When product approval data can be manipulated, why data exclusivity and data protection to hide the facts?

1. Why hide the facts, if they are true?
Is Product Approval Data Exclusivity & Data Protection
in Consumer Interest & in National Interest?
Blog: Vijay Sardana Online 1
Analysis by:
VIJAY SARDANA
PGDM (IIM-A), M.Sc. (Food Tech.) (CFTRI), B.Sc. (Dairy Tech.), Justice (Harvard),
PG Dipl. in Int'l Trade Laws & Alternate Dispute Resolution (ADR) (ILI), LL. B (in Progress)
Trade Law & Business Strategist
Policy Discussion Note

2. Please Recall…
• Cholesterol is bad for health…new research says this was all manipulated data
• Mustard oil is bad for health …new research says there is no evidence, data used to
prove mustard is bad is questioned
• Ghee is bad for health …new research says there is no evidence, data used to prove
Ghee is bad is now questioned
• Spices are bad for health …
• Tea is bad for health…
• Chocolate is bad for health…
…. new research says there is no evidence, data used to prove these products bad are
now questioned, so the question is what is the use of Data Protection and Exclusivity
when they are found wrong so often… and consumer is forced to suffer
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3. How many Scientists Fabricate and Falsify Research?
What about NGOs data?
•On average 2% of scientists admit to have falsified research at least
once and up to 34% admit other questionable research practices, the
actual frequencies of misconduct could be higher than this.
Source: http://journals.plos.org/plosone/article…
•The question is Should we trust data submitted by NGOs when they
target other research data? Who is ensuring that NGOs do not
manipulate or fabricate data?
•Read further, share your views and comments... how to address this
problem of data manipulation.
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4. What is Data Exclusivity & Its implications?
• Data exclusivity is a form of exclusivity, which prevents regulators from using the clinical trial test data that
had been used to approve the originator’s product, to also approve the chemically (or otherwise) equivalent
generic product.
• This means that if the generic company wants to get regulatory approval during the period of data
exclusivity (generally 5-10 years), it needs to duplicate the expenses and time taken to take its product
through clinical trials.
• If the period of data exclusivity completely overlaps with the patent duration, there is usually no substantial
effect as the patent would anyway prevent generics from releasing the product.
• However, off-patent or non-patented products can also be granted data exclusivity – in which case they
would enjoy 5-10 years of exclusivity. Data-exclusivity rights are also not necessarily ‘bound’ by the same
exceptions and flexibilities that patent rights are. It goes beyond legal framework.
• Data exclusivity may result in delay in ensuring role of domestic enterprises through compulsory licensing
system; and
• Data exclusivity will result in preventing other parties from developing similar data.
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5. India is Signatory to WTO including TRIPS…
The TRIPS Agreement in Article 39.3 stipulates as follows:-
• “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of
agricultural chemical products while utilize new chemical entities, the submission of
undisclosed test or other data, the origination of which involves a considerable effort, shall
protect such data against unfair commercial use.
• In addition, Members shall protect such data against disclosure, except where necessary to
protect the public, or unless steps are taken to ensure that the data are protected against unfair
commercial use.”
Please note:
• It does not specify time lines for data exclusivity
• It talks about unfair commercial use, but does not bar the authorities from using it for approval
of similar products by competitors.
• This would mean that data could be used for fair commercial use on payment of compensation.
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6. Negotiated Final Text of the TRIPS Agreement addressed this issue
Please note, the Text of Draft Submitted to Brussels Ministerial Conference in 1990:
• “Parties, when requiring as a condition of approving the marketing of pharmaceutical product or
of a new agricultural chemical product, the submission of undisclosed tests or other data, the
origination of which involves a considerable effort shall protect such data against unfair
commercial use. Unless the Person submitting this 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. In addition parties shall protect such data
against disclosure, except where necessary to protect the public” (emphasis added).
Please note: The Final Text of the TRIPS Agreement this was rejected as mentioned earlier. There
is no mentioned of “Period of Non-reliance”. Why Pesticide Management Bill is bringing this
issue when even TRIPS do not favour this.
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7. Data Protection cannot be a universal right under Law
• Article 39.3 requires governments to provide protection to marketing approval
data only under certain conditions. Test data must be protected if national
authorities require its submission.
