India; I am not saying -follow their footsteps; follow the tactical line that was adopted by so many countries? It is not being done. The Minister has tried to explain things in his own way so many times, but I was not at all convinced.