Policy, Legal, and Regulatory Environment

Problem: Legal and regulatory systems provide a lens through which to assess a country’s seed system; evaluate implementation challenges; identify relevant regulatory good practices and models that have worked in other markets; integrate legal and political economy considerations to evaluate how policy, law, and regulation can work as an incentive (or disincentive) for change; and identify which interventions could be prioritized.

Vision of a healthy system: •A well-developed policy and regulatory environment is central to a functioning seed system that ensures farmers access to affordable, available, and appropriate quality seed. Each of the key elements of the seed system notably; (i) breeding and variety release; (ii) early generation seed supply; (iii) certified seed production; (iv) awareness by farmers; and (v) seed marketing and distribution is affected by, and requires adequacy of, the policy and regulatory environment at national, regional and international levels.  Key components include:

  • Clear policies laws and regulations that promote rather than restrict private sector access to public varieties for multiplication and accessibility by farmers
  • Policies and laws that allow private sector to produce EGS to complement government institutional capacity to meet the needs of farmers
  • Policies and regulations that provide for third-party seed inspection with audit and oversight from government regulatory agencies
  • Policies and regulations that promote quality and standard seed inspection services 
  • Stronger regional and national policies for the domestication and implementation of regional harmonized regulations
  • Effective policy instruments that prevent the distribution and sale of fake or counterfeit seed
  • Clear and simplified registration process for seed producers and traders
  • Guidelines in place for strong variety development and variety release
  • Guidelines that stipulate and ensure adherence to (and sanctions for non-adherence of) seed packaging and labeling requirements
  • Private sector is aware of policies and rules and has access to updates; Channels and systems exist to allow for private sector engagement, feedback, and right of action where appropriate (e.g., against counterfeit products)

Basis of Comparison =  Under development

Assessment goal = Evaluating seed policy, legal, and regulatory systems against “health of the system” and effective implementation

Strategic ObjectiveDescriptionSystem IndicatorsProcess Categories
Policy, Legal and Regulatory Framework Design•Legal model followed (common law, civil law, etc.), division of responsibilities between national and sub-national, regional agts.
•Policy, legal, and regulatory measures and their design
•Structural Completeness Measures
•of policy, law, and regulation
•Reference to Regional Trade Agreements
•Variety release and registration
•Plant Breeders’ Rights
Implement Rules/Regs to Improve Efficiency of Seed System Performance (NML Implementation Dimension I)•Time, cost, and completion of regulatory processes, such as a license or registration issued•Time, Cost, Completion of Regulatory Process, Number of Steps Involved•General
•Market Entry/Registration of Seed Dealers
•Variety Release and Registration
•Plant Breeder’s Rights/IP
•Seed Quality Control and Certification (Questions also covered under QA component)
Reduce Regulatory Gateways/Preconditions (NML Implementation Dimension II)•Tracks regulatory preconditions, meaning that  one regulatory process will require or trigger completion of another regulatory process (e.g. seed dealer registration required to register a variety, variety registration required for commercialization, etc.). •Regulatory preconditions that prevent market entry and/or movement to another stage in the seed value chain•General
•Market Entry/Registration of Seed Dealers
•Variety Release and Registration
•Plant Breeder’s Rights/IP
•(Certification questions also covered under QA component)
Engagement in Rulemaking (NML Implementation Dimension III)•Clear channel for private sector participation in rulemaking and enforcement, including when measures are amended.​
•Sector actors are familiar with relevant rules and regulations, especially following changes.
•Increased engagement in seed system•General
Implement Rules to Improve Effectiveness of  Regulatory System (NML Implementation Dimension IV)•Degree to which rules are effective in achieving purpose; for example, clear counterfeiting rules are established with appropriate sanctions, clear standards for traceability (including rules on packaging and labeling), and identification of counterfeits.
•For counterfeiting, there is a private right of action (farmer can bring a claim), and/or link with consumer protection law.​
•Effectiveness of  Regulatory System•General
•Varietal Research and Development
•Plant Breeder’s Rights/IP
•Variety Release and Registration
•Seed Certification and Quality Control (Questions also covered under QA component)
•Anti Counterfeiting

Description of Methodology

Typology of Stakeholders: Public and Private (Public to include Ministry of Agriculture, Regulatory Bodies, Variety Release Committee, Ministry of Trade, NARS, etc.; Private Sector will also be consulted to “ground truth” policy, legal, and regulatory processes and procedures)

Method for conducting the assessment:

  1. Desk review to identify gaps in legal framework (nearly complete)
  2. Request for documents where gaps exist
  3. Pre-interview survey for content/processes and institution infrastructure, personnel, budget etc., extended via web-based application providing context through facts, figures and background information
  4. Remote interviews to engage stakeholders through the established questionnaire with follow up questions, discussions and clarifications

Discussion of Outputs

•Based on answers and follow up discussion, a score of 1 to 4 (Likert scale) is recorded for some questions which will summarize the overall impression

Examples of question with scoring scale:

  • Is there a sound evidentiary basis underpinning seed policy and rules?
  • How long does it take to get a seed dealer’s license (which is a regulatory precondition for many other steps in the value chain)?
  • Are the requirements for obtaining a seed dealer’s license clearly articulated?
  • How is the variety release committee structured?
  • How often does the variety release committee meet, both by law and practice?

•Other open-ended questions provide space for qualitative information and interviewer notes

•Notes taken during interview and scores assigned form the basis for identifying areas for improvement and recommending mitigation measures

•Report includes scores and areas for improvement