Generally speaking, there are two regimes that regulate the pharmaceutical production market. These are (i) traditional intellectual property rules and the (ii) the laws and regulations related to the process of drug registration and approval (non-traditional in that sense). These two sets of regimes serve specific purposes and are administered by different government agencies.1

With relation to patent protection, national patent offices are the designated authorities dealing with the process of granting patents in any country. Their role is to ensure that the patent application meets the requirements of the national law set for a patent grant. Although intellectual property in general and patent laws more specifically are territorial in nature, international agreements play a big role in shaping and forming these laws and legislations.

With the creation of the TRIPS Agreement toward the end of the Uruguay Round, which resulted in the creation of the World Trade Organization (hereinafter the WTO) in 1995,2 the world witnessed a new era in the regulation of intellectual property at the international level. This new global regime had a direct impact on public health and access to medicines nationally. In consequence, the TRIPS Agreement made it obligatory for the first time in history for all member states to grant patent protection for pharmaceutical products and processes.3 Prior to that, countries had considerable freedom and discretion in determining what to protect, or otherwise. The TRIPS Agreement was followed by various initiatives and agreements aimed toward increasing the levels of intellectual property rights protection at the national and regional levels including bilateral and regional free trade agreements (FTAs).4

On the other hand, and in order to ensure the safety and efficacy of medicines,5 countries tend to regulate the sale and marketing of medicines through designated national drug regulatory agencies dedicated to this matter such as the US Food and Drug Administration (the FDA), the European Medicines Agency and the Japan Pharmaceuticals and Medical Devices Agency.6 As such, these agencies undertake the needed measures to verify that the submitted test data meets the efficacy, safety and quality requirements of any medicines prior to its launch nationally.

National drug regulatory authorities often operate independently from national patent offices, as the latter are more concerned with ensuring that the application for obtaining a patent meets the requirements of patentability as set under the national patent law (such as novelty, inventiveness and industrial applicability), as opposed to the role of national drug regulatory authorities, which are more concerned with the quality and safety of the drug. Moreover, most of national drug regulatory authorities are affiliated with or have linkages with national health strategies and ministries while patent offices are often affiliated with ministries of trade or commerce.

Nevertheless, the role of national drug regulatory authorities has been impacted in a number of ways in recent years. The aim was to introduce additional requirements on these authorities in order for them to provide protection terms (data exclusivity protection) and to link the status of clinical trial applications with that of patent protection (patent linkage).7 These developments have huge public health impact upon the accessibility and affordability of medicines as will be explained in the ensuing sections of this paper.

Source: https://academic.oup.com/jiplp/advance-article/doi/10.1093/jiplp/jpaf057/8300189