28 July 2021
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
In my earlier articles on the proposed Agreement of Trade-Related Intellectual Property Rights (TRIPS) waiver for COVID-19 vaccines, medicines, diagnostics and technologies, I explored the scope of the intellectual property (IP) rights waiver and its potential impacts on pharma, biopharma and biotech, should it be approved. In this last instalment, I focus on the supply of COVID-19 vaccines; discussing whether the IP waiver is the best solution for addressing COVID-19 vaccination disparities, what other strategies are helping to achieve this goal and whether the TRIPS waiver may already have achieved its desired effect.
This is a key matter to determine before any IP is waived. At the time of the IP waiver submission to the World Trade Organization (WTO) there were no approved vaccines or treatments for COVID-19 – the submission document itself acknowledges this.1 Additionally, the document only details three examples of IP rights infringing upon access to technology/medicines.1 Namely:
1. Kentucky Govenor Andy Beshear’s call for 3M to release a patent on N95 respirators; however, Kaitlin Wowak, a supply chain expert and assistant professor at the University of Notre Dame, explained that, as with many COVID-19-related medicines and technologies, “how fast products like N95s [can be] made is determined by three primary factors: the complexity of the equipment used to make the product, the availability of raw materials, and the availability of trained workers.”2
2. Related to Labrador Diagnostic LLC, a patent-licensing firm, which has committed to offering its patents royalty-free to any company developing COVID-19 tests. It is notable though, that Labrador Diagnostic did file a lawsuit against bioMerieux SA to ensure that its IP was not infringed.2
Furthermore, the idea that sharing IP would overcome all shortages or supply constraints is false. It must be noted that only 47 of the 458 medicines listed on the 21st edition of the World Health Organization (WHO)’s Essential Medicines List are currently under patent;3 however, there are regularly shortages. A 2009 survey found that in 36 countries, 15 common generic medicines listed on the WHO Essential Medicines List were frequently unavailable in either the public or private sectors, with regional availability ranging from 29 percent in Africa to 54 percent in the Americas.4 This is primarily due to infrastructure failings, rather than IP.
If we just talk COVID-19 vaccine supply, when questioned about whether the vaccine rollout was slowed because vaccine patent holders were licensing too few manufacturers to make them, Adam Poonawalla, Chief Executive Officer of the Serum Institute of India, the world’s largest generics facility, stated: “No. There are enough manufacturers, it just takes time to scale up.” He added that he had been “blown away by the co-operation between the public and private sectors in the last year” in developing the vaccines and said that the lack of global regulatory harmonisation is a far greater cause of delays in the vaccine rollout.2,5 It is also widely accepted that simply suspending patent rights would not mean millions more vaccines could be produced – that necessitates the availability of enough materials (active pharmaceutical ingredients [APIs], excipients, packaging, etc), skilled workers and capable plants too.
It is also worth noting that substantial progress has been made to increase the COVID-19 vaccine supply. The Duke Global Health Innovation Center recently estimated that global production of COVID-19 vaccines will reach more than 12 billion doses in 2021.6 It also highlighted that, assuming most vaccines require two-dose regimens (only two of the 11 currently approved in at least one country are single dose), about 11 billion doses will be needed to vaccinate 70 percent of the world’s population, frequently considered the threshold to approach herd immunity.
As of 6 July 2021 there were agreements for the supply of 16.4 billion doses of the 11 COVID-19 vaccines approved for use in at least one country worldwide.7 UNICEF’s vaccine tracker also showed that there were over 130 manufacturing agreements (tech transfer or agreements with contract development and manufacturing organisations [CDMOs]) to supply the vaccines. Twenty three deals are in place for AstraZeneca’s vaccine candidate,8 while Johnson & Johnson has entered deals with more than 10 manufacturing partners worldwide.9 Vaccine developers have also partnered with rival pharma companies to supply vaccines, for instance Merck signed an agreement to support the manufacture and supply of the single-dose Janssen COVID-19 Vaccine.10
To facilitate these deals, whether they be for fill-finish, API manufacture or packaging production, technology transfer from the vaccine developer to the partner company is required to ensure the quality of the products is maintained and the optimum output attained. This is a complicated process requiring total trust and co-operation between companies. Moreover, the complexity of vaccine production requires any partner to have sufficient capacity and capability to absorb the technology; the necessary skilled workforce to produce it; the ability to scale up manufacture; and a legal and policy framework to ensure the product is made to a safe and licensable standard. There are also other considerations, such as the availability of raw materials and potential trade barriers.9 As such, selection of who is chosen to manufacture COVID-19 vaccines is not simply a profit driving exercise; continuity of supply and patient safety is imperative. If IP rights are waived, and access to the technologies granted without the necessary technology transfer, both elements could be compromised, damaging patient confidence and potentially derailing the global vaccine rollout.
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has asserted that the major challenges currently impacting COVID-19 vaccine supply are shortages in raw materials, scarcity of critical input supplies (eg, bioreactor bags, single-use assemblies, cell culture media, etc), availability of skilled workers, trade barriers and the need for harmonised regulatory standards worldwide.9 The federation also stated that accelerating the process of approving new manufacturing sites and updating vaccines to combat emerging variants are among the necessary industry focuses.
Not according to biopharmaceutical companies – and Pfizer’s CEO Dr Albert Bourla, in particular.
