HEAL UoS

Archive for November, 2011|Monthly archive page

HIDDEN LAW-MAKERS Law School Seminar

In 2011, Testing project on November 15, 2011 at 5:55 pm

In a seminar on 2 November 2011 Jonathan Montgomery, Caroline Jones, and Hazel Biggs identified two different aspects of law-making that needed to be examined. The first was descriptive – how law is made. The second was normative – the framework within which to critique law making process & judge the legitimacy of laws. In relation to the first, some law making was highly visible (e.g. by Parliament and the judiciary), some was traceable in documents such as soft law (codes of practice and guidance), but others such as settlement cultures and legal advice that influenced norms of practice was not.

There was an expected process for the production of legislation through green and white papers, possibly supplements be consultations (e.g. in relation to the legislation governing human fertilisation and embryology). A framework for critique has been developed by Caroline Jones to consider the transition between consultations and Government responses. Judicial decision making has been widely studied. The orthodox account of judicial defence to Parliament, as offered by Lord Browne-Wilkinson in the Bland decision, is known to be disingenuous and theories of adjudication (such as those offered by Ronald Dworkin) have tried to provide a normative defence of judges’ work. It is far from clear, however, that they have adequately addressed the how judges choose to take expansive or narrow approaches to the cases before them, leaving some aspects of judicial law-making substantially hidden.

In relation to ‘intermediate authorities’ (such as the GMC or HFEA) entrusted with developing guidance both the description of the ‘law making’ processes and the appropriate normative principles are under-developed. It is even less clear how one should assess the significance of those who bring cases to court with a view to changing the law. Does it matter how personal their interest is? What questions need to be asked about legitimacy or representative authority of litigants in cases such as those brought by the British Pregnancy Advisory Service (BPAS v DH [2011] EWHC 235 (Admin))or Bruno Quintavalle on behalf of the Pro-Life Alliance and Josephine Quintavalle of Comment on Reproductive Ethics where a particular policy stance is being promoted?

This seminar explored some of the learning from our seminar in May 2011, funded by the Modern Law Review, and is part of our work developing a paper for publication.

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Clinical Negligence and the NHS

In 2011, NHS on November 15, 2011 at 1:45 pm

In June 2011 the Health Select Committee published a report on Complaints and Litigation in the NHS. It supported the continuation of fault-based compensation, concluding that that ‘the existing clinical negligence framework based on qualifying liability in tort offers patients the best opportunity possible for establishing the facts of their case, apportioning responsibility for errors, and being appropriately compensated’ (Para 157). However, it was very critical of claims management firms, which it thought pushed people into litigation rather than using complaints procedures and unduly contributed to the rising costs of clinical negligence (Para 172). The Government’s response to the report indicates that the Ministry of Justice is working closely with the NHS Litigation Authority (NHSLA) and the Association of Personal Injury Lawyers (APIL) to agree a scheme that will enable a speedier resolution of lower value clinical negligence cases and aims to reduce costs (Para 147). It also notes that the Jackson reforms of civil litigation, being implemented through the Legal Aid, Sentencing and Punishment of Offenders Bill, will have a significant effect in this area (Para 19). The Ministry of Justice is now consulting on the regulation of claims management firms.

The two volumes of evidence to the Select Committee contain a considerable amount of information on concerns about this area of law and practice. The previous parliamentary report by the Constitutional Affairs Select Committee on the (non)existence of a compensation culture is also relevant. The publication of the industry review of the NHSLA is still awaited, as is the implementation of the NHS Redress Act 2006 despite the initial policy announcements from the Department of Health. It does seem clear from the Annual Report of the NHSLA for 2011 that there is a significant increase in both the number of clinical negligence claims received by the NHS and also the money paid out in compensation and legal expenses.

Legal Regulation and Xenotransplantation

In 2011, Human tissue on November 11, 2011 at 6:08 pm

The Nuffield Council on Bioethics report on Human Bodies: donation for medicine and research suggested that the initial promise of xenotransplantation has yet been realised, partly because of concerns over the risk of gene transmission (para 3.43) but that its future use should not be discounted. The regulation of Xenotransplantation has become less visible since the UK Xenotransplantation Interim Regulatory Authority (UKXIRA) was disbanded in 2006. Guidance on Xenotransplantation was issued by the Department of Health that expects Research Ethics Committees to oversee such activity. The latest guidance on research governance procedures came into effect on 1 September 2011. The Gene Therapy Advisory Committee had been responsible for licensing decisions on xenotransplantation of animal cells (but not solid organs) until June 2011, when this role transferred to the National research Ethics Service (NRES). In due course, the NRES will become part of the body established under the Health Research Authority (Establishment and Constitution) Order 2011 and  Health Research Agency Regulations 2011, as recommended by a  report of the Academy of Medical Sciences.These regulations come into force on 1 December 2011. The Academy has also recently published a report on issues raised by animals containing human material. According to the MRC, trials of xenogenic cell therapy must comply with the Advanced Therapy Medicinal Product Regulations (EC) No 1394/2007. Hazel Biggs has also drawn attention to the conundrum of consent in this area of uncertainty, see Healthcare Research Ethics and Law at page 90. Perhaps it is time to revisit this area of legal regulation.

Hidden Lawmakers

In 2011, Meetings, Testing project on November 2, 2011 at 7:02 am

Following last week’s fascinating seminar with Sarah Barclay (more on that soon in another post), today we have a Law staff seminar exploring some of our theorisation of ‘hidden lawmakers’ in the context of Health Care Law. The notion of hidden law-makers was one of the key themes explored in our two-day conference earlier this year, generously sponsored by the Modern Law Review.

The seminar will run from 1pm in the staff room on level 2 in the Law building.