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Due to major building activity, some collections are unavailable. Please check your requests before visiting. Learn more. Broken link? This is a book about management - not as a collection of functions and techniques, not as prescriptive textbooks say it 'ought' to be, but rather as a complex set of social and symbolic processes often characterized by considerable ambiguity and paradox. In particular, the book develops that body of work concerned with building experience-based, grounded description and understanding of the processes of management and managing. In their different ways each of the contributors to the volume explores and illuminates: the dynamics subtleties and complexities of managerial life; its informal as well as formalized features and practices; and the significance of the cultural and symbolic in organizations. There is a concern with meanings and the relations between managerial 'talk, thought and action'. Authors draw both on established social anthropological concepts - such as culture, myth, ritual, totem and taboo - for an understanding of the nature of managing, and on those deriving from newer postmodernist themes and developments. Understanding Management represents a fascinating and invaluable resource for all those studying, teaching and researching management, and for those in organization theory, organizational behaviour, the sociology and psychology of organizations, and general management studies. You may copy under some circumstances, for example you may copy a portion for research or study. Order a copy through Copies Direct to the extent allowed under fair dealing. Contact us for further information about copying. Copyright status may not be correct if data in the record is incomplete or inaccurate. Other access conditions may also apply. For more information please see: Copyright in library collections. Request Order a copy. In Copyright You may copy under some circumstances, for example you may copy a portion for research or study. Copyright status was determined using the following information: Material type: Literary Dramatic Musical. Published status: Published. Publication date: Report an error. Similar items. Find in other libraries at Trove.

Medicines legislation and regulation in the United Kingdom 1500‐2020

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Official websites use. Share sensitive information only on official, secure websites. Correspondence , Robin E. Email: r. The initial purposes of regulation of medicines in England, and latterly in the United Kingdom, were principally to raise government revenue, to discourage murder by poisoning and to regulate the activities of pharmacists. It was only much later that regulators sought to ensure that medicines were of good quality, reasonably safe, and at least somewhat effective, and to curtail misuse of drugs. Here we survey the history of the regulation of medicines and poisons in England from the perspective of clinicians with an interest in therapeutics. Keywords: drug legislation, England, United Kingdom, prescription drugs, illicit drugs, drug industry. Here we survey the history of the regulation of medicines and poisons in England from the perspective of clinicians with an interest in therapeutics see Table 1. Wales was annexed into the Kingdom of England by the Laws in Wales Acts of and , with extension of the legal system. Before that, legislation in Scotland and Ireland differed from that in England and Wales. He later promulgated this Act to empower the physicians to inspect apothecaries' wares and destroy them if defective. Although the apothecaries were keen to be recognized as independent practitioners, their requests were refused until , when James I founded the Worshipful Society of the Art and Mistery of Apothecaries. The struggle between the physicians and the apothecaries eventually led the former to publish the Pharmacopoeia Londinensis in The Charter established the College and invested in it the power to examine medicines kept in apothecaries' shops, and destroy those that were not of good quality; henceforth to allow only those who had been examined by the President and Censors of the College to open an apothecary's shop, its jurisdiction to extend over Edinburgh, its suburbs and its liberties. This Act gave regulatory powers to Examiners from the King and Queen's College of Physicians of Dublin to ensure the quality of drugs, medicines, oils and compositions used as medicines within the city and its suburbs. One way in which 18th century governments sought to raise income was to require certain transactions and some goods for sale to carry a tax receipt in the form of a stamp. They also required vendors to buy an annual licence. The primary aim was to pay for government expenditure. The 18th century Acts were repealed by later Acts, promulgated in , and An unintended consequence of the Stamp Acts was that proprietary medicines whose contents were not disclosed, but