Archive for the ‘2011’ Category

Joint CELS/HEAL event: 16 December 2011

In 2011, Human tissue, Meetings on December 7, 2011 at 8:43 am

On Friday 16 December, 1-2.30pm, in room 2209, building 85 (Life Sciences, Highfield), we have a joint CELS/HEAL seminar led by Jessica Wright on The Human Tissue Act 2004 and Tissue Research in England: Does the Act promote the harmonisation of cancer tissue banks?      All are welcome.

Abstract: International calls have been made for organisations that collect, store and transport human tissue samples for research purposes to standardise their practices to enable more effective scientific collaboration.  Cooperation between cancer tissue banks could encourage higher quality samples and data, allow larger, more powerful research projects to take place, and provide opportunities for rare cancers to be studied. Despite this, lack of standardisation and non-cooperation remain the prominent features of the field. This study aims to identify the barriers and facilitators to cooperation.


Preliminary results identify the Human Tissue Act and related system (HTA) as the relevant legal standard in England, so it is important to ask whether it promotes the harmonisation of cancer tissue banks. To an extent, the HTA has promoted harmonisation, for example through the introduction of the Research Tissue Bank approval system and compulsory standards that improve tissue quality. But there are concerns that the HTA impedes harmonisation by costing money to implement, holding-up tissue collection, obliging researchers to dispose of valuable samples, causing confusion and marginalising pathologists. In conclusion, while improving aspects of the system implemented by the HTA would help the harmonisation of cancer tissue banks, further standards are also needed.

Time for a ‘Silverline’?

In 2011, Care on December 5, 2011 at 7:30 am

In yesterday’s Sunday Times it was reported that Esther Rantzen has called for a ‘Silverline’ equivalent of Childline for ‘older people’ (often, but not exclusively, defined as persons aged 65 years and above, see EHRC FAQs). This call comes hot on the heels of two hard-hitting Reports in recent months, both critical of the quality of care received by older persons. In October, the Care Quality Commission reported their findings on Dignity and Nutrition for Older People and in November the Equality and Human Rights Commission published Close to Home: An inquiry into older people and human rights in home care.

The CQC inspected 100 hospitals to assess whether older people were i) treated with respect, and ii) got the food and drink fit for their needs. Of these hospitals, 20 failed to meet one or both standards. Further, the EHRC found that almost 500,000 older people receive care in their own homes, paid partly or wholly by the local authority, and while many received care that respected their human rights, it cautioned that this is not a ‘universal experience.’ Of those who gave evidence to the inquiry around 50% expressed satisfaction with the home care provided, but many examples were given that breached the human rights of the recipients.

Calls too are being made for the government to follow in the steps of the Welsh Assembly (and Northern Ireland) and to establish their equivalent of the Older People’s Commissioner for Wales. Whether by ‘Silverline’ or by Minister, or both, the demand for action to protect vulnerable older people is gathering pace – almost 6 years since one of its neighbours deemed older people important enough to have a minister of their own (Wales, February 2006).

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.

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.

Social Science in Health Forum meeting, 3 Nov

In 2011 on October 27, 2011 at 7:12 am

The next meeting of the Social Science in Health Forum will be held from 6pm Thursday 3 Nov at the Trago Lounge on Portwsood Road. The focus will be the ownership of research data.  The Economic and Social Research Council (ESRC) has a clear open access data policy, requiring that project data is placed in the ESDS (http://www.esds.ac.uk/) at the end of the project (http://www.esrc.ac.uk/_images/Research_Data_Policy_2010_tcm8-4595.pdf).  However, social science research carried out within medicopeal schools is likely to be funded from a variety of sources, including as part of large scale medical projects.  These funders are likely to have different views on whether data should be open to other researchers in the same way. 

This informal meeting will open with a quick overview of the ESRC data policy and then focus on exploring our personal experiences of working on research projects, including who owns and controls the use of data. Phd student and postdocs from any field who are concerned with the question, “who owns the data you are producing?”are all welcome.

If you’d like to attend please contact Ingrid Holme (i.holme AT soton.ac.uk).

This week’s meeting!

In 2011, Meetings, Testing project on October 25, 2011 at 8:47 pm

This week we have a HEAL meeting on Wednesday 26 October at 1pm (til circa 2pm) in 2007/4 (Law), Highfield, with Sarah Barclay, founder of the Medical Mediation Foundation.Sarah will be speaking on the Foundation’s project on mediation and conflict resolution in paediatric care.

See further: http://www.medicalmediation.org.uk/who-are-we.

Nuffield Council’s Report on Human Bodies

In 2011, Human tissue, News on October 10, 2011 at 7:46 am

The Nuffield Council’s Report on ‘Human Bodies: donation for medicine and research’ will be published on Tuesday October 11. A launch seminar will be held that afternoon with members of the Working Party and guests discussing the Report’s conclusions and policy recommendations.

According to the Nuffield Council’s website, the two key issues addressed in the Report are:

  1. How far should society go in trying to encourage people to donate their bodily material? For example, is it acceptable to offer people money?
  2. What is the role of the government and others in responding to the demand for bodily material? For example, how can barriers to donation be removed, and how can the need for donated bodily material be reduced?

Further information, including details on how to book a place at this event, can be found here.

Halsbury’s Laws reissues volume on Medical Professions

In 2011 on October 4, 2011 at 9:19 am

A new volume of Halsbury’s Laws of England has been issued covering Medical Professions broadly defined to include the doctors, opticians, dentists, osteopaths, chiropractors,  pharmacists nurses, midwives and other professions regulated under the Health Professions Council. The statutory regime for professional regulation is set out in each case, and a chapter on general duties, liabilities and regulation covers the  law on a wide range of issues from consent and confidentiality to the  regulation of fertility services and the use of human tissue and organs.

Halsbury’s Laws of England is the longest established encyclopaedia of English law and began publishing in 1907. The new volume, for which HEAL member Jonathan Montgomery was consultant editor, is Vol 74 in the fifth edition. It is a standard reference work and can be found in many libraries both in the UK and internationally. It sets out to describe the law accurately and succinctly and is a reliable place to start research. It sticks closely to the text of legal materials and avoids speculating about interpretation.