1. Introduction:
1.1. Current pharmaceutical boom promises to be the next revolution after Information Technology & BPO / Call centres in India. Within the pharmaceutical industry, Clinical Research – which relates to drug development and related procedures for approval of the same – is the major thrust area. It has attached maximum investment amongst the giants of the industry and the Indian Market is estimated to grow to $2.2 billion by 2015.
1.2. At this backdrop the Institute of Clinical Research (India) – India’s authorized Clinical Research Institution, dedicated to ethical research in this area – primarily focuses to address the Indian demand for qualified & trained professionals in this area. Cranfield University in UK, being the undisputed leader amongst the global Clinical Research Institutes, is feeding the professionals to fulfill the teaching skill required in this institute to match the global opportunity of huge expansion in this field. This institution offers education in Clinical Research at its centers of excellence in Mumbai, Delhi and Bangalore.
This institute fed professionals in top pharmaceutical companies like Pfizer, Ranbaxy, Nicholas Piramal, Cipla,
Dabur, Jonson & Jonson – to name a few. Now the tremendous expansion in this field leads to the very high demand of the required insurance policies to cover the various contingencies/risks/liabilities involved in the various stages of the processes that are vividly associated to a specific Clinical Trial of any medicine to be introduced in the market for sale.
1.3. There are also a good number of specialized organizations who provide contract research services for the Pharmaceutical industry. They conduct trials on healthy human volunteers and analyze the result of the drugs. The final output is a comprehensive document worthy of approval by the regulatory agencies across the globe. These organizations are supported by highly qualified team of R&D professionals dedicated to making the Clinical Research Operations (CRO) a center of excellence. They provide basically a full range of Clinical Pharmacology Services from Study Design to Final Report Drafting for Bio availability (BA) & Bio equivalence (BE) studies.
1.4. When any drug company is seeking registration of a generic form of an established product it is necessary to demonstrate bio equivalence between their formulation and the existing product. The Bioequivalence (BE) studies are conducted for both generic and innovative companies Their full service covers the various procedural aspects to Study Design, Protocol Writing, Clinical Record Form (CRF) Design, Ethics Committee Review, Selection of subjects, Bioassay of a drug, Pharmacokinetic and Statistical Data Evaluations, Reporting of Study Results, and Archiving of all Study Related Data.
1.5. At the time of visiting various drug manufacturing units like- AVENTIS PHARMA / CENTAUR PHARMACEUTICALS/ MACLEODS PHARMACEUTICALS / ABBOTT INDIA/, etc., from various insurance points of view – it is found that in most of the cases it is the mandatory requirement of all these drug manufacturers that they must avail SPECIAL CONTINGENCY POLICIES COVERING CLINICAL TRIALS LIABILITY – during some course of their operations. In fact, that prompted me to come forward to share with all my insurance readers the vivid detailed information & critical analysis relating to this policy.
2. Clinical Researches / Trials – Basic Idea:
2.1. A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.
2.2. Ideas for clinical trials usually come from researchers. Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning Phase I clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results.
3. The concept of ‘protocol’ in clinical trials:
3.1. All Clinical Trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a Clinical Trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
4. Protocol synopsis for the clinical trials:
4.1. Protocol Synopsis is made for the study of a specific medicine which includes the following:
1. Title – A phase I/II/III/IV (whichever is the case) whether randomized/ single or double-blind, single or multi-center study to –
i) Evaluate Tolerability ; or
ii) Pharmaceutical Safety; or
iii) Efficacy & efficiency of the medicines.
2. Sponsor Protocol No.
3. Site Address of conducting the study;
4. The detailed description about the investigational study with:
i) Introducing the Principal Investigator&/or their representatives recording their names /addresses;
ii) Involving the people & indicating therein the overview of the purpose.
5. Different phases of clinical trials:
5.1. Clinical Trials of experimental drugs proceed through four phases:
i) In Phase I of Clinical Trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
ii) In Phase II of Clinical Trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
iii) In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
iv) Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.
6. The process of ‘informed consent’:
6.1. Informed consent is the process of learning the key facts about a clinical trial before the subject decides whether or not to participate. These facts include:
1) Why the research is being done?
