MINUTES OF THE INTER MINISTERIAL MEETING HELD UNDER THE CHAIRMANSHIP OF SECRETARY (C & PC) ON 22.5.2006 ON DATA PROTECTION LIST OF THE FOLLOWING OFFICERS WHO ATTENDED THE MEETING.
Shri R.A Mashelkar, Secretary, Department of Scientific and Industrial Research.
Shri. G.K. Pillai, Special Secretary, Department of Commerce.
Shri Ashish Bahguna, Joint Secretary, Department of Agriculture.
Dr. N.K. Ganguly, Director General, Indian Council of Medical Research.
Shri Arvind Mayaram, Joint Secretary, Department of Economic Affairs.
Shri K.K. Tripathi, Advisor, Department of Bio-Technology.
Smt. Rita Teaotia, Joint Secretary, Ministry of Health and Family Welfare.
Shri G.S. Sandhu, Joint Secretary, Department of Chemicals and Fertilizers.
Shri Ashwani Kumar, Drugs Controller General (India), Ministry of Health and Family Welfare.
Shri Paresh Johri, Deputy Secretary, Department of Chemicals and Petrochemicals.
The Secretary initiated the discussion and introduced the subject to the Members. Secretary initiated the issues for the further discussion. They were.
Thereafter Shri G.S. Sandhu, Joint Secretary made power points representation covering the various issues pertaining to Data Protection in the context of Article 39(3) of TRIPS Agreement Shri. Sandhu explained the proposed model for Data Protection for Agro Chemicals and two alternative models for pharmaceuticals.
Dr. Mashelkar mentioned that Data Protection is a very vital issue related to access to medicines and affordable Healthcare there is a need to have a balanced approach which uniformly acceptable to all the stakeholders especially to a multi-national Indian industry and demanding data protection and data exclusively respectively. Therefore instead of prime to generate a consensus there is a need to have a balanced approach which is largely acceptable to everybody. He clarified that India has become innovative and it is not copying innovation being carried out by others. There is a substantial increase in R & D in the last 2 years. Therefore there is a need to respect innovations and possible data protection model should support innovations by Indian companies as well as by multinational and at the same time there should be a sufficient safeguards that basic objection of cheaper medicines is not adversely affected.
Dr. Mashelkar mentioned that there is a change in the stand of Department of Scientific and Industrial Research and now they are recommending three years data exclusivity alongwith sufficient safeguards. According to him this model should satisfy everybody and also help in promoting R&D – innovations are the common man interest. However safeguards as suggested by Department of Chemicals and Petrochemicals in the Data Exclusivity demands are sufficient to ensure that the fix term data protection regime is not misutilized by anybody. He clarified that DSIR now recommends fix term data protection for three years along with non reliance by regulator for both in Pharmaceutical and Agro Chemicals Sector. However this should be crippled with adequate safeguards as proposed by Department of Chemicals and petrochemicals in his discussion papers in the Data Exclusivity Model.
Dr. N.K. Ganguly suggested that any information which is already in public domain new uses of known drugs and minor changes in the known molecule should not be given in data protection. Department of Commerce suggested that there is a need for separate treatment for Agro Chemicals and Pharmaceuticals.
It was discussed that in the Agro Chemical Sector there is a consensus amongst that Agro Chemical Industry as well as Department of Agriculture had suggested that they are in favour of three years data protection, therefore, Agro Chemical Sector should be separately considered. The issue was discussed by the Committee and the following has agreed by consensus.
1. There is a need provide a fix term data protection for three years for Agro Chemical Sector with non reliance by the regulator.
2. For this purpose the act should be amended by the Department of Agriculture to introduce the time lack of 3 years between 9(3) and 9(4) registration.
3. There is no need to have system of price control for Agro Chemicals.
4. Adequate safeguards as enumerated in the discussion paper should be provided so as to ensure that the data protection provisions are not mis-utiliszed .
5. Dr.Mashelkar mentioned that a Expert Group should be under his Chairmanship by Department of Industrial Policy and Promotion to examine the issue of new chemical authenticity however as the report of the Group has not been submitted., therefore, it would be appropriate to consider the NCE definition as agreed upon by the industry for the purpose of pharmaceuticals. He further mentioned that this a rare occasion where entire pharmaceutical industry has agreed on one common definition. Therefore we may go ahead with the following definition of NCE.
Deptt. Of Health said that as per their existing strength they still support the data protection only ‘Model’ suggested in the discussion papers. However, in the light of the today’s discussion there is a need for Department of Health to re-examine and stand and alternative should be examined.
Ministry of Health conveyed that they will re-examine alternative (fix term data) mentioned along with non reliance and submit their comments shortly.
Department of Industrial Policy and Promotion mentioned that as of new they agreed with alternative on however they would also like to be examined their stand explore the possibilities of accepting alternative two. Their comments will be sent shortly.
Department of Bio-Technology mentioned that till now they have not fixed any problem related to data protection however, they question the rational of ‘3yeras’.
In view of the discussion mentioned above the following decision were taken.
There is a consensus amongst all the Members of this committee that there should be a fix term data protection of three years for the Agro Chemical Sector along with the non reliance by the regulator However, this model should be supported by adequate safeguards as enumerated in the discussion papers.
In view of the consensus in the Agro Chemical Sector the data may go ahead and submitted. Report for Agro Chemical Sector and report on Pharmaceutical Sector shall follow in due course.
In the Pharmaceutical Sector as per the discussion there is a shift towards fix term data protection along with non reliance and therefore there should be a need for further discussion and if possible try to achieve the consensus. For this purpose the following measures are required.
