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Advisory / BIOTECHNOLOGY

Living without Bio-Safety laws

Man has been making use of biotechnology for centuries, long before the terminology was even coined. More recently-developed gene technology has now made the word "biotechnology" a household name due to its association with the controversial subject of genetically-modified organisms, GMOs.

The reasons that this subject attracts so much public interest are twofold. On the one hand people believe that it may be the much needed solution for more effective healthcare, as well as helping to ensure world food security through high-yield and disease resistant varieties of both plants and animals through the introduction of foreign genes. On the other hand, there is a concern over the safety of these new organisms to consumers and their possible effects on the balance of the environment.

In Pakistan, research and development activities in biotechnology have recently picked up at various levels, with the agricultural sector being observed to be most active. Efforts are currently geared towards capacity building in biotechnology-related subjects and techniques involved. Also, efforts are being directed towards the formulation of frameworks for a National Biotechnology Policy and for guidelines in the safe application of biotechnology.

Two years back the Ministry of Environment, Local Government and Rural Development had constituted a National Bio-safety Expert Committee (NBEC) comprising experts from all relevant institutions in Pakistan for updating the bio-safety laws. The objective of the committee was to update the existing legislation in the field of bio-safety about handling and use of Living Modified Organisms (LMOs) and recommend measures for management, safe transfer and movements of LMOs, while the subcommittee was to draft the guideline on genetic engineering and other aspects.

In July (2002) the Ministry of Science and Technology declared that "biotechnology" is one of its the priority areas, and it will ensure that the government takes all necessary steps for the speedy induction and promotion of biotechnology in the country. It also indicated that "Biotechnology Policy" would be formulated within two months (September, 2002) Given this scenario, the big question remains in our mind - are these efforts sufficient to attract investment, funds, and technology in order for biotechnology to flourish in Pakistan?

The answer may not be so simple.
The most fundamental stumbling block remains the absence of 'bio-safety laws'.
No matter how comprehensive a policy on biotechnology the newly formed Commission on Biotechnology comes out with, unless Pakistan approves bio-safety laws (which could provide guidelines for importing, testing and commercialization of genetically improved products) tools for biotechnology cannot be effectively harnessed, because no realistic priority setting can be done.

Policy guidance, though, provides for a research strategy that maximises available resources, capacity building in biotechnology and extension of the existing research capability to handle biotechnology. Whereas applications of biotechnology techniques could only be observed through regulatory framework evolved under Bio-safety laws.

The failure of the Ministry of Environment to approve the guidelines till date reflects the lack of even a nominal support from our government and ministries.

What is bio-safety and why is it so important?

Bio-safety is the safe development of Biotechnology products and their safe application resulting from the existence of effective mechanisms for the safeguard of human and animal health, safe agricultural production, safe industrial production, safeguard of the natural plant and animal species (flora and fauna).

It is worth noting that the proposed bio-safety guidelines in Pakistan have a three-tier safety mechanism like Institutional Bio-safety Committee (IBC), Ministerial Bio-safety Committee (MBC), and National Bio-safety Committee (NBC) that controls and monitors the whole process from the lab-testing, field-testing to commercialization and the project can be stopped at any time, at any tier, if found hazardous to human beings or environment.

How does the absence of biosafety laws affect development of biotechnology in Pakistan?

R & D losses:

Pakistan started its biotechnology programme "Plant Genetic Resources" in 1976 at Pakistan Agriculture Research Council (PARC). The potential of biotechnology in Pakistan was formally recognised in 1981.When a course on recombinant DNA technology was organised by the Nuclear Institutes for Agriculture and Biology, Faisalabad. While in 1984 the Centre of Excellence in Molecular Biology at Punjab University of Lahore was established. Various programmes through genetic engineering are being tested on different plants like cotton for Antiviral gene and Bacillus thuringiensis gene (bt), Rice for Salt Tolerant (GB uptake).

Huge money and funds have been spent on these programs but these products cannot be marketed unless the Bio-safety guidelines are in place.

Economic Losses:

Needless to say that agriculture is the backbone of Pakistan's economy. It covers a total area of 19,672 million acres, of which 5,412 million acres are cultivated. Agriculture remains the dominant sector of the economy and accounts for about 25 % of GDP and about 68% of the people depend on agriculture for their livelihood, engaging about 50% of the country's workforce.

