Regulatory harmonisation lessons from comparative studies


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Biosafety Regulation: Opening up the debate - Lessons from Kenya and Philippines

Workshop in Kenya, 15 - 16 November 2010

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Regulatory harmonisation lessons from comparative studies

  1. 1. Regulatory harmonization: lessons from comparative studies of the design and implementation of biotechnology regulations in different national contexts Patrick van Zwanenberg STEPS Centre Email: [email_address]
  2. 2. <ul><li>Two broad issues to highlight </li></ul><ul><ul><li>relative flexibility allowed by supposedly harmonised rules, and their implementation and interpretation </li></ul></ul><ul><ul><li>complexity of real world seed production and use and some regulatory governance challenges </li></ul></ul><ul><li>Worth asking in the Philippine and Kenyan contexts: </li></ul><ul><ul><li>What kinds of flexibility have been/are needed? </li></ul></ul><ul><ul><li>What areas of complexity need to be considered? By whom? </li></ul></ul><ul><ul><li>What are the practical limits to the governability of these new technologies in these social/agricultural contexts? </li></ul></ul><ul><ul><li>How can regulatory systems take into account these local realities? </li></ul></ul>
  3. 3. The traditional regulatory model as practiced and/or promoted by USA, EU, OECD & WTO <ul><li>Confined to ‘back end’ of innovation process (IPRs one exception) </li></ul><ul><li>Concerned only with individual technological artefacts </li></ul><ul><li>Concerned only with biophysical risks & IPRs </li></ul><ul><li>Biophysical risks narrowly defined, </li></ul><ul><ul><li>i.e. a focus on direct, measurable, relatively well known hazards, arising under idealised use conditions: required minimal evidence of safety and thus favoured approval </li></ul></ul><ul><li>No overt consideration of other forms of non biophysical risk </li></ul><ul><ul><li>e.g. to incomes, employment, land use, food security, availability of export markets, shifts in plant breeding capabilities and research agendas from public to private sectors and domestic to foreign seed firms) </li></ul></ul>
  4. 4. <ul><li>This model exported elsewhere via regulation harmonization activities (GATT, TRIPS, SPS Agreement, OECD & Codex Guidelines, some bilateral capacity building – in part via Cartagena Protocol too) </li></ul><ul><li>But, especially after late 1990s, tensions between US/EU over how to regulate biophysical risk (although the consensus that socio-economic risk should be excluded largely remained) </li></ul>
  5. 5. One consequence of the different and changing US/EU approaches is that there is little international consensus over: <ul><li>what categories of biophysical risks to address, </li></ul><ul><li>what baseline of normality to assume </li></ul><ul><li>what changes should count as harm </li></ul><ul><li>how to investigate and measure potential risks (e.g. which causal pathways to investigate, what tests are adequate) </li></ul><ul><li>what counts as sufficient evidence to demonstrate acceptable safety or unacceptable risk </li></ul>
  6. 6. <ul><li>At the same time, WTO dispute processes </li></ul><ul><li>have affirmed: </li></ul><ul><li>right of countries to choose their own levels of acceptable risk </li></ul><ul><li>risk assessments can take into account local realities of technology use </li></ul><ul><li>countries may accept the validity of minority scientific opinions </li></ul><ul><li>evidence of risk need not be quantitative. </li></ul><ul><li>Implications: </li></ul><ul><li>individual countries have autonomy to devise biophysical assessments appropriate to their ecological and socio-economic circumstances and choices (e.g. in terms of the scope of those studies and the criteria by which they are to be interpreted) </li></ul>
  7. 7. <ul><li>Despite GATT, SPS Agreement rules, and only limited scope in Cartagena Protocol for socio-economic effects… </li></ul><ul><li>… a broad range of socio-economic risks are in practice part of formal bio-safety regulatory remits in many countries </li></ul>
