Trade, intellectual property, and the public health bearing

ABSTRACT

The objective of this article is to describe the current fracture between global trade and public health priorities, as well as examine opportunities for harmonisation. A literature review of public health, global trade, and intellectual property articles describes several issues with recommendations. Currently, there is mixed quality of research and a lack of health impact assessments to accompany the global trade agenda. Human rights concepts continue in debate as flexibilities to trade laws remain without organised surveillance or evaluation. There are specific, relevant recommendations to implement a trade agenda inclusive of public health leadership. Recent trade and intellctual property advances in public health collaborations should be supported and continued. Trade groups should produce impact assessments before decisions on policies are made, with quality to the research. Lastly, a global research and development treaty should be an open, accessed path.

1. Introduction

There is a unique relationship between public health, trade, and intellectual property (IP), and this relationship remains poorly cultivated. The history of trade policy and its impact on public health is extensive. In order to advance the relationship, this history is necessary to understand.

The historical persuasion of free trade, centred on wide markets to bring specialisation and labour division, is attributed to Adam Smith. International trade and opportunity costs, argued by David Ricardo, built from this basis. Most recent schools of thought add the consideration of property rights and provisions to the evolved free trade argument (Khan et al., 2015).

International considerations have evolved alongside free trade evolution. Global-free trade agreements became a priority in the mid twentieth century. After a broad consensus and understanding of economics in the World War eras of the 1920s-1940s, agreements and oversight of global trade formed. In 1947, 23 countries signed a trade agreement called the General Agreement on Trade and Tariffs (GATT) to promote global trade, deflect from protectionism, advance innovation and advance . GATT has reduced tariffs from 40% to 4% in member countries and is correlated with a 16-fold rise in global trade (Khan et al., 2015). The World Trade Organization (WTO) was formed in 1986 and, within time, the world was introduced to new agreements. The Trade-Related Aspects of Intellectual Property Rights (TRIPS), Sanitary and Phytosanitary measures (SPS), General Agreement on Trade in Services (GATS), and the North American Free Trade Agreement (NAFTA; Khan et al., 2015) have all influenced global markets.

Nations have specific policies to supplement IP and trade influence in health. In the United States, the Federal Food Drug and Cosmetic Act (FFDCA) provides for controlled labelling, contents, assurance of evidence and safety of medicines (United States Government Publishing Office, 2018). The Drug Price Competition and Patent Term Restoration Act (“Hatch-Waxman Act”) addresses issues related to amendments of the FFDCA. The Hatch-Waxman Act attempts to create an equal field for innovation and restricts patents from having free reign over the future(Ritter, 2014). Court rulings, such as the 1980 Bayh–Dole Act that permits universities to take out patents based on inventions arising from publicly funded research, have also driven IP considerations(Commission on Intellectual Property Rights, Innovation and Public Health, 2006).

International governance also guides trade policy. The World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) both contribute to trade rules. The U.N. Commission on International Trade Law (UNCITRAL), the U.N.’s authority on international trade law, seeks to increase harmonization and optimal outcomes of international trade. The U.N. General Assembly usually adopts one or more of the declarations from UNCITRAL through its annual meeting(United Nations, 2013). Declarations, provisions, recommendations and legislative text are all results of these governing bodies. Because trade agreements often reflect protections and policies on behalf of industry, namely on behalf of intellectual property, clarity to terminology is important. “Intellectual property (IP) refers to creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce”(What Is Intellectual Property – WIPO, 2022). IP can be found in the forms of patents, copyrights, trademarks and other protections. Patents, granted from governments and sovereign bodies to owners and inventors, have protections that date back to the 1883 Paris Convention for protection of industrial property(Flint & Payne, 2013). An owner of a patent is offered assurance that he or she has exclusive rights to make, use and sell his or her invention for a limited amount of time. Copyrights are legal rights that creators have over their literary and artistic works, including books, music, paintings, sculpture and films, computer programs, databases, advertisements, maps and technical drawings. A trademark, on the other hand, is a signature sign that distinguishes one enterprise from all others(What Is Intellectual Property – WIPO,2022.). There are overarching themes observed within the relationship between trade and public health. Trade and IP securities argue the benefits of strong IP protections and trade agreements. Innovation and new therapeutic potentials are driven, in part, by IP guarantee. Strong trade agreements assist in domestic production capability, and medical product access for countries without domestic production capability. Competition is stimulated and economies of scale can be improved with strong trade, and intellectual property assurances are a component of this. Additionally, the enforcement of quality and safety accompanies global IP protections. In example, substandard, false and counterfeit medicines remain a threat to public health and affect those in developing countries more often. In fact, half the drugs in some countries may have little or no active ingredients(Bors et al., 2015). It is estimated that just 20% of World Health Organization (WHO) members have well-developed drug regulation systems and 30% have no system or low functioning ones (Bors et al., 2015). The enforcement of safety and quality is an argument for strong trade industry protections.

