The recent unveiling by Malaysian Prime Minister Abdullah Ahmad Badawi of a new government agency tasked to develop the country's up-and-coming biotechnology industry is an exciting development. The Malaysian Biotech Corporation (MBC) is to work closely with related ministries to enhance biotech R&D, oversee the implementation of new policies and initiatives and develop the regulatory environment.
The National Biotechnology Policy will be implemented in three phases: Phase One from 2005 - 2010 will seek to set up implementation and advisory councils, educate workers and business development in related sectors such as agricultural, healthcare and industrial biotech and bio-informatics.
Phase two is scheduled to run from 2011 - 2015 and will concentrate on new drug development.
Phase three, 2016 - 2020, essentially focuses on the global development of at least 20 Malaysian biotech companies with a view to make these companies and Malaysia a global biotechnology player. Significant incentives will be offered to the private sector to encourage investment.
Building a thriving biotech sector requires significant investment and patience - attributes the Malaysian private sector have little of, however the rewards are significant. According to a recent article in the Economist, quoting Peter Singer, director of the Joint Centre for Bioethics at the University of Toronto, a healthy biotech sector is good for domestic economies and provides more appropriate and affordable solutions to healthcare problems in poor countries. And this niche market may well be the key to the success or failure of the Malaysian endeavor because the diseases or poorer countries are often not of interest or accessible to western researchers.
But patience is a critical key to the success of the endeavor. Many developing countries began investing in biotech in the 1980s and only now are they begining to see the benefits of the investment. China has impressed with its work in the field of genomics. Brazil meanwhile has become a leader in research of local issues, such as tropical diseases.
There are other potential minefields. July 1, 2002, marked the 100th anniversary of the Biologics Control Act, enacted by the US congress to regulate biological products and ensure their safety. Now there are 3 agencies responsible for regulating biotechnology in the US, they are the US Department of Agriculture (USDA), the Environmental Protection Agency (EPA) and the food and drug administration (FDA). Furthermore, some products are regulated under more than one agency.
In Europe, regulation aims to protect health and the environment as well as to respect ethical and social norms, while maximising the benefits obtainable from biotechnology. It grows with the concerns and priorities of the real world, and does not favour any theoretical framework. European biotechnology regulation was founded by the academic pioneers of the 1970s. It was then steered for a time by ambitions to realise the expected industrial and consumer benefits; but it has since been reinforced as a result of public concerns over safety and ethics. These are all honourable reasons but likely to cause the odd headache for Malaysian Biotechynology companies. India's regulatory system is already proving a thorn in the side of its biotech dreams.
South Africa meanwhile is finding it hard to keep scientists in the country. And there is also the complicated, time consuming and demoralising process of patenting biotech discoveries in America where thousands of health-biotech patents are awarded every year. Money, or the lack of it is causing Egypt's biotech plans to stall.
Nevertheless, if the impressive political commitment shown so far continues. If investors are patient. If investments in education and the health sector are forthcoming and significant long term funding is available, irrespective of the economic climate. if particular segments are researched, identified and pursued, and resources are invested in the chosen segment, If we learn from, and work with other countries to manufacture, brand and market products (as Bioven is already doing with Heber of Cuba), there is no reason why this exciting venture cannot make a significant contribution to the long term success of brand Malaysia.
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