by guest contributor Bonginkosi Shozi, PhD Fellow, African Health Research Flagship, School of Law, University of KwaZulu-Natal
An occasional blog on international developments related to intellectual property, innovation, development and public policy
Preface by Adjunct Professor Wend Wendland
The COVID-19 pandemic has exposed the eggshell fragility of global human health, safety and well-being.
The pandemic is causing severe disruption to societies, economies, supply chains, trade and travel, erasing development gains and devastating the livelihoods of people, especially the poor and most vulnerable.
As a fine dust of anxiety settles over everything we do, never before has the global race for a vaccine, treatment and cure been as urgent.
Once health products of assured quality and safety are developed, global cooperation will be needed to ensure that they will be accessible and affordable to all at the same time.
Availability, accessibility and affordability of health products (such as medicines, vaccines, diagnostic and testing kits, medical devices and protective devices) depend on several factors, such as a country’s manufacturing capacity, the height of trade barriers, the strength of its competition (anti-trust) regulations, the efficiency of procurement procedures, the effectiveness of transportation and delivery mechanisms, and the adequacy of health systems and infrastructure. The pharmaceutical and medical R&D, innovation, production and supply ecosystem is complex.
Intellectual property (IP) rules are relevant too. IP protections may secure the investments needed to produce life-saving innovations, just as they may also hinder competition and constitute a barrier to collaborative innovation and impede access to those innovations. Governments the world over grapple with designing IP systems that incentivize innovation while safeguarding public health.
IP rights are not absolute. They are subject to exceptions and limitations and countries can take advantage of these provisions (also called “flexibilities”) in international instruments to address public health objectives. Further, IP rights don’t apply in all countries: for example, patents apply only in the countries in which they have been applied for and granted. And, under the World Trade Organisation’s (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), least-developed countries need not protect pharmaceuticals until 2033.
More broadly, this extraordinary global threat underscores the critical importance of international solidarity and effective multilateralism. This “Multilateral Matters” blog series shines a beam on the need for and relevance of multilateralism in the IP arena.
For all these reasons I decided that the next “Multilateral Matters” blog post should address the IP/health question, which, with great pleasure, I invited Bonginkosi Shozi, PhD Fellow, African Health Research Flagship, School of Law, University of KwaZulu-Natal, to write under his own responsibility as a guest contributor to “Multilateral Matters”.
While acknowledging the relevance of copyright to access to health-related data and knowledge contained in scientific and medical journals and other literary works, his post specifically addresses the freighted and fraught relationship between patents and health.
This post is also timed to acknowledge “The International Day of Multilateralism and Diplomacy for Peace”, which is celebrated in April each year.
Additional readings will as usual be posted on the Multilateral Matters website.
With my thanks to Bonginkosi, over to him.
The race for a solution to the global pandemic of COVID-19 is on. All around the world researchers in both public and private institutions are working tirelessly in the hopes of finding a vaccine or some other form of treatment that is capable of mitigating the devastation caused by this virus – and there are a few promising contenders. In light of these prospects of a coronavirus therapy becoming a reality within the foreseeable future, there has also been growing concern about the price tag any vaccine or treatment would come with, and justifiably so. As we have seen in the past with other epidemics like HIV and malaria, the high cost of life-saving medical interventions can often put them beyond the reach of the poor – who are often the worst affected. In response to such concerns, there have been calls for the establishment of a voluntary pool of exclusive rights on COVID-19 related subject matter.
A “pool” in the context of intellectual property refers to an arrangement where several different parties, all with exclusive rights in relation to a particular subject matter, agree to make all their intellectual property available through a single license. Therefore, anyone doing research and development on said subject matter only has to obtain this single license in order to access all the relevant technology they need that is protected by intellectual property rights, rather having to go through the difficult, time-intensive, and often expensive process of obtaining several licenses from several different parties. This is why pools are sometimes referred to as a “one-stop-shop”. Pools ordinarily relate to patents, but can also include other forms of intellectual property like test data.