(a) The proposed alternatives for Pharmaceutical Sector should be widely circulated amongst the industry associations and others stakeholders and also if placed at the website. The Department may seek specific comments from various Industry associations and other stakeholders on proposed models.
(b) The Department of Industrial Policy and Promotion and Department of Health will re-examine their stand and examine the possibilities of adopting fix term data protection alongwith non reliance model and come up with their suggestions within two weeks.
Shri. G.K. Pillai, Special Secretary Department of Commerce conveyed that there is a emergency consensus in the Agro Chemicals Sector therefore the data may go ahead with its for Agro Chemicals Sector however, consensus there is a shift in the stand taken by DSIR. Therefore the data exclusivity option should also be examined by all the Departments. For this purpose there is a need for further discussion and the report for Pharmaceutical Sector may be delayed and the report of Agro Chemical Sector may be submitted.
The department of Agriculture will sent the comments on the proposed model along with any additional safeguards within 15 days.
The meeting ended with thanks to the Chair.
17-05-06
Discussion paper on
Protection of data in the context of the provisions of Article 39.3 of the trips Agreement
Article 39.3 of trips :
Article 39.3 of the trips Agreement reads:
“Member when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products with utilize new chemical entries, 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.”
Data protection basically implies protection provided by Governments against disclosure and unfair commercial use of certain test data (generated in the preclinical and clinical testing of a drug) which is provided to government to obtain marketing authorization for the product and where generation of such data require considerable effort. This information is generated at great expense and effort and is submitted to the regulatory authority to obtain market authorization.
As per TRIPs Agreement data protection is mandated for pharmaceuticals and agricultural chemicals containing a new entity.
Data protections different from patent rights that may exist in a particular product.
Patent provides exclusive rights over a product. It is granted on patent application filed many years before the product comes for marketing approval. Every new product may not be granted patent. Data protection on the other hand comes into picture at the time of grant of marketing approval to a product which may be patented or non-patented. Therefore there is no obligation to limit data protection to patented products only. The issue of data protection becomes especially relevant for off-patent products as well as for products such as biological that are often difficult to patent.
Ongoing Debate :
Data Protection has generated a lot of discussion in the country between industry and other stake holders. Different persons have been interpreting it in different way which has led to debate and lack of consensus on any
single approach. This debate basically revolves around the following point.
A) Nature of Protection
Two types of protection is envisaged under this clause-
a) Protection against disclosure (without any time limit)- this type of protection is well understood and is not a major issue It can be sorted out by additional legal provisions in the laws.
b) Protection from unfair commercial use –(data exclusivity -reliance by regulatory authority) There has been intense debate over the fact as to whether reliance by a national authority on data submitted by one company (originator) to evaluate a subsequent application by another company constitutes an unfair commercial use of the information Article 39.3 has not clear1y addressed this issue and has left it wide open for interpretation As such different countries have adopted different approaches in this regard. Most of the developed countries which consider this type of protection against reliance by the national authority have done so for a specified period generally ranging from 5 to 10 years. Several other countries donot provide this type of protection.
B) Different Requirements of Pharma and Agrochemicals Industry Both these industries have been demanding different type of protection due to the different nature of their products and requirements. Also within the pharma sector there are differences between the domestic and multinational companies on this matter.
Indian pharma industry wal1ts only data protection without any exclusivity as opposed to the demand for 5 years data exclusivity by the multinationals Agrochemicals industry has been demanding data exclusivity for a period of 3 three years and there is a broad consensus on this between all the different segments of this industry.
C) Definition of New Chemical Entity (NCE) -There are wide differences over the definition of a New Chemical Entity. Domestic pharma industry has been advocating NCE to be defined on the lines of the Indian Patent Act while the pharma multinationals have been advocating a definition to mean a new pharma product which has been introduced for the first time in the country irrespective of the fact whether it is patented or nor not.(somewhat on the lines of the definition of new drug in Drugs and Cosmetics Act, 1940)
As opposed to the above the Agrochemicals industry has been advocating a new chemical entity to be a chemical mixture which contains an active ingredient or formulation of such an active ingredient that has not been previously approved in India. It is inspective of whether the product is patentable or not. In the case of agrochemicals even if the product has been earlier approved in another county it is Still remains an NCE as the applicant is required to concoct studies India to testers safety and efficacy in local conditions.
D) Since Article 39.3 is applicable to both pharmaceuticals and agrochemicals and both have been interpreting it in different ways suiting the requirements this has added to the confusion
In a meeting held by Commerce Secretary on 31.12.03. the issue Article 39.3 of TRIPS Agreement was discussed in detail. It was decides that looking to peculiar nature of the matter Secretary Department of Chemicals & Petrochemicals should examine the issue and make suitable recommendations. In this regard.
Consequent to the decision taken in the above meeting, the Department of Chemicals & Petrochemicals constituted an Inter-Ministerial Committee. To examine the following issues:-
· To consider the steps to be taken by the Government in the context of the provisions of Article 39.3 of the TRIPS Agreement for protection of undisclosed information.
· Whether- protection under the existing legal provisions or an appropriate new dispensation is required for this purpose.
Meetings of the Committee under the chairmanship of Secretary (C&PC) were held but no consensus could be evolved due to different views of concerned departments basically emanating from the divergent views of industry.
Views of Various Department :
Department of Commerce :
For compliance with Article 39.3 not necessary to provide “data exclusivity” – this would tantamount to TRIPs plus If concerned administrative Ministries feel any necessity for granting it they may do so independently, without linking it to the requirements of TRIPs. While on the one hand there is no pressing need for us to make our law as TRIPs – plus, on the other hand we need to do the minimum to comply with our international obligations. Department feels that India needs to restrict the protection of data only with view to ensure that there are sufficient safeguards against disclosure of the data and it is not misused by any other party.