• Article 39.3 does not require protection be given to already public data. Protection
is required only for new chemical entities. Members have considerable discretion
in defining “new,” and may exclude applications for second indications,
formulations and dosage forms. And, prior to granting protection, national
regulatory authorities may request the applicant to prove that the information for
which protection is sought is the result of significant investment.
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8. What WTO expects from member countries?
• The World Trade Organization’s Trade Related Aspects of Intellectual Property
Agreement (TRIPS), Article 39.3, requires member countries to establish
protections for submitted test data. But this requirement is in fact narrowly drawn,
and countries maintain substantial flexibility in implementation.
• The public interest in limiting protections for data is to promote competition, and to
ensure that data protections do not become the means to block the timely
entrance of generic competitors to off-patent drugs.
• Generic competitors drive down price, thereby promoting greater accessibility of
medicines and agro-chemicals.
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9. Why Demand for data exclusivity is unfair under PMB?
• Before the entry into force of the TRIPS Agreement, countries had considerable latitude to
determine rules for the protection of test data. The Agreement introduced the first international
standard on the subject, as contained in its Article 39.3.2 But the Agreement is not a “uniform
law” -- it only establishes broad parameters for national rules.
• An important question is the extent to which the Agreement allows WTO Member countries
freedom to apply different approaches for the protection of test data protection and, in
particular, the extent to which a competitive model -- i.e., protection without exclusivity -- is
compatible with the minimum standards set forth in Article 39.3.
• To properly interpret Article 39.3, the Vienna Convention on the Law of the Treaties instructs
that the ordinary meaning and context of the terms used, and the object and purpose of the
treaty.
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10. Why Pesticide Management Bill’2008 exceeded its jurisdiction?
(6) The data submitted for the purpose of registration in respect of a pesticide under this section
which has not been previously registered shall not be relied upon for grant of registration of the same
pesticide in respect of any other person for a period of three years.
• It means PMB is proposing Data Exclusivity, this is not agreed even by TRIPS.
(7) Subject to sub-section (6), where a pesticide has been granted a patent, the period of non-
reliance on data shall be limited to the period of the patent. Explanation.. The words "not been
previously registered" in respect of a pesticide shall include its name or label expansion through "new
uses":
Provided that the provisions of non-reliance on data submitted for registration of a pesticide by the
first registrant shall be available for the period with effect from the date of the first marketing approval
granted anywhere in the world and this shall not apply to the data relating to bio-efficacy and shelf-
life part of pesticides where data is to be generated for use under Indian conditions.
• It means till patent the data exclusivity will remain.
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11. Why & Who pushed ‘Data Exclusivity’ into PMB’2008?
• As a condition for registering pharmaceutical and agro-chemical products, National
Authorities normally required applicant to submit data relating to quality, safety and
efficacy of the product.
• The issue being raised is whether directly or in-directly the test data should be
used for subsequent registration of products similar to those originally registered.
• The MNCs are demanding ‘data exclusivity’ on the data so that its use could be
prevented for allowing generic manufacture to take marketing approval;
• Since the consequences are quite serious Parliamentary Committee on IPR also
impress upon the government not to concede to data exclusivity as demanded.
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12. Why there is Conflicting Approach within India?
According to Report on Patents and Trademarks Systems in India, Rajya Sabha Secretariat -
Keeping the above in view it may be concluded that the game plan of MNCs is for market
exclusivity for a period. There can be demand for extension of such exclusivity for some reasons or
the other for further period.
It is understood that :
Ministry of Health and Ministry of Commerce are not supporting grant of data exclusivity,
whereas,
Ministry of Chemical and Petrochemical and Ministry of Agriculture and supporting the
demand for data exclusivity.
Since the consequences are quite serious Committee may look to this issue and impress upon the
government not to concede to data exclusivity as demanded.
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13. Arguments against ‘data exclusivity’ at WTO
• Article 39.3 was settled during the Uruguay Round of GATT negotiations. During negotiations the
developed countries particularly the USA demanded for providing data exclusivity on data
submitted for marketing approval to the concerned authority. This demand was rejected at the
multilateral forum and as such there should be no question of agreeing to bilateral
demand of MNCs.
• If such demand if agreed at bilateral forum there will be additional demands which may relate to
higher level of intellectual property right such as extension of patent period, restriction on
compulsory licences, restriction on parallel imports and may be also on R&D activity on patented
subject matter;
The implications are as follows:-
• Conceding to demand would mean agreeing to TRIPS plus provision. As a national position
Indian has not agreed to it. Now if agriculture department introduces this under PMB, this will
defeat the stated national position, which is not agreed by India at WTO.