2) What the researchers want to accomplish?
3) What will be done during the trial and for how long?
4) What risks are involved in the trial?
5) What benefits can be expected from the trial?
6) What other treatments are available?
7) The fact that the subject has the right to leave the trial at any time.
8) Policy covers Legal Liability to pay compensation to any Research Subject as damages for Death, Bodily Injury, Physical or Mental Illness disease or impairment, caused due to participation in a Trial.
9) Defence Costs are also covered.
10) Limits of Indemnity are fixed for Any One Occurrence and Any One Period.
11) Policies can be issued on Annual Basis or on Trial Basis.
12) Retroactive Date – Policy Period means the period commencing from the effective date and hour as shown in the policy schedule and terminating at midnight on the expiry date as shown in the policy schedule. But specific to these liability policy ‘Policy Period means the period commencing from the retroactive date and terminating on the expiry date as shown in the policy schedule. If the policy period is from 01-04-2012 to 31-03-2013 and the policy had been renewed from 01-04-2013 to 31-03-2014 then under the renewed policy the retroactive date will be 01-04-2012.
7. Basic information required for clinical trials insurance to be submitted by the proposed client:
7.1. Company Profile- Name of the Company to be insured/ Address/Business Description. In addition following items require specific answers:-
a) When established?
b) Type of the company – Whether Proprietorship /Partnership /Private Limited/ Limited / Joint Stock (Venture) Company?
c) Whether Allopathic/ Homeopathic/Herbal (Ayurvedic) Industry?
d) What phases of Clinical Research (Phase I to IV) are involved on human subjects for investigating the efficacy and safety of new products and on behalf of which sponsor?
e) Whether the clinical trials are presently conducted in India or abroad?
f) Whether the hospitals involved are Government hospitals or the Private ones?
g) What is the duration of the trials?
h) How many patients are involved?
i) What is the total cost of the project?
j) Whether preclinical studies are conducted on animals?
k) Whether phytochemical studies are conducted in their laboratories? Which are the laboratories involved for these phytochemical studies?
l) Details of the Revenue generation of the client for the last three years.
m) Detailed Product Information.
7.2. Nomenclature used for Clinical Trials – may be:
- Common, Generic, usual names
- Proprietary names- are to be described by the Insured.
7.3. Product description;
7.4. Description of intended use of the medicines;
7.5. Pro-bands of the medicines;
7.6. Background information and the preparation Clinical Trials- The standard procedural aspects may be generalized as detailed below and there may be some variation of or deviation in the processes depending upon the nature of the diseases to be treated (& cured) by the medicine & the process of ingestion of the drug. The entire process of the Clinical Trial is divided into certain phases which may noted carefully by the underwriter for the clear understanding for drafting the SPECIAL CONTINGENCY POLICY COVERING CLINICAL TRIALS LIABILITY prudently and they are as given below in seriatim –
i) Information about formulation of drugs: The multiple formulations of drug are known as bioequivalent if the rate and the extent to which the drug reaches the systematic action after administration of their respective formulations are statistically comparable. Now-a-days bioequivalence studies are pivotal part of registration dossiers. The purpose of the study is that the bioavailability of the formulations under investigation is shown to be equal. Bioequivalence studies usually are conducted in normal healthy adult under standardized conditions. Bioequivalence studies today are guided by an acronym of Good Clinical Practice (GCP). There are two hallmarks of GCP, one is credibility validity of collected data and the other is the safety and well being of research subjects. All bioequivalence studies must comply with GCP and Good Laboratory Practice (GLP) guidelines to ensure a pivotal level of the research project.
ii) Scientific Affairs: Once the client need have been identified, the scientific department will prepare a study design that will accompany their needs. This team of experienced scientist search for various data in order to provide accurate and up-to-date results. The team maintains a continuous strong relationship with regulatory agencies around the globe for study design reference purposes. They provide adapted Bioavailability/ bioequivalence trial reports thoroughly written according to regular guidelines. The Scientific Affair team provides study protocol and Informed Consent Forms in English/ Hindi/ other Regional Languages.
iii) Ethical Aspects: All studies shall be logically conducted in accordance with the Helsinki Declaration and Good Clinical Practice (GCP) guidelines. There should be an ethical committee tom approve the protocol before start of the study and ensure that the study is carried out as per scientific and ethical norms. The ethical committee should consist of qualified personnel including at least a clinical pharmacologist, a consultant physician, a social; worker, academician and a person with legal background. Sufficient and relevant data on animal’s studies and human studies should be made available to the ethical committee. If for any reason, the approved protocol needs amendments, the ethical committee should approve the amended protocol.
