Central Information Commission
Ms.Deepa Venkatachalam vs Ministry Of Health And Family Welfare on 24 March, 2011
In the Central Information Commission
at
New Delhi
File No: CIC/AD/A/2011/000115
CIC/AD/A/2011/000116
Date of Hearing : March 18, 2011
Date of Decision : March 24, 2011
Parties:
Appellant
1. Ms. Deepa Venkatachalam
Sector D8, Flat No. 8142,
Vasant Kunj
New Delhi 110 070
2. Ms. Beenu Rawat
Flat no. 1643, Block No. 22,
Sector - III,
Pushp Vihar, New Delhi.
The Appellants were present for the hearing.
Respondents
Directorate General of Health Services
Central Drugs Standard Control Organisation,
Biological Department,
FDA Bhawan, Kotla Road,
New Delhi
Represented by: Shri A.B. Ramteke, JDCGI; Shri Sunil, Technical Officer; Ms. Aruna Kukrety and Sh.
Rishi Kant Singh, LC.
Third Party
1. M/s PATH
A9, Qutab Institutional Area,
New Delhi
Represented by: Ms. Sadia Khan, Mr. V P Singh, Advocate & Mr. Dushyant Manocha, Advocate
2. M/s MSD Pharmaceuticals Pvt. Ltd.
7th Floor, Tower B,
Vatika Towers, Sector 54, Gurgaon 122002
Represented by: Mr. Bhaskar Bhattacharya; Mr. Riku Sarma and Mr. R K Rustagi, Head of Govt. Affairs
3. M/s GlaxoSmithKilne Pharmaceuticals Ltd.
Represented by: Mr. U A Rana, Advocate
Information Commissioner : Mrs. Annapurna Dixit
___________________________________________________________________
Decision Notice
The Commission is of the opinion that in the instant case, pending the Inquiry, no further information, than
has already been provided can be provided. Upon the final outcome of the Inquiry, the DCGI, out of the
information in its possession, shall provide the information to the Appellant using provisions of the Section
10 (1) of the RTI Act 2005, severing all and any patient related information as also any information which
deals with the exclusive Intellectual property rights of the pharmaceutical companies.
In the Central Information Commission
at
New Delhi
File No: CIC/AD/A/2011/000115
CIC/AD/A/2011/000116
ORDER
1. The Commission in its earlier decision dated 14.02.2011 held as follows:
".....7. After hearing the Respondents and on perusing the submissions on record , it was noted that the type of information which the Appellant has sought herein relates to matters which directly effect the public as it is the public who is the consumer of the vaccine--subject matter of the present case. It was also noted however, that the third party also should be given a chance to put forward their arguments regarding disclosure of information before the Commission, before a decision is taken.
8. In the light of these observations, the Commission considered it fit to adjourn this matter for further hearing in which all the parties (viz., the Respondents, the Appellant, the 3rd parties and the representatives of the Regulator, to whom, as recorded by the AA, the current details have to be submitted as per the provision of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 for the purpose of the technical scrutiny and approval.) should remain present to argue their case.
9. The hearing of the matter is accordingly adjourned to 17.03.2011 at 1430 hrs .... It is further directed that the 3rdparties as well as the Regulator should also file a written submission clearly stating as to how the disclosure of the information would harm the competitive position of the 3rdparties in the market. They should also react to the public interest angle in the matter......"
2. Pursuant to the directions of the CIC, detailed written submissions were received from the Third parties involved in both the related Appeals viz. M/s. PATH, M/s. MSD Pharmaceuticals and M/s GlaxoSmith Kline Ltd. as well as the Appellant.
3. While explaining why the disclosure of the information about the postlicensure HPV vaccination observation study should be exempt, M/s. PATH in its submissions dated 11.03.2011 stated that they had not received the underlying RTI application but have responded to general categories of queries as received by them from the DCGI. The representative for PATH contended that this collaborative project between PATH, ICMR, Govt. of Andhra Pradesh and Govt. of Gujarat is under review by an Inquiry Committee at the behest of the Union Health Minister. Since final outcome of the said review is pending, therefore, sharing any project related information, barring what has already been placed before the Inquiry Committee, would be inappropriate in order to avoid the risk of impeding the pending inquiry. It has further been submitted by PATH that the information as sought by the Appellant consists of vital and confidential data involving the patients who were the subjects of the trial. Such information are strictly kept confidential in terms of agreements entered into by the Pharmaceutical companies team vis a vis the patients. Leakage of any data related to the patients would invoke breach of the contract. The issue of patient confidentiality is of paramount importance in the clinical research industry and PATH stated that they had consulted the Western Institutional Review Board (WIRB), which is one of the reviewing ethical committees and WIRB also opined that every effort should be made within the Indian law to protect patient confidentiality. The gist of the contention of PATH invokes the provisions of Section 8 (1) (h) and 8 (1) (j) and states that as soon as the final report of the Inquiry Committee is issued publicly through official channels, the documents as sought by the Appellant and lying in the possession of DCGI can be furnished to the Appellant guarding only such documents as deal with patient identifiable information.
