Pharmaceutical Executive Europe - September 2008 - (Page 15) BioFutures reimbursement programme (DLO) by 43% in H1 2008 to USD$2.51bn, compared to H1 2007. Undoubtedly, the increasing wealth of the population is one of the drivers of the vigorous growth: data from The Economist shows an increase of annual GDP per capita from under USD$2000 in 1998 to USD$9000 in 2008 at current rates of exchange. Analysis by DSM Group predicts that if the trends seen in the last few years continue, we can expect to see annual drug consumption per capita increase from USD$50 today to USD$300 by 2020. For comparison, IMS Health data shows current annual drug consumption for the UK, Germany and France at USD$290, USD$373, and USD$457 respectively. The wheels of State machinery in Russia are glacially slow; it took 15 years of protracted negotiation to accede to the WTO, and the transition to GMP standards is equally painful. After a decree in 1999 requiring all manufacturing plants to adopt GMP standards within five years, we are, a decade later, still awaiting results. The Russian Federal Service for Surveillance in Healthcare and Social Development (RosZdravNadzor) has yet again set a revised timetable: manufacturers in Russia will be expected to adopt the 1991 GMP standards first, before moving to the 2004 GMP standards by 1 January 2010. “… our market research shows that by 2015 the Russian pharma market will be the largest in Europe, and will enter the global top five.” — Alexander Kuzin In an interview in the official RosZdravNadzor magazine Vestnik, RosZdravNadzor deputy director Andrei Mladentsev says: “The transition to GMP standards is contingent only on political will.” Indeed, most commentators agree that in the short term the imperative for Russian manufacturers to transition to GMP standards is at odds with the Government’s intention to increase the market share of Russian manufacturers to 50%. Mr Kuzin adds, “National manufacturers comprise only 20% of the Russian pharmaceutical market by value. The decision to move to GMP will mean that a few hundred plants will close — especially old Soviet factories supplying medium-sized towns — so in the current situation such a decision won’t be taken.” There is however political will to introduce a universal system of health insurance in Russia by 2010, according to a speech by Prime Minister Vladimir Putin earlier this year. Mr Kuzin considers this timeline optimistic: “The best scenario would be to have a region where an experiment is done by 2010, which wouldn’t be bad. If health insurance comes about for all the working population, then it will unconditionally help everyone.” As with the primary health care reforms partially funded by the World Bank, the typical model is to pilot and assess a raft of changes in one or two of the 83 Russian regions, before deciding scale up. By 2015 can we expect universal health insurance, 2004 GMP standards, Western levels of drug consumption, and a top five global pharmaceutical market? As the Russians are fond of saying: “We’ll live — we’ll see.” ■ 16 Critical Vision Jacky Law joins Pharm Exec Europe as a columnist. 18 Executive Profile Pharm Exec Europe talks to NNIT’s CEO, Per Kogut. 22 Regulatory Affairs Will the FDA/EMEA joint inspection programme work? 25 Last Words The month’s key events from the industry’s mouth.
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