If the formulations under study are likely to adversely affect the health of the volunteers, e.g. anticancer drugs, oral hypoglycemic drugs, etc. healthy volunteers should not be enrolled in such cases. An informed and written consent form of the volunteers must be obtained and kept on record. The participating volunteers should be provided with full information about the study in a language understandable to them.
The study must comply with the requirements of central and local authorities. Appropriate insurance against any risk from the study drug is mandatory. The laboratory covers insurances for the volunteers for any mishap from the laboratories side during the conduction of the study. The sponsor provides insurance for the volunteers if the mishap of the volunteers is due to the formulation. The identities of the volunteers must be treated as confidential information to which only health authorities can be given.
iv) Types of various studies: Bioavailability (BA) & Bioequivalence (BE) studies are conducted on various dosages forms, tablets, capsules, and extended release preparations, solutions etc. for pharmaceutical companies in India and abroad.
Various studies performed are-
A) Single dose- two periods cross over studies.
B) Multi-dose – cross over studies.
C) Single dose – multi-period cross over studies.
D) Food interaction studies.
v) Data Bank consisting of volunteers: Normally the Adult healthy males of the age band 18-50 years are considered as active volunteer bank. Recruitments are normally done by telephone and personal visits and sometimes through advertisements. Normally the routine include complete health checkup including ECG, Complete hematology, serum chemistry, urine analysis, serology (HIV, HBSAg and VDRL screen) as part of preclinical screening and post-clinical evaluation.
vi) Methodology for conducting of Bioequivalence (BE) Study: Bioequivalence (BE) Study is generally carried out through following steps:
1. Assessment (Possibility) of conducting Bioequivalence (BE) Study;
2. Preparation of Protocol for Bioequivalence (BE) Study;
3. Approval of Protocol by Independent Ethics Committee;
4. Conduction of Bioequivalence (BE) Study (Clinical Part);
5. Bio-analysis of Biological samples (Blood, Plasma) collected during the study;
6. Statistical Analysis;
7. Data Management & Archival.
vii) Procedures of BE Study:
a) Assessment (Possibility) of conducting BE Study- For assessing the possibility of Conducting BE Study on a specific formulation as requested by sponsor, a literature survey is done firstly. The information of drug safety, therapeutic and clinical aspects is searched trough various sources such as National local libraries, International libraries, and also through Internet websites. The possibility of study conduction is also governed by the various guidelines of the submission countries.
b) Preparation of Protocol for BE Study- The protocol for the study gives a detailed outline of how a study is to be conducted. The protocol should define the acceptable age and weight range for the subjects to be included in the study as well as the clinical parameters that will be used to characterize a normal healthy subject e.g. Physical examination, observations of clinical chemistry and hematological evaluations. The subjects should have been drug free for at least two weeks prior to eliminate possible drug-induced influences on liver enzyme systems.
Normally the subject will fast overnight prior to dosing and will not eat until a standard meal is provided 2-4 hours post dose. The dosage forms should be given to subjects in a randomized manner, using suitable crossover design, so that possible daily variations are distributed equally between the dosages forms tested. The protocol should also define sample collection times and techniques to collect the biological fluid. The method of storage of samples and their analysis also should be defined.
c) Approval of Protocol by Independent Ethics Committee- The Institutional Review Board (IRB) will review the protocol and the informed consent form for the study and no study specific procedures will be carried out until a written approval is obtained from the Committee.
Next item is the Informed Consent. Designated personnel will inform the volunteers before the initiation of the study. Volunteers will be required to understand and sign a consent form prior to screening and a study specific informed consent form summarizing the discussion of the study prior to check-in of period Initial Agreement (I.A.). A copy of the informed consent form will be given to the volunteers.