4. The MSD Pharmaceuticals Ltd. in their detailed submission dated 10.03.2011 explicitly discussed as to why the information in issue is a commercial trade secret and exclusive intellectual property of the company that develops the medicine/drug incurring considerable expense. The foremost fact is that every clinical search pertains to a new drug molecule which is developed by constant research processes by a company. The resources and time taken in developing a drug is immense and ranges from 10 to 14 years of deliberation and persistent efforts and even then only one in 5000 molecules researched eventually reach the market. The process of development of a drug by the R&D based pharmaceutical industry cost as much as $ 65 billion in 2009 for the development of only 25 new medicines. The confidential research methodologies, analysis methods, operational parameters developed and fine tuned involve decades of research expertise and form the knowledge capital of the pharmaceutical company and are shared only with the regulatory authorities of the country where the drug is sought to be approved and marketed. The components of the clinical trial have been compared to the building blocks for further research and development and disclosure thereof will hinder and jeopardize the entire future line of research by the company thereby causing irreparable commercial detriment to the company. The MSD Pharmaceuticals Ltd. has also submitted that the clinical data is submitted before the regulatory authority in developed markets as a part of the mandate in fiduciary capacity. Such submission is solely for the purpose of seeking the approval of the regulatory authorities to market the drug. Had there been no such statutory requirement, complete information pertaining to the drug would remain in the exclusive control of the pharmaceutical company. The regulatory authorities hold the information in fiduciary capacity for the pharmaceutical companies who painstakingly collect such clinical data over years of endeavour, developing the same through tedious and expensive research mechanisms to come out with the final product of a new medicine comprising of an exclusively developed and modified drug molecule to treat any particular disease. The regulatory authorities in various countries like the DCGI in India approve the marketing of a drug only upon observing stringent safety and efficacy requirements as per the statutory provisions laid down in the Drugs and Cosmetics Act and Rules made thereunder. It has been explained by MSD Pharmaceuticals Ltd. that the status of a "potential consumer" is subject to strict medical judgment and requirements of the patient to be ascertained only by a registered medical practitioner. While information like the indications, contraindications, side effects, compositions, statutory declarations, dosages etc. about the product/drug to be administered is provided to the potential consumer as a matter of moral and statutory responsibility by the pharmaceutical company, the data submitted by the company for seeking marketing approval comprises information based on which medical and scientific inference is to be drawn by trained professionals. Such data if left in public domain, is susceptible to misinterpretation leading to inaccurate and indiscriminate conclusions. Therefore, it is the contention of this Third Party that disclosure of such information would rather jeopardize public interest rather than serving any good purpose. Even the laws viz. the Section 3 & 4 of the Drugs & Magic Remedies (Objectionable Advertisements) Act 1954 and Rule 106 of the Drugs and Cosmetics Rules, 1945 prohibit any manufacturer, marketer, distributor etc. to disseminate such information to public at large. The MSD Pharmaceuticals Ltd. in fact states that the Appellant's contention seeking such information is directly against the law of the land and interferes with the sanctity of the doctorpatient relationship. Hence the MSD Pharmaceuticals Ltd. sought exemption from disclosure of the information invoking the provisions of Section 8 (1) (d) and 8 (1) (e) of the RTI Act 2005.
5. The third submission was that of M/s GlaxoSmithKline Pharmaceuticals Ltd. (GSK for short). GSK in its submission dated 11.03.2011 dealt with each query of the Appellant and responded point wise on each of them. While agreeing with the decision of the Joint Drug Controller in providing some of the information vide the letter dated 21.07.2010, the Pharmaceutical company took strong objection to the disclosure of any further information relating to the technical, analytical, operational, clinical and scientific data and detailed manufacturing, research processes, methods of analysis, statistical data all of which is commercial, confidential and proprietary information constituting the company's trade secrets and intellectual property. GSK stated that they have also submitted detailed information about knowhow of the manufacturing of proprietary products used with the vaccine before the DCGI in the process of seeking marketing approval for the product. Leakage of information regarding such products over which the company alone holds Intellectual Property Rights would obviously harm the competitive position of the company. The application for conducting clinical trials, filed with the office of DCGI is accompanied by detailed medical and scientific information, technical data, clinical trial protocol design, investigators' brochure etc., the same are meant only for the evaluation by the regulatory authorities, disclosure whereof to the general public will not be in public interest since they may not possess adequate skills or expertise to comprehend the same. Likewise, the GSK also objects to the disclosure of the reports of the clinical trial since it contains subject (patient) related information which the Pharmaceutical companies alongwith the Institution and the Principal Investigator are under obligation to maintain confidentially as per the terms of the Informed Consent Form signed by patients participating in a clinical trial. GSK objected to the disclosure of any further information than has already been provided stating that there was no proven or established need for such disclosure to the general public. They placed reliance on a judgment of the Commission passed in the case of Sri Girish Prasad Gupta vs. State Bank of India.
