abs

USERS GUIDE TO EUROPEAN REGULATION IN BIOTECHNOLOGY

1,01

197

stron

5673

LGC Limited

2006

rok

CONTENTS

General Introduction 6

Executive Summary 7

Section Map Section 1 14

Section 1 The Community Strategy for Biotechnology 15

1(i) What is the European strategy for biotechnology? 15

1(ii) What are the implications of the strategy for the development of regulation? 18

Section Map Section 2 21

Section 2 Access to Information 22

2(i) What information can the Community provide about biotechnology and its regulation? 22

2(ii) What must the biotechnology industry do to support public information and engagement? 23

2(iii) How should the public be informed, involved in decisions and treated equitably over GMOs? 26

Section Map Section 3 30

Section 3 Contained Use of Genetically Modified Organisms 31

3(i) Which legislation applies to contained laboratory and industrial use of GMOs? 31

3(ii) Which regulatory bodies in Europe are responsible? 32

3(iii) What are the basic legislative requirements? 32

3(iv) Which legislation applies to the contained use of genetically modified animals and plants? 38

List 3.1 Competent Authorities for Contained Use 39

Section Map Section 4 48

Section 4 Release and Commercialisation of Genetically Modified Organisms 49

Section 4.1 Non-Commercial Releases 49

4.1(i) Which legislation applies to the release of GMOs for any purpose other than for placing on the

market? 49

4.1(ii) Which regulatory bodies in Europe are responsible? 50

4.1(iii) What are the basic legislative requirements? 50

Section 4.2 Commercial Releases 53

4.2(i) Which legislation applies to the release and commercialisation of GMOs? 53

4.2(ii) Which regulatory bodies in Europe are responsible? 54

4.2(iii) What are the basic legislative requirements? 55

4.2(iv) Might other regulatory regimes apply to my product? 58

4.2(v) How can I obtain authorisation to market GM seeds? 60

4.2(vi) How are GM, conventional and organic agriculture kept in balance? 63

Section 4 Annex Deliberate Release of GMOs: Step by Step 66

Part A Steps required to decide whether a product is in the scope of Directive 2001/18/EC on the

deliberate release into the

environment of genetically modified organisms 66

Part B Procedure for obtaining authorisation for non-commercial deliberate releases of GMOs under

Directive 2001/18/EC 71

Part C Procedure for obtaining authorisation to place GMOs on the market under Directive

2001/18/EC 72

List 4.1 Competent Authorities 2001/18/EC 74

Section Map Section 5 91

Section 5 The GM Feed and Food Chain 92

5(i) What are the principal regulations relating to GM food and feed? 92

5(ii) Which regulatory bodies in Europe are responsible? 93

5(iii) What are the basic legislative requirements relating to GM food? 94

5(iv) How is the inclusion of GM additives in foodstuffs regulated? 102

5(v) What are the basic legislative requirements relating to GM feed? 103

5(vi) How is the inclusion of GM additives in animal feed regulated? 104

Section Map Section 6 109

Section 6 Transportation and International (Transboundary) Movement of Genetically Modified

Organisms 110

Section 6.1 Transport of Dangerous Goods 110

6.1(i) Which regulatory bodies in Europe are responsible? 110

6.1(ii) Which legislation on the transport of dangerous goods applies to GMOs? 111

Section 6.2 International (Transboundary) Movements of GMOs 117

6.2(i) Which regulatory bodies in Europe are responsible? 117

6.2(ii) How are international (transboundary) movements of GMOs controlled? 118

Section 6 Annex Practical Steps to Compliance with Transport of Dangerous Goods Regulations 123

Section Map Section 7 127

Section 7 Medicinal Products and Healthcare 128

7(i) What is a biotechnology medicinal product? 128

Section 7.1 Medicinal Products for Human Use 129

7.1(i) Which regulatory and advisory bodies cover human medicines? 129

7.1(ii) How are quality and safety standards applied to product development? 131

7.1(iii) How are clinical trials regulated? 133

7.1(iv) How are marketing authorisations obtained? 134

7.1(v) How is good practice ensured during manufacturing? 139

7.1(vi) How are orphan medicinal products regulated? 139

7.1(vii) How will tissue engineering and other advanced therapies be regulated? 140

Section 7.2 Medicinal Products for Veterinary Use 142

7.2(i) Which regulatory and advisory bodies cover veterinary medicines? 142

7.2(ii) How does legislation differ from that on medicines for human use? 142

7.2(iii) How is good practice ensured during manufacturing? 144

Section 7.3 Protection of Animals Used for Experimental Purposes 145

7.3(i) Which regulatory and advisory bodies cover animal welfare in the context of biotechnology?

145

7.3(ii) Which legislation applies to animal welfare? 145

7.3(iii) How is cloning of animals regulated? 146

Section Map Section 8 147

Section 8 Intellectual Property 148

8(i) How is intellectual property regulated in industry and agriculture respectively? 148

Section 8.1 Industrial Intellectual Property 148

8.1(i) What makes an invention patentable? 148

8.1(ii) What are the current national, European, and international options for patenting? 149

8.1(iii) Which official bodies are responsible in Europe? 150

8.1(iv) Which special law and procedures apply to biotechnology patents in Europe? 150

8.1(v) What practical arrangements must be made to patent a microorganism? 152

8.1(vi) What kind of Community patent system is being proposed? 153

8.1(vii) Are there restrictions on technology transfer by licensing intellectual property? 153

Section 8.2 Agricultural Intellectual Property 154

8.2(i) What is the procedure for protecting a plant variety? 154

8.2(ii) How do patents and plant variety rights coexist? 156

8.2(iii) Can a race of animals be intellectual property? 156

8.2(iv) Can intellectual property coexist with biodiversity and sustainability? 157

Section 8 Annex Technology Transfer 159

List 8.1 Intellectual Property Offices 162

List 8.2 Plant Variety Right Offices 168

Glossary 173

Abbreviations 184

Community Level Contact Points 186