Department of Industrial Policy & Promotion: ,
There is adequate clarity about tile level of protection - only Disclosures to third parties are to be covered and regulator can be free to use the data for scrutiny of other application. The department feels that exclusivity of data is not a comfortable proposition and is not as per the spirit of Article 39.3. Besides this, the views expressed by Department of Commerce are also applicable to Department of IPP as conveyed by Minister Commerce & Industry.
Department of Scientific & Industrial Research :
Provisions applicable under common law of India and existing IPR laws are adequate /sufficient to address the issues/concerns .
Department of Biotechnology:
The present regulatory procedures are already TRIPs complaint Another period of data exclusivity over the twenty years under product patent would lead to further greening of the patent for a product and this would hamper the progress of biogenerics for which India has a great strength. No need for data exclusivity.
Department of Agriculture & Cooperation:
Supported data protection for the pesticides sector for a period of 3 years. They are already in process of amending the Insecticides Act, 1968.
Department of Health:
The mandate of the aforesaid Committee is to consider steps to be taken by the Government in the context of the provisions of Article 39.3 of TRIPS Agreement, i.e. if these provisions are not being reflected in the Drugs & Cosmetics Act then there is need to reflect these provisions. However, the Government should guard against any provision, which is either TRIPS plus or Article 39.3 plus.
The Article 39.3 of TRIPS applies only to New Chemical Entities (NCE) and not to all patented products. The definition of NCE has to be evolved, as it is not defined either in the TRIPS Agreement or in the Indian Patents Act, 1970. Such definition may be evolved from the definition of “investigational new drug- as provided under the Drugs and Cosmetics Act, 1940 and the entities that cannot be patented as provided under the Patents Act, 1970.
While giving market approvals to drugs and pharmaceutical products the competent Regulator (i.e. Drug Controller General of India) relies on as unfair commercial use” in the context of Article 39.3.
Planning Commission
Effective protection should be provided against unfair commercial use of data Innovator drug companies need to prevent competitors from getting free ride’ by relying on data submitted by them. It is important that an informed view is taken on this issued reflecting expert opinion and keeping in mind international practice.
Views of Various Stakeholders :
The domestic pharma industry and the foreign multinational companies are clearly divided over the nature of Data Protection regime in India. The domestic companies are advocating the “Data Protection only” model only i.e. non disclosure by the Drug regulator. On the other hand the Research based Foreign Multinationals are advocating data exclusivity for a fixed period for atleast 5 years) i.e. non reliance for a fixed period by the drug Regulator on the data of the first applicant for granting marketing approval of drugs of subsequent applicants. The views of ------ stakeholders are compiled Annexure-3.
Views of Legal Experts
a) Views of Dr N.S.Gopalakrishnan of Centre for Intellectual ---- Rights Studies, Cochin Department Of Commerce nad asked Dr Gapalakrishnan to under-- study to suggest suitable legal changes in the Indian laws to make TRIPs compliant. Dr. Gopolakrishnan has suggested that there is --- to provide data exclusivity. However certain amendments are requires to strengthen data protection, which needs to be carried out in Drugs & Cosmetics Act and Insecticides Act. A summary of his recommendations is given in Annexure - 1
a)Anand and Anand -leading law firm on IPRs A detailed study has been done by them on the data protection for crop protection products.. They have proposed a 5 year exclusivity period for agrochemicals and a 3 year cross -reference period following the exclusivity period. where another registrant could rely on the data of the first, but by providing compensation to the first registrant An Executive summary of the opinion is attached at Annexure-2
Data Protection Regime in various countries:
The various data protection regime being followed in some of the countries are enumerated in Annexure – 4.
Suggested Approach:
Looking to the wide differences between the pharma industry (as also within the pharma sector) and the agrochemicals sector it would be difficult to arrive at a uniform policy for both the sectors it would be difficult to arrive at a uniform policy for both the sectors in so far as data protection in concerned. It may therefore be appropriate to adopt different approaches for the both sectors.
Brazil too has adopted a different policy for the two sectors. While data exclusivity is not allowed for pharmaceutical, it is allowed for 10 years for the agrochemicals with 5 years for additional data required by the regulatory authority to sustain / maintain registration of a given agrochemical product.
In several other countries also there is no uniform policy for these two industries in the mater of data protection. Generally the protection allowed for agrochemicals is higher than that for pharmaceuticals e.g. in USA there is 10 years data exclusivity for new agrochemicals from the date of registration – 15 years additional protection on the basis of condensability (as against 5 years for pharma). Similarly there is 10 years +5 years (for additional data in Europe, in UK it is 8 years, in Japan it is permanent, in Canada it is 10 years, In France too It is 10 years and so on and so forth.
According to Carlos Maria Correa of University of Buenos Aires, Argentina and a known authority on IPRs has clearly. brought out the fact that' 'Countries have considerable discretion to define unfair in the context of their own national laws and culture. TRIPS Agreement is not a uniform law -. it only establishes broad parameters for national rules.