which were proffered for sale with claims of therapeutic efficacy, now bore a government stamp that signified, if not endorsement of the claims, at least acquiescence in them. The claims made by manufacturers of patent medicines were for the most part both unbelievable and, by the 19th century, exceptionally profitable. Thomas Holloway's Pills, whose contents were similar, and Holloway's Universal Family Ointment provided him with the fortune that allowed him to found Royal Holloway College in the University of London and a sanatorium at Virginia Water. This provoked stormy debate in Parliament when the abolition of stamp duty on proprietary medicines was discussed in Most medical care by the end of the 18th century was administered not by physicians, but by apothecaries, but they were for the most part uneducated. The 19th century saw some progress in legislation to safeguard the public regarding medicines with beneficial pharmacological actions that were also potential poisons—opiates, digitalis, and salts of mercury and antimony, for example. The British Pharmacopoeia Pharmacopoeia Britannica was recommended and announced in the Medical Acts of and It appeared in and is still in use today. The Act contained a schedule of poisons, including arsenic, cyanides, aconite and strychnine, but also cantharides and ergot of rye. These acts dealt with adulteration of food and drugs. The bill failed because of opposition from the Society of Chemists and Druggists. One of the greatest evils of late years had been the great increase of quack advertisements of a filthy kind. It was remarked to him the other day, by a gentleman who had spent much time on the Continent, that whereas in Germany he never knew one of these indecent advertisements to be thrust in his hand, when he came to London such advertisements were thrust into his hand frequently. To summarize, medicines legislation in the 18th and 19th centuries failed to protect the public from harmful medicines and did nothing to test whether medicines had the therapeutic properties claimed, but made progress in curtailing the widespread sale of poisons and explicitly making the adulteration of medicines unlawful. The public gained some protection through restrictions on those responsible for dispensing medicines by the Pharmacy Act 44 and its successors, 45 and through restrictions on prescribing by the Medical Act The struggle to control patent medicines persisted throughout the 19th century and well into the 20th, leading to the failure of the Patent Medicines Bill and the relative success of the Pharmacy and Medicines Act both discussed below. For many poisons, it stipulated a minimum concentration that must be exceeded for it to fall within the scope of the Act. A vendor required a licence to sell poisons. This legislation was enacted a few days after Britain's entry into the First World War. It enabled the Government to make emergency provisions, as the need arose, to serve the war effort. The Army Council Orders of 11 May 48 issued under the Act, and subsequent additions and amendments, 49 , 50 made the sale of certain drugs, including cocain \[sic\], Indian hemp and morphine, to any member of his Majesty's Forces, except doctors, dentists and veterinary surgeons, an offence, unless prescribed by a registered medical practitioner. The government introduced a very wide Criminal Law Amendment Bill, which dealt with various sexual offences and also prohibited indecent advertisements. It also made it an offence for anyone other than a duly qualified medical practitioner to treat anyone for venereal disease for reward. The problem of dangerous drugs had not begun with the First World War and did not disappear with the Armistice in November The Royal Commission on Opium in had found the arguments for prohibiting the opium trade unconvincing. The Act prohibited the import and export of opium, cocaine and some derivatives, replacing the prohibition brought in under the Defence of the Realm Act Further legislation followed in , principally to bring into effect the provisions of the Geneva Convention. The efficacy of the measures was unclear. The number of those convicted under the Dangerous Drugs Act rose from in to in In a departmental committee proposed a definition of standards, provision of systems to ensure that the standards were met, and steps to prevent foreign medicines from circumventing the standards. Nevertheless, the legislation was delayed until proposals by the League of Nations made it essential, if British medicines were still to be exported to Europe. The work was initially entrusted to the Pharmaceutical Society. Neither the Pharmacy Acts nor the Medical Act stemmed the tide of proprietary medicines advertised directly to the public. It also recommended that the ingredients and their proportions in every remedy, and a full statement of the therapeutic claims made, be submitted confidentially to the Department. However, the report was published on 4 August , at the outbreak of the First