WP4 - Analysis of legislation, ethical issues, regulations and

intellectual property

ResistVir Meeting

6th July 2006, Helsinki, Finland

Dr Mike Adcock

SIBLE, University of Sheffield, UK

Part One – WP4

Partners WP4

University of Sheffield, UK (USFD) Central Science Laboratory, UK (CSL) Technology Codes Ltd, Ireland (Codes) University of Azores, Portugal (CBA-UA) Consejo Superior de Investigaciones Científicas,

Spain (CSIC) Universidad Politécnica de Madrid, Spain (UPM) Wageningen University and Research Centre,

Netherlands (WU)

Objectives To collate and analyse of existing standards, legislation, codes

of practice, regulations, and intellectual property (IP) issues at European and national level regarding virus/vector resistant GM and traditionally-bred crops

To produce recommendations and guidelines for future standards, legislation, codes of practice, regulations, and intellectual property issues, so as to promote the safe use of GM and traditionally-bred crops

To be informed of relevant issues by the project partners and disseminate information on legislation, regulations and IP

To address ethical issues, if and when they arise

Task 4.1: Review of standards, legislation, ethical issues, codes of practice, regulations, and intellectual property

issues at national and European level.

Collate and analyse legislation, codes of practice, regulations, and intellectual property issues controlling the testing and use of virus/vector resistant GM and traditionally-bred crops.

Encouraging the involvement of external organisations in this task when appropriate.

New developments will be added to the initial report at Months 19, 24 and 35.

Task 4.2: Produce a report on current legislation, regulations and intellectual property issues with

recommendations

Co-ordinate the legislation, technology practices, regulations and intellectual property issues workshop

Produce a report with recommendations for future standards, legislation, codes of practice, regulations, and intellectual property issues for the production and use of virus/vector resistant GM and traditionally-bred crops

Disseminate the report at the final seminar

Deliverables (months 1-18) Legislation, technology practices, regulations and

intellectual property issues report completed Month 10, Responsible partner: Codes

Legislation, technology practices, regulations and intellectual property issues workshop

Month 18, Responsible partner: CLS/USFD

Report on recent developments Legislation, technology practices, regulations and intellectual property Month 19, Responsible partner: CSL

Milestones

Completion of legislation, technology practices, regulations and intellectual property issues report

Task 4.1, Month 10, Responsible partner: Codes

Feedback from legislation, technology practices, regulations and intellectual property issues Workshop analysis and report

Task 4.2, Month 19, Responsible partner: CSL

Part Two – Progress

Activities

Identify relevant legislation at the EU level

Collect all Relevant EU legislation

Identify this legislation at Member State level

Gather this legislation from all member states

Main Legislation Directive 2001/18

the deliberate release into the environment of GMOs Directive 98/81

contained use of genetically modified micro-organisms Regulation 1829/2003

genetically modified food and feed Regulation 1830/2003

concerning the traceability and labelling Regulation 1946/2003

transboundary movements of GMOs Regulation 258/97

Novel food and feed Recommendation 2003/556

Co-existence Directive 98/44

Biotech patenting

Key LegislationKeywords EU UK

Plant health 2000/29 and 95/44 Plant Health order 2005

Deliberate release 2001/18 GMO regulations (DR) 2002 GMO

Contained use 98/81 Regulations (CU) 2000

Traceability and labelling

1830/2003

1829/2003

GMO regulations (T&L) 2004

Food and feed 258/97 GM Food regulations 2004

Cartagena 1946/2003 GMO (TM) 2004

Biotech inventions 98/44 Patent Regulations 2000

Legislation ObtainedKeywords EU Collected

Deliberate release 2001/18 Austria, Czech republic, Denmark, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, UK (16)

Contained use 98/81 Austria, Czech republic, Denmark, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, UK (16)

Legislation ObtainedKeywords EU Collected

Traceability and labelling

1830/2003

1829/2003

Czech republic, Denmark, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Portugal, Spain, Sweden, UK (14)

Biotech inventions 98/44 Austria, Belgium, Czech republic, Denmark, Estonia, France, Finland, Germany, Hungary, Italy, Ireland, Lithuania, Netherlands, Poland, Portugal, Spain, Sweden, UK (18)

Other Member states

Some legislation Latvia, Slovenia, Slovakia

No legislation Cyprus, Greece, Luxembourg, Malta,

Activities

Analyse whether legislation appropriate and effective with respect to the use of virus/vector resistant GM and traditionally-bred crops

Started this analysis with EU and UK legislation

Identify Intellectual Property issues

Workshop on legislation, regulations and intellectual property issues

Workshop report

Part Three - Future

Deliverables (months 18-24) Legislation, technology practices, regulations

and intellectual property issues seminar Month 18 (?), Responsible partner: WU

Recent developments in legislation, technology practices, regulations and intellectual property issues added to the web site Month 24, Responsible partner: UPM