Looking to the above and the peculiar situation of India where there is a deep concern for drug prices and growth of generic industry a calibrated approach may be adopted for Pharmaceuticals & Agrochemicals Sector. Following two options may be considered –
Option - A : For Agrochemicals Sector
Data Protection with 3 years of data exclusivity (non reliance by regulator for 3 years)
There are following industry associations in agrochemicals in India-
a) Crop Life India (CLI) – consists of 12 R&D companies.
b) Crop Care Federation of India (CCFI) – larger body of about 200-250 companies making APIs, bulk intermediates and formulations.
c) Pesticides Manufacturers and Formulators Association of India (PMFAI) – consists of a large number of formulators of me-too category)
There appears to be a near consensus amongst all the three bodies for a limited period data exclusivity for 3 years. Looking to this following approach can be adopted.
1. All the measures suggested for non disclosure and unfair commercial use as suggested in the case of pharmaceuticals should also be applicable to the agrochemicals.
2. The phrase "new d1emical entities (NCE)" in the case of agrochemicals can be defined as under-
A Chemical mixture which contains and active ingredient or formulation of such an active ingredient that has nor been previously approved in India. It is irrespective of the fact whether the product is patentable or not. Even if the product has been previously approved in another country it is still remains an NCE as the applicant is required to conduct studies in India to test its safety and efficacy in local conditions.
3. Subject to the following safeguards the Regulatory Authorities would provide data exclusivity fat a period of three years:
· All the provisions pertaining to the data protection can be waived off by the Govt. to protect public health or for academic purposes. The concerned academic institution would be duty bound to ensure that the data in its custody is not put to any commercial use by it or by any other entity.
· In the case of a specified situation the Govt. can direct to the Regulatory Authorities that they can place reliance on the data submitted by the applicant subject to the second applicant willing to pay a reasonable royalty to the first applicant for utilizing the data created and submitted by first applicant.
· In cases where Regulator or the Government feel that repealing the field trials for an agro product is harmful to public health or will have detrimental effects on substantial agricultural land, it can place reliance on the first applicants data it can place reliance on the first applicants data subject to the payment of reasonable realty to the first applicant.
· For marketing of agro products the Regulator shall be free to determine the requirement of data from the first applicant.
· The Govt. will create a suitable mechanism to ensure that the prices of such new agro chemicals remain reasonable so as to serve the interests of the fanners –
Based on the above approach, the Ministry of Agriculture can carry our suitable modifications in the Insecticides Act 1968.
Repercussions-
Positive side –
a) This will facilitate arrival of newer and safer agrochemicals for the benefit of Indian farmers by way of improving yields and quality of their produce .Farm produce produced with these new products would have a good market the world over these being comparatively safer
b) There is often no transfer of knowledge about the chemicals to the farmers resulting in wrong or overuse of ‘me too' chemicals leading to adverse consequences like damage to crops, uneconomic returns, development of resistance etc.
c) Use of new crop protection products prevents adverse effects on the environment that is germane to repeated use in higher volume of conventional products. This is because the new solutions are applied in low dose, are target specific and are fast degrading
d) It will encourage R & D based companies abroad to bring new technologies for the benefit of farmers and also encourage domestic companies and R&D institutions to invest in R&D in agro – chemicals.
e) International companies may shift their facilities to India making India a/ hub for data generation and a base for global registrations.
f) Fixation of minimum residue levels (MRLs) for products already in use are a mandatory requirement due to commitment of the Government in Parliament and before the Supreme Court Generation of residue data involves substantial effort in terms of time and money. Provision of data exclusivity will induce the companies to come forward to undertake the necessary investment in data generation.
g) It will enable the original applicant to recoup the huge investment in conducting safety and efficacy studies for the new agro-chemical product, which generally takes 3 to 4 years.
Option B- For Pharmaceuticals
Two alternatives are listed below:
Alternative –1
Protection against disclosure only (no data exclusivity)
1. This option is based on the interpretation that data protection is required against disclosure only and this is sufficient to cover cases of unfair commercial use. There is no requirement or need for providing fixed period data exclusivity on the data submitted by the first applicant The reliance placed by Government / Regulatory Authority for marketing approval of drugs on the data submitted before any other regulator elsewhere in the world in the case of first applicant or relying on the data submitted by the first applicant in India while approving the drug of the subsequent applicants would not tantamount to unfair commercial use.
2. New Chemical Entity in the context of Data Protection does not mean a novel entity in the Patent sense. It has to be seen from the angle of marketing Approval,. According to experts, like Carlos Correa, a renowned expert in IPR, a Chemical entity is deemed new, if there were no prior application for approval of the same drug or where the same drug was not previously known to commerce. It would, however, not apply to new indications, new dosage forms new combinations, crystalline forms, isomers etc. of existing drugs. Since, there would be no new Chemical entity involved. Keeping this interpretation of NCE, the NCE for Pharmaceuticals may be defined by Department of Health.
3. Protection of data against disclosure and against unfair commercial use shall only be limited to the 'New Chemical Entities (new drugs) as defined above.
4. Government shall ensure that the specified data submitted for the purpose of marketing approval of pharmaceutical products should not be disclosed to any third party The Government / Regulatory Authorities will be under legal obligation to protect the data submitted to them for approval of new drug.
5. The existing Indian Legal Framework dealing with undisclosed information is in the form of Official Secrets Act (section 5), Drugs & Cosmetics Act 1940 (rule 53 of the Drugs and Cosmetics Rules,1945),Law of Torts. The Indian Contract Act, 1872, and Insecticides Act 1968 , It is Felt by some experts that the present provisions are not sufficient to ensure the desired compliance level to fulfill India's obligation under Article 39.3 of TRIPs, Some measures need to be taken to strengthen it.
6. Measures for introducing certain amendments by way of additional safeguards against disclosure are placed in Annexure -1 Hence to make Indian legal framework TRIPS compliant, there is an immediate need to amend The Drugs and Cosmetics Act 1940 and other relevant laws.
