LIKE every crisis, the Covid-19 pandemic has also brought some opportunities, two in particular. First, it has spurred innovation. In relatively no time, experimental vaccines started queuing up. The mRNA-based vaccine was developed which is a watershed innovation. This is going to profoundly change the future of prevention and therapeutics. Regulatory pathways for emergency use authorisation for these vaccines have also worked well.
Second, on May 5, the US announced support for the Covid-19 TRIPS waiver. This is also a major development. The director general of WHO, Dr Tedros Ghebreyesus, has termed it as a “monumental moment in the fight against Covid-19” and “a powerful example of US leadership to address global health challenges”. It is indeed a paradigm shift in US trade policy which has always centred on intellectual property protection (IPP) ie time-limited monopoly on patents, trademarks, copyrights, industrial designs etc. The US has always vehemently opposed any idea of giving concessions on IPP issues, whether it was the Doha Declaration on the TRIPS Agreement and Public Health or the issuance of compulsory licences for medicines of public health significance.
What does this waiver mean and how can it enable developing countries to start the production of Covid-19 vaccines and related health technologies? And how can low- and middle-income countries, including Pakistan, benefit optimally from this waiver?
To begin with, there is no waiver at present. US support for a waiver means that as negotiations on the subject begin in Geneva in the coming weeks at the World Trade Organisation (WTO), the US will not oppose the proposal submitted by India and South Africa last October, backed by developing countries.
Once a consensus is reached, how will it be translated into action and who would benefit the most?
The Uruguay round of multilateral trade negotiations (1986-1993) culminated in the establishment of the WTO in 1995, which for the first time brought IPP on the agenda of international trade negotiations that resulted in the introduction of mandatory global standards of IPP through an agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). ‘Minimum’ TRIPS IPP standards include, in the case of patents, a monopoly of 20 years and protection of both process and product patents for all kinds of technologies. However, TRIPS also incorporated some public health safeguards (flexibilities) at the behest of the developing countries. In 2001, at WTO ministerial conference in Doha, developing countries also won a separate ministerial declaration on the TRIPS Agreement and Public Health which further affirmed the primacy of public health vs IPP. Treatment access campaigns by civil society for AIDS medicines played a vital role.
US support for the waiver would be an important factor in the negotiations, as they begin in the TRIPS council. However, reportedly, the EU and Japan are not going to make it easy. Also, an important moot point in the negotiations will be the scope of the TRIPS waiver. The US support for the waiver is categorically for Covid-19 vaccines but of course developing countries will be pushing for an expanded scope encompassing other Covid-19-related health technologies. There would be no easy giveaways in these parleys.
Pre-empting this and the multilateral dynamics, the Biden-Harris administration’s recent support for waiving IPPs for Covid-19 vaccines, released to the public through a statement by US trade representative Katherine Tai, it was already expected that “those negotiations will take time given the consensus-based nature of the institution [WTO] and the complexity of the issues involved”. So, predicting a time frame for developing a consensus for the way forward is anybody’s guess.
Notwithstanding the convolutions of the negotiations process, once a consensus is reached, how will it be translated into action and who would benefit the most? Even if we just consider Covid-19 vaccines, the developers and producers of vaccines will have to share the know-how and technology involved, including technology for mRNA vaccine. This would require technology transfer facilitation possibly by a third party.
It is stating the obvious that only those developing countries, at least in the short term, will benefit from these novel technologies that already have active vaccine research and development and manufacturing. Countries like India, China, Brazil, South Africa and Cuba would be immediate beneficiaries as they are already in biological production. Apart from production facilities they also have enough trained biotechnologists. There would also be a race among these countries to get into mRNA vaccine production which is a breakthrough technology and which is going to change a lot in biological production in future.
Pakistan, despite being the fifth largest internal market in the world, has unfortunately not paid attention to biological production. Out of 650 licensed pharmaceutical manufacturers in the country there are only seven who are involved in any kind of biological manufacturing. Primarily, these companies perform filling functions by importing concentrated vaccines. Seventy per cent of new medicines in the world market on the other hand are biological products and this is the future of prevention and treatment of diseases. Unlike India and Bangladesh in the neighbourhood, neither public policy nor the private sector has moved in the biological direction. As a consequence, we are 100pc reliant on imported vaccines, including Covid-19 vaccines.
In the context of the current vaccine inequity, WHO is now promoting wider production of vaccines in developing countries. WHO has also set up a technology transfer hub for developing countries. We have missed too many opportunities in this field. mRNA technology can help Pakistan take the required leap which would enable the country not only to meet its national needs but also to export. Once the technology is there, it can diversify the product range by going into biological therapeutics eg monocolonal antibodies for treating chronic diseases and cancers and vaccines beyond Covid-19.
Eventual TRIPS waiver for Covid-19 vaccines and the facilitation of WHO in technology transfer opens up a strategic opportunity for the Pakistan government and the private sector for major initiatives. If we do not think this way then this waiver would mean nothing for Pakistan. This window of opportunity would also close and some other countries would emerge as champions. Actually, the scramble for mRNA technology has already started.
The writer is a former SAPM Health.