[Ip-health] Senator Sanders Amendment 2858 would replace data exclusivity with cost sharing, if new trials violate medical ethics

[James Love]

Source URL: http://keionline.org/node/707

Published on Knowledge Ecology International (http://keionline.org)

Senator Sanders Amendment 2858 would replace data exclusivity with cost
sharing, if new trials violate medical ethics
By James Love
4 Dec 2009

Senator Bernie Sanders (I-VT) has offered an amendment to the health
care reform bill that would eliminate data exclusivity in cases where
duplicating clinical trials involving human subjects would violate
Article 20 of the Declaration of Helsinki on Ethical Principles for
Medical Research Involving Human subjects [1]. The relevant article from
the Declaration of Helsinki reads as follows:

<-------------
20. Physicians may not participate in a research study involving
human subjects unless they are confident that the risks involved have
been adequately assessed and can be satisfactorily managed. Physicians
must immediately stop a study when the risks are found to outweigh the
potential benefits or when there is conclusive proof of positive and
beneficial results.
------------>

In a new section of the health reform bill on "Ethical Pathway for
Pharmaceutical Products," the amendment would require the Secretary to
create a new cost-sharing arrangement, in cases where the replication of
a clinical trial would present human subjects with risks, simply to
establish something that is already known -- that a drug is safe and
effective. The details of the cost sharing would be determined by rules
adopted to implement the amendment.

The issue addressed by the amendment has long been of interest to public
health groups [2], on the grounds that regulatory rules providing
exclusive rights in clinical trial data violate medical ethics.

In May 2008, the World Health Organization (WHO) World Health Assembly
(WHA) passed a resolution that called upon governments to respect the
Declaration of Helsinki in designing regulatory policies:

<----------------------
    WHA61.21: Global strategy on public health, innovation and
intellectual property

    Element 6. Improving delivery and access

    (6.2) establishing and strengthening mechanisms to improve ethical
review and regulate the quality, safety and efficacy of health products
and medical devices

    (g) 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.
-------------------------->


The Sanders amendment would be the first time a government has
recognized the conflict between medical ethics and regulatory procedures
that demand unnecessary clinical trials on human subjects.

The WTO TRIPS agreement and several U.S. free trade agreements speak to
the issue of "unfair commercial use" of data uses to register
pharmaceutical products. The relevant provision in the TRIPS is Article
39.3, which reads as follows:

<----------------------
    SECTION 7: PROTECTION OF UNDISCLOSED INFORMATION

    Article 39

    3. Members, when requiring, as a condition of approving the
marketing of pharmaceutical or of agricultural chemical products which
utilize new chemical entities, the submission of undisclosed test or
other data, the origination of which involves a considerable effort,
shall protect such data against unfair commercial use. In addition,
Members shall protect such data against disclosure, except where
necessary to protect the public, or unless steps are taken to ensure
that the data are protected against unfair commercial use.
----------------------->

Public health groups has long argued that this provision in the TRIPS
only refers to "undisclosed information," and that any concerns over
unfair commercial use of clinical trials data is more appropriately
addressed through cost sharing agreements, rather than through the
creation of temporary exclusive rights.

Links:
[1] http://www.wma.net/en/30publications/10policies/b3/index.html
[2] http://keionline.org/content/view/86/1
[3] http://keionline.org/sites/default/files/hr3590_amend2858.pdf


--
James Love, Director, Knowledge Ecology International
http://www.keionline.org | mailto:james.love at keionline.org
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