It costs $136 million to discover, develop and commercialize a GMO

By Clet Wandui Masiga, Conservation Biologist, Geneticist and Farm Entrepreneur

It costs $136 million to discover, develop and commercialize GMOs having any specific trait. This cost represents money spent on staff, equipment and laboratory supplies, and   the regulatory testing and registration process. The time taken is about 13 years. Much of this time which is about 5.5 years is regulatory and registration.

Below is information I obtained at crop life website on October 201 (https://croplife.org/plant-biotechnology/regulatory-2/cost-of-bringing-a-biotech-crop-to-market/).

Each year, millions of farmers around the world plant biotech crops for higher yields, improved crop quality and the ability to use sustainable farming practices such as no-till.  Getting these innovative new traits from the lab to their fields requires a tremendous investment – a new research survey reveals how it all adds up.

  • The cost of discovery, development and authorization of a new plant biotechnology trait introduced between 2008 and 2012 is US$136 million.
  • The time from the initiation of a discovery project to commercial launch is 13.1 years on average for all relevant crops.
  • The time associated with registration and regulatory affairs is increasing from a mean of 3.7 years for an event introduced before 2002, to the current (2011) estimated 5.5 years.
  • Regulatory science, registration and regulatory affairs account for the longest phase in product development, estimated at 36.7% of total time involved.
  • The trend in the number of units (candidate genes, constructs or genetic events) being screened in order to develop one trait is increasing.

From discovering new genetic traits, field testing and meeting intense regulatory requirements that ensure environmental and human safety, the overall plant biotech R&D process is costly and time-consuming. To determine the relative cost and duration of this process, Phillips McDougall conducted a research survey based on information provided by six of the industry’s largest biotech crop developers – BASF, Bayer CropScience, Dow AgroSciences, DuPont/Pioneer Hi-Bred, Monsanto and Syngenta AG.

The September 2011 survey entitled, “The cost and time involved in the discovery, development and authorization of a new plant biotechnology derived trait”, focused on biotech traits in large scale commodity crops that had received cultivation approval in two countries and import approvals from at least five countries.

Key findings of the survey included:

Overall Cost

The cost of discovery, development and authorization of a new plant biotechnology trait introduced between 2008 and 2012 is US$136 million

Overall Time to Commercialization

The time from the initiation of a discovery project to commercial launch is 13.1 years on average. This does not include the time required to develop and obtain regulatory approval for stacked trait varieties which are the final product in most crops today.

Number of Years Required to Discover, Develop and Authorize a new Plant Biotech Trait (Mean Values)

Canola

Corn

Cotton

Soybean

All crops

Number of years from discovery of trait to first commercial sale

11.7

12.0

12.7

16.3

13.1

 

Duration of Each Activity Stage

The time associated with the R&D stage involving registration and regulatory affairs (Stage VII) is increasing from a mean of 44.5 months (3.7 years) for an event introduced before 2002, to the current estimate of 65.5 months (5.5 years). Because various activity stages overlap in real time, these totals do not reflect the actual duration of the overall R&D process described above.

Duration of Each Activity Stage in the Trait R&D Process (mean number of months)

Activity Stage

Duration for an event sold before 2002

Duration for an event introduced between 2008 and 2012

Duration to complete each stage in 2011

I Early Discovery

38.0

33.9

25.8

II Late Discovery

17.3

20.0

20.9

III Construct Optimization

18.0

27.0

32.8

IV Commercial Event Production & Selection

24.0

30.0

34.0

V Introgression Breeding & Wide-Area Testing

40.0

37.2

42.0

VI Regulatory Science

50.5

37.2

47.0

VII Registration & Regulatory Affairs

44.5

48.8

65.5

Total Cumulative Time

232.3

234.1

268.0

Number of Units Evaluated

The trend in the number of units (candidate genes, constructs or genetic events) being subjected to screening in order to develop one trait is increasing from a mean of 1,638 for an event introduced before 2002, to 6,204 for an event introduced between 2008 and 2012. The survey also demonstrated increasing efficiency by the industry with fewer events in the production & selection stage (Stage IV) for the events commercialized in 2008-2012 compared to events introduced before 2002.

Activity Stage

Event introduced before 2002

Event introduced between 2008-2012

I Early Discovery

1,638

6,204

II Late Discovery

302

4,005

III Construct Optimization

135

511

IV Commercial Event Production & Selection

2,853

1,302

V Introgression Breeding & Wide-Area Testing

4

2

VI Regulatory Science

2

1

VII Registration & Regulatory Affairs

1

1

 

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Factors hindering adoption of GMO Africa

By Clet Wandui MASIGA, Conservation Biologist, Geneticist and Farm Entrepreneur

Ezezika and colleagues analysis of factors that hinder the adoption of GMOs in Africa are still at large in influencing decisions on GMOs today. The four factors identified by Ezezika and team include communication, culture and religion, capacity building and commercialization.

