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Advanced therapy medicinal products (ATMPs) in the EU; USITC's July 2011 Recent Trends in U.S. Services Trade Annual Report

From the European Medicines Agency (EMA) website (Audio Videos section) (1): the May 26, 2011 SME Workshop, entitled Focus on Scientific and Regulatory Advice, during which speakers presented on advanced therapy topics under the EU regulatory framework for advanced therapy medicinal products (ATMPs). Speakers from the FDA's SME offices, Afssaps (France), PEI (Germany) provided outlines on the kind of support available to SME stakeholders. A biopharma spinoff company from a university (locations in Belgium, New York and Ireland), shared her SME company's experiences using the ATMP regulatory option (2) and noted the challenges faced by SMEs due to limited resources as compared to big pharma. EMA's Innovation Task Force (ITF)Topic speaker noted that innovation is a moving target and that ITF meetings are helpful in promoting knowledge and facilitating dialogue among stakeholders with EMA. A member of the Committee on Advanced Therapies (CAT) discussed recent experiences arising in connection with ATMP classification requests made by various stakeholders. To date, there have been 41 requests for classification of products being developed based on genes, cells or tissues. He observed that while there is only 1 certification given to date, there are 3 products that were recommended as NOT being ATMPs. He also observed that among other incentives, ATMP classification may help investor relations.

Also of interest, a wealth of information/data with numerous top ten lists, analysis of regulatory impacts and outlooks is provided in the U.S. International Trade Commission (USITC) 's Recent Trends in U.S. Services Trade: July 2011 Annual Report. (3) The Report indicates that it focuses principally on exports and imports of professional and other related services. Chapter 6 reviews the global healthcare services market, Chapter 7 covers the global legal services market. Recent USTIC reports (2010) include a series on Small and Medium-Sized Enterprises.
(1) http://www.ema.europa.eu/ema/index.jsp?curl=pages/home/Home_Page.jsp&murl=&mid=go to News and Events and click on Audio and videos to find this event
(2) see below
(3) http://www.usitc.gov/research_and_analysis/commission_publication_4243.htm

From EMA's website: To determine whether a given product based on genes, cells or tissues meets the scientific criteria which define Advanced therapy medicinal products (ATMPs), applicants have access to an optional procedure according to article 17 (Scientific recommendations on advanced therapy classifications) of Regulation (EC) No 1394/2007 on advanced therapy medicinal products . The CAT's interested parties are defined as not-for-profit, European or international organisations in the field of advanced therapies.

From USITC's report:
Chapter 6 reviews the global healthcare services market -in summary, since 2003 global spending on healthcare has steadily risen and the world's largest markets are still found predominantly in the US and Europe, however faster growing markets are in developing countries where private expenditures are rapidly growing. Chapter 7 indicates that the steady growth during 2001-2005 of the global legal services market faltered substantially due to the economic downturn. US and European law firms have lost global market share to firms in the Asia -Pacific region- between 2005-2008 US imports of legal services grew faster than exports reflecting growing competitiveness of foreign legal services providers. However US firms are taking advantage of commercial opportunities in developing countries.

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