[Ip-health] AMTC Submission on Article 39.3

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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 In=
dia.AMTC submissionis given below.

For AMTC
Gopakumar

Affordable Medicines and Treatment Campaign (AMTC)

Submission before the Committee for the Protection of Undisclosed Informati=
on under Article 39.3 of the TRIPS Agreement


Introduction


  1.. The Affordable Medicines and Treatment Campaign (AMTC), is a national=
 campaign aimed at creating an environment that will ensure sustained acces=
sibility 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 implem=
entation of the TRIPS Agreement in India and its implication for the access=
ibility and availability of drugs. We are concerned about the implementatio=
n of Article 39.3 of the TRIPS Agreement because it may have serious implic=
ations 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 pro=
tect the data submitted for market approval from unfair competition in acco=
rdance with Article 10 bis of the Paris Convention on Industrial Property (=
'the Paris Convention').



  2.. The following paragraphs discuss the nature of obligations under the =
TRIPS Agreement, the nature of obligations under Article 39.3 and the desir=
able way to implement the obligations without compromising the accessibilit=
y and availability of drugs and the Right to Health, as guaranteed by the C=
onstitution of India (Article 21) and the International Covenant on Economi=
c, Social and Cultural Rights - ICESCR (Articles 12 & 15).


  Nature of TRIPS Obligations





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



  4.. According to Article 1 of TRIPS, members "shall not be obliged to, im=
plement in their domestic law more extensive protection than required by th=
is Agreement". Thus there is no obligation under TRIPS to provide extra pro=
tection to any intellectual property rights other than what is mentioned in=
 the TRIPS Agreement. Further, TRIPS permits states to "determine the appro=
priate method" to implement the provisions of the TRIPS Agreement within th=
eir legal system. As a result it is up to each state to decide the mechanis=
ms 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 u=
nder an appropriate new dispensation'. We submit that the implementation of=
 Article 39.3 should be carried out within the framework of the Drugs and C=
osmetic Act, 1940.



  5.. The objective of TRIPS mentioned in Article 7 states that "the protec=
tion 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 t=
o protect public health and nutrition, and to promote the public interest i=
n sectors of vital importance to their socio economic and technological dev=
elopment.". These concerns are further clarified and articulated in the Doh=
a Declaration on TRIPS and Public Health. It states that ".TRIPS Agreement =
does not and should not prevent members from taking measures to protect pub=
lic health. These principles is also recognaised in the Patents Act ( secti=
on 83). Accordingly, while reiterating our commitment to the TRIPS Agreemen=
t, we affirm that the Agreement can and should be interpreted and implement=
ed in a manner supportive of WTO Member's right to protect public health an=
d, in particular, to promote the access to medicines for all". Hence, India=
 has a legal right to interpret and implement the TRIPS Agreement to promot=
e access to drugs.



  6.. According to Articles 31 and 39 of Vienna Convention on the Law of Tr=
eaties (Appendix 1), preambles, objectives, principles, preparatory documen=
ts and subsequent agreements between parties are relevant tools to interpre=
t the provisions of treaties.



  7.. Further, TRIPS implementation should not result in the compromise of =
any right guaranteed by any previous international treaty. Therefore, as In=
dia is a party to the ICESCR, it cannot compromise the right to health (Art=
icle 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 Unio=
n of India 1987 (2) SCC 165). The Supreme Court has recoganised that Articl=
e 21 has to be interpreted in consonance with international treties. Hence,=
 the implementation of any provision in TRIPS should not result in the deni=
al of any of the rights guaranteed under the ICESCR and the Constitution of=
 India.



  8.. 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



  9.. 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 a=
re to protect data submitted to the government or government agencies in th=
e course of ensuring effective protection against unfair competition as pro=
vided in Article 10 bis of the Paris Convention. Article 10 bis of the Pari=
s 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 Organisatio=
n (WIPO) model provision on unfair competition also does not give any exclu=
sive rights on undisclosed information (Appendix 3). Hence there is no obli=
gation under Article 39.3 to extend exclusive rights on data submitted for =
marketing approval.



  10.. Further, according to Article 1.2 of TRIPS "the term intellectual pr=
operty refers to all categories of intellectual property that are the subje=
ct of sections 1 to 7 of Part II". Section 7 of the Agreement titled "Prote=
ction 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.



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



  12.. Protection of data against unfair commercial use does not prevent go=
vernment or its agencies from using the same data to evaluate the safety an=
d quality of the same drug submitted for subsequent market approvals. Such =
use by government or its agencies is permissible because such use is not co=
mmercial 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 drug=
s in the public interest. This is permitted under Article 8 of the TRIPS Ag=
reement. Further, the obligation is to protect the data against unfair comm=
ercial use. This necessarily implies that the data can be used for fair com=
mercial use. Use of data for subsequent market approval is a fair commercia=
l use for the competitor and fair use for the government authorities and th=
erefore permitted under Article 39.3.



  13.. The negotiating history of Article 39.3 justifies this position. The=
 text for the Brussels Ministerial Conference on Uruguay Round Agreements c=
ontained an explicit provision for preventing use of data for subsequent ma=
rket 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 year=
s, commensurate with the efforts involved in the origination of the data, t=
heir nature, and the expenditure involved in their preparation". This provi=
sion was removed from the final text. This shows that there was no intentio=
n to prevent governments and its agencies from using the data for subsequen=
t market approval.



  14.. India's submission to the World Trade Organisation (WTO), along with=
 other developing countries, expressed the above position. India's submissi=
on 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 imp=
lement the obligation to protect test data against unfair competition pract=
ices. The Agreement provides that 'undisclosed information' is regulated un=
der the discipline of unfair competition, as contained in Article 10 bis of=
 the Paris Convention. With this provision, the Agreement clearly avoids th=
e 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.



