Medicines and Procedures in UK Law
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Actavis Ltd v Merck & Company Inc. (Costs)
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In BMS Jacob J wondered how such a claim might work so far as infringement is concerned and thought it might create difficulty. And so it might in some cases (e.g. where the product is just sold as a standard product, like aspirin tablets). But in many cases the difficulty may be more theoretical than real.
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Airedale NHS Trust v Bland
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First, it is established that the principle of self-determination requires that respect must be given to the wishes of the patient, so that if an adult patient of sound mind refuses, however unreasonably, to consent to treatment or care by which his life would or might be prolonged, the doctors responsible for his care must give effect to his wishes, even though they do not consider it to be in his best interests to do so (see Schloendorff v. Society of New York Hospital 105 N.E. 92, 93, per Cardozo J. (1914); S. v. McC. (Orse S.) and M (D.S. Intervener); W v. W [1972] A.C. 24, 43, per Lord Reid; and Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] A.C. 871, 882, per Lord Scarman).
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Re J (A Minor) (Wardship: Medical Treatment)
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This gives effect, as it should, to the fact that even very severely handicapped people find a quality of life rewarding which to the unhandicapped may seem manifestly intolerable. But in the end there will be cases in which the answer must be that it is not in the interests of the child to subject it to treatment which will cause increased suffering and produce no commensurate benefit, giving the fullest possible weight to the child's, and mankind's, desire to survive.
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Re A (Medical Treatment: Male Sterilisation)
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Pending the enactment of a check list or other statutory direction it seems to me that the first instance judge with the responsibility to make an evaluation of the best interests of a claimant lacking capacity should draw up a balance sheet. At the end of that exercise the judge should be better placed to strike a balance between the sum of the certain and possible gains against the sum of the certain and possible losses.
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Re TF (an Adult: Residence)
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The family life for which Article 8 requires respect is not a proprietary right vested in either parent or child: it is as much an interest of society as of individual family members, and its principal purpose, at least where there are children, must be the safety and welfare of the child. It is not to allow other individuals, however closely related and well-intentioned, to create or perpetuate situations which jeopardise their welfare.
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MM (Zimbabwe) v The Secretary of State for the Home Department
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The only cases I can foresee where the absence of adequate medical treatment in the country to which a person is to be deported will be relevant to Article 8, is where it is an additional factor to be weighed in the balance, with other factors which by themselves engage Article 8.
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Re S (Sterilisation: Patient's Best Interests)
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In deciding what is best for the disabled patient the judge must have regard to the patient's welfare as the paramount consideration. Indeed it would be undesirable and probably impossible to set bounds to what is relevant to a welfare determination. In my opinion Bolam has no contribution to make to this second and determinative stage of the judicial decision.
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The Human Medicines Regulations 2012
... ... (EC) No 726/2004” means Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;“Regulation ... ...
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The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
... ... for such use and is used in a safe way;(f) where equipment or medicines are supplied by the service provider, ensuring that there are sufficient ... (2) Recruitment procedures must be established and operated effectively to ensure that persons ... ...
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The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013
... ... 2005/258 and S.I. 2006/358 ... (66) The Medicines for Human Use (Clinical Trials) Regulations 2004(1) The Medicines for ... (126) The Local Health Boards (Constitution, Membership and Procedures) (Wales) Regulations 2009(1) The English text of the Local Health Boards ... ...
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The Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013
... ... product” has the meaning given by regulation 2(1) of the Human Medicines Regulations 2012 ;“relevant list” means—(d) a relevant list for the ... ) where a right to cancel exists, the conditions, time limit and procedures for exercising that right in accordance with regulations 27 to 38;(m) ... ...
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Exploring the relationships among tacit knowledge sharing, mentoring and employees’ abilities. The case of Al-Hikma pharmaceutical company in Jordan
Purpose: This study aims to assess the relationships among tacit knowledge sharing, mentoring and employees’ abilities in the areas of solving the work problems, adaptation to environments and crea...... ... data were examined following the structuralequation modeling procedures.Findings –Results revealed that tacit knowledge sharing had a positive ... in terms of investing in human capitaland offering wide range of medicines to localand international markets. Since the 1990s,the sector has been one ... ...
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Convergence, Divergence and Hybridity: A Regulatory Governance Perspective on Health Technology Assessment in England and Germany
Countries adopt different methods and processes to evaluate the benefits and costs of health technologies. It is important to identify and analyse the factors that influence the uptake and use of t...... ... The former is a process for producing knowledge about new medicines, or the structured analysis of a health care technology, which is ... to local health authorities on whether or not new medicines, procedures and medical devices should be part of the basic bene fi ts package, in ... ...
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New Enforcement Mechanisms Challenge the Legality of Generics in the Name of Public Health: The Emergence of Anti-Counterfeiting Legislation in East Africa
... ... over the status of perfectly legal generic products such as medicines which may result in them being placed in the same category as illegally ... In general, Arts 41–9 provide for civil and administrative procedures in cases of IPR infringement, including injunctions, damages and remedies ... ...
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The Regulation of Non-Surgical Cosmetic Procedures
The growth of non-surgical cosmetic procedures has brought with it concerns over the regulation of the industry. Procedures such as dermal fillers and botox injections are becoming increasingly pop...... ... Practitioners ... Firstly, there are few statutory limits governing who can lawfully offer such procedures. Under the Medicines Act, prescription medicines such as botox may only be prescribed by dentists, doctors and qualified independent prescribers. 16 Yet there are no ... ...
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Fast-Tracking Approval of Medicines – UK Publishes Detailed Guidance on its New International Recognition Procedure
On 30 August 2023, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) published detailed guidance on its recently announced new International Reliance Procedure (“IRP”) (see our ...
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UK Life Sciences and Healthcare Newsletter: Regulatory Updates
MHRA updates post-transition guidance Since 31 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) has been updating various aspects of the regulatory regime for medicines...... ... Since 31 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) has been updating various ... MHRA’s decentralised or mutual recognition procedures which would enable MAs approved in EU member states (or Iceland, ... ...
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Brexit And Life Sciences Update
... ... authorisations using either the centralised or decentralised procedures. CE marking for medical devices will continue to be used and recognised ... -stated with 823 applications for commercial clinical trials of medicines having been submitted in the UK in 2017 ... Proposals in the report ... ...
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UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high growth sectors,” which the UK Government ...