Biotechnology Laws and Regulations in Asia Pacific

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INTRODUCTION

Asia is in the middle of fast economic growth and now provides exciting opportunities in research, mainly in the area of biotechnology. A few years ago, advanced biotechnology research was centered mainly in the U.S. and Europe, and many researchers and students from Asia went there to pursue their postgraduate studies. With the thriving Asian economy and progressively lively research environment, many of those researchers have brought their expertise with them. They established biotech forces in both academe and industry, and also form a large network of connections between researchers in Asia and around the world.

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BIOTECHNOLOGY LAWS

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The field of biotechnology is tremendously broad and multidisciplinary, with applications fluctuating from energy and materials manufacture to pharmaceuticals and molecular and tissue engineering.

 

Many chemical engineers use their knowledge and expertise in biological processes and applications. Foremost the growth in biotechnology in Asia is China, Japan, South Korea, and Singapore.

 

However, each country has followed exclusive research instructions, interest has been fixed on three important areas:

  1. Biomanufacturing of chemicals and biomaterials for numerous industries, including health, food, energy, and agriculture
  2. Diagnostics and biomedical technologies
  3. Synthetic biology.

 

Association of Southeast Asian Nations (ASEAN)

ASEAN’s robust interest in biotechnology as one of the key areas of cooperation in science and technology in ASEAN was known when the Working Group on Biotechnology was established in 1983, after the establishment of the ASEAN Committee on Science and Technology (COST) in 1978.

 

The Sub-Committee on Biotechnology (SCB), one of the eight sub-committees under COST, is accountable for the administration, management, assessment, and application of regional biotechnology projects in ASEAN.

 

S&T cooperation in ASEAN is directed by the various initiatives, references, and choices made by the various bodies in ASEAN such as the Summit of the ASEAN Heads of Government, the Meeting of Ministers for S&T, and the Meeting of COST.

 

  1. The Hanoi Plan of Action (HPA): adopted in 1998. The HPA is the first in a series of plans of action building up to the understanding of the goals of ASEAN Vision 2020. All ASEAN bodies, including SCB, have now been tasked to instrument pertinent actions under the HPA.
  2. The ASEAN Plan of Action on Science and Technology: adopted in 1994, offers suitable strategies for the identification and preparation of programs and projects.
  3. The Medium Term Programme (1996-2000) for ASEAN S&T Development identifies the ASEAN COST Programmes and activities over the planned period of 1996 to 2000 in line with the objectives of the ASEAN Plan of Action on S&T.
  4. The SCB seeks to indorse regional cooperation in biotechnology for the following:

(a) development of drugs, diagnostics, and vaccines;

(b) improvement and production of selected bio-materials for agriculture and industry;

(c) application of biotechnology improving quality and production of plants and animals and their products;

(d) pilot scale design and computer control of biological reactors; and

(e) environment and biodiversity conservation.

(f) It also seeks to develop human resources along with the above areas; a network on biotechnology; technology transfer and licensing; joint ventures with the private sector. Specific objectives of the SCB are to carry out collaborative research on selected topics of the core projects in the areas of agricultural (plant, animal, and microbial) biotechnology, environmental biotechnology, industrial biotechnology, and medical biotechnology; and to establish the ASEAN biotechnology information network.

 

 

Regulatory System

Biosafety regulatory systems in countries of the Asia-Pacific region are in the process of development and implementation. The process of creating the legal and administrative frameworks has been initiated at different times and Follows different approaches.

 

The countries have to balance between obligations of free trade under WTO and environmental safety based on the “precautionary approach” of the Protocol. Thus, the biosafety regulatory systems in the Asia Pacific regions fall into two broad groups.

 

The first group has developed its biosafety regulations independently while the second comprises 28 countries that have developed their NBFs with UNEP-GEF assistance. The policies on agricultural production, food security, and economic, trade, and social considerations have shaped the regulatory systems on biotechnology and biosafety.

