Developed countries, dwindling national flexibilities, and access to essential medications during public-health emergencies

Dr Olugbenga Olatunji, Lecturer, The University of Sydney

Photo by Diana Polekhina on Unsplash

In a recently published paper, I historicise the gradual but potent attacks of the developed countries on the breadth and effectiveness of flexible obligations in international patent agreements. Flexibilities are usually included in these agreements to strike a balance between the monopolistic nature of patent rights and the right of states to suspend or abridge them in national interests. The paper discusses this flexibility-winding-back phenomenon through the lens of two treaties – the Paris Convention for the Protection of Industrial Property (Paris Convention) and the Agreement for the Trade-Related Aspects of Intellectual Property Rights (TRIPS). This post summarises the highlights of this paper. Given the currency of this topic, especially in view of the COVID-19 pandemic, a cursory comment is also provided on the recently adopted Decision of the World Trade Organisation (WTO) on improved access to COVID-19 vaccines.

Paris Convention – the ‘draining’ of a hitherto broad flexibility reservoir

The Paris Convention (PC) was adopted in 1883 to regulate industrial property (IP) like patents, trademarks, service marks, geographical indications, utility models, etc. It is pivoted on a tripartite principles of national treatment (NT), priority rights (PR), and common rules (CRs). NT (article 2, PC) requires subscribers to the PC to extend to citizens of other subscribers the same level of IP protection enjoyed by their citizens. PR (article 4, PC) is particularly useful for applicants who intend to protect their IP in multiple jurisdictions, as it allows them a grace period within which to submit applications for the same IP in other jurisdictions without losing the filing date of their first application – the duration of PR depends on the type of IP involved. Lastly, CRs outline principles of general application in respect of each of the IP categories covered in the agreement (e.g., see articles 4, 4bis, 4ter, 4quater and 5).

Two broad heads of patent-related flexibilities in the PC are discussed in the paper. The first and the most comprehensive one is the ‘non-binding’ nature of the PC tripartite principles. This is because these principles (NT, PR, and CRs) are only activated for members who offer protection for any of the IP categories under the PC. This approach is particularly advantageous in that a member may invoke not offering patent protection as a policy tool for expanding national technological base and promoting access to needed medications. Even where patent protection exists, this fluid approach means members could suspend or abridge patent rights to cater to access demands during public health emergencies. The second (equally broad) flexibility is forfeiture/revocation (article 5, PC). PC subscribers are empowered to revoke granted patents for abuses of patent rights like non- or insufficient working of the patents or other anti-competitive practices. This makes sense given one of the oft-cited justifications for rewarding creativities with monopoly rights is to foster industrial development through technical education and technology transfer.

Next, the paper traces the barrage of attacks directed at the broader forfeiture/revocation flexibility incorporated into the original PC (see 3.2). The first stop is the 1900 Brussels Revision which imposed two conditions for using the exception: first, members must wait 3 years post-patent-filing before invoking the flexibility even after non- or insufficient working of the invention had been established; and second, affected patentee must have no justification for not working or for insufficiently working their inventions (see article 2). The 1925 Hague Revision heralded a further tightening of this flexibility by requiring, in addition to the Brussels conditions, that forfeiture/revocation would only be available if the remedy of compulsory licensing (CL) could not resolve an alleged patent abuse (see article 5). In 1934, the London Revision added another condition, to wit, flexibility not to be available unless an alleged patent abuse remains unredressed two years after the grant of CL (see article 5(4)). The 1958 Lisbon Revision completes this process by refining the period within which CL could issue in addition to providing that CL must only be non-exclusive (see article 5(4)).

Cumulatively, all of these revisions decimated the revocation/forfeiture exception as patentees are now allowed to ‘justify’ alleged abuse of patent rights. Interestingly, the developed countries still yearned for more pro-patentee revisions and were only stopped by the increased membership of low-and-middle-income-countries (LMICs) who not only opposed further pro-patentee revisions, but also unsuccessfully pushed pro-access revisions of their own (e.g., see Loughran at 424-31). This stalemate led to a US-championed forum-change to the General Agreement on Tariffs and Trade (GATT) – now the WTO.                          

