This keynote address was delivered at the Konrad Adenauer Stiftung (KAS) African Media Thermometer Access to Medicines and Treatment during Covid-19 and Beyond virtual conference on Friday, 4 September 2020. 

I want to start off with a quote from the Financial Times (FT) from a few months ago, when the World Health Organisation (WHO) had just declared Covid-19 a “public health emergency of international concern” (PHEIC) – this declaration is critical and its time-bound significance is something I will return to later.

“The desire to be responsible members of society, and recognised as such, is one motivation for companies to share intellectual property. Some will also realise they have little choice. Trade rules allow compulsory licensing. Such a radical step – allowing countries to make drugs cheaply without the patent holder’s consent – is justified. Universal access is likely to be required to get the pandemic under control. Desperate diseases require desperate measures.” Financial Times

The situation – there is a pandemic                                                           

The Africa Centres for Disease Control and Prevention (CDC) reports that as at end-August 2020, known and reported cases of infection in Africa have reached the 1.2 million mark, known and recorded deaths, at least 30,000, with just over 1 million known recoveries. Media reports across the continent paint a picture of a lack of affordable testing, silent deaths and bulging hospital admissions in many parts of Africa, amidst a pre-existing context of struggling public healthcare systems. 

Coupled with this, there has been a worsening of our hunger and unemployment crisis due to the socio-economic impact of Covid-19 and the measures taken by some governments to prevent infection, which include varying forms of lockdowns and social distancing, disproportionately affecting women in Africa, and primary caregivers. Frontline health workers in many parts of Africa are ringing the warning bell, many are also getting infected, becoming ill, and in some cases dying. 

Patients with TB, HIV/Aids, cancer and other chronic conditions (regarded as comorbidities) are at even greater risk of premature death due to Covid-19 not only because of their underlying infection, but because several studies now show that patients across health settings have not sought out timeous medical care and treatment as a result of Covid-19. 

I have also previously stated that a “season of death” is approaching – unless we are able to prevent new infections and treat existing infections, while attending to disinformation (about the seriousness of the pandemic, the role of the WHO, claims of cures and magic bullet treatments) and geo-political pressures, aggravated by the upcoming US elections. 

Against this backdrop, in the context of Covid-19, access to healthcare and access to affordable diagnostic and therapeutic advances, especially a vaccine (there are over 150 vaccine candidates in various stages of investigation) will be critical, if we are to meaningfully manage this pandemic. But access requires political will and affordability. And in this context, both are heavily influenced by those who hold the intellectual property (IP) ‘rights’ to these potential life-saving advances – in other words, the patent holders.  

What do we mean by patents and patent rights?

Ordinarily, the idea behind the awarding of patents is that it encourages and rewards innovation, for a limited period of time, where the patent holder is given the right, by law, to exclusively manufacture that product or sub-license it and determine a price, in any country where it is patented. At times, a patent holder may even decide not to exercise its ‘exclusivity’ rights and share its technology with others, with either a royalty fee, or for free. 

But patent protection does not always facilitate optimal innovation levels: recent reports show quite the opposite – health product patent holders. These reports show, are ‘gaming the system,’ using patent rights to:  evergreen patents (having rights indefinitely), build monopolies, and profiteer off public health crises, while the innovation for treating and preventing key diseases that could assist millions of vulnerable and sick people is missing, and access to essential and life-saving diagnostics and therapeutics for many chronic conditions is limited.

The ‘patent – innovation’ trap 

A recent op-ed by Tahir Amin of I-MAK in Medium stated that, “while companies are patenting more, they are actually inventing less…” (in the US) and “… nearly 80% of medicines association with new drug patents are for old drugs, like insulin or aspirin’’. And “pharmaceutical companies have been amassing dozens – in some cases upward of a hundred patents on a single drug for tweaks that are not especially inventive…”                                    

Patents as a form of economic power 

But patent protection coupled with trade pressure, and in turn, the exercise of geopolitical and economic power (or strength), is often the basis for exercising unchecked economic power, which in turn prop up or create unregulated monopolies and oligopolies. 

In Africa, for example, there are some countries classified as low-income countries – LICs and some as middle-income countries – MICs. Some countries have strong or very weak foreign policies and trade delegations, and many do not enjoy the protection of a Constitution or a regulatory framework (antitrust) that can govern corporate or private sector behaviour. Also, some countries remain at war and are in a current situation of human conflict which results in the mass movement of people across borders in Africa. This combined, results in the limited ability of many African governments, journalists and civil society groups to navigate and hold such monopolistic and pricing power to account.  

In some jurisdictions in Africa, patent holders (MNCs) can also be in collusive or vested interest relationships with national governments or health policymakers, thus making oversight and state regulation even harder (via political party funding, or bribery and collusion, for example).  

The World Trade Organisation 

Yet, even in this highly uneven and unequal world, we have a global IP and patent regulatory system that applies to countries considered ‘eligible’ by the World Trade Organisation (WTO)– based on its narrow economic classification system. In other words, it determines which countries must comply with TRIPS in their domestic laws and by when. International trade is then in turn largely governed by a country’s voluntary or forced acquiescence of the rules of this system. During the Mandela administration in South Africa (SA), for example, the USA, under the Clinton administration, included SA on a US ‘trade watch list’ because of domestic efforts to amend SA’s medicine laws. The WTO’s IP rules are set out in what is commonly called “TRIPS” – The Agreement on Trade-Related Aspects of Intellectual Property Rights.  