In the following, I provide an overview of what such a pool would entail, and consider the potential of a voluntary pool as a mechanism to ensure African countries have access to a COVID-19 cure (in the form of a vaccine or treatment) should one become available. I then consider what other measures African countries can take to secure affordable access to healthcare for their citizens in a time of global crisis.
COVID-19 and Intellectual Property
Driven by concerns of profiteering in the time of global crisis, on the 23rd of March of 2020, the government of Costa Rica made a statement calling on the World Health Organization (WHO) to “undertake an effort to pool rights to technologies that are useful for the detection, prevention, control and treatment of the COVID-19 pandemic”. Two weeks later, WHO Director-General Tedros Ghebreyesus announced the WHO’s endorsement of this proposal and began taking measures to implement it by calling on all relevant stakeholders to sign a memorandum of understanding on the intent to share rights (MoU). More recently, the establishment of a voluntary IP rights pool has been backed by the European Union (EU), which has proposed a draft resolution to be tabled at the World Health Assembly, the annual meeting of WHO Member States.
The way the proposed IP rights pool is intended to function is that all signatories to the MoU – which is intended to include states, companies and research institutions – will make available any patents, clinical trial data or any other IP related to COVID-19. All this informationwill be available in a central database, and the use of this data will either be free or subject to a “reasonable” pricing fee. The incentive to rights holders here is that by making their information accessible, they too benefit from having access to the data others make available as part of the pool. Under ordinary circumstances, because of exclusive rights, obtaining access to this information could be both very time-consuming and very expensive.
More broadly, the motivation behind the call for a pool of rights on COVID-19 related healthcare products is that in the absence of some form of intervention, any IP linked to any form of a vaccine or life-saving treatment would make it too expensive for people in poorer countries to be able to afford it. An IP pool has the benefit of aiding research and development, by making data which would otherwise be expensive or challenging to procure (because of exclusive rights) readily available to all researchers who have access to the pool – thus lowering both time and expenses of developing a COVID-19 vaccine or treatment. This, in turn, should expedite the process of developing a safe and efficacious COVID-19 vaccine or treatment and, (ideally) lower the cost of the eventual end-product.
But ultimately, as a voluntary measure, the success of an IP pool is primarily in the hands of those public research institutions and private companies which conduct the research that may lead to a patentable vaccine or treatment. If key actors do not agree to co-operate despite pressure from the WHO, EU, scholars, and civil society, an accessible vaccine or treatments for COVID-19 may still end up being beyond the reach of those who need them most. Does this mean that the fate of millions of Africans lies in the hands of public and private actors, especially private companies primarily beholden to their shareholders? Not necessarily – IP pools are simply one of several strategies that can be utilised to mitigate the excesses of IP regimes and make healthcare products more affordable. Another important strategy, which puts the fate of Africans in the hands of the governments which lead them, is that of utilising what are referred to as public health flexibilities.
Overview of TRIPS Flexibilities
In simple terms, “flexibilities” are provisions in international IP treaties that give governments the discretion to mitigate the usual rules relating to acquiring or exercising IP rights over a product, for reasons related, but not limited, to public health. Governments can take advantage of these flexibilities when developing their national IP policies and enacting their domestic IP legislation.
Prior to 1994, each country had the discretion to determine their IP policies, and to include certain safeguards, known as flexibilities, as they saw fit. This “room for manoeuvre” diminished with the advent in 1994 of TRIPS, which seeks to ‘harmonise’ IP standards globally.
The effect of TRIPS and the endeavour of the WTO to achieve standardised, global benchmarks for IP regulations has been to require all countries to adopt uniform minimum standards of protection of IP rights. This has been problematic for poorer states, as much of TRIPS leans in favour of strong protections for IP at a global level. However, in the original agreement itself, and in subsequent agreements which expand on it, concessions have been made in order to make the agreement more accommodating to public health flexibilities. To a large extent, these flexibilities focus on patents since patents are the main kind of IP that influences the pricing of healthcare.
