PHA-Exchange> AMTC Submission on Article 39.3

[AMTC India]

Hi
 
Affordable Medicines and Treatment Campaign (AMTC) made presentaion before the Committee for the Implementaion of Article 39.3 of TRIPS. The committee is established by Ministry of chemicals and Fertilisers , Government of India.AMTC submissionis given below.
 
For AMTC
Gopakumar
 

Affordable Medicines and Treatment Campaign (AMTC)

Submission before the Committee for the Protection of Undisclosed Information under Article 39.3 of the TRIPS Agreement



Introduction


   The Affordable Medicines and Treatment Campaign (AMTC), is a national campaign aimed at creating an environment that will ensure sustained accessibility and affordability of medicines and treatment for every individual in India, including access to affordable Anti-retroviral Therapy (ART) for persons living with HIV/AIDS. As part of our campaign we monitor the implementation of the TRIPS Agreement in India and its implication for the accessibility and availability of drugs. We are concerned about the implementation of Article 39.3 of the TRIPS Agreement because it may have serious implications on the accessibility and affordability of drugs. We have come across reports that certain multinational pharmaceutical associations are seeking exclusive rights for the data submitted for market approval. We would like to submit that Article 39.3 does not mandate the creation of any exclusive rights on the data and the central obligation under Article 39.3 is to protect the data submitted
 for market approval from unfair competition in accordance with Article 10 bis of the Paris Convention on Industrial Property (‘the Paris Convention’). 






   The following paragraphs discuss the nature of obligations under the TRIPS Agreement, the nature of obligations under Article 39.3 and the desirable way to implement the obligations without compromising the accessibility and availability of drugs and the Right to Health, as guaranteed by the Constitution of India (Article 21) and the International Covenant on Economic, Social and Cultural Rights – ICESCR (Articles 12 & 15). 




Nature of TRIPS Obligations



 



   The Preamble of TRIPS states that measures and procedures to enforce intellectual property rights should not themselves become barriers to legitimate trade. Further, the Preamble recognises the underlying public policy objectives of national systems for the protection of intellectual property, including developmental and technological objectives. 






   According to Article 1 of TRIPS, members "shall not be obliged to, implement in their domestic law more extensive protection than required by this Agreement". Thus there is no obligation under TRIPS to provide extra protection to any intellectual property rights other than what is mentioned in the TRIPS Agreement. Further, TRIPS permits states to "determine the appropriate method" to implement the provisions of the TRIPS Agreement within their legal system. As a result it is up to each state to decide the mechanisms for implementation of Article 39.3 of the Agreement. Hence, there is no need for the Committee to look at whether ‘data protection can be offered under an appropriate new dispensation’. We submit that the implementation of Article 39.3 should be carried out within the framework of the Drugs and Cosmetic Act, 1940. 






   The objective of TRIPS mentioned in Article 7 states that "the protection and enforcement of intellectual property rights should contribute
 to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare
". Further, principles of implementation under Article 8 state that "members may, in formulating or amending their national laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio economic and technological development
". These concerns are further clarified and articulated in the Doha Declaration on TRIPS and Public Health. It states that "
TRIPS Agreement does not and should not prevent members from taking measures to protect public health. These principles is also recognaised in the Patents Act ( section 83). 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 Member’s right to protect public health and, in particular, to promote the access to medicines for all". Hence, India has a legal right to interpret and implement the TRIPS Agreement to promote access to drugs. 






   According to Articles 31 and 39 of Vienna Convention on the Law of Treaties (Appendix 1), preambles, objectives, principles, preparatory documents and subsequent agreements between parties are relevant tools to interpret the provisions of treaties. 






   Further, TRIPS implementation should not result in the compromise of any right guaranteed by any previous international treaty. Therefore, as India is a party to the ICESCR, it cannot compromise the right to health (Article 12, ICESCR) and the right to enjoy the benefits of scientific progress and its applications (Article 15, ICESCR). The right to health also falls within Article 21 of the Indian Constitution (Vincent Panikurlangara v Union of India 1987 (2) SCC 165). The Supreme Court has recoganised that Article 21 has to be interpreted in consonance with international treties. Hence, the implementation of any provision in TRIPS should not result in the denial of any of the rights guaranteed under the ICESCR and the Constitution of India. 






   In the absence of a contrary statute enforceability of ICESCR and the International Covenant on Civil and Political Rights (ICCPR) in India has been upheld by the Supreme Court through a number of judgements (Vishaka v State of Rajsthan (1997) 6 SCC 241). 




