B3.4.2 Types of health technology transfer programs reported by WTO developed country members under TRIPS Agreement, art. 66.2, 2018–20

Box 3.4 Health technology transfer to least developed countries (Continued)

Figure B3.4.2 Types of health technology transfer programs reported by WTO developed country members under TRIPS Agreement, art. 66.2, 2018–20

Regulatorystandards Reproduc... health

Child health Safety an ... Diabet es

Regulatorystandards,safety an.. . Non...

Maternal and child health

Services

Reproduc... maternal and health

Health caresystem,services,andequipment

Equipment Health care system Infectious disease

HIV

Communicable diseases Malaria

TB

Parasitic and vectordisease COVID-19Respirator ...Viral hemorrhagi.. Diarrheal...

Source: World Trade Organization (WTO) calculations based on the reports (required under WTO TRIPS Agreement, art. 66.2) submitted by WTO developed country members. Note: The figure indicates relative shares of the number of programs, by program focus. “Developed country members” of the WTO include Australia, Canada, the European Union (and its member states), Japan, New Zealand, Norway, Switzerland, the United Kingdom, and the United States. TB = tuberculosis; TRIPS = Trade-Related Aspects of Intellectual Property Rights.

States provided 72 percent of those programs. Uganda and Tanzania were among the top-ranking beneficiaries, each benefiting from at least 30 health technology transfer programs.

Around 42 percent of the reported health technology transfer programs have a particular focus on communicable diseases such as HIV, malaria, and tuberculosis (figure B3.4.2).

(Continued)

Box 3.4 Health technology transfer to least developed countries (Continued)

Four programs reported by the United States were related to COVID-19 training, testing, data collection, and analysis (WTO 2020b).

Research and technical assistance are the most prominent incentives used for delivering these health technology transfer programs.

a. The “developed country members” of the WTO are Australia, Canada, the European Union (and its member states), Japan, New Zealand, Norway, Switzerland, the United Kingdom, and the United States.

that would apply to IP licensing are closely related to the multilateral framework for IP rights. Making those conditions public merits close consideration in relevant international forums because they could affect, among other things, the pricing of licensed technologies and could influence trade in relevant technologies. Given significant government support for R&D and the extensive funding for product development initiatives provided by the governments of WTO developed member countries, reviewing the deployment of the results of publicly funded research has also been advanced as an area of work.

The severe global inequities in access to COVID-19 vaccines have motivated a debate on whether, and how, such funding programs should set conditions for sharing resulting IP rights. This could encompass engaging with multilateral technology-pooling initiatives, disseminating technologies, and leveraging access to COVID-19 vaccines and treatments. Contracts could, for example, cover conditions on how to manage IP rights in a manner that facilitates equitable access to transfer technology and manufacturing know-how, while improving transparency, in return for R&D funding.

Cooperation to address illicit trade Illicit trade in medical goods can be addressed through improved regulatory coherence and international cooperation. Illicit trade in medical goods—and in particular the trafficking of substandard, unregistered, or falsified products—can have serious health, economic, and socioeconomic consequences (WHO 2017). There are a number of areas where the multilateral rules contained in WTO Agreements matter.

Customs controls. First, better customs procedures foster the sort of improvements in customs controls that can help in addressing illicit trade concerns. The TFA has several provisions that bolster the capacity of customs to maintain such controls, by requiring greater transparency of customs rules and procedures, the advent of risk management systems and pre- and postclearance processes, and a focus on increased domestic coordination and international customs cooperation. Greater transparency

and customs functioning both enhances governments’ ability to address the threat of illicit trade (including with respect to medical goods) and curbs discretionary practices that can give rise to malfeasance and corruption.

Regulatory coherence and coordination. Improving regulatory coherence and international coordination regarding medical product quality and safety can help address risks arising in national regulatory systems regarding illicit trade. To meet surging demand for medical goods during the pandemic, governments introduced a range of emergency measures to accelerate access, including by relaxing certain safety and quality approvals and other regulatory requirements. Although this approach was helpful in addressing acute shortages, it also has the potential to create opportunities for illicit trade.

The TBT Agreement helps regulators strike the appropriate balance between (a) adopting regulatory interventions for ensuring the safety, quality, and efficacy of medical goods, and (b) facilitating trade in these goods. The Agreement covers, in particular, conformity assessment procedures (CAPs) for ensuring that goods, including medical products, fully comply with safety and quality specifications. Well-designed and applied CAPs can be important tools for preventing and combating illicit trade, and the TBT Committee is currently preparing guidance in this regard.

TRIPS standards. Tackling illicit trade in medical goods also relies significantly on various disciplines in the TRIPS Agreement. TRIPS minimum standards provide a basis for action against the production, distribution, and sale of intellectual property rights (IPR)-infringing illicit goods and helps to protect consumers from their effects. In particular, the border measures spelled out in the Agreement provide effective tools to fight the importation and, where WTO members opt to do so, the exportation and transit of illicit IPR-infringing goods. The TRIPS Agreement also mandates international cooperation in that members are required to establish contact points and be ready to exchange information on trade in infringing goods. The TRIPS Council receives notifications and updates of these contact points from its members and serves as a forum for discussion in this regard.

Traceability programs. In addition, the safety of medical products crucially depends on supply chain integrity and transparency, and thus measures that ensure traceability along value chains are critical in addressing some of the harmful consequences of illicit trade. Traceability programs implemented in many high-income countries and in some LMICs, and adherence to global traceability standards, make it much harder for illicit products to enter legitimate supply chains. Theft, diversion, and parallel trade also become easier to spot. Initiatives such as those launched by the Global Steering Committee for Quality Assurance—hosted by the World Bank (box 3.5)—will improve LMICs’ capacity to ensure health products’ traceability.