Implementing the Jordan FTA rules on exclusive rights in regulatory test data

September 2, 2011
From KEI staff review of Wikileaks cables (http://keionline.org/wikileaks)

On August 30, 2011, Wikileaks published a December 19, 2005 cable written by Daniel Rubinstein. The cable illustrates the degree to which the U.S. Department of State monitors the implementation of the Jordan-US FTA agreement, as regards disputes over rules on data exclusivity.

At the time, Rubinstein was the Deputy Chief of Mission at the U.S. Embassy in Amman, Jordan. The cable provides a detailed account of several cases where pharmaceutical companies sought the most favorable interpretation of rules on data exclusivity, and the interventions by the US government on behalf of the pharmaceutical companies.

In one case:

a company filed for protection for a once-a-week-dose drug in 2004 less than a year before the daily dosing would lose its data exclusivity protections (for the clinical data that, once in the public domain, would allow a generic firm to make the same drug and market it at reduced costs)

This case ended up in court, where it was "dismissed on a technicality unrelated to the substantive dispute." According to the cable:

The weekly-dose case raises the general problem with data exclusivity and NCE's in Jordan. For example, an adult dosage, a children's dose, and a pre-school or infant dose - each with its own set of data in support of JFDA approval - should receive, each in its own turn, five years of protection, according to the manufacturer. But the JFDA can't square that proposition with its view of a single NCE deserving only one period of five-year protection. As PhRMA and individual companies read it, the FTA appears to come down more strongly in favor of protections from "unfair competition" and to be more favorable toward data exclusivity in the narrowest sense, for each dose.

In another dispute, PhRMA argued that when a product was approved for a "new use," the period of exclusivity should be expanded from five to eight years:

. . . when innovators are permitted to market a "new use" and to change a patient package insert describing the drug including the "new use" on it, JFDA experts concede that they are not certain this affords every "protection" of the new use for an additional three years. Once the drug's five-year registration expires and a generic becomes available, it is difficult to monitor how doctors prescribe and patients use that generic, versus the original, innovative drug. PhRMA argues that the drug should get full protection for the additional three years, giving it exclusive market access for eight years.

In yet another case, involving a cancer treatment, there was a dispute over when the exclusivity period begins -- when the drug is first used under a tender, or first approved by the regulator?

In 2001, an innovating firm's cancer treatment was approved for tender in a government hospital, where most patients in Jordan with the relevant disease are treated. (In these special tender cases, a waiver is obtained from the traditional JFDA approval process.) Soon afterward, the manufacturer filed a formal request for the drug's approval by the national JFDA. This year, an Australian generic of the same drug turned up on the market before five years had elapsed from the JFDA approval. JFDA DG Salah Mawajdeh explained that officials reasoned that the drug had enjoyed five years of data exclusivity, dating from the special tender bid. The manufacturer does not agree, citing the date of the more recent JFDA approval as the time when the clock should have started ticking. JFDA maintains that the same rule applies to all: if a company gets approval under the tender, that's when the data exclusivity clock begins.

Clearly pressing for pro-big-pharma-industry positions, the US Embassy called for a review of the FTA, and asked that Jordan put a PhRMA representive on the "High Committee for Drugs".

In exchanges with the JFDA and the Ministry of Industry, embassy has emphasized that the GOJ needs to abide scrupulously by its FTA commitments regarding pharmaceuticals. Most recently, we stressed to the JFDA that more bilateral consultation might be in order, given that FTA commitments should be part of Jordan's legal-regulatory framework. The USAID AMIR program has already tasked legal consultants to conduct a gap analysis over the next month to study where relevant legislation might be lacking. Since July, the Embassy has asked the JFDA to consider having the High Committee for Drugs that rules on Directives regarding drug approvals and IPR issues include wider representation of the innovator firms by having a PhRMA representative among three private sector members on the committee.

The cable reports that the government of Jordan invited the US government to provide its own "position papers outlining any concerns" about "international best practices."