Transition to GATT, TRIPS, and access concerns

Sections 4, 5, and 6 of the paper examine the behind-the-scenes political intrigues that produced TRIPS as well as potential effects of the new treaty on access. In a nutshell, TRIPS’s structure mirrors that of the PC to the extent that it provides for NT, PR, CRs, and flexibilities. However, one distinction between TRIPS and the PC is that TRIPS exterminates the most consequential flexibility under the PC, namely, deference to members on if and how to incorporate the three pillars of the PC at national level. Hence, TRIPS now requires that all WTO members must entrench in their national laws TRIPS minimum standards, including provisions on enforcements and dispute resolutions. This universalisation of minimum standards is an incredible win for developed countries and their multinational corporations (MNCs) for two reasons: one, it makes it easier for their MNCs to obtain and enforce IP protection in LMICs; and two, with no obligation to exploit patents in countries of grant, it arguably legitimises ‘rent-seeking’ behaviour also in LMICs. It is for these reasons, among others, that TRIPS has been criticised as an impediment to access (e.g., see FM Abbott article).

The above notwithstanding, the paper acknowledges the simultaneous inclusion of flexibilities like parallel importation and compulsory licence in TRIPS. Theoretically, these could be used by members to temperate potential threats that TRIPS may constitute for access. The problem here though is that the freewill of LMICs to utilise flexibilities is tremendously constrained by developed countries, using different political-cum-economic stratagems to thwart their attempts. Apart from political/economic might, developed countries have also deployed Free Trade Agreements (FTAs) to diminish the scope and effectiveness of flexibilities post-TRIPS. FTA IP chapters are notorious for enacting TRIPS-plus obligations – obligations far higher than TRIPS minimum (see section 6). Countries like India, Brazil, Argentina, Thailand, and South Africa (just to mention a few) have been strategically targeted by the US, for example, either for using or attempting to use TRIPS flexibilities (e.g., see Drahos and Braithwaite).

In section 7, the paper identifies four ways through which this continuing attack on national flexibilities could exacerbate the access situation in LMICs, namely by:

  • legitimising external influence in national IP rule-setting (US & EU use trade access to control IP rule-settings in several LMICs);
  • imposing additional constraints on the use of certain flexibilities (e.g., compulsory licence for export and parallel importation);
  • unjustifiably adopting higher IP regime in the mistaken belief that this would foster technology transfer and FDI (e.g., Tanzania and Kenya); and
  • threatening the continued existence of India as the ‘pharmacy of the developing world’ (US has repeatedly placed India on a priority watchlist for using flexibilities, MNCs have developed strategies for challenging legitimate use of flexibilities in India, and a section of the Indian generic industry is becoming exceedingly pro-patent owing to influence from MNC collaborators).         

Postscript: the WTO Decision on improved access to COVID-19 vaccines   

Since early 2020, the world has witnessed a once-in-a-lifetime pandemic which originated in China in December 2019. The resulting shortage of PPEs, ventilators, diagnostics, vaccines, and therapeutics, later complemented by a wave of vaccine nationalism among developed countries, led South Africa and India to submit a proposal in October 2020 to the WTO offering ways out of this access quagmire. This proposal called for a blanket waiver of section 1 (copyright and related rights), section 4 (industrial design), section 5 (patents), and section 7 (protection of undisclosed information) of Part II of TRIPS for 3 years to enable a fast-tracked containment and treatment of COVID-19 infections.

After over 18 months of negotiations, a Decision finally emerged at the Ministerial Conference held in June 2022. Unsurprisingly, this Decision has no scintilla of resemblance to the original proposal from India and South Africa. Instead, it considerably reflects an alternative proposal sponsored by the EU, which identifies the overhauling of TRIPS’s CL framework as the holy grail to improved access for COVID-19 vaccines and therapeutics. It is worth noting however, that though based on the EU proposal, the Decision is narrower in scope. For instance, unlike the EU proposal, the approved Decision will only apply to vaccines, while negotiations regarding diagnostics and therapeutics will follow 6 months from the date of adoption (see paras 1 and 8).

The Decision’s substantive provisions may be grouped into three: the first refines TRIPS provisions on article 31 CL by removing the need for prior authorisation under article 31(b) and re-defining adequate remuneration under article 31(h) (paras 3a and 3d). In the second group are provisions focused on addressing some of the criticisms raised against article 31bis (CL for exports). These provisions clarify the circumstances for waiving TRIPS article 31(f) (para 3b); the re-exportation of imported vaccines (para 3c); and the timing of communication of actions under the Decision to Council for TRIPS (para 5). The last group of provisions addresses the issue of duration (5 years, though extendable) (para 6), and the problem associated with access to test data where CL has been granted under articles 31 and 31bis (para 4).       

In retrospect, the process that produced this Direction confirms how emboldened the developed countries have become, not only in attacking national flexibilities pre-TRIPS, but also in manipulating LMICs to ‘voluntarily’ surrender flexibilities. As explained in the paper, this domination is heightened by the successful linkage of trade and IP under the WTO, such that developed countries can now use trade access as a carrot-and-stick instrument to reward cooperating LMICs (increased trade access) or punish recalcitrant ones (withdrawal of trade access). This seems to explain why the India-South Africa proposal did not see the light of the day (in whole or in part) despite the tremendous supports it garnered within and outside the WTO. It also seems to explain why LMICs with capacity to manufacture COVID-19 vaccines would agree to undertake not to use the Decision, even though the Decision is intended to benefit all LMICs (see footnote 1 of the Ministerial Decision).                      

