Top 10 Pharmaceutical, Healthcare & Life Sciences Headlines from Europe New measures for foreign currency loans and foreign currency indexed loans. To sell a medicine in the European Union (EU), a marketing authorisation (MA) is required. Draft laws published by the BRSA: The BRSA has published two draft laws on its web site. The first draft foresees various amendments in the Banking Law. The second draft foresees a new law on the establishment/operation of finance leasing, factoring and finance companies. Research and Development (“R&D”) activities are an investment field that has become more of an issue in Turkey in recent years. On 6 October 2009, the European Court of Justice (ECJ) issued its judgment in the long-running wrangle regarding the legality of GlaxoSmithKline's (GSK) dual pricing arrangements with Spanish pharmaceutical wholesalers. Bureaucratic burden and uncertainties caused by lack of sufficient and relevant regulation were blamed by the pharmaceutical industry as one of the significant reasons for the relatively low number of clinical trials conducted in Turkey despite its potential in terms of population, qualified personnel and geographical location. The map of European pricing and reimbursement systems is quitecomplex. New price controls for life-saving and essential medicines have been introduced by the government. Originators beware: The marketing authorization granted by theGerman authority for a generic formulation of Plavix, and thesubsequent decision of the competent court in preliminaryproceedings to allow the marketing of the drug, raises questionsabout the protection of data under the European regulatoryframework. In Turkey, the advertising matter of pharmaceutical products is governed by the Regulation on the Promotion of the Medicinal Products for Human Use which is based on Pharmaceutical and Medical Preparations Law numbered 1262. |