A model for regulation of medical nanobiotechnology: The European status quo

Nanotechnology Law and Business

Volumn 3, Issue 1, 2006, Pages 84-92

  Guerra, Giorgia ^a  

^a UNIVERSITY OF TRENTO   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

NANOBIOTECHNOLOGY; NANOTECHNOLOGY DEVELOPMENT; PHARMACEUTICAL REGULATIONS;

BIOMEDICAL EQUIPMENT; BIOTECHNOLOGY; DRUG PRODUCTS PLANTS; PUBLIC POLICY; REGULATORY COMPLIANCE;

NANOTECHNOLOGY;

EID: 33748756039     PISSN: 15462080     EISSN: 15462080     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (50)

1. EUR. COMM'N, COMMUNICATION, THE EUROPEAN RESEARCH AREA: PROVIDING NEW MOMENTUM. STRENGTHENING-REORIENTING-OPENING UP NEW PROSPECTIVES 565 (Oct. 16, 2002), available at http://europa.eu.int/eur-lex/en/com/cnc/2003/ com2003_0226en02.pdf (last visited Nov. 6, 2005).
2. See id.
3. EUR. COMM'N, THE THIRD EUROPEAN REPORT ON SCIENCE & TECHNOLOGY INDICATORS: TOWARDS A EUROPEAN STRATEGY FOR NANOTECHNOLOGY (Apr.12, 2004), available at http://www.cordis.lu/nanotechnology/src/communication.htm (last visited Nov. 6, 2005).
4. st Century Nanotechnology Research and Development Act in 2003. See JOHN C. MILLER, RUBEN M. SERRATO, JOSE M. REPRESAS-CARDENAS & GRIFFITH A. KUNDAHL, THE HANDBOOK OF NANOTECHNOLOGY BUSINESS, POLICY AND INTELLECTUAL PROPERTY LAW 116 (2004).
5. EUR. COMM'N, NETWORKING THE EUROPEAN RESEARCH AREA: COORDINATION OF NATIONAL PROGRAMMES (2005), available at http://www.cordis.lu/coordination/home. html (last visited Nov. 6, 2005).
6. EUR. COMM'N, EURONANO FORUM 2003 (2003), available at http://www.euronanoforum2003.org (last visited Nov. 6, 2005).
7. More information is available at http://europa.eu.int/comm/research/fp6/ index_en.cfm?p=3 (last visited Nov. 6, 2005).
8. As in the United States, Europe carefully considers ethical and social dimensions of new technology like nanotechnology. The European Commission has already commenced ethical inquiries to address issues facing nanomedicine. See EUR. COMM'N, NANOSCIENCES AND NANOTECHNOLOGIES: AN ACTION PLAN FOR EUROPE 2005-2009, at 243 (Apr. 7, 2005) ("The European Group on Ethics in Science and New Technology to carry out an ethical analysis of nanomedicine. This will identify the primary ethical concerns and enable future ethical reviews of proposed into N&N R&D projects to be carried out appropriately.").
9. Specifically contemplated at articles 152, 153 and 174 of the Community Treaty, available at http://europa.eu.int/eur-lex/lex/en/repert/0850.htm (last visited Nov. 6, 2005).
10. EUR. COMM'N, supra note 3.
11. There is as of yet no written legal root for this. The current definition comes from scientists, such as Mihail C. Roco. See Mihail C. Roco, The Challenge of Transforming and Responsible Nanotechnology, Presentation (Mar. 3, 2005), available at http://www.nsf.gov/crssprgm/nano/reports/ nni_05_0916_inemi_transfrespnt.pdf (last visited Nov. 6, 2005).
12. CCR, ANNUAL REP. No. 14.05.2004 (2004). CCR furnishes technical and scientific support for elaborating, controlling and fulfilment of community policy purposes.
13. A detailed definition of what nanobiotechnology is, and how it is employed for medical purposes, is contained in the important document that provides information about all nanotechnology activity in the U.K. This document was drawn up by the Royal Society and the Royal Academy of Engineering. ROYAL SOC'Y & THE ROYAL ACADEMY OF ENG' G, NANOSCIENCE AND NANOTECHNOLOGIES: OPPORTUNITIES AND UNCERTAINTIES (2003), available at http://http://www.nanotec. org.uk/finalReport.htm (last visited Nov. 6, 2005).
14. The discussion about data available on risks caused by nanoparticles is only in its infancy and concerns mainly studies of pulmonary problems reporting that carbon nanotubes after intracheal inhalation show signs of toxicity (granuloma formation and interstitial inflammation). Peter H. M. Hoet et al. Nanoparticles - Known and Unknown Health Risks, 2 J. OF NANOBIOTECH. 12 (2004), available at http://www.jnanobiotechnology.com/content/2/l/12 (last visited Nov. 6, 2005).
15. Nanoscience is defined as "horizontal," "key" or "enabling" since it can pervade virtually all technological sectors. See EUR. COMM'N, COMMUNICATION AND DEBATE (2004), available at http://www.cordis.lu/nanotechnology/src/communication.htm (last visited Nov. 6, 2005).
16. For an American perspective on this problem, see John Miller, Beyond Biotechnology: FDA Regulation of Nanomedicine, 4 COLUM. Sci. & TECH. L. REV. 5 (2002);
17. see also S. B. Foote & R. J. Berlin, Can Regulation Be as Innovative as Science and Technology? The FDA's Regulation of Combination Products, 6 MINN. J. L., Sci. & TECH. 619 (2005).
18. For more details, see MILLER ET AL., supra note 4, at 92.
