Policy Brief Volume 1, No. 1: The Cost of Regulatory Delays for Genetically Modified Crops

Policy Brief Volume 1, No. 1: The Cost of Regulatory Delays for Genetically Modified Crops

SUMMARY:

Regulatory approval times for genetically modified (GM) crops are increasing in many countries. The impact of unjustified regulatory delays due to inefficiencies, lack of coordination or unnecessary and redundant requirements can be devastating. Regulatory delays may especially affect the public sector and international R&D investments which are particularly intended to address needs in developing countries.

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The study sought to analyze the economic impact of regulatory delays for GM crops. The authors concluded in their study that longer regulatory delays are associated with higher investment risk which could discourage investors to invest in the development of a GM crop. Results of the analysis emphasize the need for regulators, decision-makers, and developers to reduce time delays and increase the efficiency of coordinating decision points along the product development cycle — for R&D, regulatory review, and compliance to optimize costs and time in delivering a product. 

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Leyte Farmers, Local Officials Briefed on Philippine Biosafety Regulations

“The greatest resource of a nation is its people. We consider our farmers as our jewels in Leyte.”

Governor Leopoldo Dominico Petilla welcomes speakers and participants to the Biotech 101 and Joint Department Circular (JDC) Public Briefing held at the Oriental Hotel in Tacloban City on October 26, 2018. (Image Credit: SEARCA BIC)
Governor Leopoldo Dominico Petilla welcomes speakers and participants to the Biotech 101 and Joint Department Circular (JDC) Public Briefing held at the Oriental Hotel in Tacloban City on October 26, 2018. (Image Credit: SEARCA BIC)

With this, Governor Leopoldo Dominico Petilla of Leyte welcomed more than 150 farmers and officials of selected municipalities in Leyte to the Biotech 101 and Joint Department Circular (JDC) Public Briefing held at the Oriental Hotel in Tacloban City on October 26, 2018. Governor Petilla said that the objectives of the activity were aligned with the local government’s thrust of improving the province’s economy through agriculture. “Science is good if we use it wisely for the benefit of the people,” he added.

Dr. Edgardo Tulin, President of Visayas State University discusses the food and environmental safety issues of biotech crops. (Image Credit: SEARCA BIC)
Dr. Edgardo Tulin, President of Visayas State University discusses the food and environmental safety issues of biotech crops. (Image Credit: SEARCA BIC)

Experts from the Institute of Plant Breeding – University of the Philippines Los Baños (IPB-UPB), Philippine Genome Center (PGC), and Visayas State University (VSU) oriented the participants on the science of biotechnology, food and environmental safety of genetically modified (GM) crops, and biotech products in the pipeline. Representatives from the Departments of Health, Agriculture, Science and Technology, and Interior and Local Government were also on hand to discuss the JDC guidelines and address questions from the audience.

 

Mr. Charles Anthony Vega, Local Government Operations Officer III from DILG explains the significance of public participation in the approval process of biotech crops. (Image Credit: SEARCA BIC)
Mr. Charles Anthony Vega, Local Government Operations Officer III from DILG explains the significance of public participation in the approval process of biotech crops. (Image Credit: SEARCA BIC)

Among the concerns raised during the open forum was the rigid biotech regulatory process in the country, which the experts explained was crucial in ensuring the safety of GM crops released in the market. The participants were also eager to promote the adaption GM crops in their province through a signature campaign and are now discussing the matter with the Department of Agriculture (DA) officials in the region.

The activity was organized by the International Service for the Acquisition of Agri-biotech Applications (ISAAA), DA-Biotechnology Program Office, and the Southeast Asian Regional Center for Graduate Study and Research in Agriculture – Biotechnology Information Center (SEARCA BIC) in coordination with DA Regional Field Office 8.

