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Abstract
The evolution and diversity of institutions across the United States, the EU and Japan, and the timing of the medical device framework splitting off from the drug regulatory framework, are striking. Regulatory agencies face a new landscape: the combination of industry-paid user fees and appropriations, and a general pro-business climate coupled with dramatic advances in medical technology, shortage in skilled experts trained in the latest state-of-the-art science, and necessary legal and administrative changes. This paper seeks explanations for the complex structure of medical device regulation by focusing on the meaning of the “life cycle” concept, opportunities for patient voices, and the scope of, and potential for conflicts of interest of, industry, physicians, scientific advisors and regulatory authorities. The paper concludes that the initial international differences between medical device frameworks tend to be mitigated by voluntary global harmonization, but that actual, effective integration into the national regulatory framework significantly depends on each nation's and the EU's embedded norms, rules and procedures, and politics.
Acknowledgements
I wish to acknowledge the financial support of the Social Science Research Council and the Japan Foundation for Global Partnership for an Abe Fellowship during my sabbatical in 2006–2007. I spent three months at the University of Tokyo, Faculty of Law and Politics, conducting interviews with stakeholders involved in medical device regulation in Japan.
Notes
1. Using the US FDA database of market approvals that differentiate between pre-market approvals for Class II and Class III devices, this empirical study challenges the conventional wisdom which argues that small and medium-sized companies are the innovators in the medical device sector in contrast to the pharmaceutical sector. Innovating is one thing getting it through the FDA was found to be another thing. The database covers the period from 1976 to 2007.
2. The National Institutes of Health understands regulatory science as “the development and use of scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, quality, potency and performance” (Yeo Citation2010).
3. The term “medical device” stands for a huge spectrum of very different medical devices. This paper uses the terms “medical devices” and “medical technologies” interchangeably.
4. The demand for least burdensome regulation was the rationale underlying the FDA Amendments to the Federal Food, Drug, and Cosmetic Act of 1997. This phrase has been heard around the globe ever since.
5. STED means Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices. Study Group 1 of the Global Harmonization Task Force, 21 February Citation2008, signed by Larry Kessler, Chair, GHTF/SG1/No. 11, 2008. Available from: www.ghtf.org
6. Global Harmonization Task Force. Final Document. Clinical evidence, May 2007. Endorsed by the Global Harmonization Task Force (signed by the then chair, Larry Kessler, US FDA. SG5/N1R8, 2007).
7. IMDRF Terms of Reference, 1 March 2012, Larry Kelly, IMDRF, Chair. He is the chief of Therapeutic Goods Administration of Australia. The IMDRF seeks “international medical device regulatory convergence” (understood as “ a voluntary process whereby the regulatory requirements and approaches across countries and regions become more similar or aligned over time as a result of the adoption of the same technical documents, standards, and scientific principles (harmonization) and similar regulatory cooperation which in turn makes possible additional enhanced forms of cooperation and collaboration between regulatory authorities”).
8. Available from http://www.imdrf.org [Accessed 15 June 2012).
9. The parallel with the pharmaceutical sector is striking. In a three country comparison – the United States, Germany, and Switzerland – Robert Kaiser (Citation2008) provided the empirical data to show how non-market incentives provided the head start for innovation and eventual commercialization of the US pharmaceutical biotechnology industry. The German and Swiss industries did not benefit from such historical advantages. According to the 2007 report of the US International Trade Commission, venture capital in the medical device sector is readily available in the United States, but only to a much lesser extent in the EU and Japan.
10. The issue of independent certification bodies or notified bodies, which are commercial entities in the EU and Japan, could be an exception to this claim.
11. Directives and regulations stand for different legal implications and authority over implementation. Directives need to be transposed by national parliaments in their entirety and are binding on the member state. In contrast, regulations take immediate effect in the member state. The Commission is in control of monitoring and enforcing compliance and implementation. Most standards for consumer protection and technical production standards, including health, safety and environmental standards, in the EU in the past were issued as “Commission regulation”.
12. CE stands for Conformité Européenne, in other words conformity with European law.
13. The American Medical Devices and Diagnostics Manufacturers Association started to operate in 2010.
14. For simplicity sake, the three versions of the “life cycle” concept are used interchangeably.
15. The main congressional research materials are from the following Government Committees: The US Senate Health, Education, Labor and Pension Committee, The US Senate Finance Committee, The Senate Special Committee on Ageing, The House Energy and Commerce Committee – Subcommittee on Health, and the House Ways and Means Committee in the period of 1992–2012.
16. Twenty percent of the device budget and 60% of the drug budget out of the total FDA budget comes from user fees, according to testimonies in Congress. Informants in the EU and Japan spoke about a fairly similar constellation and confirmed that the relative share of user fees in the overall device budget has been growing over the years.
17. In the period of 2000–2011, a total of 750 high-risk devices were approved. Of these 150 were approved by the FDA through the pre-market authorization approval process and the remaining 600 were cleared through the less demanding 510(k) process in four medical specialty areas: cardiovascular care, neurology, obstetrics and gynecology, and orthopedics (Resnic and Norman Citation2012; 875). If the entire time period is taken, and depending on the source, between 80 and 95% of all devices were cleared through the laxer 510(k) procedure.
18. Medtronic spent $1.7 million, its rival Boston Scientific $1.96 million and St Jude Medical a negligible sum of $460,000.