Towards Equitable and Affordable Medicine Prices Policies in Jordan: Interpretation of Jordanian Patent Law and JUSFTA to Improve Access to Medicines

In this 15-slide PowerPoint presentation, an intellectual property attorney explores legal approaches to increasing access to essential medicines in Jordan. The presentation was given at a December 4-5 2007 Dead Sea event organised by the Jordan Food and Drug Administration and Health Action International (HAI).

Hiba A. Zarour begins by advising the government to engage in a process of listening to and learning from other governments, as well as non-governmental organisations (NGOs), regarding access issues. He advises advocacy where appropriate, encouraging openness to interpreting or even challenging intellectual property (IP) laws. He advises legislating wisely, balancing rights with exceptions and insisting on flexibility. In the area of pharmaceuticals, he urges that the need for a balanced legal system is essential. While rules are important to ensure IP protection of new medicines, limitations on these rules are equally important so that the medicines are made readily available and affordable.

For example, he urges interpretation of agreements so as to prevent "ever-greening", which he describes as a "social idea used to refer to the innumerable ways in which pharmaceutical patent owners utilize the law and related regulatory processes to extend their high rent earning intellectual property privileges particularly over highly profitable 'blockbuster' drugs." Zarour notes that Australia and Canada have enacted anti-ever-greening legislation to battle provisions of the Free Trade Agreement (FTA) that could delay introduction of generics. Unlike later-signed FTAs which include language linking marketing approval and patent protection, the Jordan FTA does not have such a linkage. Zarour moves to explore the interpretation of treaties, such as the Jordan-United States Free-Trade Agreement (JUSFTA), under international law. He encourages that good faith and ordinary meanings of text be evident within the treaty's context (the preamble, annexes, and the agreement, as included within the conclusion of a treaty or instrument accepted as part of a treaty). Furthermore, he urges that a special meaning be given to a term if so intended. Also, Zarour stresses that preparatory work and circumstances of the conclusion should be consulted if the interpretation under the general rules leaves the meaning ambiguous or leads to a result which is manifestly absurd or unreasonable.

To illustrate these claims, Zarour provides a number of examples from the text of the JORDAN-USFTA. One excerpt from Article 4.23 highlights the importance of "ordinary meaning" in the context of Jordan USFTA provisions related to pharmaceutical products: "Each Party shall make available an extension of the patent term to compensate the patent owner for unreasonable curtailment of the patent term as a result of the marketing approval process." Zarour discusses the meaning of "make available" here, noting that the extension cannot exceed 5 years and the total term of a patent plus extension cannot exceed 14 years. He then asks what "unreasonable" means, urging that there should be a timeline that takes into consideration many factors, including the applicant's diligence.

In conclusion, he notes that access to medicine can be facilitated through a stable legal environment characterised by transparency of laws and balance between rule and exception. He adds that the government should not assume the role of legislator by reading into the law what is not written, nor should it assume a role reserved for courts by becoming the enforcer of private IP rights. He urges that the government keep a record of the negotiating history of any agreement that affects access to medicines. Learning the field is important, and can be fostered by creating teams of international and national lawyers who work to prevent problems as well as to solve them.