The government promulgated the Transplantation of Human and Tissues Ordinance 2007, on September 3, 2007. Meanwhile, the process of legislation in the National Assembly will continue and the relevant standing committee will carry forward its process.
The Transplantation of Human Organs and Tissues Bill, 2007 was introduced in the National Assembly on August 17, 2007 and was referred to the National Assembly Standing Committee on Health the same day.
The Transplantation of Human Organs and Tissues Bill, 2007 is aimed at regulating the removal, storage, sale and transplantation of human organs and tissues in end stage diseases. The Bill is envisaged to impact and curb the widely prevalent unethical and illegal practices in human organ trade.
Pakistan has one of the highest rates of unrelated commercial transplantations in the world; the process of organised organ brokerage has been institutionalised in the country with the help of the unethical community of health care providers and a range of vendors.
As a result, poor patients in desperate need of money are exploited for meager sums. The determinants of this pattern include an unregulated private sector, absence of quality assurance institutional mechanisms and lack of policy and legislative arrangements to check unethical practices. Pakistan is the only country in the region as, of this date without a law on organ transplantation and therefore this Bill is aimed to set standards and ensure compliance with these standards.
In terms of its Status, the legislation was previously under heavy criticism with concerns being expressed that the trade can get legal sanctions through the legislation. On August 1, 2007 the Federal Cabinet mandated an inter-ministerial committee to address these concerns with specific recommendations to modify the law, albeit while approving the law in principle.
However in an unexpected move, while the legislation was being processed as an Ordinance, a Bill was moved on the floor of the National Assembly on August 17, 2007. The objective of this move is a subject of active debate. Notwithstanding this controversy, it is important that the National Assembly Standing Committee on Health should now convene a meeting soon to deliberate on this matter given that the Assembly will be completing its term on November 15, 2007.
However, it must also be recognised that the revised version of the law still has many limitations. Although the previously controversial Clause' 3(2) does not endorse compensation anymore, it also does not regard doing so illegal, by virtue of which the Clause may still remain exploitable. In addition, this brief also outlines many other gaps in the law which have not received due attention and must be addressed during parliamentary deliberations.
However, it must be recognised that due to paucity of donors, kidney transplants can only be performed in 5% of the total number of patients who actually require the procedure. There are two prevailing modes of kidney transplantation. The ethical mode involves cadaver donations and altruistic donations from live related donors, which reflect a donor's motivation to save a life.
The unethical mode involves donations from live unrelated donors and is generally based on putting a price on human body parts. Due to scarcity of human organs, the latter option has greatly increased over the years in resource challenged countries with poor regulations where the poor are willing to trade a kidney for incentives as they realise that one kidney is sufficient for a good quality of life.
Analysis of kidney transplantation trends in Pakistan is indicative of this pattern. In the1990's unrelated commercial transplantations constituted 25% of all the transplantations carried out in Pakistan; by 2004, this had risen to 80% of all transplants.
The existence of an unregulated private sector has greatly facilitated the institutionalisation of this trade in Pakistan, as has the absence of legislation on organ transplantation. Presently, the trade has an estimated turnover of Pak Rs 1 Billion in Pakistan according to conservative estimates.
More than 80% of the transplants are currently being performed in private hospitals, which openly offer 'transplant packages' to clients both within and outside the country. As a result of these practices, Pakistan is unfortunately being ranked amongst the few countries of the world where transplant related-tourism is burgeoning.
Shortly thereafter, in November 2006, the Chief Justice of Pakistan took suo moto action based on a complaint in the Yazman case, which related to the coercive and illegal removal of a poor man's kidney without his knowledge. The Supreme Court also directed the Ministry of Health to pursue legislation; in addition, the Deputy Attorney General of Pakistan suggested that an Ordinance be pursued in the interest of expediency, a suggestion also endorsed by the Ministry of Law.
In January 2007, the Ministry of Health submitted the Ordinance's first draft to the Cabinet Division, based on which inputs were officially solicited from the Federal Law Minister and the Prime Minister's Senior Advisor on Law, Justice and Parliamentary Affairs.
In tandem, a request was also sent by Secretary Health to the Prime Minister requesting him to exercise his authority under Rule-16 (2) of the Rules of Business of Pakistan 1973, so that the Federal Cabinet could be bypassed and an advice could be sent to the President directly to promulgate the ordinance expeditiously.
However it was ultimately decided to seek the Cabinet's approval on the draft Ordinance, which resulted in some delay as the item was awaiting its turn to be placed on the Cabinet's agenda. The Supreme Court took notice of this delay and on July 26, 2007 directed the Cabinet Division to accord high priority to the matter in the next Cabinet meeting; the case was adjourned to the first week of September 2007. Subsequently, the matter was discussed in the Cabinet on August 1, and the law was approved in principle; however, the matter was referred to an inter-ministerial committee with recommendations, based on which several changes were made to the law.
These include changes in the membership of the Evaluation Committee (Clause 5), and Monitoring Authority (Clause 8); the use of fund established as a statutory entity (Clause 8 [5]); the term of imprisonment (Clause 10) and modification of Clause 3(2), which was the most controversial of all the Clauses.
These changes were made as a response to the extensive criticism on the earlier draft of law by the professional community both internationally as well as within the country. The extent to which these amendments are likely to influence the true spirit of the bill true spirit of the bill has been referred to in a subsequent section of this brief.
However, from a process-related perspective, it is interesting to note that the legislation was not processed further as an Ordinance but in an unexpected move, was tabled as a Bill on the floor of the National Assembly on August 17, 2007 in the absence of the key parliamentary representatives on health (Federal Minister of Health, Minister of State for Health and the Parliamentary Secretary for Health).
The bill was referred to the National Assembly Standing Committee on Health the same day; however the Assembly session was also prorogued indefinitely the same day. The objective of this move is a subject of active debate. Clearly, with the National Assembly in session the law could not have been processed as an Ordinance; one school of thought therefore, is of the opinion that this move is in response to that constraint. The other school of thought regards it as a strategy to further delay the promulgation of the law.
In view of these circumstances, the National Assembly Standing Committee on Health should now convene a meeting at the earliest to deliberate on this matter and forward its report to the National Assembly. In order to assist the parliamentarians, citizens and media in this task, a review is presented on the strengths, weaknesses and limitations of the law.
These have been based on a comparison of the law with internationally recognised ideal attributes of a law, which draw on the principles of international guidelines published by the World Health Organisation. These guidelines aim to ensure protection against exploitative and unethical practices that can allow people to sell their organs and specify that procuring human organs in lieu of monetary payment is unethical.

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This Legislative Brief is a part of the PILDAT Legislative Development programme and is authored by Dr Samia Nishter S.I FRCP PhD, Founder and President, 'Heartfile' at the request of Pakistan Institute of Legislative Development and Transparency (PILDAT) conforming to the format set by PILDAT.
The objective of the Brief is to assist the parliamentarians to understand the context, objective and the issues relating to the legislation. The Brief is also intended to enhance awareness of the citizen and media in general.
(To be concluded)