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Issue 19 - 18 February 2005 A new Pharmaceutical Price Regulation Scheme (PPRS) started on 1 January 2005. The scheme states that subject to public consultation, 'standard' branded generics will no longer be covered by the PPRS and will be transferred to the new arrangements for the reimbursement of generic medicines. This letter seeks comments on these proposals by April 2005. LInk to press release Japan's Ministry of Health and Welfare is considering banning AstraZeneca's lung cancer drug Iressa™ (gefitinib) after accepting a report which linked it to 588 deaths in the country. The Department of Health has announced the phased withdrawal of co-proxamol, and has issued further guidance on the management of patients who have been on co-proxamol. Drug fears prompt new test plan BMJ news reports on an article in the Times newspaper which suggests that the Department of Health is considering introducing a new fourth stage in the drug approval process, in an attempt to reduce the number of harmful medicines which are approved. It is reported that whilst this move would improve the safety standards of drugs, it could however delay access to life-saving treatments and increase the cost of developing new medicines by hundreds of millions of pounds. The Health Minister Lord Brockley said he is looking at giving conditional licences to monitor new drugs among a large group of patients before treatments get full approval. The proposals are at an early stage, and would involve drug companies launching a fourth trial among much larger groups of patients. The proposals come in the wake of safety concerns about drugs such as Vioxx™, which was withdrawn last year. A new service has been launched to give people access to vital health information through their televisions. NHS Direct Interactive provides more than 2,500 pages of information, ranging from an A-Z of illnesses and conditions to tips on registering with a GP. Sanofi-Aventis is facing a patent challenge to Plavix (clopidogrel) in the UK. In a statement, the company said its patent in the UK covering the drug’s active ingredient had been challenged by Scotland’s Aircoat. Plavix is already subject to patent challenges in the US from India and Canada, but this is believed to be the first time that a European patent on the drug has been threatened. Sanofi-Aventis said it believes Aircoat’s arguments to be without merit, and will vigorously defend its patent. Plavix is not due to lose patent protection in the US until 2011 and until 2013 in Europe. Patent expiry Due to complexity of patent protection, the dates given below are for guidance only. Fluticasone Mar 2005 Lamotrigine May 2005 Nafarelin June 2005 Cladribine July 2005 Marketing authorisations published in January 2005/February 2005 All Device Evaluation Service reports since 2002 are now available on the MHRA website. The new National electronic Library for Health (NeLH) Skin Conditions Specialist Library is now available online. The Skin Conditions Specialist Library aims to provide quality, evidence-based information on skin conditions and their treatment. ======================== Did you know ... Rare diseases affect 20 million European citizens. ======================== Talkback If you have any comments or questions, please contact the editor at helpdesk@alliance-eras.com. ======================== |
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