1.This Act may be cited as
the Ethical Pathway Act of
2010
.
2.Ethical pathway
for the approval and licensor of pharmaceutical and biological
products
(a)
(1)In this section:
(A)The
term applicant means a person who submits to the Secretary an
application described in subsection (a)(2).
(B)The
term Commissioner means the Commissioner of Food and Drugs.
(C)The term regulatory test data means the
evidence regarding the safety and efficacy of new pharmaceutical drugs or
biological products used in order to obtain marketing approval for use in
humans or vertebrate animals.
(D)Relevant
application or licenseThe term relevant application or
license means a new drug application or new biological product license
application approved by the Secretary or relevant authority in a foreign
country which contains regulatory test data requested by an applicant under
this section.
(E)The
term Secretary means the Secretary of Health and Human
Services.
(2)An application described in this paragraph
is—
(A)an abbreviated
new drug application submitted under section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j));
(B)an application
for license of a biosimilar biological product submitted under section 351(k)
of the Public Health Service Act; or
(C)an application
for a license to sell a drug in the United States that has been approved for
marketing in a foreign country, as permitted by the Secretary.
(b)As soon as practicable after the date of enactment of
this Act, the Secretary, acting through the Commissioner, shall establish a
mechanism by which an applicant may request a cost-sharing arrangement
described in subsection (c). Such an applicant may request such an arrangement
if, but for the arrangement—
(1)such applicant
would be required to conduct clinical investigations involving human subjects
that violate Article 20 of the Declaration of Helsinki on Ethical Principles
for Medical Research Involving Human Subjects in order to obtain approval or
licensure from the Secretary of the application described in subsection (a)(2)
submitted by the applicant; or
(2)the duplication
of the clinical investigations required for such application would violate
other applicable ethical standards concerning the testing of products on humans
or other vertebrate animals.
(c)
(1)Responsibility
of applicantAn applicant that intends to perform clinical
investigations involving humans or vertebrate animals in order to file an
application described in subsection (a)(2) shall take all necessary measures to
verify that those investigations have not been performed or initiated by
another person.
(2)Voluntary
agreement procedures
(A)An applicant and the holder or holders of relevant
applications or licenses shall make every effort to ensure that any regulatory
test data and results of clinical investigations involving humans and
vertebrate animals conducted with respect to such relevant applications or
licenses is shared with the applicant, including the regulatory test data
necessary for the applicant to obtain marketing approval from the Secretary
with respect to an application described under subsection (a)(2).
(B)
(i)An applicant and the holder or holders of the relevant
applications or licenses shall make every effort to agree upon a fee that is
reasonable and fair that permits the applicant to rely upon information from
the regulatory test data referred to in subparagraph (A).
(ii)Clause (i) shall apply only to the regulatory test
data that such applicant is required to submit with the application described
in subsection (a)(2), and upon which such applicant does not have the right to
rely in the absence of a license or a cost-sharing agreement.
(3)Failure to
reach voluntary agreement
(A)Notification to
CommissionerThe applicant shall notify the Commissioner or the
appropriate designee of the Commissioner—
(i)if the applicant
or the holder or holders of the relevant applications or licenses refuses to
participate in the efforts to agree upon a fee described in paragraph (2)(B);
or
(ii)if
the applicant and the holder or holders of the relevant applications or
licenses fail to reach agreement on a reasonable and fair fee for reliance by
the applicant on the regulatory test data described in paragraph (2).
(B)Upon receipt of a notification under subparagraph
(A), the Commissioner or such designee—
(i)shall refer the
matter to binding arbitration to determine a reasonable and fair fee for the
reliance by the applicant on the regulatory test data, and encourage the
parties to participate in such arbitration; or
(ii)if
1 or more of the parties refuses to participate in such arbitration, or if
determined appropriate by the Commissioner, shall determine a reasonable and
fair fee for the reliance by the applicant on such regulatory test data.
(4)Reliance on
regulatory test data in applicationIf the applicant or the
holder or holders of the relevant applications or licenses refuses to
participate in the efforts to agree upon a fee described in paragraph (2)(B),
or if an applicant and the holder or holders of the relevant applications or
licenses fail to reach agreement on a reasonable and fair fee for reliance by
the applicant on the regulatory test data under paragraph (2)—
(A)the applicant
shall—
(i)pay
to the holder or holders of such relevant applications or licenses a fee in the
amount of the reasonable and fair share of the costs of the regulatory test
data determined through binding arbitration or by the Commissioner or
appropriate designee under paragraph (3), as applicable; and
(ii)in
the application described in subsection (a)(2) that is submitted by the
applicant, include a notification to the Commissioner that the Commissioner
shall incorporate into the application the regulatory test data contained in
such relevant applications or licenses that is the subject of the reasonable
and fair fee; and
(B)subject to the
payment of the fee described in subparagraph (A)(i), the Commissioner shall
incorporate into the application such regulatory test data.
(d)The
reasonable and fair fee for the reliance by the application on the regulatory
test data under subsection (c)(3) shall be determined after considering the
following factors:
(1)The actual
out-of-pocket costs of the applicable clinical investigations.
(2)The risks of the
investigations, as reflected in the probabilities that similar investigations
result in successful applications for marketing.
(3)Any Federal
grants, tax credits, or other subsidies that reduce the net cost of the
investigations.
(4)The expected
share of the global market for the product involved, by the party seeking to
rely upon the investigations for marketing approval.
(5)The amount of the
time the holder or holders of the relevant applications or licenses has
benefitted from exclusive rights, and the cumulative revenue earned on the
products that relied upon the regulatory test data at issue.
(e)
(1)In order to enhance the transparency of the costs of
innovation, and to provide greater predictability as to the liability
associated with nonvoluntary reliance upon regulatory test data, the Secretary
shall adopt procedures and rules under which sufficient information about the
costs and fees will be made public by the arbitrator or the Commissioner (or
the appropriate designee of the Commissioner), as applicable.
(2)The
information made public under paragraph (1) shall include at least summary data
of the actual costs of the clinical investigations, the factors considered
under subsection (d), and the amount of the fee provided to the holder or
holders of the relevant applications or licenses.
(3)The
requirements for public disclosure of the costs of the clinical investigations
shall not apply to cases where the owner of the rights in the regulatory test
data does not assert an exclusive right to rely upon such test data. If the
owner of the rights in the regulatory test data asserts an exclusive right, but
reaches a voluntary agreement on the fee for relying upon the data under
subsection (c)(2), the amount of the fee paid by the applicant shall be
provided to the Secretary or a designee, and be made public.