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Trips – Pubic Health with special referecne to India – The Doha follow up

Dr. R. Anita Rao,  B.Sc, M.L, Ph.D          
Date   :           15.09.2002          

Introduction:

The Brettenwood conference of 1944 resulted in the birth of IMF and IBRD.  At this conference the participants agreed to formulate a set of rules and regulations relating to international trade and tariff which led to the formation of an agreement on trade and tariffs generally known as GATT in the year 1947.  The main objective of GATT was to reduce tariffs and other trade restrictions and to facilitate international trade.  The eighth round negotiations commonly termed as Uruguay round launched at puntadeleste in 1986 was a unique one in the sense that the rules of international trade and negotiations were restructured and reformulated in inclusion of new issues.  It was the most comprehensive round of multilaterial negotiations that took eight weary years, had been concluded on 15th December at Geneva.  A remarkable feature of Uruguay round was that paved the way for further liberalization of international trade with a fundamental shift from negotiation approach to institutional framework envisaged through transition from GATT to W.T.O established on January, 1995.  Prior to Uruguay round IPRS were not covered by GATT because every nation has its own national law on IPRS based on their ethical & socio-economic conditions.  IPRS at the Uruguay round became crucial for industrialized countries because they knew that they have near monopoly knowledge and realized that the future of their economies depend on property in knowledge than property in material things and goods.   Thus, the industrialized countries made attempts to thrust upon all the countries of the world irrespective of their level of development a uniform IPR regime.

The setting up of W.T.O with a new comprehensive mandate contained in 29 legal texts (agreements) has brought up a totally new environment of IPR policy and law making at the national and international levels.  In particular the agreements on trade related aspects of intellectual property rights (trips) are the most contentious and comprehensive international instruments on all types of intellectual property rights (IPRS).  The member countries of W.T.O are under obligation to enact or amend their domestic legislations for various IPRS to conform to the provisions of the trips agreement.  The important issue is that while the WTO was set up to ensure free trade, the issues covered in the TRIPS agreement, may make for the strengthening of monopolies and dilution of competition resulting in strong barriers to free trade.  The TRIPS became enforceable in developoed countries one year after WTO came into existence i. E on 01.01.1996 and in case of developing countries a transition period of five years for all the items except for drugs and agro-chemicals has been provided.  In case of drug and agro-chemicals the switch over period to product patents is 10 years i.e from 01.01.2005.  This will give tremendous impact on Indian patent regime as it recognizes only process patent but not product patents.  The product patents would increase the price of Medicines and drugs.  Secondly, patenting indigenous knowledge will make seeds and medicines inaccessible to the poor.  The accessibility and affordability of medicines is certainly going to the adversely affected after the patent law are changed in India to bring in line with TRIPS agreement.

II         Provisions of trips Vis-a-Vis Indian patent regime:

W.T.O agreement signed by 124 countries on 01.01.1995 to which India was a signatory.  Being a member country, India is committed to implement the provisions of TRIPS agreement.

  • TRIPS agreement provided fir a transitional period of 5 years for all items except Medicines, drugs and agro-chemicals.  Any member country availing this transitional period shall ensure that any change in domestic laws, regulations and practice made during that period do not result in a lesser degree of consistency with the provisions of this agreement.
  • The most significant chance in the IPRs through TRIPS is the expansion of the domain of the subject matter which is patentable.  Art 27.1 of TRIPS agreement states that the patent shall be available for any inventions whether product or process in the fields of technology provided they are now, involving an inventible step and are capable of industrial production.

Art 27.1 of the TRIPS agreement having a direct impact on the public health of Indian masses would be having disastrous effect on the Indian population and would defeat the basic objective of the Indian Constitution under Art 21 and the International Human Rights Law.  The right of every person to enjoy the benefits of the scientific progress and its application to the right to life, which includes the right to health and right to self-determination, are the conflicting areas with our Indian constitution. The patent (amendment) Act of 1999 was trying to resolve these conflicts with two important modifications.

-           Establishing of Mail-Box Procedure

-           Granting of exclusive Marketing Rights (EMRs)

But those modifications have led to compromisation of our national interests as the provision of TRIPS are not catering for the interests of developing countries like India, due to the differences in the prices of medicines. The data compiled in 1999 clearly indicates that once India switches over from process patent to product patent in pharmaceuticals, the accessibility and affordability of medicines would  certainly have adverse affect on the interests of the Indian masses.