Conversely, trade agreements and movements in the late twentieth century have widely been regarded as detrimental to the health of the public. Access to medications in developing countries is of concern. Additionally, research and development into treatments for diseases that affect these countries and the management of non-communicable disease are subjects of concern when assessing global trade and health impact (Commission on Intellectual Property Rights, Innovation and Public Health, 2006).

2. Current concerns

There are trends in the observations on the current relationship between public health and global trade. Trade and IP actions impact public health to an unknown extent. Additionally, moral priorities and industry interest are maligned. There is disorganisation of IP and trade law in the context of public health. Intermittent health impact assessments are also disorganised. Research on trade, IP and public health remains suboptimal. Finally, there are also advances in global trade and public health harmonies that will require analyses.

Communicable diseases are intimately connected to trade and IP, and the impacts remain contested. High-level negotiations with TRIPS flexibilities have affected tuberculosis strategic planning at the United Nations level (Branigan, 2018), and the effect on outcomes related to tuberculosis disease is unknown. Impacts of the HIV/AIDS epidemic are a continued debate in the literature. Neglected tropical diseases (NTDs) are also impacted. NTDs do not receive the necessary therapeutic research and development attention due to the geographic and economic characteristics of the demand. Because pharmaceutical companies recoup their expenditures via sales, companies do not profit from low-income country treatment production. Thus, encouraging sufficient and available treatments for diseases plaguing low- and middle-income countries can be difficult (Bors et al., 2015). Public–private partnerships (PPPs) have been designed to address what the R&D and trade industries do not (Aerts et al., 2017), yet the specific impact of trade on NTD remains unknown and thus unresolved.

Public health is affected by trade outside of medicine and medical products. Tobacco, alcohol, and food trade impact non-communicable diseases. A recent review of one journal’s publication portfolio was conducted; multiple WTO policies were correlated to unhealthy consumption of products. The literature has also indicated that the liberal trade agenda has increased tobacco consumption, while reduction in tariffs and non-tariff barriers increased negative diet patterns (Labonté, 2019). The literature has noted an association between regional trade agreements (RTAs), related policies and increased consumption of processed food and sugar-sweetened beverages. Implementing trade agreements and associated policies has been correlated with higher cardiovascular disease incidence and higher BMIs. In this same study, correlations with under-five mortality, maternal mortality, tuberculosis, and life expectancy were inconclusive (Barlow et al., 2017).

The right balance between moral priorities and trade industry best practices is elusive. Human rights, universal access, and morality convictions are debated. While the consequences of trade, IP protections and population health are unclear, the concerns for low- and middle-income countries (LMIC) accessibility are clear. Affordability and accessibility of medicines exacerbates an already fragile situation. It is estimated that 10 million people die every year because they do not have access to life-saving drugs (Schroeder & Singer, 2011). It is also estimated that about 2 billion people do not have access to medications they need (Lee & Hunt, 2012).

The right to health and access to medicine challenges intellectual property strategies. The concept of human health as a right is not new. It is found in the 1948 Universal Declaration on Human Rights and was reaffirmed in 1966 with the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Committee on Economic, Social and Cultural Rights (CESCR) interpreted Article 12 of the ICESCR with a decision that patents are a social product with a social function, and patents have an obligation to strike a balance to achieve the right of health (World Intellectual Property Organization, 2013).