  8. 8. <ul><li>Argentina – licensing conditional on availability of </li></ul><ul><li>export markets </li></ul><ul><li>Brazil – licensing may involve assessment of ‘convenience, socio-economic opportunity and national interest’ </li></ul><ul><li>Uganda – draft regulations: “no approval shall be given unless the GMO will not have adverse socio-economic impacts.” </li></ul><ul><li>Philippines - “Impacts on small farmers, indigenous people, women, small and medium enterprises, and the domestic scientific community to be taken in to account.” </li></ul><ul><li>Indonesia – “must pay attention to and take into consideration the religious, ethical, socio-cultural and esthetical norms.” </li></ul><ul><li>Norway – “to ensure that the production and use of genetically modified organisms takes place in an ethically and socially justifiable way…” </li></ul><ul><li>EU – labelling requirements reflect extra-scientific issues, i.e. consumer choice </li></ul><ul><li>Source: STEPS; Falck-Zepeda 2009 </li></ul>
  9. 9. Transgenic cotton – Chaco Province, Argentina <ul><li>Context </li></ul><ul><li>98% of cotton farmers are small/medium sized, with no access to credit and are not served by commercial markets. 2% are large commercial farms producing most of the cotton </li></ul><ul><li>Conventional cotton seed varieties were traditionally bred and sold by the public sector and sold through cooperatives </li></ul><ul><li>GM commercialisation in the 1990s led by MNCs (soya, maize, cotton) </li></ul><ul><li>In late 1990s two GM varieties were introduced by Monsanto – they cost 4 times price of conventional varieties </li></ul><ul><li>By late 2000s, conventional cotton varieties no longer available in the market </li></ul>
  10. 10. Transgenic cotton – Chaco Province, Argentina <ul><li>Formal regulation </li></ul><ul><li>Bio-safety licensing (harmonised rules + export potential) </li></ul><ul><li>Intellectual property (harmonised rules based on UPOV 1978, patents) </li></ul><ul><li>Seed quality </li></ul><ul><li>Private regulation – contracts between seed firms and large commercial farmers (require payment for saved seed & planting of refuges) </li></ul><ul><li>And its limits: </li></ul><ul><li>uncertified GM seeds are 90% of the total seed use </li></ul><ul><li>seed quality control only for the 10% of certified seeds </li></ul><ul><li>private contracts are unenforceable (including refuge requirements) </li></ul><ul><li>unapproved GM varieties also available in parallel markets </li></ul>
  11. 11. Transgenic cotton – Chaco Province, Argentina <ul><li>Local realities: </li></ul><ul><li>Large farms (2% of all cotton producers) re-use seed extensively (in breach of both IP legislation and private contracts) but purchase a small proportion of certified seeds each year to maintain seed quality. </li></ul><ul><li>Small/medium farms (98% of all cotton producers) are trapped in parallel seed markets </li></ul><ul><ul><li>Cannot afford or access credit for certified GM seeds, and seed firms do not make them available </li></ul></ul><ul><ul><li>Conventional seed no longer available </li></ul></ul><ul><ul><li>Cannot re-use own seed because they do not own cotton gins </li></ul></ul><ul><ul><li>Only source of seed is uncertified GM varieties in parallel market – but no control over seed choice, and seeds are often of poor quality and uncertain identity. </li></ul></ul>
  12. 12. Transgenic cotton – Chaco Province, Argentina <ul><li>Regulator challenges </li></ul><ul><li>Local regulator not well enough resourced to control trade in uncertified seed </li></ul><ul><li>But as a matter of design too, regulations are concerned only with formal seed supply channels – they by-pass parallel markets </li></ul><ul><li>Regulators often assume farmers can choose to avoid parallel markets. They effectively fail to recognise small/medium farmer realities and the problems they face </li></ul><ul><li>Small cotton farmers have to deal with risks and problems of access to seeds that are entirely different from those regulators address </li></ul>
  13. 13. Transgenic cotton – Chaco Province, Argentina <ul><li>Possible ‘post-regulatory’ responses? </li></ul><ul><li>formalising parallel markets (Monsanto proposal) </li></ul><ul><li>state provision of/subsidy for seeds to small/medium farmers </li></ul><ul><li>exempting small farmers from intellectual property rules, but providing seed quality controls </li></ul><ul><li>Upstream solutions? e.g. renewed plant breeding by public sector, e.g. targeted at local pest problems. Niche markets (e.g. support for agro-ecological production) </li></ul>