The provision of Subject Compensation- The subjects will be compensated for the inconvenience borne during the study. In case of dropouts/ withdrawal of any subject before completion of the study, the amount proportionate will be given.
d) Conduction of Bioequivalence (BE) Study (Clinical Part – Contract to a definitely reputed organization) – All the volunteers should be admitted in ward bio-center at least 16-18 hours prior to the administration of the study drug dosage form. They should be housed for adequate period of time.
Informed written consent should be obtained from volunteer and should be countersigned by at least two witnesses.
All volunteers should fast for 12 hours pre-dosing and continue to fast for at least 4 hours post-dosing. Time of administration for the medication (test & reference) should be in the morning and the same time should be strictly adhered to during the entire study.
Tea, coffee, and caffeine/xanthenes-containing beverages and foods should not be allowed during each phase of the study. A precise work schedule should be prepared in advance and explained to the volunteers stating all these Dos & Don’ts.
The exact time of drug administration, sample collection and meals need to be strictly adhered to and the actual time of each & every activities should be properly and accurately documented.
Uniform and identical meals must be provided at identical times to all volunteers from the time they are admitted and till they are housed. Test tubes & vials required for sample collection should be elaborately labeled in advance and kept ready.
The investigator will provide the medication to the volunteers and the volunteers must consume the drug in the presence of the investigator. After ingestion of the medication the volunteer should rest in supine position at least for 2 hours at a stretch to ensure proper gastric emptying. Standard quality of water (one glass: 250 ml) should be allowed for proper ingestion of the specified dosage of the drug.
Blood samples then need to be collected by using volunteers. The separation of plasma/serum should be done immediately following the collection and it should be stored in two identical containers with distinct identification labels. Once separated, the samples should be immediately frozen to -20 degree centigrade till the time the item is taken for analysis. An attending will be present at all times to oversee the conduct of the investigation as well as to answer any queries by the volunteers. Emergency medical equipment and support services will be available and accessible throughout the investigation. After an appropriate wash out period mentioned in the protocol, the crossover study should be carried out in a similar fashion.
e) Bio-analysis of Biological Samples- Analytical methods that are used for the quantitative determination of drugs in biological samples play a significant role in the evaluation and interpretation of pharmacokinetic data. Validated method will then required to be employed for the estimation of the drug from biological fluid. Details of the analytical method intended to be used for the analysis of the biological sample should be included in the protocol. The analysis should be performed immediately.
f) Statistical Analysis- The methods & techniques to be used should be decided and mentioned in the protocol before the study begins. Whenever a user -defined software is used for analysis, it should be validated. When the analysis is performed manually, all the results of intermediate step should be properly recorded.
g) Data Management- This involves the following items:-
i) Documentation: Entire data except the analytical data of pathology and other tests generated during the conduct of the study will be directly recorded in raw data as per the related procedures. The computer-generated chromatograms will also be treated as bio-analytical raw data.
ii) Quality Assurance Audits: The clinical and bio-analytical raw data and reports generated during the course of the study will be liable for inspection and quality audit for conformance to the protocol. An audit schedule will be drawn prior to the study and audit certificates will be issued after verification of final report.
iii) Confidentiality of Data: The data identifying the subjects name will be kept confidential and will be accessible only to concerned study personnel, Sponsor, Quality Assurance Unit and if necessary, Independent Ethics Committee (IEC) and regulatory agencies. The Sponsor and the Laboratory will sign a confidentiality agreement and study defining the responsibilities of all parties.
iv) Archival Record: A representative sample of the drug product used in the study will be archived. All the documents generated during the study will be archived after the issuance of the audited report. All such materials will be retained in the laboratory as mentioned in study contract.
Summary of Planned Major Pre-clinical and Clinical Activities is required to be submitted to the insurer. Protocol Development Resources are to be carefully maintained for insurance purpose.