 

The structure of NBFs of the latter countries is according to a common format comprising: description of the government policy on biosafety; description of existing law and enforcement system of the country involving principal acts on biosafety and tribunals responsible for their execution; an administrative scheme for processing requests for sanction of import, export, local use, field examination, intentional dissemination into the atmosphere, etc.; risk management and follow up on administration and compliance; and instruments for public awareness and participation.

 

The countries that have developed their regulatory systems independently of UNEP-GEF are more diverse on the other hand, countries like Bangladesh, Indonesia, and the Philippines have some or the other form of a regulatory system already in place before joining the NBF.

 

Government Support

Government support also plays a vital part in driving the direction of biotechnology research. For instance, synthetic biology in Singapore, China, South Korea, and Japan has much backing at the national level, with the establishment of state-sponsored programs and national institutes, and the growth of essential research abilities.

 

In China, government-sponsored programs provide huge enticements to create biotech infrastructure, progress biotech and life-science parks, and employee foreign talent. Legislation is being developed to inspire innovation in China.

 

Moreover, Biotechnology is named as a Strategic Emerging Industry, and plans such as Made in China 2025 and the 13th Five-Year Plan highlight its development. More partnerships are taking place between academic institutes and biotech companies within and outside China.

 

Sustainability

This area has great unused potential to address pressing global challenges, such as climate change and sustainable growth and development. Biotechnological development of chemicals and raw materials in a sustainable manner is drawing considerable attention, and few conventional petrochemical companies have begun commercializing bio-based chemical production.

 

Prominent examples are Malaysia’s Bio-economy Transformation Programme to promote specific bio-based industries; China’s strategic focus on commercialization of agriculture biotechnology; and the National Biotechnology Strategy of Japan.

 

Development

Currently, there continues to be much collaboration between researchers in Asia and those in the U.S. and Europe. The dramatic rise in the quality of research in Asia, coupled with increasing research opportunities spurred by rapid economic growth, draw a growing number of international researchers into Asia.

 

The current healthy infrastructure supporting biotech development in Asia is also enabling many native young people to stay and work in biotech companies in Asia. To support and strengthen these collaborations, AIChE holds some of its major biotech conferences in Asia.

 

Conclusion

While, modern biotechnology offers innovative technologies and applications in healthcare, agriculture, and environmental protection, a favorable environment policy is essential for promoting innovation and commercialization.

 

Some countries in the Asia-Pacific have established focused policy and institutional frameworks to support their biotechnology sectors. Biotechnology is also considered a capital- and knowledge-intensive sector. For acquiring these critical resources, enterprises need to establish strong collaboration and networking with domestic and international partners.

 

Further, biotechnology is also seen as a primary force for economic growth in South Asia, even though there is a resilient inadequacy of funding, infrastructural and skilled manpower.

Our team of advanced patent attorneys assists clients with patent searches, drafting patent applications, and patent (intellectual property) agreements, including licensing and non-disclosure agreements.

Advocate Rahul Dev is a Patent Attorney & International Business Lawyer practicing Technology, Intellectual Property & Corporate Laws. He is reachable at rd (at) patentbusinesslawyer (dot) com & @rdpatentlawyer on Twitter.

Quoted in and contributed to 50+ national & international publications (Bloomberg, FirstPost, SwissInfo, Outlook Money, Yahoo News, Times of India, Economic Times, Business Standard, Quartz, Global Legal Post, International Bar Association, LawAsia, BioSpectrum Asia, Digital News Asia, e27, Leaders Speak, Entrepreneur India, VCCircle, AutoTech).

Regularly invited to speak at international & national platforms (conferences, TV channels, seminars, corporate trainings, government workshops) on technology, patents, business strategy, legal developments, leadership & management.

Working closely with patent attorneys along with international law firms with significant experience with lawyers in Asia Pacific providing services to clients in US and Europe. Flagship services include international patent and trademark filingspatent services in India and global patent consulting services.

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