Ongoing debates over human rights, inalienable rights, and culture are weighed into IP and trade analyses. Currently, medicines are priced outside of the poor’s ability to pay, and often IP protections are blamed as a contributor to this issue. Accessibility of medicine has become a moral question of priorities (Westerhaus & Castro, 2006). Contentious arguments over access to medication have been particularly spotlighted for HIV/AIDS therapeutics. Universal access to antiretroviral therapy (ART) has demonstrated benefit to population health and is correlated with a decrease in HIV prevalence and a decrease in AIDS mortality, though outcomes are affected by study limitations. Trade industry and global advocacy have debated IP consequences to ART and highly active antiretroviral therapy (HAART) access. Concerns that IP laws allow for pharmaceutical company monopolies and create unaffordable costs for developing countries are discussed. In fact, when pharmaceutical companies argued that HIV/AIDS was not an emergency due to the longevity of the epidemic and government oversight failure, the 2001 Doha Declaration was created. HIV/AIDS medication access for developing countries was a primary Doha Declaration concern (Haakonsson & Richey, 2007). While the mid-2000ʹs encouraged individual strategies for country access, such as reduction in medication costs in Uganda or the importation of medications from low-cost producers in India (Haakonsson & Richey, 2007), access issues remain. Countries including Brazil and Thailand have been extremely successful with universal access to ART, utilising strategies such as compulsory licencing, generic production, and cost negotiation (Granich et al., 2010; Nunn et al., 2009; Rosenberg, 2014; Siraprapasiri et al., 2016; Westerhaus & Castro, 2006). Global health has pointed to individual country success and has established global goals for universal access to these medicines.

The concept of IP rights outside of industry is connected to moral balance. Some believe IP rights should be shaped on behalf of common good while others believe inventors should have total control (Schroeder & Singer, 2011). The rights to cultural life and access to IP and R&D have been examined as potential critical rights placed above IP and health industry proprietary decisions (Gibson, 2010). Global workgroups have also called for education around industry IP when including indigenous communities and traditional knowledge (TK; World Intellectual Property Organization, 2013).

IP and trade law remain disorganized in the context of public health. Flexibilities in trade agreements, namelyTRIPS, are argued to be the best strategies for countries in need of accessibility and affordability. The primary flexibility introduced is that of compulsory licencing, yet creative strategies and partnerships have also prevailed. There is no singular tracking of when and how these flexibilities and strategies are utilised, and there is no primary organization to navigate and match opportunities with a country’s needs. There is also no singular tracking of IP flexibilities that an industry may undertake, such as patent extensions, despite trickling effects across the globe.

For many countries, access to medications depends on strategic and consensual solutions like compulsory licencing. Compulsory licencing, provided by a government, allows someone to produce a patented good without the consent of the patent owner. While there is evidence of increased use when a country experiences a crisis (Urias & Ramani, 2020), there has been an overall unexpected underuse of compulsory licencing. Cumbersome processes, domestic capabilities, corporate threats of retaliation and system abuses all add to the inefficiency of use (Halajian, 2012). Notably, some countries have traded away the use of flexibilities like compulsory licencing in an effort to be a part of the United States and European markets, markets that demanded this negotiation (Rosenberg, 2014). Compulsory licencing is no longer contingent upon domestic production capabilities, yet an advantage of using compulsory licencing is its ability to jumpstart scientific and technological domestic development. Data on this trade flexibility are conflicting. Some literature has found evidence that pricing drops with compulsory licencing (Urias & Ramani, 2020), while other literature has found that compulsory licencing is not cost-effective (Beall et al., 2015). There is limited transparency and ease of compulsory licencing data. According to one study, there have been 108 attempts to issue compulsory licencing for 40 pharmaceuticals in 27 countries since 1995. Most of the attempts were in Asian, Latin American, and African countries and mainly for HIV/AIDS medicines (Son & Lee, 2018). Another author noted at least 74 licencing events (Urias & Ramani, 2020).