8.1. The Insured means:-
1. Any firm , partnership, institution, company or other Research Organization named as the Insured in the Schedule;
2. Any person who is, has been or may become during the Period of Insurance a Principal, Partner or Director of the Insured Organization named in the schedule, but only in respect of claims arising out of a trial covered by this insurance;
3. When required by the named Insured, any employee or past employee of the Insured but only in respect of claims arising out of a trial covered by this insurance. Any past employee may be included who at the request of the insured acted for the insured and who agrees to be bound by the terms of this policy;
4. And on condition that such employee or past employee agrees in writing to be bound by the terms and conditions of this insurance as if he or she was an Insured under this insurance;
5. Any sub-contractors, Doctors, Consultants, Physician, Hospital or contract Research Organization or nurse who will be performing the work for the insured in respect of the trial covered by this policy;
6. Any Ethics Committee ( and each and every member thereof ) that had approved the trial, but only in respect of Legal Liability in respect of claims arising out of a Trial covered by this insurance.
8.2. Research Subject means:-
Any person participating in a Trial or the Pre-Trial Assessment, including the estate or personal representatives of any such person after their death, and including also any children venturesome whose parent participates in a trial.
8.3. Trial means: The clinical or healthy voluntary study as covered in the policy schedule which complies with the statutory requirements or guidelines of the relevant person, authority, department or public or private body in India.
8.4. Accident means: a fortuitous event or circumstances which is sudden, unexpected and unintentional including resultant continuous, intermittent or repeated exposure arising out of the same fortuitous event or circumstance.
8.5. Claim means: A written demand made against the insured for money or services in respect of bodily injury. For the purpose of this policy the date of such demand shall represent the date of claim is first made against the insured.
9. Questions* asked in the proposal form:
9.1. Normally the following questions asked in the Proposal Form for issuing the no fault compensation for clinical trails involving the volunteer studies (wherever the applicable answer is ‘NO’ the full details are being sought on that account):
1. Are all trials/ studies are in full accordance with-
i. Department of health requirements with protocols approved by an independent Ethics Committee- Yes/ No.
ii. Royal Collage of Physicians/ similar recommendations is available? And, also the Government Permission from Drug Controller of Government of India whether obtained – Yes / No.
iii. Applicable Government Department or Medical Body or Pharmaceutical Industry Body guidelines are strictly followed? – Yes /No.
iv. Ethics Committee guidelines on good Clinical Practices is available there? – Yes /No.
v. I.C.H. Harmonized Tripartite Guidelines are followed? – Yes/ No.
2. Are all trials/ studies conducted in India? – Yes/ No.
If the answer is “No”, submission of the summary of trials/ study of countries in which they are conducted needs to be submitted to the insurer.
3. Are all rights of recourse retained against Product manufacturers- Yes/ No.
4. Are all volunteers tested for HIV and Hepatitis prior to entering the trials/ study – Yes/ No.
5. Give details of incidents during the last 5 years resulting in disease/ illness (physical or mental) to patients or volunteers any circumstances which might give rise to a claim for compensation against the insured. If there is no such incident before the insured must state the reply as ‘None’.
6. Summary of trials / studies performed during the last 12 months:
Date Title/ Country Phase No. of Status
Descrip- Subjects/ Whether-
tion Persons/ Ongoing/
Volunteers Completed
7. Summary of trials /studies planned during the next 12 months :
Date Title/ Country Phase No. of Status
Descrip- Subjects/ Whether-
tion Persons/ Ready to
Volunteers Completed
start/ under
preparatory
stage
If trials overlap period, please include in both tables allocating the appropriate number of Research Subjects to each timescale.
For each trial and study to be covered the insured requires attaching a copy of –
- Protocol ( the summary will suffice) or Ethics Committee Submission;
- Volunteer Consent Form – as per the Format given in ANNEXURE-A ( Please find Enclosed at the End )
- Patients’ Information( if or as appropriate);
- Any Hold Harmless Agreement / Contract Indemnities with other parties (if applicable/appropriate).
(*All the above answers will be duly attested / signed by the authorized representative of the insured. It is the duty of the insured to disclose all material facts of the risk proposed to be covered by the insurers. A material fact is one that is likely to influence a prudent Insurer’s judgement and acceptance of the proposal submitted by the Insured. If the Insured are in any doubt as to whether or not certain information is material then it should be always disclosed.)