Nature of Obligations under Article 39.3





   The obligations under Article 39.3 should be understood in the light of Article 39.1 of the TRIPS Agreement. According to Article 39.1 members are to protect data submitted to the government or government agencies in the course of ensuring effective protection against unfair competition as provided in Article 10 bis of the Paris Convention. Article 10 bis of the Paris Convention defines unfair competition as "any act of competition contrary to honest practices in industrial or commercial matters" (Appendix 2). The examples given in the same Article do not talk about any exclusive rights on the undisclosed information. The World Intellectual Property Organisation (WIPO) model provision on unfair competition also does not give any exclusive rights on undisclosed information (Appendix 3). Hence there is no obligation under Article 39.3 to extend exclusive rights on data submitted for marketing approval. 






   Further, according to Article 1.2 of TRIPS "the term intellectual property refers to all categories of intellectual property that are the subject of sections 1 to 7 of Part II". Section 7 of the Agreement titled "Protection of Undisclosed Information" does not deal with any other sui generis system for data protection. Hence, the obligation under Article 39.3 is to protect undisclosed information as mentioned in the Paris Convention. 






   There are two obligations under Article 39.3 viz. 1) to protect data submitted for market approval against unfair commercial use and 2) to protect such data against disclosure by the authorities. In the second case disclosure can be made only in two exceptions i.e. to protect the public and to disclose data after taking steps against unfair commercial use. Hence, there is no obligation under Article 39.3 to create exclusive rights on the data submitted for market approval. 






   Protection of data against unfair commercial use does not prevent government or its agencies from using the same data to evaluate the safety and quality of the same drug submitted for subsequent market approvals. Such use by government or its agencies is permissible because such use is not commercial use, let alone it being unfair commercial use. The purpose of such use by government and its agencies is to ensure safety and quality of drugs in the public interest. This is permitted under Article 8 of the TRIPS Agreement. Further, the obligation is to protect the data against unfair commercial use. This necessarily implies that the data can be used for fair commercial use. Use of data for subsequent market approval is a fair commercial use for the competitor and fair use for the government authorities and therefore permitted under Article 39.3. 






   The negotiating history of Article 39.3 justifies this position. The text for the Brussels Ministerial Conference on Uruguay Round Agreements contained an explicit provision for preventing use of data for subsequent market approval. The Brussels text reads that, "Unless the person submitting the information agrees, the data may not be relied upon for the approval of competing products for a reasonable time, generally no less than five years, commensurate with the efforts involved in the origination of the data, their nature, and the expenditure involved in their preparation". This provision was removed from the final text. This shows that there was no intention to prevent governments and its agencies from using the data for subsequent market approval. 






   India’s submission to the World Trade Organisation (WTO), along with other developing countries, expressed the above position. India’s submission to the TRIPS Council on 29 June 2001 (IP/C/W/296) states: "Article 39.3 of the TRIPS Agreement leaves considerable room for Member countries to implement the obligation to protect test data against unfair competition practices. The Agreement provides that ‘undisclosed information’ is regulated under the discipline of unfair competition, as contained in Article 10 bis of the Paris Convention. With this provision, the Agreement clearly avoids the treatment of undisclosed information as a ‘property’ and does not require granting ‘exclusive’ rights to the owner of the data". We do not find any valid reason for India to change its position. 






   State practices also justify such position. Argentina implemented Article 39.3 without granting any exclusive rights on the data submitted for market approval. The US request for constitution of the panel under the WTO Dispute Settlement Understanding against Argentina was withdrawn. Further, Israel one of the major drug exporters to the USA, does not provide any exclusive rights on test data. 






   Therefore the first obligation under Article 39.3 is to protect data against unfair commercial use in accordance with Article 10 bis of the Paris Convention. This protection is against using the data for unfair commercial purpose and does not prevent government authorities for using the data for subsequent market approval. To qualify for protection under Article 39.3 the data should satisfy the following criteria: the data should be 1) related to new chemical entities, 2) undisclosed or other data, and 3) the origination of data should involve considerable effort. These terms are not defined in the TRIPS Agreement. Therefore it is up to each member to define these terms. We would like to suggest the following: 






   New Chemical Entities: should be defined to exclude new uses and dosage formulations. Hence the data to be protected can be restricted to only new chemical entities. 




   Undisclosed or Other Data: this should not include data, which is already in the public domain. 




   Considerable Effort: The data, which is entitled to protection should involve considerable effort in the origination of data. Therefore the data created for local conformity etc. should not be entitled for protection. 






   Further, the protection should be confined to those data submitted on demand of regulatory authorities. The protection should not extend to those data, that is submitted voluntarily by the parties. 






