Patient compensation laws: Need to streamline the processes
The clinical trial market in India has expanded its bandwidth over the years. Today, several MNCs are choosing India over other nations to conduct clinical trials. Although this has resulted in increased growth of the industry, a few areas like patient compensation are being neglected. Here, we discuss the state of clinical trials along with the regulatory bodies regarding patient compensation in India.
According to a joint study conducted by Ernst & Young and the Federation of Indian Chambers of Commerce and Industry, India now participates in over 7 per cent of all global phase III and 3.2 per cent of all global phase II trials. Another study conducted by WEMOS and the Centre for Research on Multinational Corporations in 2006 indicates that approximately 22 unethical clinical trials were conducted in that particular year worldwide, of which eight took place in India. This clearly indicates the state of clinical trials in India, and also raises a question on the patient compensation system.
Looking at the state of patients suffering adverse effects from clinical trials, the Government of India felt the need to establish a law that would not just regulate the clinical research market but also provide the patients with certain rights. This is how The Drug and Cosmetics Act, 1940 came into force and was meant to ensure that proper measures are being taken while performing clinical trials. The Central Drug Standards and Control Organisation (CDSCO) and the Drug Controller General of India (DCGI) that come under the Ministry of Health and Family Welfare are responsible for approving and regulating clinical trials in India.
The Act essentially laid down a few rules and regulations for the clinical research industry as well as provided a set of guidelines that were to be followed to help regulate the patient compensation segment. “Schedule Y of the Drugs and Cosmetics Act, 1940 states that the law governing conduct of clinical trials in India requires that these trials be conducted in accordance with Indian Good Clinical Practices (GCP) guidelines. These guidelines recommend that patients who suffer physical injury as a result of their participation in a clinical trial are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from the ethics committee. In case of death, their dependents are entitled to material compensation,” informs Suneela Thatte, Executive Director, Customer Operations, Quintiles (India).
The current scenario in India
The clinical research market in India has recorded significant growth in the recent past. It has experienced over 84 per cent growth during 2006-2008 and there are further prospects considering that global clinical market is growing at 12 per cent. On an average, the clinical research industry in India touched $ 320 million in 2009, up from $ 140 million in 2006.
In addition, the International Committee for Medical Journals Editors (ICMJE) released an editorial statement on compulsory registration of clinical trials in 2004. According to this statement, the ICMJE proposed comprehensive trial registration as a solution to the problem of selective awareness, and announced that all eleven ICMJE member journals would adopt a trials registration policy to promote this goal. The ICMJE member journals now require, as a consideration for publication, registration in a public trials registration. Trials must be registered at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after July 1, 2005. For trials that began enrollment
before this date, the ICMJE member journals were required registration by September 13, 2005, before considering the trial for publication.
Further, considering the current state of clinical trials in India, the government made an amendment in the law in November 2011. The Ministry of Health & Family Welfare issued a draft notification on compensation in case of study-related injury or death in clinical trials. “The Ministry invited feedback to the recommendations from the industry and has subsequently held discussions with various stakeholders including industry and professional bodies, NGOs, medical institutions, academics, CROs and the pharmaceutical industry. We believe that guidelines on compensation should be in place before the end of 2012,” says Thatte.
The state of patient compensation
The GCP guidelines of India currently state that compensation must be paid subject to confirmation from independent ethics committee. Also, the Schedule Y of the Drugs and Cosmetics Act, 1940 requires that clinical trials be conducted in accordance with Indian GCP guidelines. The clause 2.4.7 of Indian GCP guidelines clearly states that research subjects who suffer from physical injury as a result of their participation in the clinical trial are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability subject to confirmation from the independent ethics committee. “There are several levels of protection in place to ensure the safety of a patient in a clinical trial. No clinical study is initiated by Quintiles without a careful review of all the existing pre-clinical and clinical trial information to ensure that the study is designed in such a way as to minimise any potential risks to the patients,” says Thatte.
Also, the procedures for management of a patient in a clinical trial are well-documented in GCP guidelines as well as study protocols. At the core of this is patient well-being and safety. Once a patient enrolls in a study, it is the responsibility of the ethics committee and the principal investigator to safeguard his/her rights, safety and well-being. The CRO, in turn, monitors the study to ensure compliance with local and international guidelines and regulations. In continuation to this Dr P P Bapsy, Senior Consultant, Medical Oncologist, Apollo Cancer Institute, Bengaluru, explains, “All adverse events that occur in a trial are meticulously recorded and appropriate treatment is always given. If a Serious Adverse Event (SAE) occurs, it should be promptly reported within 24 hours of its occurrence or awareness of the event. The patient must be given appropriate treatment until he/she is stable.
If the trial is sponsored by a company, the sponsor must be intimated within 24 hours. All data regarding SAE must be reported to the ethics Committee, DSMB and DCGI within specified timelines.”
In case a patient suffers from any side-effects, loss of organ or life, the regulatory authorities have made a few guidelines that need to be followed for the patient or his/her family in case of death to receive the compensation amount. Reporting of and managing adverse events, including compensation, in a clinical trial are handled in accordance with applicable regulations and guidelines. Any adverse event is immediately brought to the attention of the ethics committee whose responsibility is to investigate the event in consultation with the key stakeholders and determine causality. However, the process of giving the patient the deserved compensation is a lengthy and time-consuming process. Each case varies from one another depending on the time taken to investigate the adverse event and to determine causality. “At times, an interim payout may be made immediately followed by a full and final payout after determining the patient’s medical, employment and family history,” observes Dr Bapsy.
Tracing the growth story of clinical trials in India, one can certainly establish that India is one of the best destinations, not just due to factors like low cost but also due to the
large patient population. This further adds to the responsibility of the clinical research industry to ensure that no patients suffer from adverse effects. This would not just pool in more patients for the trial but would also increase the goodwill of the Indian clinical market.