  15.. State practices also justify such position. Argentina implemented Ar=
ticle 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 ex=
clusive rights on test data.



  16.. Therefore the first obligation under Article 39.3 is to protect data=
 against unfair commercial use in accordance with Article 10 bis of the Par=
is Convention. This protection is against using the data for unfair commerc=
ial 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) rel=
ated to new chemical entities, 2) undisclosed or other data, and 3) the ori=
gination of data should involve considerable effort. These terms are not de=
fined in the TRIPS Agreement. Therefore it is up to each member to define t=
hese terms. We would like to suggest the following:



  a.. New Chemical Entities: should be defined to exclude new uses and dosa=
ge formulations. Hence the data to be protected can be restricted to only n=
ew chemical entities.


  b.. Undisclosed or Other Data: this should not include data, which is alr=
eady in the public domain.


  c.. 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.



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



  2.. 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-clini=
cal and clinical trial data for every marketing approval of new drugs. It d=
emands 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 for=
eign 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 cha=
nge in the present rules.



  3.. The protection of undisclosed information is already provided under c=
ommon law.



  4.. The implementation of the second obligation under Article 39.3 i.e. t=
o protect the data (if it fulfills all qualifying criteria) against disclos=
ure should safeguard peoples' right to access the data for evaluating safet=
y and quality of drugs. Accessibility of safe and quality drug is an import=
ant 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 app=
roved standards of drugs in general. The issues that fall for consideration=
 are not only relating to technical and specialised matters relating to the=
rapeutic value, justification and harmful side effects of drugs but also in=
volve examination of the correctness of action taken by the government on t=
he 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 obligat=
ion by law to disclose formula of preparation and other statutory informati=
on on the national language and at least one or two other languages, keepin=
g in view the place of manufacture of the drug and the area of its circulat=
ion. Any statutory warning to be administrated also follow the same course"=
.



  5.. The implementation of the second obligation under Article 39.3 i.e. p=
rotection of data against disclosure should not hamper the availability of =
data for fair commercial use. Towards this objective the exceptions availab=
le under Article 39.3 should be used. These exceptions include 1) disclosur=
e 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 c=
ompulsory license mechanism to meet the public needs or as a remedy against=
 anti-competitive measures.



  6.. 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 ordin=
ary 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 comp=
rise, in addition to the text, including its preamble and annexes:

  (a) any agreement relating to the treaty which was made between all the p=
arties in connection with the conclusion of the treaty;
  (b) any instrument which was made by one or more parties in connection wi=
th the conclusion of the treaty and accepted by the other parties as an ins=
trument related to the treaty.
3. There shall be taken into account, together with the context:

  (a) any subsequent agreement between the parties regarding the interpreta=
tion of the treaty or the application of its provisions;
  (b) any subsequent practice in the application of the treaty which establ=
ishes the agreement of the parties regarding its interpretation;
  (c) any relevant rules of international law applicable in the relations b=
etween 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 do=
wn 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 cou=
ntries effective protection against unfair competition.

(2) Any act of competition contrary to honest practices in industrial or co=
mmercial 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 w=
ith the establishment, the goods, or the industrial or commercial activitie=
s, of a competitor;

2. false allegations in the course of trade of such a nature as to discredi=
t 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 li=
able to mislead the public as to the nature, the manufacturing process, the=
 characteristics, the suitability for their purpose, or the quantity, of th=
e 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, a=
ny act or practice, in the course of industrial or commercial activities, t=
hat is contrary to honest practices shall constitute an act of unfair compe=
tition.

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

(2) [Relationship Between Articles 1 to 6 and Provisions Protecting Inventi=
ons, Industrial Designs, Trademarks, Literacy and Artistic Works, and Other=
 Intellectual Property Subject Matter] Articles 1 to 6 shall apply independ=
ently of, and in addition to, any legislative provisions protecting inventi=
ons, 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 Act=
ivities

(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 produ=
cts or services offered by such enterprise, shall constitute an act of unfa=
ir competition.

(2) [Examples of Confusion] Confusion may, in particular, be caused with re=
spect 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 com=
petition, 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 fr=
om 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 busines=
s identifier, the appearance of a product or the presentation of products o=
r 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 product=
s or services offered by such enterprise, shall constitute an act of unfair=
 competition.

(2) [Examples of Misleading] Misleading may arise out of advertising or pro=
motion 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 servi=
ces;

(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 calcula=
ted.

Article 5 Discrediting Another's Enterprise or Its Activities

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

(2) [Examples of Discrediting] Discrediting may arise out of, advertising o=
r 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 servi=
ces;

(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 calculat=
ed.

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 ho=
lder") and in a manner contrary to honest commercial practices shall consti=
tute an act of unfair competition.

(2) [Examples of Unfair Competition in Respect of Secret Information] Discl=
osure, acquisition or use of secret information by others without the conse=
nt 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 gro=
ssly 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, in=
formation shall be considered "secret information" if

(i) it is not, as a body or in the precise configuration and assembly of it=
s 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 th=
e rightful holder to keep it secret.

(4) [Use or Disclosure of Secret Information Submitted for Procedure of App=
roval of Marketing] Any act or practice, in the course of industrial or com=
mercial 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 co=
mpetent authority for the purposes of obtaining approval of the marketing o=
f pharmaceutical or agricultural chemical products which utilize new chemic=
al entities, or

(ii) the disclosure of such data, except where necessary to protect the pub=
lic, or unless steps are taken to ensure that the data are protected agains=
t unfair commercial use.


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