  14. 14. Transgenic cotton – Tianm é n County, Hubei, China <ul><li>Context </li></ul><ul><li>Farm sizes are homogenous and small (less than 1 hectare) </li></ul><ul><li>Before late 1990s, public sector bred and disseminated conventional seeds (free) to local centers for adaptation and subsidized sale </li></ul><ul><li>But privatisation and liberalisation of seed market has led to very rapid explosion in number of seed firms and seed varieties </li></ul><ul><li>GM technologies in China mainly developed by the public sector, as part of a strategy to develop a nationally and globally competitive biotechnology industry. </li></ul><ul><li>GM cotton varieties introduced in late 1990s by Monsanto and Chinese Academy of Sciences, the latter via commercial spin off firm, Biocentury </li></ul>
  15. 15. Transgenic cotton – Tianm é n County, Hubei, China <ul><li>Formal regulation </li></ul><ul><li>Bio-safety licensing (harmonised rules + socio-economic criteria, e.g. trade, competition and food sovereignty ) </li></ul><ul><li>intellectual property (harmonised rules based on UPOV 1978, patents) </li></ul><ul><li>Seed quality </li></ul><ul><li>And its limits: </li></ul><ul><li>many seeds are re-named copies of existing varieties, or marketed before they receive variety approval, or before they are registered </li></ul><ul><li>seeds are often labelled ‘insect resistant’ but no biosafety certification numbers </li></ul><ul><li>F2 seeds (second generation crosses) are sometimes labeled as F1 </li></ul>
  16. 16. Transgenic cotton – Tianm é n County, Hubei, China <ul><li>Local realities: </li></ul><ul><li>rapid emergence of an extensive market in seed production and retail </li></ul><ul><li>faced with an overwhelming choice of seeds, compounded by the challenge of counterfeits and inaccurate labeling, farmers struggle to choose and source reliable cotton seeds. </li></ul>
  17. 17. Transgenic cotton – Tianm é n County, Hubei, China <ul><li>Regulator challenges </li></ul><ul><li>Limited legislative, technical and financial resources prevent regulators from identifying counterfeit seeds and limited focus on seed quality beyond basic issues (e.g. limited checks on germination rates) </li></ul><ul><li>Scarcity of financial resources also results in a focus on control activities that generate revenue rather than focus on quality assurance </li></ul><ul><li>Local political realities mean that regulators tend not to exert too much pressure on local seed firms </li></ul><ul><li>Activities that are problematic for farmers – the sale by licensed vendors of poor quality seeds – are not dealt with by regulators or at the village level. </li></ul>
  18. 18. Transgenic cotton – Tianm é n County, Hubei, China <ul><li>Possible ‘post-regulatory’ responses? </li></ul><ul><li>consolidation of the seed sector – plans to support 50 “champion” seed firms, and raise licensing standards, leading to the closure or take-over of smaller firms </li></ul><ul><li>private regulatory strategies to constrain counterfeiters (e.g. seed firms provide a telephone number for farmers to check the legitimacy of the seed packet number) </li></ul>
  19. 19. Summary <ul><li>The two country cases contrast markedly. </li></ul><ul><ul><li>structural/historical differences between the two countries (e.g role of state/private sector; big/small farmers) Technologies and their regulation therefore play out differently. </li></ul></ul><ul><ul><li>In Argentina a MNC-led process has led to a narrowing down of options which is squeezing out small farmers. </li></ul></ul><ul><ul><li>In China a state-led process has led to an explosion of 'options' (and private seed companies) in which farmers are not empowered to make real choices. </li></ul></ul>
  20. 20. Summary <ul><li>Flexibility </li></ul><ul><li>Both Argentina and China have used flexibilities in regulatory rules. In Argentina to support commercial farming sector; in China to support domestic GM seed industries </li></ul><ul><li>Complexity / Context Responsiveness </li></ul><ul><li>Local regulatory implementation challenges are evident in both cases – resource limitations, local politics, but also regulatory design issues </li></ul><ul><li>Smaller farmers’ circumstances and problems fall at least partially outside of regulatory design and practice </li></ul><ul><li>Realities of imperfect regulation are prompting new approaches amongst commercial interests (e.g. Monsanto in Argentina trying to formalise the parallel seed market) </li></ul><ul><li>Roles and capacity </li></ul><ul><li>Regulators; public research system; civil society?? </li></ul><ul><li> Implications for designing regulation in Kenya? </li></ul>