I wish to add my views based on my experience in developing biotechnology and patent law practice on how Pakistan can satisfy its healthcare needs. A dramatic paradigm shift that took place because of the pandemic was the first emergency-use authorisation of a new class of vaccines — mRNA. Under development for decades, the RNA and DNA vaccines take a different approach to inducing immunity. Instead of injecting an antigen (whole or part of a virus inactivated) into the body, the DNA and RNA vaccines introduce a gene (in DNA vaccines) and a protein precursor (in mRNA vaccines) to produce an antigen that is found on the surface of the virus.
The DNA vaccines work by entering the nucleus, where they transform the genes and thus present a risk; the mRNA vaccines are a small strip of amino acids that serve as a template to synthesise a protein and then disappear. The road to assessing mRNA vaccines was long since it requires a fast-spreading infection to validate effectiveness. Then came Covid-19, where testing was completed within months, something that would have taken years if the virus was not spreading fast. The two mRNA vaccines approved come with an efficacy of 95 per cent-plus compared to 50pc-plus efficacy of traditional vaccines.
The US companies Pfizer (BioNTech) and Moderna own dozens of patents on the technology used to produce and formulate Covid-19 and other mRNA vaccines. Joe Biden has stated that he will use his authority to remove the exclusivity of the US patents pertinent to these vaccines. Still, it will require the concurrence of the European Patent Office and other agencies that is not likely to come soon. However, there is a blessing in disguise here; Pakistan is one of the few countries that are not part of the Patent Cooperative Treaty and therefore not bound to any patents in the treaty — as all are. The individual patents must be registered in Pakistan to be applicable. Even if there is a patent in Pakistan, there is a clause of humanitarian use that allows the use of the invention with a royalty arrangement which is always minimal. A similar situation had risen in the past regarding AIDS treatment when India chose to go around the patents despite being a member of the PCT. This opportunity is not available to most other countries, including India and Bangladesh.
The mRNA vaccine technology, compared to traditional vaccines, is much simpler and faster to adapt.
As Dr Mirza said, “Pakistan, despite being the fifth largest internal market globally, has unfortunately not paid attention to biological production.” This is a profound statement, given that more than 70pc of all new drugs are of biological origin. Pakistan was left behind without any chemical industry to produce raw materials (they all come from India and China). Now it is losing the race in biological drugs. Some companies are filling biological products, but one has moved to adopt this fast-approaching technology that has already been a standard technology in the neighbouring countries.
The mRNA vaccine technology, compared to traditional vaccines, is much simpler and faster to adapt. Moderna, after receiving the sequence of the protein from the US National Institutes of Health, produced the vaccine within three days. Pakistan has human resource that can be trained to synthesise mRNA vaccines, not just for Covid-19 but for many other widespread infections like meningococci, influenza and HPV. The most dramatic element of mRNA vaccines is that they can prevent autoimmune disorders like diabetes, Parkinson’s disease, Alzheimer’s, and many more. There is no current treatment available. These new vaccines to prevent conditions other than infections will appear soon, but they will carry a high price tag. In Pakistan, where the burden of payment mainly falls on the patients, cost-effective biologicals must be made available soon.
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Biological medicines are produced in living entities like bacteria or mammalian cells in a bioreactor rather than in a chemical reactor. A 40-year-old technology of modifying the genes of these cells to produce biological products is now widely used; the technology is also widely applied to crops and food production. Despite a robust technology base, surprisingly, the focus on this technology has been missed in Pakistan.
One reason for this failure can be attributed to the emerging pharmaceutical industry that had a large market of traditional medicines. They were able to produce these at a lower cost to generate income that satisfied their business goals. Responsibility for failing to adopt newer technologies lies not only with the pharmaceutical industry but also with the government. As one example, there is a large pool of money collected as the 1pc tax on the pharmaceutical industry for decades that could be used to train personnel and establish biological manufacturing technology. For example, Moderna, one of the two mRNA Covid-19 vaccine suppliers, started with a grant from the Defence Advanced Research Project Agency of the US government; the best-selling monoclonal antibody adalimumab and others were developed under US government grants.
While it is already late, it is never too late for Pakistani healthcare stakeholders to realise that it is time to catch up by moving into mRNA and recombinant technology to produce antibodies and cytokines to care for its population at an affordable cost. For a population growing as fast as it is in Pakistan and in the absence of any structured social support for healthcare, the cost of future medicines will leave most of the population suffering. The solution lies in promoting private-government partnerships and policies that will encourage the modernisation of the Pakistani pharmaceutical industry. However, instead of taking traditional approaches that often get bogged down in bureaucracy, it is time for innovative planning, creative approaches, and a belief that the future is fleeing fast.
The writer is an adjunct professor of pharmaceutical sciences at the University of Illinois, Chicago, HEJ Research Institute, and Comsats in Pakistan, and a licensed US patent law practitioner.
