By Donald Zuhn --
The Biotechnology Industry
Organization (BIO) and American Seed Trade Association (ASTA) announced
today that the Generic Event Marketability and Access Agreement (GEMAA)
has received four signatories, and as a result is now effective. The GEMAA is one of two agreements -- the
Data Use and Compensation Agreement (DUCA) being the other -- that form the
Accord, a private-sector driven framework for
dealing with the transition of regulatory and stewardship responsibilities for genetically
modified seed technology (i.e., seed
varieties containing "biotechnology events"), after patent
expiration. The GEMAA, which was
launched late last month,
has thus far been signed by five agricultural biotech companies: BASF Plant Science, Bayer Crop Science, Dow
Agro Sciences, DuPont Pioneer, and Monsanto Company.
According to BIO's
statement on the GEMAA taking effect, the agreement "will provide
confidence to growers, breeders and grain handlers in the use of generic
biotechnology events [and] benefit the entire agriculture value chain by
ensuring the maintenance of foreign regulatory authorizations and stewardship
obligations following the expiration of patents for biotechnology events
utilized in seed varieties." The
Accord website (www.AgAccord.org) notes that nearly 90% of cotton, corn, and
soybean acreage in the U.S. is planted with seed varieties containing
biotechnology events, and that grain from these crops accounts for more than
$40 billion in global trading annually, making the U.S. the largest global producer
and exporter of crops and grain derived from biotechnology. With the first genetically modified seed
patents set to go off patent by 2015, such patent expirations present challenges
such as the maintenance of global regulatory authorizations for biotechnology
events and associated stewardship obligations so that farmers can continue to
cultivate seed varieties containing off-patent events without jeopardizing U.S.
export markets.
Under the GEMAA, companies
that have developed proprietary regulatory information to support the global authorizations
for biotechnology events (known as Proprietary Regulatory Property (PRP)
Holders under the agreement) will provide notice of patent expiration three
years before the last patent on the biotechnology event expires, provide access
to the biotechnology event at patent expiration, and opt for one of three
choices with respect to regulatory responsibility. Those choices include Independently maintaining
regulatory responsibility for the event at no cost to users of the generic
event for at least four years after the last sale of the product, seeking to share
regulatory responsibility, or discontinuing regulatory responsibility (If no
interest is expressed by other signatories).
The GEMAA will be overseen
by a Committee of Signatories that will be formed, and will hold its first
meeting, within three months.
Additional information
regarding the Accord can be found here.
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