Data Protection for Agricultural Chemicals

1
Data Protection for Agricultural Chemicals

• 
  Alfredo Ruiz
• 
  President
• CropLife Latin America

Intellectual Property, Trade and Economic
Developing Seeking consensus Summit of the
Americas Center, FIU. Miami, March 2006
2
What is CropLife Latin America?
Is the Regional Association representing the
Plant Science Industry in Latin America

• The Plant Science Industry invents, develops,
  manufactures and sells products and services
  designed to improve the global production of
  food, feed, fibre and other useful products in a
  sustainable way. (i.e. Insecticides, Herbicides,
  Biotechnology).

3
The CropLife Network
European Crop Protection Association www.acpa.be

• CropLife Latin America
• CropLifeamerica.org

Japan Crop Protection Association www.jcpa.org
Crop Life International
www. croplife.org
Crop Life Asia www.croplifeasia.org
Crop Life Africa Middle East www.croplifeafrica.or
g
Crop Life Latinamerica www.latinamerica.org
4
National Industry Associations Network
CropLife Latin America
5
Leading Plant Science Companies
CropLife Latin America
6
A New Agricultural Chemical is the result of

• Identifying a disease, pest
• or weed that needs to be
• controlled in a crop.
• Synthesizing 140.000 new
• chemical entities.
• Selecting those with the
• desired properties.
• Filing Patents in major
• markets.

7
A New Agricultural Chemical is the result of

• One of the new chemicals entities is selected
• Ten years of research and development start
• By the time a product based on the new chemical
  entity enters the market US200 million have been
  invested.

8
A New Agricultural Chemical is the result of

• Developing the REGISTRATION DATA required by the
  Regulatory Authorities to demonstrate the new
  chemical safety and efficacy. This is a requisite
  to grant the sales permit

FIFRA Section 3 Registration Data Requirements

• 120 - 150 Studies demonstrating safety to
  humans, animals, and the environment.
• Studies demonstrating effective crop protection
  in different countries, conditions and locations.
• Studies demonstrating that food from crops
  treated with the new product is safe to the
  consumer.

9
What is Data Protection (DP)

• A tool to protect research efforts investments
  made in order to demonstrate the safety and
  efficacy of the new chemical entity -registration
  data- and obtain the sales permit.
• Effective DP legislation offers the first
  registrant temporary exclusive use of
  registration data resulting in
• Market advantage that allows the innovator to
  recoup the investment
• Balance between fair competition and access to
  market

10
Equivalence FAO Specifications

• Once the exclusivity period is over, a second
  registrant can use the data to register his/her
  product as long as this product is equivalent to
  the first product registered
• FAO specifications are the international standard
  and should drive the equivalence process
• They determine the quality of an agrochemical,
  both for chemical entity and impurities
• They are developed with consideration of
  particular methods of manufacturing
• They may be used by national authorities as
  registration requirements
• (FAO United Nations- Food and Agriculture
  Organization )

11
Benefits of Data Protection
A Tool that guarantees Quality and Safety

• The data required by the FAO equivalence
  procedure will demonstrate safety of a copy
  product to the health and the environment.
• For equivalent products Regulatory Authorities
  can rely on the Extensive Registration Data
  submitted by the first registrant, once the
  exclusivity period expires.
• The combination of Data Protection and a sound
  process to grant Registration, guarantees that
  only quality Ag chemical enter the market,
  resulting in increased protection to the farmers,
  the consumer and the environment.

12
Myths around Data Protection

• Data Protection is an extension of the patent.
• Data Protection is designed to block competition.
• Data Protection will close the market to generic
  products.

13
Data Protection And Patents
Myths around Data Protection
Patents and DP may coexist in one same product
14
Crop Life Latin America Position on Data
Protection

• In line with legislation in the United States,
  the European Union and several Latin American
  Countries, the Plant Science Industry advocates
  that the best way to foster and protect
  innovation is to
• Ensure to the titleholder of the studies a
  minimum of ten years exclusivity period of the
  Registration Data for new chemicals entities,
  followed by five years of compensation (Beginning
  from the date the sales permit is granted to the
  innovative product in the country where the
  product is approved).
• Ensure a five-year protection for additional Data
  requested by the authorities to maintain market
  approval.
• Copy products must demonstrate chemical
  equivalence to the first product that entered the
  market according to the FAO equivalence
  procedures.

15
Data protection in Latin America

• Brazil has a law granting 10 years of data
  protection to Ag Chemicals and 5 years to
  additional data.
• Chile, Five Central American Countries and
  Dominican Republic have FTAs with the USA
  including 10 years of data protection. Colombia
  and Peru have just finished negotiating
  agreements containing similar provisions.
• Colombia has a decree granting 5 years of data
  protection
• Argentina has a law granting data but it is
  ineffective due to lack of implementation
• Mexico within NAFTA offers a minimum of 5 years
  of data protection.

16
Crop Life Latin America Position on Data
Protection

• The generation of safety and efficacy studies
  for approval of new agrochemicals products or for
  re-approval of existing chemicals protects the
  health of the users, the consumers and the
  environment. It involves a considerable effort
  that should be protected.

17
THANK YOU!
Alfredo Ruiz President CropLife Latin America