Dr Bourla wrote in an open letter to his employees: “Currently, infrastructure is not the bottleneck for us manufacturing faster. The restriction is the scarcity of highly specialised raw materials needed to produce our vaccine. These 280 different materials or components are produced by many suppliers in 19 different countries. Many of them needed our substantial support (technical and financial) to ramp up their production.”11
The Association of the British Pharmaceutical Industry (ABPI) corroborated this in a statement. Chief Executive Richard Torbett said: “Companies have been working with international partners for months to scale up the supply of vaccines, voluntarily licensing and transferring technology where it is safe to do so. The real challenges are a lack of advanced manufacturing skills and critical raw materials.”12 He stated that the primary focus should now be “sharing excess doses of vaccines, maintaining the free movement of raw materials and properly funding COVAX,” concluding that “we share the goal of getting COVID-19 vaccines to the people who need them as fast as possible, but waiving IP is not the solution. In the short term, it will hinder vaccine scale-up and in the long term, significantly impact global investment into new vaccines and medicines, including for future pandemics.”
Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen Ubl shared this view, stating: “In the midst of a deadly pandemic, the Biden Administration [in supporting the TRIPS rights waiver] has taken an unprecedented step that will undermine our global response to the pandemic and compromise safety. This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.”13
Conversely, some groups operating outside or in conjunction with the pharma industry praised the announcement that Biden’s Administration would back the waiver, including the WHO and Amnesty International. WHO Director-General Dr Tedros Adhanom Ghebreyesus praised the commitment asserting: “I commend the United States on its historic decision for vaccine equity and prioritising the wellbeing of all people everywhere at a critical time…” He added that such extraordinary circumstances require extraordinary measures and that the waiving of IP protections on vaccines was needed to help end the pandemic.14
waiving IP is not the solution. In the short term, it will hinder vaccine scale-up and in the long term, significantly impact global investment into new vaccines and medicines”
Amnesty International’s Secretary General Agnès Callamard also commented: “Only by sharing knowledge and technology can the production of vaccines be accelerated to reach as many people as fast as possible. The only way to end the pandemic is to end it globally. The only way to end it globally is to put people before profit.”15
Médecins Sans Frontières (MSF) also stated that the belief that emerging countries are not significantly advanced enough in their scientific and technological abilities to manufacture such complex products has been proven wrong on multiple occasions in the past. Therefore, their ability to help combat the pandemic should not be discounted.16 They also note that, without technology transfer, manufacturers in developing countries are currently producing complex products such as recombinant and conjugate vaccines, monoclonal antibodies and reverse transcription polymerase chain reaction (RT-PCR) testing platforms when patent barriers are absent or expired.
When asked to comment on the IP rights waiver in May 2021, Marc Matar, partner and pharma expert at Simon-Kucher & Partners, a strategy and marketing consultancy firm, stated: “By floating the possibility of an IP waiver, governments in mature markets are seemingly putting pressure on vaccine manufacturers to find solutions to make doses available to low- and middle-income countries. It is questionable whether they would actually want to follow through on the threat—waving IP rights would lead to a lose-lose outcome:
“We have observed in the last few days new pledges from the vaccine innovators to deliver doses at significant scale to low- and middle-income countries. This suggests that the threat is having its intended effect. We fully expect to see additional announcements including technology transfer initiatives in the short term as manufacturers seek to shift the dialogue back to conventional solutions.”
On 19 May 2021, IFPMA, the ABPI, the Biotechnology Innovation Organization (BIO), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Council of Biotechnology Associations (ICBA), PhRMA and Vaccines Europe released five steps that the biopharma industry and governments should commit to, to increase the availability of vaccines.17 Key steps for pharma/biopharma to note are:
Perhaps the real intention of the IP rights waiver has already been achieved – promoting collaboration and maintaining the industry’s drive to supply safe and effective vaccines”
WHO’s Access to COVID-19 Tools (ACT) Accelerator,18 also seeks to promote global collaboration and knowledge sharing for COVID-19 interventions, diagnostics and technologies with its vaccines pillar COVAX for the acquisition and equitable distribution of COVID-19 vaccines. Additionally, the organisation’s recently established mRNA Technology Transfer hub seeks to expand the capacity of low- and middle-income countries to produce COVID-19 vaccines and generally scale up their global manufacture. WHO stated that more than one of these hubs could be set up to “transfer a comprehensive technology package and provide appropriate training to interested manufacturers in low- and middle-income countries. This initiative will initially prioritise the mRNA-vaccine technology but could expand to other technologies in the future… The intention is for these hubs to enable the establishment of production process at an industrial or semi-industrial level, permitting training and provision of all necessary standard operating procedures for production and quality control.”19
Overall, the potential impacts of an IP rights waiver would be wide, but whether such a policy’s potential benefits outweigh their negatives is yet to be seen, especially in the context of an ever-changing pandemic. Could developing countries manufacture highly complex vaccines, therapeutics and diagnostics to the necessary standard? This is unknown; however, the level of development of a nation is less a consideration than whether the technology transfer and associated support would be in place to allow this to occur in a reasonable timeframe and to the required standard. Would IP sharing actually increase vaccine supply safely? This is unlikely, particularly in the shorter term, since many other factors – from materials to skilled worker shortages and trade barriers – are all major factors hindering the supply of COVID-19 vaccines, which could not be solved by simply removing IP rights.
Additionally, without strong governance in place, the potential pitfalls of waiving COVID-19-related IP range from potentially slowing the global vaccine rollout to causing patient harm and reputational damage for vaccine innovators, not to mention reducing the likelihood of investment into pharmaceutical/biopharmaceutical R&D going forward.
Generally, the belief of the industry is that an IP rights waiver for COVID-19-related interventions, diagnostics and technologies would do more harm than good. Instead, attention should be turned to overcoming the tangible supply bottlenecks not associated with IP or numbers of available manufacturers. Perhaps the real intention of the IP rights waiver has already been achieved – promoting collaboration and maintaining the industry’s drive to supply safe and effective vaccines under the threat that inaction could lead to significant financial penalties going forward.
17 September 2021
17 September 2021
16 September 2021
16 September 2021