in brief...
The European Medicines Agency (EMEA) is making e3.7m available in 2005 to pharmaceutical manufacturers seeking exemptions from administrative fees regarding the development of orphan drugs. The subsidies would cover fees for pre-authorisation work, such as scientific advice over existing pharmaceutical protocols; and for companies using EMEA's centralised procedures, they would cover marketing authorisations, inspections and post-authorisation demands including annual fees and permit variations. The entire cost of protocol assistance fees can be covered, with EMEA meeting half the cost of all other charges.
Poland and Taiwan have remained on a US government watch list on counterfeiting and fraud, largely because Washington thinks they could do more to fight pharmaceutical piracy. The US Trade Representative office said it would push Taiwan to pass a law preventing unfair commercial use of pharmaceutical test data. And regarding Poland, it said: 'Problems remain with the protection of test data and co-ordination between the (national) health ministry and the patent agency.'
The European Investment Bank (EIB) has drawn up plans to lend Finnish pharmaceutical company the Orion Corporation up to e150m for its research into medicines for central nervous system problems, cardiovascular diseases and hormonal therapies. The bank is supporting the Espoo-based company's work, under its Innovation 2010 Initiative fostering innovation and research.
The European Medicines Agency (EMEA) has released a paper on environmental risk assessments for medicinal products containing genetically modified organisms.
An explanatory memorandum regarding EU rules on clinical trials documents has been published by the European Commission.
EU governments must make a clear ruling within 180 days of a manufacturer's application for a medicine to be eligible for refunds under a state health insurance scheme, the European Court of Justice (ECJ) has ruled. In a case involving the Belgian government and Merck, the ECJ added that where a government missed this deadline, a company could not assume a positive decision. Merck was contesting Belgium's refusal to say whether Proscar could be supplied under its medical insurance scheme.
An additional protocol to the Council of Europe's Convention on Human Rights and Biomedicine, concerning Biomedical Research, has been opened for signature by the organisation's 46 member states. The protocol defines and protects fundamental rights of human bio-medical research subjects, saying who can consent to taking part in experiments, and in what circumstances. Countries that have so far signed the protocol include: Denmark, Greece, Iceland, Luxembourg, Moldova, Norway, Slovakia, Slovenia, Sweden and Turkey.