So, TRIPS sets the minimum standards for IP protection for WTO Member States. It is viewed as ‘part and parcel’ of the WTO machinery. Patents are a key part of this ‘protection’ and often, in the health sector, diagnostic technology and therapeutic related patents are a key barrier in advancing the right to universal healthcare, and in turn, access to life-saving treatment. This is because patents facilitate or legalise monopolies, which in turn permit high or excessive prices for the benefit of the patent holder and its shareholders. 

There is a history of affordable medicine access struggles in Africa  

There are many historical and current struggles for equitable access to affordable life-saving medicines and treatment for multiple chronic diseases, that disproportionately affect/ed people in Africa, and these struggles were and are championed by several health and human rights organisations in Africa (Kenya, SA, Botswana, Namibia, etc) and elsewhere in the world. 

These struggles have led to a direct confrontation with local and global patent regimes, and in turn, patent holders (MNCs) – mainly focused on pricing conduct, as unaffordable healthcare, even if the most innovative, will not reach those who are poor or uninsured.  

For example, when we litigated for PLWHA and clinicians and trade unions and FBOs, against GSK and BI for affordably priced 1st line ARVs in the early 2000s, it took about two years for the regulatory authorities in SA to establish a prima facie excessive pricing contravention, and because drug companies are notorious for not wanting to reveal its true R&D costs, it entered into a settlement agreement issuing a handful of “voluntary licences”, which made the medicines slightly more affordable in the private sector.

Having worked on issues of IP, patents and access to lifesaving medicines for PLWHA before, and now on Covid-19, many health justice access advocates are, like me, concerned that the global system that is in place will hinder access, it is overly protectionist and extremely difficult to use, which has the effect of severely limiting and delaying access to life saving diagnostics, vaccines, and treatment. Covid-19 has exposed the fault lines of this largely access limiting regime. In its current form, it limits global health rights and undermines urgent public health imperatives.

This systemic limitation or failure, largely attributable to the way in which the IP rules of the WTO are designed and implemented, coupled with the disproportionate power of the multinational pharmaceutical industry, mostly located in the US and the EU, have a direct impact on the local regulatory context of small and low or middle income countries, who were already struggling to expand access to healthcare services before this pandemic.

The pandemic and patents – implications for access

At present, patent monopolies exist in such a way that companies are profiteering off a pandemic, ironically and unfairly by very often benefiting from public investment in the research and development phase, but still qualifying for a patent, charging excessive prices, or not fully (or at all) sharing or pooling technologies for broader public use, that could prevent human suffering and death during this pandemic. 

For example, pharmaceutical companies issue limited and partial licensing or regrettably, act in ways that fall short of basic transparency norms and standards, most notably in the vaccine development phase of this pandemic. For example, Public Citizen and KEI have revealed that Moderna’s Covid-19 vaccine programme is 100% funded by US taxpayer dollars, which it has not disclosed (about $1 billion in grants) – yet it justifies its patent rights and monopoly by also trying to set ‘the highest price of all vaccine candidates’.[i]

The impact of patents for access – barriers to the highest attainable standard of healthcare 

Not only health justice activists and human rights lawyers, but even the SA government delegation at the WTO have argued that IP rights create a barrier to access Covid-19 technologies: using the example of Gilead’s current global remdesivir licensing deals (about 9 licensing agreements to supply 127 countries, with time-bound conditions, and until a vaccine comes to market) the SA delegation stated that ‘these limited, non-transparent exclusive licenses seem to be an attempt to contain competition by creating an oligopoly. Generic manufacturers globally that can contribute to expanding global supply have been excluded. The lack of transparency and accountability in this present dire time is extremely worrying and dangerous. It is an indicator of the IP and access challenges ahead of us, that the WTO Members need to address effectively and swiftly’.[ii]

It is of course true that certain flexibilities exist under TRIPS to – in theory – ensure affordable and equitable access to healthcare, including medicines, especially in time of a public health crisis, a flexibility largely prompted by the activism of the historical global HIV/Aids medicine access movement – contained in what is commonly called the Doha Declaration.[iii]

The Doha Declaration 

The Doha Declaration basically enables compulsory licensing (a mechanism that allows a government to break a patent monopoly under certain conditions, in a time of a public health crisis, for non-commercial purposes, and even, in cases of anti-competitive conduct). In other words, a patent monopoly would not be protected, even though the patent holder would still benefit from a royalty fee (it is not expropriation without compensation). 