Repercussions of Option A
Positive side
a) It will allow competition to take place and thus avoid giving monopoly rights to the innovator drug companies on the new drugs (not patented) and thus help keep a check on their prices.
b) It will help domestic companies to continue to make generics of the pioneer drugs (not under patent) since there is no data exclusivity.
Negative side
a) MNCs would be critical about this approach for not providing what in their perception is data protection i.e. data exclusivity for a fixed period.
b) USA has already included India in the IPR Defaulters list of Countries using the special 301 provisions of its Trade Act Of 1988. India may be put in the priority watch list.
c) Increasing Free Trade Agreements by USA with various countries are likely to affect our generic exports. USA has entered into FTAs with several countries. Presently USA is negotiating FTA with Thailand, Kuwait, Australia etc.. All these FTAs include IPR restrictive clauses like 6 years data exclusivity, rigid procedures for parallel importation and other JRIPS plus provisions. All these would have negative implications for generic exports from India. In case we introduce some data exclusivity provisions US/other countries may be induced not to introduce stringent TRIPS plus measures in the FTAs. This would benefit exports of our generic medicines.
Alternative –2
Protection against disclosure and Fixed – term Data Exclusivity for three years coupled with safeguards
a) All the. measures for non disclosure as in Alternative-1 of data to be taken and suitable amendments in the laws (Annexure-1 ).
b) Subject to the following safeguards the Regulatory Authorities would provide data exclusivity for a period of three years:
· In the case of drugs utilizing the new chemical activities which are patented in India the data protection shall not exceed the patented term, the meaning thereby data protection can not be extended beyond the life of the patent.
· The protection for the above said data shall be Available for the specified period as above with effect from the date of the first marketing approval granted anywhere in the world.
· Further, the benefit of data protection can only be granted if the application for marketing approval is filed in India within a period of one years of first marketing approval granted anywhere else in the world.
· All the provisions pertaining to the data protection can be waived of by the Government in case of an emergency or a public health crisis.
· In the case of a specified situation such as drugs of mass consumption, anti-HIV drugs, etc. the Government can direct the Regulatory Authorities that they can place reliance on the data submitted by the applicant subject to the second applicant willing to pay the reasonable royalty to the first applicant for utilizing the data crated and submitted by first applicant.
· In the cases where Regulatory and the Government feels that repeating the clinical trials for a drug is harmful to public health or the Govt. can direct the Regulatory Authority to place reliance on the first applicant data subject to the payment or reasonable royalty to the first applicant.
· To ensure the interest of the patient in India. the Govt. in public interest can issue directions to the Regulatory Authorities to place reliance on the data either submitted in India or elsewhere in the world without payment of reasonable royalty also. However, this power of the Govt. should be used only in the rare cases.
· The Regulatory Authorities for marketing of pharmaceutical products shall be free to determine the requirement of data from the first applicant.
· The Government will create a suitable mechanism to ensure that the prices of such new drugs continue to remain reasonable so that there is a wider coverage as far as the patients / farmers are concerned.
· India should follow a system that will allow generic filing to be done during the DP period. The regulatory could tentatively approve the products if they meet' the regulatory requirements. The approval will automatically become final the day the market exclusivity expires
· Any authorization of generic by the first applicant should automatically end the DP period for all companies.
Based on the Guidelines mentioned above, the Ministry of Health - can carry out suitable modifications in Drugs and Cosmetics Act / Rules.
Repercussions-
Positive side-
This will facilitate arrival of newer medicines for the benefit of Indian patients. Also, the MNCs may like to make greater investments in India in drug manufacturing and research.
Negative side:
Domestic Pharma Companies may perceive it as a barrier for their growth and are likely to raise objections to it.
Review of Position :
Since a calibrated approach is being advocated for data protection, it would be appropriate to review position after 3 years both for Pharmaceuticals & Agrochemicals and make such, modification/changes as may be required at that stage.
Department of Commerce had asked Or. N S Gopalakrishnan of Centre for intellectual Property Rights Studies, Cochin to undertake a study to identify the suitable mode of protection of test data in India considering the interest of the Indian industry. while complying with the TRIPS obligations In his report Dr Gopalakrishnan has suggested the following:
a) Mandatory provision for ensuring the safety and quality of drugs;
b) Power of the DCGI to demand undisclosed information for drug approval for manufacture or import;
c) Limit the data requirement to new drugs that are introduced first in India and not available in the market anywhere in the world;
d) Provision creating obligation on the part of the officials in the office of Drug Controller General of India (DCGI) to keep the undisclosed information submitted to the DCGI for approval of a new drug is secret;
e) Obligation of the person submitting data to declare the status and nature of the information that require protection; -
f) Power of the Central Government to disclose this information on public interest;
g) Liability of persons in the office of DCGI under the Official Secret Act, 1923 in case of, unauthorized, disclosure of the secret information;
h) Liability of the third parties incase of use of this information without the consent of the parties.
Similar provisions can be included in Insecticides Act also.
Proposed Amendments to the Drugs and Cosmetic Act:
(Note : We are introducing this new section to make express provision in the Act for drug approval which as of now is only in the Rules. This is needed since we are suggestion undisclosed information form of protection for test date submitted for approval of new drugs with liability on the officials disclosing it and third parties using the same.)
Add new Section 18A
Section 18A Prohibition and liability for disclosure of information:
(1) No person shall be entitled to the license under the section (c) of Section 10 or under sub section (c) of section -18 for a drug unless Approved by the licensing authorities in accordance with the Rule prescribed under this Act
(2) For the purpose of approval under subsection (1) the licensing authorities may insist on the submission of any information to be considered as undisclosed by the applicant.
