George F. Tomossy

Ethical challenges of innovative surgery: a response to the IDEAL recommendations

1–3 addresses some but not all these concerns. Here, we build on this important work by identifying gaps that warrant further attention and by making additional suggestions for dealing with the ethical challenges associated with surgical innovation. The most obvious source of patient harm is physical, with the potential for increased mortality and morbidity from innovations compared with standard treatment. This concern is supported by historical reports in which innovative surgery has generated harm—eg, by routine episiotomy, treatment of peptic ulcer disease with gastric freezing, and early eff orts to artifi cially sustain circulation with implant devices. 4 Although technologies might be independently safe and eff ective, their combination could generate unanticipated problems—eg, a major innovation in gastrointestinal surgery, laparoscopic cholecystectomy, resulted in a substantial increase in biliary injuries. 5 Noneff ective treatments also generate potential harms, since surgery itself is not benign; ancillary risks arise from infection and anaesthesia, and the commitment to surgical intervention could mean other treatment options are foreclosed. Even if new procedures are deemed safe and eff ective, the learning curves associated with innovative treatments heighten risks to patients while a surgeon obtains competency in such procedures. Additionally, there can be burdens for patients and their families that are caused by innovative surgery, which go beyond physical diffi culties, and include fi nancial and psychological hardship. 4

GLOBALIZATION AND CLINICAL TRIALS

Globalization has contributed to fundamental changes within the biomedical research endeavor. Indeed, when considered in concert with the effects of commercialization, the transformation might be described as dramatic. With the ongoing consolidation of the pharmaceutical research industry into massive multinational corporations, the scope of the business of developing medical products has grown to unprecedented levels, spanning across national boundaries and affecting health care consumers throughout the world. The influence of the global pharmaceutical industry is both reflected in and strengthened by international treaties protecting drug patents and initiatives to harmonize regulatory requirements. 1 At the national level, industry has been shown to have a significant influence on setting research agendas, public health policy and the education and practices of health care professionals. 2 And as this chapter will argue, globalization of the pharmaceutical industry can also be felt on an individual level. Specifically, we will address the problem that arises when a human subject from a developing country is injured or dies in a clinical trial conducted by a first-world sponsor. We submit that this scenario, which operates at the interface of developing world ethics, human rights advocacy and international law, is instrumental in examining how conflicts of laws may interfere with the goal of promoting global social justice. Protecting human subjects in international clinical trials requires a range of solutions, including capacity building within developing countries to establish or improve regulatory oversight mechanisms, professional education to foster ethical conduct by investigators and political pressure to promote socially responsible corporate practices. As this chapter will contend, it is also vitally important that legal systems in first-world jurisdictions protect subjects from developing countries and permit access to justice in first -world courts to enable them to obtain compensation.

The UK House of Commons report on the influence of the pharmaceutical industry: Lessons for equitable access to medicines in Australia

AbstractThis paper examines the recent UK House of Commons Health Committee report on the Influence of the Pharmaceutical Industry in relation to its findings and recommendations concerning access to medicines, and in particular the continuance of cost effectiveness or reference pricing. This mechanism of bargaining down the price of drugs on social justice grounds recently has been targeted by the US Department of Commerce as an unjustifiable non-tariff barrier to trade that should be eliminated in all OECD countries. Concerns have been raised that certain provisions in the AUSFTA may have been designed to achieve this end, in defiance of norms of democratic legitimacy, moral responsibility and the international right to health. Here we examine some implications of the UK House of Commons Report for the PBS in Australia.

Ethical regulation or regulating ethics? The need for both internal and external governance of human experimentation

AbstractResearch regulation is a timely topic for discussions in bioethics and public health policy. This response to articles in the previous special issue of the Monash Bioethics Review emphasises the importance of having both internal and external controls of human experimentation. Unless both elements are incorporated into research ethics governance frameworks, they will ultimately fail to achieve what should be their primary goal: human subject protection.

Overcoming the SPS concerns of the Bangladesh fisheries and aquaculture sector: From compliance to engagement

Purpose The purpose of this paper is to address the challenges developing countries face in attempting to balance sanitary and phytosanitary measures (SPS) health and safety measures against concerns about protectionism, illustrated by the impact of trade barriers on the fisheries and aquaculture sector in Bangladesh. The paper then provides recommendations to overcome the effects of these trade barriers. Design/methodology/approach The author uses a close doctrinal approach for the first three parts of the paper by analysing the provisions of the World Trade Organisation (WTO) SPS Agreement and the effect of those provisions in creating domestic compliance gaps in the Bangladeshi fisheries and aquaculture sector. A qualitative approach is then adopted in suggesting potential reforms and future directions to assist the Bangladeshi fisheries and aquaculture sector overcome SPS trade barrier issues. Findings To overcome the market access issues created by SPS trade barriers, Bangladesh and other developing countries require multilateral assistance, accommodation by trading partners and internal reforms. This includes reforming internal governance structures, improving trade participation and negotiation, increasing infrastructure investment and learning from similar countries who have improved their supply chain management. Research limitations/implications This paper will have significant implications by contributing to law and policy reform debates involving international trade law and domestic compliance gaps. It will also assist other developing countries that experience SPS trade barriers to learn from the experience of the Bangladeshi fisheries and aquaculture sector. Practical implications This paper has practical implications by providing recommendations for how Bangladesh can overcome SPS trade barriers and improve its market access. This will help Bangladesh integrate into the global trading system by enhancing its participation in the SPS framework. Social implications By addressing and providing recommendations for the SPS trade barrier challenges faced by Bangladesh fishery and aquaculture sector, this paper provides a framework to improve the economic development and global competitiveness of the industry. This will contribute the gross domestic product growth and help increase the overall living standards of the people involved in the fisheries and aquaculture business in Bangladesh. Originality/value This paper is an original work that has not been published elsewhere. It is the first time a paper has dealt with the legal, policy and compliance challenges faced by the fisheries and aquaculture sector in Bangladesh.

Regulating Ethical Research Involving Cognitively Impaired Elderly Subjects

Canada is experiencing a renaissance in health research. In 1998, the Federal Government responded to the problem of an ailing health research sector1 by reversing the downward trend of per capita public funding. This was followed in 2000 by the creation of the Canadian Institutes of Health Research (CIHR).2 This new body, which replaced the Medical Research Council of Canada, has a noble objective:

Regulating ethical research: Canadian developments

AbstractThe Canadian experience and current trend in research ethics regulation provides a useful model for consideration by other jurisdictions, including Australia. The creation of the Canadian Institutes of Health Research and recent amendments to federal Canadian regulations governing clinical trials should provide the impetus for implementation of much-needed reforms in the oversight of research activities. It is submitted that existing legal structures in Canada are inadequate, which the regulations go partway to solve. Further reforms must be undertaken in order to provide a uniform system of ethical governance and to protect properly human research subjects across Canada, regardless of whether funding derives from public or private sources. A set of five criteria is proposed as essential precursors to the implementation of an effective regulatory framework that would respond to these concerns.