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TRIPS & PUBLIC
HEALTH:
DATA PROTECTION UNDER ARTICLE 39.3 OF TRIPS
13 July 2006, ICMR, New Delhi
Summary Report
The above-mentioned workshop was organised
at ICMR on 13th July 2006 where all the stakeholders put forward their
viewpoints on the two issues of focus in respect of Article 39.3, viz., the
interpretation of “Unfair Commercial Use” and “New Chemical Entity”. The stakeholders included: the representatives
of the three pharmaceutical associations (IDMA, IPA and OPPI), public health
groups and civil society, WHO, DCG(I), ICMR etc.
Crux
On the key question of “whether reliance placed by
the drug authority while granting marketing approval to subsequent applicants
for drugs based on the data that has been earlier submitted to the regulatory
authority in India or abroad by the first applicant would amount to “Unfair
Commercial Use”, the opinion of the House, except for OPPI, was unanimously
NO. The House was unanimous in opposing Data Exclusivity or adhering to any
TRIPS-plus approach. This is in
conformity with the Health Ministry’s viewpoint.
Although the OPPI failed to put forward any concrete
legal justification in support of their interpretation of the said phrase
within the purview of Article 39.3, cognisance was,
however, taken by the participants of their key concern. OPPI’s
key concern is that their generic competitors gain unjustly if reliance is
made on their data to approve drugs of the second (generic) applicant. However,
the house was opposed to the idea of addressing this concern through grant of
“Data Exclusivity” or any other kind of monopoly rights to the originator of
data. “Whether or not OPPI’s concern could be addressed by adopting any other
type of measure(s)” was not only outside the scope of this workshop but also
outside the scope of Article 39.3 of TRIPS.
On the issue of NCE, it came out that in addition to
the definition of “Investigational New Drugs” under the D&C Act and “the
entities that cannot be patented” as provided under the Indian Patents Act [S.3(d)], the definition of NCE as provided under the
relevant US law and that provided under relevant EU Directive may be
considered for the purpose of defining NCE for India. Rejecting the notion of having a separate
NCE definition in the Insecticide Act for the purpose of agro-chemicals and
another NCE definition in the D&C Act for the purpose of pharmaceuticals,
it was largely felt by the participants that ideally there should one
definition of NCE for both the legislations.
Highlights
Shri Rajesh Bhushan, Director (IH), MOHFW
 We
need to amend D&C Act with the limited objective to reflect Article 39.3
of TRIPS and need to guard against any “TRIPS plus” or “39.3 PLUS”
provisions.
According
to the case law of the US and Canada, the reliance by drug regulator on the
originator’s data to grant marketing approval to second entrant does not
amount to unfair commercial use within in the meaning of Article 39.3.
As
TRIPS does not provide for any fixed time period of protection, countries are
not obligated under Article 39.3 to confer exclusive rights on the originator
of test data in terms of fixed time period.
Mr. Raghu Cidambi (Dr. Reddy’s Lab), IPA
Whether
there should be any laps of time before a generic drugs gets marketing
approval is a concern with respect to “access to drugs”.
The
reliance by the drug regulator on the test data of the originator company for
granting marketing approval to subsequent entrants is neither “unfair” nor
“commercial”. “Whether or not such reliance is benefiting the subsequent
entrants” is NOT a determinant to judge whether it is unfair or not.
Mr. Gajanan Wakanker, Executive Director, IDMA
The
Article 39.3 of TRIPS as it is now was arrived at after rejecting several
drafts. The Dunkel Draft had originally proposed 5
years Data Exclusivity.
The
‘unfair commercial use’ argument cannot be invoked till the first two
conditions namely (1) undisclosed registration data and (2) ‘new chemical
entity’, are satisfied.
What
is really meant by the term
‘unfair Commercial Use’ are acts such as industrial espionage,
selling of data for gain etc. The so called implied reliance by Govt on data of first applicant and their not asking the
subsequent applicants to repeat it, is not ‘unfair Commercial
Use’. Such use has to be by an opponent, not by Govt. Regulatory Authorities.
The
term “new chemical entity” (NCE) is normally restricted only to mean a new
chemical substance, which is not known earlier. Incremental improvements,
derivatives, etc. cannot be called a “NCE”.
The definition of NCE should be done inter alia
to avoid any possibility of “ever-greening”.
India’s
official submission to TRIPS Council on 29 June 2001 (IP/C/W/296): “Art 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 10bis 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”. There is
no valid reason for India
to change its earlier position.
Dr. Shoibal Mukherjee (Pfizer), OPPI
While
the drug developer invests time, money and efforts on (1) complete animal
testing and toxicology, (2) Phase I, II and III trial on humans, and (3)
Bio-equivalence and Bio-availability studies; the unfair gainers (read the
subsequent generic applicants) have to perform only BE and BA study. This
amounts to the freedom to free ride on the investment, risk taking and hard
work of the developer.
Data
Exclusivity is a tool to stop unfair commercial use. It provides a period of relative
exclusivity to compensate the developer / innovator for the subsequent
implicit or explicit use of its data by others. Historically India
has provided DE of 4 years (Rule 122E of Drugs & Cosmetics Act, which was
amended/deleted in 2001). All other countries
provide DE of ≥ 5 years.
