[Ip-health] Sanders amendment on data exclusivity and ethical pathway for registration of generic medicines

[James Love]

Senator Bernie Sanders (I-VT has submitted the amendment 2858 to the
health reform bill.

If adapted, it eliminates data exclusivity in favor of cost sharing,
when a clinical trial would otherwise have violated Article 20 of the
Declaration of Helsinki on Ethical Principles for Medical Research
Involving Human subjects.  Since nearly all requirements that generic
drug companies replicate clinical trials when there is no scientific
benefit of the experiment, this would essentially eliminate data
exclusivity.  It would not change the status of products protected by
patents, and it would require cost sharing if a generic company relied
upon clinical trial data, during the period of data protection.

I have a short blog about it here:

http://keionline.org/node/707

We would like to present Senator Sanders with a letter that endorses
this amendment.

Please let me know if you or your group can endorse this letter:

Dear Senator Sanders,

Thank you for submitting amendment 2858, to create an ethical pathway
for the registration of generic medicines.  We strong support this
amendment, because it would ensure that U.S. regulatory requirements for
registering generic medicines do not include requirements for clinical
trials that violate the ethical standards set out in Article 20 of the
Declaration of Helsinki on Ethical Principles for Medical Research
Involving Human subjects.  As you know, the United States government and
all other members of the World Health Organization (WHO) have agreed
that drug registration requirements should be consistent with the
ethical standards set out in the Declaration of Helsinki.  Your
amendment will ensure that patients are protected by these ethical
standards, while providing for a system of cost sharing for drug
registration data that will protect the legitimate interests of the
innovators.

Sincerely,


--
James Love, Director, Knowledge Ecology International
http://www.keionline.org | mailto:james.love at keionline.org
Wk: +1.202.332.2670 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.6584