There appears to be strong pharmaceutical influence where trade flexibility navigation should be. Tactics such as pharmaceutical marketing aggression and bidding processes that include direct persuasion may be more desirable actions by companies (Godoy & Cerón, 2011). This is supported by research of five Central American countries, which found that governments purchase pharmaceuticals at extremely high prices despite generic competition availability (Godoy & Cerón, 2011). Numerous drugs are purchased at higher rates, some as high as 160 times the international reference price (Godoy & Cerón, 2011).

Strategies such as public–private partnerships, prize schemes, patent pools, and tax incentives are also intermittently utilised (Nicol & Owoeye, 2013). Private–public partnerships, non-governmental organisations, civil society organisations, generic drug manufacturers, universities, and certain developing country initiatives have increased innovation support for developing countries (Commission on Intellectual Property Rights, Innovation and Public Health, 2006). Public health considerations are often collaborations involving these agencies, such as the Trilateral cooperation effort involving the WHO, WTO and WIPO (Trilateral Cooperation on Intellectual Property and Public Health, 2021). While some literature describes impact, such as the use of import licenses correlating with increased medicine access (Barlow et al., 2017), much of the impact is unknown.

Patent reform is also of current debate, and pharmaceuticals, biotechnology, extension, and exhaustion principles are considered. There is a lack of data on international work to addressglobal health threats experienced through patent-term extensions, mandated linkage between safety and patient protection, and data exclusivity that delays the availability of generic drugs (Godoy & Cerón, 2011). The appropriateness of patents in the context of genomes and DNA is unclear (Amani & Coombe, 2005; Cook-Deegan & Heaney, 2010). The National Academies made several recommendations for patent reform decades ago, specific to the United States. Recommendations include the preservation of a flexible, unitary, open-ended patent system, the reinvigoration of the non-obviousness standard, a post-grant open review procedure, the strengthening of USPTO capabilities for personnel, electronic processing, analytical capability, and financial resources, infringement liability reform, limitations to the subjective elements of patent litigation, including wilfulness, best mode, and inequitable conduct, and the harmonisation of the US, European, and Japanese patent examination systems (National Research Council, 2004). Follow-up literature has indicated sporadic court involvement where legislation could have championed these recommendations (National Research Council, 2004; Rooklidge & Barker, 2009). There is no publicly available strategic patent report inclusive of public health considerations, and there is no global plan.

Health impact assessments (HIA) now accompany trade agreements, inconsistently. HIAs are specific. In example, the Comprehensive and Progressive TPP (CPTPP) is a trade agreement between Canada and ten other nations. It was built from the original Trans-Pacific Partnerships (TPP). Separate HIAs in Canada and Australia pointed to TPP risks for public health that included the potential for negative diet changes, risks to generic medicine availability and risks to drug affordability. Specific concerns on food labelling, tobacco control, alcohol control, and medicine costs were identified. The potential implications of changes to intellectual property rights, sanitary and phytosanitary measures, technical barriers to trade, investor-state dispute settlement, and regulatory coherence provisions and domestic policymaking impacts were described. However, one study distinguishes the standard six-step process while another discusses three initial steps in the standard HIA process (Hirono et al., 2016; Labonté, 2019; Labonté et al., 2016a, 2016b; Ruckert et al., 2017).

There is also great disorganization to the HIA requirements. HIAs are not required for trade policies or industry decisions. Some major trade agreements have not been accompanied by transparent, published impact analyses. For example, while some experts believe TRIPS may be a better option for drug availability, especially if pharmaceutical companies show interest in a drug needed in low-income areas, the general consensus shares that TRIPS is not ideal for accessibility (Schroeder & Singer, 2011). Despite decades in action, there has not been a formal, international report on the health impact of TRIPS. Additionally, informal HIAs continue in major study. One such example is that of the ASEAN Regional Comprehensive Economic Partnership (RCEP) assessment, which found that TRIPS-plus provisions recommended by South Korea and Japan would negatively impact LMIC. Using a prospective policy analysis, the assessment determined that countries would need to rewrite their patent laws and generic medicine availability would be delayed (Townsend et al., 2016). There are no global standards to the assessment methodology. There is great disorganisation to the HIA process and its inclusion in trade.

