Update on the UK law on consent

Sokol, Daniel K

doi:10.1136/bmj.h1481

Cited by 108 publications

(71 citation statements)

References 2 publications

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“…For instance, on 11 th March 2015 the UK Supreme Court ruled that doctors are required to take "reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternatives or variant treatments" and emphasized that doctors must avoid "bombarding the patient with technical information which [he/]she cannot reasonably be expected to grasp" (Sokol, 2015;Dyer, 2015;Montgomery V Lanarkshire Health Board, 2015). This decision contrasts sharply with the old paternalistic model that is arguably expressed most clearly in the 1938 US Federal Food, Drug and Cosmetic Act, which stated that "[information in drug labels would] appear only in such medical terms as are not likely to be understood by the general public" (Schwartz and Woloshin, 2013: 14069).…”

Section: "Ema Expects the New [Transparency] Policy To Increase Trustmentioning

confidence: 99%

Medicines transparency at the European Medicines Agency (EMA) in the new information age: the perspectives of patients

Way

Bouder

Löfstedt

et al. 2016

Journal of Risk Research

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The concept of transparency has gained widespread appeal in the European pharmaceutical domain, not least at the European Medicines Agency (EMA). Agency policies have two main objectives: (1) to enable the re-use of data (e.g. clinical study reports) and (2) to empower patients to directly and indirectly make more informed decisions on medicines. Past research has almost exclusively focused on the perspectives of external researchers intending to reanalyse data made publically available. Few studies, however, have explored what can be learnt from the perspectives of other actors (e.g. healthcare professionals, patients, the regulators themselves, industry and others). This empirical study explores the EMA's transparency policies from the perspectives of patients. After presenting the results of a survey (N=1010) with a sample of individuals diagnosed with five specific medical conditions (HIV/AIDS, multiple sclerosis, rheumatoid arthritis, osteoporosis, idiopathic pulmonary fibrosis) from four EU countries (Germany, Spain, France and the UK), the authors argue that EMA's transparency policies do not adequately address the real-world complexities of communicating with patients. In turn, the paper concludes that the perspective of patients provides an essential contribution to understanding the full net effects (positive, negative, limited) of EMA's transparency policies. Keywords: Transparency; patients; European Medicines Agency; pharmaceutical regulationThis is an accepted manuscript of an article published by Taylor & Francis in the Journal of Risk Research on 12/07/2016, available online: http://www.tandfonline.com/doi/full/10.1080/13669877.2016.1200652 (1). IntroductionOver the past 20 years, the European Medicines Agency (EMA), the decentralised European Union (EU) body responsible for the scientific evaluation of medicines developed by pharmaceutical companies 1 , has introduced many policies aimed at enhancing 'transparency' (EMA, 2009(EMA, , 2015a. In this risk regulation context, transparency can broadly be defined as "the conduct of [regulation] in a fashion that makes decisions, rules and other information visible from the outside" (Hood, 2010: 989). EMA's policies have overwhelmingly focused on publishing increasing quantities of information online regarding a wide range of its scientific and non-scientific activities (EMA, 2009, 2015a), or what Meijer (2009 describes as "computer-mediated" transparency. The 'objects' of transparency (see Heald, 2006a: 30-32) at EMA have included, but are not limited to, documents that provide the basis for decisionmaking in the Agency's seven scientific committees (i.e. policy inputs) (EMA, 2014a(EMA, , 2014b, management board and scientific committee meeting minutes (i.e. policy processes) (EMA, 2015a) and summaries of both its positive and negative opinions on medicines (i.e. policy outputs) (EMA, 2015a).Although many reasons for enhancing transparency at EMA have been debated in the medical literature (Hampton, 2012;Doshi et al., 2012;Groves and Godlee...

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Section: "Ema Expects the New [Transparency] Policy To Increase Trustmentioning

confidence: 99%

Medicines transparency at the European Medicines Agency (EMA) in the new information age: the perspectives of patients

Way

Bouder

Löfstedt

et al. 2016

Journal of Risk Research

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“…This contributes to the continuing discussion in the medical literature around the implications of recent changes in UK law. 10,11 All decisions have the potential to confer benefit but equally all decisions entail risks. In order to optimise safe practice, a prescriber should always consider two aspects of their actions:…”

Section: Resultsmentioning

confidence: 99%

Legal implications of deprescribing: a case scenario

Barnett¹,

Kelly²

2017

Prescriber

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“…The Bolam test no longer stands and clinicians must determine the materiality of a risk by either asking whether a reasonable person in the patient's position would be likely to attach significance to the risk; or the clinician should reasonably be aware that the patient would likely attach significance to it. [17][18][19] Applying rules about disclosure of a risk based on percentages of occurrence is no longer acceptable. The meaning of that complication to the individual patient is what is important.…”

Section: Montgomerymentioning

confidence: 99%

The changing face of informed consent

Main

Adair

2015

Br Dent J

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All healthcare professionals are required to gain a patient's consent before proceeding with examination, investigation or treatment. Gone are the days when consent was about protecting the professional. Following a recent landmark Supreme Court case, 'informed' consent is now embedded in UK law. Patients have the right to high-quality information that allows them to be involved in making decisions about their care. Dentists have a duty of care to provide this information and guide their patients through the process. This paper reviews key ethical, legal, and professional guidance available to dentists about informed consent and concludes by discussing how shared decision-making is a model of healthcare delivery with much to offer dentist and patient alike.

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Update on the UK law on consent

Abstract: Last week’s case of Montgomery v Lanarkshire Health Board has important implications for doctors

Cited by 108 publications

References 2 publications

Medicines transparency at the European Medicines Agency (EMA) in the new information age: the perspectives of patients

Medicines transparency at the European Medicines Agency (EMA) in the new information age: the perspectives of patients

Legal implications of deprescribing: a case scenario

The changing face of informed consent

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