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14. Why WTO do not support Data Exclusivity?
• The TRIPS Agreement has obliged WTO Member countries to treat test data as a
component of “intellectual property”. However, the rationale for test data
protection is the investment made in data production, rather than their creative or
inventive content. Data generation do not add to creativity or innovation of already
known molecule in the world.
• Article 39.3 of the TRIPS Agreement requires data protection against disclosure
and “unfair commercial use”. Article 39.3 develops Article 10bis of the Paris
Convention; that is, it requires the protection of data against dishonest
commercial practices.
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15. Principal Argument in favour of Data Exclusivity itself is Flawed
• A principal argument of the proponents of data exclusivity is that it would result in increased
foreign direct investment. However, the available data suggests that the introduction of data
exclusivity in other countries has not resulted in any greater proportion of R&D expenditure
being incurred in these countries.
Caution:
• There is no evidence from anywhere in the world to back this argument.
• Please refer he EU study as mentioned in this presentation, on this point, which proves this
argument does not hold good.
• If India were to go TRIPS Plus, the way it is proposed in PMB’2008, and introduce data
exclusivity for agrochemicals, pesticides and medicines, not only the small farmers and poor
patients will be denied access to affordable, competitively priced products, but the domestic
industry will suffer irreparable loss as its ability export these products will be severely
compromised.
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16. ‘Data Protection’ does not promote investment as perceived, in fact
harms the availability of affordable products for masses
EU study findings says:
• The introduction of data exclusivity would delay the entry of affordable generic product. This is
corroborated by an analysis of the new drug approvals by the EMEA for three years (2007-09).
• The analysis shows that of 113 drug products approved, 92 were granted data exclusivity. Of
these 92, 32 drugs did not have subsisting patents for the actives. The patents had either expired
or were not patentable, but they were eligible for data exclusivity.
• Of the remaining 60 drug products, the data exclusivity for 38 had monopoly beyond expiry of
patent.
• Thus, 70 of 92 products approved in the EU in 2007-09, the data exclusivity period extended
beyond patent expiry.
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17. Government has right to use the Submitted data for approvals in
National Interest to create competition & ensure affordable products
• All drug regulatory authorities require the first applicant to submit data on safety and efficacy of
a new drug. Likewise, regulator for agro-chemicals and pesticides require the first applicant to
submit data on safety and efficacy of a new substance.
• The generation of this data requires substantial expenditure and effort including clinical/field
trials. However, the subsequent applicants are not required to duplicate the effort as the safety
and efficacy of the drug/substance is already established. They are required only to establish
equivalence to the previously approved product.
• The TRIPS Agreement therefore requires the Government to protect the data submitted
for regulatory approval from "unfair commercial use" by the competitors.
• However, reliance on this data by the regulator for approval of subsequent applicants is
not unfair commercial use. This helps in cross verification of facts and advancement of
research.
• This is acknowledged by several international organizations and eminent authorities.
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18. Data Exclusivity Clause under PMB is against National Policy and
beyond the Legal Scope – Must be removed from the Bill.
• The TRIPS Agreement requires protection of data, not data exclusivity, which in the present
context is synonym with market exclusivity.
• This market exclusivity results in extended legal monopoly. It can be granted whether the
product has patent or not and is in addition to the period of exclusivity granted under the
patent.
• Unlike in the case of patents which can be challenged and invalidated, data exclusivity cannot
be challenged.
Submission: Considering the above mentioned facts and evidences, it is request to the
concerned authorities. Please stick to the national policy and remove all the refences
related to data exclusivity from the proposed Pesticide Management Bill.
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19. Why Transparency in data is so Crucial for Consumers?
• Why wrong vaccines and medicines get approval under the law?
• Why suddenly few products are labelled as bad for environment and public health after
few years of use?
• Why suddenly there are news that there is no concern about diabetes?
• Why sudden few products are declared bad after use of few years?
• Why sometimes bad products are declared they are good for health?
• The fact is all these are based on the data submitted by the applicant. It is common
knowledge that due to commercial pressure there are manipulation of data submitted
and authorities have no method of cross verification in the name of IPR.
• To ensure authenticity of submitted data make them transparency so that manipulations
can be detected early.
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20. Open for Discussion
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Please feel free to contact in case of any clarification.
Thank you.