In addition to intellectual property rights disputes, ISDS could be used to challenge or “relax” in other pharmaceutical policy decisions, such as decisions. B not to approve certain medicines, drug reimbursement conditions through public drug plans, rules against promoting off-label consumption, safety rules and inspections or measures that benefit local producers. Possible effects include extended exclusivity periods, the relaxation of regulatory standards, less rational requirements and the viability of the domestic pharmaceutical industry. BT is a member of the Australian Public Health Association and has represented the association on trade agreements and public health issues. It has been funded by various non-governmental organizations for conferences on trade agreements and health. The analysis presented here has highlighted the wide range of provisions and avenues that, beyond the protection of intellectual property per se, need research, with potential implications for pharmaceutical policy, that go beyond issues of access and affordability. Some of these provisions (. B, for example, regulatory requirements for safety, efficacy and quality assessment, SO And and regulatory coherence rules) have only recently been included in trade agreements and have been little or no empirical research as they begin to be adopted and implemented. The analytical framework proposed in Table 1 summarizes these provisions into a comprehensive checklist, with provisions, pathways and potential effects. If these rules are not carefully managed, they can facilitate entry (and potential interference) in drug selection decision-making and reduce flexibility in prioritization and timing of list decisions.
In the case of a dispute brought by a pharmaceutical company within the TPP and the CPTPP under the ISDS mechanism, the rules could be used to give weight to the industry`s arguments, for example with respect to the rights of investors to a minimum standard of treatment . At least compliance requires the need to have resources to manage processes that serve the interests of the industry and not useful public purposes. One final point: the provisions we are debating can affect countries` ability to achieve SDGs 3.8 through other means, in addition to the four main pharmaceutical objectives. To the extent that, for example, one of these provisions increases public costs with little or no improved therapeutic benefits, they become opportunity costs for achieving SDG 3.8. Many of these provisions carry a significant administrative burden on compliance with BMI rules, which have implications for human resources and infrastructure. Walls and colleagues point out that “if states do not find ways to increase their administrative regulatory capacity in terms of the negotiation, implementation and day-to-day management of ATPs [preferential trade agreements], these EPZs could lead to increased health inequalities . One limitation of our study is that the framework is based exclusively on the content of four recently negotiated trade agreements. Other trade agreements that have been negotiated recently or are under negotiation may include amendments to the provisions described here or may contain new provisions that are not included in previous agreements.
What we have presented is an overview of the potential avenues and implications for the development of the analytical framework, rather than a detailed assessment of the health impact of the likely effects of trade agreements in certain contexts. The right balance between the import of medicines and local production is a country-by-country balance: in some cases, importing can be more financially efficient.