Research on trade law, intellectual property rights, and health of the global population is sporadic and inconsistent. A recent systematic review found that quantitative studies have attempted to estimate the impact on access to medicines in two major IP categories: the TRIPS Agreement with implementation into national IP laws and the TRIPS-plus provisions that include patent-term extensions and exclusivity (Islam et al., 2019). There are not enough studies in general on trade and intellectual property, and those available are of poor quality (Coombs, 2014). Additionally, the differential impact of IP provisions on different medicines for similar condition remains unknown (Islam et al., 2019). There are substantial gaps where consistent and reproducible findings should be, all within the limited portfolios of retrospective and prospective studies on trade, intellectual property, and health.

There is no consistency to the methodology, including for definitions of health outcomes or formulas to factor social and governance variables. There is no one design to account for macro-level specifics such as changing demographics, economic growth, or disease prevalence in a country (Islam et al., 2019). There are often little qualitative data on the impact on health. Another research deficit is that of policy and legislative support. There is no international pragmatic design work that accompanies trade agreements. Most notably, there is no legislation that requires data analytics before trade negotiations or implementation nor is there legislation to require ongoing public health evaluation.

Some literature indicates that studying trade and impact has proven difficult due to reliance on future data and projections, gradual feel of aggregate impact, and the reality that developing countries IP provisions have only recently been implemented. Despite new abilities for current data collection and analysis, the literature remains focused on projections (Godoy & Cerón, 2011).

Recently, notable advancements may lead the way to improved trade and public health relations. In 2006, the WHO’s newly formed Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) set an objective of increasing innovation sustainability along the life cycle of health related intellectual property, reviewed 22 studies on intellectual property and published 60 recommendations (Commission on Intellectual Property Rights, Innovation and Public Health, 2006). In 2008, upon guidance from the World Health Association (WHA), the WHO developed the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI) to promote new thinking on innovation and access to medicines, promote, and build capacity for innovation and R&D and to improve access to medical technologies mobilize resources for R&D (World Intellectual Property Organization, 2013). Within the past decade, the Trilateral Cooperation of WHO, WIPO and the WTO has offered expert review, insight, and guidance (World Intellectual Property Organization, 2013). Notably, there are no evaluations or standard benchmarks to which these organisations are accountable.

Advancements also include formal concerns with introduced trade actions. Once introduced, the Anti-Counterfeiting Trade Agreement (ACTA) was the subject of international discord. Medical communities were alarmed at the stipulations around generic medicine and circumvention of legitimate medicines (Frontières, 2012). The SPS Sanitary and Phytosanitary Measures (SPS Agreement) has also been flagged as potentially negatively affecting health consequences due to technical barriers (World Intellectual Property Organization, 2013).

Flexibility with trade and IP during global health emergencies has been practiced as recently as COVID-19. With the Coordinated Global Research Roadmap, genetic sequence, epidemiological, and other data are shared openly. With the Solidarity Call to Action, the COVID-19 Technology Access Pool (C-TAP), IP, data, and knowledge are shared. Previous projects such as CEPI have been tapped for assistance. CEPI requires equitable access to any vaccine developed through its funding and that those involved are open to technology transfer on behalf of global production. Medicines for Malaria Venture (MMV) has compiled 80 compounds with known or predicted activity against SARS-CoV-2 and provided open access free to researchers (Organization & World Trade Organization, 2020). While competition policy experts voiced the need for cooperative industry collegiality during times of public health emergency, trade expertise voiced the need for strong cross-border supply chains. The global trading system during COVID was asked to be predictable, transparent, non-discriminatory and open, and trade restrictions were recommended to be targeted, proportionate, transparent, and temporary (Organization & World Trade Organization, 2020). However, there is no evaluation metric strategy to evaluate these actions in real time.

