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Indian Journal of Pharmacology, Vol. 38, No. 1, January-February, 2006, pp. 70-72 Point and Counterpoint Patent laws must be in the national interest. Thawani V, Gharpure K, Thawani* M Department of Pharmacology, Government Medical College, Nagpur-440 0030. *Pharmanza India, Kansari, Gujrat, India. Code Number: ph06018 In 1947, 23 nations reached the General Agreement on Trade and Tariffs (GATT) to promote and regulate the trade between the nations.[1] In 1995, the World Trade Organization (WTO) was created to succeed GATT. Currently, WTO has 141 member countries, including India. According to the WTO treaty all members must introduce patent regime for product and/or process in accordance with the trade-related aspects of intellectual property rights (TRIPS). To enforce this, uniform standards were set by all member nations so as to strengthen and harmonize the protection of intellectual property rights (IPR). The enforcement period of a decade was given to India to adopt laws for protecting IPR, which ended in December 2004. Hence the new patent laws were brought in. The Indian Patents Act 1970 gave protection to only process patents. It suited the Indian pharmaceutical industry, which exploited it by specializing in modification of the manufacturing process-what popularly came to be known as "reverse engineering".[2] This served the national interest as well since India could manufacture cheaper generic alternatives to many medicines, which were patented in other countries. Indian pharmaceutical industry, which is the fourth largest in the world, exported medicines at affordable prices to about 200 countries across the globe,[3] which brought-in the foreign exchange for the country. On 26th December 2004 Government of India promulgated the Ordinance incorporating product patent regime to meet the deadline of 1st January 2005 set by WTO for protection of IPR and the Patent Bill was passed by the Indian Parliament on 22nd March 2005 and The President of India gave assent to it on 5th April 2005[4] and now it is known as The Patent (Third Amendment) Act 2005. The Patent (Third Amendment) Act 2005 recognizes product patent and will give patent protection for 20 years. Now the pharmaceutical companies will have to make provisions for high inputs in research to develop new products. Under the new Act the patent holder of a product will continue to retain the IPR and will have to be compensated if others manufacture the product. Any manufacturer of generics can apply to copy a patented drug after it has been marketed for three years after paying a reasonable royalty to the patentee. India has a huge pharmaceutical industry, which has prospered in the past because of cost-effective manufacturing.[5] Under the new Patent Act it is feared that India will be out of the run in international generic market, whereas generic manufacturers from other countries such as Brazil, China, and Thailand will fill the demand for cheaper medicines. Bangladesh, a member of least developed country (LDC) group, which continues to enjoy the exemption of the Patent Law till 2016, has already jumped in to take its slice of cake in international generic market.[6] By blindly accepting what others wish, we are slitting our own throat and at the same time starving other developing countries dependent on our supplies of cheaper generic medicines. For AIDS patients India′s generic three-in-one fixed-dose combinations are cheap, convenient to use, and ensure better compliance. These are under patent protection abroad, but are manufactured by giant Indian companies such as Ranbaxy and Cipla and currently cost $350 per patient per year, as against the going cost of the same combinations of patented products which cost $10,000-15,000 per patient per year.[7] The Act is likely to adversely affect treatment of millions with HIV/AIDS globally, as resistance develops to current medicines. New generation of more expensive AIDS medicines innovated by multinational companies (MNCs) may not be made available because all such medicines invented post January 1995 will now be covered by product as well as process patent. The impact of the new act could be gauged by the international concern shown by WHO, UNAIDS, and development agencies such as Oxfam and MSF among other institutions, which have already written to the government expressing concern about the current draft, as have AIDS treatment groups in Africa.[8] Protestors in Kenya, Tanzania, and Uganda marched to the Indian High Commissions in their countries to express their concern. Petitions have also been flowing fast and furiously among West African activists. The UN Special Envoys for HIV/AIDS in Asia and Pacific and Africa also waded into the debate by sending a joint letter calling for continued access to generic drugs to the Indian government.[9] In the light of abysmal government health facilities and virtually nonexistent health insurance, availability and affordability of new medicines under the Patent Act directly threatens the health of citizenry. India has more people living in absolute poverty than the whole of sub-Saharan Africa. Let us not forget the fact that India also has progressively growing HIV/AIDS population. Its health system is going to be under stress owing to constantly growing population, prevalence of traditional diseases such as tuberculosis and malaria, and heavy demand of newer diseases such as cancer and AIDS. Commenting on the situation, the activist from Medecins Sans Frontieres opined that wide patentability is clearly done to favor the MNCs.[10] Oxfam has charged rich nations with using WTO to undermine poor.[11] WHO cherishes "Health for all" and WTO patent rules ensure that equity in health is not attainable. Even the UK commission on IPR (report of 2002) recommended that developing countries should aim at limiting the subject matter of patents.