MDG5234 Independent Study Module (CBmE) Projects for AY2015/2016 Semester 1 (1) ISM Project Title: The social value of drug development Supervisor: Assistant Professor Calvin Ho Wai Loon, Centre for Biomedical Ethics Title: The Social Value of Drug Development Prerequisite: MDG5231 Topics in Biomedical and Behavioural Research Ethics (or equivalent) Summary: The problem of high-cost medicines is symptomatic of a drug development system driven by values that are incongruent with those that increasingly characterise health systems which have or are on the road towards Universal Health Coverage (UHC). Arguably, the values that underpin UHC – two of them being fairness and cost-effectiveness – should also guide the innovation of pharmaceutical products, particularly if this enterprise is to sustain social value. The ethical mandate of UHC requires all member states of the World Health Organization to assume a greater role in managing drug development, negotiating access to new drugs and facilitating their distribution to all countries. There is at present little incentive for a drug producer to enable generic licensees to manufacture a new drug for all countries. The drug developer or producer is also unlikely to have the resource and capabilities needed to devise and manage varying royalties charged to different countries, through a process that is transparent, accountable and legitimate. But if drug development is to be a socially valued enterprise, redressing the current failings is an important step forward towards implementation of the Sustainable Development Goals. This health policy and systems research project is concerned with explicating the social value of drug development, with a focus on the impact of UHC on health systems within the United Nations’ sustainable development framework. (2) ISM Project Title: The ethics and practice of preimplantation genetic diagnosis and screening in Singapore Supervisor: Assistant Professor Tamra Maree Lysaght, Centre for Biomedical Ethics Title: The ethics and practice of preimplantation genetic diagnosis and screening in Singapore Prerequisite: None Summary: Preimplantation genetic diagnosis (PGD) and preimplantation genetic screening (PGS) are reproductive technologies that are available to patients undergoing in vitro fertilization (IVF). While PGD allows couples to select embryos for implantation based on certain genetic characteristics, PGS allows couples to screen embryos for chromosomal abnormalities. Both techniques promote the reproductive rights and autonomy of women by providing some limited choices over the embryos that are selected for implantation. However, in Singapore, only PGD is legally accessible to some couples in certain circumstances; PGS is not allowed. The claimed rationale for this limitation is based on the uncertain efficacy of the technique and its potential application in embryo sexing, which allows patients to choose the gender of future children. This project will conduct two systematic reviews; one of the scientific literature on the efficacy of PGS, the other of the bioethical and social science on the current uses of PGS in Singapore and abroad. Both reviews will inform an ethical analysis of the regulatory and social contexts in which PGD and PGS are practiced in Singapore. (3) ISM Project Title: Human Bio-enhancement Supervisor: Dr G. Owen Schaefer, Centre for Biomedical Ethics Title: Human Bioenhancement Pre-requisite: MDG5231 Topics in Biomedical and Behavioural Research Ethics (or equivalent) Summary: Medicine has traditionally strove for interventions that prevent or alleviate diseases or disabilities, restoring individuals to normal healthy functioning. But many recent biomedical discoveries (in genetics, pharmaceuticals and neuroscience) go beyond merely restoring or maintaining normal functioning; they rather enhance individuals and cause them to exceed normal levels of functioning Areas of enhancement include: lifespan; mood; appearance; cognition; physical ability; and even moral thought and behaviour. These developments have led to considerable ethical and policy debates over whether such interventions should be permitted, encouraged or even required. In this Independent Study Module, the supervisee will learn about both the recent developments in biomedical enhancements and the central ethical debates surrounding those enhancements. The supervisee will then select a particular subtopic within the enhancement debate, and develop a position paper on that topic suitable for submission to a peer-reviewed academic journal. The paper will engage with both the empirical and moral sides of the debate, integrating the two into a rigorous and coherent argument for a particular position concerning the ethics of human enhancement. (4) ISM Project Title: Incidental Findings Supervisor: Dr G. Owen Schaefer, Centre for Biomedical Ethics Title: Incidental Findings Pre-requisite: MDG5231 Topics in Biomedical and Behavioural Research Ethics (or equivalent) Summary In the course of conducting a study, researchers may come across a finding outside the scope of the research question, but potentially relevant to research subjects. In an imaging study, this may be what appears to be a malignant tumour; in a genetic study, this may be a variant that significantly increases the likelihood of developing a particular form of cancer. There has been a flurry of recent policy debates concerning what to do with such findings – whether to report them in order to facilitate participants’ wellbeing and respect their rights to the information, or withhold it due to uncertainty over the findings’ validity and limitations of clinical utility. The debate over incidental findings reveals some areas of consensus, and other areas of disagreement. The supervisee will survey existing literature and policies on the topic to come to an understanding of the state of the debate. Based on this understanding, the supervisee will write a paper defending a particular policy or set of policies for the reporting of incidental findings, and explain why that policy is superior to alternatives and withstand potential objections. The proposed policy may be broad or limited in scope, at the supervisee’s discretion, but should aim at making a novel contribution to the existing literature rather than simply summarizing existing proposals and arguments.