The main challenge limiting GMO adoption is limited understanding of GM crops by the public. This was closely followed by elitism in reporting and ineffective and inaccuracies.  Full report is available at http://www.nature.com/nbt/journal/v30/n1/full/nbt.2088.html

 

 

 

Potential economic impact of genetically modified Banana in Africa

By Clet Wandui Masiga Conservation Biologist, Geneticist and Farm Entrepreneur

A study done by John Herbert Ainembabazi and  colleagues published on September 28, 2015 by PLOS supports investment in the development  of GM banana resistant to Xanthomonas wilt disease. The main beneficiaries of this technology development are farmers and consumers, although the latter benefit more than the former from reduced prices. The study recommends that designing a participatory breeding program involving farmers and consumers signifies the successful adoption and consumption of GM banana in the target countries.

The results from the study indicate that on the release of GM banana for commercialization, the expected initial adoption rate ranges from 21 to 70%, while the ceiling  adoption rate is up to 100%. Investment in the  development of GM banana is economically viable. However, aggregate benefits vary substantially across the target countries ranging from US$20million to 953million, highest in countries where disease incidence and production losses are high, ranging from 51 to 83% of production. The study was done in the great lakes region focusing on Uganda, Kenya, Rwanda, D R Congo, Burndi, Rwanda and Tanzania where banana bacterial wilt disease is a big threat to banana production. The full article is available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4587572/

 

 

 

 

Monsanto vs. Freedom of Information Act

By Clet Wandui Masiga, Conservation biologist, Geneticist, and Farm Entreprenuer

Ralph Nader examines Monsanto Vs. Freedom of Information Act (FOIA). In his piece Nader reviews the history of FOIA and It is a vital investigative tool for exposing government and corporate wrongdoing. Ant-GMO activists are using it to expose public publics with ties to multinational businesses in agro input producers and manufacturer. Am personally concerned that this act is being misused and may have significant negative consequences for developing countries where a majority go without food. Details of Ralph Nader article is available at http://ecowatch.com/2015/10/05/ralph-nader-monsanto-foia/

 

Genetically Modified Seed Central in Saik’s Agricultural Manifesto

By Clet Wandui MASIGA, A conservation Biologist, Geneticist and Farm Entrepreneur

Email: wmasiga@hotmail.com

Hype, misinformation, and twisting of facts have been used to deny farmers in developed countries access to genetically engineered (GE) seed for farming. This has created fear towards GE crops, thus enabling organic food dealers to make more profits in North America and Western Europe. AGRI-TREND CEO Robert Saik makes these arguments and more in his Agriculture Manifesto (May 2014).

The 52 page book contains ten key drivers that will shape agriculture in the next decade. On September 3, 2015, the Cornell Alliance for Science hosted a lecture by Saik to twenty-five Global Leadership Fellows (myself included), communications champions from around the world focused on to enhancing their capacities for ensuring that farmers have access to scientific innovation. It’s hoped that this diverse group of champions from Uganda, Kenya, Tanzania, Ghana, Nigeria, Bangladesh, India, Philippines, Indonesia, and USA will build a global community of advocates in support of science and evidence-based decision-making.

Central in Saik’s lecture was that the future of agriculture could be genetically modified organisms, which he has re-baptized as genetically modified organic (GMO). He explained why GMOs have been resisted and continue to be. In his message, Saik suggests that commercial interests such as Whole Foods, Trader Joe’s, and Chipotle—grocery chains and restaurants that seem interested in pushing a mandate of anti-industrialization of agriculture onto consumers—have led to a great deal of suspicion about GMO technology. In other words, he argues that a non-science movement is closely related to money; the rise of “Big Organic” the back of fear and suspicion, not on science.

Due to misinformation, particularly by biosafety entrepreneurs, many countries have difficulties making decisions on whether or not to adopt use of GMOs in agriculture. In Uganda, some of these biosafety entrepreneurs include the Centre for Health, Human Rights and Development (CEHURD), Food Rights Alliance Uganda (FRA), the Southern and Eastern African Trade Negotiations Institute (SEATINI), and Action Aid Uganda. Their businesses thrive by attracting money from donors purposely to create fear that GMOs are not safe. They twist facts and provide many non-science references to deny farmers access to genetically modified (GM) seed that could have huge benefits for better crops and more healthy food.