Where patents exist over products that are necessary in order to protect public health (as is the case with many potential COVID-19 vaccine candidates and treatments), flexibilities may be utilised in order to secure access to these products. Some public health flexibilities are applicable before patents are granted – such as high standards of patentability – however, where such flexibilities are not already provided for and in force, they would not assist a state in taking swift action to ensure their citizens obtain access to a COVID-19 vaccine or treatment. As such, in the following, I outline three key TRIPS-enabled flexibilities which may be utilised by a state during times of crisis to obtain access to subject matter which is under patent either in that state or elsewhere:
1) LDCs Transition Provision
In terms of Article 66.1 of TRIPS, states which are classified as “Least Developed Countries” (LDCs) have been granted a transition period, during which they are not obligated to enforce certain provisions of the TRIPS agreement, including the provision requiring WTO members to provide patent protection to pharmaceuticals. These provisions were included in recognition of the special needs of LDCs, their economic, financial and administrative constraints, and the need to afford them the requisite policy space to enable the creation of a viable technological base. The general LDC transition period has been extended several times, most recently to 1 July 2021, or until a country ceases to be an LDC. In particular, the exemption regarding pharmaceuticals has been extended to 1 January 2033, or until a country ceases to be an LDC.
2) Compulsory licences and government use
A compulsory licence is an authorisation granted by a government allowing third parties to produce a patented product or to utilise a patented process without the consent of the patent holder. In a similar vein, ‘government use’ or ‘crown use’ is a grant by the government, to itself or other entities or contractees acting on behalf of government, to make use of a patented product or process without the consent of the patent holder. In both instances, however, a reasonable royalty is required to be paid to the patent holder. Article 31 (a) to (l) of the TRIPS Agreement provides for the grant of compulsory licences provided certain conditions are satisfied and procedures followed. Article 31 of the TRIPS Agreement does not specify or otherwise limit the grounds upon which licences can be granted.
3) Parallel imports
Parallel importation refers to the practice of “comparison-shopping” in other countries to secure a (usually) patented product at a more favourable price. This flexibility is enabled by Article 6 of the TRIPS Agreement. This is based on the notion that once a product has been placed on the market and sold into commerce, the patent holder loses any proprietary rights to it. A country using this flexibility can elect a national, regional or international exhaustion regime and, if the last, it will have the right to parallel importation. For developing countries that cannot locally manufacture generics, international exhaustion is usually the best option. This provision is often framed in legislation as a limitation on the rights of the patent holder, or an act of non-infringement.
Faced with their inability to deal with public health crises in the wake of the TRIPS Agreement, developing countries organised themselves and presented a united front at the Fourth WTO Ministerial Conference in 2001 in Doha, Qatar, requesting the TRIPS Council to hold a Special Session to clarify the relationship between the TRIPS Agreement and public health, in particular, the flexibilities to which members were entitled. The ensuing Doha Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001, reaffirmed the maximum use of public health flexibilities and safeguards in the TRIPS Agreement.
A significant advancement of TRIPS flexibilities that came about in the wake of the Doha Declaration, is the 2003 WTO General Council decision implementing paragraph 6 of the Doha Declaration. Paragraph 6 of the Doha Declaration was an instruction to the TRIPS Council to find an expeditious solution to the difficulties faced by members with insufficient or no manufacturing capacity in the pharmaceutical sector, in making effective use of the compulsory licensing provision. In response, the WTO General Council later that year ruled that where a pharmaceutical product is produced under a compulsory license, that product may be exported to another state which has insufficient or no manufacturing capacities to produce generics – this is known as the 2003 Waiver. The 2003 Waiver was entrenched in the form of an amendment to Article 31 of TRIPS referred to as Article 31bis, which, inter alia, allows for compulsory licences to be issued for public health reasons, and implemented through importing the drugs from other countries. Article 31bis is, however, only applicable to states which have accepted the Protocol in which this amendment was introduced. Most WTO member countries have done so, however many African countries have not.
Do the Flexibilities Possible under TRIPS Work? An Analysis of the Use of Public Health Flexibilities in Africa
In a 2020 study conducted by Professor YA Vawda and myself, we examined the existence and use of public health flexibilities since TRIPS came into being in order to determine if they work, and if not, why. We examined the patent laws of 28 African countries, selected because they were member states of one of three major regional organisations in Africa with an influence on their members’ IP policy: the African Regional Intellectual Property Organisation (ARIPO), the Southern African Development Community (SADC) and the Eastern African Community (EAC). We also looked at which of these states had utilised any of the flexibilities that their policies provided for.
