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2. The advertising of a non-prescription medicinal product to persons qualified to prescribe or supply may however include only the name of the medicinal product, if it is intended solely as a reminder and provided that this form of advertising has been authorized by national law. ARTICLE 9 1. Information about medicinal products shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her opinion of the therapeutic value of the medicinal product concerned. 2. Any documentation relating to a medicinal product transmitted as a part of the promotion of the medicinal product concerned shall be faithfully reproduced and the precise sources indicated. Clear reference shall be given as to where they can be found. ARTICLE 10 1. No gifts, pecuniary advantages or benefits in kind may be supplied offered or promised to health professionals unless they arc inexpensive and relevant to the practice of medicine or pharmacy. 2. Hospitality at sales promotion shall always be reasonable in level. 3. Hospitality at professional or scientific events shall always be reasonable in level and remain subordinate to the main purpose of the meeting. 4. Hospitality shall not be extended to persons other than health professionals. 5. The provisions of this article do not apply to normal commercial trade practices which fall outside the scope of this Code. ARTICLE 11
them and shall have sufficient knowledge to be able to provide precise and complete information about the products which they promote. 2. In accordance with national law, medical representatives shall give the persons visited, or have available for them, e.g. through compendia, summaries of the product characteristics of each medicinal product which they promote. 3. Medical representatives shall transmit to the competent service within their firm any information which they receive about the usc of the medicinal product which they promote, with particular reference to adverse reactions reported to them by the persons visited." •
Origin and genesis of the Transplantation of Human Organs Act, 1994, of India ORIGIN
In accordance with national law, samples of medicinal products may be supplied to persons qualified to prescribe them to familiarize themselves with the products concerned in response to a written request, signed and dated from the recipient. ARTICLE 12 1. Medical representatives shall be given adequate training by the firm which employs INTERNATIONAL DIGEST OF HEALTH LEGISLATION, 1996, 47 (1)
On returning from a tour abroad in 19H9, the then Prime Minister of India, Shri Rajiv Gandhi, asked the Ministry of Health and Family Welfare why heart and liver transplants were not being performed in India. Such procedures were commonplace in the West, their techniques had been standardized, and the introduction of the new immunosuppressant drug, cyclosporin, had dramatically improved the success rate of transplantation. More than HO~, of recipients (who might otherwise have died from organ failure within six months) were alive after a year and 50% after five years. The procedures were expensive, the cost of a liver transplant in the USA being out of reach for all but the richest Indians. In addition, trade in human organs was rife, especially in the cities of Bombay and Madras. This had tainted the reputation of the country and that of its medical profession. SAMIRAN NUNDY
GENESIS
The Ministry set up a committee, with the task of defining the problems that had to be overcome before heart and liver transplantation could be performed in India. The problems it identified were twofold.
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Firstly, Indian law did not recognize brainstem death and it was uncertain that the concept would be acceptable to the Indian population. Death is defined in Section 46 of the Indian Penal Code as: "Death of a human being unless the contrary appears from the context" and in Section 29 (13) of the Registration of 13irths and Deaths Act, 1969 as "the permanent disappcamncc of all evidence of life at any time after live birth has taken place". These definitions were clearly inadequate and could be confusing. Furthermore, they did not permit transplantation of organs such as the heart and liver, which required a heart-beating, brain-stem-dead donor. The Union Territory of Delhi had, however, enacted the following: the Ear Drums and Ear 13oncs (Authority for Usc for Therapeutic Purposes) Act, 19H2; and the Eyes (Authority for Usc for Therapeutic Purposes) Act, 19H2. In Maharashtra State, the following were in force: the Kidney Transplantation Act, 19H3; and the Corneal Graft Act, 19H6. Secondly, trade in human organs, especially kidneys, had been the subject of many parliamentary debates. There was widespread repugnance to this blatant exploitation of the poor by the rich, to the idea that parts of the human body were being treated as commodities, to the risk to recipients from unnotified diseases in donors, and to reports of criminal activities involving middlemen and even physicians. The Committee also felt that, while this trade was allowed to continue, there was little possibility of developing a cadaver organ donation programme. Accordingly, it was decided that legislation should be prepared in order to establish a legal framework for the concept of brain death, to prohibit the sale of organs, and prevent abuse of the law. Public opinion seemed to be strongly in favour of such legislative changes. This was clear from the conferences held in the major cities with the aim of familiarizing people from all walks of life with the Government's intentions. These conferences took place: in August 19H9 in 13ombay under the auspices of the National Academy of Medical Sciences and the 13iomcdical Ethics Centre; in January 1990 in Madras and in Professor S. Nundy is Head of the Department of Gastrointestinal Surgery, All India Institute [)[Medical Sciences, New Delhi.