19. In the United States, the Food & Drug Administration ("PDA") and the Foresight Institute have attempted early formulations of guidelines in this field. See, e.g., FORESIGHT INST., FORESIGHT GUIDELINES ON MOLECULAR NANOTECHNOLOGY (2000), available at http://www.foresight.org/ guidelines/current.html (last visited Nov. 6, 2005).
20. EUR. COMM'N, COUNCIL DIRECTIVE 65/65/EEC OF JAN. 26, 1965, O.J. 022, Sept. 2, 1965, at 369-73 (on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products).
21. EUR. COMM'N, COUNCIL DIRECTIVE 93/42/EEC of JUN. 14, 1993, O.J. 169, Dec. 7, 1993 (concerning medical devices).
22. J. Y. Chai, Medical Device Regulation in the United States and the European Union: A Comparative Study, 55 FOOD & DRUG L. J. 57 (2000);
23. B. Sieff, Rigenerazione di Dispositivi Medici e Responsabilità- Profili di Regolamentazione Nella Normativa Comunitaria ed Italiana, DANNO E RESPONSABILITÀ 772-790 (2004).
24. Article 1 lett. b) defines "accessory" as follows: "an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device." EUR. COMM'N, COUNCIL DIRECTIVE 93/42/EEC OF JUNE 14, 1993, at Art. 1, O.J. 169, Dec. 7, 1993.
25. See id.
26. See note 19, supra, at 369-73 (directive as last amended by Directive 92/27/EEC, O.J. L 113, 30.4.1992, at. 8).
27. See id. at Art. 1.2.
28. See note 13, supra.
29. OJC 146 A, 15.6.1990, all.
30. HEALTH & SAFETY COMM'N, PROPOSALS FOR AMENDING NEW REGULATIONS FOR THE NOTIFICATION OF NEW SUBSTANCES: NONS 2001, available at http://www.hse.gov. uk/consult/condocs/cdl65.pdf (last visited Nov. 6, 2005).
31. Proposal for a Regulation of the European parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) {on Persistent Organic Pollutants} Proposal for a Directive of the European parliament and of the Council amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) of the European Parliament and of the Council concerning the registration, evaluation, authorisation and restriction of chemicals, COM (2003) 0644.
32. See art. 9 and Annex XI of the Directive 93/42/CEE.
33. To understand the vulnerability and uncertain risks of a product incorporating nanosized particles, consider the carbon nanotubes in micro-sensors. This new technology is very promising thanks to its physical and chemical properties. It has, however, shown at the first phase of experimentation, problems of biocompatibility. See B. J. Feder, As Uses Grow, Tiny Materials' Safety is Hard to Pin Down, N. Y. TIMES, Nov. 3, 2003;
34. see also D. Pinson, Is Nanotechnology Prohibited by the Biological and Chemical Weapons Conventions?, in 22 BERKLEY J. IN'LL. 279 (2004);
35. and B. BHUSHAN, HANDBOOK OF NANOTECHNOLOGY (2004).
36. EUR. COMM' N, DIRECTIVE 2001/95/CE, of the European Parliament and of the Council of 3 December 2001, O.J. L. 11/4, June 15, 2002 (on general product safety).
37. See id. The overlapping between specific definitions and rules, and generic ones can be verified, for example, with attention to the dispositions of the directive 2001/95/CEE that provide definitions for safe and dangerous products (articles 2, 3) and the more specific definitions of different classes of products (included definition of dangerous medical products of Class III) contained in Directive 93/42/CEE.
38. See ROYAL Soc' Y & THE ROYAL ACADEMY OF ENG'G, supra note 13, at 35.
39. Id. at 41.
40. Feder, supra note 31 ;
41. see also Pinson, supra note 31.
42. Precautionary concept and "logic" act in a different way in the American product liability system and in the European one. For a detailed view, see U. IZZO, LA PRECAUZIONE NELLA RESPONSABILITÀ CIVILE. ANALISIDI UN CONCETTO SUL TEMA DEL DANNO DA CONTAGIO PER VIA TRASFUSIONALE 424 (Padova, 2004);
43. see also K. H. Laudeur, The Introduction of the Precautionary Principle into EU Law: A Pyrrhic Victory for Environmental and Public Health Law? Decision-Making Under Conditions of Complexity in Multi-level Political Systems, 40 COMM. MARKET L. REV. 1455 (2003);
44. J. MORRIS, RETHINKING RISK AND THE PRECAUTIONARY PRINCIPLE (2000);
45. J. Wejnert, Regulatory Mechanisms for Molecular Nanotechnology, 44 JURIMETRICS J. 323, 323-50 (2004).
46. EUR. COMM'N, COUNCIL DIRECTIVE 85/374/EEC ART. 7(E) OF 25 JULY 1985, O.J. L 210, July 8, 1985, at 0029-0033 (on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products).
47. J. Huet, La Paradoxe des Médicaments et les Risques de Developement, DALLOZ-CHRONIQUE 73 (1987);
48. C. Castronovo, Danno VII) Danno da Prodotto - Diritto Italiano e Straniero, ENC. GIUR., X (Rome, 1995 updated), at 12.
49. Ineke Maisch & Mireille Oud, Outcome of the Open Consultation on the European Strategy for Nanotechnology, at 79 (Dec. 2004), available at http://www.nanoforum.org (last visited Nov. 6, 2005).
50. Id. at 77.