III        Doha Declaration – Public Health

The 4th Ministerial conference at Doha (Qatar) adopted on 14th November, 2001 recognizing the gravity of public health problems afflicting many development and least developed countries resulting from HIV / AIDS, T.B., Malaria and other epidemic laid stress on the needs of the W.T.O. agreements and TRIPS to be a part of wider national and international action to address these problems.  The conference while reiteration the commitment to the TRIPS agreement affirmed that the agreement can and should be interpreted and implemented in a manner supportive of W.T.O members right to protect public heath and in particular to promote access to medicines for all.  The flexibility they included are the liberal interpretation of Public International Law, that each provision of the TRIPS agreement shall be read in the light of the objective and the purpose of the agreement as expressed.  Secondly that each member has the right to grant compulsory licensed and freedom to determine the grounds upon which licenses are granted.  Thirdly the most crucial aspect is that each member has the right to determine what constitutes a national emergency or other circumstance to extreme urgency.  This includes the public health crisis relating to HIV / AIDS, T.B., Malaria etc.

The conference also reaffirmed the commitment of the members of the developed countries to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least developed country members in pursuance of Art 66.2.  At Doha conference the biggest gain claimed by the developing countries is the flexibility provided to them in the declaration in the TRIPS agreement.  The declaration enables the developing countries especially India to reacquire a considerable part of the space it will loose in a few years when India is expected to fully implement the TRIPS agreement in pharma industry.
 

The declaration is of particular relevance with reference to the proposal made by the developing countries specially India and Pakistan to interpret Article 30 of TRIPS agreement.  This exception to the exclusive rights conformed by the relevant patent to permit production to export to a third country of a patented product or a product produced by patented process where the export addresses health needs in the 3rd country and product / process is either (a) not patented (b) a compulsory license has been granted or government made use of relevant period in the 3rd country.  Article 30 that deals with the export of medicines has many advantages it is the most simple and least contentious approach to address the needs and to permit exports.   Secondly the patent owner is compensated in the country where it is consumed.   Thirdly it would allow exports to the countries that lack the capacity of the local production.   Thus, the Doha declaration appears to confirm the primacy of public health over the trade related aspects of intellectual property rights.   The patents (second amendment) bill 2002 was passed by Rajya Sabha on 9th May’ 2002 and the same passed by Lok Sabha on 14th May’ 2002.  The bill has received assent of the President on 25th June’ 2002 and become patent (amendment) Act of 2002.  Under sections 83, 84, 85 and 89-95 where the provisions relating to compulsory licenses are extensively dealt are now further liberalized under the patent act of 2002.  The compulsory license procedure vide section 92 with procedure to deal with grant of license in the national emergency, extreme urgency or public non-commercial use which may arise be required as the case may be due to public health crisis. This includes the procedure relating to HIV / AIDS.  The control of patent shall on application made on any time after the notification of central government may grant under the patent under the such terms and conditions.  The controller shall endeavor to secure these medicines under the patent shall be available to the public at the lowest prices.

Conclusion:

The TRIPS agreement should be interpreted and implemented in a manner supportive of W.T.O. members right to protect the public health and promote the access to medicines.   This objectives can be well achieved:

-           By granting compulsory licenses
-           Effective use of licenses of Right by the central government in the vital areas of public health.
-           The freedom of member countries to determine what constitute a national emergency and other cases of extreme urgency.

Our constitution guaranteed fundamental rights like Right to life which includes Right to health.   Due care must be taken to protect this basic right and the national drug policy should be in conformity with the basic philosophy of the constitution.  There  must be a strong correlation between the TRIPS agreement, the constitution and the drug policy of the Government.  A careful analysis of Art 7 and Art 8, read with the preamble of TRIPS agreement would solve the problem without bringing any inconsistency with the Indian constitution.  No doubt patent is a reward and in inducement to the patent holder and a social obligation is imposed on the patent holder to serve the society at large.  The society’s health and welfare should be given primary concern over individual patent holder’s right.  Due consideration must be given while giving holistic interpretation to TRIPS agreement to ensure the public health rather protecting the interest of the monopolistic activities of the multinational drug companies.
 
 
References:
1 ANNE O RUEGER        

:

“The W.T.O as an International  Organization” – Oxford University Press, 1999
2 Jayashree Watal         :

“Intellectual Property Rights in the W.T.O and developing countries” – Oxford University Press, 2001

3 Bibek Debroy :

“Beyond the Uruguay Round – The Indian Prospective on GATT” – Sage Publications, 1996.

4

Dr. Nilima M. Chandi Ramani

:

“World Trade Organisationis and Globalization on– An Indian Overview” – Shroff Publishers and Distributors Ltd., 1999

5 Vandana Shiva :

“Patents – Myths & Realty” Oxford University Press, 2001

6 B.K. KEAYLA :

“TRIPS Patent System – Implications for Health Care and Pharma Industry Patents (second amendment) Bill 1999 – Centre for study of Global Trade System and Development, New Delhi 2000

7 Nilima M. Chandi 
Ramani
: “ Legal Factors in TRIPS“ – Economic and Political Weekly, January 2002 
8 V. Sridhar : “Perilous Patent” – The Frontline, Dec’ 2001
9 Siddartha Deva :

“Doha Declaration and TRIPS:  Importance of Article 30” – The Hindu, March 14, 2002

       
 
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