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European Regulatory Issues in Nanomedicine

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Abstract

The paper is intended to focus on peculiarities of nanomedicine and the importance of social concerns implicated, in order to understand if existing regulations are appropriate to maintain its safety or if a new ad hoc regulatory framework is needed. Consideration of social challenges will underline the crucial role of medical ethics in regulatory discussion.

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Notes

  1. Specifically contemplated at articles 152, 153 and 174 of the Community Treaty, retrieved November 6, 2005 from http://europa.eu.int/eur-lex/lex/en/repert/0850.htm.

  2. European Commission, The Third European Report on Science & Technology Indicators: Towards a European Strategy for Nanotechnology, Apr. 12, 2004, retrieved November 6, 2005 from http://www.cordis.lu/nanotechnology/src/communication.htm.

  3. European Commission, The Third European Report on Science & Technology Indicators: An Action Plan 2005–2009, COM (2005) 243, June 7, 2005, retrieved June 7, 2005 from http://www.cordis.lu/nanotechnology/.

  4. As in the USA, Europe takes into account 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, Apr. 7, 2005, at 243 (“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.”).

  5. European Science Foundation, ESF Forward Look on Nanomedicine, November 2005, retrieved December 15, 2005 from http://www.esf.org/publication/214/Nanomedicine.pdf.

  6. The public issue about the combination of products arouse in the United States at the beginning of the nineties. During the preparation of the Safe Medical Device Act (Pub. L. No 101–629, Section 16, 104 Stat. 4511, 4526), the representatives of the industrial categories noticed the weakness of the application of the pre-market approval to the new industrial products. On this basis, the Senate decided to add to the Safe Medical Device Act a final note about the importance of the regulation of a combination of products. In particular, it wrote: “devices impregnated with biologically-active materials, medical devices, implantable drug pumps and biological sensors, and therapeutic devices used in conjunction with drugs for the extra-corporeal treatment of diseases”. [11] (p. 545); [10] (p. 619).

  7. Office of Science and Technology Policy, (1986). Coordinated Framework for Regulation of Biotechnology. Fed. Reg., 23, 302.

  8. These informal mechanisms are valuable, but are insufficient to provide the public confidence, and the capability for rapid regulatory responses that are needed for this technology to succeed [1] (p. 36).

  9. OJ L 102, 7.4.2004, 58.

  10. OJ L 294, 25.10.2006, 50.

  11. OJ L 38, 9.2.2006, 52.

  12. OJ L 213, 30.7.1998, 21.

  13. Lin [18]. The Author observed that “many commentators have suggested parallels between the development of biotechnology – the use of recombinant DNA techniques to transfer genetic materials from one species to another – and the challenge presented by nanotechnology today. In particular, these commentators point to the controversy surrounding genetically modified organisms as a mistake for the nanotechnology industry to avoid. A comparison of the two fields also reveals a striking similarity in the government’s approach to each: minimal oversight, and a stubborn insistence on the adequacy of regulatory schemes that fail to account for the unique problems posed by new technologies. Both nanotechnology and biotechnology offer the prospect of revolutionary benefits, with advances cutting a wide range of products and industries. Both fields, however, are also plausibly linked to catastrophic scenarios of new and unpredictable technologies gone awry”.

  14. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. OJ L 189, 20.7.1990, 36.

  15. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L 169, 12.7.1993, 43. See also Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices. OJ L 210, 12.8.2005, 43.

  16. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. OJ L 331, 7.12.1998, 37. For a general comment see [9] (p. 57); [25] (p. 772).

  17. Article 1 of the Directive states that a medical device and its accessories is “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of (a) diagnosis, prevention, monitoring, treatment or alleviation of disease; (b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; (c) investigation, replacement or modification of the anatomy or of a physiological process; (d) control of conception; (e) and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”. European Commission, Council Directive 93/42/EEC of June 14, 1993, at Art. 1, O. J. 169, Dec. 7, 1993.

  18. The European regulation on pharmaceutical products is expressed by Council directive 65/65/EEC. Article 1.2 of the Directive 65/65/CE defines a medicinal product: “any substance or combination of substances presented for treating or preventing disease in human beings or animals; any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product”.