– Danellie Joy O. Medina, SEARCA-BIC

The panel addresses queries from the audience. From left: Ms. Zyrine Lorizo (DA-BPI), Mr. Charles Anthony Vega (DILG), Ms. Julieta Fe L. Estacio, Head Secretariat of the National Committee on Biosafety of the Philippines, and Engr. Rolando Santiago, Supervising Health Program Officer from DOH. (Image Credit: SEARCA BIC)
The panel addresses queries from the audience. From left: Ms. Zyrine Lorizo (DA-BPI), Mr. Charles Anthony Vega (DILG), Ms. Julieta Fe L. Estacio, Head Secretariat of the National Committee on Biosafety of the Philippines, and Engr. Rolando Santiago, Supervising Health Program Officer from DOH. (Image Credit: SEARCA BIC)

 

Federation of Seed Industry of India Bats for GM Variety

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Uganda: African biosafety agencies move to bridge GMO communication gap

Kampala, Uganda | ISAAC KHISA | African countries are currently having trouble releasing their biotech crops popularly known as Genetically Modified Organisms (GMO) to farmers, but scientists seem to be embracing a new strategy to ensure that there exist relevant regulatory systems.

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Cambodia: Biotechnology Introductory Workshop in Cambodia

This report summarizes the outcomes of the Biotech Introductory Workshop, which was organized to increase awareness of agricultural biotechnology and ensure science-based regulatory decisions in Cambodia.

Cambodia: Biotechnology Introductory Workshop in Cambodia

Published by the USDA Foreign Agricultural Service as its Global Agricultural Information Network (GAIN) Report. View article link here.

Review of Australia’s Gene Technology Regulations: Opportunity to Strengthen Australia’s Biotechnology Industry

As Australia faces the challenges that come with the end of the resources boom and a shift away from many traditional manufacturing industries, the biotechnology industry represents an important opportunity for economic growth. With an increase in the demand for biotech products comes the potential for Australia’s biotechnology sector to offer substantial growth and investment opportunities if supported by the right policy settings. It was recently reported that the sector is expected to grow at a rate of 4.4% a year until 2021, bringing AUD8,675M of revenue to industry.[1]

Further, last year alone, more than 630 biotechnology patent applications including claims referring to “nucleic acids” were filed with the Australian Patents Office – many claiming subject matter that no doubt will test the boundaries of what constitutes patentable subject matter.[2]

In an industry that has undergone rapid technological advancement since the Regulator last conducted a technical review (which resulted in amendments being made to the Gene Technology Regulations 2001 (Gene Technology Regulations) in 2011), it is timely that the Australian Gene Technology Regulator (Regulator) has initiated a technical review of the Gene Technology Regulations.

This latest review seeks to clarify whether organisms developed using newly developed technologies should be regulated as genetically modified organisms (GMOs) to ensure that new technologies are regulated in a manner commensurate with the risks they pose, and importantly, to ensure the Gene Technology Regulations reflect the current state of technology and scientific knowledge. Among the “new” technologies noted in the Regulator’s discussion paper as being relevant to the present technical review are agroinfiltation,[3] grafting,[4] RNA interference (RNAi)[5] and, of course, genome editing.[6]

Background
Under the terms of the Gene Technology Act 2000 (Gene Technology Act), “dealings” with organisms that meet the definition of “genetically modified organism” (GMO) – being an organism that has been modified by gene technology or an organism that has inherited particular traits that has occurred because of gene technology – are tightly regulated, and generally prohibited unless authorized by a GMO licence or otherwise may be characterised as “low risk”, “exempt” or specifically included in the GMO Register. While these restrictions on dealings with GMOs are aimed at minimising the risks posed by GMOs to people and the environment,[7] it is clear that the definition of “GMO” was intentionally cast broadly to ensure that it could be adapted to new technology as it develops.

The Gene Technology Regulations currently exclude a number of techniques from the definition of gene technology (including somatic cell nuclear transfer, protoplast fusion and various forms of induced mutagenesis) and a number of organisms from the definition of GMOs.[8] However, the applicability of those exclusions has become less clear with the fast development of new technologies. A major focus of the technical review will therefore be to clarify what is excluded from the definition of “gene technology” and “GMO”.

The Technical Review
The Regulator seeks submissions from interested stakeholders, offering the following four options for the regulation of new technologies:

  1. no amendment to the Gene Technology Regulations
  2. regulate certain new technologies
  3. regulate some new technologies based on the process used
  4. exclude certain new technologies from regulation on the basis of the outcome they produce.