On December 8, Minister Zu'bi conducted a meeting with JFDA Director General Mawajdeh to review pharmaceuticals IPR and access issues raised by the FTA. Zu'bi invited Econ/C and Econoff to join the meeting, during which Zu'bi made a firm commitment to reach clear understandings on pharmaceutical IPR protections in line with the FTA. Zu'bi told Econ/C that Jordan wished to be consistent with international best practices and adhere to the FTA. He requested that the USG furnish his ministry with position papers outlining any concerns. Jordan will follow those best practices identified, he said. If any process is not in line with FTA obligations, Jordan will rectify the situation.


http://cablegatesearch.net/cable.php?id=05AMMAN9748&q=exclusivity%20phar...
http://wikileaks.org/cable/2005/12/05AMMAN9748.html
UNCLAS SECTION 01 OF 04 AMMAN 009748

SIPDIS

SENSITIVE

STATE PLEASE PASS TO USTR
STATE FOR EB/TPP/IPE - A. ADAMO
STATE ALSO FOR NEA/ELA - M. ROSENSTOCK
DHHS FOR FDA - M. PLAISIR

E.O. 12958: N/A
TAGS: KIPR ETRD KTIA PGOV ECON JO
SUBJECT: JORDAN'S IPR CHALLENGES AND SOLUTIONS: PART III -
PHARMACEUTICALS POSE FRONTIER IPR ISSUES

REF: A. AMMAN 9708
¶B. AMMAN 8330 AND PREVIOUS

SENSITIVE BUT UNCLASSIFIED. FOR USG USE ONLY.
NOT FOR INTERNET DISTRIBUTION.

THIS IS THE THIRD IN A SERIES OF CABLES ON
INTELLECTUAL PROPERTY RIGHTS IN JORDAN. ACTION
REQUEST FOR USTR IN PARA 13.

¶1. (SBU) SUMMARY: Protection of original pharmaceutical
formulations in Jordan is governed not by patent laws, but by
drug registration procedures that allocate exclusive
marketing rights for innovative drugs for five years from the
date of approval by the Jordan Food and Drug Administration
(JFDA). The bilateral Free Trade Agreement (FTA) contains
language to protect innovative pharmaceuticals under this
registration regime, mainly in the area of data exclusivity
and in "unfair competition" provisions. The JFDA is just
beginning to confront the IPR issues posed by requests for
approvals, and protection, by innovative drug companies.
JFDA leadership is committed to Jordanian compliance with
international best practices, but notes that these issues are
not easily resolved at the international level. At present,
unresolved pharma-related IPR issues include affording
protection to clinical data regarding different dosages for
the same drug submitted at different times; resolving a
similar timing problem on data protection between limited
government approvals for tenders versus a full market
authorization; and protecting rights for "new uses" for
previously approved drugs. Beyond IPR, another FTA-related
issue is that the JFDA's pharmaco-vigilance regulations may
limit initial market access to innovative drugs.

¶2. (SBU) NOTE: The Embassy continues to work with individual
U.S. drug companies, as well as the Pharmaceutical
Researchers and Manufacturers of America (PhRMA), in pressing
the GoJ about its compliance with FTA commitments on
pharmaceuticals. After some initial stumbles - including a
court case thrown out on a technicality - there is growing
recognition within the GoJ that more clarity is required;
Minister of Industry and Trade Sharif Zu'bi is working with
the JFDA and the Embassy to address these problems, and has
underlined that the GoJ will live up to all FTA obligations.
END NOTE AND SUMMARY.

First Came the Case of the Weekly Dose
--------------------------------------

¶3. (SBU) International R&D-based drug firms are comfortable
with the registration system in Jordan; to date, Embassy
received no complaints of excessive bureaucracy or delayed
decisions by the JFDA. Indeed, the JFDA is given good marks
by the drug firms for its professionalism and constant
efforts at self-improvement. COMMENT: Its multi-agency
committees, however, do not have the same reputation, being
holdovers from a former paternalistic era of healthcare. END
COMMENT. During the first four years of the FTA, IPR
protection on clinical trial data for innovative drugs
applied to what is called "data exclusivity" by the industry.