Proportion
of cost involved in the “discovery” and “development” of a new drug is 30%
and 60% respectively. While the tool
for protection of discovery (read invention) is patents,
that for development is Data Exclusivity.
Mr. Anand Grover, Lawyers Collective
The
following interpretation of the phrases contained in the Article 39.3 should
be adopted:
“As
a condition of approving”: Obligation under Article 39.3 operates only if
the Statute requires data to be submitted as a condition precedent of
approval. If it is not made a condition and the drug company submits data of
its own then Article 39.3 obligation does not operate. Thus, today, a drug
that is approved on the basis of marketing approval in another country does
not require submission of undisclosed data. 39.3 obligation
does not come into existence.
“Undisclosed
test or other data”: Data anywhere in the world that is not protected by
law from disclosure. This would include data supplied to the Drug Controller
of India.
“New
chemical entities”: The obligation under Art 39.3 is only in respect of
new chemical entities, which is not defined. Countries are free to define
this. If new usage, new forms etc. are included then the protection may
extend even beyond the period of patent. Under section 3(d) of the Patent Act
i.e. new forms are not new substances unless they differ in efficacy.
“involves a considerable effort”: The only
objective standard can be the amount of money spent. Drug Regulator should be
satisfied that the originator has spent the money that is considered
considerable. Therefore the Drug Regulator should have the power to call for
documentation in this behalf to be satisfied which would ultimately stand up
in court, if challenged. None of the firms would share this data.
“Unfair
commercial use”: According to Vienna Convention ordinary meaning has to
be taken while interpreting a treaty provision. “Unfair” ordinarily means not
equitable, honest or impartial. Therefore, Government in the present case is
not unfair use. Drug Regulator, using the data himself cannot ever be
considered unfair commercial use, See R v Licensing Authority, ex parte Smith Kline & French Laboratories Ltd (Generics
(UK), [1989] 1 ALL ER 175, holding that the Authority entitled to use the
confidential information of the originator to decide a generic company’s
application for approval
Data
Exclusivity is not mandated under TRIPS, and there is no reason India
should go for TRIPS plus approach.
Mr. Gopa Kumar, CENTAD
Reliance
by the drug controller on the originator’s test data is not “unfair
commercial use”.
Article
39.3 should be read with Article 39.1.
TRIPS
does not require DE, hence it should not be given.
Mr. G. S. Sandhu, Joint
Secretary, D/o Chemicals & Petro-chemicals
The
government is exploring the possibility of having two different definitions
of NCE for agro-chemicals and for pharmaceuticals.
Such
possible definition of NCE could be as narrow as that which could be
construed from Section 3(d) of the Patents Act or as wide as the definition
of “New Drug” in the D&C Act.
The
word “New” in the phrase New Chemical Entity could either be “absolute” (i.e.
non-disclosure/non-approval anywhere in the world) or “relative” (i.e.
disclosure/approval only in India
would be taken into account). If we go
by the US
definition of NCE, it is the “relative” NCE i.e. it need
not be universally “novel” or “New”.
Mr. Narendra Zaveri, Advocate
Clinical
trail results are for the safety and efficacy and must be open to public. In
the US
also such results are placed on the FDA website. Hence data protection cannot
be extended to clinical trial data.
The
use of NCE in the Article 39.3 clearly indicates that the intention is to
limit the scope of protection. There is other restrictive condition i.e. the
reference to data in respect only of NCE ‘the origination of which involves a
considerable efforts’.
Therefore
data in respect of new formulations, new forms, salts, esters, new uses etc.,
which though required to be approved as “new drugs” – may not contain NCEs or may not involve ‘considerable efforts’ – are
excluded from the purview of Article 39.3.
The
US FDA Regulations define NCE to mean “a drug that contains active moiety or
the basic molecule that has not been approved by FDA in any other application
submitted under Section 505(b) of the Act”. This means that if a drug product
containing an NCE has been previously approved, subsequent new drug
applications containing the same active moiety or the basic molecule, will
not be treated as NCE for Article 39.3 requirement.
Mr.
Ashwini Kumar, DCG(I)
The
term NCE appears in the definition of IND
under Rule 122DA of the D&C Rules, 1945.
The
term NCE used in Article 39.3 is to be interpreted in the context of definition
of NCE used by US FDA and the Drugs and Cosmetics Rules of India, the data
protection and non-reliance by the Indian Regulatory Authority on
innovator’s data could be then limited to the data submitted for first
approval of an NCE or IND as a drug.
Dr. K. Satyanarayana, Sr. DDG
& Chief, IPR Unit, ICMR
The
vital information related with clinical trials, particularly those related
with the safety of patients & volunteers, needs
to be made transparent and should be placed on website. Consequently, what would be the status of
Data Protection if such data is made Public?
Mr.
Bejon Mishra
In
the ultimate analysis it is the consumers who are making “investments” in the
drug discovery and development, therefore all the information, including
trial data, need to be a public information.
Ms.
Leena Menghaney
Once MOHFW has drafted the amendment to Drugs
and Cosmetics Act, it should be made public and their comments should be
invited before introducing it in the Parliament.
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