3. Recommendations

There are several overarching recommendations to improve the trade and IP relationship with public health, and these recommendations can provide clarity on questions of impact. Specific criteria to assure human rights and moral alignment should be determined. Trade and IP should be organized, with flexibilities accompanied by tracking, organisation, and analyses. HIAs should be required and organized, as well. The trade and public health research portfolio should reflect quality and integrity. Finally, recent advances in trade and IP efforts should be met with continued commitment. A global R&D treaty should be secured as the opportunity of a lifetime.

Evaluating the impact of trade policies could improve accuracy of correlations with public health by addressing previously identified factors. Factors such as reductions in tariff and non-tariff barriers, services trade that impacts advertising and manufacturing, barriers to foreign direct investment and subsequent domestic production, trade compliance costs that reduce funding for public health prevention programs, and enforceable trade and investment rules that stifle regulatory work in countries (Labonté, 2019) could become formal expectations in impact analyses.

Human rights and morality to global trade could be balanced more clearly through specific actions. How universal access is determined, cost-effectiveness of universal access, cost impacts to LMIC and burden to LMIC could be defined. The right to health and the right to a healthy quality of life could be specifically delineated at the WTO and WIPO tables. Evaluation of trade and IP protection policies could be assigned a metric reflective of the respect to rights stipulations, as well. Education and training of rights concepts should be available for private biomedical industry, trade industry, patent regulation and public health administration, as well. For example, should the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) work around an international legal instrument for the effective protection of traditional knowledge (World Intellectual Property Organization, 2013) be completed, the instrument’s standardisation and implementation logistics should be clear.

There must be organization to the IP and trade processes in public health. Health system determinants related to access and essential medical issues could be measured with consideration to IP and trade policy effects. IP-related access, including the trilateral considerations of pre-patent access, patent quality, diagnostic, surgical, or therapeutic exclusions, patent registration, and pre-grant and post-grant review procedures (World Intellectual Property Organization, 2013) could be assigned a metric or indicator. Additionally, post-grant patent access issues, such as limitations, voluntary licencing, exhaustion of rights, parallel exports, patent extension, and enforcement of IP (World Intellectual Property Organization, 2013), could be assigned metrics.

The use of patents involving health and medicine should be tracked with standard terminology for categorization, including with extensions, humanitarian causes, and tradable patent terms and transparent to global health. Too, follow-up of comprehensive recommendation reports, such as the National Academies 2004 report, should become a consistent expectation at national and global trade tables. Finally, education, training, and inclusion of public health authorities in patent processes and patent reform should be funded.

Global health organization should include tasked oversight of the CIPIH considerations for improvement to public health considerations in trade policy work. Training on, use of and evaluation of patent policy changes, compulsory licensing, patent pools, university patent partnerships, financing, and priority setting, funding strategies inclusive of public–private partnerships, the strengthening of regulatory and clinical trials in developing countries, special incentive schemes, such as transferable intellectual property rights (TIPRs), tax credits, orphan drug schemes, pricing strategies, purchasing agreements, generic drug innovation with patent expirations, open-source options during R&D, are all recommendations to advance medical innovation with intellectual property considerations (Commission on Intellectual Property Rights, Innovation and Public Health, 2006). As these recommendations are realized in flexibilities for TRIPS and other avenues, they should be tracked and reported on. Additionally, there should be an ethics forum to report on the informal or formal use of industry pressure and retaliation on a country .

Workarounds to WTO agreements should be a component of analyses. Workarounds are barriers to public protections and include sanitary measures, technical regulations, pre-shipment inspections, import licencing, price control measures, charges and taxes, restrictions on distribution and after-sales services (World Intellectual Property Organization, 2013). An organized process could address the risk of workarounds before the policy leaves the development stage.

Economic impact metrics, international trade activity by health product import and export, trade and tariff policies, inclusion of consideration for national emergency management and availability of home manufacturing should be a component to trade evaluations. Stronger WTO and global predictive policy on anti-trust and competitive interventions, including the use of strategic patenting to extend the breadth and duration of patents, should be a component to trade evaluations as well. Additionally, litigation, settlement agreements, interventions before national regulatory authorities, and/or pricing and reimbursement bodies and life cycle strategies should be included.

