A dose of truth

Published May 17, 2021
The nations against the waiver doubt the capacity of LDCs to achieve standards and efficacy of vaccines if permitted to produce it.
The nations against the waiver doubt the capacity of LDCs to achieve standards and efficacy of vaccines if permitted to produce it.

Pakistan’s health professionals are confused and the pharmaceutical firms reluctant. The government is cautiously optimistic. It expects the Covid-19 vaccine to eventually get the IP waiver as at stake is not just the fate of small people in poor nations but the humanity and the global economy.

“It might take time (months) but we are positive that the World Trade Organisation (WTO) will understand the need and grant a temporary Trade-Related Aspect of Intellectual Property Rights (TRIPS) waiver,” a member of the government’s health team told Dawn. This perception has yet to energise the health hierarchy to initiate work on a strategy to produce Covid-19 vaccines locally as soon as the waiver becomes operational.

Citing the intensity of the health crisis and disparities in access to the Covid-19 vaccines, India and South Africa jointly proposed to the WTO in October 2020 to waive the intellectual property protection for the life-saving Covid-19 vaccine to boost the global manufacturing capacity and close the availability gap between rich and poor nations. Later, Pakistan joined eight other nations (Venezuela, Egypt, Kenya, Mozambique, Bolivia, Mongolia, Zimbabwe and Eswatini) and two groups (the African and LDC Group) to co-sponsor the proposal.

As new hotspots emerged in emerging countries mounting the global infection and death count amidst the demand-supply and access gaps, the waiver debate gained traction.

‘The intellectual property rights will have to be compromised sooner or later for achieving herd immunity at the global scale without which nobody anywhere is ever going to feel really safe again’

The balance shifted last week in favour of the waiver when the United States switched its position and decided to side with the proponents of the waiver proposal. US Trade Representative Katherine Tai is reported to have said: “The United States will now actively participate in negotiations for the text of the waiver at the WTO and encourage other nations to back it to increase global supply and easy access.” As for the timeline, she admitted the process will be difficult given the complexity of the issue and the WTO’s condition of consensus on decision-making.

The Covid-19 vaccine producers (Pfizer, Moderna and Johnson & Johnson) and several countries and regions (European Union, United Kingdom, Switzerland, Japan, Norway, Canada, Australia and Brazil) vigorously oppose the proposal.

Private companies, which developed the vaccine with generous public funding, oppose sharing the formulas for profits though they try to veil their true target by arguing that the waiver will suppress production by building pressure on the limited raw materials. They say that technologically upgrading factories in LDCs could take years.

The nations against the waiver doubt the capacity of LDCs to achieve standards and efficacy of vaccines if permitted to produce it. Some do not see the need for TRIPS waiver as the WTO protocols already empower governments of its members to relax rules to protect public health.

In practice, however, global experts believe the provisions embedded in TRIPS are insufficient to speed up the global solution required to end the pandemic.

Pakistan, in the midst of the third wave, lifted the lockdown only today after eight days. It is too overwhelmed by economic and political challenges to plan ahead for the waiver. The health hierarchy in Islamabad was not forthcoming. The secretariat of Asad Umar, planning minister who heads the National Control and Command Centre (NCOC), deflected Dawn’s query to SAPM Dr Faisal Sultan.

His response was short. “It will help in the supply situation. Not immediately but in the intermediate term,” Dr Faisal said in a message while referring probably to the delay at the WTO and the time needed to streamline the system for local production.

Dr Azra Pechuho, Sindh minister for health, shared her views. “We do not currently have the capability of vaccine production like most LDCs. Waiving copyrights would only benefit nations that are already manufacturing vaccines. The production of vaccines, therefore, will not be significantly ramped up by the waiver to the benefit of the world’s population.

“Also even India, which has the capability and was producing the Covid-19 vaccine, had to stop production because of the unavailability of raw material, which can only be imported from the United States.”

Dr Saad Shafqat, professor of neurology at Aga Khan University Hospital, found the excitement over the WTO IP waiver completely misplaced. “The waiver alone means nothing. The public doesn’t understand that vaccine production is a highly demanding operation. This waiver is the equivalent of giving permission to the developing world to start producing commercial passenger airliners. Without massive technical help, this permission will be hollow.

“It carries public appeal, but doesn’t amount to much in reality. Producing vaccines is at least ten-fold more complicated than producing regular medicines. The capacity in the developing world isn’t there and it will require a great deal of work, time and infrastructure development to get there.”

The private-sector representatives were apprehensive and doubted the government’s capacity to benefit from any waiver. “How can an establishment that can’t handle private imports be expected to deal with the complexities of manufacturing?” a former president of the Pakistan Pharma­ceutical Manufacturers Association (PPMA) asked bitterly, hinting at the fate of the sole Covid-19 vaccine importer currently entangled in court cases.

“The vaccine will have to be manufactured at a private facility, if at all. No public official has approached us. In fact, we are treated as aliens in the health ministry. Who can expect of a ministry that messes up routine simple issues to manage complex operations? It’s all talk not going anywhere beyond that,” said another senior leader unwilling to own his comment.

Dr Kaiser Waheed, a top leader of the local drug-makers, stopped saying anything beyond, “It’s still a long way.”

A former executive of a multinational privately commented: “In general, an IP waiver should be good for developing countries to meet their vaccination demand. The use of new technology will also help in their future development. The IPR restricts the use of technology which delays the advancement process.”

A source familiar with health affairs found the waiver question as tricky as the path to controlling Covid-19. He saw no clear-cut solutions. “What is clear, however, is the need to approach the subject with an open mind rather than from a firm stand based on some preconceived notion.

“The intellectual property rights will have to be compromised sooner or later for having herd immunity at the global scale without which nobody is ever going to feel really safe. Compromising the IPRs should not be opposed per se because vaccine development protocols themselves were compromised for the manufacturers.

“On the other hand, quality control mechanisms and the availability of raw material for the vaccines are issues that are just as critical as the IPRs. Old-world formulas won’t apply to a situation that is terribly novel and calls for refreshingly novel solutions,” he concluded.

Published in Dawn, The Business and Finance Weekly, May 17th, 2021

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