June of the same year in Calcutta; and in September 1990 in Delhi (this was a national conference sponsored by the Ministry and WHO). The Government then established a committee under the chairmanship of Dr L. M. Singhvi, an eminent constitutional lawyer, with a view to clarifying: (a) the concept of brain death and its definitions; (b) the desirability of enacting separate legislation for this purpose and the legal, medical, and social implications of such legislation; (c) the safeguards to be adopted to prevent the misuse of the concept of brain death; and (d) the manner in which the concept ofbrdin death should be utilized to facilitate the availability of human organs for transplantation. The report of the Singhvi Committee was submitted in June 1991 and received Cabinet approval in October of the same year. A 13ill was prepared and three States - Goa, Maharashtra, and Himachal Pradesh - passed resolutions in its favour. On 5 May 1993, the Transplantation of Human Organs 13ill was submitted to the Rajya Sabha (the Upper House of the Indian Parliament), where it received unanimous approval. In December 1993, however, the Lok Sabha (the Lower House) decided to refer the 13ill to a Select Committee for further examination. The latter suggested minor amendments concerning the inclusion of in-laws as ncar relatives and the payment of living donors. These were not accepted by the Union Cabinet and on 15 June 1994 the 13ill was passed by the J.ok Sabha. It received Presidential assent on H July 1994. India's first successful heart transplantation was performed in the All India Institute of Medical Sciences on 3 August 1994. The Act (No. 42 of 1994) provides for the regulation of the removal, storage, and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs. The principal matters covered arc discussed below. Autbori~y .for tbe removal of buman organs. Any donor over 1H years of age may grant authorization in writing before his or her death in the presence of two witnesses, one of whom must be a ncar relative. In the event of brain-stem death (which has to be certified by a board of four medical experts - the registered medical prdctitioncr in charge of the hospital concerned, a member of a panel approved by the Appropriate Authority, a neurologist or INTERNATIONAL DIGEST OF HEALTH LEGISLATION. 1996, 47 (1)
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neurosurgeon, and the attending physician), permission to remove an organ may he given by a ncar relative. No organ donations arc to he permitted from living donors unless they arc ncar relatives (spouse, son, daughter, father, mother, brother, or sister) or if there is "affection or attachment" between the donor and recipient (in which case prior approval must be obtained from the Authorisation Committees set up by the Government). Regulation of hospitals. Hospitals carrying out organ transplantation must he registered by the Appropriate Authority. Appropriate Authori(v. Officers arc to be appointed by the Central or State Governments for the purposes of granting or cancelling the registration of hospitals, enforcing standards, investigating breaches of the Act, and inspecting hospitals periodically. Registration of hospitals. A hospital may not be registered to carry out transplantation procedures unless the Appropriate Authority is satisfied that it is adequately equipped and able to maintain the necessary standards. Q[fences and penalties. The unauthorized removal of human organs is punishable with imprisonment for up to five years and a fine of up to Rs 10 000 (US$ 300). This might result in physicians involved in organ trading being struck off the Medical Register for two years for a first offence and permanently for subsequent offences. There arc also penalties for soliciting or offering organs against payment. THE PRESENT SITUATION IN INDIA
Parliamentary Assembly of the Council of Europe adopts Recommendation on quality in health care The following "Recommendation 1270 (1995) on a quality pledge in health care and clinical and biological examinations", was adopted by the A~scmhly on 2H April 1995: "1. The Assembly draws attention to the Health for All in the Year 2000 campaign launched by the World Health Organization (WHO) and the many recommendations adopted within the Council of Europe, both by the Assembly and the Committee of Ministers, concerning public health and health care. 2. All these legal instruments have been drafted out of a concern to guarantee and improve the quality of medical care in particular and to ensure that care is dispensed in humane conditions with due respect for the right of each individual to social and health protection. Although the value of the texts is recognised and they remain entirely relevant, health care professionals and users arc, unfortunately, unfamiliar with them, even though they arc often incorporated into domestic legislation. There is therefore a need for them to be publicised and applied more widely. 3. The health sector is sensitive to the economic difficulties and budgetary constraints facing most European countries, in particular the countries undergoing a transition, which arc striving to introduce fundamental reform of their health systems. Controlling health costs means increasing the health capital of all individuals by making them more responsible and improving the quality of the care dispensed. 4. All citizens can play an active part in this process. To this end, it is vital to promote education for health and information and familiarise citizens with the main standards adopted at European level. Generating awareness among providers of health care and patients will guarantee an improvement in the quality of care and clinical and biological examinations of all kinds. 5. In addition, research needs to be promoted effectively and findings disclosed as rapidly as possible so that scientific circles as well as patients may be informed. 6. The A~scmbly therefore recommends that the
The Act has been adopted by six States (Goa, Himachal Pradesh, Maharashtra, Andhra Pradesh, Karnataka, and Tamil Nadu) and all the Union Territories. It is under consideration in West Bengal and Uttar Pradesh. Three heart transplants and more than 20 renal transplants have been performed using organs obtained from brain-stem-dead heart-heating cadavers. Trade in human organs has largely been halted in the States that have passed the Act and there has been police action against erring physicians and middlemen in more than one city. Although there arc many difficulties ahead, it seems that organ trdnsplantation in India is entering a new em chardctcrizcd by major medical advances, not only in tcchnolO!-.'Y hut also in ethics. • INTERNATIONAL DIGEST OF HEALTH LEGISLATION, 1996, 47 (1)