Critically consider whether the English law governing medical research meets the standards laid down by these provisions, and whether these standards are the right ones.

Dr Craig Purshouse

QUESTION1 below, and ONE other question. The maximum word count is 3,000 words.The word count excludeswords used in footnotes,citationsand the bibliography.QUESTION 1In April 2017 Ms Deidre Driscoll consulted her doctor complaining of urinary incontinence. She underwent a diagnostic test which confirmed that she had an overactive bladder, but was inconclusive as to whether she had stress urinary incontinence.

The following month Ms Driscoll was referred to Dr Moynihan, a consultant in uro-gynaecology, who recommended a trans-vaginal mesh repair, a common treatment for stress urinary incontinence.

This was carried out at the end of 2017. Meshes of this type (though not this specific one) had been approved by the MHRA. In late 2020 MsDriscoll was referred to the uro-gynaecology service and requested there moval of the mesh used in the 2017 repair. She had been complaining of chronic and unbearable pain, and upon examination erosion of the mesh was found.

The mesh has not yet been removed, and it is unclear whether this is going to be possible. Ms Driscoll now brings an action for negligence against Dr Moynihan, alleging that she should have known in 2017 that there were serious concerns about mesh implants and recommended an alternative treatment.

Dr Moynihan says that she was not aware of problems with surgical mesh until the US Food and Drug Administration ordered manufacturers to stop distributing their products in April 2019.

(a)Advise the parties as to the likelihood that the action by Ms Driscoll against Dr Moynihan will succeed.

(b)Critically assess whether the law which determines the result of this case is logically and ethically satisfactory.

QUESTION 2“... [I]t could be argued that the priority given to patient confidentiality rests upon an unrealistically individualistic model of medical decision-making. In practice, most patients do not want to keep information about their health secret from the whole world.”Emily Jackson, Medical Law: Text, Cases and Materials5thedn (OUP 2019) 423In the light of these observations, critically evaluate the balance struck by English law between the need to protect medical confidentiality and the need to record and share medical information.

QUESTION 3“As a society we need to consider whether, having developed the infrastructure, we should be satisfied that we have done all we can and accept that we have reached the limit of our potential for donation in the UK, or whether we should seek to build on what has already been achieved by shifting our attention to additional ways of increasing the number of organ donors.”BMA Medical Ethics Committee, Building on Progress: Where next for organ donation policy in the UK?(BMA 2012) 68 In light of the BMA’s views, critically evaluate the present law and practice on organ donation in England and Wales, and discuss whether any further changes to the law are desirable on practical or ethical grounds.

QUESTION 4“

8.While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects….

16…. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.” World Medical Association‘WMA Declaration of Helsinki –Ethical Principles for Medical Research Involving Human Subjects’ (2018)Critically consider whether the English law governing medical research meets the standards laid down by these provisions, and whether these standards are the right ones.

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