Activities

Analysis of member states legislation and regulations

Analysis of Intellectual Property Issues

Organisation of workshop

Addition of information on legislation to website

Deliverable (months 24-36) Recent developments in legislation, technology

practices, regulations and intellectual property issues added to the web site Month 35, Responsible partner: USFD

Suggested guidelines and recommendations report Month 35, Responsible partner: USFD

Milestones Report circulated to interested stakeholders

(Tasks 4.1/4.2, Month 36, Responsible partner: USFD)

Part Two - Regulation

Regulation Why

Scientific uncertainty Public concern Economic factors

Purpose The purpose of regulations should be to

insure safety and efficacy, to limit potential product risks while encouraging innovation and economic development.

Trigger for Regulatory Mechanism

Europe Using modern biotechnology as defined in the

Directives that triggers the regulatory process

US The use of organisms, i.e. the product not the process

Canada The concept of novelty is used to trigger the

regulatory process

Background Series of Directives, Regulations and

Guidelines From the laboratory to field trials to

placing on the market to labelling and traceability

Case by case basis Risk assessments of its impact on

human health and the environment, food safety assessments

Directive 2001/18 Principles for the environmental risk

assessment Mandatory post-market monitoring Mandatory information to the public First approvals to be limited to a maximum

of ten years The consultation of the Scientific

Committee(s)

Environmental Risk Assessment

Identification of any characteristics of the GMO(s) which may cause adverse effects

Evaluation of the potential consequences of each adverse effect

Evaluation of the likelihood of the occurrence of each identified potential adverse effect

Estimation of the risk posed by each identified characteristic of the GMO(s)

Application of management strategies for risks from the deliberate release or placing on the market of GMO(s)

Deliberate Release (Part B)

Submit dossier to MS Regulatory Authority Consent permits GMO to be grown on

specified sites under certain conditions Releases are small scale / strict risk

management conditions Monitored for several years Subsequent releases larger All applications placed on public register

Placing on the Market (Part C) Decision at EU level Dossier submitted by one MS to European

Commission Other MS evaluate and comment No objections then Commission instructs

MS to issue marketing consent GMO can be marketed in all MS

Placing on the Market (Part C)

If MS objections raised and maintained decision taken at Community level

Scientific Committee and European Food Safety Authority

If favourable, then goes to Regulatory Committee If favourable, Committee adopts decision If not favourable a draft decision submitted to

Council of Ministers Must adopt or reject within 3 months No decision, then Commission can adopt decision

Directive 98/81 Regulates the contained use of genetically

modified micro-organisms for research and industrial purposes

Requires MS to take measures to avoid adverse effects of human health and the environment

Requires risk assessment, premises to meet certain standards and management and emergency plans

Regulation 1829/2003 To protect human life and health, animal health and

welfare, the environment and consumers' interests in relation to GM food and feed, whilst maintaining the effective functioning of the internal market;

To lay down Community procedures for the authorisation and supervision of GM food and feed

To lay down provisions for the labelling of GM food and feed.

Food containing or consisting of GMOs Food produced from or containing ingredients produced

from GMOs.

Labelling

Traces of GMOs in products, whose presence is adventitious or technically unavoidable, will continue to be exempt from the labelling requirement unless they exceed the 0.9% threshold.

The threshold fro the adventitious presence of GMOs is set at 0.5% for this type of "contamination" for GMOs which have been given scientific approval.

Regulation 1830/2003 Framework for the traceability of

products of or containing GMOs, and food and feed produced from GMOs

Facilitate accurate labelling, monitoring the effects on the environment and health

Facilitate appropriate risk management and withdrawal of products

Traceability

Producer of product consisting of or containing GMOs must inform receiver of product that that it contains or consists of GMOs; the unique identifier(s) assigned to those GMOs

Information passed on but can be if form of unique identifier(s)

Systems and standardised procedures in place to allow the holding of information for a period of five years from each transaction,

Other legislation

Regulation 258/97 Rules for authorisation and labelling of novel foods

and food ingredients Regulation 1946/2003

Sets out procedures that must be followed for the export of GMOs to third countries

Implements obligations under the Cartagena Protocol Recommendation 2003/556

Co-existence of GM and non-GM agriculture Liability and redress systems

Initial Questions

Highly regulated The purpose of regulations should be to insure

safety and efficacy, to limit potential product risks while encouraging innovation and economic development.

Are the regulations effective, appropriate and proportional with respect to virus/vector resistant GM and traditionally-bred crops?

Do we have to many Regulations in EU? If so why?