Bridging Domains: The Role of Health, Trade & IP in Fostering Medical Innovation

International cooperation on public health is inherently multi-dimensional, focusing on building effective health systems.

Towards this goal, the World Health Organization (WHO), the World Intellectual Property Organization (WIPO), and the World Trade Organization (WTO) have been working closely together, along with other international partners, for almost two decades to support global endeavors to improve health outcomes.

This edition of Arar Notes Highlights the trilateral efforts to help countries develop the capacity to deal with multi-dimensional challenges in the public health sector through the interplay between the distinct policy domains of health, trade & intellectual property, yet how they affect medical innovation and access to medical technologies.

Access to essential medicines and the lack of research to address neglected diseases have been a major concern for many years. To promote innovation and to ensure equitable access to all vital medical technologies, such as medicines, vaccines, and medical devices, policymakers need a clear understanding of the innovation processes that lead to new technologies & how these technologies are disseminated.

A dramatic impact on Health Systems & responses at the global level

The COVID-19 pandemic constituted an extraordinary global public health crisis, creating a pressing need for intensified global cooperation to respond to the pandemic being better prepared for future health emergencies. From the outset, the pandemic raised issues at the crossroads of public health, trade, and IP policy considering the framework for and the management of innovation & access, including those relating to tech transfer.

Ensuring equitable, affordable, timely & universal access for all countries to vaccines in response to the COVID?19 pandemic, recognized the importance of international cooperation and effective multilateralism in ensuring that all states have affordable, timely, equitable & universal access to COVID?19 vaccines as a matter of global priority since it's fundamental to tackling the pandemic & expresses concern that the unequal distribution of vaccines delays the end of the?pandemic.

International organizations & other stakeholders work collaboratively at all levels to develop, test, and scale up the production of safe, effective, quality, affordable diagnostics, therapeutics, medicines, and vaccines especially when needed. This includes existing mechanisms for voluntary pooling and licensing of patents, to facilitate timely, equitable, and affordable access to the technology, medicines, and vaccines needed, consistent with the provisions of relevant international treaties.

Strengthening local production of medicines and other health technologies to improve access, signals WHO member states’ commitment to distribute production capacity more equitably. Promoting access to medicine for all & recognizing the importance of IP protection developing new medicine, as well as the concerns about its effects on prices to promote access to pharmaceutical products.

Strengthening WHO preparedness for and response to health emergencies, requests the WHO to collaborate with member states, other international organizations, civil society, and the private sector, based on lessons learned from the COVID-19 response and prior health emergencies, to propose strategies to enable rapid research, development, production and global equitable distribution of quality, safe, effective and affordable medical and other countermeasures and commodities at national, regional and global levels to respond to future health?emergencies.

Meeting Demand for Health Technologies & Medical Services

The pandemic triggered a massive global demand for vaccines & existing health technologies to respond to COVID-19, including diagnostics, medicines, ventilators & other medical devices, in addition to consumables used in hospitals, such as personal protective equipment (PPE).

This put pressure on public procurement systems and led to shortages besides other supply & access challenges for certain products in developed and developing countries Creating sustainable regional and global partnerships is essential to the development of local production?capacity.

Preserving effective International Trade

Before the pandemic, trade in the medical goods sector was just 6.4% of total world trade in 2018. During the pandemic, this share increased to 8.3% in 2020.

Between 2019 and 2021, imports and exports of medical goods increased by an annual growth rate of 14.4%, reaching US$?2,654 billion in 2021.

More?recently, the share of medical goods in total merchandise trade has reverted to pre-pandemic levels, declining to 6.9% in 2022. Ensuring equal access to needed health technologies will support countries in recovering from the crisis and foster greater resilience against future?pandemics facilitating a smooth cross-border flow of vital medical supplies & avoiding unnecessary disruptions to global trade and supply?chains.

Intellectual property aspects

The global IP system provides an incentive framework to encourage urgently needed innovation related to COVID-19. It covers the stages from invention to supply of a product or service.

The impact of patents on access is complex and an area of particular focus. IP policy and the administration and enforcement of the IP laws aim to balance and accommodate a range of interests in a way that promotes overall public welfare. A wide range of policy options and flexibilities are built into the international IP regime and can be used to facilitate access to health products and other public health?objectives.

Universities & Research Organizations were highly active in vaccine patenting during the pandemic’s early days having a level of collaboration among pharmaceutical companies, biotechnology start-ups, universities, and public research institutions across different regions is even higher in the product development, clinical trials, and manufacturing stages.

Regulatory responses

Regulatory assessment & approval of health technologies are essential in every health system to ensure product quality, safety, and efficacy.

The WHO Emergency Use Listing (EUL) procedure aims to streamline the process allowing new or unlicensed products to be used during public health emergencies. The EUL provides a time-limited listing for unlicensed products in an emergency context when limited data are available & products are not yet ready to apply for WHO prequalification.

In this context, products are still undergoing development but not yet licensed. The WHO assesses the quality, safety, and efficacy of the data generated during development and conducts a risk-benefit assessment to determine use outside clinical trials.

Certain eligibility criteria apply to EUL for COVID-19 products, including:

1. Whether the disease may cause an outbreak, epidemic, or pandemic
2. Whether there are any products available capable of eradicating or preventing the disease
3. Whether products are manufactured in compliance with good manufacturing practices
4. Whether the applicant undertakes to complete the product development & apply for prequalification once it is?licensed.

The way forward?

The COVID-19 pandemic has placed immense pressure on health & trade systems globally.

National and international responses to the pandemic reflect policymakers’ growing experience in tackling pressing health needs, with initiatives considering health, trade, and IP elements holistically.

Indeed, the global health crisis caused by the COVID-19 pandemic has highlighted the importance of keeping the momentum; and securing global equitable access to new technologies to effectively respond to future health emergencies.

Adequate management of IP is central to achieving these goals, laying the ground for and framing the work on pandemic preparedness &?response.

Stay tuned for more updates on how global efforts are shaping the future of public health and enabling countries to tackle complex challenges head-on.

Arar Notes is Bayan A. Arar newsletter issued monthly with the latest updates across HealthCare & Life Sciences. Read about this month’s insights and subscribe to get monthly updates on the latest in global health, Life Sciences, wellness, and more.