Regional Assessment of Patent and Related Issues and Access to Medicines: Caricom Member States and the Dominican Republic (HERA)
Frederick M. Abbott
Florida State University - College of Law
Southwestern Law School; University of California, Los Angeles - David Geffen School of Medicine
affiliation not provided to SSRN
affiliation not provided to SSRN
December 31, 2009
Health Research for Action Final Report- Main Report, Vol. 1, 2009
The objectives of this study were: (a) to explore the possibilities of developing a harmonized, pro-public health regional (Caribbean) IP regulation and drug policy (to include generic drugs) framework; (b) to make recommendations on the promulgation/up-dating of IP legislation and regulation that will maximize TRIPS flexibilities while being TRIPS compliant; (c) to identify the requirements and process for establishing a regional negotiating platform for drugs; (d) to identify mechanisms for building/strengthening coalitions and negotiating positions at the WTO, and in bilateral and regional fora for ensuring access to drugs; and (e) to make recommendations on the adequacy of the systems in Member States for regulation of the pharmaceutical market to ensure the timely supply of safe, effective and quality medicines.
All 15 CARICOM member states were included in the study: Antigua & Barbuda, the Bahamas, Barbados, Belize, Dominica, Grenada, Guyana, Haiti, Jamaica, Montserrat, St Kitts & Nevis, St Lucia, St Vincent & the Grenadines, Suriname, and Trinidad & Tobago. The Dominican Republic had been identified as an additional beneficiary of the study in the Pan Caribbean Partnership against HIV/AIDS (PANCAP)/World Bank agreement.
The subject matter of IPRs is complex. It is made more so when a relatively large basket of international, regional and bilateral agreements and rules are brought into the picture. At the present time, patents and other forms of IPRs do not constitute a significant obstacle to the procurement of essential medicines by CARICOM/DR public health and private sector enterprises. The main reason is that the administrative systems for granting patents within the region are largely non-operational, and a relatively low volume of pharmaceutical related patents appears to have been granted up to this point. However, the fact that patents and other IPRs have not played a significant role to date in the procurement of medicines in the CARICOM/DR region is a “backward-looking” assessment.
The CARICOM/DR countries have recently entered into new international agreements that promise to focus new attention on their intellectual property systems. The forward-looking assessment and analysis in this report therefore urges CARICOM/DR countries to closely examine their existing patent and data protection legislation with a view towards implementing IP-related flexibilities that are permitted under international rules, but which have not yet been adopted or implemented. These flexibilities may well be critical to maintaining adequate supplies of new pharmaceutical products in the future.
Among other issues, the study examined the possibility of establishing a regional patent office and system, and this report makes recommendations about how that system might be structured in a way more likely to promote public health and consumer interests. It suggests that CARICOM countries avoid adoption of a “unitary” patent model and adopt instead a model in which patent rights are granted and enforced for each designated country, allowing each country to retain flexibilities and exceptions. It observes the potential advantages in establishing a regional patent office with consolidated technical capacity to examine pharmaceutical-related patent applications (consistent with whatever policies and rules CARICOM countries adopt).
The report recommends the establishment of a working group or groups to consider the potential structure of a regional patent system, recognizing that there are a number of difficult legal and technical issues to assess.
Number of Pages in PDF File: 128
Keywords: medicines, patents, trade, HIV-AIDS, pharmaceuticals, TRIPS agreement, public health
JEL Classification: D60, F02, F14, H41, H42, H51, H57, I18, K32, K33, O54
Date posted: August 15, 2011
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