HIAs should accompany the global policy agenda and be required for trade, policy, and IP protection policy changes. Formal efforts to standardize methodology maximises efficiency, provides a basis for future policy proposals to reference and eases the burden of proof often placed on LMIC. Formal HIAs should be mandated with global health at the table and attached to any WTO work as a formal process. The timeliness, documentation presence, follow-up, and key changes should be a component to WTO evaluation, with consequences for poor management of the HIA handling.

The public health research portfolio, as it pertains to trade and IP, should be one that prioritizes quality. Definitions and determinant methodology should be consistent, including for access, affordability, and pricing. Additionally, the contribution of qualitative and quantitative data, within the context of IP, should be better understood. Limitations often include mismatch between time period and trade implementation and/or data pool and potential exclusion of private healthcare data (Islam et al., 2019); these limitations should be avoided. In data collection and research, generic drug market complexities, drug pricing practices, and state purchasing decisions must all be part of future analytics (Godoy & Cerón, 2011). Formulas for these considerations could be standardized.

Literature reviews should grade quality consistently. For example, a recent literature review on regional trade and investment agreements (RTA) graded studies by measuring the strength of study design, selection bias, confounders, data collection, data analysis, and reporting of the Quality Assessment Tool from the Effective Public Health Practice Project. The quality of the studies was determined to be mostly weak or moderate, and there was weak co-citation between public health and economics with psychology. For this review, reforms and macroeconomic changes, confounding variables, were not factored into the analyses (Barlow et al., 2017). Literature reviews should have reliable criteria to grade quality.

With quality to the methodology and publishing secured, global trade, industry, government, and non-governmental organization interests could begin identifying priorities for needed data. Importantly, graded and tiered evidence should be a part of the future global trade policy agenda. Also, adding either pragmatic design for policy implications or policy considerations in the overview of innovation policy instruments would be of benefit.

Recent operational efficiencies have the potential to facilitate public health good within the trade and IP realm. The Patent Cooperation Treaty (PCT) has been created as an international effort to file for legal protections simultaneously in all PCT contracting states (World Intellectual Property Organization, 2013). The Madrid System has managed international applications for trademark holders who wish to maintain protection in export markets, obtaining protection in more than 80 countries, including the European Union (World Intellectual Property Organization, 2013). International non-proprietary names (INN) have been assigned uniquely and are globally recognised in almost all WHO member states, without being subject to exclusive rights (World Intellectual Property Organization, 2013). The WHO Global Influenza Surveillance and Response System (GISRS) develops influenza viruses for vaccine development and acts as a global alert mechanism for the emergence of influenza viruses with pandemic potential. The PIP framework, which allows for sharing laboratory data at risk of pandemic potential, is already practiced under WHO leadership (World Intellectual Property Organization, 2013).

Current advances for public health considerations with trade and IP should be supported with continuous quality improvement, funding, and structure. Metrics to evaluate advances in collaborative public health and trade work could include measuring the use of the International Clinical Trials Registry Platform (ICTRP) for data sharing, the cost savings associated with the priority review voucher and the voucher’s return on investment, digitization of patents and inclusion of INN in applications and reliability of submitted patent information by country. Additionally, patent literacy and national search literacy by stakeholders could be measured and included in annual reports.

The recent COVID crisis brought about specific asks from the global trading system. Trade requested that workarounds be predictable, transparent, non-discriminatory and open.Trade restrictions were recommended to be targeted, proportionate, transparent, and temporary (Organization & World Trade Organization, 2020). These terms could be attached to evaluatory descriptors or metrics.

