European Union Draft Research Articles

Reporting suspicions of money laundering and whistleblowing under German law

Outlines the reporting duties of credit institutions in cases of suspicious transactions, for instance when there is no apparent purpose, the transaction does not meet the client’s needs or is unnecessarily complicated; and the reporting procedures, including who must notify the authorities, form requirements, consequences for the transaction, internal procedure, and legal privileges and risks. Continues with the reporting duties of other professionals, including the envisaged changes under the European Union draft guidelines and the implications for legal advisers, who have protested against the proposed changes as a violation of civil rights to secrecy and confidentiality; this view is shared by the European Parliament. Gives a case study of a court decision which acquitted an defence attorney of knowingly accepting a fee derived from drug dealing, while another case convicted two lawyers for knowingly accepting a fee from a pyramid selling scheme; defence attorneys are still excluded from reporting duties, so the legal position is not clear.

Assessing the safety profile of a new antihypertensive agent.

GUIDELINES ON DRUG SAFETY: Recent European Union draft guidelines for the safety evaluation of drugs intended for long-term use state that during drug development the safety profile of the new compound should be assessed over a period of time consistent with intended usage. This is in reasonable agreement with guidelines prepared by other regulatory authorities. CLINICAL DRUG DEVELOPMENT: Satisfactory preclinical data on a new compound are used to obtain authorization for human testing from the National Committees on Safety of Medicines. Clinical trials are performed in four phases, ranging from phase I studies performed on healthy volunteers (n = 20-50) to postmarketing (phase IV) studies. The latter are of great importance as they cover large patient populations (n = 2000 to > or = 10,000) and allow detection of rare adverse drug reactions. ADVERSE DRUG REACTIONS: Type B reactions are serious, unpredictable reactions to a drug that necessitate treatment withdrawal. Type A reactions are dose-dependent, and represent the majority of adverse reactions. They are often managed by dose reduction rather than drug withdrawal. ADVERSE REACTIONS TO ANTIHYPERTENSIVE AGENTS: Examples of type B adverse reactions to antihypertensives are the cutaneous and ocular reactions to practolol, and angioneurotic oedema associated with angiotensin converting enzyme inhibitors. Lacidipine, a second-generation calcium antagonist, is an example of a modern antihypertensive agent with a favourable safety profile. The adverse reactions associated with lacidipine are mild to moderate and of the A type, the major ones being those typical of calcium antagonists (headache, flushing and pedal oedema due to vasodilation.