The study revealed some important aspects of IP regulation in Africa, and the extent to which African countries are committed to the agenda of access to medicines.
The first aspect is that the majority of these African countries in the study (15 in number) are LDCs. This means they are in an opportune position to capitalise on public health flexibilities, as they are not currently required to comply with TRIPS provisions in terms of the LDC transition provision explained above.
Secondly, regional organisations have a key role to play in helping (or hampering) access to medicines. Despite being LDCs, many African countries have IP regimes that are still governed by colonial-era statutes which do not take advantage of public health flexibilities. As such, legal reform is often necessary in order to make use of TRIPS flexibilities possible, and regional organisations have been an important factor in this reform process, in some cases for good – in others for ill. An example of a positive experience is the EAC, which actively campaigned for reforms, and published detailed guidance documents to help their members along on this process. The result is that all but one of the EAC’s members have reformed their patent laws since the TRIPS Agreement came into effect.
Thirdly, the utilisation of TRIPS flexibilities is often hindered by the limited capacity of many African countries to receive and process patent applications. It is for this reason that the ARIPO office exists, to act as a central patent office and provide support to patent offices of their member states. However, ARIPO’s omissions to apply TRIPS flexibilities and the limited technical capacity amongst some of its member states have resulted in the grant of patents that have impeded access to medicines. An example of this is the aforementioned flexibility of exempting pharmaceuticals from patentability. Despite the LDC transitional provision applying to 10 of ARIPO’s members, there are still patents approved by ARIPO (sometimes referred to as “ARIPO patents”) that are valid in these states, which relate to pharmaceutical products. This is because in terms of the ARIPO system, member states have six months within which to “opt-out” of recognising in their jurisdictions patents approved by ARIPO, but countries often struggle to communicate their objection to the ARIPO patents within this period, due to capacity constraints. In smaller and poorer countries that qualify as LDCs, patent offices simply do not have the manpower or expertise to comb through all the ARIPO patent filings and object to those relating to pharmaceuticals – and this effectively frustrates any benefits they might gain from providing for the LDC transitional provision in their own IP policy. The validity of these patents can be challenged, but their prima facie existence is enough to discourage generic manufacturers because of the risk of costly litigation. Over 60 health organizations have called on ARIPO to reform how it examines applications and grants patents.
Fourthly, it also seems the utilisation of TRIPS flexibilities is influenced by necessity. For instance, in relation to compulsory or government use licenses, the TRIPS Flexibilities Database records 26 instances where the Article 31 flexibility has been invoked, in some 14 African countries. Of these, almost all were in the period between 2000 and 2007 – the height of the HIV/AIDS pandemic. They were also almost exclusively for HIV-related medicines. These licenses were important in ensuring that the underprivileged denizens of Africa were able to access life-saving medicines.
Finally, possibly more than any other factor, the utilisation of TRIPS flexibilities is a matter of political will. Even where the regulatory mechanisms exist, in many states these have not been utilised to benefit public health. Conversely, in some states, even where the patent law in question did not have express legal provisions relating to certain flexibilities, they were still able to take the necessary steps to ensure that their denizens were able to access much needed healthcare. For instance, Comoros, Mozambique, and Sao-Tome and Principe reportedly made use of parallel imports even though their respective patent laws do not provide for them.
Can TRIPS Flexibilities Work for COVID-19?
The prospects of African countries using TRIPS flexibilities as a mechanism to ensure access to any potential vaccines or treatments exist; however, whether they will be effective in doing so depends on their ability to overcome the challenges highlighted above.
If this is so, the TRIPS flexibilities discussed above could potentially be applied to the COVID-19 pandemic if and when the innovation ecosystem produces safe and effective health products:
1) LDC Transition Provision
Article 66.1 applies to pharmaceuticals, therefore any cure or treatment which qualifies as a pharmaceutical product may be exempted from patentability by LDCs. This would include any COVID-19 vaccine which may be developed, as well as any drug which is revealed to have a therapeutic effect.