¶4. (SBU) When a company filed for protection for a
once-a-week-dose drug in 2004 less than a year before the
daily dosing would lose its data exclusivity protections (for
the clinical data that, once in the public domain, would
allow a generic firm to make the same drug and market it at
reduced costs), however, pharmaceutical IPR problems ensued.
The JFDA did not see why it should protect the separate data
set referring to the once-weekly dose; in the eyes of the
decision-taking committee, it was the same active chemical
ingredient (the "new chemical entity" or NCE) for which the
original patent was issued that required protection for one
five-year term. Rather than consult or seek a regulatory
solution, the JFDA committee at that time was content to see
the matter referred to the courts and to abide by a court
decision. The court case, however, was dismissed on a
technicality unrelated to the substantive dispute. To the
JFDA, the generic company had "won."

¶5. (SBU) In early 2005, a generic company not only produced
a daily dose of the
contested drug, but also a weekly dose, which incontestably
relied on data generated only for the weekly substance and
not submitted until 2004. COMMENT: Some in the PhRMA
community believe it was a breach of law for the GOJ to fail
to uphold the FTA obligation to protect data submitted for
the once-weekly dose, regardless of any lower court decision.
However, to maintain harmonious relations with its
regulator, the aggrieved company - which continues to believe
itself to have been wronged - decided not to pursue the case.
END COMMENT.

¶6. (SBU) The weekly-dose case raises the general problem
with data exclusivity and NCE's in Jordan. For example, an
adult dosage, a children's dose, and a pre-school or infant
dose - each with its own set of data in support of JFDA
approval - should receive, each in its own turn, five years
of protection, according to the manufacturer. But the JFDA
can't square that proposition with its view of a single NCE
deserving only one period of five-year protection. As PhRMA
and individual companies read it, the FTA appears to come
down more strongly in favor of protections from "unfair
competition" and to be more favorable toward data exclusivity
in the narrowest sense, for each dose. The main FTA
provisions on drugs - FTA Article 4, paragraph 22 and its
related footnotes - have yet to be interpreted in a manner
acceptable to all, however.

Then Came the non-New-Use "New Uses"
------------------------------------

¶7. (SBU) Addressing another drug issue, FTA Article 4, para
22, footnote 10 reads: "...protection for 'new chemical
entities' shall also include protection for new uses for old
chemical entities for a period of three years." PhRMA
companies interpret that to mean that when a drug has a
proven new use, it can get an additional three years of data
protection, at least for that new use. Just such a drug came
along in 2005 - it had been used as an anti-asthma therapy,
but new clinical data showed it was also effective for those
patients who exhibit both asthma and co-existing allergic
rhinitis. NOTE: The U.S. and EU have already approved this
new "indication" as a new approved "use". END NOTE

¶8. (SBU) The JFDA ruledthat the drug was approved for the new
use, but not for a "new indication." This prompted some in
PhRMA to ask, "When is a new use not a new use?" The JFDA
argues that the gray area of overlapping uses does not permit
a distinction. However, even when innovators are permitted
to market a "new use" and to change a patient package insert
describing the drug including the "new use" on it, JFDA
experts concede that they are not certain this affords every
"protection" of the new use for an additional three years.
Once the drug's five-year registration expires and a generic
becomes available, it is difficult to monitor how doctors
prescribe and patients use that generic, versus the original,
innovative drug. PhRMA argues that the drug should get full
protection for the additional three years, giving it
exclusive market access for eight years. The JFDA is
studying the issue further. Embassy initially heard that the
JFDA was drafting a
circular to support the first, ambiguous ruling on the
anti-asthmatic. After the innovator appealed, and
when Emboffs highlighted the appeal for the JFDA DG, it
appears the JFDA will be taking a second, harder look at what
"protection" means.

Government Tender Approval vs. Market Authorization
--------------------------------------------- ------

¶9. (SBU) In 2001, an innovating firm's cancer treatment was
approved for tender in a government hospital, where most
patients in Jordan with the relevant disease are treated.
(In these special tender cases, a waiver is obtained from the
traditional JFDA approval process.) Soon afterward, the
manufacturer filed a formal request for the drug's approval
by the national JFDA. This year, an Australian generic of
the same drug turned up on the market before five years had
elapsed from the JFDA approval. JFDA DG Salah Mawajdeh
explained that officials reasoned that the drug had enjoyed
five years of data exclusivity, dating from the special
tender bid. The manufacturer does not agree, citing the date
of the more recent JFDA approval as the time when the clock
should have started ticking. JFDA maintains that the same
rule applies to all: if a company gets approval under the
tender, that's when the data exclusivity clock begins.