8. Limits of Indemnity Required:
a) Any One Accident: Amount in Rs.
b) Any One Year: Amount in Rs.
9. Since the liability admitted by the insurer relates to that associated with the product of the particular /specific medicine which is about to be introduced, the proposal form for the product liability insurance has also be duly filled up as detailed below:
10. General conditions applicable to the clinical trials liability insurance policy:
10.1. The policy and the schedule shall be read together as one document and any word or expression to which a specific meaning has been attached in any part of the policy or of the schedule shall bear such specific meaning wherever it may appear.
10.2. Upon receipt of this policy the insured agrees that it has been issued upon the truth of his declarations and representations made to the insurance company or any of its agents relating to this insurance.
10.3. The terms of this Policy shall not be waived, altered or changed in way except by memoranda issued by the insurer.
10.4. The insured shall take reasonable precautions to prevent any occurrence which may give rise to liability under this policy and to maintain all building furnishings ways works machinery plant and vehicles in sound condition and as soon as possible after discovery cause any defect of danger to be made good or remedied and in the meantime shall cause such additional precautions to be taken as the circumstance may require.
10.5. The insured shall as a condition precedent to their right to be indemnified under this policy and regardless of any deductible give immediate written notice to the insurer of –
a) The receipt by the insured of any claim;
b) Any specific event or circumstance which in the opinion of the insured may give rise to a claim.
Every Claim writ summons or process shall be forwarded to the insurance company immediately on receipt.
10.6. No admission, offer, promise, payment or indemnity shall be made or given by or on behalf of the insured without the written consent of the insurer. The insurance company shall be entitled to conduct in the name of the insured the defense or settlement or any claim or to prosecute in the name of the insured for its own benefit any claim and shall have sole discretion in the conduct of any proceedings and in the settlement of any claim save as hereunder provided in condition (7) & (8).
10.7. The insured shall give all such assistance to deal with claims and conduct of legal proceedings arising there from as the insurer and/or its legal advisors and consultants may require the choice of counsel is to agreed by the insured and the insurer but failing agreement the insurer alone shall be entitled to nominate the counsel of their choice.
10.8. In connection with any claims against the insured the insurer may at any time pay to the insured the limit of indemnity or any less amount for which such claims can be settled and thereupon the connection therewith except for costs and expenses which the insurer already agreed to bear in respect of matters prior to the date of such payment.
10.9. The insurance afforded by this policy is excess over and reduced by any other valid and collectable insurance available to the insured. Valid and collectable insurance includes any self insurance plan which would be applicable to the loss.
10.10. The insurer may cancel the policy by sending 30 days’ notice to the insured at the insured’s latest known address. The insured shall thereupon become entitled to a return of premium after deduction of premium at the insurer’s short period scale rate.
11. General exclusions applicable to the clinical trials liability insurance policy:
11.1. The policy does not cover liability-
1. Arising out of deliberate, willful or intentional non-compliance of any statutory provision.
2. Arising out of pure financial loss such as loss of goodwill and loss of market.
3. Arising out of fines, penalties punitive and/ or exemplary damages.
4. Directly or indirectly occasioned happening through or in consequence of war, invasion, act of foreign enemy, hostilities (whether war be declared or not), civil war, rebellion, revolution, insurrection or military or usurped power.
5. Directly or indirectly caused by or contributed to by or arising from-
a. Ionizing, radiation or contamination by radioactivity from any nuclear waste from the combustion of nuclear fuel.
b. The radioactive, toxic, explosive or other hazardous properties of any explosive nuclear assembly or nuclear component thereof.
6. Arising out of earthquake, earth-tremor, volcanic eruption, flood, storm, tempest, typhoon, hurricane, tornado, cyclone or other similar convulsions of nature and atmospheric disturbance.
7. Arising out of all personal injuries such as libel, slander, false arrest, wrongful eviction, wrongful detention, defamation etc. and mental injury, anguish or shock resulting there from.
8. Infringement of plans, copy right, patent, trade name, trade mark, registered design.
9. Employees and visitors’ clothing and personal effects.
10. For damage to any property belonging to insured or held in trust or in custody or control of the insured or a person in the service of the insured.
