Medicines and Procedures in UK Law

Leading Cases
  • Actavis Ltd v Merck & Company Inc. (Costs)
    • Court of Appeal (Civil Division)
    • 21 Mayo 2008

    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.

  • Airedale NHS Trust v Bland
    • House of Lords
    • 04 Febrero 1993

    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).

  • Re A (Medical Treatment: Male Sterilisation)
    • Court of Appeal (Civil Division)
    • 20 Diciembre 1999

    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.

  • Re J (A Minor) (Wardship: Medical Treatment)
    • Court of Appeal (Civil Division)
    • 19 Octubre 1990

    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.

  • MM (Zimbabwe) v The Secretary of State for the Home Department
    • Court of Appeal (Civil Division)
    • 13 Marzo 2012

    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.

  • Re TF (an Adult: Residence)
    • Court of Appeal (Civil Division)
    • 26 Junio 2000

    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.

  • Re S (Sterilisation: Patient's Best Interests)
    • Court of Appeal (Civil Division)
    • 18 Mayo 2000

    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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Legislation
  • The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
    • UK Non-devolved
    • 1 de Enero de 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 ... ...
  • The National Health Service (General Medical Services Contracts) Regulations 2015
    • UK Non-devolved
    • 1 de Enero de 2015
    ... ... of which is equal to the number of occasions on which the drugs, medicines or appliances ordered on the non-electronic repeatable prescription may be ... must nominate a person with responsibility for practices and procedures relating to the confidentiality of personal data held by it ... ...
  • The Human Medicines Regulations 2012
    • UK Non-devolved
    • 1 de Enero de 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 ... ...
  • The Medicines for Human Use (Clinical Trials) Regulations 2004
    • UK Non-devolved
    • 1 de Enero de 2004
    ... ... (3) Clinical trials shall be scientifically sound and guided by ethical principles in all their aspects ... (4) The necessary procedures to secure the quality of every aspect of the trial shall be complied with ... (5) The available non-clinical and clinical information on an ... ...
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Books & Journal Articles
  • Exploring the relationships among tacit knowledge sharing, mentoring and employees’ abilities. The case of Al-Hikma pharmaceutical company in Jordan
    • No. 50-1, November 2019
    • VINE
    • 34-56
    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 ... ...
  • Convergence, Divergence and Hybridity: A Regulatory Governance Perspective on Health Technology Assessment in England and Germany
    • No. 8-S2, March 2017
    • Global Policy
    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 ... ...
  • New Enforcement Mechanisms Challenge the Legality of Generics in the Name of Public Health: The Emergence of Anti-Counterfeiting Legislation in East Africa
    • No. , September 2010
    • African Journal of International and Comparative Law
    • 238-253
    ... ... 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 ... ...
  • The Regulation of Non-Surgical Cosmetic Procedures
    • No. 11-1, January 2021
    • Southampton Student Law Review
    • Sophie Cole
    • LLB (Soton)
    • 37-49
    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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Law Firm Commentaries
  • Fast-Tracking Approval of Medicines – UK Publishes Detailed Guidance on its New International Recognition Procedure
    • LexBlog United Kingdom
    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 ...
    ... ... 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 ... ...
  • UK Life Sciences and Healthcare Newsletter: Regulatory Updates
    • JD Supra United Kingdom
    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, ... ...
  • Brexit And Life Sciences Update
    • Mondaq UK
    ... ... 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 ... ...
  • UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
    • LexBlog United Kingdom
    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 ... ...
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