   The current practice in India as mentioned in 122 A to E, Schedule Y and Form 44 of the Drugs and Cosmetic Rules, 1945 does not demand pre-clinical and clinical trial data for every marketing approval of new drugs. It demands all data only when the drug is discovered in India and not approved anywhere in the world. If the drug has already got market approval in a foreign country only local re-conformity data is required for market approval. Hence, the implementation of the first obligation under Article 39.3 i.e. protection of test data against unfair commercial use does not need any change in the present rules. 






   The protection of undisclosed information is already provided under common law. 






   The implementation of the second obligation under Article 39.3 i.e. to protect the data (if it fulfills all qualifying criteria) against disclosure should safeguard peoples’ right to access the data for evaluating safety and quality of drugs. Accessibility of safe and quality drug is an important component of right to health guaranteed under Article 12 of the ICESCR and Article 21 of the Indian Constitution. The Supreme Court as reiterated this in Vincent Panikulangara v Union of India. The Court states that "the issues raised are of vital importance as they related to maintenance of approved standards of drugs in general. The issues that fall for consideration are not only relating to technical and specialised matters relating to therapeutic value, justification and harmful side effects of drugs but also involve examination of the correctness of action taken by the government on the basis of advice, the matter also involves the interest of manufacturers and traders of drugs as
 also the interest of patients who require drugs for their treatment... every indigenous drug manufacturer must have an obligation by law to disclose formula of preparation and other statutory information on the national language and at least one or two other languages, keeping in view the place of manufacture of the drug and the area of its circulation. Any statutory warning to be administrated also follow the same course". 






   The implementation of the second obligation under Article 39.3 i.e. protection of data against disclosure should not hamper the availability of data for fair commercial use. Towards this objective the exceptions available under Article 39.3 should be used. These exceptions include 1) disclosure for protecting public and 2) disclosure after taking steps that data will not be used for unfair commercial use. Data can be made available against a payment for competitors for the purpose of further research and under a compulsory license mechanism to meet the public needs or as a remedy against anti-competitive measures. 






   Lastly, we submit that there should not be any linkage between patent rights and registration for market approval as advocated by the US through Free Trade agreements. 





For AMTC



Anand Grover

K M Gopakumar



 

 

Appendix 1



Article 31
General rule of interpretation



1. A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.

2. The context for the purpose of the interpretation of a treaty shall comprise, in addition to the text, including its preamble and annexes:
(a) any agreement relating to the treaty which was made between all the parties in connection with the conclusion of the treaty;(b) any instrument which was made by one or more parties in connection with the conclusion of the treaty and accepted by the other parties as an instrument related to the treaty.
3. There shall be taken into account, together with the context:
(a) any subsequent agreement between the parties regarding the interpretation of the treaty or the application of its provisions;(b) any subsequent practice in the application of the treaty which establishes the agreement of the parties regarding its interpretation;(c) any relevant rules of international law applicable in the relations between the parties.
4. A special meaning shall be given to a term if it is established that the parties so intended.



 

 

Article 39
General rule regarding the amendment of treaties

A treaty may be amended by agreement between the parties. The rules laid down in Part II apply to such an agreement except in so far as the treaty may otherwise provide.

 

 

 

 

 

 

 

 

 

 

 

 

Appendix: 2 



 

Article 10bis
[Unfair Competition]



(1) The countries of the Union are bound to assure to nationals of such countries effective protection against unfair competition.

(2) Any act of competition contrary to honest practices in industrial or commercial matters constitutes an act of unfair competition.

(3) The following in particular shall be prohibited:

1. all acts of such a nature as to create confusion by any means whatever with the establishment, the goods, or the industrial or commercial activities, of a competitor;

2. false allegations in the course of trade of such a nature as to discredit the establishment, the goods, or the industrial or commercial activities, of a competitor;

3. indications or allegations the use of which in the course of trade is liable to mislead the public as to the nature, the manufacturing process, the characteristics, the suitability for their purpose, or the quantity, of the goods.



 

 

 

Appendix 3



WIPO MODEL PROVISIONS ON PROTECTION AGAINST UNFAIR COMPETITION (1996)



Article 1 General Principles 

(1) [General Provision]

(a) In addition to the acts and practices referred to in Articles 2 to 6, any act or practice, in the course of industrial or commercial activities, that is contrary to honest practices shall constitute an act of unfair competition.

(b) Any natural person or legal entity damaged or likely to be damaged by an act of unfair competition shall be entitled to the remedies referred to in ...

(2) [Relationship Between Articles 1 to 6 and Provisions Protecting Inventions, Industrial Designs, Trademarks, Literacy and Artistic Works, and Other Intellectual Property Subject Matter] Articles 1 to 6 shall apply independently of, and in addition to, any legislative provisions protecting inventions, industrial designs, trademarks, literary and artistic works, and other intellectual property subject-matter. 

