Eyeworld

Rudy M.M.A. Nuijts, M.D., Ph.D., Department of Ophthalmol- ogy, University Hospital of Maas- tricht, the Netherlands, agreed that the European regulatory system de- emphasizes efficacy, but there are many hurdles to practical use of medical treatments in Europe, too, he said. "It's totally different here," Dr. Nuijts said. "CE marking approval is important, but in terms of being im- plemented in a regular standard-of- care program, you need more." Dr. Nuijts explained that be- yond CE marking (which itself is only a mandatory conformity mark for products—including industrial goods—placed on the market in the European Economic Area), national regulatory bodies of European coun- tries get involved in product evalua- tion, and only when products pass these additional standards do they qualify for reimbursement. For example, in the U.K., there's the National Institute for Health and Clinical Excellence (NICE), the health authority of the NHS, while in the Netherlands, there's College Voor Zorgverzekeringen, or CVZ (the Dutch health insurance board). "They rate the evidence in the literature … the Cochrane Database and randomized clinical trials," Dr. Nuijts said. "Certain treatments are not officially tolerated for market here [even when they have a CE marking]." Dr. Nuijts cited premium IOLs as an example. "Premium IOLs like multifocal and toric IOLs have CE marking, but that doesn't mean these treatments —in the view of the national author- ity bodies—belong to our vast arma- mentarium of treatments," he said. "So in the Netherlands, toric and multifocal IOLs are not seen as regu- lar standard-of-care treatments. Co- payment is not officially tolerated." This raises a sort of if-a-tree- falls-in-the-woods kind of question: If a treatment is approved but practi- cally speaking physicians can't use it, is it helpful? Consider that rhetor- ical. NICE has come under fierce at- tack, much like the U.S. FDA has. In 2007, the Royal National Institute of Blind People criticized NICE for, in its view, imposing stringent prelimi- nary recommendations related to anti-VEGF treatment that hamstrung patient options and led to more blindness. "It is simply unacceptable that NICE is recommending that only a small minority of patients within England and Wales will benefit from these ground-breaking treatments," the Institute's head of campaigns, Steve Winyard, said at the time. "NICE must reconsider." In 2008, all patients in England and Wales with wet AMD became el- igible to begin NHS treatment with Lucentis [ranibizumab, Genentech, South San Francisco], but a 3-month implementation period caused fur- ther treatment delays, the Institute said. Dr. Nuijts thinks something needs to change in European regula- tion. "I think ideally there should be a system where you have a European judgment office in terms of safety and efficacy," Dr. Nuijts said. "It would be one opinion for a product that could be implemented. Now it's so different between European coun- tries. Drug companies often try to get approval in some individual Eu- ropean countries and then spread it out." Moving East In China, the State Food and Drug Administration (SFDA)—perhaps now the toughest regulatory body worldwide—has been getting tougher still. "Every week it will change something," said Emery Fu, manag- ing director, China division, Emergo Group. Emergo is an ISO-registered medical device consulting firm. "For certain kinds of medical de- vices, it always requires more infor- mation and documents during review," he said. Mr. Fu, who has 13 years of ex- perience working within SFDA, said the regulatory environment there is needlessly complex. "I don't think our regulation and process is a good one," he said. "A lot of SFDA officials do not know what they really need to review. They want to show they are knowl- edgeable so they ask a lot of ques- tions. The reality is they are careless in key parts [that need review]. They spend a lot of time and energy on unnecessary parts [for review]. Timewise, he said, most ap- provals take a little longer than the U.S. FDA process, around 1.5 years, not including clinical trials. Meanwhile, the median U.S. FDA review time for new drugs was 6.7 months under priority review (for those that seemingly offer major treatment advances) and 13.8 months via standard review in 2003—the last year for which com- parisons are available. Premarket ap- proval (PMA) review for new de- vices, meanwhile, also took 13.8 months on average in 2005. Interestingly, China welcomes innovation in pharmaceuticals. The nation is more cautious of new med- ical devices. Mr. Fu cited pharmaceu- tical reviewers as being more international and knowledgeable at SFDA, while medical device review- ers are younger with poorer knowl- edge. Nonetheless, SFDA approval is required for commercial usage in China, he said. "I have a lot of colleagues in dif- ferent countries—Japan, Korea, Tai- wan, Europe, the U.S., Canada," Mr. Fu said. "We are the most difficult one in the world—even a bit more difficult than the U.S. China takes the longest time because SFDA needs a lot of procedures and papers." EW Editors' note: Drs. Lindstrom and Nuijts have no financial interests related to this article. Mr. Fu has no financial interests related to this article. Contact information Fu: +86 10 82609560, reg@jtmedical.com Lindstrom: 800-393-8639, rlindstrom@mneye.com Nuijts: rnu@compaqnet.nl EW International 49 November 2011

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