(3) The ------ authority ------ on submission of information under sub-clause. (2) for new drugs shall keep such information as undisclosed by the applicant Provided that the government may by notification direct the authority to disclose such information in public interest based on such terms and conditions as it may deem fit.
(4) Any person violating the breach of confidence under subsection (3) may be liable to De prosecuted under the Official Secret Act, 1923.
(5) The applicant under subsection (1) shall be entitled to injunction, compensation or account of profit from any person using the information submitted under subsection (3) in violation of breach of confidence.
Proposed Amendments to the Drugs and Cosmetics Rules, 1945
Amendments to Rule 122-A (Amendment in bold letter)
(1) ……………
(2) The importer of a new drug that is not approved or marketed in other countries when applying for permission under sub-rule (1) shall submit data as given in Appendix 1 to Schedule & including the results of local clinical trials in the format given in Appendix II to the said Schedule.
Provided further that the requirement of submitting the results of local trials may not be necessary if the drug is of sud1 a nature that the licensing authority may in public interest decide to grant such permission on the basis of data available from other countries.
Delete last proviso
Amendments to Rule 122-8 (Amendments in bold letters)
(1) ………………
(2) The manufacture of a new drug that is not approved or marketed in other countries under sub-rule (1) when applying for approval to the licensing authority mentioned in the said sub-rule, shall submit data as given in appendix I to Schedule Y including the results of clinical trials carried out in the country in accordance with the guideless------ Schedule Y and submit the report of such clinical that’s in the formats in Appendix II of the said Schedule.
Provided that in case of new drugs already approved or marketed in other countries or there is adequate published evidence regarding the safety of the drug, the manufacturer shall submit only data of local clinical trial as given in Appendix I to Schedule Y carried out in accordance with the guidelines specified in that Schedule.
Provided further that in case of subsequent approval for already approved new drugs as per sub-rule(1) the manufacture shall submit only data as provided in Appendix I-A of Schedule Y.
(3)…………….
Delete second proviso in 122-8(3).
Amendments to Form 44
Add the following after (2) I() (3) ……..
3. Specify the data require protection as per section 18A(3) of the Act
………
-----------
4. Certified that the data specified in column 3 is data generated by us and is not disclosed to any one. This data is also not publicly available from any other source.
Annexure – 2
Views of Anand and Anand
Data Protection for Agrochemicals
Crop Protection product companies spend vast amounts of time and money generating test data required by regulatory authorities in order to reach / access the market. In India, a second registrant can prove bio-equivalence. with a registered chemical and avoid this vast effort. This is a clearly inequitable outcome. Furthermore, there are no proper data protection laws in operation in India protecting this valuable data against misuse and theft. This lack of respect for the data generated by the original company has created an unfavorable environment for introduction of innovation and new technology., Therefore, it is appropriate to propose the following changes to the Insecticides Act, 1968:
A five-year exclusivity period, where no other registrant may rely on Co the data of the first registrant by "proving mere chemical/bio- equivalence. This period should apply to new uses and new formulations, as well as data submitted for sustaining its registration "c - re-registration and data-call in purpose.
A three year cross-reference period, following the exclusivity period, first, but only by providing compensation to the first registrant and the amount to be fixed by the title-holder.
Data must be kept secure and not be accessed by any unauthorized person, nor be accessible to such person. All technical and organizational safeguards possible must be implemented. Data must be kept secure and not be accessed by any unauthorized person, not be accessible to such person. All technical and organizational safeguards possible must be implemented.
Data shall not be kept longer than is necessary for the purpose for which it was submitted.
If data is transferred to any authority or entity, it must follow the same data protection requirements.
The consent of the titleholder/originator must be taken for any act which involved s exposing data to the public, or competitors or any one other than official who are processing the data.
These data protection rights shall subsist as long as the data is in the hands of the authority.
Liability for breach of any of these provisions must be criminal as well as civil and must apply to both authorities and third parties that breach the law.
The amendments would encourage both foreign and domestic entities to invest in the research and development of new and more effective crop protection chemicals, as their investment would be an exclusivity period as well as with general data security. This benefit will translate into healthier crops, better crop yields and efficient and productive agricultural sector, besides generation of research and test data in India for use across the World.
Views of various stakeholders:
Indian Pharmaceutical Alliance
(Representing leading Indian domestic manufacturers (11) with sound R&D base)
IPA supports data protection but not market exclusivity. Data protection should be limited to:
a) new chemical entities only
b) allowing R&D during the life of the patent should override the provision of data protection
c) compulsory licensing should also override the provisions of data protection
d) data protection should not exceed the life of the patent
e) period of protection should be limited to expiry of the patent or until the first liberation of the data in any country, whichever is earlier.
f) Any provision that may be abused to delay the launch of generic version of the drug beyond its patent life in the country should be avoided.
Organisation of Pharmaceutical Producers of India (OPPI):
(Leading association representing majority of MCS outside)
Their main demand is that during data protection period, generics can only be given marketing approvals based on their independent clinical dossier. They have requested for a lest five years period for data protection.
In the process of approval of a new drug for marketing in India, the fist entrant in the market conducts the necessary tests to generate such data and receives approval.
Unfair commercial use occurs, when subsequent entrants in the market place do not independently conduct such tests but expect the regulatory authority to rely on the data generated by the first entrant.
Patent Protection protects the Invention, ensuring that the first step of actual discovery of the pharmaceutical compound occurs.
Data Protection protects the safety and efficacy data submitted, ensuring that the drug company establishes or proves that their product is safe and effective for patients.
