Lead Author: Hayel Obaidat Obaidat
Additional Authors: Wael Armouti and Wesal Haqaish
Organization: Jordan Food and Drug Administration
Country: Jordan

Abstract

The contribution is regarding Jordan Data Exclusivity in Pharmaceuticals Sector and their implementations at Jordan FDA, since joining World Trade Organization (WTO) in 2000, the adoption of the Unfair Competition and Trade Secrets Law, and signing a free trade agreement with the United States in 2001, Jordan has strengthened the intellectual property protection provides for pharmaceutical products.

JFDA is keen to bring new medications to the patients as quickly as possible to allow the worldwide therapeutic opportunities available in Jordan , so by applying the protection ( data exclusivity) this will encourage the international companies to invest in the pharmaceutical sector and the arrival of newer medicines, Nevertheless, JFDA has been implementing a standing operating policy and measures to accept receiving applications of generic version of an innovator during the last year protection in order to accelerate the registration of generic drugs and its affordability, also has included restricting market exclusivity to a narrow definition of “new” uses and limiting applications for data exclusivity to a short period 18 months following first market approval in worldwide..

This contribution contains some suggestion and recommendation taking in consideration human right in access to medicine

Submission

Jordan Data Exclusivity in Pharmaceuticals Sector

Since joining World Trade Organization (WTO) in 2000, the adoption of the Unfair Competition and Trade Secrets Law, and signing a free trade agreement with the United States in 2001, Jordan has strengthened the intellectual property protection provides for pharmaceutical products.
Jordan Food and Drug Administration (JFDA) the independent public sector institution that is the sole national competent authority for ensuring drug safety and efficacy in addition to food safety and quality has a role in implementing the data protection obligations, which refers to a practice whereby, for a fixed period of time (5years )( in compliance with TRIPS Agreement), drug regulatory authorities do not allow the registered data of an innovator (new chemical entities) to be used as a reference for application for a therapeutically equivalent generic version of that medicine , it is worth noting that several products that were registered prior to year 2000 were granted data protection (retrospective implementation of the law). To date, 362 products have been granted a five year data protection .
JFDA also abides by Jordan’s obligation to provide three-year protection to new indications since December 17, 2004, and since then, it has approved new indications for more than 68 products.
In order to effectively communicate the status of applications submitted and notify originators of all applications of concern to them, JFDA committed to post on its website list of products submitted for marketing approval in Jordan


JFDA is keen to bring new medications to the patients as quickly as possible to allow the worldwide therapeutic opportunities available in Jordan , so by applying the protection ( data exclusivity) this will encourage the international companies to invest in the pharmaceutical sector and the arrival of newer medicines. .
Nevertheless, JFDA has been implementing a standing operating policy and measures to accept receiving applications of generic version of an innovator during the last year protection in order to accelerate the registration of generic drugs and its affordability, also has included restricting market exclusivity to a narrow definition of “new” uses and limiting applications for data exclusivity to a short period 18 months following first market approval in worldwide.
The following measures are recommended to mitigate the negative impact of data exclusivity while still complying with our obligations set in both article 4.22 of our FTA with the United States and article 39.3 of TRIPS agreement. Many of these measures are already adopted in some countries without any fair of WTO ruling. To apply these measures amendments of the Unfair Competition and Trade Secrets Law and registration criteria in the JFDA or to establish a special regulation for granting data exclusivity, the followings are needed:
- Shortening the term of data exclusivity for new chemical entity: neither TRIPS nor Jordan-US FTA request the five years.
- Start Date of Data Exclusivity: a country can consider that the start date for granting data exclusivity is the first registration of the product worldwide.
- JFDA should examine the test data protection conditions before granting data exclusivity: Then, JFDA can issue a protection certificate confirming complaint of data exclusivity conditions:
- Undisclosed test data: this should be defined in the registration criteria and JFDA should examine this condition by requesting a certificate from the originator company declaring that the submitted test data have not been published by any means or in any way. If the data become non-confidential, then the JFDA has the right to end the data exclusivity period.
- Considerable efforts: this should be defined in the registration criteria and JFDA should examine this condition by requesting evidence from the originator company to show that the generation of the submitted test data involved considerable efforts by reporting the cost and the period involved in the generation of the submitted test data.
- Data exclusivity term should not extend beyond the patent term.
- Allow registration of the generic product for the purposes of export.
- Grounds for revocation of the data exclusivity period: such as anti-competitive practices of the originator company: high prices, delay in marketing the product more than six months from approval date, stop marketing for more than six months or insufficient marketing of the product.
- Waive data exclusivity protection in cases of compulsory licensing : in case of the issuance of a compulsory license, the generic company is still required to submit clinical trials. Therefore, data exclusivity should be waived in such cases.
- Waive data exclusivity in cases of emergency and public interest.
- Waive data exclusivity for products intended for the treatment of life threatening diseases.
Applying all these measures may raise many challenges for Jordan and it will take time, but some of these measures are more easily to be implemented especially those not requiring law amendments. JFDA can apply some of these measures, which may need only regulations amendments or create a new regulation to control data exclusivity granting.
In future negotiations of bilateral agreements, the governments should involve all concerned stakeholders to prevent any negative consequences.

Bibliography and References

US- Jordan FTA..
Jordan unfair completion law
Jordan Drug and pharmacy law
Jordan patent law
www. jfda.jo.
Data exclusivity for pharmaceuticals was it the best choice for Jordan, Wael Armouti ,thesis , university of Jordan, faculty of law