Moving forward despite dwindling flexibilities

It is indisputable that there is no quick fix to the ubiquitous conundrum of inadequate access, especially during a deadly pandemic like COVID-19. However, a few potential solutions may be explored. The lead recommendation in the paper is a political one, which makes sense given the political nature of this problem. Thus, since the laws of many LMICs provide for TRIPS flexibilities, they are advised to muster political will to use these flexibilities not minding any threat of economic sanctions from their developed country counterparts. India is a leading example here as it has defied repeated US harassments aimed at preventing it from using flexibilities. Second, while the June Decision falls short of the widely supported proposal, LMICs could still take advantage of the clarified provisions of TRIPS articles 31 and 31bis CLs. This recommendation, however, circles back to the need for LMICs to show unabashed political will to use the Decision. Third, LMICs may also consider the possibility of using the WTO platform to secure an undertaking from developed countries not to interfere in attempts by LMICs to use flexibilities. Lastly, not all countries can or should venture into pharmaceutical production; as such, a specialised agency could be instituted (perhaps, within the WHO) to coordinate the donation of urgently needed pharmaceutical products to these vulnerable countries where patent is not the issue.

COVID-19, patients’ mental capacity and prisoners

@mbaumi via Unsplash

The coronavirus pandemic has raised an abundance of issues at the intersection of law and medicine. In recent co-authored articles, Cameron Stewart, Professor of Health, Law and Ethics at the University of Sydney Law School considers some of these issues.

Mental capacity assessments for COVID-19 patients: Emergency admissions and the CARD approach

In this Journal of Bioethical Inquiry articleProfessor Cameron Stewart and colleagues examine the principles of mental capacity and make recommendations on how to assess the capacity of COVID-19 patients to consent to emergency medical treatment.

“The combination of very sick patients, knowledge deficits, and high pressure environments is likely to make capacity assessment very difficult during the COVID-19 pandemic.”

The article provides examples of mental capacity disputes in a number of common law jurisdictions before recommending that in emergency admissions for COVID-19, health practitioners use what Professor Stewart and his co-authors term the “CARD” approach (Comprehend, Appreciate, Reason, and Decide).

“CARD gives clinicians a legally defensible means of rapidly determining the mental capacity of COVID-19 patients, essential to guide urgent treatment and ensure that patients’ best interests are ultimately served in the process.”

COVID-19, Australian prisons: Human rights, risks and responses

Australian prisons have, so far, avoided the levels of COVID-19 infection experienced in the United States and elsewhere, but the potential for high infection rates remains.

In a November 2020 article in the Journal of Bioethical InquiryProfessor Cameron Stewart and colleagues consider what steps the state should take to protect prisoners. The article looks at Australian prisons’ regulatory responses to COVID-19 and considers calls for the release (decarceration) of some prisoners, including the Victorian case of Rowson v Department of Justice and Community Safety [2020] VSC 236. In that case, a prisoner unsuccessfully sought release pending departmental consideration of his application for release into home detention on health grounds — namely, risk of serious injury or death from COVID-19.

Professor Stewart and his co-authors conclude:

“Ultimately, COVID-19 presents an opportunity to reconsider the deeper issues regarding use of incarceration as a punishment and the human rights of prisoners more generally.”

Cameron Stewart teaches in Sydney Law School’s Master of Health Law program, including subjects on Death Law, Health Care and Professional Liability, and Government Regulation, Health Policy and Ethics.

Related posts on COVID-19 from the Sydney Health Law team:

https://sydneyhealthlaw.com/2020/11/04/covid-19-medical-research-governance-and-public-health-orders/

https://sydneyhealthlaw.com/2020/03/18/whos-in-control-of-australias-response-to-coronavirus-part-1-legal-frameworks/

https://sydneyhealthlaw.com/2020/03/19/whos-in-control-of-australias-response-to-coronavirus-part-2-operational-responses/

https://sydneyhealthlaw.com/2020/08/26/rule-of-law-in-the-covid-19-response/

https://link.springer.com/article/10.1007/s11673-020-10055-2

Cracking the Codex: the new frontier for nutrition labelling

Alexandra Jones, Global health lawyer and PhD Candidate at The George Institute for Global Health and the University of Sydney
Dr Anne Marie Thow, Senior Lecturer in Health Policy at the University of Sydney
Dr Carmen Huckel Schneider, Senior Lecturer, Health Policy at the University of Sydney and co-lead of the Health Governance and Financing Group and the Menzies Centre for Health Policy

Food labels hit the New York Times recently when leaks from North American Free Trade Agreement negotiations suggested the US was being urged by big American food and soft-drink companies to limit the ability of the pact’s three members – Mexico, Canada and the US – to implement warning labels on unhealthy foods.