  19. About the important issue of access and protection of genetic data see [25] (p. 193).

  20. OJ L 311, 28.11.2001, 128.

  21. Available at: http://www.governo.it/bioetica/testi/farmacogenetica%20.pdf.

  22. Page 39 of the document.

  23. Recent analyses have shown the fundamental importance of the environment in determining genetic mutations and diseases. With those premises the same analysis have, in fact emphasized that knowledge about individual genetic information doesn’t allowed to exactly know future diseases of that specific person.

  24. Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency, O.J. L 396, 30.12.2006, 856.

  25. OJ C 146 A, 15.6.1990, 1.

  26. Also in the American regulations, in fact, the Toxic Substances Control Act (TSCA) provides EPA with regulatory authority in three key areas: regulating chemicals that present health or environmental risks; screening new chemicals and significant new uses of existing chemicals; and testing chemicals where risks are unknown. See [18]. The Author underlines that “under section 6 of TSCA, Epa has the authority to regulate the manufacture, processing, distribution, use or disposal of any chemical substance if it finds that there is a “reasonable basis to conclude” that such an activity “presents or will present an unreasonable risk of injury to health or the environmental. This standard requires both a factual finding of risk and a normative finding that such risk is unreasonable. In determining whether a demonstrated risk is unreasonable, EPA must balance the health and environmental effects with the benefits arising from use of the substance. Furthermore, under a leading judicial interpretation of Section 6, EPA must evaluate the availability of substitutes for the chemical in question, and it may apply only the least burdensome regulatory measure that provides adequate protection”.

  27. Differently in the USA some specific legal initiatives are just practicable. See [17], 1. The author wrote: “currently, a combination product is routed to one of the FDA's regulatory product centers by the two-year old Office of Combination Products (“OCP”). Its function is to “ensure the prompt assignment of combination products to agency centers, the timely and effective pre-market review of such products, and consistent and appropriate post-market regulation of like products subject to the same statutory requirements to the extent permitted by law.” The OCP assigns a product to a center based on its “primary mode of action” (“PMOA”). If the product's PMOA is determined to be that of a drug, biologic, or device, then the appropriate center for primary jurisdiction is the CDER, CBER, or CDRH, respectively”.

  28. These features of medical damage are extensively described by [12] (p. 257). See also [13].

  29. Best and Khushf [5], 655. Recently the Authors wrote: “A common theme in the ethics and policy literature is the uncertainty and speculative nature of much research related to nano-science and - technology. This uncertainty poses a catch-22 when considering regulation: On one hand, advocates promise a revolutionary, disruptive technology. This implies that conventional models of risk assessment and regulation will not be adequate, and that the social impact of the technology will be great. However, uncertainty regarding the specific form such disruptive innovation takes makes it extremely difficult to anticipate the kinds of policy and regulatory changes that are needed. We thus seem to have a context where we can't do much to mitigate significant dislocations that will emerge”.

  30. Agenda 21, (1992). UN Conference on Environment and Development, U.N. Doc. A/CONF.151/26.?

  31. Recommendation 10 (2003) from the European Committee on xenotransplantation. June 19, 2003.

  32. An important role was played by the European Commission’s Communication on precautionary Principle, February 2, 2000.

  33. Lin [18], p. 40. The Author observed: “Also counselling in favour of a precautionary approach is the fact that nanoparticles are likely to be difficult to remove from the environmental, meaning that negative consequences may be irreversible as a practical matter”. On this topic see also [8].

  34. Principal aim of US Environmental Agency, Consumer Product Safety Commission, together with other regulatory Agencies, was to come into force risk regulation policies. See [19] (p. 23). See also [28].

  35. The famous mad cow disease case is one of the recent examples of insufficient level of protection and consequent public opinion negative reaction see Joerges et al. [14] (p. 1).

  36. Beyond the chosen regulatory approach, in the modern era law is always in connection with technology. [22] (p. 208).

  37. Best and Khushf [5], p. 733. The Authors underlined that the preliminary consideration of social and ethical issues “can reduce the likelihood of lock-in to suboptimal systems”.

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  1. Centro interdipartimentale per le decisioni giuridico-ambientali e la certificazione etica di impresa (CIGA), University of Padova (Italia), viale Porta Adige, 45, Rovigo, Italy

    Giorgia Guerra

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Guerra, G. European Regulatory Issues in Nanomedicine. Nanoethics 2, 87–97 (2008). https://doi.org/10.1007/s11569-008-0031-1

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