Trips Agreement On Pharmaceutical

The first step in developing the analytical framework was to identify a number of key pharmaceutical policy objectives that are internationally agreed upon or that have generally been adopted in pharmaceutical policy: (i) access and affordability; (ii) safety, efficiency and quality; (iii) rational use of medicines and (iv) local production capacities and health security. These goals, first identified by the first author, then discussed and agreed among all authors, were based on SDG 3.8 [15] and WHO recommendations to Member States on the development and implementation of a pharmaceutical policy [17]. SDG 3.8 highlights the need for “access to safe, effective, high-quality and affordable medicines” in order to achieve universal health care [15]. The WHO recommendation on “overall objectives of a national drug policy” includes access (considered “equitable and affordable availability of essential drugs”); quality, safety and efficacy; and the rational use of medicines [17]. For some countries, strengthening “national pharmaceutical production capacities” is also recognized as a legitimate national drug objective [17]. It is important to note that there may be tensions between these policy objectives that require careful negotiations in a country`s pharmaceutical policy: for example, affordability must be weighed against the need to ensure safety and efficacy, and local production must be carefully weighed against affordability. However, a 2011 WHO report on local production concluded that local production is a means for governments in developing countries to maintain a balance between the availability of quality products and meeting priority public health needs with acceptable and affordable products [18]. The principles set forth in Annex 26-A of the TPP (Art. 2) (and maintained in the CPTPP) and Chapter 29 of the USMCA (Art. 29.6) are not drafted in the contractual language and cannot be implemented through state-to-state dispute settlement. However, these principles can serve a normative purpose by reinforcing the values and priorities of the sector and could possibly be referenced by people in dispute in ISDS judgments. While the principles recognize “the importance of protecting and promoting public health,” they are emphasized on the goals of the pharmaceutical industry, using languages such as “innovation in the context of research and development” and “the value of pharmaceuticals.” The four agreements contain chapters on the management of customs procedures, which are mainly aimed at ensuring that customs rules and procedures are transparent, predictable and streamlined and facilitate international trade in goods. However, Chapter 5 of the TPP (Customs Administration and Trade Facilitation) and USMCA Chapter 7 contain provisions relating to the exchange of information on customs matters – for example, Article 5.2.3 of the TPP, which requires parties to respond to written requests for information “where a party has a well-founded suspicion of illegal activities related to its import laws or rules.” Article 7.21 of the USMCA goes further and requires cooperation between the parties on border controls, including the inspection of goods.

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