Archive

BY KEITH NUTHALL
THE EUROPEAN Agency for the Evaluation of Medicinal Products (EMEA) has released guidance papers on the clinical development of medicinal products for the treatment of HIV infection (http://www.emea.eu.int/pdfs/human/ewp/063302en.pdf) and the clinical investigation of medicinal products for the treatment of rheumatoid arthritis (http://www.emea.eu.int/pdfs/human/ewp/055695en.pdf).…

BY KEITH NUTHALL
A EUROPEAN and Developing Countries Clinical Trials Partnership has been launched by the European Commission. Commanding Euro 200 million of Brussels’ money, the initiative will develop new medicines and vaccines against AIDS, malaria and tuberculosis. It will involve the pharmaceutical industry and Norway as well as developing countries and will also see EU institutions participating in Member States’ national research and development programmes.…

BY KEITH NUTHALL
THE EUROPEAN Commission has published detailed guidelines on the packaging of medical products, including on labelling and inserted leaflets containing additional information. Notably, the rules say that “rational” packaging should be used, with clear pack sizes governed by the duration of treatment, such as one for a short course, another for a monthly course and another for a longer multiple course.…

BY KEITH NUTHALL
THE FIRST update to the European Union’s inventory of national policies and regulations promoting the availability of orphan drugs has been completed and published by the European Commission. This new detailed inventory lists all incentives made available by the EU and its Member States to support research into orphan medicinal products.…

BY KEITH NUTHALL
EUROPEAN Commission officials have codified in a single piece of legislation all the many existing EU rules on good laboratory practice and the verification of tests on chemical substances. They have done the same for EU regulations on the inspection and verification of good laboratory practice.…

BY KEITH NUTHALL
A UNIFORM and streamlined system on the monitoring of illicit drug precursors for trade between EU Member States has been proposed by the European Commission. Brussels wants rules on licensing, customer declarations, labelling and monitoring procedures written as an EU Regulation, which national governments must implement to the letter.…

BY KEITH NUTHALL
AN INTERNATIONAL convention improving the right of access by children to separated parents who live in different countries is expected to become European law, with the European Commission proposing that the European Union signs up to its terms.…

BY MONICA DOBIE
CANADIAN publishers are licking their wounds after a summer ill spent with paperwork, lawyers fees and frustration because of the crash of Jack Stoddart’s General Publishing Co. Ltd. and its book distribution arm, General Distribution Services Ltd. (GDS), which filed for voluntary bankruptcy last month at an Ontario court.…

BY KEITH NUTHALL
MANY European Union Member States fail to give writers and publishers the royalty rights that they are due under EU law through their national public lending rights rules, the European Commission is claiming. In a report that could lead it to take legal action at the European Court of Justice, Brussels says that France, Greece and Luxembourg fail to give right-holders any remuneration for books lent from public libraries; in Sweden royalties are only paid to national or resident authors; and in Denmark and Finland, payments are only made for books in the local national language.…

BY KEITH NUTHALL
THE EUROPEAN Commission has published a list of exported American book industry products that could attract protective duties of up to 100 per cent, because of a WTO ruling allowing Brussels to retaliate against the US’s use of foreign trade corporations to give its exporters tax breaks.…