'The access to medicine puzzle: scaling back the negative effects of the Jordan–US Free Trade Agreement' by Laila Barqawi in (2019) 14(9)
Journal of Intellectual Property Law and Practice 678–686 comments
Jordan is the first Arab country to have agreed to sign a Free Trade Agreement (FTA) with the USA. The Jordan–US agreement (JUSFTA) contains Trade Related Aspects of Intellectual Property Rights (TRIPs)-plus clauses which affect Jordan’s access to medicine by raising the price of drugs, delaying generic entry of medication into the market and therefore limiting access to medicines. Commentators have noted several concerns about FTAs, including their lack of flexibilities, such as compulsory licensing, and of exceptions for fair or non-commercial use.
This article examines recommendations by the Jordanian Food and Drug Administration (JFDA) and explains the workability of these recommendations, using examples from countries which have signed FTAs with the USA and have successfully curtailed the negative effects of FTAs. The article also recommends further options which the Jordanian government can utilize to limit the negative impacts of TRIPs-plus clauses within their national laws. These options do not contravene JUSFTA and TRIPs and can increase access to medicines.
Barqawi states
Jordanian officials have started to recognize the negative impact of data exclusivity as can be seen through the Jordan’s food and drug administration’s (JFDA) submissions to the UN High Level Panel below. We explore their workability in an attempt to scale back the negative effects of TRIPS-plus and data exclusivity.
Data exclusivity operates as a ‘wholly distinct form of intellectual property rights and could not be overcome by a compulsory license.’ Furthermore, TRIPS protects only ‘undisclosed data’ to prevent ‘unfair commercial use’; it does not confer either exclusive rights or an automatic period of marketing monopoly. TRIPS does not define what constitutes ‘commercial use’. There have been arguments for data exclusivity in that it incentivizes innovation in the field of pharmaceutical drugs and assists pharmaceutical companies in recouping the costs of clinical trials and clinical trial data transparency. These arguments have been refuted on the basis that a few years of patent protection is adequate to recover the cost of clinical trials as US companies, for example, have made an excess of USD 1 billion on 55 ‘blockbuster’ drugs in 2013.
As part of Jordan’s WTO’s accession package, Jordan agreed to block registration and marketing approval of generic medicine for five years, ‘even when no patents exist’. This has been implemented through the Trade Secrets and Unfair Competition Draft Law, which had been referred to Parliament in November 19998 and is now Article 8 of Jordan’s Law No 15 of 2000 on Unfair Competition and Trade Secrets (UCTS). This is clearly TRIPS-plus in nature.
Moreover, restrictions by JUSFTA also require three further years for data exclusivity for new uses, which clearly is an excessive form of protection for an existing TRIPS-plus condition. The effect of this restricted use of data exclusivity is evidenced by the 103 registered medicines which were launched since 2001 and had no patent protection in Jordan; of these, at least 79 per cent had no competition from a generic equivalent as a consequence of data exclusivity. This suggests that data exclusivity limits competition. Beyond implications for competition, there are financial effects as well. For example, an analysis funded by the Medicines Transparency Alliance estimated that the delayed market entry of generics resulting from TRIPS-plus requirements in JUSFTA cost consumers in Jordan’s retail market US$ 18 million in 2004.
The Jordanian government should implement the recommendations in this article with backing from the USA, because the USA is the main financer to Jordan’s economy. Furthermore, defying the USA means that countries such as India, which challenge the USA on IP, feature regularly on the USA’s ‘Priority Watch List’ in its 301 Reports. For example, the USTR’s 2018 Special 301 Report clearly states that India has ‘Longstanding IP challenges facing US businesses in India’.
She concludes
There is policy space that the Jordanian government could utilize to limit the effects of TRIPS-plus. Jordan’s data exclusivity clauses are the most harmful to Jordan’s access to medicine. However, this article offers practical solutions to scale back Jordan’s data exclusivity restraints, following the example of other countries that have signed similar terms with the USA. This article builds on the recommendations of the JFDA by advocating further measures for the Jordanian government to increase its access to medicine. Jordan could restrict definitions such as NCE, patentability criteria and bar second use patenting, a decision that would prevent ‘evergreening’ of existing patents, supporting wide access to medicines. Jordan’s laws could also allow for policy space to be interpreted within its national laws as per Peru’s Amended Article 4 in its Legislative Decree. The Jordanian government could put a cap on the drug prices in comparison with other similar economies. Consequently, Jordan could attempt to overhaul its national legislation to streamline its IP. The Jordanian government should, ideally, have its decisions backed by the USA to maintain its relationship with the USA and not feature in the USTR’s 301 Report’s Watch List.