Option 1 is self-explanatory. Option 2 proposes to amend the Gene Technology Regulations so that dealings with all organisms developed using oligo- and site-directed nuclease techniques are regulated under the Gene Technology Act. Under option 3, techniques which use a nucleic acid as a guide for directing DNA repair would result in a GMO, whereas certain techniques which do not involve the application of a nucleic acid guide would not result in a GMO. Option 2 and, to a lesser extent, option 3, would appear to have the effect of regulating organisms that are indistinguishable from those that are presently excluded from the definition of GMO, such as organisms brought about by natural, chemical or radiation mutagenesis. Option 4 proposes to exclude organisms from regulation as GMOs if the genetic changes they harbour are similar to, or indistinguishable from, those brought about by “conventional” breeding (including radiation and chemical mutagenesis).

A number of other issues will also be examined as part of the technical review including issues surrounding gene driven research and the applications of RNA interference. Stakeholders are asked to provide answers to eight consultation questions which are focused on these issues. The discussion paper also foreshadows the possibility of amending the Gene Technology Regulations to clarify the meaning of certain terms which have become increasingly ambiguous in light of technological developments such as “mutational event”, “introduction”, “foreign nucleic acid” and “non-homologous”.

The technical review must maintain the current policy settings and so cannot alter the definition of “GMO” in the Gene Technology Act. However, it is within the scope of the technical review to add to the list of techniques that are not “gene technology” and to the list of organisms that are not “GMOs”. In the event that amendments to the Gene Technology Regulations are deemed necessary, the Regulator will conduct another public consultation on any proposed amendments.

The discussion paper is available here. The initial deadline of 2 December 2016 for lodging a submission to the review has been extended to 16 December 2016.

[1] The McKell Institute BioSavvy Report, October 2016.

[2] Reference more here.

[3] Voinnet O and Baulcombe D.C. Nature 389, 553 (1997).

[4] Brosnan C.A., Mitter N., Christie M., Smith N.A., Waterhouse P.M., Carroll B.J. Proc. Natl. Acad. Sci. 104, 14741-14746 (2007)

[5] Christie M., Croft L.J., Carroll B.J. Plant J. 53, 799-805 (2010).

[6] Kim J. Nat. Prot. 11, 1573-1578 (2016).

[7] section 10.

[8] GT Regulations sch 1, 1A.

-Published in The National Law Review.  See article link here.

About the Authors:

Michael Christie Ph.D., KL Gates, biotechnology lawyer, patent application attorney
Dr. Christie is a registered Australian and New Zealand patent attorney with a technical background in biotechnology. His work includes drafting and prosecuting patent applications, providing advice on the validity and infringement of patents, and acting in opposition matters.

Dr. Christie acts across a range of technical fields including pharmaceuticals, diagnostics, agriculture, genetics and genomics, biochemistry, chemistry, food technology, nanotechology and medical devices.

Dr. Christie also assists clients to…

Michael.Christie@klgates.com
61-2-9513-2497
klgates.com

Veg Tran, KL Gates, life sciences lawyer, food technology attorney
Special Counsel
Ms Tran is an intellectual property litigator with a substantial depth of experience in advising and representing a wide range of clients in proceedings before the Federal Court and High Court of Australia, as well as in matters before the Australian Patent Office.

With a First Class Honours degree in Biotechnology and training from leading research and development organisations such as the CRC for Biopharmaceuticals, CRC for Food Industry Innovation and the Garvan Institute of Medical Research, Ms Tran practices intellectual property law with a specific interest in the biotechnology, pharmaceutical, life sciences and food technology industries. She has represented a large number of clients with global business operations and has significant experience working within multi-jurisdictional teams in patent infringement and revocation matters involving technologies such as electronic devices and components, medical devices, industrial equipment, as well as pharmaceuticals.. Many of these clients are the owners of extensive and highly valuable intellectual property portfolios world-wide, and are leading companies within their fields.

Veg.Tran@klgates.com
61-2-9513-2437
klgates.com