The urgency and dependence on imports of medical products in many countries shows the need to simplify and streamline customs procedures and technical regulations during times of crisis such as the COVID-19 pandemic. This requires Innovative approaches to bridge divergent regulatory practices and increase “regulatory cooperation” between countries. In this regard, a study by the United Nations Conference on Trade and Development (UNCTAD) shows how access to these products can be improved through regional trade agreements (RTAs).
Specifically, UNCTAD, in the research entitled Improving access to medical products through trade: What can regional trade agreements do in times of crisis?, notes that "Provisions on regulatory cooperation in RTAs can help countries respond quickly to medical emergencies by simplifying unnecessary burdens posed by technical regulations.".
Regulatory cooperation is a means to “reduce trade costs, in particular by reducing high information values and shortening the lengthy conformity assessment process, without undermining policy objectives such as the protection of health, safety and the environment,” the study says.
This collaboration provides countries with the opportunity to minimize the negative impact of national regulatory measures on trade, particularly in times of emergency. It manages to reduce trade costs by more than 25%, according to UNCTAD estimates.
Regulatory cooperation can be achieved through multiple actions, such as improving the exchange of information and the creation of a joint committee to implement sanitary and phytosanitary measures and technical barriers to trade.
It would also involve aligning with international standards and treating them as equivalent, among others.
The role of Regional Trade Agreements
The UNCTAD study then provides an assessment of how such regulatory cooperation can be achieved through RTAs.
In this regard, it draws attention to the three common approaches in RTAs, which are: mutual recognition, equivalence and harmonisation.
To this end, the research is based on a systematic review of 107 ACR in force and a review of the efforts of nine countries (Brazil, Canada, Kenya, Kuwait, European Union, Namibia, Switzerland, Uganda and the United States) to reduce regulatory divergence to facilitate trade in medical products during the pandemic, and proposes a debate on the need for emergency provisions in future RTAs.
According to UNCTAD, a large proportion of existing RTAs contain provisions for mutual recognition, equivalence and/or harmonization with respect to international standards or those of other parties, including conformity assessment procedures, whether mandatory or voluntary.
In this regard, the study adds that RTAs are a good platform to build on. However, it clarifies that “many of these provisions are vaguely worded.” They also lack those that promote regulatory cooperation, particularly for medical products or “emergency-specific” situations.
Efforts to harmonize standards
Among the results of the research, UNCTAD considers that Several of the countries analysed sought equivalence and harmonisation of standards and evaluation procedures of conformity to facilitate trade in specific medical products. Although such actions brought changes only to the countries that imposed them, they reduced regulatory divergence, benefiting not only themselves but also their trading partners.
In addition, it was applied temporally the equivalence of standards and conformity assessment together with other complementary measures. Countries did not seek to conclude a new mutual recognition scheme even though existing agreements of this kind (MRAs) would have helped to partially address the problem.
Criteria for incorporating emergency provisions
The UNCTAD study outlines the "criteria" to incorporate emergency provisions into the RTAs, including:
- Clearly define a “public health emergency” situation or a “shortage” of essential goods.
- Classify, at the tariff line level, “essential” goods that could be critical during an emergency.
- Agree on the temporary adoption of international standards as a basis for regulatory cooperation.
It also proposes six “model provisions"which can be a starting point for RTA negotiators and serve as a formal basis for advancing regulatory cooperation, while making good use of the available mechanisms and possibilities.
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