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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Cohen v General Medical Council
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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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Maynard v West Midlands Regional Health Authority
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I would only add that a doctor who professes to exercise a special skill must exercise the ordinary skill of his speciality. Differences of opinion and practice exist, and will always exist, in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A court may prefer one body of opinion to the other: but that is no basis for a conclusion of negligence.
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The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
... ... 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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Children and Social Work Act 2017
... ... 68: Affirmative and negative resolution procedures ... (1) ... Medicines Act 1968 ... (2) ... ...
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The Human Medicines Regulations 2012
... ... 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 ... ...
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The Veterinary Medicines Regulations 2013
... ... Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (3) ... In accordance with section 56(1) ... ...
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Implementing Paediatric Extensions to Spcs: Marketing Authorization in ‘all Member States’
... ... the paediatric population, for whom the development of specific medicines has been essentially abandoned.In exchange for the new requirements, ... extensive discussions aimed at implementing the correct grant procedures for these SPC extensions. Thus, on 26 September 2008, the EMEA hosted an ... ...
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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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Health Technology Assessment: Current Issues Impacting on the Regulatory and Legal Framework
... ... In: The Law and ... Regulation of Medicines and Medical Devices. Edited by Peter Feldschreiber, Oxford University ... broad range of treatments, such as medicines, surgical procedures, diagnostic scans or ... tests, medical devices, and health apps. Public ... ...
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Introduction
...Peter Feldschreiber, Introduction. In: The Law and Regulation of Medicines and Medical Devices. Edited by Peter Feldschreiber, Oxford ... University ... In 1987 ... the concertation procedures for central marketing authorisation and mutual recogni- ... tion of ... ...
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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 ...... ... our prior blog and audiocast). The IRP will apply from 1 January 2024 and will replace and significantly expand on existing EU reliance procedures to apply to authorizations from 7 key international regulators. As such, the “IRP will allow the MHRA to take into account the expertise and ... ...
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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 ...... ... The UK currently has reliance procedures in place for medicines that are centrally authorized by the European Commission or authorized in the EU through decentralized and mutual recognition ... ...