World War, and little came of it. The recommendations of the Select Committee on Proprietary Medicines had been largely eclipsed by the events of the First World War, and the problem of proprietary medicines persisted. The Pharmacy Act , and the related Acts of and , left enforcement of the law and control of the sale of poisons in the hands of the Pharmaceutical Society. The Poisons List specified those substances that fell within the scope of the Act. The Medicines and Surgical Appliances Advertisement Bill sought to curb the advertisement of patent medicines. As we have noted, the Bill had fallen at the first fence. There was good reason for this. The newspaper proprietors, whose finances depended on carrying advertisements for patent medicines, imposed a form of censorship. The fee was two guineas. One patient was a woman, one a man and the third a dog. The Pharmacy and Medicines Act finally succeeded in enacting provisions to regulate the patent medicine trade. The Act prohibited with exceptions advertisements of articles 'in terms which are calculated to lead to the use of that article … for the treatment of human beings for any of the following diseases, namely, Bright's disease, cataract, diabetes, epilepsy or fits, glaucoma, locomotor ataxy, paralysis or tuberculosis. The Act at last required the nature and amount of all active ingredients but not all ingredients to be displayed on the label of a medicine. One World War had halted progress in this field; it took a second World War to bring it about. Following its isolation from Penicillium notatum in and its marketing by US companies during the war, penicillin was initially in very short supply, and an Order in under the Defence Regulations made its sale a criminal offence unless it had been prescribed by a doctor. This sort of amateur treatment causes noxious germs to lose their sensitivity to penicillin , with the result that the patient is likely to succumb to the next attack of any illness which might otherwise have responded to this treatment. The committee was established in and was chaired by Sir Derrick Dunlop, who had just retired as Christison Professor of Therapeutics in Edinburgh. I want to suggest that our own methods of testing and controlling the market in drugs are wholly inadequate and that what is required is a central drug licensing agency, free from commercial pressure, which will have the power to provide essential safeguards which do not exist today. It established the apparatus for licensing medicines and the criteria that had to be met before a licence could be granted, namely:. These remain the guiding principles by which the Licensing Authority—the Minister of Health, the Secretary of State concerned with health in Scotland, and the Minister of Health and Social Services for Northern Ireland—judges, on the advice of a committee of experts, whether a medicine can be licensed, under the direction of a Medicines Commission. The Medicines Act requires that a licence now known as a marketing authorization should be held in respect of all medicinal products, that is, products used for one or more medicinal purposes, namely:. It also regulated the packaging of medicines, their promotion, the conduct of pharmacies and several other matters relating to them. Herbal remedies sold by herbalists were largely exempt. The Act now runs, with amendments, such as the Medicines Cyanogenetic Substances Order , to over paragraphs. Schedule 1 drugs, such as lysergide, are not used medically. Schedule 5 covers formulations, such as pholcodine linctus, that are so weak that controls are minimal. The Secretary of State also looked to the Poisons Board to recommend or advise on the Poisons Rules, which set out, for example, the ways in which poisons must be bottled or stored. The list distinguished between poisons that could only be sold by a retail pharmacist, and those that could also be sold by a person or business licensed to do so. It did not set out to generally restrict poisons used in the practice of medicine or the activities of wholesale or export businesses. This Statutory Instrument curtailed the exemptions enjoyed by herbal medicines by virtue of sections 56 3 and 57 1 of the Medicines Act The Misuse of Drugs Regulations allow for lawful possession and supply of controlled illegal drugs for legitimate purposes. Between the United Kingdom's accession to the European Economic Community on 1 January and its exit on 31 December , medicines regulation became increasingly dependent on directives from the European Union, and specifically the European Medicines Agency, of which, at that time, the MHRA was a member. Regulation EC No. Baroness Cumberlege, in a report titled First Do No Harm, described in detail the harms arising from three medical interventions, of which two were medicines: hormones taken as pregnancy tests and the antiepileptic drug sodium valproate. Since the MHRA was founded, it has introduced various regulations in response to adverse drug reactions, requiring