Pakistan is the world's fourth largest producer of cotton after China, the USA and India. Cotton or white gold as it is aptly called is grown for its lint and seed, which yield cotton fibre and seed oil, respectively. In Pakistan, average yield of conventional cotton per acre is around 25-28 maund or 933 kg-1,044 kg. Bt Cotton in Pakistan can increase per acre yield from 14 to 30 per cent. Which means that on the one hand, it will bring prosperity for Pakistani farmers, on the other, it will bring a boom to all industries and business activities which are directly or indirectly associated with agriculture sector.

In the Asian region, a number of countries like India and China have allowed farmers to grow Bt Cotton, which may have an impact on our cotton and textiles export of value Rs 4880.00 billion. Pakistan offers a rapidly expanding market for insecticides and pesticides. The total market has expanded from Rs 7.20 billion ($120m) in 1990 to Rs11.00 billion ($184m) in 2000. By not introducing Bt Rice and Bt cotton, in Pakistan, farmers have to depend on pesticides to save their crops from pests. This would mean loss of billions apart from the negative impact on the environment and human health.

Fall off direct investment:

Biotech investors often wait for years to receive investment returns since it typically takes over seven years and Rs 10-12 billions to bring a new biotech drug to market. Although the agriculture time line is shorter it still takes about 6 to 7 years but costs much less. Therefore, the encouragement of risky and long-term capital inflows from investors is important to the continued health of the industry.

In the absence of bio-safety laws no investor would be willing to come to Pakistan and invest in biotech industries. In a situation, if the Government of Pakistan gives approval to the bio-safety guidelines today, for biotech companies it would take about two to three years to commercialise Bt products due to trials and testing procedures required across the country.

Biotech brain drain:

Large numbers of students in Pakistan are studying in "biotechnology" at various universities. Tomorrow, if we fail to provide them jobs or business opportunities in the biotech industry then they will move to other countries like Canada and Australia.

Dwindle in foreign aid:

World Bank, ADB, and other donor agencies have given aid / loan for Biotech R&D projects in number of countries. In a region with no Bio-safety laws they will be reluctant to offer aid for biotech industry. This year World Bank has approved 100 millions loan for Biotech industry in India. On the other hand we are only persuading and appealing to the Muslim countries to generously contribute for creating a "fund" to uplift science and technology programs in the field of Biotechnology and Information.

Loss of competitiveness in the world:

The 21st century is generally dubbed as a "Biotech Century". Biotechnological revolution has led to the establishment of many a thousand new "bioengineering" firms around the world. In case we fail to keep up the pace with the rest of the world in this area due to the lack of bio-safety laws, we will lose our competitiveness and once again be left behind as had been the case in the IT field.

In the US alone there are now 1500 biotech companies with a total revenue of about $ 14 billion and more than 150,000 people are employed there. Even the most cautious countries on GMOs such as Germany and UK are spending Rs 70.5 billion and Rs 1.7 trillion respectively in a year in the field of biotechnology.

Now, let's look at how are we faring compared to our most trusted friend - China. Biotechnology, first heard of in China some 30 years ago, has developed into a big industry in the country. In 2000, the industry made sales worth about 2.4 billion $ compared to about 31 million $ in 1986. The central government invests about 271 million $ in biotechnology every year.

In China, five officially approved genetically modified plants are grown on 700,000 ha, ranking it fourth in the world in terms of acreage. Currently, over 60 companies are allowed to produce drugs developed through genetic engineering. Eighteen drugs using biomedical technology have been officially sanctioned for use in hospitals.

This development has occurred only in the first decade of a technological and economic revolution that is likely to span several decades in future. Pakistan's 140-million population is going to double by the year 2025 with the present rate of population growth. We need to ask ourselves, whether with current growth level of our GDP, the current agricultural practices and dwindling arable land, would we be able to provide food to our hungry.

UNDP's Human Development Report 2001, "Making New Technologies Work for Human Development", launched on July 10, 2001, outlines the significance of this technology in meeting such challenges. It says. "Many developing countries might reap great benefits from genetically- modified foods, crops and other organisms" and "These crops could significantly reduce malnutrition, which affects more than 800 million people world-wide".

Our indifference to activate bio-safety laws reflects our lack of responsiveness to our current responsibilities, leave aside our strategy for the future Scientists, entrepreneurs, investors, and farmers are urging the Government to approve the Bio-safety guidelines. Failing to do so, all of the research, investment, knowledge and money would go wasted.

Ijaz Ahmad Rao
luckystarpk@yahoo.com