Medicines and Procedures in UK Law

Leading Cases
  • Actavis Ltd v Merck & Company Inc. (Costs)
    • Court of Appeal (Civil Division)
    • 21 Maio 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 Fevereiro 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 Dezembro 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 Outubro 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.

  • Re TF (an Adult: Residence)
    • Court of Appeal (Civil Division)
    • 26 Junho 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 Maio 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.

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

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Legislation
  • The Human Medicines Regulations 2012
    • UK Non-devolved
    • 01 de Janeiro de 2012
    ......) No 726/2004 ” means Regulation  (EC) No 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 40 ; . ......
  • Animals (Scientific Procedures) Act 1986
    • UK Non-devolved
    • 01 de Janeiro de 1986
    ......animal by way of a medicinal test on animals as defined in subsection. (6) of section 32 of the Medicines Act 1968. is not a. regulated procedure if the substance or article is administered in. accordance with the provisions of subsection (4) of that ......
  • The Veterinary Medicines Regulations 2013
    • England & Wales
    • 01 de Janeiro de 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) of the Finance Act 1973(  4 ), the Treasury consent to the making of these ......
  • The Veterinary Medicines Regulations 2006
    • UK Non-devolved
    • 01 de Janeiro de 2006
    ...... and of the Council laying down the general principles 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) of the Finance Act 1973 4 , the Treasury consent to the making of these ......
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Books & Journal Articles
  • The CJEU’s ruling in the Novartis Farma case: Money, health and medicines
    • Núm. 27-2, April 2020
    • Maastricht Journal of European and Comparative Law
    ...... held that the decision of a Member State (Italy) to reimburse a drug used off-label (Avastin), and for that purpose submitted to repacking procedures, is not in violation of European law, even if there is a duly approved therapeutic alternative (Lucentis) on the market and the procedure is solely ......
  • Exploring the relationships among tacit knowledge sharing, mentoring and employees’ abilities. The case of Al-Hikma pharmaceutical company in Jordan
    • Núm. 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 ... pharmaceuticalindustry in terms of producing high-quality medicinesthat improve health of humansand the society at large.VJIKMS50,134Received6 ......
  • Book Review: Pharmaceutical Medicine, Biotechnology, and European Law
    • Núm. 8-4, December 2001
    • Maastricht Journal of European and Comparative Law
    ......), Antoine Cuvillier (Administrator Legal Affairs at the European Medicines Evaluation Agency), Ian Dodds-Smith (Head of the Health Care Group at ... which are no longer under pate nt), the so-called abridged procedures may be used by applicants if they can show that the generic product is ......
  • Linking Levels of Government: European Integration and Globalization
    • Núm. 66-1, March 2000
    • International Review of Administrative Sciences
    ...... both the interests of users of pharmaceuticals in having better medicines available and the interests of the pharmaceutical industry in having ... field, which conduct the product evaluations within separate procedures for pharmaceuticals for human and veterinary use. The committees and ......
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Law Firm Commentaries
  • 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 publishes "no deal" guidance for medicines and medical devices
    • JD Supra United Kingdom
    The UK government has published several guidance documents on how to prepare for Brexit in the event of a "no deal" scenario (i.e. if the UK and EU do not agree a future trade deal and th...
    ...... . The UK would no longer be part of the EU centralised, mutual recognition or decentralised procedures for authorising medicines. Existing medicines that received a marketing authorisation for the UK via the mutual recognition or decentralised routes ......
  • Brexit and COVID-19: Changes to the Regulation of Medicines
    • JD Supra United Kingdom
    The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines. On 16 October 2020...
    ......This follows a set of guidance issued on 1 September 2020. The October guidance provides greater clarity on the procedures for supplies to and from Northern Ireland. The guidance published so far includes the following:. Clinical Trials. Guidance for clinical trial ......
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