Article 2 Causing Confusion with Respect to Another's Enterprise or Its Activities

(1) [General Principle] Any act or practice, in the course of industrial or commercial activities, that causes, or is likely to cause, confusion with respect to another's enterprise or its activities, in particular, the products or services offered by such enterprise, shall constitute an act of unfair competition. 

(2) [Examples of Confusion] Confusion may, in particular, be caused with respect to

(i) a trademark, whether registered or not;

(ii) a trade name;

(iii) a business identifier other than a trademark or trade name;

(iv) the appearance of a product;

(v) the presentation of products or services;

(vi) a celebrity or a well-known fictional character.

Article 3 Damaging Another's Goodwill or Reputation

(1) [General Principle] Any act or practice, in the course of industrial or commercial activities, that damages, or is likely to damage, the goodwill or reputation of another's enterprise shall constitute an act of unfair competition, regardless of whether such act or practice causes confusion.

(2) [Examples of Damaging Goodwill or Reputation]

(a) Damaging another's goodwill or reputation may, in particular, result from the dilution of the goodwill or reputation attached to 

(i) a trademark, whether registered or not; 

(ii) a trade name; 

(iii) a business identifier other than a trademark or a trade name;

(iv) the appearance of a product;

(v) the presentation of products or services;

(vi) a celebrity or a well-known fictional character. 

(b) [Definition of ADilution@] For the purposes of these Model Provisions, "dilution of goodwill or reputation" means the lessening of the distinctive character or advertising value of a trademark, trade name or other business identifier, the appearance of a product or the presentation of products or services, or of a celebrity or well-known fictional character. 

Article 4 Misleading the Public

(1) [General Principle] Any act or practice, in the course of industrial or commercial activities, that misleads, or is likely to mislead, the public with respect to an enterprise or its activities, in particular, the products or services offered by such enterprise, shall constitute an act of unfair competition. 

(2) [Examples of Misleading] Misleading may arise out of advertising or promotion and may, in particular, occur with respect to 

(i) the manufacturing process of a product;

(ii) the suitability of a product or service for a particular purpose; 

(iii) the quality or quantity or other characteristics of products or services;

(iv) the geographical origin of products or services;

(v) the conditions on which products or services are offered or provided; 

(vi) the price of products or services or the manner in which it is calculated. 

Article 5 Discrediting Another's Enterprise or Its Activities 

(1) [General Principle] Any false or unjustifiable allegation, in the course of industrial or commercial activities, that discredits, or is likely to discredit, another's enterprise or its activities, in particular, the products or services offered by such enterprise, shall constitute an act of unfair competition. 

(2) [Examples of Discrediting] Discrediting may arise out of, advertising or promotion and may, in particular, occur with respect to 

(i) the manufacturing process of a product;

(ii) the suitability of a product or service for a particular purpose; 

(iii) the quality or quantity or other characteristics of products or services; 

(iv) the conditions on which products or services are offered or provided; 

(v) the price of products or services or the manner in which it is calculated.

Article 6 Unfair Competition in Respect of Secret Information 

(1) [General Principle] Any act or practice, in the course of industrial or commercial activities, that results in the disclosure, acquisition or use by others of secret information without the consent of the person lawfully in control of that information (hereinafter referred to as "the rightful holder") and in a manner contrary to honest commercial practices shall constitute an act of unfair competition. 

(2) [Examples of Unfair Competition in Respect of Secret Information] Disclosure, acquisition or use of secret information by others without the consent of the rightful holder may, in particular, result from 

(i) industrial or commercial espionage; 

(ii) breach of contract; 

(iii) breach of confidence;

(iv) inducement to commit any of the acts referred to in items (i) to (iii);

(v) acquisition of secret information by a third party who knew, or was grossly negligent in failing to know, that an act referred to in items (i) to (iv) was involved in the acquisition.

(3) [Definition of Secret Information] For the purposes of this Article, information shall be considered "secret information" if 

(i) it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; 

(ii) it has commercial value because it is secret; and 

(iii) it has been subject to reasonable steps under the circumstances by the rightful holder to keep it secret. 

(4) [Use or Disclosure of Secret Information Submitted for Procedure of Approval of Marketing] Any act or practice, in the course of industrial or commercial activities, shall be considered an act of unfair competition if it consists or results in 

(i) an unfair commercial use of secret test or other data, the origination of which involves considerable effort and which have been submitted to a competent authority for the purposes of obtaining approval of the marketing of pharmaceutical or agricultural chemical products which utilize new chemical entities, or 

(ii) the disclosure of such data, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use. 

 




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