drug developers to undertake the studies necessary for the award of a marketing authorization. Examples include:. Contraindications and cautions are also added to the label from time to time when adverse effects become apparent. In some cases a licence may be revoked if a serious adverse reaction is discovered. At least the Stamp Acts of the late 18th and early 19th centuries had as their clear objective the financial interest of the State. Even after the shock of the thalidomide tragedy, several years passed before effective legislation was enacted, and at last specifications were laid down for medicines to be acceptably safe, efficacious and of good pharmaceutical quality. The Medicines Act has, with modifications, allowed regulators to operate for over half a century with a largely good record on the provision of safe and effective medicines. When regulation has failed to weed out medicines that have subsequently proved problematic, because of adverse reactions or interactions, the introduction of further regulations has sought to prevent similar problems, as discussed above. The fear of poisoning, and evidence that murder by poisoning was rife, encouraged successive pieces of legislation to control the sale of poisonous substances. Even then, the enforcement of the Poisons Act with respect to proprietary medicines was laggardly, and itself a response to the increasing number of inquests into deaths from overdose with chlorodyne, which contained morphine and chloroform. The tensions between commerce and public safety persist. Proposed legislation, permitting provisional market access without the thorough investigations required for a full marketing authorization, could shift the balance between benefits and harms. Medicines regulation, which must balance access to effective medicines against the safety of the public, is hard. In England over several centuries legislators have often been slow to protect the public and reactive rather than proactive. Commercial interests have from time to time significantly influenced the shape and enactment of legislation, as have incidental events, such as wars, and serious adverse drug reactions. Neither author has a direct conflict of interest in relation to this work. He has written articles on the history of drug regulation and legislation. They have written articles on drug advertising, medicines regulation and the Prevent Future Deaths report of English coroners. Br J Clin Pharmacol. In the case of The King v. His conviction was quashed by the Court of Justiciary, which found that the indictment had not stated that the book was obscene, indecent or an advertisement. The Court of Appeal disagreed. As a library, NLM provides access to scientific literature. Find articles by Robin E Ferner. Find articles by Jeffrey K Aronson. Open in a new tab. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. To regulate apothecaries and ensure the quality of medicines. To reduce the risks of criminal arsenic poisoning. To establish the licensing of doctors with the right to prescribe; to set up the British Pharmacopoeia. To criminalize the malicious administration of poisons. To ensure the examination and registration of pharmacists; to identify scheduled poisons. To make the adulteration of food and drugs a crime. To legislate against the sale of patent medicines not enacted. To prevent misleading advertisements about ineffective treatments. To regulate the sale of certain poisonous substances. To prohibit treatment for venereal diseases except by registered medical practitioners. To limit the supply of drugs such as morphine, heroin, cocaine and amphetamines. To regulate the manufacture, sale and advertisement of patent medicines. To transfer the responsibility of regulating poisons from the Pharmaceutical Society to the Home Secretary, assisted by a Poisons Board. Medicines and Surgical Appliances Advertisement Bill. To prohibit the sale of any drug not of the nature, substance or quality demanded. To prohibit advertisements containing offers to treat, prescribe for or offer advice on cancer. Control of Penicillin Order No. To restrict the use of penicillin to qualified prescribers. To regulate the licensing, manufacture and advertising of medicines and to establish the Medicines Commission. To replace the Medicines Act and about other pieces of secondary legislation; to encompass such matters as licensing, pharmacovigilance, sale and supply, and advertising. To supersede the Pharmacy and Poisons Act , including licensing the sale of poisons. Medicinal Products: Prescription by Nurses etc. To supplement the regulations, allowing lawful possession and supply of controlled drugs for legitimate purposes. To lay down community procedures for the authorization and supervision of medicinal products for human and veterinary use, and to establish the European Medicines Agency. To require the reporting of results of clinical trials, including pharmacological interventions.

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