Patents are a negative right. The owner has to enforce his right in a court of law.
Data protection is a positive right. It is provided by the governmental health authorities by NOT granting third party market registrations based on the originator's data during the period of protection.
Data protection is granted for mandatory submission of safety and efficacy data, which has been generated after considerable effort.
Period of 5 years suggested not linking to the period of patent expiry as suggested by Nicholas Piramal
The protection of information in Govt. Offices under Official Secrets Act is inadequate as intent of Article 39(3) is for a specified period of non reliance of information in the Govt. office and also to protect against “unfair Commercial use”.
Even for generics regulators need to ensure safety of drug though clinical trails etc. instead of treating the exercise as application.
It is myth that data protection would delay entry of generics in the market, generic manufactures can submit their own data within the period of protection.
Indian Drugs Manufacturers Association and Bulk drug manufacturers association (IDMA and BDMA)
Both the associations are of the opinion that the demands for data exclusivity under Article 39.3 of TRIPs Agreement is designed to ultimately grab the MNCs monopoly in the Pharma ,Agrochemical market in the country. The present provisions of Indian Patents Act and the Drugs and Cosmetic Act & Rules take adequate care of provisions of Article 39.3 of TRIPs provisions. Protection is already available and Doha declaration has also provided for precedence to the public health over any other consideration including profit margins in the field of medicines & agro chemicals. Any demand for additional legislation to take care of Article 39.3 of TRIps Agreement through data exclusivity is uncalled for and needs to be rejected.
Corporation Law Group
(law consultancy firm representing NMCs)
· It is an unfair practice to allow a third party to benefit commercially form the proprietary data produced by the originator, via a marketing approval system based on similarity.
· If the indirect use of an originator’s proprietary data by the government leads to commercial advantage by third parties, it will amount to “unfair commercial use” which is to be prevented under the terms of Article 39.3.
· “new chemical entity” is not defined in Art 39.3
· Art 393 protects data associated with products undergoing marketing approval ; in the associated “new” refers to the status of a chemical entity in the approval system and not in respect of “newness” or novelty in the patent sense of TRIPs Art 27.1 or 34.1
· Under Rule 122 E of the Drugs and Cosmetics Rules,1945 “new” is used in conjunction with “drug” to refer to “drugs” including bulk drug substances which has not been used in the country to any significant extent …..and has not been recognized as effective and safe by the licensing authority.
· The longer of 5 years or the time taken for submission of additional data required by a country and the time taken by the regulatory authority to grant the approval.
· Existing Data Protection is typically 5-10 years compared with parents at 20 years but rungs from marketing authorization and during any relevant patent term.
· Data Protection will lapse before relevant patents expire for most patented products marketed 12-14 years after patent filed
· “Data exclusivity is NOT synonymous with “market exclusivity”
· The term “data exclusivity” was coined to distinguish the obligation contained in Article 39.3 of TRIPS from mere data “Protection” that has been inferred to mean that data must merely be securely filed or stored and not leaked out.
· Emphasis is on the non-reliance on origination’s proprietary data and on its protection against unfair commercial use.
· Strike balance between innovation and duplication of testing and clinical trials.
· Establish period during which government authorities respect confidentiality of data and don’t rely on it for other purposes.
· Fixed period of protection recognizes proprietary nature of data.
· After protection lapses, Regulatory authorities can refer to original registration data on the file and generics approved based on bio equivalence with the originator product.
· Data Protection will result in lower costs for generics, while valuing the proprietary nature or originator’s data.
· Bio equivalence and other tests can continue to be performed by competitors during period of non-reliance on originator’s data.
· Second applicant can obtain marketing authorization using own independently generated data for same similar product.
Confederation of India Industry (CII)
They have made the following recommendations
a) Data Protection should refer to test and other data that a pharmaceutical company must provide to a regulatory authority in order to get first-time registration for any new medicine it wishes to market in a country. This test data is necessary to demonstrate the efficacy and safety to the product.
b) This period of protection maybe for a period of five years;
c) The Brazilian model, which differentiates between pharmaceutical and agrochemical products, should be used in India too. In the case of pharmaceutical, Data Protection (DP) should be restricted to NCEs that have been patented in India. However for agrochemicals, it is proposed that DP should be allowed for all registrations, including products that have not been patented.
d) DP should not constitute a barrier to compulsory licenses ----- generic manufacturer is granted a compulsory license to overcome the patent, the generic manufacturer will not be able to make effective use of the license if it has to wait for to expiry of DP period before it can get it generic version approved by the regulatory and market it (a) for pharmaceutical products, DP for a patented product must run concurrently with the term of the patent and not allowed to be used to extend its term.
e) India should follow a system that will allow generic Drug tobe done during the DP period. The regulatory could tentatively approve the products if they meet the regulatory requirements. The approval will automatically become final the day the market exclusivity expires. This will eliminate the possibility of virtual exclusivities and ‘unfair commercial use” will also be avoided; and
f) Any authorization of generic by the first applicant should automatically end the DP period for all companies.
Affordable Medicines & Treatment Campaign (AMTC)
(AMTC is a national campaign initiated in 2001 is aimed at creating an environment that will ensure sustained accessibility and affordability of medicines. It consists of civil society organizations., NCOs, patients groups, healthcare providers etc)
Under Article 39.3 Data against unfair commercial use does not prevent government of 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. Use of data for subsequent market approval is a fair commercial use for the competitor and fair use for the government authorizes and therefore permitted under Article 39.3. Besides this, there should not be any linkage between patent rights and registration for market approval as advocated by the through Free Trade agreement.
