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International Clinical Trials

Stemming the Tide

 

One of the most interesting developments of 2008 has been the news that the US Food and Drug Administration (FDA) is considering the intention of three US biotechnology companies, Geron Corporation, Advanced Cell Technology, and Novocell, to commence clinical development of human embryonic stem cellbased therapies (1). It can only be a matter of time before European regulators will have to face similar issues. Given that means of isolating human embryonic stem cell hESC lines were only discovered in 1998, the regulatory framework has had a comparatively short period of time to respond to the challenges presented by these innovative therapeutic agents. This article examines the UK’s response to such challenges.

WHAT REGULATORY ISSUES WILL BE FACED IN THE UK?

Anyone seeking to develop a therapy that has been derived from human embryonic stem cells is faced with three, to some extent overlapping, sets of regulatory issues affecting the following matters, each of which is overseen by a separate regulatory authority (2).

  • Work on human embryos – regulated by the Human Fertilisation and Embryology Authority (HFEA)
  • Processing and storing tissues and cells for use in human subjects – regulated by the Human Tissue Authority (HTA)
  • Conducting clinical trials in human subject – regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) (3)

Each raises its own legal and regulatory issues, which are examined in turn below.

WORK ON HUMAN EMBRYOS

Using human embryos as a source of material for therapeutic agents has been an ethically controversial topic for some time, and this has resulted in widely differing approaches in different European countries to the permissibility of such activity. The UK has, through the HFEA, regulated the creation, storage and use of human gametes and embryos since 1990 in a comparatively permissive manner (4).


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John Wilkinson is a partner in the Life Sciences Health Industry Group at international law firm Reed Smith. John’s practice focuses primarily on the life sciences sector, advising pharmaceutical, biotechnology and medical technology companies, as well as financial institutions, on a wide range of IP, regulatory and transactional matters. John’s practice has involved advising companies in the US, UK, Denmark, Hungary, Switzerland, Portugal, Germany and Belgium. John trained and qualified at law firm Lovells in 1993 and moved to Cancer Research Technology Limited in 1998. In 2000, John joined the law firm Bird & Bird, before moving to Reed Smith in 2005.

 

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