2) Compulsory licences and government use
A less drastic, but potentially similarly effective, strategy would be the utilisation of compulsory/government use licenses for COVID-19 related products. Of the states referred to in the aforementioned study, 19 of them provide for such licences. And in many cases the relevant provisions recognise a product being necessary to protect the public interest or public health as a ground for granting the licences. It is beyond doubt that any COVID-19 related healthcare product would qualify as necessary to protect public health. What is more, several states allows the government use of patented products in cases of national emergency, which TRIPS allows in terms Article 31(b). While grounds for involuntary licenses may vary between states, due to the explicit recognition of epidemics as crises constituting circumstances of extreme urgency, all states are within their rights to declare national emergencies as outlined in the Doha Declaration and thereby permit the use of subject matter related to COVID-19.
However, even where such enabling regulations exists, in most cases involuntary (compulsory) licences in African states require a formal application to the authority responsible for administering patents in that country. Thus, for this mechanism to be practical it would require that a state have the technical capacity to receive and process applications quickly and efficiently. States with pre-existing provisions for expediting compulsory licences in times of crisis are particularly well positioned for this. A notable example is that of Malawi, with the Patents Act (Chapter 49:02) 1958, as amended, providing for a presumption in favour of granting compulsory licences which have been applied for to access medicines for the public. For those without such a mechanism, swift action by lawmakers may yet make compulsory licences for COVID-19 viable, as exhibited by the example of Canadian government which recently fast-tracked the passing of a bill that would expedite the process of granting a compulsory licence.
3) Parallel imports
Another avenue, which requires less of an administrative burden on individual states, is for African countries to utilise parallel importation of COVID-19 related products from other countries where they may or may not be under patent. This would enable poorer countries without manufacturing capacity to procure and import stock from other countries where stock is available. This provision is, however, dependant on there already being enabling provisions in a country’s IP legislation , otherwise it may be stalled by legal action on the part of patent holders who object to said importation being a violation of their rights. It should be noted that of all the flexibilities available to African states, this is arguably the most under-utlised. This is a missed opportunity given that parallel importation can be utilised on short notice to provide access to a potential COVID-19 cure or treatment, especially where local manufacturing capacity is limited.
Where countries do not provide for parallel imports in their domestic law, LDCs also have available to them the option of importing a potential COVID-19 cure or treatment from another county in terms of the 2003 Waiver/the Article 31bis amendment, if one is made under a compulsory license, as explained above.
A pool of exclusive rights on COVID-19 related subject matter potentially provides access to both developed therapies and data which can benefit research and development. It is, however, not without its limitations, and whether it will function as anticipated is far from certain. In light of the seriousness of this global pandemic, as Thomas Cueni of the International Federation of Pharmaceutical Manufacterers and Association (IFPMA) put it, “no easy ‘one size fits all’ solution exists”. Although this statement likely alluded to the trepidations of private industry to the pool, it is also applicable when considering what measures African states can and should take in responding to concerns about access to a future possible COVID-19 vaccine or treatment. I have outlined a few flexibilities here which may potentially be utilised during the R&D and innovation phase and if and when effective and safe treatments and vaccines become available; however, these are but three mechanisms of severalthat are available to African states.
In conclusion, governments cannot afford to be complacent and hope for voluntary compliance with the call for a pool of exclusive rights relating to COVID-19. Nor can they do nothing if it is not forthcoming. African states in particular must be proactive in postioning themselves to use the measures available to them to protect public health and promote access to healthcare, which includes the utilisation of TRIPS flexibilities. The number of lives lost by not doing so is the biggest price-tag we should be concerned about.
My thanks to Professor Yousuf Vawda for his helpful comments that assisted in the drafting of this piece.
This blog is written exclusively in the author’s capacity. Any views expressed are those of the author alone and do not necessarily represent the views of any organization or institution.
Additional readings are listed on the Multilateral Matters portal (http://ip-unit.org/multilateral-matters/)
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