GM seeds have the opportunity to provide many benefits to farmers. In Uganda GM maize seeds have been developed to tolerate drought and resist pests, GM cassava to resist diseases, GM sweet potatoes to resist pests and viruses, GM cotton to resist pests, and GM banana to resist pests and diseases. Denying farmers access to such technology deprives them of key input for production and makes farming more expensive.

The other nine key drivers in the agricultural manifesto are non-science, market, sensor technology, 3D printing, Robotics, water, precision agriculture, artificial intelligence, and data. This book is written to enable farmers, agribusiness communities, and consumers to stay informed about the future of agriculture. This book was an Amazon 2014 Best of Books.

It has taken developing countries more than 20 years to decide on whether or not to adopt GE seed and it’s therefore time for farmers to liberate themselves by demanding for access to GE seeds. Not all issues against GM seed are based on science.

The main set back of Saik’s book is that it’s self published and has not been reviewed by anyone independent and or experts in agriculture. As such it’s limited to his personal opinion.  There are no references cited which makes it difficult for anyone to access the quality of his publication. Nevertheless he does an excellent job in sharing his own personal opinion on the technologies for the future of agriculture.

Uganda’s Innovation Policies Profiled at the Current Global Ranking

Clet Wandui MASIGA at the Screen houses for Vegetable seed production
Screen houses for Vegetable seed production

By Clet Wandui MASIGA

Conservation Biologist and Geneticist and Farm Entrepreneur

Email: wmasiga@hotmail.com

Uganda is among a group of six countries outperforming their economic peers in the recently released report on Global innovation index (GII) according to the report released on Friday 17th September 2015 in London, UK. Other countries that outperformed their peers include China, Malaysia, Viet Nam, India, Jordan, and Kenya. The GII 2015 looks at “Effective Innovation Policies for Development” and shows new ways that emerging economy policymakers can use to boost innovation and spur growth by building on local strengths and ensuring the development of a sound national innovation environment.

Speaking at the release of the report, Francis Gurry the current Director General of the World Intellectual Property Organization re-echoed the known fact that Innovation holds far-reaching promise for spurring economic growth in countries at all stages of development. He further indicated that each nation must find the right mix of policies to mobilize the innate innovative and creative potential in their economies.

According to the report the top five most innovative countries include Switzerland, the United Kingdom, Sweden, the Netherlands and the United States of America while China, Malaysia, Viet Nam, India, Jordan, Kenya, and Uganda are among a group of countries outperforming their economic peers. In my own analysis there is one thing that is common among the top innovators. They have a tradition of attracting the best talented and innovative brains from around the world and provide them scholarships to study in their universities or work in their established scientific and industrial institutions. In addition they have a tradition in investing in science and research and accordingly they tend to produce more quality research.

The innovation quality is measured by university performance, the reach of scholarly articles and the international dimension of patent applications which is facilitated by the fact that the top countries happen to host the world top class universities.

The Uganda government needs to continue its commitment to making Uganda the best place to innovate, patent new ideas and start and grow a business. This can be achieved by focusing on human capital development and research and development funding. Human capital development can be enhanced by continuing to innovate in the education system and our university education.

In Uganda, Makerere university ranks top in innovation but these gains are likely to be stagnated when you get its influential scholars against innovations and discouraging partnerships for innovation. This has been the case for biotechnology innovations and genetic engineering in particular in the college of agriculture and environmental sciences.

Another institution that is on top of innovation is the National Agricultural Research Organization (NARO). The recently adopted plant variety protection act is enhancing the innovation process in breeding new varieties of crops. The act provides for promotion and development of new varieties of crops and their protection as a means of enhancing breeders’ innovations and rewards through granting of plant breeders’ rights and other related matters. However, we have a group of civil activist in courts challenging it. This group is closely linked to anti-innovation lecturers such as Gregory Olupot at Makerere University. Olupot is a lecturer of soil biophysics in the department of Agricultural Production at the College of Agriculture and Environmental Sciences (CAES). He is opposed to any technologies and innovations largely due to conspiracy theories. He promotes outdated traditional approaches of farming such as farmer saved seed systems and out fashioned agricultural practices to new problems. Government should find a way of ignoring such groups and move on with policies to support innovations.

Finally Uganda government should continue to support private-public partnerships for establishment of innovation institutions/universities and in investing in research. One best approach to do this is to allocate private institutions/companies land to research, training, development and promotion of innovations. We also need government to strengthen the copyright registration services to support innovations and rewards to innovators.