[12] In the opinion of the Convenor of the National Working Group on Patent Law and Trustee and Secretary of Centre for Study of Global Trade System & Development, explanation of Section 3, clause (d) of amendment to Patents Act about containment of the subject matter should have been deleted or modified. The third proviso of Section 11A, subsection 7, can mean that we are making more stringent provision for products falling in public domain as on the first day of January 2005, than the TRIPS stipulation.[13] Doha Declaration of November 2001 was sought as a result of obstacles the developing countries faced while trying to make effective use of flexibility allowed in the TRIPS agreement in relation to exceptions in patent rights. The flexibility in relation to grant of compulsory license and the grounds on which such licenses are granted seem to have been ignored. Compulsory licensing, exhaustion of rights, and parallel imports have been identified as key instruments for limiting the exclusive rights of the patent owners. In the opinion of B. K. Keayla, Section 47, clause (iv) of subsection 6 of the act, which is in favor of the patentee, should have been deleted, making the controller as the issuing authority for compulsory license. The question of controller directing the patentee to grant the license should not arise.[13] Representative of South Africa′s AIDS Law Project pointed that India provided "greater patent protection than what it is required to do under the WTO agreement." He further commented, "We are not opposed to (India) complying with its WTO obligations, but we have to question their motives, and whose interests they are advancing. The bottom line is that India does not need to do all that it is currently doing.". According to them, India had failed to take "full advantage" of key opportunities in the WTO rules, which allowed poorer countries to access cheaper medication.[9] The exploitation by innovator medicine industry can be realized from the example of London-based Glaxo Smith Kline. Two years back, it demanded 40% of the sales proceeds of an AIDS drug, which it licensed to a South African company. Later, under pressure from South African regulators and activists, it licensed the same to three rival companies for a mere 5%. Another example of how wrong the things could go is when the Indian Government caved into pressure from Swiss pharmaceutical giant Novartis in November 2003 to remove generic competitors to its anticancer drug Glivec from the Indian market. The generic version was available earlier for $2700 per year; Novartis brand now costs ten times over. Realizing the problem, India′s National Pharmaceutical Pricing Authority has proposed to impose price controls on the drug.[14] The bullying from the "haves" to raise the cost of innovator medicines, to milch the "have-nots" is nothing new. The world economy has been revolving around such mean efforts. Getting new patent laws enforced is one more means in achievement of that end. Although they talk of human rights, it is time we asked them for humane medicine rights for the patients suffering in developing world. Although differential pricing of medicines has been suggested to get the desired profits to the manufacturing companies, by charging higher price from the affording to offset subsidies that should flow to developing nations, the effort via IPR enforcement shows reverse thinking. Since the Patent Act has seen adverse public opinion, the concerned ministers of the Government of India who initially boasted that the prices of medicines would not rise, later admitted that patents would increase the prices of medicines for anticancer and some other diseases.[15] In apparent damage control, to build favorable sentiments they are repeatedly informing that the Government would be vigilant in curbing any misuse of patent rights by withdrawing the "exclusive marketing rights" (EMRs) which were earlier granted to some and later found to be misused,[16] setting up a task force to examine the availability of drugs at a cheaper price, allowing patented medicines only after price negotiations,[15] during public health emergencies provision for grant of "compulsory licensing" under which patented medicines can be licensed to be manufactured by companies other than the patent holder[17] and export of medicines to countries having insufficient manufacturing capacity to meet the emergent health situations. The new law does have the mechanism for the government to declare an emergency and cancel a patent. Most governments, including the United States, have such patent powers, though they use them sparingly. When the Bush administration felt the need for huge supplies of ciprofloxacin during the 2001 anthrax scare, it threatened to cancel Bayer′s patent if the company did not cut its price.[10] The mail box created by the Indian Government two years ago where medicine makers could deposit the patents they wished to file when the law was amended, had 1500 proposals from Indian companies as compared with 7000 from foreign ones, suggesting that the new law would benefit foreign companies more. Medicine prices in India, which were among highest in the world before 1970, had become among the lowest in the world owing to patent-friendly laws.[7] With the new Patent Act in place, it remains to be seen if our fears about all pervasive hike in medicine prices come true. The actual impact will be assessable after the new drugs are patented and launched in the country. The Union Minister of Commerce and Industry reiterated that the impetus for amending the Act might have been India′s obligation under the WTO Agreement on the TRIPS. The content of the Patents Amendment Act 2005 is "not an externally driven, it is nationally driven"[18]. Since we have limited understanding of such political nuances, like rest of the world we are not convinced with the reassurance. We still feel having tripped over the TRIPS and sacrificed patient interest for patent interest. If the patent rights are the sole concern, then let us prepare for patient rites. References
Copyright 2006 - Indian Journal of Pharmacology |
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