6. The final submission came from the Appellant justifying the need for disclosure of the information in public interest in view of the allegations made by her stating that marketing approvals received for both the drugs Gardasil and Cervatrix are for use in an age group outside the age group on whom they were tested during trial stage in India. She further elucidated that the purport behind the RTI application was in fact to verify whether the Licensing Authority had in fact verified the data generated in Indian population to be in conformity with the data generated abroad before granting the approval to the Phase II studies of the drugs. She pointed out that the "HPV vaccine Demonstration Projects" conducted by PATH in collaboration with ICMR and the two State Governments of Andhra and Gujarat, had raised several pertinent ethical questions including that of informed consent, safety protocols and other gross violations of ethics of clinical research in the course of implementation of the "projects". These very inadequacies and deficiencies have led to the Inquiry being conducted by the Investigative Committee. The Appellant emphasised that she sought only the protocol and approval documents in this regard and not at all about the participant patients who were part of the study. The Appellant stressed the need for transparency and accountability in the field of biomedical research especially when any trial is done on the Indian population and thus justified the need for disclosure of the information as sought by her. DECISION
7. The submissions invited in these cases are detailed and deal substantially with the highly specialized field of clinical research. It has been the constant plea of the Appellant/s that through the RTI application/s they seek information primarily about the protocol and approval documents submitted by the pharmaceutical companies and approved by the DCGI. On the other hand, it becomes clear from the submissions of all the three pharmaceutical companies that the application submitted by the pharmaceutical companies seeking marketing approval for the medicines as well as the approval documents contain substantial strategic, scientific data alongwith patient related information. Since the patients are intrinsic part of the clinical trials therefore, results of the clinical trial are nothing but the recording and reports of the effects, side effects, symptomatic behaviour etc. of the patient upon being administered with the concerned drug. However, the data related to the patients is confidential as is borne out from the discussion above particularly as submitted by GSK noted in paragraph 5 (supra) that ".....Pharmaceutical companies alongwith the Institution and the Principal Investigator are under obligation to maintain confidentially as per the terms of the Informed Consent Form signed by patients participating in a clinical trial". In the paragraph 4 above, even the MSD Pharmaceuticals Ltd. have submitted that the clinical trial data apart from being sensitive from the commercial aspect for the company, the data contains variety of information regarding the pharmaceutical company's laboratory, pre clinical and clinical data including product indications, efficacy, tolerability and safety, pharmaco kinetics, drug interactions, side effects, contra indications, adverse effects etc. which are data directly related to patient. Even the Drugs and Cosmetics Act, 1945 in the Schedule Y holds that in every clinical trial, patient related information is to be held in strictest confidentiality by the institutions concerned. Thus, the clinical trial reports cannot be furnished without severing the information which deals with patient related data in order to protect the privacy and confidentiality of the individual. Another pertinent aspect is the pendency of the final report yet to be issued by the Inquiry Committee set up by the Union Minister of Health. Even the submissions (alongwith the annexure indicated in the submission) by the Appellant indicated that only the interim report has been issued so far which at present is being scrutinized by the Standing Committee of the Parliament. Therefore, the provisions of the Section 8 (1) (h) of the RTI Act 2005 are attracted and in my opinion, it is not worthwhile to hinder and/or impede the process of the said investigation. In so far as the remaining contentions and allegations of the Appellant are concerned, most of them are being either looked into in the aforementioned Inquiry. Some of the allegations in so far as "....marketing approvals received for both the drugs Gardasil and Cervatrix are for use in an age group outside the age group on whom they were tested during trial stage in India..." the same are unsubstantiated by adequate evidence. Even otherwise, it is not within the jurisdiction of this Commission to deal with these aspects of the case, there are appropriate regulatory authorities who observe stringent measures while dealing with such highly specialized issues.
8. Therefore, this Commission while addressing the case at hand, is of the opinion that in the instant case, pending the Inquiry, no further information, than has already been provided can be provided. Upon the final outcome of the Inquiry, the DCGI, out of the information in its possession, shall provide the information to the Appellant using provisions of the Section 10 (1) of the RTI Act 2005, severing all and any patient related information as also any information which deals with the exclusive Intellectual property rights of the pharmaceutical companies. The PIO is directed to forward copy/s of the order to the concerned Third Parties within a week of receipt of the order.
9. The Appeal/s are thus disposed of.
(Annapurna Dixit) Information Commissioner Authenticated true copy (G.Subramanian) Deputy Registrar Cc:
1. Ms. Deepa Venkatachalam Sector D8, Flat No. 8142, Vasant Kunj New Delhi 110 070
2. Ms. Beenu Rawat Flat no. 1643, Block No. 22, Sector - III, Pushp Vihar, New Delhi.
3. The Appellate Authority Directorate General of Health Services Central Drugs Standard Control Organisation, Biological Department, FDA Bhawan, Kotla Road, New Delhi
4. The Public Information Officer Directorate General of Health Services Central Drugs Standard Control Organisation, Biological Department, FDA Bhawan, Kotla Road, New Delhi
5. Officer Incharge, NIC