Scientists beg EU to repeal new rules for clinical trials
BMJ 2004; 328 doi: https://doi.org/10.1136/bmj.328.7433.187 (Published 22 January 2004) Cite this as: BMJ 2004;328:187All rapid responses
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Big government=big business contracts=death of innovation and efficiency=avoidable death of patients
What a disaster. Might the model be the innovative successes of
selected defence contractors during the cold war? If so they go hand-in-
glove with secrecy and covert operatives to protect proprietary knowledge.
It also means interminable delays before patients have access to new
advances if they are ever to benefit from them. How can start-up companies
who develop cheaper and more effective ways of treating patients survive
let alone thrive in these circumstances? Political correctness has gone
raving mad. Has it not caused enough avoidable complications and deaths?
Having said that what an effective instrument to employ against those
countries undermining the rule of law and intellectual property rights. It
has the potential to destroy the financial infrastructure of companies and
even countries overnight. That could send us straight back to the cold
war.
Competing interests:
None declared
Competing interests: No competing interests
The concerns expressed by the signatories to the ‘Save European
Research’ petition are well founded and the threats foreseen are in the
main real for academic research as well as for smaller biotech and
pharmaceutical companies.1 At stake in the EU Directive on Implementing
Good Clinical Practice is the very possibility of realising a European
dimension to clinical research that has the support of public confidence
in the research community. This was at the core of the discussion when the
first concept paper was introduced in 1995, and it remained the focus
throughout much of the public debate in the latter 1990’s and early 2000’s
that preceded the co-decision by the European Parliament and the Council
of Ministers. Even more recently, over the past two years this debate has
heated the discussion between the Member State representatives and the
Commission on the supporting guidance documents.
Certainly the role and responsibilities of the sponsor in clinical
research are key issues. The Directive failed to tackle the complexity of
the structures and tasks of the sponsor in clinical trials, perhaps in
part because the role and responsibilities of the sponsor had been
addressed in the 1990 EC GCP, 1996 ICH/CPMP Note for Guidance on GCP, and
the 1995 WHO GCP (where the topic is currently being addressed more
broadly by a working group). For the sake of patients, the issue of
sponsor responsibilities does need to be settled throughout European
research, with or without the support of the Directive.
The future health of European citizens depends upon the contributions
of government and non-government funded research at the local, national,
and European levels. The petitioners are rightly concerned about their
future role in today’s globalised research environment. Europe cannot
afford to lose the power and creativity of its academic researchers, nor
the possibilities offered by the smaller research enterprises. The
importance of academic research for European health was not well
articulate in the debate that resulted in the Directive, with the
exception of the steadfast engagement of the European Organization for
Research & Treatment of Cancer (EORTC). For whatever reasons, this was
unfortunate.
Fundamentally, however, European researchers need to decide what they
are wanting to save. Is it their wish to pool their knowledge and
resources at the European level? or do they prefer that research (as
matters now largely stand) be organised and supported primarily at the
national level? The upshot of the Directive may well be that the latter is
strengthened. Still, sooner or later the communities of researchers in
Europe will need to articulate their vision alongside their
responsibilities.
Surely the answers to the challenges in front of us do not lie
singularly or wholly in the Directive. The discussion provoked by the
Directive is, however, crucial. Directive or no Directive, the question
needs to be faced: How can we create a robust European research
environment that ensures patient protections and public confidence in all
areas of health research?
1Rory Watson. ‘Scientists beg EU to repeal new rules for clinical
trials’ News Roundup BMJ 2004; 328: 187.
Competing interests:
None declared
Competing interests: No competing interests
Time to draw a line between commercial and non-commercial research
I agree with Crawley (1) that "the concerns expressed by the
signatories to the ‘Save European Research’ petition are well founded".
But I also think that it is high time to draw a sharp dividing line
between commercial research, whose finality is economic profit, and
academic research, including research done by health organisms for public
health reasons.
Traditional concept of health research was that of an activity aiming
to produce knowledge, local or universal, with the intention of
contributing to the public wellbeing, and it was associated with a frame
of ethical consciousness and beneficial thought. No such frame of
intentions can be attributed to pharmaceutical corporations, whose single
objective is money and share dividends, even at the price of unethical
behaviour (2).
It is dangerous to mix in a single regulation commercial and academic
research since, even if participating citizens should be protected in both
cases, supervision and control should be more stringent for profit-making
trials. The reason is simply the absence of any moral restraints to the
search for benefit that characterizes drug industry procedures.
I am conscious that untangling commercial and beneficial research may
be a difficult task, given the extent of links interweaving both, but it
is a task that sooner or later will need to be undertaken, if a real
concern for research participants and public welfare is present in the
legislators’ mind.
Luis Justo
Bioethics Chair
School of Medicine,
Universidad Nacional del Comahue, Argentina
(1) Crawley F. Is European research possible? BMJ, 27 January 2004.
(2) Justo L. A patent to kill? Developing World Bioethics, 2;1,82-
87, 2002.
Competing interests:
None declared
Competing interests: No competing interests