[Ip-health] Ethics, clinical trials, and data exclusivity: 5.1(h) moved to 6.2, with new language.

[James Love]

Ethics, clinical trials, and data exclusivity

The discussion on this topic was long, and sometimes confused.  However,
it was probably also the first extended policy debate where the issue of
ethics and data exclusivity were raised.  The US and several European
delegates argued there was no conflict between data exclusivity and
medical ethics, but they were willing to accept some text on the issue
of ethics and medicine registration requirements.  The result was an
agreed upon text that is potentially quite powerful, but only if
countries do some more work exploring its consequences.

The starting text this morning, which was in brackets, was in the
intellectual property section, and read as follows:

-----------
5.1 (h) [establish measures to avoid unethical experiments involving
human beings as a requirement for registration of medicines and
technologies.]
-----------

The final text, which is now consensus text, was moved to element 6.2,
on improving delivery and access, and reads as follows.

--------------
6.2) promote ethical principles for clinical trials involving human
beings as a requirement of registration of medicines and health-related
technologies, with reference to the Declaration of Helsinki and other
appropriate texts, on ethical principles for medical research involving
human subjects, including good clinical practice guidelines.
-------------

How will this be used?  Consider, for example, paragraph 17 of the
Helsinki declaration, which reads:

"Physicians should abstain from engaging in research projects involving
human subjects unless they are confident that the risks involved have
been adequately assessed and can be satisfactorily managed. Physicians
should cease any investigation if the risks are found to outweigh the
potential benefits or if there is conclusive proof of positive and
beneficial results."

This language would seem to rule out requirements for trials to repeat
safety and efficacy tests, where there is already "conclusive proof of
positive and beneficial results."

The entire Declaration of Helsinki on ethical principles for medical
research involving human subjects is on the web here:
http://www.wma.net/e/policy/b3.htm

Note in particularly, paragraphs 17-19 and 29 and 30.

17.  Physicians should abstain from engaging in research projects
involving human subjects unless they are confident that the risks
involved have been adequately assessed and can be satisfactorily
managed. Physicians should cease any investigation if the risks are
found to outweigh the potential benefits or if there is conclusive proof
of positive and beneficial results.

18.  Medical research involving human subjects should only be conducted
if the importance of the objective outweighs the inherent risks and
burdens to the subject. This is especially important when the human
subjects are healthy volunteers.

19.  Medical research is only justified if there is a reasonable
likelihood that the populations in which the research is carried out
stand to benefit from the results of the research.

29.  The benefits, risks, burdens and effectiveness of a new method
should be tested against those of the best current prophylactic,
diagnostic, and therapeutic methods. This does not exclude the use of
placebo, or no treatment, in studies where no proven prophylactic,
diagnostic or therapeutic method exists. See footnote

30 At the conclusion of the study, every patient entered into the study
should be assured of access to the best proven prophylactic, diagnostic
and therapeutic methods identified by the study. See footnote

----------
Note: Note of clarification on paragraph 29 of the WMA Declaration of
Helsinki

The WMA hereby reaffirms its position that extreme care must be taken in
making use of a placebo-controlled trial and that in general this
methodology should only be used in the absence of existing proven
therapy. However, a placebo-controlled trial may be ethically
acceptable, even if proven therapy is available, under the following
circumstances:

  - Where for compelling and scientifically sound methodological reasons
its use is necessary to determine the efficacy or safety of a
prophylactic, diagnostic or therapeutic method; or

  - Where a prophylactic, diagnostic or therapeutic method is being
investigated for a minor condition and the patients who receive placebo
will not be subject to any additional risk of serious or irreversible
harm.

All other provisions of the Declaration of Helsinki must be adhered to,
especially the need for appropriate ethical and scientific review.

Page back to paragraph 29.

Note: Note of clarification on paragraph 30 of the WMA Declaration of
Helsinki

The WMA hereby reaffirms its position that it is necessary during the
study planning process to identify post-trial access by study
participants to prophylactic, diagnostic and therapeutic procedures
identified as beneficial in the study or access to other appropriate
care. Post-trial access arrangements or other care must be described in
the study protocol so the ethical review committee may consider such
arrangements during its review.


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_____________________________
James Love, Knowledge Ecology International (KEI)
http://www.keionline.org, mailto:james.love@keionline.org
voice +1.202.332.2670, fax +1.202.332.2673, US mobile +1.202.361.3040, Geneva mobile +41.76.413.6584

When everyone thinks the same, no one thinks.  Bill Walton remix of Walter Lippmann