Waking Up to Post-pandemic Healthcare

The Op-Ed article “Optimising Covid-19 TRIPS waiver” by Dr. Zafar Mirza (21 May 2021)
should serve as guidance and motivation to the Pakistan government and the pharmaceutical
industry.

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 authorization 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
synthesize a protein and then disappear. The road to assessing mRNA vaccines was long since it
requires a fast-spreading infection to validate effectiveness. Now came the COVID-19, where the
testing was completed within months what would have taken years if the virus was not spreading
fast. The two mRNA vaccines approved come with an efficacy of 95%+ compared to 50%+
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 EPO (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
few countries that are not part of the Patent Cooperative Treaty (PCT) 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 PCT. This opportunity is not available to most other countries, including
India and Bangladesh.

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 70% 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 neighboring countries.

The mRNA vaccine technology, compared to the traditional vaccines, is much simpler and faster
to adapt. Moderna, after receiving the sequence of the protein from the US NIH, produced the
vaccine within three days. Pakistan has the manpower that can be trained to synthesize 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 these 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.

Biological medicines are produced in living entities like bacteria or mammalian cells in a
bioreactor rather than in a chemical reactor. A forty-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 1% 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 DARPA (Defense 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 the Pakistani healthcare stakeholders to realize that
it is time to catch up by moving into the mRNA technology 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 an 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 modernization of
the Pakistani pharmaceutical industry. However, 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 away fast.

Sarfaraz K. Niazi 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.