Data Protection, the Trans Pacific Partnership, and the US-Jordan FTA (Post 1 of 2)

Patently BIOtech

The Trans Pacific Partnership (TPP) negotiation does not yet include a section on data protection (typically included in the Pharmaceutical Chapter of Free Trade Agreements).  Organizations against the inclusion of data protection in the TPP cite as evidence an Oxfam International study titled “All Costs, No Benefits: How TRIPS-plus intellectual property rules in the US-Jordan FTA affect access to medicines.”

The Oxfam paper concludes that “medicine prices have increased drastically, and TRIPS-plus rules were partly responsible for this increase.  Furthermore, stricter levels of intellectual property protection have conferred few benefits with respect to foreign direct investment, domestic research and development, or accelerating introduction of new, effective medicines.”

Meeting

Photo Credit: Gobierno de Chile

However, Michael P Ryan, PhD at George Washington University Law School, in a paper titled “Intellectual Property Reforms, Pharmaceuticals, and Health Competitiveness in Jordan: Misunderstanding and Misinformation from Oxfam International,” concludes that “Unfortunately, Oxfam misunderstands the goals and strategies of the Jordanian reform initiative and offers misinformation to support their claims.”

  1. The Oxfam study claims that IP reform has had a negative impact on Jordanian bio-medical innovation by asserting:
    1. Since 2000, no Jordanian manufacturer has filed a patent application for a new medicine.
    2. Jordanian innovative R&D only introduces “trivial modifications to existing medicines.”

Ryan responds:

A.  Changes in local regulatory climate have spurred entrepreneurial activity to address local health conditions through innovation.

i.            Jordan Pharmaceutical Manufacturing Company – claimed its 30th patent in 2005 for its innovative efforts.  The company earned $2.7 million from sale of its patented technology in 2005 and in 2006 earned $3.9 million.

ii.            Triumpharma – launched in 2003, has 4 innovative drug formulations – patent applications have been submitted – ready to license to international manufacturer-distributors, and 6 more innovative drug formulations are under development.

B.  If Oxfam’s claim that IP reforms have cost Jordan $6.3 to $22.04 million in higher prices (claim refuted later in the paper) is true, the Jordan Pharmaceutical Manufacturing Company alone has earned more money from its R&D efforts than the low-end of Oxfam’s cost estimate.

2.  Oxfam suggests that IP reforms have prevented local generic competition to the detriment of local industry as well as Jordanian society.

Ryan responds:

a.  Before IP reforms, Jordanian industry dominated the local pharmaceutical market of about $70 million.

b.  Economic reforms have increased the size of the pharmaceutical market in Jordan to about $160 million.

c.  Though the generic market share declined 40%, their local market sales of generic drugs have increased, not decreased, to $75 million.

d.  At time of reforms, only one Jordanian company was certified for Good Manufacturing Practices (GMP) (raising questions about the quality of generics before reforms).  After reforms, at least four more Jordanian companies achieved international GMP certification.

e.  Jordanian pharmaceutical exports have grown during the post-reform era from $49 million to more than $280 million.

f.  Post-reform, Jordan has become the #1 Arab exporter of drugs, exporting 75% of their production to some 66 countries.

3.  Oxfam states that the FTA conferred few benefits with respect to foreign direct investment, domestic R&D, or accelerating introduction of new, effective medicines.

Ryan responds:

a.  Before IP reforms, no multinational drug innovator companies conducted clinical R&D in Jordan owing to the lack of patent and data protections and of an enabling regulatory environment.

i.      Post reform, in 2006, 6 companies were carrying out 13 pre-market launch clinical research trials involving 104 doctors and 3,600 patients at 32 hospitals valued at $360,400.

ii.      Jordanian doctors and patients were getting access to innovative pharmaceutical knowledge and therapies in the areas of cancer, renal failure, schizophrenia, epilepsy, antibiotics, painkillers, anti-infectives, and cardiovascular disease.

Read the follow-up post: Data Protection, the Trans Pacific Partnership, and the US-Jordan FTA (Post 2 of 2).

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