When product approval data can be manipulated, why exclusivity and data protection to hide the facts?
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The document discusses the implications of data exclusivity in the context of consumer health and national interest, questioning the integrity of research data used to approve various food and health products. It highlights concerns about potential manipulation of data by researchers and NGOs, and advocates for transparency in data to protect consumer interests. The document asserts that data exclusivity can delay the entry of affordable generics, contradicting the goals of fair competition and accessibility in the pharmaceutical and agro-chemical markets.
When product approval data can be manipulated, why 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 Blog:Vijay SardanaOnline 2
- 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. Blog:Vijay SardanaOnline 3
- 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. Blog:Vijay SardanaOnline 4
- 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. Blog:Vijay SardanaOnline 5
- 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. Blog:Vijay SardanaOnline 6
- 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. Blog:Vijay SardanaOnline 7
- 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. Blog:Vijay SardanaOnline 8
- 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. Blog:Vijay SardanaOnline 9
- 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. Blog:Vijay SardanaOnline 10
- 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. Blog:Vijay SardanaOnline 11
- 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. Blog:Vijay SardanaOnline 12
- 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. Blog:Vijay SardanaOnline 13
- 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. Blog:Vijay SardanaOnline 14
- 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. Blog:Vijay SardanaOnline 15
- 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. Blog:Vijay SardanaOnline 16
- 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. Blog:Vijay SardanaOnline 17
- 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. Blog:Vijay SardanaOnline 18
- 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. Blog:Vijay SardanaOnline 19
- 20. Open for Discussion Blog:Vijay SardanaOnline 20 Please feel free to contact in case of any clarification. Thank you.