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|| Friday: September 28: 2023 || ά. In most European countries, as well as, Japan, Canada and Australia, the regulation of marketing practices relies heavily on industry self-regulation in which industry trade groups are trusted to set and police the rules of appropriate industry conduct. Among these, the Code of Practice of the Association of British Pharmaceutical Industry:ABPI is one of the best-known industry rule books.

Healthcare professionals and organisations need to respond more forcefully to unethical marketing from the pharmaceutical industry by holding offending companies to greater account and by supporting stronger regulation, according to the authors of a new British Medical Journal:BMJ Study. The BMJ review argues that leaving self-regulation in the industry’s hands is not sustainable. The research cites the recent example of the Danish drug company Novo Nordisk, which in March 2023 was suspended from the ABPI for serious breaches of its Code of Practice, following a widely publicised scandal, involving the unethical marketing of its anti-obesity drug Saxenda. ::::ω::::

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 Nuffield Council of Bioethics Responds to the Announcement of UK COVID-19 Human Challenge Trials


|| Wednesday: November 11: 2020 || ά. On October 20 the UK Government announced that it would work with partners to develop a COVID-19 human challenge study model. This will include the manufacture of the challenge virus and will be the first in-human characterisation study for COVID-19. In human challenge studies, participants are deliberately infected with the virus in question in order to gain knowledge in controlled circumstances about how the virus behaves or, in order to see, if, an investigational vaccine provides protection.

In response to this Nuffield Council of Bioethics has said the following: Given the scale of the global challenges, that COVID-19 poses, challenge trials could, potentially, play a useful role alongside the many other studies, currently taking place. However, they come with their own unique set of ethical considerations and risks, that must be addressed by all those, involved in the study, a properly constituted ethics committee, researchers and funders.

The World Health Organisation:WHO has published guidance on the issues, that such a committee should consider and, also, recommended that any proposed COVID challenge study should be reviewed by a specialist ethics committee with the necessary scientific and ethical expertise. We understand that the Health Research Authority has established such a specialist ethics committee in order to be prepared for any applications to run a challenge trial in the UK and we warmly welcome the establishment of this committee.

Today’s announcement highlights an early stage of the human challenge trial process and will require ethical approval before it goes ahead. Those, involved in the developing the study model and in any specific research proposal, must, now, consider the following:

::: Scientific justification: is a challenge study the most appropriate approach? Can the same benefit be gained for lower risk in a different kind of study?

::: Engagement with the wider public. Researchers and funders must consult and engage with the wider public from the beginning. They must make sure that public concerns are properly understood and addressed and that anxieties based on misconceptions can be avoided.

::: Assessment of risks and benefits: potential benefits must outweigh risks, taking into account the interests of three groups: participants, society in general and third-party contacts of participants. Researchers and funders must consider what actions must be taken to minimise risks, such as, finding an appropriate dose of the challenge virus and mitigate those risks, that remain, for example, by determining which volunteers are highly unlikely to develop serious disease, how volunteers will be monitored and ensuring that they have access to the best possible care.

::: Informed consent: There are significant challenges in ensuring volunteers thoroughly understand the risks and the uncertainty of any benefit. Volunteers will, also, be committing to stay within a bio-secure facility until they are no longer infectious.

The Council hopes that this process will involve a wide range of voices in considering how this might go forward.

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The World Health Organisation Establishes Expert Panel to Develop World Standards for Governance and Oversight of Human Gene Editing



|| December 17: 2018 || ά. The World Health Organisation:WHO is establishing a global multi-disciplinary expert panel to examine the scientific, ethical, social and legal challenges, associated with human gene editing, both somatic and germ cell. The panel will review the current literature on the state of the research and its applications and societal attitudes towards the different uses of this technology.

WHO will, then, receive advice from the panel on appropriate oversight and governance mechanisms, both at the national and international level. Core to this work will be understanding how to promote transparency and trustworthy practices and how to ensure appropriate risk:benefit assessments are performed prior to any decision on authorisation.

The recent application of tools, such as, CRISPR-Casp9 to edit the human genome, have highlighted the need for the development of standards in this area. WHO’s expert working group will work in a consultative manner and build on existing initiatives.

As WHO proceeds, it is liaising with relevant UN and other international agencies and is in communication with the Academies of Science and Medicine, as well as, with bodies, that have produced previous reports.

WHO will be approaching leading experts in the world and publishing the membership of the panel, once, it receives responses and assesses conflicts of interest.:::ω. 

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