5:49 AM May 14, 1997

HEALTH: HUMAN CLONING UNACCEPTABLE, OTHER CLONING PERHAPS

Geneva 14 May (Chakravarthi Raghavan) -- The 50th session of the World Health Assembly has affirmed as "ethically unacceptable, and contrary to human integrity and morality" the use of cloning for replication of human individuals, but appears to have left wide open some of the wider questions being raised on a range of issues relating to bio-genetics.

These questions, raised by many non-governmental organizations as well as health and other professionals, range from the social, economic and political implications to the mis-appropriation (by corporations and academic institutions who have corporatised themselves), as monopolistic private property through claims to patents and other IPRs, ownership and control over processes and formulae of life.

In a resolution adopted Wednesday, the Assembly has asked the WHO Director-General to take the lead, in clarifying and assessing the ethical, scientific and social implications of cloning in the area of human health. The task of clarification and assessment is to be undertaken, in appropriate consultations with other international organizations, national governments and professional and scientific bodies, and, with the relevant international bodies to consider related legal aspects.

The Director-General has also been asked to inform the Member-states of the outcome in order to foster a public debate on these issues, and to the WHO Executive Board at its 101st session (in January 1998) and to the next World Health Assembly in May 1998.

In its preambular paragraphs, the resolution has recognized the need to respect the freedom of ethically acceptable scientific activity and to ensure access to the benefits of its application.

It also recognizes that developments in cloning and other genetic procedures have unprecedented ethical implications and that related research and development should therefore be carefully monitored and assessed, and the rights and dignity of patients respected.

However, the resolution stops short of any outright condemnation of 'cloning' or its use in therapeutics and research and development, and makes no reference to the entire issues of patenting (and thus claiming monopoly rights) of life and genes, and micro-organisms and plants and animals with implanted genes, occurring naturally in other species.

A report by the Director-General to the Assembly had referred to the cloning of 'Dolly' the sheep through nuclear transfer to an unfertilized enucleated egg and its opening up of "entirely new avenues for basic research and its therapeutic applications in the area of human health".

The report also cautioned against any indiscriminate ban on all cloning procedures and research, noting that cloning of human cell lines is a routine procedure in the production of monoclonal antibodies for diagnosis and research on diseases such as cancer, the development and use of animals in which human genes have been introduced to produce tissues and organs for transplantation, use of transgenic animals to produce medical products.

The resolution adopted made no judgement on these, beyond the preambular statement of having noted the report and the DG's statement of 11 March 1997, and the statements of member-states on this issue at the Assembly.

But by placing the issue of use of cloning to replicate human beings as one relating to 'morality', the Assembly may have provided its support to countries that might want to use the exception -- 'to protect ordre public or morality' -- set out in Art. 27 (2) of the WTO's TRIPs accord and to deny exclusive monopoly patents to processes and formulae of life -- plants, animals and other living species.

This is the course advocated by the Canada-based international NGO, the Rural Advancement Fund International (RAFI), which in a press release and material made available to the WHO participants, drew attention to the fact that the Roslin Institute of Scotland which had successfully cloned the sheep "dolly" has applied for and taken out patents for the cloning technology and encompassing its use for cloning all animals, including humans.

The applications were filed by the Roslin Institute of Edinburgh and PPL Therapeutics, the company set up by Roslin to commercialise its research. Filed on 31 August 1995, at the World Intellectual Property Organization (WIPO) under the Patent Cooperation Treaty (PCT), the WIPO has published the details of the patents sought and the designated countries where it is sought. The WIPO made the information public, on 6 March 1997 (a few days after the announcement of the successful cloning of the sheep Dolly) after an international search report indicating there are no prior pending applications.

A WIPO application under the PCT enables simultaneous filing of the application in all member-states, and the WIPO undertakes an international search to make sure no patents have been issued nor any application pending anywhere.

But each WIPO/PCT member is free to decide whether or not the patent is allowable and RAFI is asking governments to use this, and not blindly grant patents because of the WIPO's certification and publication.

RAFI's Edward Hammond said of the worldwide patents sought by Roslin and PPL Therapeutics,"This isn't just a mutton monopoly; the patents cover everything that crawls, flies, swims, walks or talks.

"The issue is never just the science. It's who owns and controls the technology."

RAFI has appealed to patent authorities in all the countries to refuse patents on this, and other applications for plant or animal species patents using the exceptions in Art. 27 (2) of the TRIPs accord, or where granted, for governments to exercise their rights and revoke the patents.

Art. 27 of TRIPs creates an obligation on countries to grant patents in any area (provided the three tests of 'new', 'involving an inventive step', and 'capable of industrial application' are satisfied). But Art. 27 (2) provides an exception enabling a WTO member to deny a patent:

"Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animals or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law"

Other patent applications pending or granted, that RAFI has asked countries to refuse or revoke include those on J'oublie (Pentadiplandra brazzeana), Barbasco, Greenheart, Neem, Bitter Melon, Snakegourd, Mamala, Sangre de Drago, Kava, Quinoa, Endod, Ayahuasca, Turmeric, Human Cell Lines, Human Growth Hormone, Human Umbilical Cord Cells, Transgenic Soya, Transgenic cotton and Transgenic Brassica.

RAFI quotes Roslin Institute and PPL therapeutics, as confirming that the patents filed by them on cloning cover all animals, including humans, but that Roslin and PPL insist that they have no commercial interest in, and no moral tolerance of, human cloning.

While some other biotech companies confronted with similar ethical concerns, have worded their patents to specifically exclude humans, RAFI notes that Roslin patents make no such exclusion.

RAFI cites the Institute as saying that the inclusion in its patent application would ensure that nobody could lay claim to human cloning and thus Roslin would try to ensure that humans are not cloned.

While not questioning the sincerity of the Institute's intentions, RAFI points out: "The ethics and fate of human cloning is not a matter to be entrusted to the Roslin Institute. This is an issue of profound global importance and must be resolved at highest levels."

RAFI says that Roslin Institute has agreed to give an exclusive license to PPL Therapeutics (a small biotech company with offices in the UK and USA) for the production of therapeutic proteins in the milk of genetically modified animals. It also quotes PPL Managing director, Ron James as saying "We're still talking to them (Roslin) about other licensing uses and I expect others are talking to them as well".

Depending on the conditions of licensing agreements, RAFI points out, PPL or other companies could be well within their rights to develop human cloning and/or to sub-license other companies to pursue this research. PPL has research agreements with three major pharmaceutical enterprises with interests in human therapeutics.

"Behind the Roslin Institute is PPL," says Hope Shand of RAFI. "But behind PPL are Boehringer Ingelheim of Germany, Novo Nordisk of Denmark and American Home Products of US. All these are large players in the life industry. In particular Boehringer is actively collaborating with human genomic companies."

RAFI notes that the patents give exclusive monopoly over the cloning of all animals - not excluding humans - until atleast 2017. The patent implications are not just for people but for animals genetic resources as well, says RAFI.

"The immediate impact may be felt on the farm and steps must be taken to ensure that cloning does not destroy breed diversity. We are losing livestock breed diversity at an annual five percent rate. Cloning could make the situation much worse."

The Dolly patents are only the most recent of a number of instances where patent monopolies threaten public morality, says Jean Christie at RAFI. The UN General Assembly which is meeting in Special Session in New York (June 23-27), RAFI says, should take up the issue and seek an advisory opinion from the World Court of Justice at the Hague.