Acknowledgements 5 Glossary 6 List of Tables 8 List of Figures 9 List of Boxes 10 Pakistan Fact Sheet 11 Executive Summary 12

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11.2 Threats

Revolutionary breakthroughs in genetic engineering during the last two decades have enormously increased the ability of scientists to manipulate genetic material. This is clearly reflected in the development of Transgenic crops and animals. Such genetically modified organisms (GMOs) and living modified organisms (LMOs) do have enormous economic potential but also raise serious issues related to biosafety and environmental imbalance. The hazards of accidental release of modified organisms can have unpredictable consequences. There could be epidemics for humans, livestock or plants. In a developing country like Pakistan, these problems can become unmanageable. Alternately, the accidental release of modified organisms can also cause the complete extirpation of vulnerable creatures including man. Genetically modified food, is food prepared from genetically modified seeds. Although, sale of this type of food for consumption has been allowed in the West, strong objections and controversy continues regarding its use. Monsanto, a US Company, tried to establish its activities in Pakistan, but due to strong lobbying by the environmental the programme has been shelved for the time being. The release of such microbes and plants into the environment needs to be seriously monitored and continuously debated.

In view of the foregoing, it is obvious why the conservation of microbial diversity should be an integral part of a national bio-conservation strategy. In terms of the review of the implementation of the CBD, it is important to pay attention to the issues related to microbial diversity. At present, there is no national centre for the preservation and collection of microbes in Pakistan. This extremely important initiative merits special attention.

A great deal of emphasis has been laid on the need to establish a strong regulatory system for the control of possible risks associated with the use and release of LMOs. However, very little attention has been paid to developing legislation or polices on biosafety guidelines in this area in Pakistan.

11.3 Conservation Projects

The document currently available on this subject is the Voluntary Code of Conduct for the Release of Organisms into the Environment prepared by the National Institute of Biotechnology and Genetic Engineering (NIBGE), Faisalabad. A committee has been constituted by the MELGRD to draft biosafety guidelines in genetic engineering and biotechnology. The National Biosafety Expert Committee (NBEC) has recently given its conceptual approval to the guidelines. The guidelines propose a three-tier system to meet this biosafety requirement, i.e. the implementation of biosafety practices in genetic engineering and biotechnological work. The institutional biosafety convention has been proposed to implement and supervise low-risk elements. The Ministerial Biosafety Committee (MBC) deals with medium-risk elements and the National Biosafety Committee deals with high-risk elements. The guidelines also explain the policies, powers, functions and the responsibilities of the three committees. Standard forms are to be used by the three committees for the collection of necessary information.

11.4 Trade Related Intellectual Property Rights

The World Trade Organisation (WTO) includes the multi-trade agreement, the Trade-Related Aspects of Intellectual Property Rights (TRIPS). Members of the WTO are free to determine the appropriate methods of implementing the provisions of the TRIPS agreement within their own legal system and practice. This agreement establishes a minimum standard of intellectual property protection. The TRIPS agreement requires the member states of the WTO to provide protection to plants either by patent or by an effective sui geris system or any combination thereof. Each country is free to decide on the form of protection i.e. plant breeder’s right or plant patent right. There is a ban on double protection for the same variety.

With the strengthening and widening of the Intellectual Property Rights (IPR) regime, the instances of attempts in industrialised countries to patent material based on traditional knowledge and genetic strains derived from other countries is increasing. This has led the Consultative Group on International Agricultural Research (CGIAR) to call for a moratorium on IPR claims on seeds held in trust in gene banks. This was done at their International Agricultural Research Centres such as the (IRRI), (ICARDA), (ICRISAT) located at Los Banos – Philippines, Aleppo-Syria, and Hyderabad – India respectively. Other materials, whose properties have not been fully understood, such as Neem and turmeric, have been grown in Pakistan for centuries. In recent years, these plants have been subject to IPR claims in industrialised countries. Even plant material of well-established geographical identities, such as Basmati rice grown and developed in Pakistan, has been subject to IPR claims. These rules prevent, among other things, the use of an old well-known name for a new variety, or a name similar to that recognised name.

11.5 Protection of Varieties through Patented Genes

The protection of the variety of plants by a Plant Variety Protection system is as important as the patent of genes. The practical implication of patented varieties is that these varieties cannot freely be used as a gene source for commercial breeding. This may lead to a monopolisation of a certain variety-type (e.g. insect resistant), which may harm the community and farmer, as well as discourage competition between companies. Licensing and patenting is being finalised in Pakistan, when the rules for licensing will be notified. Such a license may be granted if the exploitation of the variety is in the interest of the public, and the variety or the invention (the gene) represents important technological progress. The patent holder is in that case also entitled to get a license for the variety in order to insert genes and exploit the possible resulting, dependent variety. Although this regulation gives some comfort for breeders, but it is still uncertain whether such a compulsory license will ever be granted. If that is the case, whether it will be in time to have any commercial profit. Moreover, it would have been better to obtain the license during the breeding and selection process, before the release of the variety. One must consider the special case of self-reproducing, living plants, which function as a carrier for the inserted gene(s). It is in the interest of society to have a balanced system between the rights of the patent holder and the importance of free competition in order to avoid monopolisation. The exclusive rights of the patent holder can be restricted by the creation of a Breeder’s Exemption from the Plant Breeders’ Rights. This means that without the consent of the patent holder, the patented variety can be used as a source for commercial breeding. However, with the obligation to pay a reasonable royalty if the resulting variety, is commercially exploited. The patenting of plant and plant varieties is not very common in Pakistan. With the recent development of the utilisation of plants without the Prior Informed Consent (PIC) of Pakistan, the plant and plant product patenting has created awareness among researchers. The HEJ Institute of Chemistry, Karachi, holds a patent on a pesticide composition based on Neem (Azadirachta indica). The Plant Genetic Resources Institute has submitted a case for the patenting of 18 medicinal plants to safeguard and protect the valuable properties of Pakistan's indigenous plants.

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