Agro –chemicals Industry Associations:
Corp Life India (this is the Indian member of Crop Life International, a federation of plant science industry associations in more than 80 countries)
The data provided for regulatory purposes to government authorities are assets, which must be protected against unfair commercial use by competitors.
According to their understanding, under Article 39.3 of the TRIPS Agreement are New Chemical Entity (NCE) is “an NCE and chemical mixture, which contains an active ingredient or formulation of such an active ingredient that has not been previously approved in India.
They have registered for grant of Data Protection to the original registrant of Crop Protection products u/s 9(3) of the Insecticides Act as under “protection against unfair commercial use needs to be ensured through amendments to the Insecticides Act to block registration u/s 9(4) for a period once an Agro - Chem is registered for the first time u/s 9(3)
Corp Care Federation of India
Article 39.3 of TRIPS provides for protection of registration data submitted to the Regulator for the purpose of getting market approval. The protection is against both disclosure as well as “unfair commercial use”. The latter connotes that the Government must not give market approval to subsequent applicant relying on the data submitted by the original registrant.
The argument that data used by the government to give market approval to a subsequent applicant (without his own data package) does not constitute “unfair commercial use” is flawed as, the subsequent applicant has not made any efforts and gets he access to market.
The main points raised by them are:
a) minimum 5 years data protection for the new product coming up for registration.
b) ‘me-too’ registrations to be discontinued
latter connotes that the Government must not give market approval to subsequent applicant relying on the data submitted by the original registrant.
The argument that data used by the government to give market approval to a subsequent applicant (without his own data package) does not constitute “unfair commercial use” is flawed as, the subsequent applicant has not made any efforts and gets he access to market.
The main points raised by them are:
c) minimum 5 years data protection for the new product coming up for registration.
d) ‘me-too’ registrations to be discontinued
Pesticides Manufacturers & Formulators Associations
(Representing 220 members from Small, Medium and Large scale and also from Multinational companies.)
In a joint presentation made to the Department both CCFI and CLI submitted that both these associations were in favour of going for Data protection keeping in view the strength of research base in India in the days to come.
Further, it is understood that PMFAI had submitted a letter to Ministry of Agriculture to have three years of data protection and delaying the 994) registration by three years.
Data Protection Regime in various countries:
Countries Granting Data Exclusivity for a period of Time
United States :
The Hatch –Wax man Act of 1984 provides for a 5 years data exclusivity for new molecular entities (NMEs) Under this act made a NMR is approved no generic version can be approved. This Act also calls for a three-year data exclusivity period for supplements requiring clinical trials. Besides this, U.S. Orphan Drug Act as revised in 2002 provides for seven years market exclusivity when the client population for drug is less than 200,000 patients for any single indication .
Philippines :
As per the Food, Drugs, and Cosmetic Act has provisions to protect undisclosed test data submitted by an applicant to the state agency seeking market authorization of pharmaceutical or of an agricultural chemical product. In the case of agricultural chemical product the authority protects the property nature of all required data submitted by the first applicant for a period of 8 years from the date of approval of registration.
China :
Under the Chinese Drug Administration law, test and other data submitted for marketing approval of pharmaceutical products which utilize new chemical entities cannot be used by the second party without the permission of the first party for a period of six years.
Australia :
In Australia, a 5 year data exclusivity period for new products containing pharmaceutical active approved after 17.4 1998. The period beings on the date of marketing approval.
Czech Republic :
Under the Czech law on medicines, a six year protection is given unless written authorization is not received from registration holder.
European Union:
Under the law the members of the Union are permitted to have any one of the following options.
(a) a 6-years data exclusivity period.
(b) A 10-years data exclusivity period; and
(c) A ----DE period which does not extend be and patent protection
Norway:
Undisclosed test and other data are protected from “unfair commercial use” by an administrative practices that prevents an applicant from relying on data provided by another applicant without the atters consent for medicinal products for a period for six years.
New Zealand :
New Zealand provides data exclusivity for a period 5 years, besides providing an administrative structure for ensuring that undisclosed information is protected . There is no data exclusivity period for data relating to new uses or formulations old active ingredients.
Israel :
No specific law is known to exist. All undisclosed test and other data submitted to a government agency for the purpose of obtaining marketing approval for new or existing chemical entities contained in a pharmaceutical and agricultural chemical entitled product are held in confidence and are not open to public inspection , spe the law for the Protection of the Privacy.
Countries not granting protection of undisclosed information for a fixed period of time:
Thailand:
Under the Trade Secrets Act, Data submitted as a condition for marketing approval should neither be disclosed to a second applicant nor relied upon by the regulatory authorities in the consideration of another’s applicant during the data exclusivity period. Other applicants seeking drug approval may not make use of the originator data, but instead must produce their own independent data for regulatory review. The trade secret period is to be indicated by the authority.
South Korea :
The Data submitted to the Government authorities for the marketing approval of pharmaceutical products are prohibited from being disclosed to the public when the person who submitted such data requests the protection of the data. However, if the authorities feels the --- to disclose the data to the public, the data can be disclosed. An violation carries a – of imprisonment for upto 3 years or line not exceeding ten million ---
Canada :
Test or other data which are submitted to the Government of Canada are protected for a period of 5 years. However in the case of generic manufacturer is able is to establish the safety and effectiveness of is product on the casts of bio-equivalence or bio- variability studies without the government having to examine an reply upon confidential data filed by the innovator, permission is granted.
Brazil :
There is no data exclusively for Pharmaceuticals. However, there is data exclusivity of 10 years for agrochemicals