This allows countries facing a public health crisis to issue a compulsory license where a company refuses to give up the protections ordinarily associated with holding a patent (exclusivity, pricing and market power). However, even as health outcomes worsen globally, and TB, malaria, cancer, HIV/Aids, and now Covid-19,  challenge the resilience of public health systems in many countries, even the SA government with its advanced Constitutional protections and antitrust laws, and current AU leadership role, has admitted that these flexibilities are not widely used, especially by developing countries in Africa, also due to the following 7 factors:

1. the difficulties associated with actually understanding and using the flexibilities to benefit local populations,
2. the lack of understanding of TRIPS flexibilities for matters outside of just patent protection (‘trade secrets, big data and 3D printing technology’),[iv]
3. the real-time trade or other forms of barriers that de facto limit its use,
4. the bi-lateral pressure placed on low-income and middle-income countries by wealthier nations that seek to protect intellectual property rights,
5. the lack of political will – worsened by armed conflict in many places where population health indicators are already a concern,
6. the lobbying and pushback by patent holders, that wield extraordinary influence in global geopolitical relations, and
7. parallel structures that promote bi-lateral partnerships or not for profit, time-bound partial pooling.

South Africa, for example, despite its high TB, cancer and HIV/Aids burden, has never issued a compulsory license against a pharmaceutical company.

This begs the question – is the WTO medicine access framework during a public health crisis so unworkable, inflexible, and anti-poor, that it should be totally reformed? And just this week the DG of the WTO suddenly resigned, citing the need for reform and systemic change. This is no ordinary time for the WTO.   

Given the speed of global infections, accelerated efforts to find a treatment or vaccine, and hundreds of patent rights being invoked, it may take even more time for the flexibilities in TRIPS to be fully used, if at all, even by developing countries, unless institutions such as the African Union (AU) offer the necessary technical support and leadership to do so (take for example, the AU ‘Vaccine Roadmap’). And so far, the AU has remained silent on this issue, unlike the governments of Costa Rica, France, Germany, Canada, Chile, and Ecuador.[v]

Health justice                                                                                 

Finally, in my view, the global patent model is not aligned with the health and human rights needs of millions of people around the world. Covid-19 is exacerbating this. It may offer a theoretical deviation, but its complexities make it near impossible to use regularly and consistently, across countries for public health emergencies-it would require a herculean effort to do so, which most developing countries are not in a position to manage or lead. 

What is even more concerning is that with the almost daily announcements of new vaccine and treatment research trials, during this pandemic, several companies who already hold patents for therapeutics that they did not on their own fully research or develop, are tying their limited and partial voluntary concessions for access for the global south to the PHEIC declaration by the WHO. In some cases, within a year after the declaration is lifted, the royalty exemption falls away. 

This needs monitoring, regulation and even later, perhaps the issuing of a pandemic compulsory license, in Africa. On top of this, some of these companies have agreed to advanced purchasing agreements with the US and UK governments (stockpiling), meaning, potentially, Africa could be last in the access line. 

This is why, if we reimagine the patent and IP global order and system, access for the most vulnerable and the most at risk of ill health, has to become a key feature of that system. In a public health crisis, exclusivity must be replaced with equitable access and the opening up of science. Otherwise, only patents will drive medical and life saving innovation, and that innovation will then continue to mainly benefit the wealthy and powerful.  

There really can be no other way, other than change. DM

Fatima Hassan is a human rights lawyer and social justice activist who heads the Health Justice Initiative – hji @healthjusticein (Twitter). 

[i] See: KEI: www.keionline.org/moderna  – and in the Financial Times.

[ii] July 2020, TRIPS Council Meeting. SA Delegation. 

[iii] See: Resolution UN A/RES/65/277. Political Declaration on HIV and Aids: Intensifying our efforts to eliminate HIV and Aids. New York: United Nations General Assembly; 10 June 2011.  

https://www.unescap.org/resources/ga-resolution-65277-political-declaration-hiv-and-Aids-intensifying-our-efforts-eliminate#:~:text=GA%20Resolution%2065%2F277%3A%20Political,and%20Aids%20%7C%20United%20Nations%20ESCAP

https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm

https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

https://www.who.int/bulletin/volumes/91/7/12-115865/en/

[iv] The SA government delegation to the WTO has identified this as a challenge and has asked the following additional questions (assuming that the WTO and TRIPS continues to play a direct role in the ability of millions of people to access life-saving healthcare during this pandemic):

1.     To what extent are TRIPS flexibilities embedded in areas outside patent protection well understood? If so, how are Members implementing such understandings in their national and regional laws? 
2.     What are the likely difficulties that Members may face in dealing with a changing technology landscape where embedded IP rights may affect the dichotomy between IP rights as private rights and the public interest dimensions recognised in the TRIPS Agreement? 
3.     What are the benefits and limitations of initiatives such as voluntary licenses and pledges to access much needed technology to deal with the Covid-19 pandemic? 
4.     Are there circumstances where trade secrets can be shared more broadly? If so, what are those circumstances? Would national or international health pandemics fall within this category?

[v] See: https://www.dailymaverick.co.za/article/2020-07-08-a-Covid-19-vaccine-when-solidarity-meets-nationalist-profiteering/#gsc.tab=0

Global North member states of the WTO, have explicitly stated their intention to make use of the flexibilities contained in TRIPS, and in some cases their “threat” to do so, has resulted in partial technology transfer for select jurisdictions, such as the Netherlands.