11. Arising out of injury/ sickness and/or damages occurring prior to the retroactive date stated in the schedule.
12. Arising out of deliberate, conscious or intentional disregard of the insured’s technical or administrative management of the need to take all reasonable steps to prevent claims.
13. Arising out of pollution or contamination.
14. Any claim made by research subjects for bodily injury caused by an occurrence prior to the retroactive date. Any claim arising to the patient who are suffering from cancer and the drug applied on them, the death due to cancer will not be covered but any other diseases, if any develop resulting in death of the cancer patient for the drug applied on him/her may be considered for payment. Similarly any claim arising from hepatitis or any conditions directly or indirectly caused by or associated with Human T-Cell Lymphotropic Virus Type III (HTLV-III) or Lymphadenopathy associated Virus (LAV) or mutants derivatives or variations thereof or in any way related to Acquired Immuno Deficiency Syndrome or any condition of similar kind howsoever it may be named- is always kept outside the purview of the policy.
11.2. IT MAY BE NOTED THAT- Main Exclusions of clinical trial are:-
a) Radioactive & Nuclear perils.
b) Intentional Non-Compliance of Statutory regulations.
c) Punitive Fines, Penalties.
d) Loss prior to Retroactive date.
e) Trials already commenced.
12. General extensions applicable the clinical trials liability insurance policy:
12.1. The following extensions are allowed (subject to the terms/exceptions and conditions contained in the policy) –
12.1.1.Indemnity to Principal: As far as is necessary to meet the requirements of any contract or agreement entered into by the insured with any principal the insurance company will at the request of the insured treat the principal as though they were also the insured but only in respect of liability(as provided under the policy) arising out of the performance of such contract by the insured in connection with the business provided that the principal shall observe fulfill and be subject to the terms of the policy in so far as they apply.
12.1.2.Cross Liabilities: Where there is more than one insured is involved in the policy then this policy shall apply to each insured as though a separate policy has been issued to each provided always that the total liability of the insurer shall not exceed the limits of indemnity.
12.1.3. Discovery: In the event of the insurer –
a) Canceling or refusing to renew this section for any reason other than –
i) non-payment of premium;
ii) any act of fraud or dishonesty;
iii) non-disclosure of material fact;
b) Agreeing to the renewal or replacement of this section but requiring to impose exceptions or conditions that are not contained herein;
c) Increasing the premium by 300%or more.
The insurer will provide an indemnity to the insured subject to the terms , conditions and limitations of the policy in respect of any claim which is first made in writing against the insured and notified to the insurer during a period of twelve months immediately following the final period of insurance as if the claim had been made against the insured and notified to the insurer during the final period of insurance except where otherwise stated in proviso(v) below.
Provided always that:-
a. The indemnity will not apply where indemnity is provided by any other insurance or by virtue of extension (4) below.
b. The total amount payable for all claims made during the final period of insurance and claims deemed to have been so made by virtue of the terms of this extension shall not exceed the limit of indemnity for the final period of insurance.
c. In the event of (b) above the indemnity afforded by this extension shall apply only in respect of the exception(s) and/or condition(s) imposed.
d. Such claims results from bodily injury or property damage happening on or before the retroactive date and prior to the end of the final period of insurance.
e. Any such claim in connection with occurrence which has given rise to any other claim first made and notified during any period of insurance may be deemed to have been made and notified on the date the first of those claim was made.
Basically the indemnity afforded by this extension (subject to the proviso thereof) will also apply in the event of the cancellation or non-renewal of this section by the insured other than in circumstances connected with (a),(b) or (c) above. Provided always that in the event of such cancellation or non-renewal the period of twelve months specified above shall be reduced to a period of six months immediately following the final period of insurance.
12.1.4.Notification of event of circumstance: If during any period of insurance the insured shall give written notice to the insurer in accordance with condition that in the event of an accident including continuous or repeated injurious exposure to substantially the same general conditions which results in bodily injury or property damage or other contingencies neither expected nor intended from the stand point of the insured, the insurer may accept the liability of the claim or claims which may subsequently be made against the insured arising out of that event or circumstance regardless of when such claim may actually be made.