Drug Approval Process as Market Access Barrier?
--------------------------------------------- --

¶10. (SBU) Adding to manufacturers' concerns, the JFDA
includes an extra layer of safety to its drug approval
process by requiring that a drug be on the open market in one
of seven countries with high safety standards for a full year
before it can receive a formal approval in Jordan. As the
JFDA speeds up its approval process - it is aiming for 90
working days from submission to approval - that leaves the
innovator's drug off the market for at least half a year.
PhRMA companies deem this a technical barrier to market
access.
¶11. (SBU) For its part, the JFDA argues that clinical
trials may be statistically significant, but are still
conducted on limited numbers of patients, and cannot equal
population-wide use of a drug where rare side effects are
seen over the course of a year. The one-year public use
monitoring safety requirement is already a compromise on
safety concerns, according to the JFDA; some in Jordan would
like the period to be as long as five years. A remaining
concern for companies is that they might lose access to
Jordan's growing, sophisticated medical tourism population
during a critical time when a competing drug is already on
the market. Firms wonder why - if the drug is the best
available - Jordanians should be denied its use when it is
already approved in major, safety-conscious countries.

Next Steps: Trade Minister Zu'bi Takes Action
--------------------------------------------- -

¶12. (SBU) NOTE: In exchanges with the JFDA and the Ministry
of Industry, embassy has emphasized that the GOJ needs to
abide scrupulously by its FTA commitments regarding
pharmaceuticals. Most recently, we stressed to the JFDA that
more bilateral consultation might be in order, given that FTA
commitments should be part of Jordan's legal-regulatory
framework. The USAID AMIR program has already tasked legal
consultants to conduct a gap analysis over the next month to
study where relevant legislation might be lacking. Since
July, the Embassy has asked the JFDA to consider having the
High Committee for Drugs that rules on Directives regarding
drug approvals and IPR issues include wider representation of
the innovator firms by having a PhRMA representative among
three private sector members on the committee. A review of
the law that establishes the committee's membership is also
needed. Minister of Industry and Trade Sharif Zu'bi took on
board in early December Econ/C's suggestion that he consider
whether the ministry might join the High Committee, given the
growing influence of international trade and trade
commitments on the country's overall drugs regime. END NOTE.

¶13. (SBU) On December 8, Minister Zu'bi conducted a meeting
with JFDA Director General Mawajdeh to review pharmaceuticals
IPR and access issues raised by the FTA. Zu'bi invited
Econ/C and Econoff to join the meeting, during which Zu'bi
made a firm commitment to reach clear understandings on
pharmaceutical IPR protections in line with the FTA. Zu'bi
told Econ/C that Jordan wished to be consistent with
international best practices and adhere to the FTA. He
requested that the USG furnish his ministry with position
papers outlining any concerns. Jordan will follow those best
practices identified, he said. If any process is not in line
with FTA obligations, Jordan will rectify the situation.
Zu'bi referred the matter to the JFDA, and offered to help if
his further intervention is needed. JFDA's Mawajdeh
suggested that the JFDA could speak directly to USG technical
experts if that would help resolve FTA-related pharmaceutical
matters. He noted that the JFDA has held digital video
conferences with U.S. FDA colleagues, and offered to make his
team available via this format to any concerned USG agencies.
ACTION REQUEST FOR USTR: Please advise on next steps in
furnishing requested U.S. position papers on pharma IPR
issues to the GOJ.

¶14. (SBU) COMMENT: Over the past 18 months, circumstances
have created a critical mass of test cases related to the
FTA-mandated data exclusivity and "unfair competition"
protections. Taken together, these issues now command
high-level attention in the Ministries of Trade and Health,
and in the JFDA. Embassy will follow up on developments over
the next months in the run-up to the FTA Joint Committee.
END COMMENT.

¶15. (U) Next installment on IPR: Enforcement.

RUBINSTEIN

RUBINSTEIN