International News In Brief
This article was originally published in The Gray Sheet
Executive Summary
EC considers cost of innovation: EU Health Commissioner David Byrne quashes parliamentary inquiry from MEP Camilo Nogueira Roman (Greens-Spain) on the "right to health" in EU citizens' health rights charter. Adopted by stakeholders last November, the charter contends that individuals should have the right to innovative procedures independent of economic considerations. On June 11, Byrne indicated that the EC Treaty delegates medical care delivery to member states, effectively ending the initiative at the European level. Trade associations will now focus on individual countries...
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EC considers cost of innovation: EU Health Commissioner David Byrne quashes parliamentary inquiry from MEP Camilo Nogueira Roman (Greens-Spain) on the "right to health" in EU citizens' health rights charter. Adopted by stakeholders last November, the charter contends that individuals should have the right to innovative procedures independent of economic considerations. On June 11, Byrne indicated that the EC Treaty delegates medical care delivery to member states, effectively ending the initiative at the European level. Trade associations will now focus on individual countries.... MDD: European Parliament adopts all amendments in plenary vote on "Health Implications of the Medical Devices Directive," which made recommendations on reclassification, postmarket surveillance, single-use and PVC-containing devices. EP's Environment Committee added the amendments in April (1 (Also see "International News In Brief" - Medtech Insight, 5 May, 2003.), p. 18).... UK sterilization: National Health Service hospitals must conform to new surgical instrument decontamination standards by 2007, Department of Health says June 12. The UK announced the $330 mil. MDD-based initiative in January 2001....MHRA: Merger of Medical Devices Agency with Medicines Control Agency provides an opportunity to "strengthen and clarify" the agency's regulatory function, House of Commons Committee of Public Accounts says in June 26 report. The document, 2 'Safety, quality, efficacy: regulating medicines in the UK,' criticizes MCA pre-merger performance.... Australian fees: 3 Therapeutic Goods Administration fees effective July 1 include $1,870 for high-level registration application, $13,700 for design/materials/testing evaluation and $25,000 for initial conformity assessment, schedule 3, clause 1.6 design examination. TGA also releases 4 guidance on the use of medical devices in alternative therapies....Whole-body CT scans: TGA bans procedure "without a written request from an independent medical doctor" or informed consent. Registered device owners and licensed operators of the devices could face fines of up to $110,000 for violating the ban.... GHTF: Eucomed Director-General Maurice Wagner named as Global Harmonization Task Force vice-chairman during the organization's European presidency, which begins Jan. 1, 2004 and will last for three years. An as-yet-unnamed European Commission official will chair GHTF.... |