Finally, a global treaty for R&D cooperation, with fixed contributions and pooled funding, has been proposed for decades. The most recent version of the proposal was rooted in Consultative Expert Working Group on Research and Development (CEWG) work. CEWG reviewed over a hundred financing and allocation schemes before determining that the pooled funding was a best approach (Abbott, 2012; Røttingen & Chamas, 2012). This treaty would require WHO members to spend at least 0.01% of their GDP on R&D that addresses health needs of developing countries. At least 20% of funding would need to be spent through a pooled mechanism (Abbott, 2012), a mechanism that allows for sustainable, predictable funding with representation.

There are benefits to the global treaty recommendation. A global treaty counters historical preferences, such as the United States preference for alternative schemes that treat market exclusivity similar to the Orphan Drug Act (Abbott, 2012). However, while previous treaty proposals were contested by the pharmaceutical industry, this most recent proposal includes incentives for the pharmaceutical industry and garnered industry support (Hersher, 2012). A global treaty benefits science in that knowledge can be distributed across the globe without decreasing ability to share. There is non-rival actions in consumption and non-excludable actions in practice (Health Action International Global, Initiative for Health & Equity in Society, Knowledge Ecology International, Médecins Sans Frontières, Third World Network (TWN), 2011). Additionally, global standards in research operations, ethics, data transparency, and shared goals (Health Action International Global, Initiative for Health & Equity in Society, Knowledge Ecology International, Médecins Sans Frontières, Third World Network (TWN), 2011) have the potential to transform the entire R&D landscape.

To advance a R&D treaty, secured leadership is necessary. It has been noted that for WHO to assume greater leadership in a global R&D treaty, WHO would need financing that separates itself from major donation. Avenues that seek global treaties at the WIPO and WTO tables could align with stronger public health standards (Moon, 2014). Barriers to implementation should be fully accounted for and acknowledged. Individual country support should be a work in liaisonship and trust. The proposals that would call for impoverished country alternative contributions, such as genetic material (Abbott, 2012), should undergo immediate ethics review and decision. Countries that cannot afford the minimum financial contribution should be asked for their suggestion of fair alternatives, and these alternatives should always respect individual rights first. Rather than start and stop conversations on a global R&D treaty, the mission of a future global treaty should be a visualised path.

4. Conclusion

For better or worse, global trade evolution has supercharged the discussion of trade in public health. The unique relationship between public health, trade, and intellectual property (IP) requires ongoing investment and commitment to integrity. This investment should include clarity to health impacts, a balance of moral responsibilities, organization to the trade and IP processes, organization to HAIs, improved policy development and analytics, quality to research, and a path forward for an R&D treaty. By placing public health as a partner at the trade and IP protection tables, our world thrives.

Funding Statement

The author(s) reported that there is no funding associated with the work featured in this article.

Abbreviations

Anti-Counterfeiting Trade Agreement (ACTA)

Antiretroviral therapy (ART)

Consultative Expert Working Group on Research and Development (CEWG)

Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH)

Committee on Economic, Social and Cultural Rights (CESCR)

Comprehensive and Progressive Trans-Pacific Partnership (CPTPP)

Federal Food Drug and Cosmetic Act (FFDCA)

General Agreement on Trade in Services (GATS)

General Agreement on Trade and Tariffs (GATT)

Global Influenza Surveillance and Response System (GISRS)

Health Impact Assessment (HIA)

Highly active antiretroviral therapy (HAART)

International nonproprietary names (INN)

Intellectual Property (IP)

International Covenant on Economic, Social and Cultural Rights (ICESCR)

Neglected Tropical Disease (NTD)

North American Free Trade Agreement (NAFTA)

Public–private partnerships (PPPs)

Regional Comprehensive Economic Partnership (RCEP)

Research and Development (R&D)

Sanitary and Phytosanitary measures (SPS)

Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Traditional Knowledge (TK)

Trans-Pacific Partnership (TPP)

Transferable Intellectual Property Rights (TIPR)

U.N. Commission on International Trade Law (UNCITRAL)

World Health Assembly (WHA)

World Health Organization (WHO)

World Intellectual Property Organization (WIPO)

World Trade Organization (WTO)

Consent for publication

The author consents to publication of this article.

Availability of data and material

There is no original data to aggregate or report.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Author contributions

The author is the sole author of this manuscript