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Mrs Graham is staff editor for Hospital Pharmacist |
Recent advances in biotechnology have led to new products either coming onto the market, undergoing clinical trials or being developed in laboratories. Such products include, for example, genetic diagnostic kits, gene therapy products and stem cells (harvested from either human embryos, fetal tissue or adult organs) that could ultimately be used to produce “body parts” to treat human disease, particularly degenerative diseases such as Parkinson's. As biotechnology has
advanced, however, the
systems regulating it have not
necessarily been able to keep up with the scientific progress made.
Should this concern hospital pharmacists? For a start, it
clearly impacts on the relatively small (but growing) number of pharmacists
who are involved on a practical basis with
biotechnology products. For example, several gene therapy products are
undergoing clinical trials, with pharmacists often being responsible
for handling the viral vectors used to insert either working versions
of a faulty gene, or additional genes, into patients. Some general advice
and regulation is already in place for pharmacists
working in this field. In
particular, all clinical trials involving gene therapy need to be approved
by the Gene
Therapy Advisory Committee (a governmental advisory body). For the more
specific
pharmaceutical aspects,
however, such as labelling, the standards of pharmacy facilities, and
aspects of the handling of genetically modified organisms,
pharmacists have basically had to adapt related rules already in existence,
such as those in the “Orange guide” and, more recently, the
Genetically
Modified Organisms
(Contained Use) Regulations 2000 issued by the Health and Safety Executive.1 Pharmacists
manage, but the situation does not seem to be ideal.
Aside from these more
practical issues that currently effect pharmacists, recent reports2–4 have
highlighted problems with the way the
system for granting patents in the United Kingdom handles biotechnology
inventions. In particular, applying the rules and procedures that have
developed for traditional
pharmaceutical agents to
biotechnology products has apparently resulted in patents being granted
when they should not have been. This is presumably not something over
which the average hospital pharmacist is going to lose much sleep. But
granting patents for “inventions” that do not deserve them
can stifle
further research. This ultimately results in there being fewer new
medicines on the dispensary shelves and fewer diagnostic kits in the
hospital laboratory. As pointed out by Professor
Enderby, at the time of a report by The Royal Society: “This affects
all of us. If patents are granted which are too broad in scope, they
block other researchers from carrying out related work and so hold up
the development of medicines and treatments. This is tremendously bad
for science, but the ultimate losers are the patients who wait longer
for beneficial drugs to reach their hospitals and
pharmacies.”4
As with clinical trials, there are steps that can be taken to reduce
the impact of the
regulatory system lagging behind. For example, it has been suggested
that the Department of Health, on behalf of the NHS, should take an active
role in pointing out problems with patent applications currently being
processed to reduce the chances of “undeserving” patents
being granted in the
first place.3
On a more philosophical level, many pharmacists, as both members of society
and
scientists, will have their own opinions on the ethical issues associated
with advances in biotechnology. An area of
particular controversy, for example, is harvesting stem cells from human
embryos. Some believe that it is wrong to use embryos “left over” from
in vitro fertilisation cycles as a source of stem cells. More would likely
take issue with using cloning
techniques to create embryos, where the extracted stem cells will be
grown into “body parts” for treating disease
(“therapeutic” cloning). Still more would no doubt object
to implanting the cloned embryo into a womb to produce a human being
(“reproductive” cloning).
Whatever your viewpoint, having regulation lagging behind technology
generally helps no-one, except perhaps for those at the extremes of public
opinion. This was aptly demonstrated when it was realised that legislation
in place in the United Kingdom to
control the use of human embryos5 did not actually cover cloning them.6 This seemed to please only an Italian fertility specialist who wanted
to exploit the loophole by starting a reproductive cloning
programme in the UK. The
situation (which has now been rectified)7 arose because the
definition of embryo under the then existing law assumed that fertilisation
had happened, but technology had advanced such that creating embryos
by cloning did not technically involve fertilisation.
Problems arise when
regulation does not keep up with science, and the
biotechnology field is no exception. With a view to the future, we should
all be
concerned. References
1. Simpson J, Stoner NS. Implications of gene therapy for hospital pharmacists.
Pharm J 2003;271:127–30 (PDF 100K)
2. Nuffield Council on Bioethics. The ethics of patenting DNA. London:The
Council 2002.
3. Cornish WR, Llewelyn M, Adcock M. Intellectual property rights and
genetics: A study into the impact and management of intellectual property
rights within the healthcare sector. Cambridge: Public Health Genetics
Unit 2003.
4. The Royal Society. Keeping science open: the effects of intellectual
property policy on the conduct of science. London: The Society 2003.
5. The Human Fertilisation and Embryology Act 1990.
6. R v Secretary of State for Health, ex parte Bruno Quintavalle (on
behalf of Pro-life Alliance) (Crane) 15 November 2001.
7. The Human Reproductive Cloning Act 2001. |
