The woes caused by the second wave of the COVID-19 virus, which continues to drain the Indian healthcare system, are currently being amplified by the shortage of vaccines in the country. India has already begun inoculating its population with the Oxford-AstraZeneca vaccine and the domestically produced Bharat Biotech jab. Moreover, the Sputnik V vaccine, too, is scheduled to be made available starting in August. Meanwhile, Indian authorities continue to negotiate with other pharmaceutical companies, including Moderna and Johnson and Johnson, to make their vaccines available in India. Negotiations with Pfizer, however, are proving to be more tedious and complicated than with other companies, and have invited public pressure for the government to speed up the process. However, prolonged negotiations are necessary and Pfizer must be approached with scepticism by the Indian officials.
Pfizer has already begun negotiations with 100 countries and successfully entered into agreements with several, including Colombia, Ecuador, and Mexico. In India, it has been negotiating with the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), which comprises officials from the Ministry of Health and takes calls on all aspects related to the COVID-19 vaccines in India, including the roll-out, vaccine selection, procurement, and delivery. While Pfizer has said that it will be able to deliver 50 million vaccines to India by the end of the year, there is still a long way to go before its jabs will be welcomed by the Indian government.
Several Indian commentators have criticised India for prolonging its negotiations with Pfizer. While it provides a more expensive alternative to the vaccines currently available, its high efficacy rate has made it the preferred choice for several citizens, with some even travelling abroad to secure the jab. In fact, several state governments, such as Punjab and New Delhi, have even individually approached Pfizer to allow distribution until it reaches a compromise with the central government. However, Pfizer has reiterated that it will only negotiate with the federal government, thereby increasing the pressure on Indian officials to conclude discussions expeditiously.
Negotiations between Pfizer and India have hit several obstacles. In March, Reuters reported that the Indian officials and representatives of Pfizer had hit an impasse because the Indian government refused to give complete control over pricing and exports to the pharmaceutical giant. Furthermore, in December, Pfizer withdrew its application for emergency approval in India, after government officials insisted on mandatory small-scale trials as a pre-condition to its distribution in India. However, while the Oxford-AstraZeneca and Sputnik V candidates had to abide by this requirement, the Indian government announced in April that jabs approved by the United States, the European Union, the United Kingdom, and Japan, or the World Health Organisation, need not undergo Phase II or Phase III trials in India. Despite this, over a month and a half later, negotiations with Pfizer continue with no end in sight.
The recent impasse in negotiations is centred around the issue of indemnity. According to Pfizer’s negotiators, the company will only enter a country’s market if governments are willing to provide it with indemnity against any civil action following an adverse reaction to the vaccine. They believe that during a pandemic, companies are forced to develop vaccines at unprecedented speeds and that clinical trials may not catch the infrequent side effects. For instance, pharmaceutical companies had also sought such indemnity during the H1N1 outbreak, the vaccine for which resulted in narcolepsy in certain individuals. Hence, in such situations, pharmaceutical giants like Pfizer argue that they should be protected and compensated for any civil suits arising from these rare and adverse effects.
Considering the dire need of several countries to secure vaccines, Pfizer has been accused of “high-level bullying” during its negotiations with low- and middle-income countries. According to an investigation conducted by British non-profit media company The Bureau of Investigative Journalism, during its negotiations with several Latin American countries, Pfizer took advantage of this desperation, as its vaccine was the first to be made accessible to the public. In fact, Pfizer compelled governments to agree to indemnify the company against civil actions arising from adverse effects of the vaccine along with fraud, negligence, and mismanagement. In the Dominican Republic, Albania, and Peru, Pfizer has secured protection from liability at all steps of the supply chain, including packaging, manufacturing, and storage. More concerningly, it has also asked the countries to put up public assets, such as embassy buildings, military bases, and federal bank reserves, as a guarantee for any such civil suits.
Unlike these countries, India has stood its ground during these negotiations, and rightly so. Speaking to Reuters, an Indian government official said that the Indian side is unwilling to budge on the issue of indemnity. The official said that India wishes to retain the power to question Pfizer in case of adverse effects of the vaccines or if the company’s negligence in handling or delivering the jabs result in a patient’s death. While this inflexibility of the government officials is prolonging negotiations and further delaying the Pfizer jabs’ entry into the Indian market, Indian officials are justified in putting their foot down on the issue of indemnity and pushing for the pharmaceutical giant to compromise.
Unlike their Latin American counterparts, India has much more negotiating power due to the presence of multiple existing vaccines in the country. While there is an undeniable need to expedite the vaccine drive, India has one of the highest vaccine production capabilities and does not need to rely on the Pfizer candidate for its vaccine drive. In fact, India has the ability to leverage its vaccine production capability to lure Pfizer into the Indian market and ramp up the production of its vaccines. In addition, with a population of over 1.3 billion, the Indian market is also a crucial one for Pfizer. Consequently, Indian officials must remain committed to protecting the country’s long-term goals, which include securing its sovereign assets and ensuring that the pharmaceutical company does not hold them ransom in the long run.
The importance of bringing in vaccine candidates is undeniable. However, Indian officials must weigh the long-term impact of negotiations and the agreed-upon terms of the entry of the jabs into the Indian market. Not only will this help India achieve a more reasonable agreement with Pfizer, but it will also push other countries to stand up to the pharmaceutical giant’s pressure tactics. Nevertheless, the negotiators from both sides should acknowledge the time-sensitivity of the issue, specifically in light of the rampant second wave that has been causing thousands of deaths each day.
India is Right to Deny Pfizer Indemnity Against Civil Actions
In its negotiations, India must continue to push against providing indemnity to Pfizer for any civil actions arising because of adverse effects of its vaccine, fraud, or negligence, amongst others.
May 27, 2021
SOURCE: INDIAN EXPRESS