There is no escaping the health imperative here. Obesity has nearly tripled since 1975 worldwide: 41 million children under 5 are now overweight, while 1.9 billion adults are overweight or obese. Spiralling health and economic costs mean governments are turning to evidence-based policies to prevent and control diet-related diseases like obesity, heart disease, stroke, diabetes and dental caries.

Better nutrition labelling – including front-of-pack labels that interpret nutrition information through symbols, colours or words – are part of the comprehensive package recommended by the World Health Organization. Over 20 countries already have policies in place – they include the UK’s traffic lights, France’s Nutriscore, Chile’s ‘stop sign’ warnings (which Peru appears set to follow), and Australasia’s Health Star Rating.

This proliferation and diversity poses trade and commercial challenges, and calls for some degree of consistency in global approach have been made.

Cracking the Codex (Alimentarius Commission)

This is where the international food standards body – the Codex Alimentarius Commission – comes in.

A UN body created by the WHO and UN Food and Agriculture Organization, Codex has a dual mandate: to protect consumer health, and promote fair trade practices.

Codex standards and guidance are voluntary, but in practice frequently act as a touchstone for countries looking to develop national policies. As Codex enjoys recognition as an international standards setting body by the WTO, guidance it develops also has potential to show up in trade discussions around food.

In short: what happens at Codex matters for public health nutrition.

Done well, Codex could bolster countries to take action. Left unchecked, there’s a risk outcomes could deter countries’ from implementing policies desperately needed to stem the rising global tide of non-communicable diseases.

As Codex is also notoriously slow – there’ll be a general meeting 2-6 July in Rome, and a further discussion paper for feedback later this year – it’s critical that the process itself not be used as a ‘brake’ on growing global momentum to implement strong front-of-pack labels.

Time for public health to assume a seat at the Codex table

Industry Observers have been quick to jump on opportunities to provide input into new Codex work on front-of-pack labelling. The first working group included representation from 13 international organizations representing the food industry, particularly the sugar and beverages sectors. Only two consumer groups were there.

It’s now critical we ensure public health bring their perspective to the table.

What you can do:

Read our briefing note for more information, and

  • Get involved – contact your national Codex Contact Point or join an Observer organization
  • Speak up about the public health priorities, like:
    • the importance of a definition of ‘front-of-pack nutrition labelling’ that supports schemes most likely to be effective in achieving public health objectives – and not, for example, industry preferred options such as the Guideline Daily Amount that aren’t backed by evidence
    • preserving policy space for strong and innovative measures – evidence is rapidly evolving but currently suggests for informing consumers and improving diets, this may include mandatory labels that use interpretive elements like colours, symbols or words, underpinned by robust and transparent criteria for scoring foods
  • Encourage continued action at a national level – remember, nothing in the current process prevents interested countries from pursuing front-of-pack labelling

Want to read more?

 

This piece was originally posted on the PLOS Global Health Blog on 25/06/2018, and has been re-posted with author consent.

 

How can pacific island countries reduce the crippling burden of non-communicable diseases?

Pacific island countries and territories (PICTs) are some of the most geographically isolated in the world.  Non-communicable diseases (NCDs), including cardiovascular disease, cancers, tobacco-related diseases and diabetes are rampant in PICTs.  These diseases are partly driven by loss of traditional diets, global trade in harmful products, and by a cluster of inter-related risk factors including tobacco use, harmful use of alcohol, poor diet (excess intake of  saturated fat, salt and sugar), obesity and lack of physical activity.

Building on the World Bank’s NCD Roadmap Report, Pacific Economic and Health Ministers have agreed that non-communicable diseases are financially unsustainable and committed to implementing cost-effective policies.  Global and regional architecture to support these changes is coming into place.  But the challenges of implementation remain.

In a recent paper published in Asia & the Pacific Policy Studies, Roger Magnusson and David Patterson (Department of Strategy and Innovation, International Development Law Organisation) suggest some promising strategies for strengthening the governance and law reform processes that will be needed if PICTs are to reduce the crippling burden of NCDs on their health systems and economies.  In a previous paper, the authors reviewed the role of law and governance reform in the global response to NCDs and identified some priorities for development assistance for NCD-related law and governance reform.